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 United States Court of Appeals for the Federal Circuit

                                       06-5039



                        MICHAEL and MELISSA MARKOVICH,
                           Parents of Ashlyn M. Markovich,

                                                      Petitioners-Appellants,

                                           v.

                SECRETARY OF HEALTH AND HUMAN SERVICES,

                                                      Respondent-Appellee.



      Mark L. Krueger, Greenhalgh Krueger & Hernandez, SC, of Baraboo, Wisconsin,
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.

Appealed from: United States Court of Federal Claims

Judge Susan G. Braden
 United States Court of Appeals for the Federal Circuit
                                        06-5039

                        MICHAEL and MELISSA MARKOVICH,
                           Parents of Ashlyn M. Markovich,

                                                       Petitioners-Appellants,

                                            v.

                 SECRETARY OF HEALTH AND HUMAN SERVICES,

                                                       Respondent-Appellee.

                            __________________________

                             DECIDED: February 20, 2007
                            __________________________


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)

(“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 Markoviches 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,

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 a day, including seizures documented

on October 11, 14, 18, 20, 21, and 22, 2000; November 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. ¶ 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.




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      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 Hearing” was necessary in order to determine whether the Markoviches’ petition

was time-barred 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 than three years later. See

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




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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, capricious, an abuse of discretion, or otherwise

not in accordance with the law.” 42 U.S.C. § 300aa-12(e)(2)(B). We effectively 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-1. 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




06-5039                                      4
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.

§ 300aa-16(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



06-5039                                     5
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 there is a manifestation of onset of injury that would trigger the

statute of limitations. The Markoviches argue that, pursuant to the logic of Setnes, 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 the 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




06-5039                                     6
manifestation of onset” of injury means that either a “symptom” or a “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, e.g., Shalala v. Whitecotton, 514 U.S. 268,

274 (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 that, in cases where symptoms are hard to recognize, courts

should look instead to the manifestation prong. The court in Setnes was concerned with




06-5039                                     7
the very subtle symptoms attributed with autism that can be easily confused with typical

child behavior, and it distinguished the terms “symptom” 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 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.

       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.

       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:



06-5039                                      8
              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), aff’d on other

grounds, 240 F.3d 1367 (Fed. Cir. 2001). In Brice, we held that equitable tolling is not

available for claims arising under § 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), aff’d, 27 Fed. Cl. 457 (1993), aff’d, 17 F.3d 1442 (Fed. Cir. 1994) (table)

(holding that “in many Vaccine Program cases the injuries are first manifested 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”).




06-5039                                      9
       The Supreme Court, in Whitecotton, interpreted the terms “first symptom or

manifestation of onset,” as that language is used in §§ 300aa-11(c)(1)(C)(i)1 and 300aa-

14(a)2 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. 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 argue that it supports causation, reasoning that

“[a]lthough petitioners’ experts are using that event [eye blinking on July 10, 2000] to



       1
              § 300aa-11(c)(1)(C)(i) 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-11(c)(1)(C)(i) (emphasis added).
       2
             § 300aa-14(a) provides:
      The following is a table of vaccines, the injuries, disabilities, illnesses,
      conditions, and 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).


06-5039                                      10
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 statue of limitations.

       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 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 eye blinking episode
              occurred] there was a mild seizure . . . .




06-5039                                      11
              [T]here 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 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.,




06-5039                                     12
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)), aff’d, 4 Fed. Appx. 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, i.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.

                                         COSTS

       No costs.




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