Mondello v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 15-972V

Filed: January 24, 2018

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

PAUL MONDELLO, * To Be Published

*

Petitioner, *

v. * Ruling on Entitlement on

* Remand; Vaccine Act

SECRETARY OF HEALTH * Entitlement; Hepatitis A

AND HUMAN SERVICES, * Vaccine; Aseptic Meningitis;

* Seizures.

Respondent. *

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

Verne E. Paradie, Jr., Paradie Sherman, et al., Lewiston, ME, for petitioner.

Darryl Wishard, U.S. Department of Justice, Washington, DC, for respondent.

RULING ON ENTITLEMENT ON REMAND1

Roth, Special Master:

On September 30, 2015, Paul Mondello (“petitioner” or “Mr. Mondello”) timely filed a

petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §

300aa-10, et seq.2 (“Vaccine Act” or “Program”). The petition alleges that Mr. Mondello suffers

from a seizure disorder caused by the hepatitis A vaccination he received on November 15, 2013.

Petition at ¶¶ 2, 15. The petition further alleges that Mr. Mondello’s injuries persisted for more

than six months. Id. at ¶ 12.

Petitioner’s claim was denied by the undersigned after petitioner filed a Motion for Ruling

on the Record. Mondello v. Sec’y of HHS, No. 15-972V (Fed. Cl. Spec Mstr. Nov. 15, 2016).

Petitioner filed a Motion for Review and the Court of Federal Claims remanded the decision,

ordering reconsideration of the evidence. Mondello v. Sec’y of HHS, 132 Fed. Cl. 316 (2017).

1

Because this published ruling contains a reasoned explanation for the action in this case, I intend to post this decision

on the United States Court of Federal Claims' website, in accordance with the E-Government Act of 2002, Pub. L. No.

107-347, § 205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). In accordance with

Vaccine Rule 18(b), a party has 14 days to identify and move to delete medical or other information that satisfies the

criteria in § 300aa-12(d)(4)(B). Further, consistent with the rule requirement, a motion for redaction must include a

proposed redacted decision. If, upon review, I agree that the identified material fits within the requirements of that

provision, I will delete such material from public access.

2

National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (1986). Hereinafter, for ease of

citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012).

In accordance with the Court of Federal Claims’ order, the undersigned has reviewed all

of the evidence after remand. The Motion for Ruling on the Record was filed on an

underdeveloped record; therefore, the undersigned heard testimony from the petitioner and his

treating neurologist. Respondent filed an expert report in response to the oral opinions of

petitioner’s neurologist, Dr. Bourque. Now that petitioner’s record is more developed, he has

provided preponderant evidence that supports the Althen prongs. Therefore, petitioner is entitled

to compensation.

I. Procedural History

A. Office of Special Masters

The petition was filed on November 3, 2015. ECF No. 1. The medical record was

completed on December 26, 2015. ECF No. 19. On January 11, 2016, respondent filed his Rule

4(c) report recommending against compensation. Resp. Rpt., ECF No. 20. In his report, respondent

stated that petitioner had failed to satisfy the causation standards for an off-Table case as

articulated in Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).

Respondent stated that “the more likely cause of petitioner’s seizure onset was the resultant side

effect of his first dose of cyproheptadine.” Resp. Rpt. at 6.

This case was initially assigned to Special Master Hamilton-Fieldman, but reassigned to

me on January 14, 2016. ECF No. 21. Following a status conference on January 28, 2016,

petitioner was ordered to retain an expert. Scheduling Order, ECF No. 23. On April 17, 2016,

petitioner filed medical records from Dr. Bourque, petitioner’s treating neurologist, as Pet. Ex. 9,

along with a status report (“Pet. S.R.”), in which petitioner stated that “Dr. Bourque’s latest record

and opinions establish that the vaccination was a substantial factor in bringing about his current

condition.” Pet. S.R., ECF No. 26, at 1.

A status conference was held on May 19, 2016, to discuss petitioner’s need for an expert

report which complied with “the Althen criteria required to prove causation in the program.”

Scheduling Order, ECF No. 27, at 1. On July 18, 2016, petitioner filed a status report stating “he

does not intend on submitting an expert report and instead, anticipates filing a Motion for Ruling

on the Record.” Pet. S.R., ECF No. 31, at 1. On August 1, 2016, petitioner filed a motion for a

ruling on the record along with the Twinrix (Hepatitis A/B) package insert, vaccine information

sheets for Hepatitis A and B vaccines, and two articles of medical literature.3 Pet. Ex. 10-14, ECF

No. 32. At a status conference on September 22, 2016, petitioner’s counsel confirmed that

petitioner “requested a ruling on the record as opposed to a dismissal decision.” Scheduling Order,

ECF No. 33, at 1. The undersigned issued a Ruling on the Record on November 15, 2016, denying

entitlement to compensation and dismissing the petition. Decision, ECF No. 34.

B. Court of Federal Claims

Petitioner filed a Motion for Review on December 14, 2016. ECF No. 40. Petitioner

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Though the records indicate that petitioner received a Twinrix (hepatitis A and B) vaccine, according to the

petition, petitioner alleges injuries only as a result of the hepatitis A vaccine and the petition was not amended to

allege otherwise. See Petition at ¶¶ 2, 15.

2

submitted that, while he did not proffer an expert opinion providing a biological mechanism, the

combination of Dr. Bourque’s opinion and the medical literature filed was sufficient to establish a

prima facie case under Althen. Id. at 5. Respondent filed a response on January 11, 2017,

maintaining that petitioner failed to proffer a medical theory of causation which complied with the

Althen criteria. ECF No. 42.

On May 1, 2017, the Court granted petitioner’s motion for review, finding that petitioner

had proffered “at least some evidence suggesting a theory of causation,” that the undersigned erred

in assigning to petitioner the burden of disproving alternate causes and that it appeared the

submitted literature was not considered. This matter was remanded to the undersigned for further

proceedings. Mondello v. Sec’y of Health & Human Servs., 132 Fed. Cl. 316 (2017).

C. Office of Special Masters on Remand

A status conference was held on May 9, 2017; the undersigned suggested hearing testimony

from petitioner as well as his treating physician, Dr. Bourque. Scheduling Order, ECF No. 45.

Petitioner’s counsel advised that Dr. Bourque was no longer petitioner’s treating physician and

may be difficult to contact. The undersigned informed the parties that, in order to allow time to

further develop the record, petitioner should file a Motion to Stay the Proceedings.

Petitioner filed a Motion to Stay Proceedings on June 12, 2017, and a 30 day stay was

granted. Motion, ECF No. 47; Order, ECF No. 48. On June 22, 2017, petitioner filed a status report

advising the Court that Dr. Bourque had moved her practice from Maine to San Rafael, California;

petitioner had reached out to Dr. Bourque but had not yet received a response. Pet. S.R., ECF No.

49. Petitioner was ordered to file a status report by July 6, 2017, indicating petitioner’s availability

to testify at a fact hearing.

Petitioner filed two status reports on July 5, 2017, stating that petitioner was available to

give testimony via video conference on July 12 and 13, 2017, and advising that petitioner would

be submitting an affidavit from Dr. Bourque “regarding her conclusions and opinions on the cause

and mechanism of Petitioner’s medical condition.” ECF Nos. 50, 51.

Petitioner was ordered to file a status report by July 17, 2017, suggesting dates in August

of 2017 on which both petitioner and Dr. Bourque would be available to testify. Non-PDF Order,

issued July 5, 2017. On July 17, 2017, petitioner requested an extension of time until July 31, 2017

to file his status report. ECF No. 52. Petitioner filed a status report on July 31, 2017, stating that

petitioner would be available to give testimony in late August, and advising that, while petitioner

expected to file an affidavit from Dr. Bourque, it may be necessary to issue a subpoena in order

obtain Dr. Bourque’s testimony. ECF No. 53.

Petitioner was ordered to file an affidavit from Dr. Bourque by August 14, 2017, as well

as a status report indicating both petitioner’s and respondent’s availability for a hearing on either

August 29 or August 30, 2017. Scheduling Order ECF No. 54. Petitioner was also ordered to file

a motion to further stay proceedings. Id. On August 14, petitioner filed an affidavit from Dr.

Bourque and a status report advising that petitioner’s counsel was available for a fact hearing on

August 22, 28, 30, and 31. ECF Nos. 55, 56. Petitioner also filed a Motion to Stay Proceedings,

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requesting a 150 day stay. ECF No. 57. The undersigned granted petitioner’s motion in part for a

stay of 60 days. ECF No. 58.

Hearings were held via video conference on August 28, 2017 and September 7, 2017 for

the testimony of petitioner and Dr. Bourque, respectively. See Prehearing Order, ECF Nos. 59-60.

On October 3, 2017, respondent filed an expert report from a neurologist, Dr. Leist. Pet.

Ex. E-J, ECF No. 68. That same day, I issued an order stating that on September 7, 2017, Dr.

Bourque testified that petitioner suffered from aseptic meningitis as a result of his hepatitis

vaccine, which lowered his seizure threshold and was one of several contributing factors to his

development of seizures following his ingestion of cyproheptadine eight days after the vaccination.

Scheduling Order at 1, ECF No. 69. The order further stated that respondent’s expert, Dr. Leist,

opined that there was no evidence in the medical records that petitioner suffered from aseptic

meningitis following the hepatitis vaccine. Petitioner was ordered to file medical literature in

support of Dr. Bourque’s opinions showing (1) a connection between the hepatitis vaccine and

aseptic meningitis; (2) a connection between aseptic meningitis and seizures; and (3) a connection

between the hepatitis vaccine and seizures. Id.

On November 14, 2017, petitioner filed a status report stating that he had no further

evidence to offer and requesting the opportunity to cross-examine respondent’s expert. Pet. S.R.,

ECF No. 70. During a status conference held on November 15, 2017, respondent objected to

petitioner’s request to cross-examine Dr. Leist and referred to a discussion on the record following

Dr. Bourque’s testimony in September, in which petitioner mentioned only reserving his right to

have Dr. Bourque respond to Dr. Leist in a written submission. Scheduling Order at 1, ECF No.

71. I agreed that petitioner had reserved his right to have Dr. Bourque respond to Dr. Leist’s report,

but noted that petitioner’s counsel would be allowed to cross-examine Dr. Leist if he felt that it

was necessary to ensure that the record was complete. Id. Petitioner’s counsel stated that he

considered the record to be well-developed, and asked for time to reconsider his request to cross-

examine Dr. Leist. Id. On November 16, 2017, petitioner filed a status report withdrawing his

request to cross-examine Dr. Leist, indicating that he no longer felt it was necessary. Pet. S.R. at

1, ECF No. 73. Dr. Bourque did not respond to Dr. Leist’s report or opinions.

This matter is now ripe for decision.

II. Relevant Medical History and Petitioner’s Testimony

Petitioner provided testimony via videoconference on August 28, 2017. At the time of his

testimony, he was very confused. Since his vaccination, petitioner has been diagnosed with stage

IV metastatic prostate cancer. Tr. 6. At the time of his testimony, he had just concluded radiation

treatment. Tr. 6-8. He often conflated what he claimed to be complaints following the vaccination

with those associated with his cancer. For example, when his counsel asked him if he was sick part

of the week, or the whole week after receipt of his vaccination, petitioner responded, “It was

horrible. It was horrible. I was awake, I hurt, I can’t describe how I felt. There’s no way to describe

how it feels. It hurts – I didn’t know I had the bone cancer for years, and that’s why it got advanced,

and that’s why it hurts so bad. Everything hurts. And I just had the thing last – shot yesterday –

yesterday or the day before yesterday and I’m still trying to recover from the shots.” Tr. 15.

4

Petitioner was referring to his last cancer treatment received the day before his testimony.

Petitioner’s counsel did an admirable job trying to keep petitioner focused and on point.

A. Petitioner’s Health Prior to the Hepatitis Vaccination

Petitioner was born on October 2, 1943. Pet. Ex. 3 at 218. Petitioner served in the Vietnam

War; he was honorably discharged after receiving a severe blow to the head and crush injuries to

his knees and back. Pet. Ex. 2 at 80, 83. Petitioner received his primary care at Togus Veterans

Administration Hospital (“Togus”). He was treated for hypertension, Post-Traumatic Stress

Disorder (“PTSD”), osteoarthritis, hearing loss, gastroesophageal reflux disorder (“GERD”),

migraines, abnormal glucose, chronic back pain, and chronic hepatitis C. Id. at 99-100. His past

medical history also included Agent Orange exposure, alcohol dependence, Stevens-Johnson

syndrome after taking hydrochlorothiazide,4 hyponatremia,5 and an allergy to sulfa drugs. Id. at

83, 155; Pet. Ex. 3 at 304, 308; Tr. 30-32, 45.

On November 22, 2012, one year prior to his alleged vaccine related injuries, petitioner

presented to the emergency room with nausea, vomiting, fever and headache as a result of

hyponatremia. See generally Pet. Ex. 5. Petitioner returned two or three days later due to continued

headache. He had apparently fallen and hit his head. A head CT was performed and was normal.

Id.

Just prior to the receipt of the vaccine alleged herein, petitioner was admitted to Togus’

inpatient rehabilitation program for alcohol and cannabis dependence following 15 years of a fifth

of whiskey a day. Pet. Ex. 2 at 79. Petitioner had a certificate for medical marijuana and ate a

brownie at night to help him sleep. Id. at 118. Petitioner regularly used benzodiazepine to treat

panic attacks and anxiety but claimed to have discontinued its use prior to his vaccination. Id. at

111, 117.

On November 15, 2013, petitioner presented for follow-up at Togus. Pet. Ex. 2 at 99. He

was noted to be without alcohol for 36 days. Id. During that visit, he received a Twinrix hepatitis

A and B vaccine. Id. at 102. Petitioner alleges that only the hepatitis A vaccine caused him to

develop seizures. Pet. at ¶¶3, 15. At hearing, petitioner stated that he did not recall the nurse who

administered the vaccine informing him that he could develop fever, chills, or muscle aches after

the vaccine. Tr. 33-34.

4

Petitioner had Stevens – Johnson Syndrome from hydrochlorothiazide, which treats water retention. Stevens-

Johnson Syndrome is a reaction to medications or injection, with a red-purplish rash that spreads and blisters. It

requires emergency medical attention, usually hospitalization, and permanent avoidance of the medication. Stevens-

Johnson syndrome, MAYO CLINIC (Apr. 22, 2014), http://www.mayoclinic.org/diseases-conditions/stevens-johnson-

syndrome/basics/definition/con-20029623 (LAST VISITED OCT. 31, 2016).

5

Hyponatremia is a condition that occurs when the level of sodium in the blood becomes abnormally low.

Hyponatremia can cause nausea, vomiting, headache, confusion, fatigue, muscle weakness, and seizures.

Hyponatremia, MAYO CLINIC (May 28, 2014), http://www mayoclinic.org/diseases-

conditions/hyponatremia/basics/symptoms/con-20031445 (LAST VISITED NOV. 2, 2016). Petitioner had been

diagnosed with hyponatremia a year prior to the administration of his hepatitis vaccine, during his hospital visit on

November 22, 2012. See generally Pet. Ex. 5.

5

B. Petitioner’s Health after the Hepatitis Vaccination and Testimony

Petitioner testified that as soon as he received the vaccine, he immediately felt sick; his

headache was “screaming.” He had no idea how he drove home. He admitted to having headaches

since Vietnam, but this one was worse, but he didn’t say anything to anyone at Togus. Tr. 11; 39.

According to the petitioner, Togus is over a two-hour drive, or 250 miles, from his home, and

though he put his home address into the GPS, he got lost several times and drove past his own

house. Tr. 11. By the time he got home, he had a fever, headache, nausea, and vomiting. Tr. 39-

40. He has not “eaten right” since receiving the hepatitis vaccine. Tr. 13.

Petitioner stated that in the week following the vaccination, he suffered from vomiting,

fatigue, headaches, and could not stay awake. He also had a high fever. Tr. 13, 16-17. Petitioner

testified that other than his usual medications, he did not take anything for the vomiting, headache,

or fever that week. Tr. 49-50. Petitioner did recall his wife making him a protein drink during the

week after the vaccination. Tr. 52.

According to petitioner the headache, fever, nausea, and vomiting persisted until his wife

called an ambulance to take him to the hospital. Tr. 14. Petitioner testified that his wife called the

doctor at Togus twice to report petitioner’s symptoms and left messages, but the doctor did not

call back. Tr. 40. He later stated that his wife called the doctor in Newport, not Togus, but he

couldn’t remember her name.6 Tr. 49.

Petitioner was reminded by counsel that his wife had to call an ambulance after he took

cyproheptadine.7 Tr. 18. According to the petitioner, he was given cyproheptadine for pain and he

took it for the first time four or five days after the vaccination because he was in severe pain, his

headache was “so bad,” and he was “sick as a dog.” Tr. 19, 52. He later conceded that the pain he

was referring to after the vaccination was probably from the cancer, not the vaccination, admitting

that he has had pain from the cancer way before he received the vaccination. Tr. 27, 44. Petitioner

stated that after he took the cyproheptadine, he began seeing flashing lights as well as “little tiny

red bugs.” Tr. 18. His wife became scared and called an ambulance when she found him in a La-

Z-Boy recliner, seizing. Tr. 18, 20. According to the petitioner, he was shaking so much that the

EMTs could not administer the propofol. Tr. 20. Petitioner stated that his wife was told he stopped

breathing at least three times. Tr. 20.

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Petitioner has not produced any medical records or telephone records to confirm that any phone calls were made to

any doctor the week following the vaccination. Petitioner’s wife did not testify at hearing, though she was present

outside of the hearing room during petitioner’s testimony. The undersigned asked both counsel if either wanted

testimony from Mrs. Mondello after petitioner had finished testifying, but both counsel stated that they did not.

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Cyproheptadine is an antihistamine used to relieve allergy symptoms such as sneezing, itching, watery eyes, runny

nose, and other symptoms of allergies. Cyproheptadine, University of Michigan Health System (Dec. 3, 2013),

http://www.uofmhealth.org/health-library/d00790a1 (last visited Nov. 1, 2016). Side effects of cyproheptadine

include sedation, dizziness, urticaria, blurred vision, palpitations, and fatigue; overdosage may produce

hallucinations, CNS depression, and convulsions. Cyproheptadine may have “additive effects” with alcohol and

other CNS depressants, like sedatives or antianxiety agents. Cyproheptadine is contraindicated for “elderly,

debilitated” patients. Cyproheptadine Hydrochloride Tablets – Drug Summary, PDR net, http://www.pdr net/drug-

summary/Cyproheptadine-Hydrochloride-Tablets-cyproheptadine-hydrochloride-1549 (last visited Nov. 1, 2016).

6

When asked what medications he was taking at the time of the seizure, petitioner could

not recall, but stated that his wife gives him his medications. Tr. 40-41. When asked about

gabapentin,8 petitioner responded he believed he took it to help with his memory, and to help him

eat. Tr. 42. Petitioner indicated that he used medical marijuana, but denied that he used it at the

time he received the vaccine. Tr. 47-48.

Upon his arrival to St. Joseph’s Hospital on November 22, 2013, it was noted, “Patient was

last known well (about 1 hour PTA). (pt’s wife at bedside and reports that pt. recently had a

hepatitis A vaccination given to him on Friday and has not been feeling well since.

Nausea/vomiting and poor apetite. (sic) Per pt’s wife at approx. 5 pm today he began to hallucinate

(visual)).” Pet. Ex. 1 at 7. Petitioner’s wife also reported that petitioner had taken cyproheptadine

for the first time at around 4 p.m.; he became confused shortly thereafter and began hallucinating

and talking about flashes of light. Pet. Ex. 3 at 296. Petitioner then had a seizure and his wife called

an ambulance. Id.

Petitioner’s Glasgow Score (GCS)9 upon arrival was 7; he was intubated and administered

Valium. Pet. Ex. 1 at 8, 21. A head CT was normal. Id. at 25. A urine test was positive for

benzodiazepines and marijuana, with elevated glucose, trace blood, and protein. Id. at 26-27.

Petitioner was then transferred to the emergency department at Eastern Maine Medical Center

(“EMMC”) with an assessment of “generalized status epilepticus of unknown cause.” Id. at 31. It

was noted that petitioner was a longstanding alcoholic but had been sober for 46 days, and had no

prior history of seizures. Id. at 7, 22.

While at EMMC, petitioner underwent testing, including a chest x-ray, EEG, and head MRI

without contrast. Pet. Ex. 5 at 1393-99. The chest x-ray revealed that petitioner’s heart was “mildly

enlarged.” Id. at 1396. Petitioner’s EEG reflected “diffuse right-sided slowing,” “transient periodic

right lateralized discharges involving frontal area,” and “intermittent spikes throughout the record

involving right frontal area.” Id. at 1394. Petitioner’s MRI of the head showed “no acute or

malignant intracranial process,” with “moderate burden of white matter signal changes” and “mild

diffuse cerebral volume loss.” Id. at 1400. The general impression of the MRI was a finding of

uncertain clinical significance. Id.

Petitioner came under the care of Dr. Bourque, a neurologist. Dr. Bourque ordered a lumbar

puncture to rule out herpes simplex virus encephalitis “or other bacterial meningitis.” Pet. Ex. 7 at

1435. Dr. Bourque noted a concern that petitioner “may have an aseptic meningitis related to the

vaccination.” Id. Petitioner’s labs were negative for cryptococcus and herpes simplex virus. Pet.

Ex. 3 at 290. His lumbar puncture showed a “modest elevation in cerebrospinal fluid protein.” Id.

at 289. Dr. Bourque prescribed 500 mg of Keppra twice a day for seizures. Pet. Ex. 7 at 1435.

8

Gabapentin is an anticonvulsant used to treat refractory focal seizures, neuropathic pain, and migraines. Common

side effects include dizziness, ataxia, sedation, fatigue, and nystagmus. See Dorland’s Illustrated Medical

Dictionary 753 (Saunders eds., 32nd ed. 2012); see also Pediatric Neurology: Principles & Practice 962-63, 1197,

2378 (Swaiman, Ashwal, & Ferriero eds., 4th ed. 2006).

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“GCS” is the abbreviation for “Glasgow Coma Scale.” The Glasgow Coma Scale is the most common scoring

system used to gauge the severity of an acute brain injury, with a score of “3” as the most severe and a score of “15”

as the least severe, or normal. What Is the Glasgow Coma Scale?, BRAINLINE.ORG,

http://www.brainline.org/content/2010/10/what-is-the-glasgow-coma-scale html (LAST VISITED NOV. 1, 2016).

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Petitioner was discharged from EMMC on November 27, 2013, with a diagnosis of “new-

onset seizure,” delirium and hyponatremia. Pet. Ex. 3 at 285. Petitioner’s discharge summary

stated:

“[at] the time of this dictation, there is no specific etiology assigned to this patient’s

symptoms. Certainly his general condition was consistent with alcohol withdrawal

although the patient and multiple family members state that there has been on (sic) use of

alcohol in the past six weeks. One must also consider the possibility of withdrawal from

benzodiazepines, the effects of the hepatitis A vaccine that he received a few days prior,

withdrawal from other medications, side effects of other medications, and a multitude of

other metabolic derangements. In addition, the patient’s history of a traumatic brain injury

in Vietnam may put him at increased risk for development of a seizure disorder. Despite

the lack of a specific diagnosis, the patient’s general condition has improved remarkably.

He is now essentially at his baseline.”

Id. at 290.

Petitioner received physical therapy at home through December 2013. See generally Pet.

Ex. 4. Petitioner next presented to Mayo Practice Associates (“Mayo”) on January 9, 2014,

complaining of left trapezius strain and knee pain. Pet. Ex. 8 at 1475. Petitioner’s records list

“cyproheptadine HCl” as one of his allergies, with a reaction of “seizures, confusion.” Id. at 1476.

Petitioner returned to Mayo on January 23, 2014, for a follow-up of palpitations. Id. at 1477. The

assessment was that he had an elevated prostate-specific antigen, palpitations, and benign localized

prostatic hyperplasia. Id. at 1479.

On January 30, 2014, petitioner presented to Dr. Bourque for a follow-up. Pet. Ex. 7 at

1421. Dr. Bourque noted that she had initially met petitioner at the hospital on November 23, 2013

when he presented with a new onset of seizures. Id. Her notes for that date state:

“At the time of the hospitalization, he had had a hepatitis A vaccination 1 week

prior, and for that week had had nausea, vomiting, headache, and chills. He had

been tremulous and just generally not feeling well. On the day of presentation, he

took for the first time ever cyproheptadine 4 mg, and he had never taken this

medication before. His wife states that within 20-30 minutes he started having

visual hallucinations, and she went to call 911 and when she came back, she found

him seizing.”

Id. “He has not had any further severe headaches that occurred the week of presentation. He also

has not had any fevers or lateralized weakness. There have been no seizures.” Id. Following her

examination, Dr. Bourque documented

“Impression and Plan: [Petitioner] presented to hospital in November 2013 one

week following hepatitis A vaccination and was found to have altered mental status

following intake of cyproheptadine and subsequent recurrent seizures. He has done

well post discharge on Keppra in terms of no further seizures. Overall, his mental

status has returned close to baseline according to the family, although his wife states

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he has occasional episodes where his ability to give directions seems impaired.”

Id. at 1422. Dr. Bourque suggested he be seen by neuropsychology to get a baseline and assess

cognitive strengths and weaknesses. Id.

On February 24, 2014, a repeat EEG was performed which was normal. Prior findings seen

during his hospitalization had resolved. Pet. Ex. 7 at 1430.

On April 7, 2014, petitioner returned to Dr. Bourque for follow up of seizures. Dr. Bourque

noted: “He has been on Keppra ever since the episode, which occurred during a week when he had

had the hepatitis A vaccine and was not feeling well and was subsequently given 4 mg of

cyproheptadine and shortly after developed visual hallucinations and seizures. He has continued

on the (sic) Keppra and has not had any further seizures.” Pet. Ex. 7 at 1429. He had gone back to

drinking alcohol but stopped again a week and a half ago. Id. He started driving with no issues and

there has been no further “confusion spells.” Id. A repeat EEG performed on February 24, 2014

was normal and the prior findings seen during the hospitalization had resolved. Id. at 1430.

Following examination, Dr. Bourque reported:

“Impression and Plan: [Petitioner] had presented to hospital on November 2013 one

week after a hepatitis A vaccination and developed hallucinations and seizures

shortly after taking cyproheptadine. He has had no further seizures. His EEG is now

normal. I did discuss with [petitioner] and his wife today that in light of the

provoked nature of his seizures and the normal EEG, we could consider tapering

off the Keppra, although there is potential for recurrent seizures. He is not interested

in pursuing this option as it would mean stopping driving for 6 months. We also

discussed the possibility of switching Keppra to Trileptal, however, he finds he is

tolerating it better and is not interested in not driving for 3 months during the

switch.” Id.

Petitioner next presented to Dr. Bourque nearly a year later on March 20, 2015 for possible

“breakthrough seizure.” Pet. Ex. 7 at 1426. Petitioner testified that he had tried to wean himself

off Keppra without consulting a doctor; he became sick immediately. Tr. 22-23. He stated that

after he started slurring his words and his speech was garbled, he started retaking Keppra. Tr. 23.

Dr. Bourque noted that petitioner “had hepatitis A vaccine and was given 4 mg of cyproheptadine.

He had an abnormal EEG at that time and was started on Keppra. We continued the Keppra as we

did not know if he would have any further predisposition to seizures, and he did not want to go

with driving cessation and his wife was worried about another seizure.” Id. Dr. Bourque advised

that he should remain on the full dose and she would see him in the fall to discuss tapering. Id. at

1427.

Petitioner returned to Dr. Bourque on October 2, 2015 for follow up. Pet. Ex. 7 at 1450.

He had no further seizures. Under “Impression and Plan,” Dr. Bourque noted that petitioner

“continues to have a history of hospitalization with what was suspected to be possible be (sic) a

provoked seizure in 2013, with an abnormal EEG at that time. When he tried taking himself off

Keppra earlier this year, he had what was an atypical spell that may have represented a seizure so

we will continue the Keppra.” Id. at 1451.

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On March 18, 2016, petitioner returned to Dr. Bourque for a follow up. Pet. Ex. 9 at 1485.

He was again noted to have had a seizure in November of 2013 after he had “a hepatitis vaccine

and had been feeling unwell and was given cyproheptadine.” Id. Since an “unusual episode” when

he tried to wean off Keppra, he has had no further seizures. Id. “He does find that overall he is not

very good in familiar places and finding his way. He also finds it difficult to do things that he

previously did for years. He does continue to have intermittent lapses in his alcoholism.” Id. After

her examination, Dr. Bourque noted

“Impression and Plan: [petitioner] continues to have a history of hospitalization in

November 2013 for suspected provoked seizure, which was likely a combination

of being unwell from a hepatitis A vaccine and the compilation of

cyproheptadine….He has some various cognitive complaints, which are likely

multifactorial in light of his prior head injuries, alcoholism, chronic pain and

untreated psychiatric illness.…He does continue on thiamine.”

Id. at 1486. He was discharged from neurological care on that date. Id.

Petitioner testified that, in the summer of either 2016 or 2017, his Keppra was increased

after his wife accidentally slammed the trunk lid on his head, causing him to have a seizure the

next day. Tr. 24. Petitioner is being treated for Stage IV metastatic prostate cancer. Tr. 6.

III. Expert Opinions and Literature

The petitioner relied upon his treating neurologist, Dr. Suzanne Bourque, to support his

claim that the seizures he suffered were caused by the hepatitis A vaccine he received. Dr. Bourque

is a neurologist with a specialty in neuromuscular disease. Tr. 60; Pet. Ex. 15. She earned her

medical degree from the University of British Columbia, Vancouver, in 2006 and completed a

residency in neurology in 2011, followed by a one-year fellowship in neuromuscular disease. Tr.

60-61; Pet. Ex. 15. Dr. Bourque practiced at EMMC until April of 2016. Tr. 61. She now works

for Kaiser Permanente in San Rafael, California. Tr. 60.

In response to Dr. Bourque’s testimony and the literature submitted by petitioner,

respondent submitted an expert report from Dr. Thomas Leist. Dr. Leist has a Ph.D. in

biochemistry from the University of Zurich and a medical degree from the University of Miami.

Resp. Ex. F at 1. He completed his residency in neurology at Cornell Medical Center. Id. Since

2000, Dr. Leist has been a professor of neurology at Thomas Jefferson University, where he is also

the director of Hospital-based Neurology Infusion Services. Id. Dr. Leist did not testify.

Dr. Bourque based her theory upon her experience as a neurologist, petitioner’s clinical

presentation, and elevated proteins present in the petitioner’s cerebrospinal fluid (“CSF”). Her

theory was that petitioner developed aseptic meningitis10 following receipt of the hepatitis A

10

Aseptic meningitis describes any clinical syndrome characterized by meningeal inflammation not caused by an

identifiable pathogen in the CSF. Allan R. Tunkel et al., Acute Meningitis, 1 MANDELL, DOUGLAS, AND BENNETT’S

PRINCIPLES AND PRACTICES OF INFECTIOUS DISEASES 1189 (7th ed. 2010), hereinafter “Infectious Diseases.”

Common symptoms in adults with aseptic meningitis include headache, photophobia, stiff neck, rash, diarrhea,

cough, upper respiratory symptoms, anorexia, and vomiting. Id. at 1204-05.

10

vaccine, which lowered his seizure threshold to the extent that introducing cyproheptadine to his

already-primed system caused him to have a seizure. Tr. 77.

Dr. Bourque explained that viral illness or vaccination can cause the tissues covering the

brain and spinal cord to become inflamed, leading to aseptic meningitis.11 Tr. 74, 82; Pet. Ex. 16

at 2. According to Dr. Bourque, “meningitis” is the general term for inflammation of the meninges

and brain. When no bacteria is present, it is called “aseptic.” Tr. 83. According to Dr. Bourque,

there is no test for aseptic meningitis, but symptoms of fever and elevated protein are an indication

of the disease. Tr. 83. Petitioner’s history of nausea, vomiting, and worsened headaches after the

hepatitis vaccine made her suspect aseptic meningitis. Tr. 67-68; Pet. Ex. 16 at 2; Pet. Ex. 3 at 307.

She therefore ordered a lumbar puncture to rule out herpes simplex virus encephalitis and aseptic

meningitis. Pet. Ex. 16 at 2. The test results were negative for a viral infection. Dr. Bourque

admitted that sometimes CSF proteins are elevated for no reason.12 Pet. Ex. 16 at 2; Tr. 101-02,

119-20.

Dr. Leist dismissed Dr. Bourque’s theory of aseptic meningitis, stating that petitioner’s

medical records did not support the diagnosis. Resp. Ex. E at 6. According to Dr. Leist, petitioner’s

diagnostic work up showed a white cell count of less than 1, red cell count of 3, glucose of 82 and

protein of 88. Pet. Ex. 3 at 1279; Tr. 141. When aseptic meningitis is present, the white cell count

is elevated; petitioner’s white cell count was not elevated. Resp. Ex. E at 6; see also Resp. Ex. G13

at 1. Dr. Leist further stated that petitioner’s elevated CSF protein was a normal increase typically

seen after seizures. Resp. Ex. E at 7; Resp. Ex. I14 at 1, 3. Dr. Leist also stated that petitioner’s

medical history of lower back injury or his later diagnosis of stage IV prostate cancer could have

been responsible for the elevated CSF protein level.15 Resp. Ex. E at 7.

11

Noninfectious etiologies of aseptic meningitis include, but are not limited to, certain drugs, vaccines, systemic

illness, and medical procedures. Infectious Diseases at 1190.

12

“CSF pleocytosis is almost always presents” in aseptic meningitis. The total CSF cell count is usually 100 to 1000

cell/mm3. However, “elevated CSF protein and decreased CSF glucose concentrations, if present, are usually

mild….” Infectious Diseases at 1207.

13

Barbara Negrini et al., Cerebrospinal Fluid Findings in Aseptic Versus Bacterial Meningitis, PEDIATRICS, 105(2):

316-19 (2000), filed as Resp. Ex. G. In this study, cases of aseptic meningitis were defined as having at least 20

white blood cells/mm3. This study was done on children and the authors noted that the data was difficult to interpret

because many of the patients received antibiotics prior to the lumbar puncture. Petitioner was given acyclovir on

November 24, 2013, due to Dr. Bourque’s concern for viral infection, but discontinued after the lumbar puncture

results were available. Pet. Ex. 3 at 959.

14

Vaso Zisimopoulou et al., Cerebrospinal fluid analysis after unprovoked first seizure, FUNCT NEUROL, 31(2):

101-07 (2016), filed as Resp. Ex. I. This study was on males with an average age of 36. The results showed that CSF

protein was higher than normal after an unprovoked seizure, and implied a disruption of the blood-brain barrier in

patients with unprovoked seizures. Abnormal protein levels showed significant positive correlation with male

gender and older age. It was noted that “Lumbar degenerative changes and/or stenosis found in older patients can

potentially confound the correlation of age with CSF protein elevation.” Id. at 3. Petitioner had chronic back pain.

Pet. Ex. 2 at 99-100.

15

Petitioner refused a referral for a prostate biopsy for elevated prostate-specific antigen (PSA) during a visit to

Mayo Practice Associates on January 23, 2014. Pet. Ex. 8 at 1479; Resp. Ex. E at 4.

11

Dr. Leist submitted that the Institute of Medicine reviewed the adverse events following

hepatitis A and B vaccination, and aseptic meningitis is not listed as an adverse event for either

vaccine. Resp. Ex. E at 6. The IOM Report states that three publications reported encephalitis or

encephalopathy after hepatitis B vaccine, but did not provide any support for a connection other

than temporal relationship. Id. at 6-7; Resp. Ex. H.16

Dr. Bourque further opined that seizure activity can manifest itself after anything that

lowers the seizure threshold, such as a prior head injury. Tr. 68, 70, 74. She explained that

petitioner had a “provoked” seizure because he seized after a triggering event, like the use of a

medication, noting that unlike unprovoked seizures, someone suffering from a provoked seizure is

less likely to have another seizure. Tr. 77-78. When petitioner came under her care, she researched

the role of the hepatitis vaccine to determine a cause for his seizures. She could not recall if she

found anything about hepatitis vaccine specifically, versus vaccinations in general. Tr. 105, 120.

She did not research the medically appropriate time period for a vaccine to cause seizures, nor did

she know whether hepatitis A vaccine can cause seizures. Tr. 105-06, 120.

She also looked up cyproheptadine to determine whether it was a potential cause for

petitioner’s seizures and found that seizures were a potential side effect of the medication. Tr. 65-

66; 117-18; see Resp. Ex. C,17 Resp. Ex. D.18 Dr. Bourque agreed that the cyproheptadine could

have been responsible for petitioner’s abnormal EEG while hospitalized, but did not believe that

it would have caused petitioner’s elevated CSF protein. Tr. 118-20.

According to Dr. Bourque “…anything in theory could have triggered this.” Tr. 95, 98-

102. “That’s the hard thing with seizures, it’s always kind of estimating the potential contributors

and what their susceptibility is and it’s hard to be definitive.” Tr. 118. Dr. Bourque opined that a

combination of petitioner’s prior traumatic brain injury, his recent sobriety after a long history of

alcoholism, and the hepatitis vaccine contributed to his lowered seizure threshold. Tr. 131-32. The

cyproheptadine was the “trigger” for petitioner’s seizures, based on timing, and had a major role.

Tr. 85, 132.

Dr. Leist agreed that the cyproheptadine taken by the petitioner was the “provoking agent”

of petitioner’s seizures. Resp. Ex. E at 6. Dr. Leist submitted that animal models show that

administering cyproheptadine made it easier to induce seizures, increase the severity of seizures,

and reduce the efficacy of anti-epileptic medications. Resp. Ex. E at 6; Resp. Ex. C.19

16

K. Stratton, et al., ADVERSE EVENTS OF VACCINES: EVIDENCE AND CAUSALITY (2012) at 421-38, filed as Resp.

Ex. H.

17

Damanpreet Singh and Rajesh Kumar Goel, Proconvulsant potential of cyproheptadine in experimental animal

models, FUNDAM CLIN PHARMACOL, 24: 451-55(2010) (Noting that cyproheptadine is frequently prescribed as an

appetite stimulant, and found that cyproheptadine reduces seizure threshold and decreases the efficacy of clinically

used anti-epileptic drugs), filed as Resp. Ex. C.

18

Luke Shankar et al., Cyproheptadine induced seizures, MED RES CHRON, 2(1) 41-43 (2015) (concluding that

cyproheptadine reduces seizure threshold, increases the severity of seizures, and decreases the efficacy of clinically

used anti-epileptic drugs), filed as Resp. Ex. D.

19

Supra, n.17.

12

Dr. Leist added that petitioner’s other health issues were more likely to blame for his

feeling ill in the week prior to the seizure. Dr. Leist stated that though petitioner’s wife had reported

that he had experienced nausea, vomiting and poor appetite following the hepatitis vaccine, he had

similar gastrointestinal complaints a year earlier associated with hyponatremia and had been

hyponatremic on October 10 and 15 of 2013 during his alcohol rehabilitation. Resp. Ex. E at 7;

Pet. Ex. 2 at 65. Dr. Leist added that petitioner was discharged from alcohol rehabilitation with a

new prescription for Venlafaxine, which may have been responsible for his not feeling well and

has been associated with hyponatremia in the elderly with symptoms of headache, difficulty

concentrating, memory impairment, confusion, weakness and unsteadiness which may lead to

falls. Seizures are also associated with the medication. Resp. Ex. E at 7-8; Resp. Ex. J.20

Dr. Leist concluded that there was no evidence in the record that petitioner suffered from

aseptic meningitis on November 22, 2013, or that petitioner had any adverse reaction to the

hepatitis vaccine he received. Dr. Leist concluded that the cyproheptadine was the cause of Mr.

Mondello’s seizures and that the hepatitis vaccine had no role. Resp. Ex. E at 8.

In support of his petition, petitioner submitted a vaccine information sheet for hepatitis A;

a vaccine information sheet for hepatitis B; the package insert for Twinrix vaccine, an article titled

“A case-control study of serious autoimmune adverse events following hepatitis B immunization”

by David and Mark Geier;21 and an article titled “Population-Level Evidence for an Autoimmune

Etiology of Epilepsy” by Mei-Sing Ong et al.22 Pet. Ex. 10-14. None of the literature submitted

addressed hepatitis A vaccine and/or aseptic meningitis.23

The vaccine information sheets submitted by petitioner list the benefits of receiving the

hepatitis vaccine, the complications that receiving hepatitis A or B vaccine can cause, and the risks

of reaction from the vaccinations which include soreness or redness where the shot was given,

low-grade fever, headache and tiredness which could last one to two days, feeling faint, shoulder

pain, or an allergic reaction which could happen within minutes to a few hours after vaccination.

See generally Pet. Ex. 10-11.

Petitioner submitted the package insert for Twinrix which lists “convulsions” among the

events that have suspected causal connection to the components of Twinrix. Pet. Ex. 12 at 7. The

package insert contains the following: “These events are reported voluntarily from a population of

uncertain size, [so] it is not possible to reliably estimate their frequency or establish a causal

relationship to product exposure.” Id. at 6. Special masters have found that vaccine package inserts

are not probative of causation. See H.L. v Sec’y of Health & Human Servs, No. 10-197V, 2016

WL 3751848, at *13 (Fed. Cir. 2017); Sullivan v. Sec’y of Health & Human Servs., No 10-398,

20

Effexor (venlafaxine hydrochloride) prescribing information, Wyeth Pharmaceuticals, Inc., filed as Resp. Ex. J.

21

David A. Geier and Mark R. Geier, A case-control study of serious autoimmune adverse events following hepatitis

B immunization, AUTOIMMUNITY, 38(4): 295-301 (2005), filed as Pet. Ex. 13.

22

Mei-Sing Ong et al., Population-Level Evidence for an Autoimmune Etiology of Epilepsy, JAMA NEUROL, 71(5):

569-74 (2014), filed as Pet. Ex. 14.

23

Dr. Bourque did not provide any literature in support of her opinions in this matter, despite an opportunity to do

so. See Scheduling Order, ECF No. 69.

13

2015 WL 1404957, at *20 (Fed. Cl. Spec. Mstr. Feb 13, 2015)(“[s]tatements contained in vaccine

inserts do not constitute reliable proof of causation, and cannot be deemed admissions that vaccines

in question have the capacity to harm a particular petitioner in a specific manner”); see also

Werderitsh v. Sec’y of Health & Human Servs., No. 99-319V, 2005 WL 3320041, at *8 (Fed. Cl.

Spec. Mstr. Nov. 10, 2005)(quoting CFR § 600.80 as saying “A report or information submitted

by licensed manufacturer…does not necessarily reflect a conclusion by the licensed manufacturer

or FDA that the report or information constitutes an admission that the biological product caused

or contributed to an adverse effect.”).

Petitioner submitted a 2005 case study by Dr. Mark Geier and Mr. David Geier24 titled “A

case-control study of serious autoimmune adverse events following hepatitis B immunization.”

The study relied upon data from the Vaccine Adverse Events Reporting (VAERS) database and

discussed the increase of autoimmune diseases following hepatitis B vaccine.25 Dr. Leist pointed

out that VAERS is a passive reporting system which collects data on adverse events associated

with vaccinations for signal finding purposes. Pet. Ex. 13; Resp. Ex. E at 5. He explained that

VAERS provides neither conclusions regarding causation nor data on incidence. See Manville v.

Sec’y of Health & Human Servs., 63 Fed. Cl. 482, 494 (2004) (finding that the special master did

not err in dismissing “any significant value” of VAERS reports proffered by petitioner where the

special master “noted that a VAERS report can be filed by anyone, thereby bringing into question

the quantity and quality of the information gathered…”). The article provided no evidence for any

association between Hepatitis A/B vaccination and seizure disorder. Id. It is notable that studies

by David and Mark Geier have been routinely discredited in this program due to Dr. Mark Geier

not being qualified to opine on issues of neurology, immunology, or rheumatology.26

The Ong article, “Population-Level Evidence for an Autoimmune Etiology of Epilepsy,”

submitted by petitioner, examined “the relationship between epilepsy and 12 autoimmune

24

David A. Geier is not a doctor. He has not earned any advanced medical or scientific degrees. Riggins v. Sec’y of

Health & Human Servs., No. 99-382V, 2009 WL 3319818, at *6-7 (Fed. Cl. Spec. Mstr. June 15, 2009). The State

of Maryland revoked Mark Geier’s license to practice medicine in 2012. Hooker v. Sec’y of Health & Human Servs.,

No. 02-472V2016 WL 3456435, at *30-31 (Fed. Cl. Spec. Mstr. May 19, 2016).

25

Pet. Ex. 13, supra n.21.

26

See Doe/78 v. Sec’y of Health & Human Servs., 2010 WL 3154546 (Fed. Cl. Spec. Mstr. Jul. 26, 2010) (finding

the published medical research of Dr. Mark Geier and his son to be unreliable. (Fn. 16)); Pafford, 451 F.3d 1352

(concluding that the special master was justified in rejecting the testimony of Dr. Mark Geier based on the

insufficiency of Dr. Geier’s credentials); Raj v. Sec’y of Health & Human Servs., No. 96-294V, 2001WL 963984

(Fed. Cl. Spec. Mstr. Jun. 14, 2001)(criticizing Dr. Mark Geier as poorly qualified to opine on neurologic issues and

finding his testimony to be “quite unpersuasive.”); Haim v. Sec’y of Health & Human Servs., No. 90-1031V, 1993

WL 346392 (Fed. Cl. Spec. Mstr. Aug. 27, 1993) (holding that the testimony of Dr. Mark Geier did not meet the

level of evidentiary reliability required by Daubert, because it was not based upon scientific validity, valid

methodology, peer review or testing, and more than minimal support within the scientific community.); Marascalco

v. Sec’y of Health & Human Servs., No. 90-1571V, 1993 WL 277095 (Fed. Cl. Spec. Mstr. Jul. 9, 1993)(according

no weight to Dr. Geier’s testimony and finding his affidavit to be “seriously intellectually dishonest” and “an

egregious example of blatant, result-oriented testimony” which “undermines wholly his credibility as a witness.”);

Ormechea v. Sec’y of Health & Human Servs., No. 90-1683V, 1992 WL 151816 (Fed. Cl. Spec. Mstr. Jun. 10,

1992)(finding that, “[b]ecause Dr. [Mark] Geier has made a profession of testifying in matters to which his

professional background (obstetrics, genetics) is unrelated, his testimony is of little value to the court.”).

14

diseases: type I diabetes mellitus, psoriasis, rheumatoid arthritis, Grave’s disease, Hashimoto

thyroiditis, Crohn’s disease, ulcerative colitis, systemic lupus erythematosus, antiphospholipid

syndrome, Sjogren syndrome, myasthenia gravis and celiac disease.” Pet. Ex. 14 at 1.27 Dr. Leist

pointed out that the study was of children under the age of 18 and nonelderly adults under the age

of 65. Resp. Ex. E at 5. Petitioner was 70 years of age at the time of his seizure, with well

documented risk factors for seizures. Id. Dr. Bourque confirmed that petitioner did not have an

autoimmune disease. Tr. 128.

In order for an article to be relevant to petitioner’s claim, petitioner must offer some

connection between the disease discussed in the article, the vaccine and petitioner’s claimed injury.

See H.L., 2016 WL 3751848, at *14, n. 20 (Fed. Cir. 2017)(“Establishing a theory that a vaccine

can cause injury “X” is not the same as proving that it can cause injury “Y,” absent some evidence

showing that injuries X and Y share sufficient commonality.”).

IV. Legal Framework

The Vaccine Act provides two avenues for petitioners to receive compensation. First, a

petitioner may demonstrate a “Table” injury—i.e., an injury listed on the Vaccine Injury Table

that occurred within the provided time period. § 11(c)(1)(C)(i). “In such a case, causation is

presumed.” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006);

see § 13(a)(1)(B). Second, where the alleged injury is not listed on the Vaccine Injury Table, a

petitioner may demonstrate an “off-Table” injury, which requires that the petitioner “prove by a

preponderance of the evidence that the vaccine at issue caused the injury.” Capizzano, 440 F.3d at

1320; see § 11(c)(1)(C)(ii). A petitioner need not show that the vaccination was the sole cause, or

even the predominant cause, of the alleged injury; showing that the vaccination was a “substantial

factor” and a “but for” cause of the injury is sufficient for recovery. Pafford v. Sec’y of Health &

Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006); Shyface v. Sec’y of Health & Human Servs.,

165 F.3d 1344, 1352 (Fed. Cir. 1999).28 Once a petitioner has proven causation by preponderant

evidence, “the burden then shifts to the respondent to show by a preponderance of the evidence

that the injury is due to factors unrelated to the administration of the vaccine.” Deribeaux ex rel.

Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013) (citing §

13(a)(1)(B)).

The process for making factual determinations in Vaccine Program cases begins with

analyzing the medical records, which are required to be filed with the petition. § 11(c)(2). Medical

records created contemporaneously with the events they describe are presumed to be accurate and

“complete” such that they present all relevant information on a patient’s health problems. Cucuras

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

contemporaneous reports, “accuracy has an extra premium” given that the “proper treatment

hang[s] in the balance.” Id. Contemporaneous medical records that are clear, consistent, and

complete warrant substantial weight “as trustworthy evidence.” Id. Indeed, “where later testimony

27

Supra, n.22.

28

The Vaccine Act also requires petitioners to show by preponderant evidence that the “residual effects or

complications” of the alleged vaccine-related injury lasted for more than six months. § 11(c)(1)(D)(i). It is

undisputed that this six-month requirement is satisfied in this case.

15

conflicts with earlier contemporaneous documents, courts generally give the contemporaneous

documentation more weight.” Campbell ex rel. Campbell v. Sec’y of Health & Human Servs., 69

Fed. Cl. 775, 779 (2006); see United States v. U.S. Gypsum Co., 333 U.S. 364, 396 (1948). But

petitioners can support their claim with oral testimony if it is credible and consistent with the

medical records. See, e.g., Stevenson ex rel. Stevenson v. Sec’y of Health & Human Servs., No. 90-

2127V, 1994 WL 808592, at *7 (Fed. Cl. Spec. Mstr. June 27, 1994) (crediting the testimony of a

fact witness whose “memory was sound” and “recollections were consistent with the other factual

evidence”). In short, “the record as a whole” must be considered. § 13(a).

Furthermore, establishing a sound and reliable medical theory connecting the vaccine to

the injury often requires a petitioner to present expert testimony in support of his or her claim.

Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). The Supreme

Court’s opinion in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), requires

that courts determine the reliability of an expert opinion before it may be considered as evidence.

“In short, the requirement that an expert’s testimony pertain to ‘scientific knowledge’ establishes

a standard of evidentiary reliability.” Id. at 590 (citation omitted). Thus, for Vaccine Act claims, a

“special master is entitled to require some indicia of reliability to support the assertion of the expert

witness.” Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1324 (Fed.

Cir. 2010). The Daubert factors are used in the weighing of the reliability of scientific evidence

proffered. Davis v. Sec’y of Health & Human Servs., 94 Fed. Cl. 53, 66-67 (2010) (“…uniquely in

this Circuit, the Daubert factors have been employed also as an acceptable evidentiary-gauging

tool with respect to persuasiveness of expert testimony already admitted…”). Where both sides

offer expert testimony, a special master’s decision may be “based on the credibility of the experts

and the relative persuasiveness of their competing theories.” Broekelschen v. Sec’y of Health &

Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d at 1362). And

nothing requires the acceptance of an expert’s conclusion “connected to existing data only by the

ipse dixit of the expert,” especially if “there is simply too great an analytical gap between the data

and the opinion proffered.” Snyder ex rel. Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl.

706, 743 (2009) (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)).

Because petitioner did not allege an injury listed on the Vaccine Injury Table, his claim is

classified as “off-Table.” As noted above, for petitioner to prevail on an “off-Table” claim, he must

show by preponderant evidence that his injury resulted from the vaccination at issue. Capizzano,

440 F.3d at 1320. Doing so shifts the burden to respondent to show that the injury was caused by

factors unrelated to the vaccinations. Deribeaux, 717 F.3d at 1367.

To prove causation, petitioner must satisfy the three-pronged test established in Althen v.

Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). Althen requires that petitioner

show by preponderant evidence that the vaccination received caused the injury “by providing: (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 a

proximate temporal relationship between vaccination and injury.” Id. at 1278. Together, these

prongs must show “that the vaccine was ‘not only a but-for cause of the injury but also a substantial

factor in bringing about the injury.’” Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373,

1379 (Fed. Cir. 2012) (quoting Shyface, 165 F.3d at 1352-53). Causation is determined on a case-

by-case basis, with “no hard and fast per se scientific or medical rules.” Knudsen v. Sec’y of Health

16

& Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). The petitioner is not required to identify

“specific biological mechanisms” to establish causation, nor is he required to present

“epidemiologic studies, rechallenge, the presence of pathological markers or genetic disposition,

or general acceptance in the scientific or medical communities.” Capizzano, 440 F.3d at 1325

(quoting Althen, 418 F.3d at 1280). “[C]lose calls regarding causation are resolved in favor of

injured claimants.” Althen, 418 F.3d at 1280.

In essence, the special master is looking for a medical explanation of a logical sequence of

cause and effect (Althen, 418 F.3d at 1278; Grant, 956 F.2d at 1148), and medical probability

rather than certainty (Knudsen, 35 F.3d at 543, 548-49). Medical probability has been explained

as biologic credibility rather than specification of an exact biologic mechanism. As the Federal

Circuit stated in Knudsen:

Furthermore, to require identification and proof of specific biological mechanisms

would be inconsistent with the purpose and nature of the vaccine compensation

program. The Vaccine Act does not contemplate full blown tort litigation in the

Court of Federal Claims. The Vaccine Act established a federal “compensation

program” under which awards are to be “made to vaccine-injured persons quickly,

easily, and with certainty and generosity.” House Report 99-908, supra, at 3, 1986

U.S.C.C.A.N. at 6344.

The Court of Federal Claims is therefore not to be seen as a vehicle for ascertaining

precisely how and why DTP and other vaccines sometimes destroy the health and

lives of certain children while safely immunizing most others.

35 F.3d at 549.

As for epidemiological support for causation, the Federal Circuit in Knudsen, 35 F.3d at

551, ruled for petitioners even when epidemiological evidence directly opposed causation from

DPT vaccine. The case concerned the cause of a baby’s encephalopathy after a vaccination.

Respondent provided evidence that more encephalopathies are caused by viruses than by vaccines,

convincing the special master to rule against petitioners. However, the Federal Circuit thought the

epidemiologic evidence should not bar petitioners from prevailing. Even though epidemiological

evidence supported respondent’s defense in Knudsen that viruses were more likely to cause

encephalopathy than vaccinations, the Federal Circuit held that that fact alone was not an

impediment to recovery of damages. In Knudsen, the Federal Circuit stated:

The bare statistical fact that there are more reported cases of viral encephalopathies

than there are reported cases of DTP encephalopathies is not evidence that in a

particular case an encephalopathy following a DTP vaccination was in fact caused

by a viral infection present in the child and not caused by the DTP vaccine.

35 F.3d at 550.

17

The special masters “are entitled–indeed, expected–to make determinations as to the

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

presenting that evidence.” Moberly, 592 F.3d at 1325.

The Federal Circuit also stated that petitioner does not need epidemiological support in

order to prevail and does not have the burden of proving a specific biological mechanism. Id. In

Althen and Capizzano, the Federal Circuit stated that petitioner does not need to file supportive

medical literature to prevail.

V. Discussion

Respondent defends this case by submitting that there is a lack of support in the medical

records for Dr. Bourque’s theory of aseptic meningitis. Respondent did not address Dr. Bourque’s

opinions regarding petitioner’s lowered seizure threshold resulting from the hepatitis vaccine and

other co morbidities, causing the cyproheptadine to trigger his seizures. Respondent states that the

cyproheptadine petitioner took was the sole cause of petitioner’s seizures, and petitioner’s co-

morbidities were the cause of him not feeling well in the week after the hepatitis vaccine. The

Federal Circuit rejected respondent’s sole cause defense in Knudsen, where respondent’s expert

stated that “the only single thing that could explain all of [the baby’s] symptoms, encephalitic and

non-encephalitic, was a systemic viral infection.” 35 F.3d. at 550. The Federal Circuit in Knudsen

decided that the baby’s rhinorrhea was due to a virus, but her encephalopathy was due to her DPT

vaccination. Id.

Dr. Bourque stated that when she first saw petitioner, he was already intubated and sedated,

and unable to give a history. Tr. 63-64. It was her understanding at that time that petitioner had

received a vaccination about a week before and had been feeling unwell for several days, with

trembling, headaches, nausea, vomiting, and chills. According to the medical records she had,

petitioner’s headache was worse that week; she knew little more than that. Tr. 68; Pet. Ex. 3 at

307. She was unclear about the details, but believed he went to his health care provider during that

week, who prescribed cyproheptadine; within 20 to 30 minutes of taking the cyproheptadine,

petitioner started hallucinating, then seizing. Tr. 64-65, 92.

Dr. Bourque explained that infection can cause seizures; petitioner’s EEG results

resembled those of patients with herpes simplex virus, which was why she ordered the lumbar

puncture. Tr. 74. When petitioner tested negative for viral infection, Dr. Bourque became

concerned that “he had some kind of aseptic meningitis from the vaccination, and that

superimposed with the cyproheptadine had predisposed him to have seizures at presentation.” Tr.

67, 77. According to Dr. Bourque, vaccinations are one of many etiologies listed for aseptic

meningitis; symptoms of fever and elevated protein are an indication of the disease. Tr. 83. She

explained that viral illness or vaccination can cause the tissues covering the brain and spinal cord

to become inflamed, leading to aseptic meningitis. Tr. 74, 82; Pet. Ex. 16 at 2. Petitioner’s history

of nausea, vomiting, and worsened headaches after the hepatitis vaccine raised a concern for

aseptic meningitis. Tr. 67-68; Pet. Ex. 16 at 2; Pet. Ex. 3 at 307. Once the tests ruled out viral

infection, but showed elevated CSF protein, it was suggestive of aseptic meningitis. Pet. Ex. 16 at

2; Tr. 101-02, 119-20.

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Petitioner’s discharge summary did not mention aseptic meningitis.29 In Dr. Bourque’s

opinion, that was “because it’s – I guess we can’t say for certain what – you know, there’s no test

for aseptic meningitis, rarely protein can be elevated for an unclear reason, but in the context of

that picture in the acute setting that’s what I suspected…aseptic meningitis is something that is a

one-time event and resolves,30 so it wasn’t felt to be an ongoing relevant issue….” Tr. 102.

Dr. Leist disagreed that petitioner had aseptic meninigitis, pointing out that despite

petitioner’s testimony that he suffered from headaches, nausea, vomiting, and fever immediately

after receiving the vaccination on November 15, 2013, there was no medical record of anaphylaxis.

He further noted that petitioner was able to drive two hours home, and though petitioner states that

he got lost, that could be attributed to his other preexisting cognitive issues. Resp. Ex. E at 7; Tr.

11. Dr. Bourque agreed that petitioner’s claim of developing severe headache, nausea, chills, lack

of appetite, and shakiness immediately after receiving the hepatitis vaccine was unusual. Tr. 129.

Dr. Leist added that petitioner had prior episodes of nausea, vomiting, and poor appetite,

which were associated with hyponatremia, and that petitioner’s alcohol rehabilitation records a

month prior to his vaccination in October of 2013 noted that he had hyponatremia.31 Id.; Pet. Ex.

2 at 65.

Dr. Bourque agreed that hyponatremia can cause these symptoms and seizures; however,

she did not believe that hyponatremia contributed to petitioner’s seizure, as his electrolyte panel

at EMMC was normal. Tr. 127-28, 131. Dr. Leist countered that petitioner’s sodium levels may

have been higher due to I.V. fluids.32 Id.

Dr. Leist further proposed that petitioner was prescribed Venlafaxine (Effexor) upon

discharge from rehabilitation, which is known to affect appetite and cause weight loss; it has also

been associated with seizures. Resp. Ex. E at 7-8; Pet. Ex. 2 at 25; Resp. Ex. J.33 Patients with liver

disease metabolize venlafaxine more slowly, increasing the half-life of the medication. Resp. Ex.

E at 8. Petitioner had hepatitis C as well as alcohol dependence. Pet. Ex. 2 at 99-100; Pet. Ex. 3 at

304, 308. However, Dr. Leist admitted that he did not know if petitioner was taking the venlafaxine

at the time.

Dr. Bourque explained that petitioner had a provoked seizure, which occurs in the context

of an event or a medication that triggers it. Tr. 77-78. She explained the EEG findings stating that

petitioner had “tonic-clonic” seizures, meaning that the seizure activity involved the whole brain.

29

Dr. Bourque did not write petitioner’s discharge summary. While Dr. Bourque was consulted for her opinion as a

neurologist, petitioner’s care was coordinated by the hospitalist, Dr. Allen; he wrote the discharge summary. Pet. Ex.

290-91.

30

Treatment of aseptic meningitis is largely supportive. Recovery is usually complete, without neurologic sequelae.

Infectious Diseases at 1215.

31

Supra, n.5.

32

Petitioner’s hospital discharge summary at the time of this event lists hyponatremia as one of his conditions. Pet.

Ex. 3 at 285.

33

Supra, n.20.

19

Tr. 69. She explained that “diffuse right sided slowing,” meant slowing of the brain waves on the

right side, which is a nonspecific finding. Tr. 71; Pet. Ex. 8 at 1437. According to Dr. Bourque,

anything can cause slowing, including infection, structural abnormality, low sugar, and migraines.

“Slowing does not tell a lot.” Tr. 72-73, 75. EEG findings need to be taken as a whole and not read

in parts, explaining that the rest of the findings along with the slowing, “transient periodic right

lateralized discharges involving the frontal lobe” and “intermittent spikes,” suggested that “there

is excess irritability of the brain that is likely predisposing to seizure.” Tr. 73. According to Dr.

Bourque, the EEG results were “compatible with a focus involving the right frontal area, [and] the

diffuse slowing may have been related to postictal phenomenon or lesion state,” meaning that there

was some irritability, either due to the seizure or an underlying brain lesion. Tr. 75. She agreed

that petitioner’s abnormal EEG could have been the result of the cyproheptadine. Tr. 118-19. She

added that since petitioner’s MRI was unremarkable, there were no tumors or structural

abnormalities. Tr. 76.

Dr. Leist pointed out that petitioner’s EEGs taken before the seizure (November 20, 2008)

and four months after the seizure (February 24, 2014) were both normal. Resp. Ex. E at 6; Pet. Ex.

7 at 1430. Dr. Leist agreed that the EEGs during the hospital admission of November 22, 2013,

following the seizures, were abnormal, indicating that the EEG abnormalities were transient and

directly related to the seizure presentation on November 22, 2013 from taking the cyproheptadine.

Resp. Ex. E at 6; Pet. Ex. 5 at 1394.

When questioned about the discharge summary which stated “There is no specific etiology

sign (sic) to the patient’s symptoms, ” Dr. Bourque stated, “ I think that was accurate from their

perspective that there was no – we couldn’t prove exactly what had been the exact cause of his

problems.” Tr. 93-94; Pet. Ex. 3 at 290. The discharge note further stated that petitioner’s alcohol

withdrawal, hepatitis A vaccine, withdrawal from other medications, side effects of other

medications, and a multitude of other “metabolic derangements” should be considered in

determining the cause of petitioner’s seizure. Dr. Bourque agreed “it’s just a catch-all phrase that

anything in theory could have triggered this.” Tr. 94-95.

Dr. Bourque stated petitioner’s presenting complaints of not feeling well during the week

prior and following the hepatitis vaccine, along with the elevated CSF protein level suggested to

her that petitioner was experiencing irritation in his brain. Then the cyproheptadine was

introduced, triggering the seizure. According to Dr. Bourque, how each factor contributed to the

seizures, she did not know, only that it was a combination of petitioner’s prior head injury, long

term alcoholism, and hepatitis A vaccination that could lower his seizure threshold, and the

contribution of the cyproheptadine was needed at that time for the seizure to occur. Based on the

timing, the cyproheptadine played a major role, and with seizures, it is all about threshold. If

petitioner had been at a different threshold when he took it, he may not have seized. “That’s the

issue with seizures and that’s why it’s hard to say with any certainty the contributors.” Tr. 85-86,

131-32.

While Dr. Bourque agreed that petitioner’s abnormal brain activity seen on the EEG could

have been a side effect of the cyproheptadine alone, she would not agree that cyproheptadine was

the only cause of petitioner’s seizures, referring to the elevated CSF protein which led her to

suspect aseptic meningitis. Tr. 100-02, 118-19, 121.

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Dr. Leist submitted that, although petitioner reportedly did not feel well in the week

following his vaccination, there is no record that he suffered from changes in awareness, alertness,

perception, or cognition from his usual baseline until around 4:30 pm on November 22, 2013,

shortly after he took cyproheptadine for the first time. Resp. Ex. E at 7; Pet. Ex. 7 at 1435; Tr. 77.

In Dr. Leist’s opinion, the cyproheptadine was the “provoking agent” of petitioner’s seizures.

Resp. Ex. E at 6. Dr. Leist disregarded petitioner’s testimony that he had vomiting, fatigue,

headaches, high fever, and could not stay awake in the week following the hepatitis vaccine. Tr.

13, 15-17.

Dr. Bourque and Dr. Leist agreed that the cyproheptadine provoked petitioner’s seizures.

Dr. Bourque opined that she suspected aseptic meningitis caused by petitioner’s receipt of the

hepatitis vaccine and reported fever, severe headaches, and vomiting thereafter, but she considered

that all of petitioner’s co-morbidities in combination with the hepatitis vaccine lowered petitioner’s

seizure threshold so that introducing the cyproheptadine to an already primed system resulted in

the development of seizures. While Dr. Leist disagreed and explained why he believed that

petitioner did not have aseptic meningitis, he never addressed Dr. Bourque’s theory of lowered

seizure threshold. He opined that the cyproheptadine alone was the cause of petitioner’s seizures.

Dr. Leist attributed all of petitioner’s complaints in the days following the hepatitis vaccine to his

various co-morbidities, concluding that the hepatitis vaccine had nothing to do it. Dr. Leist even

described the effects of venlafaxine as responsible for petitioner’s not feeling well, a medication

prescribed to petitioner when he was discharged from alcohol rehabilitation, without any proof

that petitioner had ever taken the medication. Dr. Bourque’s opinion is more compelling and

persuasive in this case.

In further support of her opinions in this case, Dr. Bourque explained her office records

and its wording in detail.

In her first follow up visit with petitioner on January 30, 2014, Dr. Bourque noted under

“Impression and plan” that “[petitioner] presented to the hospital in November 2013 one week

following hepatitis A vaccination and was found to have altered mental status following intake of

cyproheptadine and subsequent recurrent seizures….” Pet. Ex. 7 at 1422-23. Dr. Bourque

explained that the cyproheptadine was closer in time to his seizures and was a contributor, but she

did not know whether petitioner would have had a seizure if he had been feeling well prior to

taking the cyproheptadine. Tr. 99-100. Dr. Bourque explained, though she did not explicitly write

that she believed that the combination of the hepatitis vaccine and cyproheptadine led to

petitioner’s seizures, “that was my implication.” Tr. 103.

Dr. Bourque was then asked about the visit on April 7, 2014, Pet. Ex. 7 at 1429-31, in

which she wrote “had presented to the hospital on November 2013 one week after hepatitis A

vaccination and developed hallucinations and seizures shortly after taking cyproheptadine.” Tr.

104. She stated that she did not explicitly state that the combination of the two things led to the

seizures but “to me I did there…it’s sort of the facts that occurred around his seizures, as I would

view it.” Tr. 104.

The next visit discussed was on March 20, 2015, in which Dr. Bourque wrote, “[Petitioner]

had a history of hospitalization with what was suspected to possibly have been a provoked seizure

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in 2013.” Pet. Ex. 7 at 1427. Dr. Bourque explained that she used the word “possibly” because

provoked seizures have a much lower risk of recurrence and a lower need for continued use of

anti-seizure medicine. Tr. 80, 108. However, petitioner described an incident following his attempt

to wean himself off Keppra in which he may or may not have had a breakthrough seizure. Tr. 78-

79. According to Dr. Bourque, this incident was unclear and she was not convinced that it was a

breakthrough seizure, but petitioner and his wife became nervous and so she continued Keppra.

Tr. 80-81; 108. Dr. Bourque further explained that another reason for keeping petitioner on Keppra

was in part because, in the State of Maine, you cannot drive for six months after tapering off anti-

seizure medication. Tr. 80.

In her October 2, 2015 office note, Dr. Bourque again referred to petitioner’s seizure as

“possibly” provoked. Pet. Ex. 7 at 1451. Dr. Bourque stated that it was seven months later and

since she was still unclear of what to make of the “breakthrough” seizure, “[I]t became unclear to

me definitively at that point what we were dealing with.” Tr. 109-10.

In his final visit on March 18, 2016, Dr. Bourque noted, “[Petitioner] continues to have a

history of hospitalization in November 2013 for suspected provoked seizures which was likely a

combination of being unwell from hepatitis A vaccine and the compilation of cyproheptadine.”

Pet Ex. 9 at 1486; Tr. 111. Dr. Bourque agreed that this was the first time that she noted in the

record that petitioner was unwell following the hepatitis A vaccine. Tr. 111-12. She stated that she

meant “combination,” not “compilation.” Tr. 111. It was also pointed out to Dr. Bourque that this

record was the first time she stated that petitioner’s suspected provoked seizures were likely a

combination of being unwell from hepatitis A vaccine and receipt of cyproheptadine. In response,

Dr. Bourque testified: “Yeah, I guess my – my other—impressions were explaining – I outlined

what had occurred without being able to say for sure, but just outlining the facts of what had

happened. And here I put that I suspected it was provoked by those two causes. I feel like that’s

what I alluded to the whole time.” Tr. 111-13.

Finally, according to Dr. Bourque, the medically appropriate time period for the onset of

seizures from aseptic meningitis varies based on the individual and other factors. Tr. 128. Dr. Leist

did not address the timing issue.

Neither expert disputes that petitioner suffered from a host of co-existing conditions at the

time he received the hepatitis vaccine. Neither disputes that petitioner suffered seizures following

his taking the cyproheptadine. They disagree, however, as to what may have caused petitioner’s

nausea, severe headache, fever and vomiting in the week following the hepatitis vaccine and

whether petitioner suffered from aseptic meningitis during that week. They also disagree as to

whether the cyproheptadine was the sole cause of petitioner’s seizures. Upon learning of all of

petitioner’s co-morbidities during the hearing in which she gave testimony, Dr. Bourque was

adamant that all of petitioner’s co-morbidities in combination with the hepatitis vaccine served to

lower petitioner’s seizure threshold so that his taking cyproheptadine triggered the onset of

seizures. Dr. Leist did not discuss the lowering of the seizure threshold, but concluded that the

cyproheptadine was the sole cause of the seizures.

I must analyze this case in terms of Shyface v. Sec’y of Health & Human Services, in which

Cheyenne Shyface was vaccinated with whole-cell DPT at the time he was beginning an E. coli

22

infection. Both the DPT and the E. coli infection could and did cause fever, which rose to 110

degrees, resulting in his death four days later. 165 F.3d. at 1345. Respondent defended the case

and argued that the E. coli infection was the cause of the baby’s fever and death. Testimony from

Cheyenne’s treating physician was that both the vaccine and the infection were equally responsible

for his fever and death. The Federal Circuit held that each of the two factors, the vaccine and the

infection, was a substantial factor in causing the baby’s very high fever and death and but for the

vaccination, the baby would not have had the high fever and would not have died. The Federal

Circuit ruled in favor of petitioners even though petitioners did not prove that DPT vaccine was

the only or predominant cause of death. Id. at 1353.

Here, petitioner’s treating physicians in the hospital included the hepatitis vaccine as a

contributing factor to the cause of his seizures, and petitioner’s treating neurologist testified to it.

The Federal Circuit’s direction in Capizzano, 440 F.3d at 1326, is for special masters to consider

seriously the opinions of the vaccinee’s treating doctors consistent with 42 U.S.C. § 300aa-

13(b)(1)(A) and (B), directing the special masters to consider the entire record, including the

diagnoses and medical judgments of doctors. Thus, the undersigned must conclude that the opinion

of petitioner's treating physicians that the combination of the hepatitis vaccine, co-morbidities and

cyproheptadine were all factors in petitioner’s development of seizures is determinative of the

outcome of this case.

The undersigned finds that petitioner has satisfied the three prongs of Althen: (1) vaccines,

which include hepatitis vaccines, can cause aseptic meningitis indicated by elevated proteins in

the CSF, and causing headache, nausea, vomiting, and fever, and either alone or in combination

with other co-morbidities can also reduce seizure threshold resulting in seizure activity if faced

with a trigger, in this case, cyproheptadine; (2) the hepatitis vaccine did cause aseptic meningitis

or irritation to petitioner’s brain resulting in fever, vomiting, more severe headache and sleepiness

and in combination with his co-morbidities lowered his seizure threshold resulting in his seizures

after taking cyproheptadine; and (3) petitioner’s onset of headache, nausea, vomiting, fever in the

days immediately following his hepatitis vaccine was appropriate in timing and indicative of

aseptic meningitis or irritation to his brain, which acting in combination with his co morbidities

lowered his seizure threshold so that he seized within an hour of taking cyproheptadine within the

week following the hepatitis vaccine.

VI. Conclusion

The undersigned finds in favor of entitlement. This case shall proceed in damages.

IT IS SO ORDERED.

s/Mindy Michaels Roth

Mindy Michaels Roth

Special Master

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