Appendix — Markovich v. Leavitt, 128 S. Ct. 92 (2007) (No. 06-1539)

App. i

TABLE OF CONTENTS

Appendix Page

Opinion of

The United States Court of Appeals

For the Federal Circuit

filed February 20, 2007 ......0...

Memorandum Opinion of

United States Court of Federal Claims

fiied October 31, 2005...........................

Decision of the

United States Court of Federal Claims

TEMES ULE Beale, MIMI cn sasievcnnvsnesuseceverecessvds

Office Notes of Steve Jaousek, M.D.

dated September 20, 2001 and

CRIRIIOE A BL sis cissassccaseseccrinsscseoss

Mayo Clinical Document Copy of

Jeffrey R. Buchhalter, M.D.

dated January 22, 2002.......................

Mayo Clinical Document Copy of

Randa G. Jannar, M.B.B.S.

dated January 29, 2002....................0.

App. i

Transcript of Proceedings before

The Honorable Margaret M. Sweeney

on November 5, 2004

Testimony of Jean-Ronel Corbier:

Direct Examination by Mr. Krueger

Cross Examination by Ms. Patton

Redirect Examination by Mr. Krueger

Recross Examination by Ms. Patton

App. 1

Markovich v. Secretary of Health and Human

Services

C.A.Fed.,2007.

United States Court of Appeals, Federal Circuit.

Michael and Melissa MARKOVICH, Parents of

Ashlyn M. Markovich, Petitioners-Appellants,

v. 3

SECRETARY OF HEALTH AND HUMAN

SERVICES, Respondent-Appellee.

No. 06-5039.

Feb. 20, 2007.

Background: Parents appealed from a final

decision of the United States Court of Federal

Claims, Susan G. Braden, J., 69 Fed.Cl. 327,

affirming Special Master’s report denying petition

filed on behalf of daughter for compensation under

the National Childhood Vaccine Injury Act.

Holding: The Court of Appeals, Linn, Circuit Judge,

held that infant’s eye blinking episode constituted

the first symptom of a seizure disorder, rather than

when infant began suffering grand-mal seizures,

triggering the running of the three-year limitations

period under the Vaccine Injury Act.

Affirmed.

West Headnotes

Federal Courts 170B 1107

170B Federal Courts

170BXII Claims Court (Formerly Court of

Claims)

App. 2

170BX11(B) Procedure

170Bk1103 Time to Sue and Limitations

170Bk1107 k. Accrual of Claims;

Continuing Claims. Most Cited Cases

Infant’s eye blinking episode constituted the first

symptom of a seizure disorder, rather than when

infant began suffering grand-mal seizures, triggering

the running of the’ three-year limitations period

under the Vaccine Injury Act; testimony confirmed

that the infant’s eye blinking episode, which occurred

within 24-hours of vaccination, was objectively

recognizable by the medical profession at large as

constituting the first evidence of vaccine injury

onset. National Childhood Vaccine Injury Act of

1986, § 311(a), 42 U.S.C.A. § 300aa-16(a)(2)

Mark L. Krueger, Greenhalgh Krueger & Hernandez,

SC, of .Baraboo, WI, argued for petitioners-

appellants. Lynn E. Ricciardella, Trial Attorney,

Torts Branch, Civil Division, United States

Department of Justice, of Washington, DC, argued

for respondent-appellee. With her on the brief were

Peter D. Keisler, Assistant Attorney General,

Timothy P. Garren, Director, Vincent J. Matanoski,

Acting Deputy Director, and Catharine E. Reeves,

Acting Assistant Director.

Before MICHEL, Chief Judge, RADER and LINN,

Circuit Judges. LINN, Circuit Judge.

Michael and Melissa Markovich (collectively the

“Markoviches”) appeal from a final decision of the

United States Court of Federal Claims (“Court of

Federal Claims”). Markovich v. Sec’y of Health &

Human Servs., 69 Fed.Cl. 327, 336 (Fed.Cl.2005)

App. 3

(“Final Decision”). That decision affirmed the Special

Master’s report, which denied the petition filed on

behalf of the Markoviches’ daughter, Ashlyn M.

Markovich (“Ashlyn”), for compensation under the

National Childhood Vaccine Injury Act (“the Vaccine

Act”) because it was time-barred. See Markovich v.

Sec’y of Health & Human Servs., No. 03-2015V

(Fed.Cl. July 22, 2005) (“Special Master Report”). We

affirm.

I. BACKGROUND

On July 10, 2000, when she was approximately two

_ months old, Ashlyn received a series of vaccinations,

including vaccinations against diphtheria, tetanus

(commonly known as lockjaw), pertussis (commonly

known as whooping cough), polio, and haemophilus

influenzae type B. That same day, the Maricoviches

observed that Ashlyn began to rapidly blink her eyes,

events that we refer to herein as the “eye blinking

episodes.” The Markoviches allege that, at that time,

they were not concerned by the eye blinking episodes

because they thought the episodes were merely an

indication that Ashlyn was tired.

The eye-blinking episodes continued after July 10,

2000. On August 30, 2000, *13855 Ashlyn became

unresponsive for approximately twenty minutes,

during which time all of Ashlyn’s extremities jerked

aggressively. The Markoviches immediately called

911. Ashlyn was taken to the Fairview Ridge

Emergency Room, where she was diagnosed with

having suffered a grand-mal seizure. Another seizure

occurred about two weeks later, on September 14,

2000. Ashlyn continued to suffer seizures almost

daily, sometimes experiencing three or more seizures

App. 4

a day, including seizures documented on October 11,

14, 18, 20, 21, and 22, 2000; Novernber 17, 2000;

January 8 and 25, 2001; March 3 and 29, 2001; April

2, 3, and 17, 2001; June 8, 2001; July 10, 17, and 31,

2001; August 11 and 24, 2001; September 17, 2001;

October 5 and 15, 2001; November 8, 2001; and

December 7, 2001. Final Decision, 69 Fed.Cl. at 328-

29. Ashlyn also experienced seizures that consisted

of eye blinking episodes between 150 and 500 times

per day. Melissa Markovich Aff. J 7. Throughout this

entire time, beginning with her hospitalization at the

Fairview Ridge Emergency Room, Ashlyn was

examined at several different hospitals by numerous

doctors. Nevertheless, the seizures persisted.

On January 29, 2002, Ashlyn was admitted to the

Mayo Clinic “to determine whether a single focus of

seizure onset is likely that would be susceptible to

surgical removal.” Final Decision, 69 Fed.Cl. at 329.

During that evaluation, a neurologist diagnosed

Ashlyn as having experienced “four types of seizures:

(1) repeated eye blinking; (2) clonic movement of the

face, arm, and leg; (3) generalized seizures with or

without focal onset; and (4) partial motor seizures.”

Id. at 330 (emphasis added). Following the

evaluation, the neurologist discussed treatment

options with Ms. Markovich.

On August 29, 2003, the Markoviches filed a petition

for compensation under the Act, alleging that Ashlyn

suffered the seizures as a result of her vaccination.

On January 27, 2004, the Special Master held a

status conference, indicating that an “Onset

Iiearing” was necessary in order to determine

whether the Markoviches’ petition was time-barred

App. 5

as having been filed more than three years after the

date on which the first symptom or manifestation of

onset of the injury occurred. On November 5, 2004,

the Special Master held the Onset Hearing to

determine whether the onset of the seizures occurred

on July 10, 2000, the date of Ashlyn’s initial eye

blinking episode, or on August 30, 2000, the date

when Ashlyn was hospitalized and diagnosed with

having a seizure.

On July 22, 2005, the Special Master found that the

date of the occurrence of the first symptom or

manifestation of onset of the seizures was July 10,

2000, and found that the Markoviches’ petition was

time-barred pursuant to 42 U.S.C. § 300aa-16(a)(2)

because the petition was filed on August 29, 2003,

more man three years later. See Special Master

Report, slip op. at 24. Accordingly, the Special Master

dismissed the petition for lack of jurisdiction. Id. The

Court of Federal Claims affirmed the Special

Master’s decision on October 31,2005. Final Decision,

69 Fed.Cl. at 335-36.

The Markoviches timely appealed to this court. We

have jurisdiction pursuant to 28 U.S.C. § 1295(a)(3).

II. DISCUSSION

A. Standard of Review

Under the Vaccine Act, the Court of Federal Claims

reviews the Special Master’s decision to determine if

it is “arbitrary, *1356 capricious, an abuse of

discretion, or otherwise not in accordance with the

law.” 42 US.C. § 300aa-12(e)(2)(B). We effectively

App. 6

review the Special Master’s decision under the same

standard, since we review the trial court’s legal

determination de novo as to whether the Special

Master acted in a manner not in accordance with the

law. Althen v. Sec’y of Health & Human Servs., 418

F.3d 1274, 1277-78 (Fed.Cir.2005) (citing Hines v.

Sec’y of Health & Human Servs., 940 F.2d 1518, 1524

(Fed.Cir.1991)). While we owe no deference to either

the Special Master or the trial court on questions of

law, Whitecotton v. Sec’y of Health & Human Servs.,

81 F.3d 1099, 1106 (Fed.Cir.1996), we review factual

findings for clear error, Hines, 940 F.2d at 1523.

B. Analysis

The Vaccine Act was established to increase the

safety and availability of vaccines. See 42 U.S.C. §

300aa-l. Under the Vaccine Act, Congress established

a Vaccine Injury Compensation Program through

which claimants could petition to receive

compensation for vaccine-related injuries. See §

300aa-10(a). Congress included a table in the Vaccine

Act that lists injuries that may occur as a result of

the administration of vaccines. See § 300aa-14

(“Vaccine Injury Table”). In relevant part, the Vaccine

Act sets forth: In the case of... a vaccine set forth in

the Vaccine Injury Table which is administered after

October 1, 1988, if a vaccine-related injury occurred

as a result of the administration of such vaccine, no

petition may be filed for compensation under the

Program for such injury after the expiration of 36

months after the date of the occurrence of the first

symptom or manifestation of onset or of the

significant aggravation of such injury.

App. 7

§ 300aa-l6(a)(2).

It is not disputed that the vaccines that were

administered to Ashlyn are listed in the Vaccine

Injury Table and that Ashlyn suffers from seizure

disorders as a result of the administration of such

vaccines. The question in this case is what standard

should be applied in determining the date of “the

occurrence of the first symptom or manifestation of

onset or of the significant aggravation of such

injury,” id., and whether the eye blinking episode

that occurred on July 10, 2000 meets that standard.

If so, the Markoviches’ petition is time-barred,

having been filed more than 36 months after the

July 10, 2000 episode.

The Markoviches argue that the standard for statute

of limitations purposes should be a subjective one,

focusing on the particular view of a specific parent.

The Markoviches suggest that the limitations period

was not triggered until they knew that “any injury or

symptom had occurred,” or “there [was] a reasonable

basis of an injury that [is] separate, distinct and

apart from a normal activity.” Br. for Appellant 17-

18. The Markoviches assert that the eye blinking

episode that pre-dated the seizure diagnosis cannot

be considered a triggering event because it was an

everyday event, which they thought meant only that

Ashlyn was tired. The Markoviches argue that the

triggering event for statute of limitations purposes

should be August 30, 2000, when, for the first time,

the Markoviches became aware of an injury. The

Markoviches also urge that we follow the logic of

Setnes v. United States, 57 Fed.Cl. 175 (2003), which,

according to the Markoviches, establishes that there

must be a recognizable sign of a vaccine injury before

App. 8

there is a manifestation *1357 of onset of injury that

would trigger the statute of limitations. The

Markoviches argue that, pursuant to the logic of

Seitnes, the first “manifestation of onset” (i.e., the

grand-mal seizure suffered on August 30, 2000), but

not the first “symptom” (i.e., the eye blinking episode

on July 10, 2000), should start the statute of

limitations because the eye blinking symptom could

not reasonably alert the Markoviches that anything

was wrong with Ashlyn.

The government responds that (he standard for

statute of limitations purposes should be objective,

focusing not on a particular parent’s view but on

recognized standards of the medical community.

The government argues that, using an objective

Standard, the Court of Federal Claims correctly held

that the July 10, 2000 eye blinking episode

constituted the first symptom of the seizure disorder,

triggering the running of the limitations period. The

government points out that the Markoviches’ own

expert testimony proves that the eye blinking

episode constituted the onset of the seizure disorder.

The government also asserts that the Markoviches’

reliance on the Setnes decision, which is not binding

on this court, is misplaced and distinguishable.

We begin our analysis with the language of the

Vaccine Act, which expressly bars a petition for

compensation that is filed more than 36 months

after the date of the occurrence of the “first symptom

or manifestation of onset” of injury. See 42 U.S.C. §

300aa-16(a)(2). Under the plain language of the

Vaccine Act, the “first symptom or manifestation of

onset” of injury means that either a “symptom” or a

App. 9

“manifestation of onset” can trigger the running of

the statute, whichever is first. Because Congress is

presumed to have intended a disjunctive meaning by

using the disjunctive word “or,” we interpret the

words “first symptom” and “manifestation of onset”

as referring to two different forms of evidence of

injury. See, eg., Shalala v. Whitecotton, 514 U.S. 268,

274, 115 S.Ct. 1477, 181 L.Ed.2d 374 (1995)

(emphasizing that the Vaccine Act refers to either a

“symptom” or a “manifestation of onset” and that

either form of evidence may show the onset of the

injury). This disjunctive interpretation is consistent

with the use of the word “or” to distinguish the

dissimilar meaning of the words “symptom” and

“manifestation of onset” as used in the Vaccine Act.

There is a difference between a “symptom” and

“manifestation of onset.” A symptom may be

indicative of a variety of conditions or ailments, and

it may be difficult for lay persons to appreciate the

medical significance of a symptom with regard to a

particular injury. A manifestation of onset is more

self-evident of an injury and may include significant

symptoms that clearly evidence an injury. For

example, in this case, the eye-blinking episode was a

symptom of a seizure disorder without any diagnosis,

while the grand-mal seizure of August 30, 2000 was

a manifestation of onset of a seizure disorder.

In Setnes, the Court of Federal Claims held that

“where there is no clear start to the injury, such as in

cases involving autism, prudence mandates that a

court addressing the statute of limitations not hinge

its decision on the occurrence of the first symptom.”

Setnes, 57 Fed.Cl. at 179 (internal quotation marks

omitted). The Court of Federal Claims concluded

App. 10

that, in cases where symptoms are hard to recognize,

courts should look instead to the manifestation

prong. The court in Setnes was concerned with the

very subtle symptoms attributed with autism that

can be easily confused with typical child behavior,

and it distinguished the terms “symptom” *1358 and

“manifestation,” construing the latter as

“synonymous with open, clear, visible, unmistakable,

indubitable, indisputable, evident, and self-evident.”

Id. at 179-80. The Setnes court concluded that

in a situation such as mat before the court, where

the symptoms of autism develop “insidiously over

time” and the child’s behavior cannot readily be

connected to an injury or disorder, the court may rely

on the child’s medical or psychological evaluations

for guidance in ascertaining when the “manifestation

of onset” occurred.

Id. at 181.

A significant problem with the rationale of Setnes is

that it effectively reads the Vaccine Act as if the

statute of limitations were not triggered until there

was appreciable evidence showing a symptom and

manifestation of the injury. However, the Vaccine Act

states that the statute of limitations is triggered by

the “first symptom or manifestation of onset.” 42

U.S.C. § 300aa-16(a)(2) (emphasis added). The use of

the words “first” and “or” require that the statute of

limitations commence with whichever event (i.e,

symptom or manifestation of onset) occurs first. The

statute does not require that both events occur

before the running of the limitations period can

commence.

App. 11

The Setnes construction also suggests that a subtle

symptom or manifestation of onset of the injury, such

as a symptom that would be recognizable to the

medical profession at large but not to the parent,

would not be sufficient to trigger the running of the

Statute. Yet the Vaccine Act has consistently been

interpreted as including subtle symptoms or

manifestations of onset of the injury within the

ambit of evidence that triggers the running of the

statute:

Turning to the issue of accrual of the statute of

limitations in Section 16(a)(2), the terms of the

Vaccine Act demonstrate that Congress intended the

limitations period to commence to run prior to the

time a petitioner has actual knowledge that the

vaccine recipient suffered from an injury that could

result in a viable cause of action under the Vaccine

Act. First, a particular symptom or manifestation,

such as a seizure, often can result from a variety of

different conditions. Hence, a petitioner typically will

recognize that a particular symptom constitutes the

first symptom or manifestation of the onset of a

certain injury only with the benefit of hindsight,

after a doctor makes a definitive diagnosis of the

injury. By commencing the running of the limitations

period on the date the first symptom or

manifestation of the onset occurs, Congress chose to

start the running of the statute before many

petitioners would be able to identify, with reasonable

certainty, the nature of the injury.

Brice v. Sec’y of Health & Human Servs., 36 Fed.Cl.

474, 477 (1996), affd on other grounds, 240 F.3d 1367

(Fed.Cir.2001). In Brice, we held that equitable

tolling is not available for claims arising under §

App. 12

300-16(a)(2), reasoning that “the statute of

limitations here begins to run upon the first

symptom or manifestation of the onset of injury, even

if the petitioner reasonably would not have known at

that time that the vaccine had caused an injury.” 240

F.3d at 1373; see also Sharpnack v. Sec’y of Health &

Human Servs., No. 90-983V, 1992 WL 167255, at *2

(Cl.Ct. Special Master June 29, 1992), affd, 27

Fed.Cl. 457 (1993), affd, 17 F.3d 1442 (Fed.Cir.1994)

(table) (holding that “in many Vaccine Program cases

the injuries are first manifested *1359 as subtle

signs and seizures of less complicated nature, e.g.,

seizures lasting less than 30 minutes or seizure

activity so subtle as to be unrecognized at their

onset”).

The Supreme Court, in Whitecotton, interpreted the

terms “first symptom or manifestation of onset,” as

that language is used in §§ 300aa-Il(c)(1)(C)(i) FX’ and

300aal4(a) ©? of the Act, to include subtle symptoms.

Although these sections deal with causation and the

temporal relationship of the administration of the

vaccine and evidence of injury, the relevant language

of those sections is virtually identical to the relevant

language of § 300aa-16(a)(2) at issue in this case. In

Whitecotton, the Court emphasized that the proper

focus is on the first evidence of injury, emphasizing

that any observable “symptom or manifestation” may

be the first evidence of injury. 514 U.S. at 274, 115

S.Ct. 1477. The Supreme Court, unlike the Court of

Federal Claims in Setnes, did not require that a

petitioner appreciate the significance of that

evidence. Notably, while the Markoviches contend

that the July 10, 2000 eye blinking episode did not

start the running of the statute of limitations, they

App. 13

argue that it supports causation, reasoning that

“lallthough petitioners’ experts are using that event

[eye blinking on July 10, 2000] to support their

opinion that the seizure disorder that manifested

itself on August 30, 2000, was caused by the

vaccination of July 10, 2000, it should not be used

against petitioners to support the respondent’s

argument that the statute of limitations began to

run on July 10, 2000.” The statutory language of the

causation provision is the same as the statute of

limitations provision. There is no principled basis to

conclude that “first symptom or manifestation of

onset” should be construed one way for causation

and another way for the statute of limitations.

FN1. § 300aa-11(c)(1)(C)G) provides:

A petition for compensation under the

Program for a vaccine-related injury or death

shall contain ... an affidavit, and supporting

documentation, demonstrating that the person

who suffered such injury or who died

sustained, or had significantly aggravated,

any illness, disability, injury, or condition set

forth in the Vaccine Injury Table in association

with the vaccine ... and the first symptom or

manifestation of the onset or of the significant

aggravation of any such illness, disability,

injury, or condition or the death occurred

within the time period... in the Vaccine Injury

Table. 42 U.S.C. § 300aa-l1(c)(1)(C)G) (emphasis

added).

FN2. § 300aa-14(a) provides:

The following is a table of vaccines, the

injuries, disabilities, illnesses, conditions, and

App. 14

deaths resulting from the administration of

such vaccines, and the time period in which

the first symptom or manifestation of onset or

of the significant aggravation of such injuries,

disabilities, illnesses, conditions, and deaths is

to occur after vaccine administration for

purposes of receiving compensation under the

Program....

42 U.S.C. § 300aa-14(a) (emphasis added).

Setnes is also factually distinguishable from the

Markoviches’ case. The eye blinking episodes here

were not so readily confused with typical child

behavior over the course of the limitations period as

were the symptoms of autism in Setnes. The eye

blinking episodes in this case began promptly after

the vaccination and were connected to the injury of

seizure disorder within ample time to have filed a

timely claim. As discussed above, the January 29,

2002 report from the Mayo Clinic established that

“repeated eye-blinking” was not only a symptom of

seizure activity but also manifested one type of

seizure activity. The record also reflects that, as

*1360 of September 20, 2001, Ms. Markovich

understood that Ashlyn’s eye blinking was seizure

activity. See Special Master Report, slip op. at 4.

Moreover, the Markoviches’ own medical expert, Dr.

Corbier, testified at the Onset Hearing that:

[T]he eye blinking could have either been some small

seizures, subtle seizures if you will, or there is also

the possibility that it could have been some type of

brain dysfunction.

There is no question that |when the cye blinking

episode occurred] there was a miid scizure....

App. 15

[TIhere was some type of dysfunction of some sort

that likely started on July 10th, leading to a

documented seizure on August 30th.

Similarly, Dr. Corbier’s expert report states that “the

patient’s onset of possible seizures (paroxysms of

rapid eye blinking) ... occurred within 24 hours

following a set of immunizations....” Thus, as

distinguished from Setnes, the eye blinking episodes

were not normal child behavior, were part of the

same injury that culminated on August 30, 2000 in a

grand-mal seizure, and would have at the very least

raised Dr. Corbier’s suspicions.

We have previously explained that the Vaccine Act’s

statute of limitations must be strictly and narrowly

construed because it is “a condition on the waiver of

sovereign immunity by the United States, and courts

should be careful not to interpret [a waiver] in a

manner that would extend the waiver beyond that

which Congress intended.” Brice, 240 F.3d at 1370.

A subjective standard that focuses on the parent’s

view would result in an uneven and perhaps overly

broad application of the statute of limitations

dependent entirely on the subjective perceptions of

lay persons having widely varying degrees of medical

awareness or training. On the other hand, an

objective standard that focuses on the recognized

standards of the medical profession at large treats

petitioners equally, without regard to their

individual degree of medical awareness. An objective

standard is_ consistent with the _— statutory

requirement that the first symptom or manifestation

of onset of the injury begins the running of the

statute of limitations, as well as the cases discussed

App. 16

supra that have consistently construed the Vaccine

Act to include subtle symptoms that would be

recognizable to the medical profession at large but

not necessarily to the parent. See generally Goetz v.

Sec’y Health & Human Servs., 45 Fed.Cl. 340, 342

(1999) (following Brice and holding that a vaccine

claim is based on “the occurrence of an event

recognizable as a sign of a vaccine injury by the

medical profession at large, not the diagnosis that

actually confirms such an injury in a specific case”

(emphasis added)), gqffd, 4 FedAppx. 827

(Fed.Cir.2001).

For all of the reasons discussed above, we hold that

“the first symptom or manifestation of onset,” for the

purposes of § 300aa-16(a)(2), is the first event

objectively recognizable as a sign of a vaccine injury

by the medical profession at large. Because the

testimony of Dr. Corbier and others confirms that

Ashlyn’s eye blinking episode on July 10, 2000 was

objectively recognizable by the medical profession at

large as constituting the first evidence of vaccine

injury onset, 1.e., the first symptom of injury, and

because the Markoviches filed their petition on

August 29, 2003, more than 36 months after the

initial symptoms, the petition is time-barred under §

300aa-16(a)(2).

CONCLUSION

For the foregoing reasons, the Final Decision is

AFFIRMED.

*1361 COSTS

App. 17

No costs.

C.A.Fed.,2007.

Markovich v. Secretary of Health and Human

Services

477 F.3d 1353

END OF DOCUMENT

App. 18

Markovich ex rel. Markovich v. Secretary of Dept.

of Health and Human Services

Fed.Cl.,2005.

United States Court of Federal Claims.

Michael and Melissa MARKOVICH, parents of

Ashlyn M. Markovich, Petitioners,

.

SECRETARY OF THE DEPARTMENT OF

HEALTH AND HUMAN SERVICES, Respondent.

No. 03-2015V.

Oct. 31,2005.

Background: Parents filed a _ petition for

compensation under the National Childhood Vaccine

Injury Act, alleging that their child’s seizure

disorder and intractable epilepsy were caused by

diphtheria, tetanus, and acellular pertussis (DTaP),

inactivated polio virus (IPV), and haemophilus

influenzae type B (Hib) vaccines that child received

on July 10, 2000. The special master ruled that

petition was untimely, and parents filed motion for

review.

Holdings: The Court of Federal Claims, Braden, J.,

held that:

(1) special master’s finding that July 10, 2000 was

the date of the “first symptom or manifestation of

onset” of seizure disorder for statute of limitations

purposes was not arbitrary or capricious,

(2) and special master did not abuse her discretion

in relying on expert testimony based on “hindsight”

to find that onset date of child’s seizure disorder for

App. 19

statute of limitations purposes was date of

vaccinations when child had repeated eye blinking

episode.

Motion denied.

West Headnotes

[1] Health 198H 389

198H Health

198HII Public Health

198Hk383 Contagious and Infectious Diseases

198Hk389 k. Vaccine Injury Programs;

Government Liability. Most Cited Cases

Special master’s finding in vaccine injury case that

July 10, 2000 was the date of the “first symptom or

manifestation of onset” of seizure disorder for statute

of limitations purposes was not arbitrary or

capricious; finding was based on testimony of

petitioners’ expert that child’s eye blinking episode

on July 10, 2000, which was the date of vaccinations,

was first objective symptom of seizure disorder.

Public Health Service Act, § 2116(a)(2), 42 U.S.C.A. §

300aa-16(a)(2).

[2] Health 198H 389

198H Health

198HII Public Health

198Hk383 Contagious and Infectious Diseases

198Hk389 k. Vaccine Injury Programs;

Government Liability. Most Cited Cases

Special master in vaccine injury case did not abuse

her discretion in relying on expert testimony based

on “hindsight” to find that onset date of child’s

App. 20

seizure disorder for statute of limitations purposes

was date of vaccinations when child had repeated

eye blinking episode. Public Health Service Act, §

2116(a)(2), 42 U.S.C.A. § 300aa-16(a)(2).

[3] Health 198H 389

198H Health

198HII Public Health

198Hk383 Contagious and Infectious Diseases

198Hk389 k. Vaccine Injury Programs;

Government Liability- Most Cited Cases

Statute of limitations on claims under the National

Childhood Vaccine Injury Act begins to run from the

first symptom or manifestation of the onset of injury,

even if a petitioner reasonably would not have

known at the time that the vaccine had caused an

injury. Public Health Service Act, § 2116(a)(2), 42

U.S.C.A. § 300aa-16(a)(2).

*327 Mark L. Krueger, Greenhalgh Krueger

Hernandez & Fasi, S$.C., Baraboo, Wisconsin, for

Petitioners.

Traci R. Patton, United States Department of

Justice, Washington, D.C., for Respondent.

MEMORANDUM OPINION

BRADEN, Judge.

On July 22, 2005, a Special Master of the United

States Court of Federal Claims (“the Special

Master”) issued an unpublished decision finding that

Petitioners did not file a *328 claim for relief under

the National Childhood Vaccine Injury Act, 42

App. 21

U.S.C. §§ 300aa-l to -34 (2000 & Supp. II 2003),

(“Vaccine Act”) within the three-year statute of

limitations and, therefore, the United States Court

of Federal Claims did not have jurisdiction to reach

the merits of this case. See Markovich v. Sec’y Dep’t

of Health & Human Servs., No. 03-2015V, slip op.

(Fed.Cl.Spec.Mstr. July 22, 2005) (“Markovich”).

On August 19, 2005, Petitioners filed a Motion for

Review challenging the Special Master’s decision. On

September 19, 2005, the Government filed a

Response. The court has issued this Memorandum

Opinion on an expedited basis to facilitate any

appellate review that Petitioners may decide to

pursue.

RELEVANT FACTS™'

FN1. The relevant facts recited herein are

summarized from factual findings found in

Markovich, at 1-13. Citations to the record are

noted as follows: “Pet. 9 __” refers to the

August 29, 2003 Petition; “Pet Ex. at __”

refers to Petitioners’ exhibits; “Aff. 7 _”

refers to the Affidavit of Melissa Markovich;

and “TR at __” refers to the transcript of the

November 5, 2004 hearing before the Special

Master.

Ashlyn Markovich (“Ashlyn”) was born on May 12,

2000 to Melissa and Michael Markovich. See

Markovich, at 4 (Pet. Ex. 1 at 1). On July 10, 2000,

Ashlyn received Diphtheria, Tetanus, and Acellular

Pertussis (“DtaP”), Inactivated Polio Virus (“IPV”),

and Haemophilus influenzae type B (“Hib”)

App. 22

vaccinations. Jd. at 1. On July 10, 2000, Ashlyn also

experienced a repeated eye blinking episode.”™’ Jd.

at 2, 14 (Pet { 3; Aff. 7 4). Ashlyn’s eye blinking

episodes continued until August 30, 2000, when she

was admitted to Fairview Ridges Hospital in

Burnsville, Minnesota (“Fairview Ridges Hospital”)

and diagnosed with a seizure, but the cause was not

identified. Id. at 2-3, 5 (Pet Ex. 18 at 5; Pet Ex. 14 at

30).

FN2. Ashlyn’s parents noticed the repeated

eye blinking, but assumed that she was tired.

See Markovich, at 2, 14 (Pet. | 3; Aff. J] 4).

On September 8, 2000, Ashlyn had a routine

examination, during which her pediatrician, Dr.

Tiffani Mullins, was advised of Ashlyn’s seizure, but,

nevertheless, found Ashlyn normal. /d. at 5 (Pet. Ex.

4 at 5). On September 14, October 11, 14, 18, 20, 21,

and 22, 2000, however, Ashlyn experienced other

seizures. Id.

On October 16, 2000, Dr. Ronald H. Spiegel, a

Pediatric Neurologist at St. Paul Children’s Hospital

in St. Paul, Minnesota (“Children’s Hospital”),

examined Ashlyn and prescribed Tegretol, an

antiseizure medication, which she began taking on

October 21, 2000. Id. (Pet. Ex. 6 at 210; Pet Ex. 16

at 45-46). On October 22, 2000, Ashlyn again was

admitted to Children’s Hospital, at which time the

Tegretol was discontinued and another series of tests

was performed. Z/d. at 5 (Pet. Ex. 6 at 159-63). On

November 9, 2000, Ashlyn had a_ folow-up

examination with Dr. Spiegel. /d. at 6 (Pet. Ex. 16 at

44). On November 17, 2000, Ashlyn experienced

App. 23

another seizure and again was taken to Fairview

Ridges Hospital. Jd. (Pet Ex. 14 at 23-26; Pet. Ex. 18

at 12). She was treated and discharged on November

20, 2000. Jd. (Pet. Ex. 16 at 4-5).

On January 8, 2001, Ashlyn returned to Fairview

Ridges Hospital and was diagnosed as having

experienced a seizure. Id. (Pet. Ex. 14 at 17-19).

After two to three weeks of coughing, congestion,

and fevers, Ashlyn was examined by Dr. Mullins on

January 25, 2001. Id. (Pet. Ex. 4 at 9). Ashlyn was

diagnosed with a prolonged upper respiratory

infection and probable acute bronchitis. Jd. Later

that same day, however, Ashlyn again was admitted

to Fairview Ridges Hospital and diagnosed as having

experienced a seizure. Jd. (Pet. Ex. 14 at 14-16). On

January 29, 2001, Ashlyn had a follow-up visit with

Dr. Spiegel, who reported that Ashlyn was

developing well, notwithstanding the seizure

episodes. Jd. (Pet. Ex. 16 at 41-42).

On March 3, 29, April 2, 3, 17, June 8, and July 10,

2001, Ashlyn experienced additional seizures. Id. at

6-7 (Pet. Ex. 5 at 89-91, 99-100; Pet. Ex. 6 at 210;

Pet. Ex. 14 at 4-7; Pet. Ex. 18 at 19; Pet. Ex. 19 at 2).

Following the July 10, 2001 seizure, Ashlyn was

admitted to St Francis Regional Medical Center, in

Shakopee, Minnesota (“St. Francis”), *329 and

underwent blood tests that indicated a mildly

elevated white blood cell count. Jd. at 7 (Pet. Ex. 5

at 90-91). Ashlyn was discharged on that date,

against medical advice. Jd. (Pet. Ex. 5 at 91).

On July 12, 2001, Ashlyn received a neurological

assessment from Dr. Steven Janousek of the Noran

App. 24

Neurological Clinic, in Minneapolis, Minnesota. Id.

(Pet Ex. 7 at 71-72). From July 18, 2001 to April 26,

2002, Ashlyn’s mother frequently contacted Dr.

Janousek to advise him of Ashlyn’s condition and

request advice about seizure management. Jd. (Pet.

Ex. 7). On July 23, 2001, Ashlyn had a urine

analysis that indicated that her organic acid pattern

screen was not consistent with that of a known

excess of acid, her urine amino acid pattern was not

consistent with a known disorder of amino acid

metabolism, but an oligosaccharides screen was

normal. Id. at 7-8 (Pet. Ex. 5 at 34-36).

On July 17, 31, August 11, and 24, 2001, Ashlyn

experienced additional seizures. Id. at 7-8 (Pet. Ex.

5 at 31-32, 85-88, 92-93, 97; Pet. Ex. 18 at 31). On

August 28, 2001, Ashlyn was re-examined by Dr.

Janousek. Id. at 8 (Pet. Ex. 7 at 58). On September

10, 2001, Ashlyn was admitted to the Pediatric

Epilepsy Ward at Children’s Hospital to start a

ketogenic diet "“* Id. (Pet. Ex. 6 at 202-206, 209-213,

216). During this time, Ashlyn also was evaluated

by the Speech Pathology Department, which

determined that Ashlyn had a mild receptive and

expressive language delay. /d. (Pet. Ex. 6 at 89).

FN3. A ketogenic diet is a:

stringent, mathematically calculated diet high

in fat and low in protein and carbohydrates

that, when followed conscientiously, produces

a by-product called ketones in patients’ blood

and urine.

High concentrations of ketones in the

body control the frequency and severity of a

seizures, although the biochemical

App. 25

mechanisms for this phenomenon are not yet

known.

The Ketogenic Diet, The Epilepsy & Brain

Mapping Program, at

http://www.epipro.com/k_diet.html (last

visited October 31, 2005) (cited by Markovich,

at 8n.19).

On September 13, 2001, Ashlyn was discharged from

Children’s Hospital, but on September 17, October 5,

15, and November 8, 2001, Ashlyn experienced

additional seizures and was taken to St Francis. Id.

at 8-9 (Pet. Ex. 6 at 202-205; Pet. Ex. 5 at 79-84; Pet.

Ex. 18 at 24).

On December 7, 2001, Ashlyn was taken to St

Francis, where her mother observed a cluster of

seizure activity. Id. at 9 (Pet. Ex. 5 at 75-76). Later

that afternoon, Ashlyn again was taken to the

hospital with seizure activity. Jd. Shortly after her

second discharge, Ashlyn returned with a recurrence

of seizure activity. Id.

On December 26, 2001, Ashlyn was admitted to

Children’s Hospital for a prolonged evaluation. Jd. to

St. Francis. Jd. (Pet. Ex. 5 at 48-49). After being

released, Ashlyn experienced a one-and-a-half hour

seizure that her mother promptly reported to the

hospital. Jd. (Pet. Ex. 6 at 5).

On October 8, 2002, Ashlyn was examined to prepare

for the implantation of a VNS. Jd. (Pet. Ex. 6 at 181-

184). On October 10, 2002, Dr. Mary E. Dunn

implanted the VNS. Jd. (Pet. Ex. 6 at 178-180). In

the months following the implantation, however,

App. 26

there was little to no improvement in seizure

frequency and intensity. Jd. (Pet. Ex. at 6 at 165-

171).

On January 3, 2002, Ashlyn received a speech and

language evaluation by Ms. Michelle Laurent at St.

Francis Rehabilitative Service. Jd. (Pet. Ex. 5 at 438-

45). After observing significant speech and language

delays, Ms. Laurent recommended that Ashlyn

receive therapy for slow development. Jd. (Pet. Ex. 5

at 44).

On February 2, April 25, and June 19, 2003, Ashlyn

experienced additional seizures. Jd. at 12-13 (Pet.

Ex. 5 at 37-42).

PROCEDURAL BACKGROUND

On August 29, 2003, Michael and Melissa

Markovich, the parents of Ashlyn Markovich,

(“Petitioners”) filed a Petition for Compensation

under the Vaccine Act (“the Petition”), alleging that

Ashlyn’s seizure disorder and intractable epilepsy

were caused by the DtaP, IPV, and/or HiB vaccines

that Ashlyn received on July 10, 2000. Jd. at 2. In

support, Petitioners submitted Ashlyn’s medical

records, Ms. Markovich’s Affidavit (“the Markovich

Affidavit”), expert Affidavits of Dr. Frank J. Ritter

(Pet. Ex. 12) and Dr. Donald H. Marks (Pet. Ex. 17),

and an expert report from Dr. Jean-Ronel Corbier

(Pet. Ex. 20).

At a January 27, 2004 status conference, the Special

Master indicated that an Onset Hearing with expert

testimony was necessary, because the Petition and

App. 27

the Markovich Affidavit raised statute of limitations

concerns. See Markovich, at 4; see also Pet. | 3; Aff.

q 4. On June 2, 2004, Petitioners filed the expert

report of Dr. Corbier, a Pediatric Neurologist. See

Markovich, at 4. On November 5, 2004, the Special

Master conducted an Onset Hearing in Washington,

D.C., at which Dr. Corbier testified. Jd. The

Government declined to proffer an expert witness to

interpret the significance of Ashlyn’s *331 July 10,

2000 and subsequent eye blinking episodes. Id.

On July 22, 2005, the Special Master issued a

decision finding that the first symptom or

manifestation of onset of Ashlyn’s seizure disorder

occurred on July 10, 2000, the date of her

vaccinations and on which she had an initial eye

blinking episode. Since Petitioners filed their claim

on August 29, 2003, fifty days after the three-year

limitations period expired, however, the Special

Master ruled that the United States Court of Federal

Claims did not have jurisdiction to consider the

merits of the Petition. Jd. at 2.

On August 19, 2005, Petitioners timely filed a

Motion for Review of the Special Master’s July 22,

2005 decision, pursuant to Appendix B, Rule 23 of

the United States Court of Federal Claims. Therein,

Petitioners assert that their claim was filed within

the 36-month limitations period, because the

limitations period did not commence until August

30, 2000, the date that Ashlyn first was diagnosed by

a licensed physician as having experienced a seizure.

Petitioners contend that the Special Master

incorrectly interpreted Dr. Corbier’s expert opinion

to fix with certainty the July 10, 2000 repeated eye

App. 28

blinking episode as the onset of Ashlyn’s seizure

disorder. See Pet Mem. of Objections at 1-2.

Petitioners also contend that the July 10, 2000

repeated eye blinking episode was not a “symptom”

of a seizure disorder and that the Special Master

erred in relying on “hindsight.” Jd. at 2-4. In

addition, Petitioners take issue with the Special

Master’s gratuitous remark that if this case were

allowed to proceed it would “open the door to

legitimate claims.” Id. at 4-5 (emphasis added).

Finally, Petitioners argue that the Special Master

misconstrued Brice v. Sec’y Health & Human Servs.,

240 F.3d 1367 (Fed.Cir.2001); Goetz v. Sec’y Health

& Human Servs., 45 Fed.Cl. 340 (Fed.Cl.1999), affd,

4 Fed. App’x. 827 (Fed.Cir.2001); and Childs v. Sec’y

Health & Human _ “Servs., 33 4Fed.Cl. 556

(Fed.Cl.1995). Id. at 5-6.

On September 19, 2005, the Government filed a

Response. Accordingly, these issues are now ripe for

review by the United States Court of Federal

Claims. See 42 U.S.C. § 300aa-12(e).

DISCUSSION

A. Standard Of Review.

Congress requires that the United States Court of

Federal Claims analyze conclusions of law made by a

Special Master under the Vaccine Act de novo, i.e.,

pursuant to a “not in accordance with law” standard.

See 42 U.S.C. § 300aa-12(e)(2)(B); see also Althen uv.

Sec’y of Health & Human Servs., 418 F.3d 1274,

1277 (Fed.Cir.2005) (“Under the Vaccine Act, the

[United States} Court of Federal Claims reviews the

App. 29

special master’s decision to determine if it is

arbitrary, capricious, an abuse of discretion, or

otherwise not in accordance with law.”) (internal

quotations omitted). The “not in accordance with

law” standard is applicable where there is dispute

over statutory construction or other legal issues. See

Saunders v. Sec’y Dep’t of Health & Human Seruvs.,

25 F.3d 1031, 1033 (Fed.Cir.1994) (quoting Munn v.

Sec’y Dep’t of Health & Human Servs., 970 F.2d 863,

870 n. 10 (Fed.Cir.1992)); Hines v. Sec’y Dep’t of

Health & Human _ Servs., 940 F.2d 1518,

1527(Fed.Cir.1991).

Factual findings of a Special Master should not be

set aside unless they are held to be arbitrary and

capricious or a Special Master has acted in a manner

evidencing an abuse of discretion. See 42 U.S.C. §

300aa-12(e)(2)(B); see also Turner v. Sec’y of Health

& Human Servs., 268 F.3d 13834, 1357

(Fed.Cir.2001). The United States Court of Appeals

for the Federal Circuit, recognizing that “no uniform

definition of this standard has emerged,” has

instructed the court that the decision of a Special

Master may be found to be “arbitrary and

capricious,” but only if there has been reliance: on

factors which Congress has not intended [the special

masters] to consider, entirely failed to consider an

important aspect of the problem, offered an

explanation for its decision that runs counter to the

evidence ... or is so implausible that it could not be

ascribed to a difference in view or the product of

agency expertise.

Hines, 940 F.2d at 1527 (quoting *332 Motor Vehicle

Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463

App. 30

U.S. 29, 48, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983))

(discussing a similar standard of review for agency

rulemaking under the Administrative Procedure

Act).

Discretionary rulings are reviewed under an “abuse

of discretion standard.” Munn, 970 F.2d at 870 n. 10;

see also Turner, 268 F.3d at 1337.

B. The Relevant Statute Of Limitations.

For vaccines listed in the Vaccine Injury Table *™®

and administered after October 1, 1988 (“post-Act”),

the Vaccine Act provides:

FN8. The DTaP, IPV, and Hib vaccinations

are listed on the Vaccine Injury Table. See 42

C.F.R. § 100.3(a) (2005).

{I]f a vaccine-related injury occurred as a result of

the administration of such vaccine, no petition may

be filed for compensation under the Program for

such injury after the expiration of 36 months after

the date of the occurrence of the first symptom or

manifestation of onset or of the significant

aggravation of such injury.

42 U.S.C. § 300aa-16(a)(2) (emphasis added). The

starting point for a statute of limitations analysis,

therefore, requires identification of the date of the

occurrence of either (a) the first symptom or (b)

manifestation of onset or of the significant

aggravation of such injury.*® Jd.; see also Shalala v.

Whitecotton, 514 U.S. 268, 274, 115 S.Ct. 1477, 131

L.Ed.2d 3874 (1995) ([Tlhe symptom or

App. 31

manifestation occurring after the vaccination must

be evidence of the table injury’s onset[.]}”)-

FN9- “The term ‘significant aggravation’

means any change for the worse in a

preexisting condition which results’ in

markedly greater disability, pain, or illness

accompanied by substantial deterioration of

health.” 42 U.S.C. § 300aa-33(4).

Since the Vaccine Act’s statute of limitations is an

explicit condition of the waiver of sovereign

immunity by the United States, the United States

Court of Appeals for the Federal Circuit has

instructed the court to be “careful not to interpret a

waiver in a manner that would extend the waiver ...

beyond that which Congress intended.” Brice. 240

F.3d at 1370 (quoting Stone Container Corp. uv.

United States, 229 F.3d 1345, 1352 (Fed.Cir.2000)

(internal quotation omitted)). Our appellate court

also has clarified that equitable tolling is not

available for claims arising under the Vaccine Act.

See Brice, 240 F.3d at 1374 (holding that equitable

tolling is not available in post-Act cases and

explaining that it is “inconsistent with the existing

statutory scheme”); see also Weddel vu. Sec’y of Health

& Human Servs., 100 F.3d 929, 931-932

(Fed.Cir.1996) (holding that equitable tolling is not

available in pre-Act cases).

App. 32

C. The Court’s Resolution Of Petitioners’

Motion For Review.

1. The Special Master’s Finding That July 10,

2000 Was The Date Of The “First Symptom Or

Manifestation Of Onset” Is Not Arbitrary Or

Capricious.

[1] Petitioners challenge the Special Master’s

determination that Dr. Corbier concluded that

Ashlyn’s July 10, 2000 repeated eye blinking episode

was the onset of a seizure disorder. See Pet. Mem. of

Objections at 1-2. Petitioners argue that “Dr. Corbier

testified that it was his opinion that the onset date of

Ashlyn’s seizure disorder was August 30, 2000.” Jd.

at 1 (citing TR at 9). The court disagrees.

The court presumes that Petitioners’ argument is

based on Dr. Corbier’s testimony that “on August

30th, 2000, the patient had a generalized tonic-clonic

seizure that lasted at least 20 minutes. So as of that

date, the patient did definitively have documented

seizures and that went beyond August 30th, 2000.”

TR at 9. To interpret this as an opinion that the

onset of Ashlyn’s seizure disorder was August 30,

2000 . misconstrues Dr. Corbier’s testimony,

particularly when viewed in its entirety. For

example, Dr. Corbier testified that Ashlyn’s July 10,

2000 eye blinking episode was the result of a

cerebral dysfunction and is “linked to” the August

30, 2000 seizure. See TR at 10. Dr. Corbier also

testified that, in his professional judgment, July 10,

2000 was the “time line of when something first

started [that] may have lprecipitated the July] 10th

lincident] ... was due to some type of cerebral

App. 33

dysfunction, and then the results culminated in her

*333 having a seizure ... on August 30th.” *%”° Jd.

And, as Dr. Corbier explained:

FN10. Dr. Corbier initially misstated the date

of the repeated eye blinking episode, but

corrected the record to identify the correct

date, July 10,2000. See TR at 10.

In terms of timing, it appears like there was some

type of precipitating event in this case with the

vaccine and on that same day you have the eye

blinking episodes, irregardless of whether the eye

blinking turned out to be some type of cerebral

dysfunction or little seizure ... [alnd that they

progressed on August 30th to a full-blown seizure.

Id. at 14.

In addition, Dr. Corbier explained that Ashlyn’s July

10, 2000 eye blinking episode was an “objective

symptom” of a seizure disorder.*’” Id. at 19, 25.

Moreover, in response to the Special Master’s

question at the Onset Hearing about whether “the

first symptom occurred with the eye blinking

episodes that were noted on July 10th[,]” Dr. Corbier

responded affirmatively: “Yes, I think there was

some type of dysfunction of some sort that likely

started on July 10th, leading to a documented

seizure.” Jd. at 19. Later in his testimony, Dr.

Corbier advised the Special Master that “the eye

fluttering and seizure disorder are both symptoms of

a single process caused by an insult to the brain at

about the time of the vaccinations.” Jd. at 25.

Accordingly, the Special Master correctly concluded

that: “Dr. Corbier made clear that even though he

App. 34

could not have gaid with absolute certainty on July

10, 2000, that Ashlyn had a seizure disorder, he was

able to testify that problematic neurological

symptoms were present.” Markovich, at 19.

FN11. Petitioners contend that the repeated

eye blinking episode is not a “symptom” of

Ashlyn’s seizure disorder. See Pet. Mem. of

Objections at 2-3. Petitioners define a

“symptom” as “any subjective evidence of a

disease or of a patient’s condition” and argue

that the eye blinking episode was neither

subjective evidence nor objective evidence of a

neurological disorder, disease, or condition. Jd.

(quoting Dorland’s). As discussed herein, the

court is bound by this precedent, not a medical

dictionary. See infra Discussion, Part (C)(3),

at 10-11.

For these reasons, the court has determined that the

Special Master’s finding that the date of the onset

was July 10, 2000 was not arbitrary or capricious.*™””

FN12. Petitioners also object to the Special

Master’s statement that:

[Pletitioners need not understand the

significance of a first symptom, the symptom

merely must be manifest. To hold otherwise

would open the door to many who would

conveniently argue that while they observed

certain activity shortly after vaccination that

was explained to be the first symptom or

manifestation of an onset of an injury, because

they lack medical training, they failed to

App. 35

recognize those first symptoms as_ the

manifestation of an injury.

See Pet. Mem. of Objections at 4-5 (referencing

Markovich, at 23). Although this statement

was entirely gratuitous and not justified by

any evidence in the record, the court holds

that it is not grounds for reversal. See Turner,

268 F.3d at 1337.

2. The Special Master Did Not Abase Her

Discretion In Relying On Expert Testimony

Based On “Hindsight.”

[2] At the Onset Hearing, Dr. Corbier acknowledged

that “hindsight is very important, in the sense that...

the full-fledged seizures started on August 30th, and

looking back ... the eye blinking episodes had been

seizures.” TR at 12-13, 23 (emphasis added).

Petitioners take issue with the Special Master’s

reliance on Dr. Corbier’s opinion for this reason. See

Pet. Mem. of Objections at 3-4; see also TR at 12-13,

23.

The court has not identified any text in the Vaccine

Act or decisions of the United States Court of

Appeals for the Federal Circuit that address this

issue, although the United States Court of Federal

Claims has directly considered this evidentiary

consideration from different perspectives. Compare

Brice v. Sec’y Dep’t of Health & Human Servs., 36

Fed.Cl. 474, 477 (Fed.Cl.1996) (observing, without

citation, that Congress was aware that “a petitioner

typically will recognize that a particular symptom

constitutes the first symptom or manifestation of the

onset of a certain injury only with the benefit of

App. 36

hindsight, after a doctor makes a definitive diagnosis

of the injury”) with Setnes v. United States, 57

Fed.Cl. 175, 180 (Fed.Cl.2003) (criticizing a Special

Master’s reliance on an expert’s opinion that was

“the product of a *334 retroactive evaluation and

enjoyed the benefit of hindsight,” because the expert

“had the fully assembled puzzle in front of him, and

when taking the puzzle apart, opined that the pieces

he was taking apart must have come from the

puzzle”).

The Setnes court was particularly concerned with the

expert’s hindsight diagnosis because it was “plainly

inconsistent with ... contemporaneous medical

evaluations.” Setnes, 57 Fed.Cl. at 180. Unlike

Setnes, the record in this case does not include any

contemporaneous medical evaluations of Ashlyn

between July 10, 2000 and August 30, 2000.

Accordingly, the court determines that the Special

Master did not abuse her discretion in relying on Dr.

Corbier’s conclusions, notwithstanding the benefit of

“hindsight.”

3. As A Matter Of Law, The Statute Of

Limitations Runs From The First Symptom Or

Manifestation Of The Onset, “Even If A

Petitioner Reasonably Would Not Have Known

At The Time That The Vaccine Had Caused An

Injury.”

[3] In the alternative, Petitioners argue that the

repeated eye blinking episode on July 10, 2000

cannot be interpreted as the onset of Ashlyn’s

seizure disorder, because they “were never of the

opinion that the eye blinking was anything other

App. 37

than their child being tired.” Pet Mem. of Objections

at 2.

The United States Court of Appeals for the Federal

Circuit, however, has held that the statute of

limitations in Vaccine Act cases “begins to run upon

the first symptom or manifestation of the onset of

injury, even if the petitioner reasonably would not

have known at the time that the vaccine had caused

an injury.” Brice, 240 F.3d at 1373; see also Goetz v.

Sec’y of Health & Human Servs., 45 Fed.Cl. 340, 341

(Fed.Cl.1999) (“[I]t is clear that Congress intended

the cause of action in a Vaccine Injury Table case to

accrue upon occurrence of the first symptom of an

injury, not upon the first identification of a link

between the injury and the vaccination.”). Because

applicable precedent does not require that a

petitioner appreciate or recognize that a symptom or

manifestation of the onset was caused by a vaccine,

but only that the symptom or manifestation occur,

the Special Master was correct in finding that:

It is not relevant to the onset query that the parents

were unaware that the blinking episodes were a

neurological symptom that served as the precursor

to the seizure that Ashlyn would experience on

August 30, 2000. What is relevant to the present

discussion is that the parents were aware that the

blinking episodes began on July 10, 2000, and

continued until the August 30, 2000 seizure.

Markovich, at 17-18.

Petitioners counter that, “although factually

dissimilar|,|” the rationale in Setnes should govern

in this case. Pet. Mem. of Objections at 3-4. The

App. 38

Setnes court held that the onset of a petitioner's

autism was not the date that the petitioner began

exhibiting behavior consistent with autism, e.g.,

temper tantrums, staring, but instead, the date on

which the petitioner’s autism “became evident.”

Setnes, 57 Fed.Cl. at 181. In determining that the

statute of limitations should not begin to run prior to

a medical diagnosis, the United States Court of

Federal Claims remanded that case to the Special

Master and explained:

As distinguished from other medical conditions, ...

the beginning stage of autism cannot be reduced to a

single, identifiable symptom. Many of the initial

‘symptoms’ are subtle and can easily be confused

with typical child behavior. Where there is no clear

start to the injury, such as in cases involving autism,

prudence mandates that a court addressing the

statute of limitations not hinge its decision on the

‘occurrence of the first symptom.’

Id. at 179 (citations omitted).**”**

FN13. The United States Court of Appeals for

the Federal Circuit has not had an occasion to

review Setnes, because the case has been

stayed pending a decision on causation. See

Autism, General Order # 1, 2002 WL

31696785, 2002 U.S. Claims LEXIS 365

(Fed.Cl.Spec.Mstr. July 3, 2002).

Although the Setnes decision concerned autism, it

suggested an interpretation of the Vaccine Act

statute of limitations that was *335 faithful to

precedent, but also recognized the important need

for the requisite medical certainty to trigger the

App. 39

statute of limitations, particularly in cases involving

children. Id.; see also Brice, 240 F.3d at 1376

(Newman, J., dissenting) (warning that a rigid

approach to the statute of limitations “defeats the

Act’s purpose to provide a non-adversarial and

equitable governmental response to vaccine-related

injury’); Katherine Marie Bulfer, Comment,

Childhood Vaccinations And Autism: Does The

National Childhood Vaccine Injury Act Leave

Parents Of Children With Autism Out In The Cold

With Nowhere To Go?, 27 Campbell L. Rev. 91, 101

(2004) (endorsing the Setnes court’s concern with

subtle symptoms and suggesting that more weight

be accorded to contemporary medical evaluations).

The court is persuaded by the logic of Setnes and

suggests, if the United States Court of Appeals for

the Federal Circuit has occasion to review the

instant decision, that a more definitive and equitable

manner of determining the time certain for the

commencement of the statute of limitations be

considered, by modifying Brice as follows: “in

Vaccine Act cases, the statute of limitations begins

to run upon identification of the first symptom or

manifestation of the onset of injury [by a licensed

physician].” °%*4

FN14. In recent years, Congress has

considered amendments to the Vaccine Act,

including an extension of the limitation

periods. See, e.g., H.R. 1297, 109th Cong., at

Sec. 7 (2005) (extending the statute of

limitations to six years and_ permitting

petitions previously dismissed as_ being

App. 40

untimely to be re-filed within two years); H.R.

1349, 108th Cong., at Sec. 7 (2003) (same).

4. The Special Master Did Not Misconstrue

Applicable Precedent.

Finally, Petitioners argue that the Special Master

incorrectly relied on Brice, 240 F.3d 1367; Goetz, 45

Fed.Cl. 340; and Childs, 33 Fed.Cl. 556, because the

injuries in those cases were “clearly apparent” and,

thus, different from the facts of this case. See Pet.

Mem. of Objections at 5. The Special Master,

however, cites these cases for propositions that

transcend Petitioners’ factual distinction.

The Special Master cites Brice for the principle that

equitable tolling is not available in Vaccine Act

cases. See Markovich, at 20. The Brice decision

extends to all cases under the Vaccine Act, as the

holding concerns statutory interpretation rather

than an adjudication of a factual dispute. See Brice,

240 F.3d at 1372-1374 (“We determine only that

equitable tolling is inconsistent with the existing

statutory scheme.”). Therefore, whether Ashlyn’s

injury was known to her parents is irrelevant

because, as a matter of law, equitable tolling is never

available in Vaccine Act cases.

The Special Master also cites Brice, for the principle

that a court may not interpret a waiver of sovereign

immunity in a way that extends the waiver beyond

that which Congress intended. See Markovich, at 13,

23. Simply because the facts in this case are

distinguishable from the facts in Brice does not

App. 41

relieve the court of its obligation to strictly construe

the Vaccine Act’s waiver of sovereign immunity.

In addition, the Special Master cites Goetz and

Childs for the holding that the 36-month limitations

period begins on occurrence of the first symptom or

manifestation of an injury, not the first identification

of a link between the symptom or manifestation and

the injury. See Markovich, at 20-21. Although the

Goetz and Childs decisions preceded the United

States Court of Appeals for the Federal Circuit’s

decision in Brice, the later case simply reaffirmed

the holding in Goetz and Childs. See Brice, 240 F.3d

at 1373 (“[Tihe statute of limitations here begins to

run upon the first symptom or manifestation of the

onset of injury, even if the petitioner reasonably

would not have known at that time that the vaccine

had caused an injury.”). As such, the Special Master

correctly cited Goetz and Childs.

Accordingly, the Special Master did not misconstrue

Brice, Goetz, or Childs, notwithstanding the factual

distinction that Petitioners proffer.

CONCLUSION

Having determined that the onset of Ashlyn’s

seizure disorder was July 10, 2000, the Special

Master correctly concluded that the United States

Court of Federal Claims does *336 not have

jurisdiction to entertain Petitioners’ claim. The

Vaccine Act states that a Vaccine Injury Table claim,

relating to a post-Act vaccine, must be filed within

three years of the date of the first symptom or

manifestation of onset. See 42 U.S.C. § 300aa-

App. 42

16(a)(2). In this case, Petitioners were required to

file a claim for Ashlyn’s seizure disorder by July 10,

2003. Petitioners, however, did not file their claim

until August 29, 2003-fifty days beyond the

limitations period. As such, the Special Master

correctly dismissed the Petition.

For the foregoing reasons, Petitioners’ Motion for

Review is DENIED. The Clerk of the Court is

hereby directed to enter judgment in accordance

with this Memorandum Opinion.

IT IS SO ORDERED.

Fed.Cl.,2005.

Markovich ex rel. Markovich v. Secretary of Dept.

of Health and Human Services

69 Fed.Cl. 327

END OF DOCUMENT

App. 43

IN THE UNITED STATE COURT OF

FEDERAL CLAIMS

OFFICE OF SPECIAL MASTERS

FILED: July 22, 2005

EE AE AS OE 5 OE OR OK OE OE EO OK OK OK RE OK OK RK EE KK KEE KK

MICHAEL and MELISSA

MARKOVICH, as parents

of ASHLYN M. MARKOVICH,

Petitioners,

v. No. 03-2015V

SECRETARY OF HEALTH

AND HUMAN SERVICES

Respondent.

RR KARR KKK RK KKK KKK KERR KKK KKK KE KE EK

* &£ &* &* * F HF HF

Mark L. Krueger, Baraboo, Wisconsin, for

Petitioners.

Traci R. Patton, United States Department of

Justice, Washington, D.C., for Respondent.

DECISION’

SWEENEY, Special Master

On August 29, 2003, Michael Markovich and

Melissa Markovich, as the parents of Ashlyn M.

Markovich (“Ashlyn”), filed a_ petition for

‘ The court encourages the parties to review Vaccine Rule 18,

which affords each party 14 days to object to disclosure of (1)

trade secret or commercial or financial information that is

privileged or confidential or (2) medical information that would

constitute “a clearly unwarranted invasion of privacy.”

App. 44

compensation under the National Childhood Vaccine

Injury Act (“Vaccine Act”), 42 U.S.C. §§ 300aa-l to -

34 (2000 & Supp. II 2003), which alleges that Ashlyn

sustained a seizure disorder and intractable epilepsy

as the result of her July 10, 2000 diphtheria,

tetanus, and acellular pertussis (“DtaP”),’

inactivated polio virus (“IPV”),’ and haemophilus

influenzae type b (“Hib”)* vaccinations. The facts of

this case present an onset issue; the disposition of

which determines whether the special master can

exercise jurisdiction over the petition.

According to the petition and Ms. Markovich’s

affidavit, repeated eye blinking episodes, which

began on July 10, 2000, the date Ashlyn received her

vaccinations, were the precursor of Ashlyn’s seizure

disorder. However, Ashlyn’s first full-blown seizure

2 The DTaP vaccine is “a combination of diphtheria toxoid,

tetanus toxoid, and pertussis vaccine; administered

intramuscularly for simultaneous immunization against

diphtheria, tetanus, and pertussis.” Dorland’s Illustrated

Medical Dictionary 1998 (30th ed. 2003).

> The IPV vaccine is “a suspension of formalin-inactivated

poliovirus ... administered intramuscularly or subcutaneously

for immunization against poliomyelitis.” Dorland’s Illustrated

Medical Dictionary, supra note 2, at 2000.

* The haemophilus influenzae type b vaccine protects against

infection by the haemophilis influenzae type b bacterium.

Dorland’s I}lustrated Medica! Dictionary, supra note 2, at

1999.

App. 45

did not occur until August 30 or 31, 2000.° The

parents claim that because they were unaware that

the repeated eye blinking episodes were the

harbinger of their daughter’s seizure disorder, they

lacked actual knowledge of a Vaccine Act injury or

claim. Thus, the threshold question to be addressed

is whether the date of onset is July 10, 2000, the

date that the repeated eye blinking episodes began,

or August 30, 2000, the date specified in the petition

and medical records as the date of Ashlyn’s first full-

blown seizure. The evidence presented in lay and

expert affidavits, expert reports, and expert

testimony at hearing leads the special master to

conclude that the first symptom or manifestation of

onset of Ashlyn’s seizure disorder occurred on July

10, 2000, the date that the repeated eye blinking

episodes, clear neurological symptoms, began.

Unfortunately for petitioners, they filed their

petition 50 days after the expiration of the 36-month

limitations period prescribed in 42 U.S.C. § 300aa-

16(a)(2). As a consequence, the special master is

° The date of onset as reflected in the contemporaneous

medical records deviates by one day from the onset date

specified in the petition. Petitioners claim Ashlyn’s first

seizure occurred on August 30, 2000. However, the records

from the emergency department at Fairview Ridges Hospital

document that the first pronounced seizure occurred on

August 31, 2000. Pet. Ex. 14 at 30-33. Similarly, ambulance

transfer records also date the first seizure as occurring on

August 31, 2000. Pet. Ex. 18 at 5. Because the petition was

filed on August 29, 2003, the determination as to whether the

first seizure occurred on August 30 or 31, 2000, would not

affect the statute of limitations analysis. Accordingly, despite

the evidence in the medical records to the contrary, for the sake

of simplicity, the special master will use the date specified in

the petition, August 30, 2000, as the date of Ashlyn’s first

seizure.

App. 46

compelled by statute and the well-settled binding

precedent of the United States Court of Appeals for

the Federal Circuit (“Federal Circuit”) to dismiss the

petition for lack of subject matter jurisdiction.

I. PROCEDURAL HISTORY

On. August 29, 2003, Michael and Melissa

Markovich filed a petition alleging that their

daughter Ashlyn’s seizure disorder and intractable

epilepsy were caused by the DTaP, IPV, and/or HiB

vaccines Ashlyn received on July 10, 2000. The

petition alleges, inter alia, that after Ashlyn’s July

10, 2000 vaccinations and continuing to August 30,

2000, the parents observed Ashlyn rapidly blinking

her eyes, realizing now that these episodes may have

been seizures.® Pet. at J 3. At the time, her parents

thought Ashlyn was merely tired; consequently, no

medical attention was sought. Id. Ms. Markovich’s

affidavit supports the averments of the petition.

Pet’s Aff. at 7 4.

Petitioners filed Ashlyn’s medical records, Ms.

Markovich’s affidavit, the expert affidavits of Frank

® All references to the Petition shall be designated herein as

“Pet. at J __.” All references to the Affidavit of Melissa

Markovich shall be designated herein as “Pet. Aff. at J _ .”

All references to the pertinent Petitioners’ Exhibit shall be

designated herein as “Pet. Ex. sat ___..”

App. 47

J. Ritter, M.D.,’ Pet. Ex. 12, and Donald H. Marks,

M.D., Ph.D.,® Pet. Ex. 17, and an expert report from

Jean-Ronel Corbier, M.D.,° Pet. Ex. 20.

” On October 27, 2003, petitioners filed the signed affidavit of

Frank J. Ritter, M.D., which differed from his unsigned

affidavit submitted with the petition. Pet. Ex. 12. The signed

affidavit, dated October 7, 2003, purports to establish onset

within the statute of limitations, but does not support a

causation theory; the affidavit indicates that the cause of

Ashlyn’s “seizure disorder and/or epilepsy is unknown at this

time.” Id. at 2.

® Dr. Marks’s affidavit, dated February 26, 2004, states that

“fijt is more likely than not (probable) that the DTaP

vaccination that was given to Ashlyn Markovich on or about

July 10, 2000, was causally responsible for the development of

the seizure disorder which occurred on or about August 31,

2000.” Pet. Ex. 17 at 2.

° The expert report of Dr. Corbier, petitioner’s testifying

pediatric neurologist, recites that a review of Ashlyn’s complete

medical history reveals that Ashlyn’s seizures were the result

of multifocal cortical cerebral dysfunction and were caused by

the vaccinations received on July 10, 2000. Pet. Ex. 20 at 3-4.

Dr. Corbier’s report notes that according to Ashlyn’s parents,

her rapid eye blinking episodes began the same day as her

vaccinations and continued through August 30, 2000, the date

of her first full-blown seizure. Id. at 1. Dr. Corbier opined that

“there may be an _ underlying, perhaps undiagnosed

neurometabolic defect, that, coupled with the two-month set of

immunizations, triggered [Ashlyn’s) epilepsy.” Id. at 3-4.

Regardless, Dr. Corbier’s report makes clear that the timing of

the July 10, 2000 vaccinations was a critical element of his

opinion:

[Tlhere is a possibility that these rapid frequent eye

blinking episodes may have represented seizures. These

could have either been brief complex partial seizures or

generalized absence seizures. From a timing standpoint,

assuming these were in fact seizures, one has to consider

App. 48

Respondent’s Rule 4(b) Report, filed on

December 3, 2003, did not recommend compensation.

In his report, respondent conceded that there is no

mention in the medical records of Ashlyn’s eye

fluttering, which occurred between the vaccinations

administered on July 10, 2000, and Ashlyn’s first

full-blown seizure on August 30, 2000. Pet. at 1] 3-4,

11. However, respondent did focus on paragraph 3 of

the petition, which alleges that, with hindsight,

petitioners “now know [that the eye blinking

episode] may have been seizures.” Resp’t Rep. at 2.

The Rule 4(b) Report further notes that, “A record

dated September 20, 2001, indicates that Ashlyn’s

mother understood that Ashlyn’s eye blinking was

seizure activity.” Id. at 5; see also Pet. Ex. 7 at 42.

On January 27, 2004, the court held a status

conference to discuss further proceedings. During

the status conference, the special master stated that

an onset hearing with expert testimony was

necessary because the petition and Ms. Markovich’s

affidavit implicated‘ the statute of limitations.

Respondent’s counsel stated her intention not to

offer an expert witness to interpret the significance

of the repeated eye blinking episodes, but rather to

that one or more of the vaccines given could have

potentially served as a trigger factor for the development of

epilepsy. Owing to what is known about pertussis and its

neurological complications, including seizures, this would

be a reasonable consideration. An alternative to this

explanation would be that the eye blinking, again

assuming that these might represent seizures, occurred

coincidentally after the immunizations and were unrelated.

In my opinion, this would be a much less likely possibility.

Id. at 3.

App. 49

rely upon the contents of Ms. Markovich’s affidavit.

It is beyond the purview of a special master to

determine what constitutes a “symptom” and to

determine the significance of a symptom. In this

case, expert testimony was crucial to determine

whether Ashlyn’s eye blinking episodes constituted

the onset of her seizure disorder. The undersigned

was unwilling to speculate on this issue. Therefore,

petitioners’ counsel agreed to produce an expert to

opine on this issue and was given additional time to

file an expert report concerning onset.

On June 2, 2004, petitioners’ counsel filed the

expert report of Dr. Corbier,; a pediatric neurologist.

Portions of Dr. Corbier’s expert report highlighted

the statute of limitations issue. Specifically, Dr.

Corbier explained that the onset of Ashlyn’s seizure

disorder occurred on August 30 or 31, 2000, but that

some symptoms may have occurred prior to that

time. Because there can be only one date for the first

symptom or manifestation of onset, the special

master conducted an onset hearing on November 5,

2004, in Washington, D.C. Only one witness, Dr.

Corbier, testified.

Il. FACTUAL HISTORY

Ashlyn was born on May 12, 2000, in Edina,

Minnesota, to Melissa and Michael Markovich.”

Pet. Ex. 1 at 1. According to Ashlyn’s pediatrician,

Jane O’Neil, M.D., Ashlyn was born fullterm and

) co ten ae i

© Prenatal records can be found at Petitioners’ Exhibits 8 and

9. Delivery records can be found at Petitioners’ Exhibit 10

Delivery was achieved by vacuum. Pet. Ex. 10 at 1.

App. 50

her first two well-baby examinations were normal.

Pet. Ex. 3 at 1; see also Pet. Ex. 4 at 6.

On May 26, 2000, Ashlyn had her two-week

well-baby examination at Fairview Cedar Ridge

Clinic. Pet. Ex. 4 at 6. Mary Homan, M.D., noted

that Ms. Markovich was concerned about Ashlyn’s

feeding, but the pediatrician found that Ashlyn was

gaining an appropriate amount of weight. Id.

Ashlyn’s next visit to her pediatrician was for her

two-month well-child visit.on July 10, 2000. Pet. Ex.

4 at 3, 6. At this visit, Ashlyn received DTaP, IPV,

and HiB vaccinations. Id.; Pet. Ex. 2 at 1-2.

At about 6:00 p.m. on August 31, 2000, one of

Ashlyn’s parents noted “extremity jerking & staring

seizure activity.” Pet. Ex. 18 at 5. The parents called

the paramedics who arrived and stopped the seizure.

Id. Ashlyn was taken to Fairview Ridges Hospital.

Pet. Ex. 14 at 30. A head computed tomography scan

(“CT scan”)? was normal. Id. at 34. Ashlyn was

discharged from Fairview Ridges Hospital with a

diagnosis of seizure of unknown etiology and

transferred to St. Paul Children’s Hospital

(“Children’s Hospital”). Id. at 32; Pet. Ex. 3 at 1; Pet.

‘A CT scan is a “recording of internal body images at a

predetermined plane by means of the tomograph.” Dorland’s

Illustrated Medical Dictionary, supra note 2, at 1919. A

tomograph is “an apparatus for moving an x-ray source in one

direction as the film is moved in the opposite direction, thus

showing in detail a predetermined plane of tissue while

blurring or eliminating detail in other planes.” Id. In a CT

scan, “the emergent x-ray beam is measured by a scintillation

counter; the electronic impulses are recorded on a magnetic

disk and then are processed by a mini-computer for

reconstruction display of the body in cross-section on a cathode

ray tube.” Id.

App. 51

Ex. 4 at 5; Pet. Ex. 18 at 5. The cause of the seizure

was not identified. Pet. Ex. 4 at 5.

Ashlyn had another well-child examination on

September 8, 2000. Pet. Ex. 4 at 5. After noting Ms.

Markovich’s report of the seizure activity, Tiffani

Mullins, M.D., indicated that the examination was

normal. Id. That finding notwithstanding, on or

about September 14, 2000, Ashlyn had another

seizure. Pet. Ex. 6 at 210. Ashlyn experienced

additional seizures on October 11, 14, 18, 20, 21, and

22, 2000. Id. On October 16, 2000, Ashlyn was

examined by Ronald H. Spiegel, M.D., of Children’s

Hospital regarding her seizures. Pet. Ex. 16 at 45-

46. Ashlyn was started on Tegretol, an antiseizure

medication, on October 21, 2000. Pet. Ex. 6 at 210.

Ashlyn was also given three chiropractic treatments;

but these were discontinued as her seizure activity

increased in frequency. Id.

When Ashlyn was admitted to Children’s

Hospital on October 22, 2000, the Tegretol was

discontinued, and a video electroencephalogram

(“EEG”)” was performed. Pet. Ex. 6 at 159-63; 210.

According to Dr. Ritter, the EEG “clearly

demonstrate[d] seizure onset from the right posterior

quadrant.” Id. at 159. Ashlyn also underwent a

2 An EEG is “a recording of the potentials on the skull

generated by currents emanating spontaneously from nerve

cells in the brain.... Fluctuations in potential are seen in the

form of waves, which correlate well with different neurologic

conditions and so are used as diagnostic criteria.” Dorland’s

Illustrated Medical Dictionary, supra note 2, at 596.

App. 52

magnetic resonance image (“MRI”)* of her head. Id.

at 164. The MRI report indicated “intracranial

contents normal” and “small amount of fluid or

mucosal thickening in the left mastoid air cells

noted.” Id.

On November 9, 2000, Dr. Spiegel saw Ashlyn

for another follow-up of her epilepsy. Pet. Ex. 16 at

44. Then, on November 17, 2000, Ashlyn had a

generalized seizure and was taken by ambulance to

Fairview Ridges Hospital. Pet. Ex. 14 at 23-26; Pet.

Ex. 18 at 12. Ashlyn was then transferred to

Children’s Hospital in status epilepticus.* Pet. Ex.

14 at 26; Pet. Ex. 16 at 4-5; Pet. Ex. 18 at 12. At

Children’s Hospital, Ashlyn underwent a video EEG,

which was normal for a child her age. Pet. Ex. 6 at

155-58. Ashlyn was discharged on November 20,

2000. Pet. Ex. 16 at 4.

‘3 An MRI is “a method of visualizing soft tissues of the body by

applying an external magnetic field that makes it possible to

distinguish between hydrogen atoms in _ different

environments.” Dorland’s Illustrated Medical Dictionary,

supra note 2, at 908.

4 Status epilepticus is “a continuous series of generalized

tonic-clonic seizures without return to consciousness.”

Dorland’s Illustrated Medical Dictionary, supra note 2, at

1756. A generalized tonic-clonic seizure is “the seizure of

grand mal epilepsy, consisting of a loss of consciousness and

generalized tonic convulsions followed by clonic convulsions.”

Id. at 1676. Tonic convulsions are involuntary and are

characterized by a “prolonged contraction of the muscles.” Id.

at 415-16. Clonic convulsions are also involuntary and are

characterized by “alternating contraction and relaxation of the

muscles.” Id. at 415.

App. 53

Ashlyn was not hospitalized again until

January 8, 2001, when she was taken by ambulance

to Fairview Ridges Hospital with a seizure. Pet. Ex.

14 at 17-19. A chest x-ray was negative. Id. at 20.

Ashlyn visited her pediatrician’s office on

January 25, 2001, with a two-to-three week history

of cough, congestion, and low grade fevers. Pet. Ex. 4

at 9, 11. A physician’s assistant noted that Ashlyn

had a seizure with a high fever a couple of weeks

prior and had been taken to the emergency room. Id.

Ashlyn was diagnosed with a prolonged upper

respiratory infection and probable acute bronchitis.

Id. Then, later that same day, Ashlyn was taken to

Fairview Ridges Hospital with a seizure. Pet. Ex. 14

at 14-16. Several days later, on January 29, 2001,

Dr. Spiegel saw Ashlyn for a follow-up visit. Pet. Ex.

16 at 41-42. Dr. Spiegel reported that despite her

seizures, Ashlyn was developing well. Id. at 41.

On March 3, 2001, Ashlyn was admitted to the

Pediatric Intensive Care Unit (“PICU”) at Children’s

Hospital “following multiple medications to stop

seizure.” Pet. Ex. 6 at 210. She was discharged

within 24 hours. Id.

Ashlyn remained seizure free until March 29,

2001, when she was taken by ambulance to Fairview

Ridges Hospital with a generalized tonic-clonic

seizure. Pet. Ex. 14 at 4-7; Pet. Ex. 18 at 19. Ashlyn

was transferred to Children’s Hospital. Pet. Ex. 14 at

5; Pet. Ex. 18 at 19. Several days later, on April 2,

2001, Ashlyn had another seizure and returned to

the emergency room. Pet. Ex. 6 at 210. Ashlyn again

returned to the emergency room on April 3, 2001,

App. 54

with yet another seizure. Id.; Pet. Ex. 19 at 2. On

that date, Ashlyn was admitted to the PICU for

observation and then discharged the following day.

Pet. Ex. 6 at 210. But, on April 17, 2001, Ashlyn was

again taken to the emergency room because of

seizure. Id.

On May 18, 2001, Ashlyn visited Metropolitan

Pediatric Specialists, P.A. for her twelve-month well-

child visit. Pet. Ex. 5 at 19. Timothy Johanson, M.D.,

noted that Ashlyn had seizures since age three-and-

one-half months and been hospitalized three times

for status epilepticus. Id.

On June 8, 2001, Ashlyn was taken to St.

Francis Regional Medical Center (“St. Francis”) due

to a seizure. Id. at 99-100. Ashlyn was transferred to

Minneapolis Children’s Hospital. Id. at 100-02.

Then, on July 10, 2001, Ashlyn again was taken to

St. Francis with a seizure. Id. at 89. Manuel Roman,

M.D., gave Ashlyn antiseizure medication, which

stopped the seizure after ten minutes. Id. at 90.

Blood tests were normal except for a mildly elevated

white blood cell count. Id. at 90-91. Ashlyn was

discharged against medical advice. Id. at 91.

On July 12, 2001, Ashlyn saw Steven

Janousek, M.D., at Noran Neurological Clinic on

referral for a neurologic assessment. Pet. Ex. 7 at 71-

72. Five days later, on July 17, 2001, Ashlyn

returned to St. Francis with a seizure. Pet. Ex. 5 at

92-93. Between July 18, 2001, and April 26, 2002,

Ashlyn’s mother frequently telephoned the Noran

Neurological Clinic to update Dr. Janousek on

Ashlyn’s progress, discuss adjustment of Ashlyn’s

App. 55

medications, inquire about seizure management, or

discuss administrative matters. See generally Pet.

Ex. 7.

On July 23, 2001, Ashlyn had her urine

analyzed for organic acids,“ amino acids,® and

oligosaccharides.” Pet. Ex. 5 at 34-36. The

interpreting physician found, “This specimen was

screened for all organic acids which are diagnostic of

organic acidurias. The organic acid pattern seen is

not consistent with that of a known aciduria.””* Id. at

34. In addition, the physician wrote, “This urine

amino acid pattern is not consistent with a known

disorder of amino acid metabolism.” Id. Finally, the

physician indicated that the oligosaccharides screen

was normal. Id. at 35.

On July 31, 2001, Ashlyn again returned to

St. Francis with a seizure. Id. at 97. James S.

Parker, M.D., noted that Ashlyn had been seizing for

1° An organic acid is an acid that contains one or more carbon

atoms. Dorland’s Illustrated Medical Dictionary, supra note 2,

at 16.

‘6 An amino acid is “any organic compound containing an

amino and a carboxyl group.” Dorland’s Illustrated Medical

Dictionary, supra note 2, at 16.

17 An oligosaccharide is “a carbohydrate that on hydrolysis

yields a small number Of monosaccharides.” Dorland’s

Illustrated Medical Dictionary, supra note 2, at 1306. A

monosaccharide is a “sumple sugar; a carbohydrate that cannot

be decomposed by hydrolosis.” Id. at 1172.

18 Aciduria is the “excess of acid in the urine.” Dorland’s

Illustrated Medical Dictionary, supra note 2, at 17.

App. 56

approximately ten minutes at the time of arrival and

administered antiseizure medication, which finally

resolved the seizure. Id. at 97-98. Ashlyn was

admitted to the hospital for further observation as

she recovered from sedation and the antiepileptics.

Id. at 98.

On August 7, 2001, Ashlyn had another brain

MRI, which was normal. Pet. Ex. 7 at 27. Despite

her normal MRI, Ashlyn returned to St. Francis on

August 11, 2001, and August 24, 2001, with seizures.

Pet. Ex. 5 at 31-32, 85-88; Pet. Ex. 18 at 31. On

August 24, 2001, Ashlyn was transported by air to

Minneapolis Children’s Hospital. Pet. Ex. 5 at 87-88;

Pet. Ex. 7 at 25-26; Pet. Ex. 18 at 31. A repeat MRI

was normal and Ashlyn was placed on antiseizure

medication. Pet. Ex. 7 at 26. Ashlyn was discharged

on August 25, 2001. Id. at 25-26.

On August 28, 2001, Ashlyn saw Dr. Janousek

for a follow-up visit. Id. at 58. Subsequently, Ashlyn

was admitted to the pediatric epilepsy ward at

Children’s Hospital on September 10, 2001, with the

goal of starting the ketogenic diet.’? Pet. Ex. 6 at

According to The Epilepsy and Brain Mapping Program:

The ketogenic diet is a _ stringent, mathematically

calculated diet high in fat and low in protein and

carbohydrates that, when followed conscientiously,

produces a by-product called ketones in patients’ blood and

urine. High concentrations of ketones in the body control

the frequency and severity of seizures, although the

biochemical mechanisms for this phenomenon are not yet.

known.

App. 57

202-06, 209-13, 216. She underwent a video EEG

throughout her admission. Id. at 150-54. Ashlyn also

was evaluated by the Speech Pathology Department

to assess her communication skills. Id. at 89. The

speech pathologist found that Ashlyn had a mild

receptive and expressive language delay. Id. Ashlyn

was discharged on September 13, 2001. Id. at 202-

05.

On September 17, 2001, October 5, 2001, and

October 15, 2001, Ashlyn returned to St. Francis

with further seizures. Pet. Ex. 5 at 79-84.

Between November 4, 2001, and June 27,

2003, Ashlyn’s mother frequently telephoned the

Minnesota Epilepsy Group, P.A., to update Dr. Ritter

on Ashlyn’s progress, discuss adjustment of Ashlyn’s

medications, inquire about seizure management, or

discuss administrative matters. See generally Pet.

Ex. 6.

On November 8, 2001, Ashlyn was taken to St.

Francis with a seizure unresponsive to rectal

Valium.” Pet. Ex. 18 at 24. Ashlyn had a chest x-ray

that was normal. Pet. Ex. 5 at 28. Ashlyn was

The Epilepsy and Brain Mapping Program, The Ketogenic Diet,

at http://www.epipro.com/k_diet.html (last visited July 21,

2005).

2° Valium is the trademark for the drug preparation of

diazepam. Dorland’s Illustrated Medical Dictionary, supra

note 2, at 2003. Diazepam is a benzodiazepine used as, among

other things, an anticonvulsant and as an antitremor agent.

Id. at 512.

App. 58

transferred to the PICU at Minneapolis Children’s

Hospital. Pet. Ex. 6 at 214-15; Pet. Ex. 18 at 24.

On November 138, 2001, Ashlyn saw Dr. Ritter

for a follow-up to her hospital admission and for a

second opinion. Pet. Ex. 6 at 116-19. Dr. Ritter

reported that “Ashlyn continues to have ongoing

seizures with frequent episodes of status epilepticus.

Seizures typically do not stop with the

administration of rectal Valium and therefore

require[] emergency medical intervention.” Id. at

119. Dr. Ritter planned to ascertain what testing

regarding the etiology of the seizures had been done

and adjusted Ashlyn’s antiseizure medication. Id.

On December 7, 2001, Ashlyn was taken to St.

Francis several times. Pet. Ex. 5 at 75-76. John

Baker, M.D., stated that in the afternoon, Ashlyn’s

mother noted cluster seizure activity and brought

Ashlyn to the hospital because Ashlyn became

lethargic after the administration of Valium. Id. at

75. Ashlyn returned to the hospital later that

afternoon with questionable seizure activity. Id.

Within an hour of her discharge, Ashlyn returned

again with a recurrence of seizure activity and was

admitted for observation. Id.

On December 26, 2001, Ashlyn was admitted

to Children’s Hospital for “clarification of seizures,

medication adjustment, PT, OT and_= speech

evaluation to determine baseline developmental

status and [etio]logic evaluation to determine cause

for seizures if not done previously.” Pet. Ex. 6 at 193-

96. Michael D. Frost, M.D., noted that although

Ashlyn had been treated with multiple

App. 59

anticonvulsant medications and the ketogenic diet,

she still had daily seizures. Id.

During her hospitalization, Ashlyn

“underwent prolonged evaluation with difficult to

control seizures.” Id. Her physicians performed a

video EEG which “revealed generalized spike and

polyspike and wave or ffrontally dominant

epileptiform discharges.” Id. at 141-49, 196. Before

she was discharged, Ashlyn’s physicians made

additional changes to her medication regimen.” Id.

at 194-96.

Also during this admission, Ashlyn was

evaluated by the Speech Pathology Department to

reassess her communication skills. Id. at 87-88. Once

again, the speech pathologist found that the gap

between Ashlyn and her peers was growing slightly

in communication skills. Id. at 87. Ashlyn also was

evaluated by the Physical Therapy Department and

the Occupational Therapy Department. Id. at 172-

76. Ashlyn was discharged from Children’s Hospital

on January 11, 2002, with diagnoses of intractable

epilepsy, partial tonic seizures and complex-partial

secondary generalized seizures, a history of status

epilepticus, and a history of Todd’s paralysis.” Id. at

196.

a. i listing of the antiepileptic medications tried by Ashlyn can

be found at Petitioners’ Exhibit 6 at 256-57.

22 Todd’s paralysis, also known as postepileptic paralysis, is

“hemiparesis or monoparesis lasting for a few minutes or

hours, or occasionally for several days, after an epileptic

seizure.” Dorland’s Hlustrated Medical Dictionary, supra note

2, at 1366.

App. 60

On January 11, 2002, after being discharged

from Children’s Hospital, Ashlyn was taken to St.

Francis with a seizure. Pet. Ex. 5 at 68. Brian

Clarkowski, M.D., administered antiseizure

medication which resolved her seizure. Id. at 69.

Ashlyn visited Metropolitan Pediatric

Specialists, P.A. on January 17, 2002, for her

eighteen month well-child visit and blood work. Id.

at 15. Judith Snook, M.D., noted “normal growth,

developmental] delay, [and] intractable seizures.” Id.

On January 24, 2002, Ashlyn underwent a

two-hour video EEG. Pet. Ex. 6 at 139-40. According

to Dr. Ritter, “This EEG would suggest diffuse

cortical dysfunction with multiple areas of potential

epileptogenesis, as well as areas of more generalized

and diffuse, but somewhat irregular spike-wave or

polyspike wave.” Id. at 140.

Five days later, on January 29, 2002,” Ashlyn

was admitted to the Mayo Clinic by Jeffrey R.

Buchhalter, M.D., to determine whether “a single

focus of seizure onset is likely that would be

susceptible to surgical removal.” Pet. Ex. 15 at 8. Dr.

Buchhalter discussed with Ms. Markovich the

possiblity of an immunologically-mediated seizure

disorder. Id. at 16. Upon admission, neurologist

Randa G. Jarrar, M.B.B.S.,* reported that Ashlyn

experienced four types of seizures: (1) repeated eye

3 Ashlyn had been referred to the Mayo Clinic by Dr. O’Neil

on February 2, 2001. Pet. Ex. 4 at 10.

24 An M.BBS. is the abbreviation for a bachelor of medicine

and bachelor of surgery.

App. 61

blinking; (2) elonic movement of the face, arm, and

leg; (3) generalized seizures with or without focal

onset; and (4) partial motor seizures. Id. at 12. Dr.

Jarrar also noted that Ashlyn was developing

appropriately for her age with the exception of her

speech. Id. at. 13. Dr. Jarrar diagnosed intractable

epilepsy and discussed with Ms. Markovich the

remaining’ treatment options, including other

medications and surgery. Id. at 14. Ashlyn was

admitted to the Epilepsy Monitoring Unit and had a

computer-assisted prolonged video EEG from

January 30, 2002, to February 3, 2002. Id. at 2-3,14.

The EEG revealed evidence of multifocal epileptic

abnormalities. Id. at 2-3. Dr. Buchhalter noted that

because Ashlyn’s seizures had different foci, surgical

intervention was not indicated. Id. at 20. Ashlyn was

discharged on February 19, 2002. Id. at 19.

On February 17, 2002, February 22, 2002,

twice on March 17, 2002, and April 5, 2002, Ashlyn

returned to St. Francis with seizures. Pet. Ex. 5 at

52-55, 64-67. At the surgical conference held at

Minnesota Epilepsy Group on April 9, 2002, Ashlyn

was recommended for the implantation of a vagus

nerve stimulator (“VNS”).” Pet. Ex. 6 at 242.

ss According to The Epilepsy and Brain Mapping Program:

The vagus nerve is one of the primary communication lines

from the major organs of the body to the neck to the vagus

nerve. Stimulation of the vagus nerve can stop seizures,

reduce the intensity and frequency of seizures in some

patients. The VNS periodically stimulates the vagus nerve,

usually for a brief period.

The VNS is an implanted pacemaker-size stimulator. It

has a wire lead that attaches to the vagus nerve by means

App. 62

Ashlyn was admitted to Children’s Hospital

on April 16, 2002, “for video EEG to clarify events

and then determine treatment options.” Id. at 185-

87. Multiple events were recorded on the EEG. Id. at

128. The EEG “strongly suggested a frontal onset to

seizures.” Id. Ashlyn was discharged on April 18,

2002.” Id. at 186.

On April 29, 2002, Ashlyn was taken to St.

Francis with a seizure. Pet. Ex. 5 at 48=49. Dr.

Clarkowski noted that Ashlyn “had a focal seizure of

just focal eye twitching and nystagmus for

approximately 30 minutes.” Id. The antiseizure

medication resolved the seizure. Id. at 49.

Ashlyn’s mother telephoned the Minnesota

Epilepsy Group on April 30, 2002, because of a one-

and-a-half hour long seizure Ashlyn had the

previous night. Pet Ex. 6 at 5. Ashlyn’s mother

reported a dramatic reduction in eye flutters, but felt

that Ashlyn was out of control the previous night

and wanted to speak with Dr. Ritter. Id.

of an incision. The incision is made on a naturally

occurring crease on the neck, thereby making the healed

scar practically invisible. The procedure takes a few hours

and the patient is usually released from the hospital on the

next day. After the patient stabilizes, the physician uses a

wand to activate the VNS.

The Epilepsy and Brain Mapping Program, Vagus Nerve

Stimulator, at http://www.epipro.com/vns.html (last visited

July 21, 2005).

°S A listing of the antiepileptic medications administered to Ashlyn

between January 1}, 2002, and April 17, 2002, can be found at

Petitioners’ Exhibit 6 at 258-60.

App. 63

After being free of seizures for three weeks,

Ashlyn was taken to St. Francis on June 23, 2002,

with a seizure. Id. at 46-47. Dr. Roman gave Ashlyn

medication which resolved the seizure. Id. However,

Ashlyn returned later that day after vomiting and

resuming atypical seizure activity. Id. at 50-51.

Antiseizure medication again resolved Ashlyn’s

seizure. Id. at 51. Ashlyn was again seen at St.

Francis for another seizure on August 11, 2002. Id.

at 29-30. On August 27, 2002, Ashlyn saw Dr. Ritter

for a follow-up visit. Pet. Ex. 6 at 352-55.

On October 8, 2002, Ashlyn had a physical

examination in preparation for the implantation of

her VNS. Id. at 181-84. Then, on October 10, 2002,

Ashlyn had the VNS implanted by Mary E. Dunn,

M.D., at Children’s Hospital. Id. at 96, 178-80.

Unfortunately, the VNS flow sheets dated from

October 15, 2002, to April 10, 2003, indicate that

minimal to no improvement occurred with Ashlyn’s

seizures.” Id. at 165-71. Ashlyn was discharged on

October 11, 2002. Id. at 180.

27 On J anuary 27, 2003, Ashlyn saw Dr. Ritter for a follow-up of

her intractable epilepsy and for additional adjustment of her

VNS. Pet. Ex. 6 at 307-10. In his assessment, Dr. Ritter

reported:

At this time, although Ashlyn has had the vagal nerve

stimulator only for approximately a three-month period of

time, seizure frequency, intensity, and quality of life

remain unchanged.... Family has considerable concerns

regarding frequency of seizures despite all the medication

changes and placement of the vagal nerve stimulator.

Mother also has questions that during her pregnancy at

approximately 34 to 35 weeks gestation, fetal bradychardia

was noted on two to three occasions; was this related to

seizure activity.

App. 64

On January 3, 2003, Ashlyn underwent a

speech and language evaluation at St. Francis

Rehabilitative Services by Michelle Laurent, CCC-

SLP. Pet. Ex. 5 at 43-45. Ashlyn’s mother’s primary

concerns at this evaluation included Ashlyn’s

language production and cognitive skills. Id. at 43.

Ms. Laurent found that Ashlyn demonstrated

significant speech and language delays and

recommended that Ashlyn receive therapy to

encourage development of her speech and language

skills. Id. at 44.

On February 2, 2003, Ashlyn was taken to St.

Francis with seizure activity. Id. at 41-42. Dr.

Roman tried several medications and eventually

was successful in arresting the seizure. Id.

Ashlyn was admitted to Children’s Hospital

~ on March 19, 2003. Pet. Ex. 6 dt 190-92. The purpose

of the admission was to determine other treatment

options and to obtain a baseline recording to

determine whether Ashlyn’s seizures had changed.

Id. at 190. During her admission, Ashlyn was started

on various antiseizure medications. Id. at 191. In

addition, the surgical option of an anterior two-

thirds corpus callosotomy”™ was discussed. Id. Ashlyn

was discharged on March 22, 2003. Id. at 190-92.

Id. at 310.

wal.’ corpus callosotomy is the “surgical transection of the fibers

in the corpus callosum ...; formerly used to treat intractable

epilepsy.” Dorland’s_IHustrated Medical Dictionary, supra

note 2, at 423.

App. 65

On April 25, 2003, and June 19, 2003, Ashlyn

was taken to St. Francis with a seizure. Pet. Ex. 5 at

37-40. As a result of his treatment of Ashlyn during

her previous visits to the emergency department for

seizure activity, Dr. Clarkowski tried several

antiseizure medications until Ashlyn’s seizure was

resolved. Id. at 37-38, 40.

On July 28, 2003, an MRI of Ashlyn’s brain

revealed:

i, Small ill-defined focus of signal

abnormality is seen in the deep right

mid frontal white matter. This is

nonspecific, but is compatible with

nondescript gliosis.

2. Possible mild-to-moderate atrophy of

the right hippocampal complex.

Intracranial contents otherwise

unremarkable.

4. Inflammatory changed noted bilaterally

in the ethmoid and maxillary paranasal

sinuses.

o>)

Pet. Ex. 11 at 4.

III. DISCUSSION

A. The Vaccine Act and Waiver of

Sovereign Immunity.

“The United States, as sovereign, is immune

from suit save as it consents to be sued.” United

States _v. Sherwood, 312 U.S. 584, 586 (1941).

Specifically, “a statute of limitations is a condition

App. 66

on the waiver of sovereign immunity by the United

tates, and courts should be careful not to interpret

[a waiver] in a manner that would extend the waiver

beyond that which Congress intended.” Brice v. Sec’y

of HHS, 240 F.3d 1367, 1370 (Fed. Cir. 2001)

(citations and internal quotations omitted). “The

court cannot expand on the waiver of sovereign

immunity explicitly stated in the statute.” McGowan

v. Sec’v of HHS, 31 Fed. Cl. 734, 740 (1994) (citing

Broughton Lumber Co. v. Yeutter, 939 F.2d 1547,

1550 (Fed. Cir. 1991)). Moreover, the statute of

limitations may not be waived by either the court or

the parties. Forman v. United States, 329 F.3d 837,

841-42 (Fed. Cir. 2003).

The Vaccine Act is a waiver of the sovereign

immunity of the United States because it permits

people with vaccine-related injuries, as well as the

legal representatives of people who have suffered a

vaccine-related death, to sue the United States for

compensation. The right to sue is not unconditional-

the Vaccine Act contains a statute of limitations that

places a condition on the waiver of sovereign

immunity. The express limitations provision of the

Vaccine Act provides that for vaccines listed in the

Vaccine Injury Table (“Table”):”

if a vaccine-related injury occurred as a result

of the administration of such vaccine, no

petition may be filed for compensation under

the Program for such injury after the

expiration of 36 months after the date of the

“9 42 C.F.R. § 100.3(a). The DTaP, IPV, and Hib vaccinations

are included on the Table.

App. 67

occurrence of the first symptom _ or

manifestation of onset or of the significant

aggravation of such injury

42 U.S.C. § 300aa-16(a)(2) (emphasis added). In

other words, the United States waives its sovereign

immunity only for 36 months in instances of vaccine-

related injury. After 36 months, the United States is

immune from suit.

The court is obligated to dismiss a petition as

soon as it finds that it lacks jurisdiction to decide the

merits of a case. See Steel Co. v. Citizens for #Better

Env’t. 523 U.S. 83, 94 (1998) (“Without jurisdiction

the court cannot proceed at all in any cause.

Jurisdiction is power to declare the law, and when it

ceases to exist, the only function remaining to the

court is that of announcing the fact and dismissing

the cause.”), citing Ex parte McCardle, 74 U.S. (7

Wall.) 506, 514(1868).

B. Threshold Jurisdictional Issue.

The threshold question presented in this case

is whether the August 29, 2003 petition was filed

within the three-year limitations provision specified

by the Vaccine Act. To satisfy the limitations

provision of the Vaccine Act, Ashlyn’s symptoms

must have begun on or after August 29, 2000;

otherwise the petition is untimely. The petition,

coupled with Ashlyn’s mother’s affidavit and

petitioners’ expert reports, implicates the statute of

limitations. Specifically, the petition avers:

App. 68

At times after the immunization of July 10,

2000, until August 30, 2000, Michael and

Melissa Marckovich observed Ashlyn having

episodes in which Ashlyn would rapidly blink

her eyes. Petitioners now know that these

episodes may have been seizures although at

the time they thought she was tired. The first

episode was approximately July 10, 2000. No

medical attention was sought during this time

due to there being no apparent cause for

concern.

Pet. at @ 3. Further, Ms. Markovich’s affidavit

explained that on July 10, 2000, after Ashlyn had

received her vaccinations at the Fairview Cedar

Ridge Clinic, she “thought... Ashlyn was just sleepy,

[but] I am now aware she may have been having

seizures between the time of the immunization and

August 30, 2000, when she had her first serious

episode.” Pet. Aff. at ¥ 4. Therefore, the critical

jurisdictional issue to be resolved is whether the

repeated eye blinking episodes, which began on July

10, 2000, were, in fact, the first symptom or

manifestation of onset of Ashlyn’s seizure disorder,

thus triggering the statute of limitations.

The parties provided differing views as to the

date of onset. Petitioners contend, relying on the

contemporaneous medical records, that the first

symptom or manifestation of onset occurred on

August 30, 2000, the date Ashlyn was rushed to the

hospital with her first seizure. To support their

assertion, petitioners argue that although the first

eye blinking episode, which occurred on July 10,

2000, may have been the harbinger of Ashlyn’s

App. 69

seizure disorder, as laypersons, they lacked the

requisite medical education and training to

comprehend the significance of the first episode. The

parents observed the repeated rapid eye blinking

episodes, but assumed that, on those occasions,

Ashlyn was fluttering her eyes because she was

sleepy. Sadly, they were unaware that what they

had begun to witness was the first neurological

symptom that either signaled their daughter’s brain

disorder or was a subtle seizure. According to the

petition and Ms. Markovich’s affidavit, it was not

until after the August 30, 2000 seizure that the

petitioners became aware of the significance of the

earlier eye blinking events. Thus, the parents argue,

it was impossible for them to make the necessary

linkage between rapid eye blinking and injury. For

this reason, petitioners urge the special master to

find August 30, 2000, as the date of onset. In

essence, petitioners argue that their inability to

recognize the significance of the first symptom of

their child’s debilitating disorder delays the running

of the limitations period.

Conversely, respondent contends that because

Ashlyn’s July 10, 2000 rapid eye blinking was the

first symptom of Ashlyn’s seizure disorder, the plain

language of the statute requires that the 36-month

period began running on that date. According to the

respondent, the limitations period is triggered by the

first symptom or manifestation of onset, not by

petitioners’ actual knowledge or awareness of a

claim arising under the Vaccine Act. Indeed,

respondent argues that petitioners need not know

that their child suffered a vaccine-related injury.

Rather, respondent contends, it is sufficient that

App. 70

these parents were aware of the July 10, 2000 eye

blinking episode-the Markovichs need not have been

aware of the significance.

Because the resolution of this factual issue is

critical to the court’s exercise of subject-matter

jurisdiction, the court conducted an onset hearing.

As explained below, because petition-rs’ expert

witness conceded that the rapid eye blinking episode

witnessed by Ashlyn’s parents on July 10, 2000, was

the first symptom or manifestation of onset of

Ashlyn’s seizure disorder, the special master is

required to dismiss the petition as beyond the .

limitations period.

1. Dr. Corbier’s Testimony Makes Plain that the

July 10, 2000 Rapid Eye Blinking Episodes

Constituted the Onset of Ashlyn’s Seizure Disorder.

Petitioners offered only one witness at

hearing, Dr. Corbier. Dr. Corbier was awarded his

medical degree in 1995 and became board-certified

in pediatric neurology in 2000.° Tr. at 5-6. Dr.

Corbier treats both adults and children with

seizures. Id. at 6. Dr. Corbier explained that a

seizure disorder and epilepsy are the same thing;

however, with seizure disorders, an individual can

experience multiple seizures daily. Id. at 7.

Dr. Corbier also opined that DPT vaccinations

can cause. seizure disorders in _ susceptible

individuals. Id. Based upon his review of Ashlyn’s

*° All references to the Transcript of the November 5, 2004

proceedings shall be designated herein as “Tr. at___.”

Ss

App. 71

medical records and her clinical picture, Dr. Corbier |

confirmed the opinion of his May 19, 2004 report

that on August 30, 2000, Ashlyn had a generalized

tonic-clonic seizure that lasted at least 20 minutes.

Id. at 9. With regard to the rapid eye blinking

episodes, which were the focus of the onset hearings

Dr. Corbier testified:

Well, they play an important part, in

the sense that from my understanding of the

records it seems that on July 10th, 2000, the

very day of her vaccinations, there was some

blinking of the eye. What is unclear is

whether it could have been the beginning of

some small unrecognized seizure activity.

That could sometimes be subtle, or it

could be some type of beginning of a brain

dysfunction that would have culminated to a

full-fledged, first full seizure on August 30th.

So my professional opinion is that the

time line of when something first [| may have

started on August 10th. [sic]** that was due to

some type of cerebral dysfunction, and then

the results culminated in her having a

seizure, a generalized tonic, or grand mal

seizure as we call it, on August 30th.

Id. at 10 (emphasis and footnote added). Dr. Corbier

explained that although rapid eye blinking alone is

3) Dr. Corbier misstated the date of the eye blinking episode

and almost immediately corrected the record to reflect the

correct date, July 10, 2000. Tr. at 10.

App. 72

insufficient to establish a seizure disorder diagnosis,

as a neurologist, the eye blinking episode would have

raised his suspicions and he would have pursued

further investigation:

If we had a situation where someone started

having eye blinking for no apparent reason,

then we start to ask questions. There are

certain things beyond the eye blinking that

would raise our level of suspicion more and

more in terms of seizure activity, such as

observation of a loss of consciousness,

ideation, and what we call post-spectral

changes.

For instance, if someone has a lot of eye

blinking, and then subsequently become|s]

very tired or confused, that would be some of

the traditional clinical findings that would

raise my level of suspicion.

So eye blinking by itself would not lead

necessarily to seizures, but would at least lead

to _a suspicion and the need for further

questioning and evaluation.

Id. at 11 (emphasis added). Dr. Corbier further

testified that he could not state with certainty

whether the eye blinking episodes themselves

constituted seizure activity, explaining:

It is hard for me to say definitively that

it was or was not a seizure,... the only way to

be certain would be to have an EEG done at

App. 73

that time while the eye blinking was going on

and correlating it with EEG changes.

Short of that, what we can do is suspect

that there are one or two possibilities. One is

that the eve blinking could have either been

some small seizures, subtle seizures if you

will, or there is also the possibility that it

could have been some _ type _ of_ brain

dysfunction that started at that time, and

manifesting as involuntary eye blinking.

And with progressive dysfunction, that

person then on August 30th had a full-fledged

seizure, and went on to have ... more and more

seizures, and you can see that there was a

progression of symptoms.

Id. at 12 (emphasis added). This testimony is

significant for two reasons. First, either possibility

posited by Dr. Corbier, a subtle seizure or a brain

dysfunction, reflects that the child had a malady

that was manifested by a clear neurological

symptom-eye blinking.” Therefore, regardless of the

ultimate conclusion-subtle seizure or brain

®? Later in his testimony, Dr. Corbier again confirmed his prior

testimony that Ashlyn’s July 10, 2000 rapid eye blinking

reflected cerebral dysfunction. Id. at 15-16. Specifically, Dr.

Corbier testified that he thought it likely that a brain

dysfunction caused the July 10, 2000 eye blinking episode, that

the brain dysfunction led to the development of the seizure

disorder, and that the first full-blown seizure occurred on

August 30, 2000. Id. at 18-19. Finally, Dr. Corbier testified

tat he eye blinking and development of seizure disorder were

ai! me rt of the same process. Id. at 19. The special master find

this evidence compelling.

App. 74

dysfunction-it was clear and unmistakable that

Ashlyn’s rapid eye blinking was not normal. It is not

relevant to the onset query that the parents were

unaware that the blinking episodes were a

neurological symptom that served as the precursor

to the seizure that Ashlyn would experience on

August 30, 2000. What is relevant to the present

discussion is that the parents were aware that the

blinking episodes began on July 10, 2000, and

continued until the August 30, 2000 seizure.

Second, Dr. Corbier makes plain that the eye

blinking episodes were part of a progression of

symptoms, which culminated in the August 30, 2000

seizure. This point is further illustrated by the

following portion of Dr. Corbier’s testimony:

The part that is very suspicious to me is,

number one, the first full-fledged seizure on August

30th was preceded by the eye blinking that according

to the record started on July 10th.

In terms of timing, it appears like there

was some type of precipitating event in this

case with the vaccine and on that same day

you have the eye blinking episodes,

(Iregardless of whether the eye blinking

turned out to be some type of cerebral

dysfunction or little seizure.

And that they progressed on August

30th to a full-blown seizure, and then

according to the record the patient continues

having a lot of seizures, and what we would

term refractory seizures.

App. 75

So there have been a lot of evaluations

to try to look for alternative diagnoses or

causes, and I could not detect any alternative

explanations. So looking at that time line, to

me, I would say that it was a vaccine related

injury causing seizures that could be

documented here.

Id. at 14-15 (emphasis added). In arriving at his

theory of causation, Dr. Corbier ruled out other

causes for Ashlyn’s injury. In so doing, Dr. Corbier

concluded that the eye blinking episodes, which

started on July 10, 2000, marked the onset of first

symptom of injury. Therefore, according to Dr.

Corbier, Ashlyn’s injury was directly tied to the

vaccinations, particularly the DTaP _ vaccine,

administered that same day. Specifically, when

pressed for an answer as to when the first symptom

of the seizure disorder occurred, Dr. Corbier

conceded that the first symptom occurred with the

July 10, 2000 eye blinking episode: “Yes, I think

there was some type of dysfunction of some sort that

likely started on July 10th, leading to a documented

seizure on August 30th.” Id. at 19.

Dr. Corbier acknowledged that the eye

blinking episode was, in fact, medically recognized as

a neurological symptom of a mild seizure or subtle

brain dysfunction. Id. at 22, 24. A symptom that is

“subtle” is, nevertheless, manifestation and cannot

be ignored. Consequently, the subtlety of the

dysfunction notwithstanding, Ashlyn’s July 10, 2000

e, > blinking episode evidenced the first symptom or

manifestation of onset of her seizure disorder.

App. 76

Throughout his testimony, Dr. Corbier stated that

Ashlyn’s eye blinking would have made him

suspicious and prompted him to ask further

questions and conduct an evaluation and order

testing. Id. at 11-12,

14,16, 22, 24. This conclusion is reinforced by the

following testimony’ elicited during cross-

examination:

Q But as far as the eye blinking alone.... is

lit) not your opinion that that alone is

evidence of a seizure disorder?

A There is no question that there was a

mild seizure, but in terms of a seizure

disorder, and seeing signs or symptoms of a

seizure disorder, we would want to see signs

or symptoms to strengthen that suspicion.

So the choices really are that it could be

mild seizures, or that instead of seizures that

there could be some subtle cerebral

dysfunction that was starting, and will

culminate in a more organized seizure activity

down the road. So it is hard to sort those two

out.

Q Dr. Corbier, just to clarify for me, would

it be your opinion that the eye fluttering and

seizure disorder are both symptoms of a single

process caused by an insult to the brain at

about the time of the vaccinations?

App. 77

A Yes, I think that is a likely-that is a

good possibility.

Id. at 24-25 (emphasis added). This testimony

highlights that Ashlyn’s eye blinking was a

neurological symptom that marked onset. Dr.

Corbier made clear that even though he could not

have said with absolute certainty on July 10, 2000,

that Ashlyn had a seizure disorder, he was able to

testify that problematic neurological symptoms were

present. This adverse testimony by petitioners’

expert, a highly qualified neurologist and a credible

witness, was critical to the special master’s decision.

It proved that from an objective standpoint, onset

was manifest even though the parents did not

recognize its significance. It is readily apparent from

his testimony that Dr. Corbier found that Ashlyn’s

eye blinking was a sign of neurological injury. It is

irrelevant that a neurologist would not have been

able to make an immediate diagnosis of the specific

injury on July 10, 2000. It is enough that the eye

blinking episodes represented the beginning of a

seizure disorder.

It is also worth noting that Dr. C€orbier

stressed the importance of the eye blinking episodes

occurring on the samme day as the vaccinations. Dr.

Corbier explained that if there had been no evidence

of brain dysfunction between July 10, 2000, and

August 30, 2000, it would be more difficult to prove

that the vaccinations Ashlyn received on July 10,

2000, were the cause of her seizure disorder. Id. at

21-22. Ironically, if the first symptom or

manifestation of onset was August 30, 2000, a date

which is approximately 51 days postvaccination,

App. 78

petitioners would face a much more difficult battle in

proving that the DTaP, IPV, and/or Hib vaccinations

caused Ashlyn’s seizure disorder. However, for

purposes of calculating the limitations period, it is

beyond dispute that there can be only one date of the

first symptom or for the manifestation of onset.

Shalala v. Whitecotton, 514 U.S. 268, 274 (1995).

2. A Formal Diagnosis Is Unnecessary to Commence

the Running of the Limitations Period.

Vaccine Act cases uniformly hold that the 36-

month limitations period “does not require a

diagnosis of a condition to start the running of the

statute of limitations.” Goetz v. Sec’y of HHS, 45

Fed. Cl. 340, 342 (1999), affd, 4 Fed. Appx. 827 (Fed.

Cir. 2001) (stating further that “the occurrence of an

event recognizable as a sign of vaccine injury by the

medical profession at large, not the diagnosis that

actually confirms such an injury in the specific case”

triggers the running of the statute of limiations);

Setnes v. United States, 57 Fed. Cl. 175, 181 (2003)

(“The court is not holding that a medical or

psychological diagnosis or verification of the

‘occurrence of the first symptom or manifestation of

onset’ begins the running of the statute of

limitations.”). Indeed, petitioners concede this well-

settled point of law.** Pet. Br. at 4. In a similar vein,

petitioners also recognize that the Vaccine Act “does

not require knowledge that the vaccine caused the

symptom or manifestation of onset in order for the

53 All references to Petitioners’ Brief in Support of Onset Date

of August 30, 2000, shall be designated herein as “Pet. Br. at .”

App. 79

statute of limitations to start running.” Id.; see also

Childs v. Sec’y of HHS, 33 Fed. Cl. 556, 558 (1995).

Those concessions notwithstanding,

petitioners argue that their claim is timely because

they “were neither aware, nor should they have been

aware, that Ashlyn had a disease or a condition as of

July 10, 2000.” Pet. Br. at 5. By framing the issue in

this manner, petitioners divert the inquiry from its

proper focus. The critical point on which the

limitations issue is decided is when onset was

manifest. The special master is not holding that the

parents were obligated to recognize or diagnose their

child’s disorder from the first moment it occurred. To

the contrary, the special master is applying an

objective standard as to what the medical

community at large would recognize as the first

symptom of Ashlyn’s seizure disorder. Dr. Corbier

testified that the first symptom or manifestation of

onset occurred on July 10, 2000, even though

petitioners did not fully comprehend what they saw

at the time. As the petition and Ms. Markovich’s

affidavit reflect, petitioners observed the rapid eye

blinking episodes, but did not realize they were

neurological signs manifesting the initial onset of

symptoms until after the August 30, 2000 seizure.

The parents’ failure to identify Ashlyn’s eye blinking

episodes as the manifestation of initial onset of an

illness or condition is insufficient to postpone the

running of the statute of limitations.

App. 80

3. Pegging Onset to the Repeated Rapid Eye

Blinking Episodes, Which Began on July 10. 2000,

Does Not Impose a Heavier Burden on Petitioners.

Petitioners essentially ask that the special

master toll the limitations period, which began when

they first observed the initial onset of symptoms on

July 10, 2000. This she cannot do. Brice, 240 F.3d at

1368, 1373-74. The testimony of petitioners’ expert

has demonstrated that Ashlyn’s July 10, 2000 eye

blinking episode was the first neurological symptom

of Ashlyn’s seizure disorder. Contrary to their

argument, pegging the date of onset to the eye

blinking, as required by statute, does not impose a

heavier burden on petitioners. The Vaccine Act does

not require that the petitioners know the precise

moment that Ashlyn suffered a seizure disorder. Nor

are petitioners required to identify one or any

combination of vaccines that Ashlyn received as

having caused her injury. An objective reading of the

statute reveals that Congress did not craft language

that required knowledge of a specific vaccine-related

injury. Rather, Congress specified that the

limitations provision of the Vaccine Act is triggered

by the first symptom or manifestation of onset of the

injury. Here, the petition, Ms. Markovich’s affidavit,

and the testimony of Dr. Corbier reflect that the eye

blinking episodes began on July 10, 2000. As

explained above, Dr. Corbier identified the July 10,

2000 eye blinking episode as the first neurological

symptom marking the onset of a vaccine-related

injury. Importantly, Dr. Corbier admitted that even

if he could not confirm a seizure disorder on July 10,

2000, Ashlyn’s symptoms “would at least lead to a

suspicion and the need for further questioning and

App. 81

evaluation.” Dr. Corbier stated that the eye blinking

could have been either “subtle seizures ... or some

type of brain dysfunction.” Regardless of the specific

neurologic injury flowing from vaccination, Dr.

Corbier explained that given that the eye blinking

episodes continued over time until the seizure on

August 30, 2000, “you can see that there was a

progression of symptoms.” This testimony

conclusively demonstrates that the only possible

date of onset is July 10, 2000.

4. The Vaccine Act Does Not Differentiate Between

Subtle and Pronounced Symptoms.

In the Vaccine Act, Congress made no

distinction between subtle and _ pronounced

symptoms for the date of onset. If Congress had

intended such a distinction, the Vaccine Act would

contain such language, but it does not and the

special master will not engraft such a provision. As

respondent correctly points out in his posthearing

brief, there are mumerous cases where the

established first manifestation of symptoms was

subtle. For example, in Lynch v. Secretary of HHS.

No. 90-3767V, 1992 WL 365457, at *4 (Fed. Cl. Spec.

Mstr. Nov. 12, 1992), the special master noted that

even though the parents did not recognize it as

significant at the time, the first symptom or

manifestation of onset was the child’s slumping over

in a chair, which marked the child’s first seizure.

Other decisions have noted that brief eye blinking or

fluttering constituted the onset of symptoms even

though the symptoms were subtle. See Gruber _v.

Sec’y of HHS, No. 95-34V, 1998 WL 928423, at *8

(Fed. Cl. Spec. Mstr. Dec. 22, 1998), rev'd on other

grounds, 61 Fed. Cl. 674 (2004); Lara v. Sec’y_ of

App. 82

HHS, No. 90-1655V, 1993 WL 215068, at *13 (Fed.

Cl. Spec. Mstr. June 4, 1993). As explained by the

Court of Federal Claims in Goetz. “{I]t is clear that

Congress intended the cause of action... to accrue

upon occurrence of the first symptom of an injury,

not upon the first identification of a link between the

injury and the vaccination.” 45 Fed. Cl. at 342.

5. The Setnes Decision Does Not Apply to the Facts

of This Case.

Petitioners urge the undersigned to apply

their interpretation of the holding in Setnes v.

United States. Setnes, instructive but non-binding

Court of Federal Claims precedent, is inapposite

here.* In Setnes. the injured child, AJ, suffered from

autism, a condition that went undiagnosed by his

physicians for many months despite their best

efforts and years of education and training. 57 Fed.

Cl. at 177. Specifically, AJ’s behavior changed after

his 15-month vaccinations-he made a constant

humming noise and was doing a lot of babbling. Id.

at 176-77. Other changes in behavior included

kicking, screaming, and even instances when AJ ate

videotape cardboard boxes. Id. at 177. Despite being

examined by his pediatrician and his obvious change

in behavior, AJ went undiagnosed for many months.

Id. It was not until ten months after the vaccinations

in question had been administered that AdJ’s

pediatrician expressed concern that he might suffer

from a pervasive developmental disorder. Id. Finally,

¥5 “Special masters are neither bound by their own decisions nor

by cases from the Court of Federal Claims, except, of course, in

the same case on remand.” Hanlon v. Sec’y of HHS, 40 Fed Cl.

625, 630 (1998), aff'd, 191 F.3d 1344 (Fed. Cir. 1999).

App. 83

nearly 16 months postvaccination, AJ was diagnosed

with autism. Id.

In order to prevent the dismissal of their

petition on statute of limitations grounds, AdJ’s

parents argued that “because of the unique nature of

autism spectrum disorder, there can be no

‘manifestation of onset’ until such time as the

medical and psychological professionals verify

through reliable medical and psychological means

that a constellation of behaviors presented in a

specific child meet the criteria for autism spectrum

disorder.” Id. at 179. Although not accepting all of

the parents’ arguments, the court agreed that:

As distinguished from other medical

conditions,... the beginning stages of autism

cannot be reduced to a single, identifiable

symptom. Many of the initial ‘symptoms’ are

subtle and can easily be confused with typical

child behavior. Where there is no clear start to

the injury, such as in cases involving autism,

prudence mandates that a court addressing

the statute of limitations not hinge its decision

on the ‘occurrence of first symptom.’

Id. (footnotes omitted) (emphasis added). The court

stated that the onset of AJ’s autism was not

manifest for a number of months after the first

symptoms occurred because the injury was not

manifest. Id. at 181. The court reasoned that if AJ’s

pediatrician were unable to diagnose an injury, then

it would be unfair to apply the statute in a

mechanical way that required the parents to have

greater skill and training than the pediatrician. Id.

App. 84

In reaching its conclusion, the court reasoned that

Congress’s use of the word manifest was not

surplusage. Id. at 180.

The Setnes court held that “in a situation such

as that before the court, where the symptoms of

autism develop ‘insidiously over time’ and the child’s

behavior cannot readily be connected to an injury or

disorder, the court may rely on the child’s medical or

psychological evaluations for guidance in

ascertaining when the ‘manifestation of onset’

occurred.” Id. at 181. The Court further remarked

that: “It is one thing to be unaware that an obvious

injury or its onset was caused by a vaccination. It is

quite another to lack knowledge, through no

assignable fault, of the existence of the onset. This is

especially true where the treating physician does not

associate the behavior as an onset of an injury.” Id.

Although not a treating physician, Dr. Corbier

identified the rapid eye blinking episodes, which

began on July 10, 2000, as a neurological indicator of

mild seizure or other brain dysfunction. Although it

was not until after the August 30, 2000 seizure that

Ashlyn’s parents realized that they may have been

observing possible subtle seizures beginning on July

10, 2000, that does not alter the reality that those

mild seizures or brain dysfunction episodes were

manifest. As explained earlier herein, petitioners

need not understand the significance of a first

symptom, the symptom merely must be manifest. To

hold otherwise would open the door to many who

would conveniently argue that while they observed

certain activity shortly after vaccination that was

later explained to be the first symptom or

ee

App. 85

manifestation of the onset of an injury, because they

lacked medical training, they failed to recognize

those first symptoms as the manifestation of an

injury.

Unlike Setnes, this case does not involve

autism. Another distinguishing feature is that in the

instant case, petitioners’ expert pediatric

neurologist testified that the eye blinking episode

was part of the same process as the dysfunction that

culminated on August 30, 2000 in a seizure. Thus,

unlike the child in Setnes. Ashlyn had a clear and

defined neurological event-repeated rapid eye

movement. There can be no serious disagreement

that neurological symptoms are not equivalent to

typical childhood behaviors. A pediatrician might

well expect to see a young child like AJ babble and

kick. However, as Dr. Corbier testified, rapid eye

movements would raise his suspicions.* In sum, Dr.

Corbier’s testimony was unmistakable that the rapid

eye blinking episodes that began on July 10, 2000,

and the August 30, 2000 seizure were all part of the

same process. Therefore, petitioners’ contention is

35 Petitioners’ counsel tried to lead Dr. Corbier through a

Setnes analysis. However, those efforts were not successful.

After being asked whether “the beginning states of epilepsy

[can] be reduced to a single identified symptom,” Dr. Corbier

responded: “Yes, in a sense that instead of what is called a

grand mal... seizure, you may have situations where instead

of having a full-blown episode, you may have something that is

less mild at first, and then may build up into a more

conspicuous and remarkable episode, such as a grand mal

seizure.” Tr. at 11. Thus, Dr. Corbier did make a direct

connection between the rapid eye blinking that began on July

10, 2000, and culminated with Ashlyn’s August 30, 2000

seizure.

App. 86

unpersuasive that because they were not so alarmed

by Ashlyn’s eye blinking episodes as to seek medical

attention, the statute of limitations did not begin to

run. As described above, this reasoning is not in

accord with other Vaccine Act decisions. As the

Federal Circuit cautioned in Brice v. Secretary of

HHS, courts must be “careful not to interpret [a

waiver of sovereign immunity] in a manner that

would extend the waiver beyond that which

Congress intended. 240 F.3d at 1372-73 (quoting

Stone Container Corp. v. United States, 229 F.3d

1345, 1352 (Fed. Cir. 2000)).

Petitioners are devoted and caring parents.

That their little girl is afflicted with a terrible

condition, which at times is life-threatening, is heart

wrenching. Magnifying their pain is the fact that the

reason petitioners had their child vaccinated was to

preserve her good health, not to jeopardize it. And

now, because they filed their petition 50 days too

late, they face dismissal of their petition in the very

program designed to compensate parents who

believe that their child sustained a vaccine-related

injury. If another option were available to her, the

special master would take it with alacrity. But the

special master is constrained by the law written by

Congress. The Vaccine Act, contains a_ specific

limitations period which unambiguously states that

the clock begins to run on the date of the occurrence

of the first symptom or manifestation of onset of

injury. Petitioners’ evidence proves that although

they may not have understood their significance,

they nevertheless were aware that the eye blinking

episodes began on July 10, 2000.

App. 87

IV. CONCLUSION

Petitioners bear the burden of proving that

the petition was timely filed. Unfortunately for

petitioners, the petition, Ms. Markovich’s affidavit,

the expert affidavits and reports, and the expert

testimony at hearing make clear that the first

symptom or manifestation of onset of Ashlyn’s

seizure disorder occurred on July 10, 2000, a date

which is more than three years prior to the filing of

the August 29, 2003 petition. Therefore, the special

master finds that the court does not have

jurisdiction to decide the merits of this case and

petitioners’ claim is DISMISSED for failure to

satisfy the statute of limitations.

In the absence of a motion for review filed

pursuant to RCFC Appendix B, the Clerk of Court is

directed to enter judgment dismissing the case as

barred by the statute of limitations.

IT IS SO ORDERED.

/s/

Margaret M. Sweeney

Special Master

App. 88

Noran Neurological Clinic

Suite #210 ,

910 East 26th Street Minneapolis, MN 55404

(612) 879-1000 Fax: (612) 879-0722

ASHLYN MARKOVICH

Female DOB: 05/12/2000 88166/1-NNC

09/20/2001 — Phone Note: having sz/probs on meds

Provider: Traci Matthews RN

Location of Care: Noran Neurological Clinic, P.A.

Home: (952) 233-8692

Work: 952-445-4368 til 10am.

Other:

Last appt:

Next appt:

Provider: Steve Janousek MD

Patient’s Home Location of Care: NNC910

September 20, 2001 8:47 AM by: Traci Matthews RN

Mom called — she is getting very fed up. Pt is very

irritated. pt having little sz this am (can tell by

looking at her eyes, freq eye blinking, head rolls to

side and quickly goes back to center—mom can tell it

is bothering pt). Will shut her eyes and kind of

moan...mom wonders if she might not be

experiencing dizziness/blurred vision. Walking was

better this am so she gave mysoline (25mg)...also on

Imt 25mg bid. Wondering if we shouldn’tconsider

getting her off all meds as she seems to be so

unhappy, and they don’t seem to work anyhow.

App. 89

September 20, 2001 10:08 AM by: Jen Pierce

Mom called again...mom thinks metabolic panel &

uric acid needs to be done today. Having a lot of

diarrhea and problems...will have drawn @ St.

Francis ASAP...needs orders faxed now. What to

order???

September 20, 2001 10:16 AM by: Jen Pierce

Called again...could the Carnitine cause the

diarrhea or stomach cramping???

Carnitine can cause stomach cramping and diarrhea

need to do carnitine levels

hold carnitine x3d then restart at 4 dose then get to

full dose in 1 wk keep us posted

carnitine may help pt

go to % dose of mysoline

September 20, 2001 10:29 AM by: Steve Janousek

MD

September 20, 2001 10:42 AM by: Traci Matthews

RN

Informed mom-she will go to St. Francis now. faxed

lab order

September 21, 2001 8:31 AM by: Jen Pierce

Mom called...she knows her meds are causing a lot

of s/e...wakes up happy in the a.m. and as soon as

meds are given, she gets very cranky, upset and not

herself. Mom is getting somewhat

frustrated...knows Ashlyn needs to be on these

meds, but it’s hard to see her cranky like this.

Labs from yesterday entered below: ¢

Added new observation of SGPT (ALT): 62 (1-50)

(09/20/2001 8:47)

App. 90

Added new observation of SGOT (AST): 49 U/L

(09/20/2001 8:47)

Added new observation of ALK PHOS: 307 U/L

(09/20/2001 8:47)

Added new observation of BILI TOTAL: 1.9 (0.0-1.5)

mg/dL (09/20/2001 8:47)

Added new observation of ALBUMIN: 4.5 g/dL

(09/20/2001 8:47)

Added new observation of PROTEIN, TOT: 6.4 g/dL

(09/20/2001 8:47)

Added new observation of CALCIUM: 10.1 mg/dL

(09/20/2001 8:47)

App. 91

mayo Clinical Document Copy

Ashlyn M. Markovich (5-449-277)

Printed 07-SEP-2003 08:57 by User ID: 10185194

Jan-29-2002 — Consult, Jeffrey R. Buchhalter, M.D.,

Child & Adolescent Neurology

DEMOGRAPHIC INFORMATION:

Clinic Number: 5-449-277

Patient Name: Ashlyn M. Markovich Age: 20 months

Born: 2000-5-12 Sex: F

Address: 2418 Thrush Street City: Shakopee MN

55379-4413 U.S.A.

Note Date: Jan-29-2002 History Section: NEN #1

Service: PDN Event Type: CON Status: Fnl

Last Printed: Jan-30-2002 10:49:55

REFERRAL:

Timothy D. Johanson, M.D., 510 Southdale Medical

Building, 6545 France Avenue South, Edina, MN

55435, (952) 920-9191

CHIEF COMPLAINT/PURPOSE OF VISIT:

ASSISTED BY: Dr. Randa G. Jarrar (127-00910).

Intractable seizures.

HISTORY OF PRESENT ILLNESS:

I had the opportunity of meeting 20-month-old,

right-greater than left-handed Ashlyn with her

mother. The history was obtained. Extensive

outside medical records and neuroimaging reviewed

and a neurological examination performed. I concur

App. 92

with the history, findings, and recommendations of

Dr. Jarrar in her note dated today.

In summary, Ashlyn is the full-term poduct of an

uncomplicated pregnancy, labor, and spontaneous

vaginal delivery. There were no difficulties until

first focal onset seizure occurred at 4 months of age.

Subsequently, Ashlyn has had a variety of seizures

including (1) eye blinking with or without a head nod

lasting seconds that can occur hundreds per day, (2)

right- or left-sided clonic activity of face and/or leg

lasting five to seven minutes, occurring

approximately every other day, (3) focal or

generalized onset of tonic-clonic seizure lasting

greater than ten minutes, requiring hospitalization

and intravenous medication. The last occurred two

months ago. (4) Right- or left-sided body clonic

activity usually in the form of a heavy convulsion,

occurring approximately once per week, lasting five

to seven minutes.

In the past, Ashlyn has been on carbamazepine,

Phenobarbital, Topamax, Lamictal, Keppra,

Depakote, zonisamide, Mysoline, Dilatin, vitamin

B6, and a ketogenic diet with significant ketosis for

one month. She is currently on Felbatol with a

Keppra taper and had a transient started less than

one week ago with somewhat improved seizures.

Ashlyn had a video EEG session at the Minnesota

Epilepsy Group in December of 2001. Her mother is

not sure of the results but thinks that most of the

seizures started on the left side. MRIs dated August

2001 and November 2000 were reviewed, and I agree

they are normal.

App. 93

Ashlyn’s development has been relatively normal

with regard to fine and gross motor skills but her

speech is at the 9- to 10- month old level. There is no

family history of seizures.

REVIEWED PMH, ALLERGIES, SH, _ FH,

MEDICATIONS, AND ROS AS NOTED ON THE

CURRENT VISIT INFORMATION FORM, DATED

29-JAN-2002 AND ON THE PATIENT FAMILY

HISTORY FORM DATED 29-JAN-2002.

PHYSICAL EXAMINATION:

Height: 80.8 cm (31.8 in). Weight: 10.31 kg

(22.73 lb).

BSA: 0.5 M2, BMI: 15.792 KG/M2.

Neurological examination reveals a well-nourished,

well-developed, slightly postictal child. Cranial

nerve testing revealed no abnormalities. Motor

examination revealed normal tone, bulk, and

spontaneous movements. She had a mild tremor

when reaching for objects.

IMPRESSION/REPORT/PLAN:

#1 Intractable localization-related epilepsy

Ashlyn has had very severe seizures which have not

been significantly affected by trials of excellent

medications as well as a ketogenic diet. At this

ppoint, we discussed a number of options. The only

modern anticonvulsant that Ashlyn has not used as

yet is vigabatrin which could be obtained from

Canada. However, it is unlikely that it would

produce dramatic seizure relief. The possibility of an

immunologically mediated seizure disorder was

discussed. A trial of intravenous immunoglobulin or

prednisone could be utilized. The lower side effect

App. 94

rate of the [VIG was noted with the downside of IV

being required. Vagus nerve stimulator is also a

possibility as a nonpharmacologic therapy. In terms

of epilepsy surgery, we discussed corpus callosotomy

if a focal ictal onset cannot be discovered. With

regard to the latter, there is no clear evidence that

the majority of Ashlyn’s seizures are coming from

one location. Therefore, we discussed obtaining a

SISCOM (subtraction ictal spect coregistered with

MRI) in an attempt to find the most epileptogenic

zone. It was explained that if Ashlyn’s surface

recording revealed clear independent hemispheric

onsets then this would not be pursued. Ashlyn will

be admitted to the Pediatric Epilepsy Monitoring

Unit tomorrow to begin her evaluation.

DIAGNOSES:

#1 Intractable localization-related epilepsy

SPECIAL INSTRUCTIONS:

Please send a copy of this note to the family at the

home address and to Dr. Johanson.

Margin Code: P5

JRB: keg Revised: Jan-30-2002 10:49 by lmc

Electronically signed Feb-24-20202 09:48 by J.R.

Buchhalter, M.D.

App. 95

mayo Clinical Document Copy

Ashlyn M. Markovich (5-449-277)

Printed 07-SEP-2003 08:57 by User ID: 10185194

Jan-29-2002 — Multi-system Evaluation, Randa G.

Jarrar, M.B.B.S., Child & Adolescent Neurology

DEMOGRAPHIC INFORMATION:

Clinic Number: 5-449-277

Patient Name: Ashlyn M. Markovich Age: 20 months

Born: 2000-5-12 Sex: F

Address: 2418 Thrush Street City: Shakopee MN

55379-4413 U.S.A.

Note Date: Jan-29-2002 History Section: NEN #2

Service: PDN Event Type: ME Status: Fnl

Last Printed: Jan-30-2002 10:51:29

REFERRAL:

Timothy D. Johanson, M.D., 510 Southside Medical

Building, 6545 France Avenue South, Edina, MN

55435, (952) 920-9191

CHIEF COMPLAINT/PURPOSE OF VISIT:

SUPERVISED BY: Dr. Jeffrey R. Buchhalter (4-

7519).

Intractable seizures.

HISTORY OF PRESENT ILLNESS:

Ashlyn is a 20-month-old, right- more than left-

handed young lady who is coming in _ today

accompanied by her mother and _ maternal

grandmother for evaluation of intractable epilepsy.

App. 96

She was a product of a full-term, planned pregnancy.

Her mother was 26 years old, gravida 1, para 1.

Delivery was vaginal, vacuum-assisted. The

pregnancy was unremarkable except for two

episodes of dehydration which were accompanied by

a drop in the fetus’s heart rate but otherwise

unremarkable. Birth weight was 7 pounds 2 ounces.

No resuscitation was required, and she was

discharged to home after two days.

Ashlyn did very well during the first 3 1/2 months of

life. On August 31, 2000, she had her first seizure.

It started out with jerking of one of the extremities—

mom does not recall exactly which one. This was

followed by a generalized clonic activity that lasted

for 20 minutes. She had basic laboratory testing and

a spinal tap at that time which was negative. Two

weeks later, she had another similar episode. Since

then, she continued to have intermittent seizures.

Currently, she has four types of seizures. (1)

Repeated eye blinking, either unilateral or bilateral

with or without head nodding. This lasts for a few

seconds and occurs hundreds of times per day. (2)

Right or left clonic movement of the face, arm, and

leg. This occurs about every other day. She is not

arousable during these episodes and these are quite

prolonged, and they never stop without Valium.

They typically last about seven minutes, and they

occasionally generalize. (3) Generalized seizures

with or without focal onset. These occur especially

with fever, and they usually last for more then ten

minutes. They typically require hospitalization.

The last one was two months ago. (4) Partial motor

right-sided or left-sided seizures that occur once per

App. 97

week, and they last for variable periods of time,

anywhere between minutes to about an hour.

Since the seizure onset, she was tried on numerous

medications. She was tried first on Tegretol for

about a week; however, she continued to have very

significant, severe seizures during that week. Then

she was tried on phenobarb for three weeks. She

sustained good levels; however, she continued to

have significant breakthrough seizures. She was on

Topamax for a period of six months. Her dose was

50 mg twice a day. On Topamax, she had her

longest seizure-free period which was nine weeks.

The mother says that she was free of the generalized

tonic-clonic seizure and the unilateral clonic, motor

seizures, but she continued to have the eye-blinking

seizures. After nine weeks of relatively good seizure

control, she started having breakthrough

generalized tonic-clonic seizures so lamotrigine was

added. She reached a dose of 60 mg per day but

continued to have significant breakthrough seizures.

Subsequently, she was tried on the ketogenic diet for

one month. She was adequately ketonic on that;

however, she did not tolerate it. Mom says she was

always hungry and irritable. Then she was tried on

Keppra, reached a dose of 1500 mg per day without

good control of the seizures. Then she was tried on

zonisamide, reached a dose of 100 mg at bedtime and

continued to have seizures. Then Keppra was added

to the zonisamide without adequate control.

Somewhere during these trials, she was put on

Dilantin, but the mother does not remember exactly

when. While on Dilantin, she continued to have the

seizures, and in addition, she developed two drop

seizures wich she never had without the Dilantin.

App. 98

She was also given pyridoxine for one month. Most

recently, she has been on felbamate. She has been

taking that for a month, and she continues to have

seizures. Tranxene has been given for the last week.

She is currently being tapered off Keppra.

Fortunately, she did not develop any side effects to

any of the above mentioned medications.

As for investigations, she has numerous EEGs and

prolonged monitoring. Her initial EEG showed

predominantly right posterior occipital quadrant

abnormalities and _ seizures. However, she

underwent prolonged monitoring in September of

2001 which showed poorly organized, slow

background. She had multifocal spikes originating

from T7, P3, T8, and P8. Several ictal events were

preceded by high amplitudes, slowing followed by

suppression. The most recent monitoring was in

December. We do not have the reports of that

monitoring stay. However, mom recalls that she was

told that she had several seizures of right- and left-

sided onset. She had two MRIs, one in October of

2000 and another in August of 2001, both of which

were negative. Her serum amino acids and urine

organic acids were checked, and they were within

normal.

Despite all these seizures, she is doing well

developmentally. Mom thinks that her gross motor

and fine motor development is appropriate. She

currently can run. She can go down stairs. She is

occasionally off balance, especially when she takes

large doses of Valium. She has an excellent pincer

grasp. She can say eight to ten words. She cannot

make sentences. Her speech tends to fluctuate;

App. 99

however, her development otherwise has been

progressing steadily. She was assessed during her

most recent hospitalization in December and was

found to be developmentally appropriate in terms of

growth and fine motor development; however, her

speech was at 9- to 12-months level. She moves her

upper and lower extremities quite well except

following a prolonged focal seizure after which she

has Todd’s paralysis. She seems to have normal

sensation. She can swallow well. She seems to hear

well and see well. She has normal bowel and

bladder function. She has no history of recurrent

fevers. She has good appetite. Ever since starting

Felbatol, she has not been sleeping well. However,

this responded to melatonin at bedtime.

Numerous outside medical records were reviewed.

Her two outside MRIs were also reviewed.

CURRENT MEDICATIONS:

Felbamate 600 mg/5 cc. She takes 4 cc in the

morning, 4 p.m, and 3 cc at bedtime.

Tranxene 3.75 mg tablets. She takes 1/4 to 1/2 a

tablet twice a day.

Rectal Valium on an as-needed basis.

Keppra 125 mg q.d. This is being tapered off.

ALLERGIES:

None.

PAST MEDICAL/SURGICAL HISTORY:

As mentioned above. She had numerous

hospitalizations because of status epilepticus but no

significant medical problems otherwise.

App. 100

SOCIAL HISTORY:

She lives with her parents. Mom is a nurse who

works on a part-time basis. Dad works with

computers. Vaccinations—she only received her 2-

month vaccines. It was thought that the seizures

started seven to ten days after the 2-month vaccine

so no further vaccines were given. Development as

mentioned above. Birth history is as mentioned

above.

FAMILY HISTORY:

She is an only child. There is no family history of

seizures, mental retardation, or developmental

delay. No family history of febrile seizures.

PHYSICAL EXAMINATION:

Head Circumference: 45.0 cm.

Head circumference was 45 cm, on the 5th percentile

for age. Mom indicates that her head has always

been the 5th percentile for age ever since she was

born.

Skin: She had no stigmata of neurocutaneous

disease. Wood lamp exam was negative.

HEENT: Head and Neck exam was unremarkable.

Heart: Normal S1, S2, no murmurs.

Lungs: Clear.

Abdomen: Soft with no organomegaly.

Spine: Straight and normal.

Neuro: During the evaluation, she had numerous

eye-blinking spells. In between them, she was

appropriate for her age. She played with her

grandma and played peek-a-boo and waved bye-bye.

During the evaluation, she had one complex partial

seizure consisting of clonic activity involving the

right face and the right upper extremity. This lasted

App. 101

for about five minutes and was aborted by giving a

rectal Valium. Cranial nerves were examined and

were within normal. Her pupils were equally

reactive to light. Fundi were within normal. She

tracked well. Visual fields appeared to be normal to

confrontation. Facial, lingual, and palatine muscles

were within normal. She appears to have normal

hearing. Motor exam, prior to the clonic seizures,

she was moving her upper and lower extremities

symmetrically and equally; however, there was some

weakness for short periods of time following the

seizure. Her tone was within normal. Her reflexes

were normal and symmetric. Plantars were

downgoing bilaterally. Sensory exam appears to be

grossly intact. She had no _ evidence of

incoordination. She reached appropriately and

adequately. Her gait prior to the seizure was within

normal; however, after getting the Valium, she was

drowsy and was unable to walk independently.

IMPRESSION/REPORT/PLAN:

#1 Intractable epilepsy

It appears that Ashlyn has an intractable epilepsy

syndrome. It consists of seizures of multifocal onset

and perhaps some seizures of generalized onset. Her

previous EEGs have been nonlocalizing as was her

MRI. She failed numerous appropriate drug trials.

There are not too many options available at this

point; however, we discussed with her the remaining

options. In terms of medications, one can try

vigabatrin or Gabitril and perhaps give some of the

previously tried medications another trial. Topamax

seemed to have worked best for her so potentially

that can be tried one more time and perhaps

Trileptal. We also discussed with mother the

App. 102

various surgical options including the vagus nerve

stimulator, the possibility of focal resective surgery

as well as corpus callosotomy. We discussed with

her that the likelihood that she will have a

respectable lesion is quite small, but it is worthwhile

the evaluations since she has been intractable since

the onset of her seizures. If the evaluation does not

reveal a surgically respectable focus then the next

step would be to evaluate her for either vagus nerve

stimulator or corpus callosotomy. The risks and

benefits of each procedure were discussed with

family. At this point, we will admit her to the

Epilepsy Monitoring Unit to record some of these

seizure and determine whether she would be a

candidate for SISCOM. I suspect that then we

would be able to record several of her seizures

without altering her medications, but if we are

unable to then we could start out by tapering of the

Tranxene. She will be seen once she is admitted to

Saint Marys Hospital.

DIAGNOSIS:

#1 Intractable epilepsy

Margin Code: P5

RGJ:tac Revised: Jan-30-2002 10:50 by lmc

Electronically signed Feb-01-2002 10:09 by R.G.

Jarrar, M.B.B.S.

App. 103

UNITED STATES COURT OF

FEDERAL CLAIMS

MICHAEL AND MELISSA )

MARKOVICH, AS PARENTS _)

OF ASHLYN M. MARKOVICH, )

Petitioners, )

)

Vv. ) Docket No.:

) 03-2015V

SECRETARY OF THE )

DEPARTMENT OF HEALTH )

AND HUMAN SERVICES, )

Respondent. )

Pages: 1 through 28

Place: Washington, D.C.

Date: November 5, 2004

App. 104

IN THE UNITED STATES COURT OF

FEDERAL CLAIMS

OFFICE OF SPECIAL MASTERS

MICHAEL AND MELISSA )

MARKOVICH, AS PARENTS _)

OF ASHLYN M. MARKOVICH, )

Petitioners, )

)

Vv. ) Docket No.:

) 03-2015V

SECRETARY OF THE )

DEPARTMENT OF HEALTH __)

AND HUMAN SERVICES, )

Respondent. )

Room 508

Courtroom No. 7

National Courts Building

717 Madison Place, N.W.

Washington, D.C.

Friday,

November 5, 2004

The parties met, pursuant to notice of the

Court, at 10:12 a.m.

BEFORE: HONORABLE MARGARET M.

SWEENEY

Special Master

App. 105

APPEARANCES: (Telephonically)

For the Petitioners:

MARK L. KRUEGER, Esquire

Greenhalgh & Hoffman, S.C.

123 Second Street

Post Office Box 41

Baraboo, Wisconsin 53913

(608) 356-2008

APPEARANCES: (Continuing)

For the Respondent:

TRACI R. PATTON, Esquire

U.S. Department of Justice

Torts Branch, Civil Division

P.O. Box 146

Ben Franklin Station

Washington, D.C. 20044

(202) 353-1589

INDEX

WITNESSES DIRECT CROSS

Dr. Jean-Ronel Corbier 5 20

REDIRECT RECROSS

23 25

App. 106

PROCEEDINGS

(10:02 a.m.)

THE CLERK: The United States Court of

Federal Claims is now in session, the Honorable

Margaret M. Sweeney presiding in the case of

Michael and Melissa Markovich, as Parents of

Ashlyn M. Markovich, versus the Secretary of the

Department of Health and Human Services, Case

Number 03-2015V.

THE COURT: Good morning, counsel.

Thank you both for being here this morning, and Dr.

Corbier, thank you for appearing by telephone. We

are here for an on-site hearing in this case, and just

as a housekeeping matter, Mr. Krueger, Petitioner's

counsel, has advised me that he intends to file Dr.

Corbier's CV, and I understand, Ms. Patton, that you

have a copy of that?

MS. PATTON: Yes, I do.

THE COURT: Thank you very much.

Would either counsel like to make an. opening

statement, or do you want to proceed to the direct

and cross of Dr. Corbier?

MR. KRUEGER: That would be fine with

me. I don't think an opening statement is necessary.

MS. PATTON: That's fine, Your Honor.

App. 107

THE COURT: Very good. Let us proceed.

Doctor, I have to swear you in, of course.

Whereupon,

DR. JEAN-RONEL CORBIER

having been duly sworn, was called as a witness, and

was examined and testified as follows:

DIRECT EXAMINATION

BY MR. KRUEGER:

Q Dr. Corbier, this is Mark Krueger

again. Good morning.

A Good morning.

Q Could you please state your full name

for the record?

A I am Dr. Jean-Ronel Corbier.

Q And, Dr. Corbier, what is your business

address?

A My address is 7024 Sydney Curve, and

that is in Montgomery, Alabama 36117.

Q And what is your occupation?

A I am a child neurologist.

Q And how long have you been a child

neurologist?

App. 108

A I have been a child neurologist since

2000.

Q And when did you receive your medical

degree?

A I received my medical degree in 1995.

Q And are you licensed to practice

medicine?

A Yes, I am licensed to practice in the

State of Alabama.

(Brief Interruption.)

THE COURT: Doctor, we are having

technical difficulties. If you could hold on, please.

(Pause.)

BY MR. KRUEGER:

Q Doctor, have you ever had your license

revoked or suspended?

A No.

Q Are you board certified?

A Yes. I am board certified in child

neurology.

Q And in this particular case, your

resume that I will be filing with the Court and which

App. 109

you provided, is that your most current curriculum

vitae?

A Yes, it is.

Q Do you specialize in -- I assume you

specialize in child neurology?

A Yes, I do.

Q Have you ever treated children with

seizure disorders?

A Yes, I have treated both individuals and

children with seizures.

Q And a seizure disorder is another word

for epilepsy?

(Brief Interruption.)

THE COURT: Doctor, can you hear us

now?

THE WITNESS: Yes.

THE COURT: All right. Thank you,

doctor.

BY MR. KRUEGER:

Q I believe I had asked you that I had

assumed that your specialty was child neurology?

A Yes, it is.

App. 110

Q And I also asked you about treating

children with seizure disorders. Is a seizure disorder

and epilepsy the same thing?

A Yes, a seizure disorder and epilepsy are

the same thing, and actually with a seizure disorder,

you can have multiple seizures on a daily basis.

Q Okay. And have you treated children

with epilepsy that have been linked to vaccinations?

A Yes, I have treated children with

epilepsy that we think have been linked to

vaccinations. Yes.

Q Do you have an opinion whether DPT

vaccinations can cause seizure disorders?

A Yes, I do have an opinion.

Q And what is that?

A My opinion is that there are susceptible

individuals where the DPT vaccination can trigger a

seizure disorder, including intractable seizures.

Q And in this particular case did you have

a chance to review Ashlyn Markovich's medical

records?

A Yes, I have.

Q And those were provided to you by Dr.

Marks?

App. 111

A Yes.

Q What was your purpose in evaluating

the medical records? What was your understanding

of what you were reviewing?

A Well, the purpose as I understood it was

to see if based on the record it was likely or if there

was a chance that the vaccine, the DPT, could be

related to the patient's seizure disorder.

Q And you did prepare a report based

upon your review of the records?

A Yes, based on everything that I had

read, I prepared a report. I looked at the history,

and the time line, and the clinical seizure disorder

that the patient developed.

Q And your report is dated May 19th, 2

004?

A That is correct, yes.

Q And that is the report that we have had

filed with the Court in this case is your

understanding?

A Yes, it is.

Q And have you personally examined

Ashlyn?

A No, I haven't.

App. 112

Q Do you feel that that in any way

impacts your ability to render opinions today?

A No, it should not.

Q Now, in this particular case, I would

like for you to look at your report, dated May 19th of

2004. Do you have that in front of you?

A Yes, I do.

Q And you also -- and are your opinions

expressed in your report?

A Yes, my opinions are.

Q And that would be on page 3?

A On page 3, yes.

Q Now, during your -- well, let me ask it

this way. Do you have an opinion as to the onset

date of Ashlyn Markovich' s seizure disorder?

A Yes, I do.

Q What is that opinion?

A The opinion, based on the records that I

have reviewed, is that on August 30th, 2000, the

patient had a generalized tonic-clonic seizure that

lasted at least 20 minutes.

So as of that date, the patient did

definitively have documented seizures and that went

beyond August 30th, 2000.

App. 113

Q Now, there is a reference in your report

that Mrs. Markovich observed Ashlyn having some

periods of time, and even the day of the vaccination,

in which Ashlyn was observed blinking her eyes

rapidly. Are you aware of that?

A Yes.

Q First of all, what significance do those

references to the eye blinking play in rendering your

opinions in this case?

A Well, they play an important part, in

the sense that from my understanding of the records

it seems that on July 10th, 2000, the very day of her

vaccinations, there was some blinking of the eye.

What is unclear is whether it could have been the

beginning of some small unrecognized seizure

activity.

That could sometimes be subtle, or it

could be some type of beginning of a brain

dysfunction that would have culminated to a full-

fledged, first full seizure on August 30th.

So my professional opinion is that the

time line of when something first started may have

started on August 10th, that was due to some type of

cerebral dysfunction, and then the _ results

culminated in her having a seizure, a generalized

tonic, or grand mal seizure as we call it, on August

30th.

Q Okay. You mentioned August 10th. I

believe you meant to say July 10th; is that correct?

App. 114

A I'm sorry, July 10th.

Q Thank you. Now, you have diagnosed

children with seizure disorders?

A Yes, many times.

Q Is eye blinking in and of itself sufficient

to warrant a diagnosis of a seizure disorder?

A Not by itself. If we had a situation

where someone started having eye blinking for no

apparent reason, then we start to ask questions.

There are certain things beyon

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