# Appendix — Markovich v. Leavitt, 128 S. Ct. 92 (2007) (No. 06-1539) > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386008_0493%3A2 ## Record - **Collection:** Supreme Court brief - **Document type:** Appendix - **Published:** January 1, 2007 ## Text 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 Lync [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386008_0493%3A2. Public record. Not legal advice.