Kidwell v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 17-651V

Filed: August 19, 2021

PUBLISHED

Special Master Horner

GINA KIDWELL,

Petitioner, Vasovagal Syncope; Table

v. Injury; Presyncope; Causation-

in-fact; Influenza Vaccine

SECRETARY OF HEALTH AND

HUMAN SERVICES,

Respondent.

Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner.

Sarah Christina Duncan, U.S. Department of Justice, Washington, DC, for respondent.

DECISION 1

On May 18, 2017, petitioner, Gina Kidwell, filed a petition under the National

Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012)2, alleging that she

suffered an episode of syncope following her receipt of an influenza (“flu”) vaccination

on October 13, 2015. Petitioner was driving at the time of the alleged syncope and was

involved in a motor vehicle accident, resulting, she further alleges, in injuries that

persisted for more than six months. 3 Accordingly, petitioner alleges that her syncope,

subsequent accident, and resulting injuries, were all caused by the flu vaccine.

1 Because this decision contains a reasoned explanation for the special master’s action in this case, it will

be posted on the United States Court of Federal Claims’ website in accordance with the E-Government

Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic

Government Services). This means the decision will be available to anyone with access to the

Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact

medical or other information the disclosure of which would constitute an unwarranted invasion of privacy.

If the special master, upon review, agrees that the identified material fits within this definition, it will be

redacted from public access.

2Throughout this decision, references to “§300aa” will refer to the relevant sections of the National

Childhood Vaccine Injury Act.

3 Petitioner is never more specific in her pleadings than to characterize her persistent symptoms as

headache and unsteadiness in her walk. (ECF No. 1, p. 2; ECF. No. 46, p. 2.) However, her medical

records reference her post-accident condition as post-concussion syndrome. (E.g. Ex. 5, pp. 21-22.) For

ease of reference, this decision refers in some instances to petitioner’s post-accident injuries as a post-

concussion syndrome; however, as discussed below, the question of whether petitioner’s post-accident

condition represented a post-concussion syndrome is not reached.

1

Additionally, following a motion for reconsideration, petitioner was provided an

opportunity to address whether she may have instead suffered a presyncope caused-in-

fact by her vaccination. For the reasons set forth below, I conclude that petitioner is not

entitled to compensation.

I. Applicable Statutory Scheme

Under the National Vaccine Injury Compensation Program, compensation

awards are made to individuals who have suffered injuries after receiving vaccines. In

general, to gain an award, a petitioner must make a number of factual demonstrations,

including showing that an individual received a vaccination covered by the statute;

received it in the United States; suffered a serious, long-standing injury; and has

received no previous award or settlement on account of the injury. Finally – and the key

question in most cases under the Program – the petitioner must also establish a causal

link between the vaccination and the injury. In some cases, the petitioner may simply

demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be

shown that the vaccine recipient suffered an injury of the type enumerated in the

“Vaccine Injury Table,” corresponding to the vaccination in question, within an

applicable time period following the vaccination also specified in the Table. If so, the

Table Injury is presumed to have been caused by the vaccination, and the petitioner is

automatically entitled to compensation, unless it is affirmatively shown that the injury

was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A); § 300aa-

11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).

As relevant here, the Vaccine Injury Table lists “vasovagal syncope” as a

compensable injury if it occurs within one hour of administration of an influenza vaccine.

§ 300aa-14(a) as amended by 42 CFR § 100.3. Table Injury cases are guided by a

statutory “Qualifications and aids in interpretation” (“QAI”), which provides more detailed

explanation of what should be considered when determining whether a petitioner has

actually suffered an injury listed on the Vaccine Injury Table. § 300aa-14(a). To be

considered a Table “syncope” petitioner must show that her injury fits within the

following definition:

Vasovagal syncope (also sometimes called neurocardiogenic syncope)

means loss of consciousness (fainting) and postural tone caused by a

transient decrease in blood flow to the brain occurring after the

administration of an injected vaccine. Vasovagal syncope is usually a

benign condition but may result in falling and injury with significant sequela.

Vasovagal syncope may be preceded by symptoms such as nausea,

lightheadedness, diaphoresis, and/or pallor. Vasovagal syncope may be

associated with transient seizure-like activity, but recovery of orientation

and consciousness generally occurs simultaneously with vasovagal

syncope. Loss of consciousness resulting from the following conditions will

not be considered vasovagal syncope: organic heart disease, cardiac

arrhythmias, transient ischemic attacks, hyperventilation, metabolic

conditions, neurological conditions, and seizures. Episodes of recurrent

2

syncope occurring after the applicable time period are not considered to be

sequela of an episode of syncope meeting the Table requirements.

42 CFR § 100.3(c)(13).

Petitioner did not initially indicate in her petition whether she was pursuing her

claim as a Table Injury. (ECF No. 1.) However, she later filed an amended petition

asserting a Table Injury of vasovagal syncope. (ECF No. 46.)

Alternatively, if no injury falling within the Table can be shown, the petitioner

could still demonstrate entitlement to an award by instead showing that the vaccine

recipient’s injury or death was caused-in-fact by the vaccination in question. § 300aa-

13(a)(1)(A); § 300aa-11(c)(1)(C)(ii). To successfully demonstrate causation-in-fact,

petitioner bears a burden to show: (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 v. Sec’y of Health & Human Servs.,

418 F.3d 1274, 1278 (Fed. Cir. 2005). Following a motion for reconsideration, petitioner

has also contended in the alternative that she suffered presyncope that was caused-in-

fact by her vaccination. (ECF No. 82; Exs. 32-33.) Because this is not a Table Injury,

there is no causal presumption available for this alternative claim.

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 v. Sec’y of Health &

Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010); 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 her assertions; rather, the petition must be supported by either medical records or by

the opinion of a competent physician. § 300aa-13(a)(1).

II. Procedural History

As noted above, petitioner initiated this case on May 18, 2017, alleging that she

suffered a syncopal episode that resulted in an auto accident and further injuries. (ECF

No. 1.) She filed supporting medical records marked as Exhibits 1-11 on May 24, 2017.

(ECF Nos. 7-8.) After an initial review, respondent requested further records and

Exhibits 12-19 were subsequently filed over the course of several months. (ECF Nos.

16, 19, 22, 28.)

3

Respondent filed his Rule 4 report on October 15, 2018, recommending

compensation be denied and the petition dismissed. (ECF No. 32.) Respondent noted

the lack of a Table Injury allegation, but also disputed that petitioner suffered a syncopal

episode and further contended that the timing of the event was unclear. (Id.) Petitioner

subsequently filed a vehicle accident report (Ex. 20), an affidavit by petitioner (Ex. 21),

and neuropsych records (Ex. 22). (ECF Nos. 35, 40, 43.) Petitioner filed an amended

petition on April 8, 2019, specifically adding the allegation that she experienced a Table

Injury of vasovagal syncope. (ECF No. 46.) On June 25, 2019, petitioner filed an

expert report by neurologist Marcel Kinsbourne, M.D. (ECF No. 50; Ex. 23.)

On August 29, 2019, this case was reassigned to my docket. (ECF No. 53.)

Respondent filed a responsive expert report by neurologist Peter Donofrio, M.D., on

November 1, 2019. (ECF No. 55; Ex. A.) A video fact hearing was subsequently held

on January 30, 2020. (ECF No. 62.) Petitioner was the only witness. (Id.) During the

hearing, additional evidence was identified. Petitioner then filed her insurance claim

relative to her auto accident (Ex. 25), an affidavit by her daughter regarding a separate

falling incident discussed during the hearing (Ex. 26), updated primary care records by

Dr. Connie Mercer (Ex. 27), and an affidavit by an eye witness to the auto accident (Ex.

28). (ECF Nos. 69, 73.)

Thereafter, I advised the parties that pursuant to Vaccine Rule 8(d) I intended to

resolve this case on the basis of written submissions and set a briefing schedule

requiring simultaneous briefs. (ECF No. 74.) Neither party objected; however, in a joint

motion to amend the schedule, the parties advised of additional outstanding medical

records and requested that their briefs be due after the filing of the outstanding records.

(ECF No. 75.) Petitioner subsequently filed additional medical records marked as

Exhibits 29-31. (ECF No. 76.)

On December 21, 2020, the parties filed simultaneous briefs in support of their

respective positions. (ECF No. 77-78.) Petitioner filed a brief responding to

respondent’s brief on January 21, 2021. (ECF No. 79.) In her briefing, petitioner raised

for the first time the suggestion that she could prevail in her claim even in the absence

of evidence that she suffered a loss of consciousness. (ECF No. 78, p. 4.)

I initially issued a decision dismissing this case on March 16, 2021. (ECF No.

80.) I explained that petitioner did not suffer a Table Injury of syncope because there

was not preponderant evidence that she lost consciousness. In further explaining why

petitioner’s expert, Dr. Kinsbourne, had not alternatively established causation-in-fact

for a syncope occurring in the absence of a loss of consciousness, I noted, inter alia,

that any suggestion that petitioner suffered vaccine-related presyncope had not been

substantiated. Petitioner moved for reconsideration, seeking an opportunity to have Dr.

Kinsbourne directly address presyncope, and filed a supplemental report by Dr.

Kinsbourne. (ECF No. 82-83; Ex. 32.)

4

I subsequently withdrew the dismissal decision so that petitioner’s argument

could be considered and ordered respondent to file a response to petitioner’s motion

and a responsive report by Dr. Donofrio. (ECF No. 84.) Dr. Donofrio’s supplemental

report and supporting literature was filed on May 26, 2021, as respondent’s Exhibit C.

(ECF No. 86.) On June 21, 2021, I issued an order granting petitioner’s motion for

reconsideration so that petitioner’s supplemental submission regarding presyncope

could be considered and noted that a superseding decision would issue pursuant to

Vaccine Rule 10(e)(3)(A)(ii). I explained that “reconsideration is granted on the basis of

concluding the record was not sufficiently complete as of issuance of the March 16,

2021 dismissal decision. This order should not be construed as indicating whether the

superseding decision will reach a different result.” 4 (ECF No. 88, p. 2.) I also provided

petitioner an opportunity to file a report by Dr. Kinsbourne responding to Dr. Donofrio’s

May 26, 2021 report. (Id.) Petitioner filed that report on August 6, 2021. (ECF No. 90;

Ex. 33.)

This case is now ripe for a superseding decision resolving this case on the

written record. In the discussion that follows (Section VI), sections A, B, and C remain

substantially the same as they appeared in the initial, now withdrawn, decision

dismissing this case. Section D, which addresses petitioner’s cause-in-fact claim, has

been replaced to reflect additional analysis prompted by the further evidence presented

by the parties relating to presyncope. Additions were also made to Section E, which

addresses proximate causation, based on further contentions included in the

supplemental expert reports.

III. Factual History

A. Petitioner’s prior medical history

Petitioner has a history of depression and hyperlipidemia. (Ex. 4, p. 1.)

Petitioner was also previously evaluated for syncope. On June 12, 2012, petitioner

visited the emergency room with multiple medical complaints including anxiety and

syncope. (Ex. 15, p. 45.) Petitioner reported experiencing aura and then flashing lights.

(Id.) On June 20, 2012, petitioner saw Dr. Ganesh Chari for further evaluation of her

syncopal episode, where she reported that she saw flashing lights followed by nausea.

(Ex. 12, p. 108.) Additionally, petitioner had a follow up appointment on July 18, 2012

for syncope. (Id. at 106.) According to petitioner there were no further syncopal

episodes.

On May 20, 2013, petitioner visited Tampa Bay Optometric Group because she

had issues with seeing “squares” followed by nausea and headache. (Ex. 12, p. 92.)

4

Special masters “must determine that the record is comprehensive and fully developed before ruling on

the record.” Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020)

(citing Simanski v. Sec’y of Health & Human Servs., 671 F.3d 1368, 1385 (Fed. Cir. 2012); Jay v. Sec’y of

Health & Human Servs., 998 F.2d 979, 983 (Fed. Cir. 1993.)); see also Vaccine Rule 8(d); Vaccine Rule

3(b)(2). The parties must have a full and fair opportunity to present their case and develop a record

sufficient for review. Id.

5

Petitioner left a message for her primary care physician (“PCP”), Dr. Daniel Terrone that

she experienced an episode where she saw squares in front of her eyes, lost her

balance, and became nauseous. (Ex. 15, p. 93.) A couple of months thereafter in

September, petitioner reported feeling dizzy and nauseated. She felt she was having

problems with her inner ear, and requested seeing a specialist. (Id. at 99.)

Petitioner then established care with a new PCP, Dr. David Herndon, on January

6, 2015 and reported her inner ear problems. (Ex. 4, p. 1.) Petitioner reported that she

felt slightly dizzy with some nasal drip. (Id.) On January 20, 2015, petitioner returned to

see Dr. Herndon for pain management. (Id. at 10.) She reported nausea and ringing in

her ear. Petitioner wanted to see an ENT specialist. (Id.) Dr. Herndon diagnosed

petitioner with subjective tinnitus and referred her to a specialist for evaluation. (Id. at

12.)

On January 26, 2015, petitioner saw Dr. Michael Sakellarides with complaints of

allergy to smoke, recent ringing in both ears, postnasal drip, and being lightheaded due

to smoke. (Ex. 8, p. 3.) Petitioner was diagnosed with benign paroxysmal vertigo and

referred for vestibular studies for dizziness and audiogram for ringing in ears. (Id. at 5.)

On October 13, 2015, petitioner saw Dr. Steven Willis regarding her back pain.

(Ex. 4, p. 61.) And additionally, on the same day, petitioner visited Dr. Herndon for

follow up. (Id. at 64.) Her vital signs were recorded at Dr. Herndon’s office at about

3:43pm. (Id. at 65.) During this visit, petitioner was given the flu vaccine at issue in this

case in her right deltoid. (Id. at 68.) The exact time of vaccination was not

documented. She was 80 years old at the time.

B. October 13, 2015 auto accident

After departing Dr. Herndon’s office, petitioner was involved in an auto accident.

(Ex. 20.) According to the official Florida Traffic Crash Report, at approximately 4:30pm

petitioner lost control of her vehicle, entered a parking lot to the right and collided with a

parked car. (Id. at 2-3.) During the hearing, petitioner described the accident as

follows: “I put my foot on the gas pedal. And then I’m going and all of a sudden, oh, my

god, I thought my brakes aren’t working. I kept – I thought it was the brakes. I kept my

foot all the way down for the gas pedal. And I kept going, I said, I’m going to – there’s

trees all around me on both sides. I’m going to get killed. I know I’m going to die. After

that I remember nothing else. Nothing.” (Tr. 10-11.) Petitioner indicated the next thing

she remembered was the airbag deploying. (Tr. 11-12.) She indicated that she fell to

the ground when she initially exited the vehicle. (Tr. 12.) Petitioner repeated

substantially the same description multiple times during the hearing. (Tr. 20, 45-46, 52-

54.)

Following the accident, the most contemporaneous third-party observation of

petitioner’s state comes from the affidavit testimony of fact witness Timothy Skarka.

(Ex. 28.) He was the individual who first helped petitioner out of the car following her

accident. In relevant part he explained that “[a]fter she hit the car her foot was still on

the gas. I ran over and opened the door and took her foot off the gas and turned the key

6

off. She did not get out of the car for a few minutes. She seemed confused. I suggested

calling an ambulance because I thought she might have suffered a concussion. She

said she was alright and did not want an ambulance.” (Id. at 1.) Mr. Skarka did not

indicate that he observed petitioner in a state of unconsciousness 5 and did not

corroborate petitioner’s recollection of falling over when she exited the vehicle.

(Compare Ex. 28 and Tr. 11-12, 14.)

Pasco County Fire Rescue arrived at the scene by 4:39pm. (Ex. 14, p. 1.) Upon

examination, they confirmed petitioner to be alert and oriented (x4) and recorded normal

vital signs. (Id. at 3-4.) Petitioner reported that she had not experienced any loss of

consciousness, voiced no medical complaints, and declined to go to the hospital. (Id. at

4.) The Florida Highway Patrol subsequently arrived on scene at 5:35pm. (Ex. 20, p.

1.) The officer indicated that petitioner was not distracted at the time of the accident,

did not have obscured vision, and was “apparently normal” at the time of the accident.

(Id. at 2.) He cited petitioner for careless driving. (Id.) Petitioner testified that following

the accident she “felt fine” and “just wanted to go home.” (Tr. 16.) It wasn’t until she

went home that she “fell on the bed [and] that was it,” causing her to conclude the next

day that she should go to the hospital. (Tr. 17.) Petitioner could not recall her

interaction with Fire Rescue (Tr. 15-16); however, on cross-examination she

acknowledged that she would have been truthful in speaking with them (Tr. 51-52).

C. Post-accident hospital visit

When she first reported for triage at the emergency department the next day,

petitioner reported that she “felt disoriented while driving” and “snapped out of it when

[the] airbag deployed.” (Ex. 13, p. 22.) A handwritten intake form further records that

she had a “’black’ out before accident.” (Id. at 23.) A further history indicates that she

“got disoriented and doesn’t remember speeding across 2 lanes and hitting a car on the

other side” and further that she “couldn’t see.” (Id. at 14.) The initial clinical impression

at the emergency department was syncope and closed head injury. (Id. at 21.)

Petitioner was admitted for disorientation and possible syncope. (Id. at 33.) Petitioner

was first evaluated by Dr. Mukeshumar Patel, who assessed her with sudden loss of

vision with disorientation of unknown etiology. (Id. at 34.)

When petitioner reported for a neurology consultation with Dr. Rakesh P. Shah,

she reported that she “was just driving back to her home, was in the car, knew that she

was making a left turn, was just waiting for the traffic to just pass by, and then she

suddenly lost her control, could not focus, could not see, and everything kind of foggy,

slightly blacked out, and without any loss of consciousness. The patient just woke up

after she hit another car in the apartment and the patient was kind of surprised herself,

was giving all the answers appropriately to the state trooper . . .” 6 (Ex. 13, p. 36

5 This is only to note that Mr. Skarka did not confirm any loss of consciousness. To the extent petitioner

contends that she “woke up” when the airbag deployed (Tr. 11-12), the two accounts are not inherently in

conflict.

6 One could question the apparent inconsistency within this record – indicating no loss of consciousness

immediately followed by reference to having “woke up.” (Ex. 13, p. 36.) However, this is consistent with

7

(emphasis added).) Dr. Shah felt petitioner’s description of not being able to see was

“questionable” and concluded there were “no signs of syncopal episode.” (Id. at 37.)

Importantly, although the emergency department histories also state that

“[patient] states hit head on roof of car” and that she suffered a “head injury” (Id. at 22-

23), petitioner subsequently acknowledged in testimony that she did not ever remember

hitting her head and that she was told by others, most notably her husband, as an after-

the-fact rationalization that she must have hit her head. (Tr. 17, 47-48, 61.) This was

the reason she ultimately sought care. (Tr. 17.) Additionally, Dr. Shah noted that

petitioner answered the state troopers questions “appropriately,” but petitioner also

testified that she was “dazed” and in “shock” as a result of the accident and, as noted

above, Mr. Skarka likewise observed petitioner to seem confused in the moments after

the accident. (Tr. 16, 65; Ex. 28, p. 1.) Petitioner further testified that Dr. Shah

observed her to be “not acting right,” contributing to the impression that she suffered a

concussion. (Tr. 18-19.) Asked to review and confirm the history recorded by Dr. Shah,

petitioner testified “I’m not sure,” but also indicated “I might have said something.” (Tr.

20.) Accordingly, it is very difficult to discern from the most contemporaneous medical

records what statements reflect reliable, independent recollections of what petitioner

experienced during her auto accident.

During the course of her one-day hospitalization, petitioner had various tests

conducted, including a chest x-ray, EEG, ultrasound, which all had presented normal

results. (Ex. 5, pp. 1-4.) Additionally, petitioner’s neck, head, brain, and spine CT

scans did not show any remarkable findings. (Id. at 7.) Petitioner was discharged from

Medical Center of Trinity on October 15, 2015. (Ex. 13, p. 38.) Petitioner’s discharge

diagnosis was “sudden loss of vision with disorientation, unknown etiology, resolved.”

(Ex. 5, p. 7.)

D. Subsequent medical history

Petitioner was not seen by any doctor again until December 10, 2015, when she

saw neurologist Indira Umamaheswaren, M.D. (Ex. 5, p. 21.) Petitioner’s description of

her alleged syncopal episode continued to evolve. Whereas she previously denied

losing consciousness and described being “slightly blacked out,” she described to Dr.

Umamahesawaren experiencing everything becoming “white.” (Id.) She was assessed

with post-concussion syndrome and an episode of loss of awareness of unclear

etiology, with a differential diagnosis being syncope versus seizures versus cardiac

etiology. (Id. at 22.)

the description elicited in the emergency department wherein petitioner described only disorientation

followed by “snap[ping] out of it.” (Ex. 13, p. 22.) During the hearing, petitioner similarly indicated that the

airbag “woke me up” in the context of indicating that this was the “next thing I can remember” in the

aftermath of having lost control of the vehicle. (Tr. 11-12.) It is also noteworthy that the record includes

the characterization of petitioner as “slightly blacked out,” further evidencing that Dr. Shah is attempting to

capture a history being provided by petitioner that indicates something less than a complete blackout.

(Ex. 13, p. 22.)

8

On January 14, 2016, petitioner returned to see Dr. Umamaheswaren for follow

up regarding her post-concussion syndrome. (Ex. 5, p. 26.) Petitioner still had mild

headaches and feelings of being off balance while walking. Petitioner was not feeling

herself and had difficulty focusing. (Id. at 27.) Dr. Umamaheswaren advised that

petitioner’s symptoms could take months to resolve. (Id. at 28.) Petitioner returned for

a follow up on June 30, 2016, complaining of similar symptoms as well as lack of

energy. (Id. at 30.)

Petitioner first saw Dr. Tedodulo Mationg on March 10, 2016 with complaints of

nausea, headache, sleep problems, and frequent urinary tract infections. (Ex. 11, p.

29.) Dr. Mationg advised petitioner to have a colonoscopy and encouraged her to follow

up with her psychiatrist. (Id. at 31.) Dr. Mationg further assessed petitioner with

generalized anxiety disorder. (Id. at 30-32.)

On August 22, 2016, through referral from Dr. Mationg, petitioner saw Dr.

Krishna Ganti for left ear problems. (Ex. 9, p. 12.) Petitioner reported that she had a

head injury over a year ago, but that there was no loss of consciousness (“no LOC”).

She presented with several months of fullness, pain, and pressure feeling over her left

ear. (Id.) Dr. Ganti suspected Meniere’s disease or inflammatory labyrinthitis. (Id. at

13.)

Petitioner saw Dr. Ganti again on September 6, 2016 regarding her hearing loss.

(Ex. 11, pp. 86-87.) Petitioner again reported that she had a car accident last year,

where she was flustered and appeared confused, and although she could not provide

more details, petitioner recalled having a concussion. (Id. at 86.) Although exam

findings and test results suggested Meniere’s disease or inflammatory labyrinthitis, at

this visit, petitioner was diagnosed with sensorineural hearing loss and subjective

tinnitus. (Id. at 87.)

Petitioner called Dr. John Pirrello’s office on June 28, 2017, stating that she lost

her eyesight and fell. (Ex. 15, p. 157.) Petitioner stated that she was not dizzy at the

time of the fall and did not know how she fell but that she could not see. (Id.) Petitioner

was subsequently seen by Theresa R. Haffner, ARNP, for her fall on June 30, 2017.

(Id. at 159.) NP Haffner recorded that petitioner lost her footing and fell forward at a

department store, and further that petitioner denied any head trauma and loss of

consciousness. (Id.) Petitioner wanted to discuss her worsening anxiety. (Id.)

Although fall precautions were discussed and there was a fall risk screening, no

advanced care planning was needed. (Id. at 160-161.) Additionally, on July 20, 2017,

petitioner called her PCP’s office again to add that when she fell, her vision went black

and after a moment she regained sight as if “someone turned the lights back on.” (Id. at

170.) Petitioner also indicated that she had a panic attack earlier on the day of the fall

that may have set off her temporary blindness. 7 (Ex. 15, p. 170.) Petitioner saw Dr.

Pirrello on July 20, 2017 regarding abdominal pain, unrelated to her fall. (Id. at 171.)

7 Petitioner’s daughter, who was with her at the time of the fall, submitted an affidavit in which she averred

that petitioner fell, but did not pass out. (Ex. 26.) The affidavit did not address whether petitioner

separately experienced any loss of vision as reflected in her reports to physicians.

9

On October 22, 2019, petitioner reported to Dr. Shah that she was in a lot of

stress, had mental confusion, and some issues with short-term memory loss. (Ex. 31,

p. 6.) Dr. Shah ordered a brain MRI to look for any signs of memory loss or dementia.

Petitioner saw Dr. Shah again on December 2, 2019 to discuss her brain MRI results.

(Id. at 1.) Her MRI showed chronic periventricular white matter changes without acute

ischemic stroke. (Id.) Compared with petitioner’s August 28, 2016 MRI, there were

extensive bilateral white matter T2 and FLAIR sequence hyperintensities and bilateral

inflammation of her mastoids. (Id. at 3.) Petitioner was diagnosed with dementia, most

likely vascular dementia. (Id. at 1.)

IV. Expert Opinions

A. Petitioner’s expert, Marcel Kinsbourne, M.D., initial report

Dr. Kinsbourne explained that syncope results when there is a drop in blood

pressure and diminution of perfusion of the brain. (Ex. 23, p. 2.) He indicated that

“[a]mong the causes is emotional distress, associated with blood drawing or needle

puncture in [the] course of vaccination. An emotional reaction to the needle, the pinprick

or the association with blood can cause an exaggerated response of the vagus nerve,

reducing the blood pressure.” (Id.)

With regard to petitioner’s own presentation, he opined “Ms. Kidwell had an

unmistakable syncopal episode. Prominent among symptoms of syncope are feeling

funny (probably dizzy), being confused and having blurry and tunnel vision. She lost

control of her car. Her [primary care physician] had omitted the recommended 15

minutes of staying seated in the office after her vaccination.” (Id. at 1.) Dr. Kinsbourne

indicated that petitioner’s medical records do not reflect any cardiovascular cause for

her syncope nor any other syncopal episodes. (Id.) Dr. Kinsbourne did not address

petitioner’s post-concussion syndrome.

B. Respondent’s expert, Peter Donofrio, M.D., initial report

Dr. Donofrio similarly described the mechanism of syncope as relating to

insufficient blood flow to the brain, but stressed that it represents a form of transient loss

of consciousness. (Ex. A, p. 5.) He identified vasovagal syncope in particular as being

reflex-mediated in response to prolonged standing or emotional distress. (Id.) Dr.

Donofrio explained that syncope has numerous causes in addition to the type of

emotional distress highlighted by Dr. Kinsbourne, including orthostatic hypotension from

dehydration or bleeding, adverse reactions to medication, dysautonomia, and can be

secondary to a number of cardiovascular conditions. (Id.)

Dr. Donofrio disagreed that petitioner’s October 13, 2015 “spell” constituted a

syncopal event. (Id.) In reaching this conclusion he relied in particular on the fact that

petitioner initially denied losing consciousness and also that her description of the event

has been inconsistent. (Id. at 5-6.) Dr. Donofrio also suggested that other causes for

petitioner’s spell are evidenced in her medical records. (Id.) Additional spells occurring

10

on June 20, 2012, May 20, 2013, and July 20, 2017, as well as reports of “squares” in

her vision, flashing lights, and nausea, are consistent with migraines. (Id. at 6.)

Petitioner was also later diagnosed with Meniere’s Disease in October of 2016. (Ex. A,

p. 6.) Additionally, petitioner previously demonstrated bradycardia on August 23, 2015

and June 11, 2012. (Id.) Dr. Donofrio opined that the October 13, 2015 spell is

consistent with bradycardia leading to loss of blood pressure and perfusion of blood to

the brain. (Id.) Dr. Donofrio did not address petitioner’s post-concussion syndrome.

C. Dr. Kinsbourne’s supplemental report accompanying petitioner’s

motion for reconsideration

In his supplemental report, Dr. Kinsbourne confirmed that his description of Ms.

Kidwell as experiencing symptoms of “feeling funny (probably dizzy), confused, and

losing her vision” antecedent to her car accident did constitute a description of

presyncope rather than syncope. (Ex. 32, p. 1.) He explained syncope as the end result

of having fainted (or lost consciousness) whereas presyncope constitutes the preceding

process of fainting. (Id. at 2.) Dr. Kinsbourne characterized petitioner’s symptoms, i.e.,

presyncope, as “inherent to the process of fainting,” but acknowledged that it is unclear

whether Ms. Kidwell ultimately reached the endpoint of lost consciousness. (Id. at 2.)

However, Dr. Kinsbourne suggested that the question of whether petitioner lost

consciousness “does not affect the interpretation of the episode of record since the

crash that ensued became unavoidable when she lost control of the vehicle. She lost

control when she became confused, she lost her vision and she depressed the

accelerator pedal rather than the brake pedal and maintained pressured on the

accelerator until she crashed.” (Id.) Dr. Kinsbourne suggested that the fact that

petitioner experienced her loss of control in the context of presyncope (which he

characterizes as “not usually so sudden”) explains why she was able to subsequently

describe the process. (Id.) He indicated that “[p]resyncopal symptoms alert people that

they are about to lose consciousness. They lie down in order not to lose consciousness.

At the wheel of a moving car that is not an option, however.” (Id. at 3.)

Dr. Kinsbourne acknowledged that Ms. Kidwell’s age and medical history may

have left her at greater susceptibility to fainting. (Id.) Additionally, whereas he indicated

in his first report that petitioner had experienced no other episodes of syncope (Ex. 23,

p. 1), he conceded in his supplemental report that there were two other episodes of

syncope (Ex. 32, p. 3.) Nonetheless, he contended that “her episode of record was

caused by her reaction to having been vaccinated and not by any other event.” (Ex. 32,

p. 3.)

With respect to Dr. Donofrio’s report, Dr. Kinsbourne agreed that Ms. Kidwell’s

spells on June 29, 2012, May 20, 2013, and July 20, 2017, which included vision

changes, were consistent with migraine, but indicated that Ms. Kidwell did not complain

of headache prior to her accident and none of her treating physicians diagnosed the

episode as relating to a migraine. (Ex. 32, at 4.) Conversely, Dr. Kinsbourne noted that

petitioner’s Meniere’s disease could not explain her vision changes or disorientation at

11

the time of the accident. (Id.) Dr. Kinsbourne contended that there is no evidence to

support bradycardia at the time of the accident or any evidence of basilar artery

narrowing. (Id.)

D. Dr. Donofrio’s supplemental report accompanying respondent’s

response to petitioner’s motion for reconsideration

In his supplemental report, Dr. Donofrio stressed that Dr. Shah’s initial post-

accident differential diagnosis included suspicion of posterior segment transient

ischemic attack (“TIA”). (Ex. C, p. 1 (citing Ex. 25, pp. 228-29.) Dr. Donofrio explained

that TIA can likewise cause loss of vision, feeling funny, and confusion, and can do so

with preserved consciousness. (Id. at 2.) TIA commonly lasts for only 10-20 minutes

and leaves no neurologic deficit, meaning that a negative evaluation does not rule it out

as a cause of petitioner’s episode. (Id.) Dr. Donofrio stressed petitioner’s advanced age

and the fact that she had a narrowed basilar artery as contributing to the likelihood she

experienced a TIA. (Id.) Whereas Dr. Kinsbourne had denied any evidence petitioner

has a narrow basilar artery, Dr. Donfrio refuted that suggestion by citing petitioner’s

October 14, 2015 CT angiogram that demonstrated “diffusely diminished caliber” of the

basilar artery. (Id. (citing Ex. 25, pp. 176, 280).)

Dr. Donofrio agreed that presyncope may be described as a prodrome of

syncope, with symptoms including lightheadedness, general weakness, warmth,

sweating, nausea, palpitations, or blurry vision, without a loss of consciousness. (Id. at

3.) It can last for seconds to minutes. (Id.) However, Dr. Donofrio indicated that it is

error for Dr. Kinsbourne to imply that presyncope is the same as syncope or always

leads to syncope. (Id. at 4.) Dr. Donofrio further stressed that the symptoms described

by Dr. Kinsbourne of feeling funny, confused, and losing vision, are non-specific and

that Dr. Kinsbourne was adding his own inference by interpreting “feeling funny” as

dizziness. (Id.)

Dr. Donofrio charged Dr. Kinsbourne with speculation regarding the cause of

petitioner’s accident. He explained that vasovagal syncope physiologically represents a

stressful event followed by a slow heart rate (bradycardia) and a drop in blood pressure.

(Id. (citing Ex. A1 (Kidd)).) He explained that “other disorders could explain the

petitioner’s symptoms prior to her MVA, including panic attacks, migraine phenomena,

seizures, Meniere’s Disease, sinus bradycardia, and a TIA of the posterior circulation.”

(Id.)

E. Dr. Kinsbourne’s final supplemental report

In his final report, Dr. Kinsbourne countered that “Dr. Donofrio maintained that

what happened was any of a set of multiple different hypothetical medical events, all

having in common that they are unconnected with vaccination but allegedly coincidental

with the post vaccination hour. He implied any one of these hypothetical other events

should be considered preponderant to the diagnosis of a syncopal process.” (Ex. 33, p.

1.) Dr. Kinsbourne ultimately agreed that petitioner’s narrowed basilar artery “might

account for the prominence of visual changes” during petitioner’s episode given that it

12

would point to already reduced blood flow. However, he maintained that this is better

explained as a further consequence of a syncope-related drop in blood pressure and

not as a stand-alone TIA. (Id. at 2.) Dr. Kinsbourne contended that “[v]asovagal

presyncope/syncope is a well-recognized cause of traffic accidents, as the medical

literature attests. The multiple possible causations that Dr. Donofrio suggested as

alternatives are in contrast hypothetical, poorly documented and not seriously

considered or follow up by treating physicians.” 8 (Id. at 3.)

V. Party Positions

A. Petitioner’s contentions

Petitioner contends that the record evidence is clear in demonstrating that

petitioner experienced an auto accident within one hour of her influenza vaccination and

that a causal presumption is therefore warranted under the Vaccine Injury Table. (ECF

No. 78, p. 1.) Petitioner asserts that, consistent with syncope, she became confused

and disoriented, which caused her to initially confuse the gas and brake pedals, and

later passed out as her vehicle crossed traffic and ultimately collided with a parked

vehicle. (Id. at 2.)

Petitioner contends that the subsequent medical records discussing petitioner’s

state at the time of the accident are “imprecise” and ultimately incorrect as far as any

reference to there having been no loss of consciousness. (Id. at 3.) Petitioner further

notes that the medical records contain no neurologic explanation for syncope. (Id.)

Initially, petitioner also suggests that “[e]ven if the Special Master finds petitioner did not

fully lose consciousness, Petitioner was clearly confused. Dr. Kinsbourne supports the

event as a syncopal episode even without a total loss of consciousness.” 9 (Id. at 4

(citing Ex. 23).) In moving for reconsideration and submitting supplemental expert

reports, petitioner also effectively asserted an alternative claim that the same ultimate

injuries occurred even in the absence of any loss of consciousness as a result of a

vaccine-caused presyncope. (ECF No. 82; Exs. 32-33.)

Petitioner acknowledges that her testimony was affected by a failing memory, but

contends that “even with that disability, the facts that are relevant to this case came

through, again and again.” (ECF No. 78, p. 5.) Petitioner also asserts that her “version

of events is the only one that makes sense. A person who is conscious takes their foot

8 In his final reported Dr. Kinsbourne cited as references “Mayo Clinic, Vasovagal Syncope” and

“Whitledge JD, Ali N, Basit H, and Grossman SA (2021) NCBI Bookshelf, NIH.” (Ex. 33, p. 4.) Petitioner

did not file these materials; however, they are available online and I have reviewed them. See

https://www.mayoclinic.org/diseases-conditions/vasovagal-syncope/symptoms-causes/syc-20350527, last

accessed August 11, 2021, and https://pubmed.ncbi.nlm.nih.gov/29083783/, last accessed August 11,

2021. The latter was also filed by respondent accompanying Dr. Donofrio’s supplemental report as

Exhibit C, Tab 1.

9 For the reasons discussed above, this would be inconsistent with a Table Injury regardless of Dr.

Kinsbourne’s endorsement. According to the QAI, vasovagal syncope “means loss of consciousness

(fainting) and postural tone.” 42 CFR §100.3(c)(13). I will separately address whether Dr. Kinsbourne’s

opinion could support an alternative cause-in-fact claim.

13

off the gas. They do not drive into a parking lot at 50 miles per hour and run into parked

cars. Syncope is the only explanation for what we know happened.” (Id. at 5.)

In response to respondent’s contentions, petitioner further stressed that there is

evidence in the contemporaneous medical records both that petitioner lost

consciousness and that she suffered syncope. (ECF No. 79, p. 2.) Petitioner also

stressed that she had no signs of dementia at the time of the accident, further

explaining “[a]nyone might miss the brake pedal and accidentally hit the gas. However,

everyone would take their foot off the pedal when they started accelerating instead of

slowing down. The exception would be if someone had lost the ability to control their

motor functions because they were suffering a syncopal event.” (Id. at 3.)

B. Respondent’s contentions

Regarding the Table claim alleged by petitioner, respondent first stressed that

petitioner has not established the time of her vaccination, leaving it impossible for her to

demonstrate that her alleged syncopal event occurred within one hour of vaccination.

(ECF No. 77-1, p. 19.) He additionally contended that petitioner’s medical records do

not substantiate a syncope diagnosis, stressing the evidence that suggests there was

no loss of consciousness. (Id. at 20.) To the extent petitioner’s testimony and

allegations contradict the medical records, respondent argues that petitioner’s failing

memory detracts from her credibility. (Id. at 21-22.)

Respondent argues that Dr. Kinsbourne’s report is not credible with respect to a

cause-in-fact claim because it relies on a diagnosis (syncope) that is not supported by

petitioner’s medical records. (Id. at 24.) Respondent also stresses that petitioner’s

treating physicians did not support vaccine-causation, noting that her primary care

physician opined that her accident was “[l]ikely not from flu vaccine.” (Id. at 24 (quoting

Ex. 4, pp. 69-70).) Respondent further argues that any cause-in-fact claim would suffer

the same limitation as her Table claim with respect to establishing the timing of the

alleged injury. (Id. at 24-25.)

Finally, respondent also argues that in either event petitioner “has ignored

potential alternative causes of her symptoms.” (ECF No. 77-1, p. 25.) Specifically,

respondent contends that petitioner’s overall medical history suggests the October 13,

2015 episode is more likely to have been caused by a migraine phenomenon, Meniere’s

disease, or sinus bradycardia. (Id. (citing Ex. 23, p. 1; Ex. A, p. 6).)

VI. Discussion

A. The weight afforded petitioner’s testimony

A critical threshold question presented in this case is how much weight to afford

petitioner’s testimony. Both parties acknowledge that petitioner’s testimony was

affected by failing memory. (ECF No. 78, p. 5; ECF No. 77-1, p. 21-22.) However, they

disagree with respect to the specific circumstances of her dementia at the time of the

hearing. While respondent stressed that petitioner was assessed as having dementia

14

two months prior to the hearing (ECF No. 77-1, n.3), petitioner replied that her dementia

was “mild, early onset” and she has never been deemed incompetent or otherwise

mentally unsound (ECF No. 79, p. 4).

The process for making determinations in Vaccine Program cases regarding

factual issues begins with consideration of the medical records. § 300aa-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.” § 300aa-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 a determination is evidenced by a rational determination).

Medical records that are created contemporaneously with the events they

describe are presumed to be trustworthy. Cucuras v. Sec’y of Health & Human Servs.,

993 F.2d 1525, 1528 (Fed. Cir. 1993); Doe 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”).

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, 968 F.2d 1226 (Fed. Cir.), cert. den'd,

Murphy v. Sullivan, 506 U.S. 974, 113 S.Ct. 463, 121 L.Ed.2d 371 (1992) (citing United

States v. United States Gypsum Co., 333 U.S. 364, 396, 68 S.Ct. 525, 92 L.Ed. 746

(1948) (“[i]t has generally been held that oral testimony which is in conflict with

contemporaneous documents is entitled to little evidentiary weight.”); but see Kirby v.

Sec’y of Health & Human Servs., 997 F.3d 1378, 1382 (Fed. Cir. 2021) (holding that

“[w]e reject as incorrect the presumption that medical records are accurate and

complete as to all the patient's physical conditions.”).

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,

15

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 often needed when determining the weight that such

testimony should be afforded. Andreu v. Sec’y of Health & Human Servs., 569 F.3d

1367, 1379 (Fed. Cir. 2009); 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 v. Sec’y of Health &

Human Servs., No. 11-685V, 2013 WL 1880825, at *3 (Fed. Cl. Spec. Mstr. Apr. 10,

2013) (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 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.

During the hearing, petitioner repeatedly denied having a medical history

consistent with what had been recorded in her medical records relative to multiple

medical providers. (For example, compare Tr. 80 (denying panic attacks) and Ex. 15,

pp. 159, 170; Ex. 27, pp. 7-9, 50-51; compare Tr. 76-77 (denying referral to psychiatrist)

and Ex. 11, pp. 31-32, 38-39; compare Tr. 22-23 (denying migraines) and Ex. 12, pp.

92-95; compare Tr. 28-29 (denying Meniere’s disease) and Ex. 9, pp. 12-13; Ex. 11, pp.

88-93.) Petitioner did not provide any reason for the discrepancies or explanation of

why her medical records did not align with her recollections. However, she nonetheless

purported to offer testimony regarding the details of encounters she acknowledged

being unable to recall. (Tr. 17-18, 56, 62, 70-75.) Petitioner also offered some

contradictory testimony regarding her prior health. (Compare Tr. 21-22 (indicating

bloodwork is “always perfect”) and Tr. 23 (acknowledging taking cholesterol

medication).) A very notable example featured prominently in respondent’s cross-

examination. Petitioner testified clearly, and unprompted, on direct examination that

she had never had a prior influenza vaccination. (Tr. 8.) She confirmed the same on

cross-examination. (Tr. 37.) On further cross-examination, respondent presented

petitioner with multiple consent forms and administration records for prior influenza

vaccinations, which petitioner acknowledged signing. (Tr. 37-40.) Petitioner’s utter

surprise when presented these documents was obvious during the hearing and even

remains discernable from the resulting transcript. (Id.)

My observation of the quality of petitioner’s testimony regarding her own medical

history is that it is clearly not reliable enough to overcome the weight typically allowed

contemporaneous medical records. Accordingly, I do not credit any of petitioner’s

testimonial denials of relevant aspects of her medical history over what appears in her

contemporaneously recorded medical records. 10 Petitioner’s dementia diagnosis and

her concession in her briefs that her memory was affected at the time of the hearing

10 Notably, however, as noted in Section III C, above, even the contemporaneous histories petitioner

provided after her accident are not entirely clear regarding what she could recall versus what she

rationalized as the cause of her condition.

16

may help to further explain how petitioner’s testimony came to be unreliable with

respect to her medical history, but the quality of the testimony is apparent regardless of

that explanation.

Importantly, however, this does not account for the whole of petitioner’s

testimony. Aspects of petitioner’s testimony that relay affirmative recollections rather

than negative recollections (i.e. denials) cannot easily be explained by mere memory

loss. Moreover, petitioner persuasively stressed in her briefs that, even faced with

advanced age and dementia, “a traumatic event like the car crash at issue is still

indelibly imprinted in her mind.” (ECF No. 79, p. 4.) In that regard, petitioner was very

clear in testifying as to the affect the accident had on her. She testified that the memory

of the accident caused her to experience ongoing fear that led her to stop driving. (Tr.

21, 67-68.) This is also supported by her reports to physicians. (E.g., Ex. 5, p. 21.)

Accordingly, petitioner’s specific affirmative recollections will be weighed against the

other record evidence on an individual basis.

B. Petitioner’s auto accident likely occurred within one hour of

vaccination

Respondent stresses that the exact time that petitioner was vaccinated is

unclear. (ECF No. 77-1, p. 19.) While this is true – the vaccination record does not

indicate the time of administration (Ex. 1) – there is sufficient circumstantial evidence to

conclude that it is more likely than not that petitioner’s alleged syncopal event (if it

occurred) happened within one hour of her influenza vaccination.

The fact that petitioner’s vaccine was administered during her primary care

appointment at Dr. Herndon’s office is well documented. (Ex. 1; Ex. 4, p. 68.) There is

no evidence that petitioner was seen by anyone in Dr. Herndon’s office prior to 3:43pm

when her vital signs were first recorded. (Ex. 4, p. 65.) Emergency dispatch and

accident report records confirm that petitioner’s subsequent auto accident was reported

between 4:32pm and 4:38pm, which is less than an hour after petitioner’s medical

appointment likely began based on the above-referenced time stamp. 11 (Ex. 14, p. 1;

Ex. 20, p. 1.) Petitioner also stresses there is no evidence of record contradicting her

assertion that the accident occurred within one hour of vaccination. (ECF No. 79, p. 4.)

Accordingly, even without knowing the precise time of vaccination, there is

preponderant, albeit not definitive, evidence that petitioner’s auto accident (immediately

preceded by her alleged syncope) occurred within one hour of her vaccination. 12

11Potentially consistent with this, petitioner believed her appointment was at 4:00pm or later and that her

vaccination occurred after she was seen by her doctor. (Tr. 6-7, 41-42.) This arguably provides further

evidence regarding the timing of petitioner’s vaccination; however, the time stamp(s) on the medical

record remain the best available evidence regarding the time she was actually seen. Notably, vital signs

are typically taken at the beginning of an appointment so they may be considered during the encounter.

The Vaccine Act instructs that the special master may find the time period for the first symptom or

12

manifestation of onset required for a Table Injury is satisfied “even though the occurrence of such

17

However, this does not necessarily mean that what petitioner experienced constituted

Table Injury of vasovagal syncope.

C. There is not preponderant evidence that petitioner lost

consciousness or suffered a Table Injury of vasovagal syncope

A difficult and fundamental issue in resolving this case is the fact that petitioner

was alone at the time of her alleged syncopal event, has acknowledged being unable to

remember key moments, and subsequently has not provided a consistent description of

what actually happened inside her vehicle at the time of the accident. The beginnings

of this inconsistency arise as early as the moments following the accident and it affects

the medical histories she provided to physicians following her accident. Because

petitioner bears the burden of establishing the factual circumstances of her claim (§

300aa–13(a)(1)(A)), these difficulties prevent any finding by preponderant evidence that

petitioner lost consciousness at or around the time of her accident. Accordingly, there

is not preponderant evidence that she suffered a Table Injury of vasovagal syncope.

As explained in greater detail in Section III B, above, petitioner’s

contemporaneous account to first responders was that she did not lose consciousness,

causing her to receive a traffic citation for careless driving. (Exs. 14, 20.) Moreover, the

only witness on the scene did not confirm any loss of consciousness. (Ex. 28.) As

reflected in Section III C, above, her subsequent reports to medical providers when

hospitalized the next day were inconsistent in reporting whether she experienced a loss

of consciousness. (Ex. 13, pp. 22, 36.) Additionally, the record as a whole reveals

even those contemporaneous accounts to be a mix of recollection and after-the-fact

rationalization.

To some extent this is understandable. If petitioner was, in fact, unconscious,

she could not be expected to recall her own unconsciousness. Nor does it seem

possible to meaningfully parse her later report of “loss of vision” or being “slightly

blacked out” coupled with an inability to recall from a true loss of consciousness. 13 (Id.

at 22, 36.) However, these explanations still remain inconsistent with petitioner’s

specific denial of having lost consciousness, made both to first responders and to her

first post-accident neurologist, Dr. Shah, the latter of whom explicitly considered and

symptom or manifestation was not recorded or was incorrectly recorded as having occurred outside such

a period.” § 300aa-13(b)(2).

13 During the hearing, I asked petitioner to compare what she experienced in her car on that day to

another seemingly similar incident, but this did not help to resolve the issue. Petitioner’s medical records

reflect that in June of 2017, she momentarily lost her vision while shopping and fell down. (Ex. 15, pp.

157-159.) As with the October 2015 episode, she denied loss of consciousness or dizziness. (Id.) In

describing this incident during testimony, petitioner confirmed that she was able to recall that “it went dark

and I knew I was going to fall.” (Tr. 80.) I asked petitioner to focus on the last moment she could recall

before the auto accident and compare it to what she experienced when she fell down. She indicated it

was “nothing like that, nothing.” (Tr. 81.) I specifically asked petitioner if she could recall losing her vision

after she saw the trees “whirring by.” She could not recall. (Id.)

18

rejected the possibility that petitioner had experienced a syncopal event. 14 (Ex. 14, p. 4;

Ex. 5, pp. 7-8.) To deny a loss of consciousness is to recall remaining conscious.

Importantly, although she repeatedly disputed during the hearing any suggestion that

she did not lose consciousness, petitioner could not disclaim the reports contained in

either Dr. Shah’s or the first responders’ records. Upon review of this history contained

in Dr. Shah’s record, she indicated that she could not recall and “might have said

something.” (Tr. 20.) She also could not recall her interactions with the fire department

at the accident scene but vouched for her truthfulness to them. (Tr. 51-52.) Petitioner

again confirmed much later that she did not lose consciousness when she first saw Dr.

Ganti in August of 2016. (Ex. 9, p. 12.)

Moreover, petitioner’s hearing testimony confirms that she has a clear and

cogent recollection of losing control of her vehicle, including her specific recollection of

seeing trees pass by along the side of the road and of being afraid for her safety. (Tr.

10-12.) Additionally, contrary to her argument that unconsciousness is the only possible

explanation for the accident, petitioner also specifically confirmed in testimony that she

continued to depress the gas pedal “all the way” after losing control because she

mistakenly believed she was pressing the brake pedal and the brakes were failing. (Tr.

10-11, 20, 54.) This testimony is not consistent with a loss of consciousness. In her

earlier affidavit, petitioner had likewise not indicated any loss of consciousness. (Ex.

21, p. 1.)

Although petitioner testified that she could not recall what subsequently

happened in the final moments before impact, without more, and especially in light of

the above, this does not a fortiori suggest that she lacked consciousness due to

syncope. She reasonably noted that “it happened so fast.” (Tr. 54.) Petitioner

described the events as “all hell br[eaking] loose” and also explained that she was

“dazed” and in “shock” as a result of the accident. (Tr. 17, 56, 65.) Additionally, the

only eyewitness available was concerned petitioner may have had a concussion and,

indeed, she was later treated for post-concussion syndrome. 15 (Ex. 28; Ex. 5, pp. 20-

23.) Petitioner also has a history of panic attacks. (Ex. 15, p. 170; Ex. 27, pp. 7-9.)

Even without suspecting her subsequently diagnosed dementia, these are factors that

could plausibly contribute to petitioner’s failure to recall the final moments of her

14 The fact that Dr. Shah discussed with petitioner whether she lost consciousness in the context of

assessing whether she experienced syncope is significant because petitioner urges that petitioner’s

motivation should be considered in assessing her medical records. (ECF No. 79, pp. 1-2.) Specifically,

petitioner argues that the first responder reports should be discounted because she denied losing

consciousness on the day of the accident in an effort to avoid being hospitalized. (Id.) In contrast, by the

time petitioner was seen by Dr. Shah she was already hospitalized and actively seeking medical

treatment.

15Given that petitioner clearly recalls initially losing control of the vehicle before later being unable to

recall subsequent events, this raises the question of whether a concussion and post-concussion

syndrome could instead explain the entirety of her presentation, including her alleged momentary loss of

consciousness and/or inability to remember the final moments of the accident. However, because this

would require additional expert opinion regarding the nature of concussions and their effects, I do not

reach that question.

19

accident that do not implicate any syncope-induced confusion or lack of consciousness.

Considering the record as a whole, petitioner’s lack of memory may be potentially

consistent with a loss of consciousness, but it does not in itself provide preponderant

evidence favoring petitioner’s assertion that a loss of consciousness did occur.

D. Petitioner has not met her burden of proof with respect to any

alternative cause-in-fact claim

Setting aside the question of whether petitioner lost consciousness as required

by the specific requirements of the Vaccine Injury Table, petitioner also asserts that Dr.

Kinsbourne’s opinion supports her contention that she suffered a syncopal or

presyncopal event caused-in-fact by her vaccination regardless of whether she

experienced a loss of consciousness. Although petitioner is correct that a flu vaccine

can cause syncope and presyncope, there are several issues relative to Althen prong

two, requiring a logical sequence of cause and effect showing that petitioner’s

vaccination did cause her injury, that prevent petitioner from establishing any cause-in-

fact claim by preponderant evidence.

Petitioner’s burden under the first Althen prong is to provide, by preponderant

evidence, “a medical theory causally connecting the vaccination and the injury.” Althen,

418 F.3d at 1278. Such a theory must only be “legally probable, not medically or

scientifically certain.” Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 549

(Fed. Cir. 1994). In that regard, Dr. Kinsbourne and Dr. Donofrio both agree that

vasovagal syncope results from a loss of blood perfusion in the brain that can be

brought about by, among other things, emotional stress. Dr. Kinsbourne’s further

suggestion that a needle injection can cause such stress appears to be sound and

reliable insofar as the potential for syncope is factored into the standard of care when

administering the flu vaccine. (E.g., Ex. 10, p. 5.) While Dr. Kinsbourne was initially

unpersuasive in applying the term “syncope” to any such episode regardless of whether

a loss of consciousness occurred (Ex. 23), his supplemental reports adequately explain

that presyncope can constitute the prodrome of syncope and represent the same

physiologic process only incomplete (Ex. 32-33).

Dr. Donofrio stresses that syncope and presyncope are not synonymous and that

it is speculative to suggest that vaccination could cause presyncope in the same

manner as syncope (Ex. C, pp. 3-4); however, he acknowledges vasovagal syncope to

stem from a stressful event leading to a slowed heart rate and a drop in blood pressure.

(Id. at 4.) Although Dr. Donofrio observed that presyncope does not always lead to

syncope, he did not explain why the physiologic process of lowered blood pressure

would necessarily lead to a complete loss of consciousness in all instances where it

was initially triggered by a vaccination. Dr. Donofrio’s objection appears to be that

presyncope as a concept is nonspecific and broader than what Dr. Kinsbourne

discusses, but this concern speaks to the “did it” type of analysis under Althen prong

two more so than the “can it” type of analysis under Althen prong one. Accordingly,

petitioner has satisfied Althen prong one with respect to either syncope or presyncope.

20

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

effect connecting vaccination and injury, usually supported by facts derived from a

petitioner's medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375–77;

Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006);

Grant v. Sec'y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992).

However, medical records and/or statements of a treating physicians 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. See 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”).

Initially, Dr. Kinsbourne, opined that what petitioner experienced was syncope,

highlighting dizziness, confusion, and blurry or tunnel vision as “prominent” symptoms16

without specific respect to a loss of consciousness and without specifically invoking

presyncope. (Ex. 23, p. 1.) Petitioner then argued Dr. Kinsbourne’s opinion supported

a claim for syncope occurring with or without a loss of consciousness. (ECF No. 78, p.

4.) That specific framing is unpersuasive in that syncope necessarily refers to a loss of

consciousness. (E.g., Ex. 10, p. 5 (vaccine package insert characterizing syncope as

fainting that “may be accompanied” by transient neurological signs such as visual

disturbance); Ex. A, Tab 1, p. 1 (characterizing syncope as transient loss of

consciousness that “is often preceded by” symptoms such as lightheadedness or

blurred vision).) Therefore, because I concluded that there is not preponderant

evidence petitioner lost consciousness, it would be impossible for petitioner to prove a

cause-in-fact claim for syncope based on the facts of this case.

In his supplemental reports, Dr. Kinsbourne confirms that syncope and

presyncope are not synonymous and contends that, in the absence of any loss of

consciousness, petitioner’s symptoms as he describes them remain consistent with

presyncope. (Ex. 32, pp. 1-2.) He further contends that this does not change the

analysis because presyncope is equally as capable of resulting in an auto accident. (Id.

at 2.) However, regardless of whether presyncope would be likely to result in an auto

accident, this more nuanced opinion by Dr. Kinsbourne remains unpersuasive in

contending that the record evidence preponderates in favor of a vaccine-caused

presyncope as a medical explanation for the events at issue.

There is no question in this case that it is impossible to know what exactly

occurred in Ms. Kidwell’s car on October 13, 2015. As described above, Ms. Kidwell

was an inconsistent historian even in the hours and days immediately following the

16 Dr. Kinsbourne’s reference to tunnel vision would seem to be potentially inconsistent with petitioner’s

testimony that she observed trees passing by as she lost control. (Tr. 11, 13, 32, 46, 53-55, 64-65, 81.)

This testimony might suggest intact peripheral vision. Dr. Donofrio also observes that Dr. Kinsbourne is

taking an inferential step by equating petitioner’s report of “feeling funny” as dizziness. (Ex. C, p. 4.)

21

accident and her initial hospitalization failed to reveal any etiology for the episode she

described. The expert reports filed in this case further highlight this fundamental

difficulty. Each expert comes to a different conclusion and each expert charges the

other with speculation. (E.g. Ex. 32, p. 4; Ex. C, p. 4.)

Importantly, however, whereas a Table Injury of vasovagal syncope would have

afforded petitioner a causal presumption that may have shifted the burden of addressing

this uncertainty toward respondent in demonstrating the injury to be related to a factor

unrelated to vaccination, a cause-in-fact claim for either syncope or presyncope

requires petitioner to do the “heavy lifting” of affirmatively proving, inter alia, a logical

sequence of cause and effect demonstrating petitioner’s vaccination to have been the

cause of her episode. Hodges v. Sec'y of Health & Human Servs., 9 F.3d 958, 961

(Fed. Cir. 1993) (indicating that in the absence of a Table Injury, “the heavy lifting [of

proving causation] must be done by the petitioner, and it is heavy indeed.”); see also

Althen, 418 F.3d at 1280 (clarifying that “heavy lifting” characterizes the preponderant

evidence standard and not any heightened burden of proof.) In that context, the

inherent difficulty in knowing what happened immediately prior to Ms. Kidwell’s accident

works against petitioner’s claim. In all events a petitioner must prove by a

preponderance of the evidence the factual circumstances surrounding her claim. 42

U.S.C. § 300aa–13(a)(1)(A). Dr. Kinsbourne is not persuasive in his attempt to find

clarity in the situation. In fact, Dr. Kinsbourne’s opinion seeks to emphasize the

coincidental temporal association between petitioner’s vaccination and auto accident

while seeking to deny, dismiss, or minimize the confounding information available in

petitioner’s overall medical history. In effect, he seeks to have a causal presumption

applied even in the absence of any Table Injury and even in the absence of any clear

understanding of what actually occurred.

The first issue is that there is not preponderant evidence from petitioner’s post-

accident treatment records that petitioner’s physicians felt her episode was explained by

any syncopal process, whether syncope or presyncope. Of course, none of petitioner’s

treating physicians directly observed the episode in question; however, of all of the

treating physicians, first responders, and experts who have evaluated this case, those

who most contemporaneously and extensively evaluated petitioner in-person concluded

on the whole that no syncopal process was implicated. Accord 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, 993 F.2d at 1528.

As explained above, first responders observed petitioner to be alert and oriented

with normal vital signs immediately after the accident and noted her to be “apparently

normal.” (Ex. 14, pp. 3-4; Ex. 20, p. 2.) The possibility of syncope was considered

during petitioner’s initial emergency department triage the next day (Ex. 13, p. 21), but

she was subsequently seen by neurologist Dr. Shah who explicitly concluded there was

22

no evidence of syncope (Id. at 37). Dr. Shah made effort to record a nuanced history

and not only confirmed that petitioner did not lose consciousness, but also noted her

report of loss of vision to be “questionable.” (Id. at 36-37.) Ultimately, syncope was not

a part of petitioner’s discharge diagnosis. (Ex. 5, pp. 7-8.)

Later, Dr. Umamahewswaran included syncope only as among a differential

diagnosis also including seizure and cardiac event. (Ex. 5, p. 21.) Dr.

Umamahewswaran’s record is confusing in that she attached a diagnosis of “syncope”

to the encounter, but in her assessment indicated that the episode of loss of awareness

was of unclear etiology. (Id.) Her later records drop the encounter diagnosis of syncope

while maintaining the assessment of a loss of awareness of unclear etiology. (Id. at 32.)

On the whole, Dr. Umamahewswaran’s treatment records reflect greater focus on

petitioner’s subsequent post-concussion syndrome than on the initial cause of her

accident. Dr. Shah’s encounter record appears to offer the most extensive

consideration of whether the history provided by petitioner represented a syncopal

event and that assessment was based on a more contemporaneous recollection than

was available to Dr. Umamahewswaran. (Ex. 13, pp. 36-37.)

Dr. Donofrio is also correct to observe that the presyncope symptoms described

by Dr. Kinsbourne are non-specific. “Presyncope can be challenging to evaluate in a

healthcare setting because of its broad differential diagnosis . . .” (Ex. C, Tab 1, p. 4.)

Petitioner’s symptoms as described by Dr. Kinsbourne (feeling funny/dizziness,

confusion, loss of vision) are also consistent in varying combinations with other

disorders for which petitioner has established diagnoses, including migraine disorder,

panic attacks, and Meniere’s disease. (Ex. C, p. 4.)

Additionally, to the extent petitioner may have suffered some type of spell or

episode, Dr. Kinsbourne’s assessment offers only short shrift to the alternative condition

most prominently considered by Dr. Shah. Dr. Donofrio highlights that after engaging

with Ms. Kidwell’s reported history, Dr. Shah considered the possibility of a TIA more

strongly than syncope. Specifically, Dr. Shah’s impression included “rule out any

posterior segment transient ischemic attack versus _______no signs of syncopal

episode.” (Ex. 13, p. 37.) Dr. Donofrio explained that TIA presents with the same

symptoms highlighted by Dr. Kinsbourne relative to presyncope, is also transient, and

like presyncope, leaves behind no lasting evidence that it occurred. (Ex. C, p. 2.) Also,

Dr. Kinsbourne ultimately acknowledges that petitioner’s narrowed basilar artery could

have contributed to her visual disturbance in the context of either syncope or TIA. (Ex.

33, p. 2.) Dr. Kinsbourne’s only response with respect to the possibility of TIA is to

dismiss it as an unlikely or unnecessary explanation due to the fact that petitioner had

recently been vaccinated. (Id.)

In any event, even assuming arguendo petitioner did suffer a presyncopal

episode, Dr. Kinsbourne is still not correct to automatically invoke petitioner’s

vaccination as the cause. “The etiologies of presyncope are diverse, ranging from the

benign to the life-threatening.” (Ex. C, Tab 1, p. 1.) Notably, presyncope can result from

conditions and activities as commonplace as dehydration. (Ex. A, Tab 1, p. 1.) In fact,

23

one of petitioner’s prior syncopal episodes reportedly occurred in the context of

foregoing anything to drink for two hours. (Ex. 15, p. 49.) Dr. Kinsbourne is also

unreasonably dismissive of petitioner’s history of bradycardia. “Atypical cardiovascular

causes of presyncope should be considered more closely in the elderly than in younger

populations.” (Ex. C, Tab 1, p. 2.) Moreover, syncope and presyncope are established

sequela of bradycardia. (See Ex. A, Tab 4, p. 4 (Table 1).)

As Dr. Donofrio noted, petitioner’s medical records confirm that bradycardia was

previously confirmed by electrocardiogram on two separate occasions. (Ex. A, p. 1

(citing Ex. 12, p. 127 (August 23, 2010) and Ex.12, p. 111 (June 11, 2012).) Dr.

Kinsbourne’s own reliance materials (Whitledge, et al) stress that dysrhythmias are a

common cardiac cause of syncope and presyncope and that bradycardia is the most

common dysrhythmia. (Ex. C, p. 2.) Dr. Kinsbourne discounts this possibility on the

basis that no bradycardia was recorded around the time of the accident (Ex. 32, p. 4);

however, petitioner’s resistance to being hospitalized following her accident necessarily

means she did not receive a full evaluation until the day after her accident. Arrythmias

can be infrequent and detectable only upon longer-term electrocardiogram study. (Ex.

A, Tab. 1, p. 2.) As with TIA, Dr. Donofrio also stresses that petitioner’s narrowed

basilar artery would be a predisposing factor. (Ex. A, p. 6.) And, again, Dr. Kinsbourne

acknowledges that this narrowing could explain petitioner’s visual changes as a

consequence of any drop in blood pressure. (Ex. 33, p. 2.)

Furthermore, petitioner’s own medical history refutes Dr. Kinsbourne’s

suggestion that the temporal relationship between vaccination and “spell” should without

more be viewed as a distinguishing characteristic of this episode. Although a definitive

etiology is not captured by her medical records, petitioner has had spell-like episodes

on a number of occasions. (See e.g., Ex. 12, p. 156 (flashing lights); Ex. 12, pp. 92-95

(saw squares); Ex. 15, p. 99 (dizziness and nausea); Ex. 15, pp. 157-59, 170 (losing

vision and falling).) She has previously been diagnosed as having had syncopal

episodes unrelated to vaccination (Ex. 12, p. 106, 108; Ex. 15, pp. 45-46) and has a

history of reported panic attacks which have been suspected as the cause of a separate

episode similarly described as involving a visual blackout without loss of consciousness

(Ex. 15, p. 170; Ex. 27, pp. 7-9). No specific recurrent trigger has been identified and

there has been no pattern of any of these events occurring following vaccination.

However, petitioner’s medical records reflect that she has received prior vaccinations

without apparent incident. (Ex. 12, pp. 12, 16.) In the context of this medical history, Dr.

Kinsbourne’s charge that it is Dr. Donofrio who is relying on “coincidence” is not

persuasive. (See Ex. 33, p. 1.)17

Additionally, given that petitioner’s theory of causation is predicated on the idea

that a type of emotionally-mediated stress response to vaccination ultimately leads to a

17 Specifically, Dr. Kinsbourne wrote “[i]n his supplemental report dated May 24, 2021, Dr. Donofrio

maintained that what had happened was any of a set of multiple different hypothetical medical events, all

having in common that they are unconnected with vaccination but allegedly coincidental with the post

vaccination hour. He implied any one of these hypothetical events should be considered preponderant to

the diagnosis of a syncopal process.” (Ex. 33, p. 1.)

24

drop in blood pressure, it is notable that petitioner emphasized in her testimony

regarding the appointment at which she was vaccinated that she “felt great going in,

great coming out.” (Tr. 12.) She also did not describe any subjective fear or discomfort

with respect to vaccinations or injections. Again, the record shows that petitioner

received multiple prior vaccinations without reported incident. (Ex. 12, pp. 12, 16.)

Additionally, whereas the Vaccine Injury Table allows a causal presumption for events

occurring up to one hour post vaccination, Dr. Kinsbourne identified the relevant

precautionary period as being only 15 minutes. (Ex. 23, p. 1.) As discussed above,

circumstantial evidence establishes that petitioner’s accident necessarily occurred after

no more than 49 minutes; however, the record evidence is inadequate to place the

episode specifically within 15 minutes of vaccination. This is not necessarily dispositive

of the temporal relationship (I do not reach the question of Althen prong three here), but

further calls into question Dr. Kinsbourne’s confidence in the fact of a preceding

vaccination itself being so significant as to exclude of all other scenarios reasonably

suggested by petitioner’s medical history.

Finally, I note that when reviewing Dr. Kinsbourne’s multiple submissions

collectively, it becomes apparent that his review of petitioner’s medical history suffers

diminished credibility. In his first report, Dr. Kinsbourne flatly denied “any

cardiovascular disease process that might be conducive to syncope” and further denied

“any previously syncopal episodes.” (Ex. 23, p. 1.) In his second report, Dr. Kinsbourne

acknowledged generally that “Ms. Kidwell’s age and medical history may suggest a

slightly greater susceptibility to fainting than average.” (Ex. 32, p. 3.) He also

specifically acknowledged, contrary to his first report, that petitioner had had “at least

two” prior episodes of vasovagal syncope. (Id. at 2.) However, in this report he

continued to deny that petitioner had a narrowed basilar artery. (Id. at p. 4.) It was not

until his third and final report that Dr. Kinsbourne finally conceded that petitioner had a

narrowed basilar artery and that it may be relevant to assessing the vision changes she

reported during her episode. (Ex. 33, p. 2.) At no point did Dr. Kinsbourne meaningfully

discuss petitioner’s history of bradycardia, dismissing it solely because it was not

documented specifically at the time of the accident. (Ex. 32, p. 4; Ex. 33, p. 3.)

“Most near syncope diagnoses are presumptive, cannot be confirmed by

standard criteria and may not be able to exclude cardiac conduction causes that have

potentially life-threating consequences.” (Ex. C, Tab 1, p. 3.) Therefore, “[a] thorough

history and physical examination are critical part of the evaluation of syncope and focus

on identifying underlying heart disease.” (Ex. A, Tab 1, p. 2 (emphasis added).) Given

the importance of patient history in assessing presyncope, Dr. Donofrio has reasonably

raised aspects of petitioner’s own medical history that are highly significant to assessing

whether any syncope and/or presyncope occurred and, if so, which among the broad

range of known etiologies best explains it. Dr. Kinsbourne is not credible in dismissing

these concerns as mere “hypotheticals.” Accordingly, petitioner has not met her burden

of proof under the Althen test with respect to any cause-in-fact-claim based on either a

syncopal or presyncopal event.

25

E. There is not preponderant evidence that petitioner’s alleged

syncopal episode caused her accident and post-accident symptoms

Regardless of theory – Table or cause-in-fact injury – petitioner must also

establish that her injuries satisfy the Vaccine Act’s severity requirement. § 300aa-

11(c)(1)(D). In relevant part the Vaccine Act requires petitioner to demonstrate that the

residual effects of her injury persisted for at least six months. 18 Id. Because syncope is

a transient and generally harmless condition, it necessarily follows that petitioner must

also somehow causally link her longer-term treatment for headaches and unsteady

walking (characterized as post-concussion syndrome) to her initial episode in order to

demonstrate a compensable injury.

Petitioner has neither alleged nor demonstrated that her longer-term symptoms

were a direct sequela of her syncope (or presyncope), but rather contends that the

persistent injuries she suffered were the result of trauma she experienced in the

ensuing auto accident. Petitioner suggests, in effect, a causal chain in which her

vaccination caused her syncopal or presyncopal episode which caused her accident

which caused her post-concussion syndrome. However, petitioner’s above-discussed

testimony that she lost control of the vehicle due to pedal misapplication contradicts that

framing of events and therefore raises an additional issue of proximate causation. In all

events, petitioner must prove that her vaccination was a proximate cause of her injury or

injuries. Shyface, 165 F.3d at 1352 (adopting the Second Restatement of Torts with

regard to proximate causation in the Vaccine Program and determining a vaccine must

be both a “but for” cause and a “substantial contributing factor”); Stone v. Sec’y of

Health & Human Servs., 676 F.3d 1373, 1381 (Fed. Cir. 2012) (examining the Second

Restatement of Torts with regard to superseding causes, but determining that such

analysis is not necessary where the special master found no casual role for the

vaccine). Even under a Table Injury approach, the causal presumption afforded

petitioner would extend only as far as the vaccine’s role in causing her alleged syncope,

which is the specific injury included on the Table.

The core of petitioner’s claim is her assertion that her “version of events is the

only one that makes sense. A person who is conscious takes their foot off the gas.

They do not drive into a parking lot at 50 miles per hour and run into parked cars.

Syncope is the only explanation for what we know happened.” (ECF No. 78, p. 5.) But

this is belied by petitioner’s own testimony. As noted above, petitioner was clear and

cogent in testifying that the cause of the accident was her own misapplication of the gas

pedal when she intended to apply the brakes. (Tr. 20, 81.) She further testified that she

18 Under the Vaccine Act, petitioner must have either:

(i) suffered the residual effects or complications of such illness, disability, injury, or

condition for more than 6 months after the administration of the vaccine, or (ii) died from

the administration of the vaccine, or (iii) suffered such illness, disability, injury or condition

from the vaccine which resulted in inpatient hospitalization and surgical intervention.

§ 300aa-11(c)(1)(D).

26

kept her foot on the gas after losing control because she continued to believe it was the

brake pedal. (Tr. 10-11, 46.) The eyewitness at the scene further confirmed that

petitioner still had her foot on the gas after her vehicle came to a stop. (Ex. 28.) It is

only the details occurring after she had already lost control of her vehicle that petitioner

cannot recall. Contrary to syncope (or presyncope) being the “only explanation” of her

accident, petitioner credibly described the cause of her accident as pedal

misapplication. In fact, because syncope involves a loss of postural tone, Dr. Donofrio

suggested that petitioner’s continued contracting of muscles to continuously depress the

gas pedal as observed by the eyewitness is not consistent with a syncopal episode. (Ex.

C, p. 1.)

Petitioner’s broader suggestion that syncopal confusion or a loss of

consciousness are the only reasonable explanations for this type of accident is also not

correct. Accidents due to sudden unintended acceleration are a well-known

phenomenon and litigation involving that type of accident has explored many potential

causes including design and mechanical defects as well as driver error. See, e.g.,

Bullock v. Volkswagen Group of America, Inc., 107 F.Supp.3d 1305, 1317 (M.D. Ga.

2015) (noting an expert’s “opinion is directly relevant and would be helpful to the jury on

the issue of causation—whether driver error, instead of design defect, caused the

wreck.”); Buck v. Ford Motor Co., 810 F. Supp. 2d 815, 838 (N.D. Ohio 2011) (“Sero

concluded that the cause of the sudden rapid acceleration could only be one of two

explanations: ‘either the driver mistakenly put ‘pedal to the metal’ or the cruise control

system electronically failed.’ Sero then proceeded to rule out driver error as a potential

cause. To make this determination, Sero relied on: 1) witness testimony; 2) brake pedal

wear; and 3) driver habit. Sero's specific causation opinion must be excluded because

he has not reliably ruled out driver error.”) (internal citation omitted); Jarvis v. Ford

Motor Co., 283 F.3d 33, 46 (2d Cir. 2002) (“Although Ford argued that the accident was

caused instead by driver error, this theory would have been rejected if the jury had

believed Jarvis's testimony that she had her feet on the brake and not on the

accelerator, as Ford claimed.”). Petitioner does not bear the burden of eliminating

alternative independent causes of her injury, but “is certainly permitted to use evidence

eliminating other potential causes to help carry the burden on causation and may find it

necessary to do so when the other evidence on causation is insufficient to make out a

prima facie case.” See Walther v. Sec’y of Health & Human Servs., 485 F.3d 1146,

1151 (Fed. Cir. 2007). Here, to the extent petitioner herself indicates that she is relying

in part on the lack of any alternative explanation, it is not self-evidently true as petitioner

suggests that a person who is conscious and of sound mind would not be involved in an

accident involving sudden unintended acceleration. As petitioner correctly

acknowledged in her reply brief, “[a]nyone might miss the brake pedal and accidentally

hit the gas.” (ECF No. 79, p. 3.)

Dr. Kinsbourne indicates (without accompanying citation) that “[v]asovagal

presyncope/syncope is a well-recognized cause of traffic accidents, as the medical

literature attests.” (Ex 33, p. 3.) However, this is beside the point. There is no real

debate in this case that a person who has fainted or near fainted while driving would be

likely to cause an accident. However, the fact that this is an uncontroversial point does

27

not automatically suggest that it explains what happened in this case given that

accidents of sudden unintended acceleration do not happen exclusively as a result of

fainting and petitioner clearly testified to misapplying the pedal and losing control of the

vehicle as a result. Dr. Kinsbourne also stresses that petitioner’s ability to recall losing

control of the vehicle is compatible with a presyncopal process. (Ex. 32, p. 2.) Again,

however, even if credited, this only speaks to whether petitioner’s version of events

even remains potentially plausible. It is not evidence that it actually occurred, especially

in light of petitioner’s testimony acknowledging that she pressed the wrong pedal and

kept pressing the wrong pedal.

Dr. Kinsbourne offers the specific rationale in his final report that “since her vision

was blurry during her presyncope it is probable that she could not verify the correct

pedal in her car by sight. A growing feeling of faintness and visual compromise is

probably why she pressed the wrong pedal while driving.” (Ex. 33, p. 3.) This raises

several issues. First, the explanation is speculative at best. Petitioner did not provide

any testimony to this effect. In fact, it is inconsistent with petitioner’s account as she

provided testimony indicating she could see trees pass by at the point she initially lost

control of the vehicle, suggesting her vision was intact at that moment. (Tr. 10-11.)

Second, Dr. Kinsbourne is a neurologist. While he is qualified to discuss the effects of

syncope and presyncope, he has no particular qualification to speak to specific

contentions of what type of human errors are likely to lead to an auto accident. Third,

even to any lay person with experience driving, Dr. Kinsbourne’s explanation remains

unsatisfying as a matter of common sense. People generally keep their eyes on the

road while driving and do not typically rely on visual confirmation to place their foot on

the appropriate pedal. Moreover, the typical driving position is not conducive to visually

inspecting the pedals. Fourth, after initially misapplying the accelerator, petitioner

described the subsequent events as occurring very fast. (Tr. 54.) Thus, it is not

apparent that Dr. Kinsbourne’s explanation is even necessary to explain how

petitioner’s initial pedal misapplication caused the accident. Dr. Kinsbourne himself

indicated that the accident became unavoidable as soon as petitioner lost control by

misapplying the gas pedal. (Ex. 32, p. 2.) He specifically opined that “once Ms. Kidwell

lost control of the car, it was going to crash regardless of her level of consciousness.”

(Id.)

Accordingly, petitioner’s auto accident is more likely than not explained by her

admitted pedal misapplication and she has therefore not established by preponderant

evidence that her post-accident symptoms were causally related to her vaccination. 19

Thus, her alleged injury also does not meet the Vaccine Act’s severity requirement.

19 Because I have concluded that there is not preponderant evidence that petitioner’s accident was

caused by her alleged syncope/presyncope, I do not reach the further questions of whether her post-

accident condition did represent a post-concussion syndrome, whether her symptoms could otherwise be

linked accident trauma, or whether her symptoms persisted for at least six months. As noted above,

petitioner does not actually recall hitting her head.

28

VII. Conclusion

Petitioner has my sympathy for the pain and suffering she endured due to her

traumatic accident, and I do not doubt her sincerity in bringing this claim. However, for

all the reasons discussed above, after weighing the evidence of record within the

context of this program, I cannot find by preponderant evidence that petitioner suffered

any injury caused by her October 13, 2015 flu vaccination. Therefore, this case is

dismissed. 20

IT IS SO ORDERED.

s/Daniel T. Horner

Daniel T. Horner

Special Master

20In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter

judgment accordingly.

29