     IN THE UNITED STATES COURT OF FEDERAL CLAIMS
               OFFICE OF SPECIAL MASTERS
                                            No. 03-2619V
                                       Filed: October 17, 2013

                                           Not for Publication

****************************
KERRI SPEIGHTS, parent of   *
TYLER SPEIGHTS, a minor,    *
                            *                              Autism; Chronic Mucocutaneous
                Petitioner, *                              Candidiasis; CMC; Statute of
     v.                     *                              Limitations; Significant Aggravation;
                            *                              Equitable Tolling; Vaccine Act
SECRETARY OF HEALTH         *                              Entitlement; Denial Without Hearing
AND HUMAN SERVICES,         *
                            *
              Respondent.   *
****************************

Brian R. Arnold, Esq., Brian R. Arnold & Associates, Dallas, TX, for petitioner.
Ann Martin, Esq., U.S. Department of Justice, Washington, DC, for respondent.

                                                DECISION1

Vowell, Chief Special Master:

      On November 3, 2003, Kerri Speights [“petitioner”] filed a petition for
compensation under the National Vaccine Injury Compensation Program, 42 U.S.C.
§ 300aa-10, et seq.2 [the “Vaccine Act” or “Program”], on behalf of her minor son, Tyler
Speights [“Tyler”]. Petitioner initially alleged that Tyler’s autism spectrum disorder
[“ASD”] was caused by one or more of the vaccines he received.


1
  Because this unpublished decision contains a reasoned explanation for the action in this case, I intend
to post it on the United States Court of Federal Claims' website, in accordance with the E-Government
Act of 2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501
note (2006)). In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to
delete medical or other information, the disclosure of which would constitute an unwarranted invasion of
privacy. If, upon review, I agree that the identified material fits within this definition, I will delete such
material from public access.
2
  National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (1986). Hereinafter,
for ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C.
§ 300aa (2006).
      Subsequently, petitioner alleged that Tyler’s vaccinations caused or significantly
aggravated his immunodeficiency disorder (chronic mucocutaneous candidiasis
[“CMC”]) and/or his developmental regression.3

      Because I conclude that the petition was untimely filed, even under a significant
aggravation theory, and further that the circumstances in this case do not warrant
equitable tolling, this case is dismissed.

                                          I. Procedural History.

A. The Short-Form Petition.

     By filing a “short-form” petition for vaccine compensation, petitioner opted into the
Omnibus Autism Proceeding [“OAP”].4

        The OAP was created to resolve what ultimately totaled about 5,700 petitions
alleging that vaccines or the thimerosal preservative contained in some vaccines
caused ASDs. In an omnibus proceeding, test cases are selected for hearings in which
the parties present evidence generally applicable to the cases in the omnibus
proceeding, as well as evidence specific to the test cases. The results in the test cases
do not bind the parties in the remaining omnibus cases, but the body of evidence thus
created can be used to resolve the remaining cases.5 In the OAP, three test cases
were selected for each of the two theories of vaccine causation advanced by the
petitioners’ bar. Hearings in the test cases were conducted in 2007 and 2008, and
decisions were issued in 2009 and 2010.6
3
 Petitioner’s original and amended claims, as well as Tyler’s medical history, are discussed in further
detail below.
4
    By electing to file a Short-Form Autism Petition for Vaccine Compensation, petitioners alleged that:

          [a]s a direct result of one or more vaccinations covered under the National Vaccine Injury
          Compensation Program, the vaccinee in question has developed a neurodevelopmental
          disorder, consisting of an Autism Spectrum Disorder or a similar disorder. This disorder
          was caused by a measles-mumps-rubella (MMR) vaccination; by the “thimerosal”
          ingredient in certain Diphtheria-Tetanus-Pertussis (DTP), Diphtheria-Tetanus-acellular
          Pertussis (DTaP), Hepatitis B, and Hemophilus Influenza[e] Type B (HIB) vaccinations; or
          by some combination of the two.

Autism General Order #1, Exhibit A, Master Autism Petition for Vaccine Compensation, 2002 WL
31696785, at *8 (Fed. Cl. Spec. Mstr. July 3, 2002), available at
http://www.uscfc.uscourts.gov/node/2718.
5
 A more detailed explanation of the creation of the OAP and the effects of opting into it can be found in
Dwyer v. Sec’y, HHS, No. 03-1202V, 2010 WL 892250, at *3 (Fed. Cl. Spec. Mstr. Mar. 12, 2010).
6
 The Theory 1 cases are Cedillo v. Sec’y, HHS, No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr.
Feb. 12, 2009), aff’d, 89 Fed. Cl. 158 (2009), aff’d, 617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. Sec’y,
HHS, No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 473 (2009),
aff’d, 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. Sec’y, HHS, No. 01-162V, 2009 WL 332044 (Fed. Cl.
Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 706 (2009). Petitioners in Snyder did not appeal the

                                                       2
        To position Tyler’s case for resolution upon the conclusion of the test cases, I
ordered petitioner to file all medical records from Tyler’s birth through the later of
petitioner’s filing date or the date of Tyler’s ASD diagnosis. Order, issued Nov. 14,
2008. Petitioner filed medical records on February 12, 2009. Petitioner’s Exhibits [“Pet.
Exs.”] 1-32.7

       On March 2, 2009, respondent moved to dismiss petitioner’s case as untimely
[“Res. Mot. to Dismiss”], asserting that the petition was filed outside the Vaccine Act’s
three-year statute of limitations. Res. Mot. to Dismiss at 1 (citing § 16(a)(2)).
Respondent argued that Ms. Speights should have filed her petition by no later than
July 13, 200[1],8 because the first symptom or manifestation of onset of Tyler’s ASD
occurred, when he was approximately 20 months old (around July 13,1998), more than
three years prior to petitioner’s November 3, 2003 filing date. Res. Mot. to Dismiss at 3-
4.

       Petitioner responded to the motion to dismiss on April 8, 2009 [“Pet. Resp. to
Mot. to Dismiss”], contending that her petition was timely filed. Ms. Speights argued
that the Vaccine Act’s statutory limitations period began on August 8, 2001, the date of
Tyler’s ASD diagnosis, and that she therefore had until August 8, 2004 to file a petition.
Pet. Resp. to Mot. to Dismiss at 2-4. A ruling on the motion to dismiss was deferred,
pending the appellate review of the test case decisions.

        On September 15, 2010, I ordered Ms. Speights to inform the court whether, in
light of the results in the OAP test cases, she wanted to proceed with her claim or move
to dismiss it. On November 17, 2010, after petitioner failed to comply with my order, I
ordered petitioner to show cause why her case should not be dismissed for failure to
prosecute. On December 21, 2010, Mr. Brian Arnold became Ms. Speights’s counsel.

B. First Amended Petition.

       On January 7, 2011, I ordered petitioner to file an amended petition, setting forth
the vaccines responsible for Tyler’s condition and a theory of causation. On February
11, 2011, petitioner filed an amended petition [“First Am. Pet.”], alleging that Tyler
“suffered an acute complication or sequella of an illness, disability, injury, or condition”

decision of the U.S. Court of Federal Claims. The Theory 2 cases are Dwyer, 2010 WL 892250; King v.
Sec’y, HHS, No. 03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); Mead v. Sec’y, HHS,
No. 03-215V, 2010 WL 892248 (Fed. Cl. Spec. Mstr. Mar. 12, 2010). The petitioners in each of the three
Theory 2 cases chose not to appeal.
7
  Petitioner failed to submit Exhibit 6, which was described in the Table of Contents as “Record of
Information Sheets from Dr. Cramer.”
8
  Respondent mistakenly stated that “this case should have been filed no later than July 13, 2000.” Res.
Mot. to Dismiss at 4. Based on Tyler’s date of birth, November 13, 1996 (Pet. Ex. 1), and respondent’s
reference to the medical records indicating his regression began around 20 months, about July 13, 1998
(Res. Mot. to Dismiss at 3), it is evident that respondent miscalculated three years from July 13, 1998.


                                                     3
as a direct result of the vaccines he received between birth and 33 months of age.9
First Am. Pet. at 2-3. Petitioner added that Tyler “suffered injury, or in the alternative
suffered an aggravation of a medical condition as a result of his multiple vaccines.” Id.
at 3. Although noting Tyler’s CMC10 diagnosis, petitioner ambiguously referred to “a
multitude of reactions and problems” and “multiple physical and health problems
following . . . vaccinations.” First Am. Pet. at 2-3.

        On February 15, 2011, I ordered petitioner to file all outstanding medical records
and an affidavit describing Tyler’s vaccinations and injuries. In petitioner’s affidavit
[“Pet. Aff.”], filed on April 4, 2011, Ms. Speights stated her belief that Tyler no longer has
an ASD diagnosis. She added that Tyler “continues to suffer from his injuries caused by
the vaccine(s) which aggravated his condition.”11 Subsequently, petitioner filed
additional medical records.

       On May 26, 2011, I stayed resolution of respondent’s motion to dismiss, noting
that the statute of limitations issues in this case appeared similar to those raised in a
case then pending before the Federal Circuit, Cloer v. Sec’y, HHS, 654 F.3d 1322 (Fed.
Cir. 2011) (en banc), cert. denied, 132 S. Ct. 1908 (2012). Following the decision in
Cloer, I ordered the parties to file simultaneous briefs addressing the impact of Cloer on
this case. Order, issued Aug. 19, 2011.

C. The Parties’ Cloer Briefs.

        On September 19, 2011, respondent filed her brief addressing Cloer [“Res. Br.”].
In her brief, respondent noted the Federal Circuit’s holding that “‘[t]he statute of
limitations in the Vaccine Act begins to run on the date of the occurrence of the first
symptom or manifestation of onset of the vaccine-related injury for which compensation
is sought, and the symptom or manifestation of onset must be recognized as such by
the medical profession at large.’” Res. Br. at 3 (quoting Cloer, 654 F.3d at 1335).

       Petitioner submitted her brief addressing Cloer [“Pet. Br.”] on October 18, 2011.12
In her brief, petitioner asserted that her petition was timely filed (Pet. Br. at 7), or,

9
 These vaccines included: “Hepatitis B1, DTP-HIB1, OPV 1PV1 [sic], Hepatitis B2, DTP-HIB2, OPV
1PV2 [sic], DTP-HIB3, Hepatitis B3, Varicella, Varivax, MMR, HIB4, DTAP4, and OPV3.” First Am. Pet.
at 2.
10
    Chronic mucocutaneous candidiasis is an immunodeficiency disorder in which the immune system
does not adequately respond to Candida [“yeasts”] due to a primary defect in T-lymphocytes. NELSON
TEXTBOOK OF PEDIATRICS (19th ed. 2011) [“NELSON’S”] at 1056. It is characterized by chronic and severe
yeast infections of the skin and mucus membranes. Id. Symptoms can present in the first few months of
life. Id.
11
  Petitioner’s affidavit appeared incomplete. However, petitioner informed the court that the affidavit was
complete as filed. See Order, issued April 7, 2011.
12
   Petitioner’s brief focused on Tyler’s CMC diagnosis, which is further discussed in Part II below. In this
brief, petitioner set forth a theory and associated arguments not clearly presented in earlier filings.


                                                      4
alternatively, that equitable tolling is warranted (Id. at 4). Petitioner argued that Tyler’s
case is distinguishable from Cloer on the facts (Id. at 3 (citing Cloer, 654 F.3d 1322)),
and that it should be evaluated under the standard set forth in Setnes v. United States,
57 Fed. Cl. 175 (2003) (Pet. Br. at 6).

        According to petitioner, “Tyler’s manifestation of onset occurred in November
2000 because it was the first time a medical professional had verified through reliable
medical means that the vaccinations were the actual cause for Tyler’s early childhood
behavior.” Pet. Br. at 6. Petitioner did not, however, specify which medical professional
had so concluded. She noted that “Tyler’s language delay was combined with other
symptoms of normal child behavior which lead [sic] his pediatrician to assure petitioner
that Tyler was reacting normally” and thus the earliest petitioner “knew or should have
known” that vaccines caused Tyler’s injury was November 3, 2000, when he was
diagnosed with CMC.13 Pet. Br. at 7. Attempting to differentiate her case from Cloer,
petitioner added that, unlike Tyler, Ms. Cloer received a diagnosis more than three
years before filing her petition. Id. at 6 (citing Cloer, 654 F.3d at 1327-28).

         Petitioner relied on Setnes as the basis for her contention that the standard for
determining the timeliness of her petition should be subjective. Pet. Br. at 3 (citing
Setnes, 57 Fed. Cl. at 179). According to petitioner, a subjective standard is
appropriate because of the unique nature of CMC for which there is “no ‘manifestation
of onset’ considered unless it is verified by a reliable medical and psychological [sic]
means.”14 Pet. Br. at 3 (citing Setnes, 57 Fed. Cl. at 179). Petitioner added that “when
there is no clear start to an injury as in autism cases, there is no manifestation of onset
until it is verified through a ‘reliable medical and psychological means that a
constellation of behaviors presented in a specific child meet [its] criteria.’” Pet. Br. at 5
(quoting Setnes, 57 Fed. Cl. at 175).

        In addition to relying on Setnes to support her timeliness argument, petitioner
also cited Judge Newman’s dissent in Brice v. Sec’y, HHS, 240 F.3d 1367, 1374-78
(Fed. Cir. 2001), without explaining how this dissent supported her contention that
“Tyler’s case should be a good candidate for equitable tolling.” Pet. Br. at 4. Petitioner
also attempted to distinguish Tyler’s case from that of the child in Brice. Acknowledging
that unawareness of an obvious injury, like the seizure suffered by the vaccinee in
Brice, is not grounds for equitable tolling, petitioner stated that “Tyler’s condition was not
diagnosed or accepted by his treating physicians until November of 2000.” Id. (citing
Setnes, 57 Fed. Cl. at 181; Brice, 240 F.3d at 1369).

        On November 1, 2011, respondent filed a reply to petitioner’s brief [“Res. Reply

13
   Although petitioner asserted in her affidavit her belief that Tyler no longer has an ASD diagnosis, in her
later-filed pleadings, she continued to reference developmental issues when discussing Tyler’s CMC.
See, e.g., Pet. Br. at 6; Petitioner’s Second Amended Petition [“Second Am. Pet.”] at 3.
14
  The diagnosis of CMC would not involve either psychological testing or psychological specialists.
Autism spectrum disorders may be diagnosed by psychologists, based on behavioral testing and
observation.


                                                      5
Br.”], contending that petitioner’s arguments regarding the application of a discovery
rule were meritless. Res. Reply Br. at 1-2. Respondent emphasized the Federal
Circuit’s holding that “there is no explicit or implied discovery rule under the Vaccine
Act.” Id. at 2 (citing Cloer, 654 F.3d at 1337). Respondent added that the statute of
limitations is not triggered by a petitioner’s actual or presumed knowledge of either his
adverse condition or the possible connection between a vaccine and his condition. Res.
Reply Br. at 2 (citing Cloer, 654 F.3d at 1339). Finally, respondent noted that the
Federal Circuit has thrice rejected the Setnes approach to triggering the running of the
Vaccine Act’s statute of limitations. Res. Reply. Br. at 2-3 (citing Markovich v. HHS, 477
F.3d 1353, 1358 (Fed. Cir. 2007); Wilkerson v. HHS, 593 F.3d 1343, 1345 (Fed. Cir.
2010); Cloer, 654 F.3d at 1334-35).

        During a December 6, 2012 status conference, I discussed the problems with
petitioner’s supplemental Cloer brief. See Order, issued Dec. 7, 2012. I also addressed
the deficiencies with petitioner’s amended petition, particularly petitioner’s failure to
specify the alleged vaccine-caused injuries and the responsible vaccine(s). See id.
Accordingly, I ordered petitioner to file a second amended petition, clearly identifying the
alleged vaccine-caused injuries, the vaccines responsible, and the exact theory
petitioner would attempt to prove with an expert report. Id.

D. Petitioner’s Motion to Dismiss.

        On February 15, 2013, petitioner, instead of filing a second amended petition,
filed a motion to dismiss [“Pet. Mot. to Dismiss”]. In her motion, petitioner noted her
realization that retaining an expert and proving entitlement would be difficult. Pet. Mot.
to Dismiss at 1. However, on February 18, 2013, petitioner moved to strike her motion
to dismiss [“Pet. Mot. to Strike”], indicating that she had located potentially supportive
evidence. Pet. Mot. to Strike at 1. I granted petitioner’s motion to strike and ordered
her to file the additional evidence. Order, issued Feb. 19, 2013, at 2. I also ordered
petitioner to file a second amended petition. Id.

E. Second Amended Petition.

        On March 7, 2013, petitioner filed a second amended petition, which constitutes
the operative petition for evaluating petitioner’s claims. Although the second amended
petition is still ambiguous as to the alleged vaccine injury, it appears that petitioner links
Tyler’s vaccinations to both his CMC and his developmental regression. Second Am.
Pet. at 3 (“After further testing it was determined that the vaccines were aggravating his
CMC condition and causing regression in the child’s development.”) (citing Pet. Ex. 8, p.
11).15 Petitioner asserts that Tyler’s vaccinations caused or significantly aggravated his

15
   Petitioner claims that, “[o]n or about November 12, 2000, Tyler’s physicians traced back Tyler’s CMC
and vaccine injuries . . . to his vaccines. . . . Petitioner filed her [p]etition for compensation on November
3, 2003, which is within three (3) years of Petitioner’s notice of vaccine related injuries.” Second Am. Pet.
at 7 (emphasis added). Contrary to my February 19, 2013 order, petitioner again used ambiguous terms
like “vaccine injuries” to describe Tyler’s condition.


                                                      6
condition. Second Am. Pet. at 5. She claims that her original petition, filed on
November 3, 2003, was timely because Tyler’s physician’s traced his “CMC and
vaccine injuries” to his vaccines on November 12, 2000. Id. at 7. Alternatively, she
again asserts that her case warrants equitable tolling because she was “misinformed
and . . . not given information as required by statute, which would have allowed [her] to
file a claim . . . sooner.” Id. Specifically, petitioner states that Tyler’s treating physicians
never notified her of the Vaccine Program. Id. at 5. Petitioner failed to file the evidence
referenced in her motion to strike or other evidence supportive of her claims of
misinformation. I therefore ordered her to show cause why her case should not be
dismissed. Order, issued Apr. 12, 2013.

       Petitioner filed additional evidence to support her equitable tolling claim on May
13, 2013. Pet. Ex. 39. According to petitioner’s response to my show cause order
[“Pet. Show Cause Resp.”], the additional evidence, consisting of copies of vaccine
information pamphlets that Ms. Speights claims she was given at the time of Tyler’s
vaccinations,16 did not put her on notice of the existence of the Vaccine Program. Pet.
Show Cause Resp., filed May 13, 2013, at 3.

        On June 21, 2013, I ordered respondent to address the allegations set forth in
petitioner’s second amended petition. In her response [“Res. Resp.”], filed July 23,
2013, respondent reasserts her position that petitioner’s case must be dismissed for
untimely filing. Res. Resp. at 1. Respondent argues that Tyler experienced symptoms
of CMC as early as October 5, 2000, more than three years before Ms. Speights filed
her petition. Id. at 2 (citing Pet. Ex. 14, p. 3). Respondent adds that Tyler’s medical
records do not support petitioner’s significant aggravation claim. Res. Resp. at 2.
Commenting on the “unacceptabl[e]” vagueness of the second amended petition,
respondent notes that “petitioner [did] not identify any specific vaccine-related
manifestations of CMC occurring after November 3, 2003.17 Id. (citing Second Am. Pet.
at 4-5). Finally, respondent asserts that ignorance of the law is “insufficient to warrant
application of the extraordinary relief of equitable tolling.” Res. Resp. at 4.

                                    II. Relevant Medical History.

      Tyler was born on November 13, 1996. Pet. Exs. 1; 2, p. 5. Tyler’s Apgar scores
were 7 and 9,18 and his size was “appropriate for gestational age” (36 weeks). Pet. Ex.
16
  These pamphlets also accompanied petitioner’s April 8, 2009 response to respondent’s motion to
dismiss. They are apparently the documents that petitioner intended to file as Pet. Ex. 6, but which were
missing from petitioner’s February 12, 2009 evidentiary filings.
17
  Respondent also notes a claim that Tyler contracted measles as a result of his brother’s MMR
vaccination, which occurred after November 3, 2000, “is not a viable vaccine injury claim under the
Vaccine Act, which requires that, except for specific circumstances related to [the] oral polio vaccine, the
vaccine recipient also be the injured party.” Res. Resp. at 2 (citing § 11(c)(1)). Respondent’s position is
correct.
18
  The Apgar score is a numerical expression of a newborn’s condition. DORLAND’S ILLUSTRATED MEDICAL
DICTIONARY [“DORLAND’S”] at 1682. It is calculated one minute and five minutes after birth by adding the
points awarded (2, 1, or 0) to five physiological markers: heart rate, respiratory effort, muscle tone, reflex

                                                      7
2, p. 5. Tyler passed his infant hearing screen on November 14, 1996. Id., p. 4. He
was subsequently discharged from the hospital on November 16, 1996. Id., p. 7.

       The medical records from Tyler’s first five months of life reflect problems with
thrush,19 feeding, vomiting, diarrhea, fever, and congestion. See Pet. Ex. 4, pp. 1-6.
The first notation of what would become a chronic problem with thrush was made during
Tyler’s two week well-baby check. Id., p. 1. At this visit, Tyler received his initial
hepatitis B vaccine. Id. He continued to receive routine childhood immunizations until
August 12, 1999. See Pet. Exs. 5, p. 2; 9; 10.

       Notes from Tyler’s well-child visits reflect very little progression in speech
between nine and 18 months of age.20 See Pet. Ex. 4, pp. 9, 11-12. Although it is
unclear from the records when his pediatrician or parents first became aware of his
speech problems, an entry on September 8, 1999 indicated that Tyler had an
appointment for testing for an early intervention program. Id., p.15. Based on the
undated telephone call note above this entry, the early intervention testing involved
Tyler’s speech. Id. On November 18, 1999, when Tyler was three years of age, he
underwent a speech evaluation, based on a referral from his pediatrician, Dr. Andrea
Cramer. Pet. Ex. 26, pp. 71-79. Although Tyler’s receptive language skills were
deemed “normal,” his articulation was determined to be severely impaired. Id., pp. 71,
73.

        In a subsequent speech evaluation on December 8, 1999, Tyler’s articulation
was described as “severe disorder – makes a few phonemes correctly.” Id., p. 59. The
evaluator recommended speech therapy. Id., p. 62. Tyler’s pediatric records also
reflect this diagnosis, with a notation of “speech delay” made on the same date as his
speech evaluation. Pet. Ex. 4, p. 16.

         Tyler was seen at a different pediatric practice in August, 2000. Notes from the
initial visit indicate that Tyler’s development was normal, except for his speech and
vocabulary. Pet. Ex. 8, p. 6. At this visit, parental concerns regarding speech and
Tyler’s diet were noted. Id. Although the records do not indicate why, Tyler was
referred to a neurologist on September 1, 2000. Id. An undated telephone call note
immediately following this entry reflects a call from a Dr. Rios,21 with notes indicating
“PDD spectrum,” a referral to a “preverbal program,” indication of a family history of
seizure disorders, and Tyler’s language disorder, suggestive of Landau-Kleffner

irritability, and color. Id.
19
  Thrush or “oral candidiasis” is a fungal infection caused by yeasts. DORLAND’S at 1924. It is
characterized by white spots in the mouth and on the tongue. Thrush is a common symptom of immune
system disorders, including CMC. Id.
20
  Tyler had “+2” words at nine months, four words at 12 months, and three to four words at 15 months.
Pet. Ex. 4, pp. 9-11. At 18 months he had “+3” words and was noted to be a babbler. Id., p. 12.
21
     Doctor Rios is identified in another record as a developmental pediatrician. Pet. Ex. 8, p. 8.


                                                        8
syndrome. Pet. Ex. 8, p. 6. Petitioner called the pediatric office on September 1, 2000,
to report that Dr. Rios had evaluated Tyler and thought he might have a rare genetic
form of autism. Doctor Rios had several suggestions for evaluation and therapy for
Tyler. Id., p. 8.

      By September, 2000, concerns about Tyler’s development had spread beyond
speech. A record dated September 8, 2000, reflects that, in addition to having “few
words,” Tyler was a finicky eater and had tactile defensiveness and light sensitivity.
These entries are followed by the notation “PDD,” an abbreviation standing for
Pervasive Developmental Disorder. Pet. Ex. 4, p. 21.

       On September 11, 2000, during a sick-child visit for thrush, the physician noted
that Tyler would not eat unless his food was mashed and his mother made him. The
physician noted “mom very concerned” followed by “[symptoms] of developmental delay
and sensory integration disorder.” Id., p. 7. A note from a September 26, 2000
pediatric visit recorded a history of “problems [with] speech . . . x [for] 16 mo.” Id., p. 9.
This would place onset of Tyler’s speech problems in May, 1999.

        Tyler continued to have thrush throughout childhood. See Pet. Exs. 4 and 8; see
also Pet. Ex. 13, p. 2 (“The mother recalls that Tyler used to have frequent bouts of
thrush since 2 weeks of age.”). On October 5, 2000, Tyler had his first visit with Dr.
Richard Wasserman, an immunologist, to rule out CMC. See Pet. Ex. 15, pp. 2-3.
Doctor Wasserman noted “Candidiasis,” “R/O [rule out] Deficiency, Cell Mediated
Immune (Chronic Mucocutaneous),” and “? of Autism, Infantile.” Id., p. 2. During the
visit, Tyler underwent a candida skin test,22 which yielded normal results. Id., p. 4.

       On October 16, 2000, Dr. Wasserman ordered a series of blood tests, resulting in
Tyler’s CMC diagnosis. See id., pp. 4, 41, 43, 47. Ms. Speights was informed of the
diagnosis on November 22, 2000. Id., p. 43. In a December 7, 2000 letter written to Dr.
John Foster, Dr. Wasserman indicated that “[t]his disorder was not induced by
immunization. I can make no comment about a possible relationship between
immunization and other problems.” Id., p. 47.

        On February 14, 2001, Tyler was seen by Dr. Gerald So for a neurological
evaluation, having been referred because of “aphasia[23] and staring spells.” Pet. Ex.
13, pp. 2-3. During the visit, Ms. Speights informed Dr. So that “Tyler was quite vocal
until 20 months of age,” but that shortly after the “DaPT [sic] shot,”24 he “began to

22
  Skin tests are used to determine prior exposure or immunity to an infectious disease and to assess how
an individual’s immune system will respond to the disease. DORLAND’S at 1899. A common example is
the tuberculin skin test. Id.
23
   Aphasia generally refers to the inability of self-expression by speech, writing, or signs due to brain
injury or disease. DORLAND’S at 115.
24
  The vaccination records indicate that Tyler received a DTaP vaccination on June 19, 1998, when he
was 19 months of age. Pet. Ex. 5.


                                                      9
regress with his language.” Id., p. 2. She reported that Tyler “stopped talking and
began pointing at things,” “began to have repetitive emesis,” and “began to have
episodes of staring.” Id. Ms. Speights further reported that “[a]t age 3 yo, shortly after
his varicella vaccine, [Tyler] began having more episodes of staring.”25 Id. Aside from
Tyler’s language, the only abnormality Dr. So observed was “toe walking.” Id., p. 3.
Doctor So referred Tyler for EEG monitoring to determine whether his staring spells
were epileptic in origin. See id.; Pet. Ex. 21, p. 1. The results of this study were
normal.26 Pet. Ex. 13, p. 4.

      Although more recent medical records were filed, they are not relevant to a
determination of the timeliness of the petition.

                                            III. Analysis.

A. Legal Standards.

        The Vaccine Act provides that, 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.

§ 16(a)(2). According to the Federal Circuit, the date on which the statute of limitations
begins to run “is a statutory date that does not depend on when a petitioner knew or
reasonably should have known anything adverse about her condition.” Cloer, 654 F.3d
at 1339. Additionally, the Federal Circuit made clear that the triggering of the statute of
limitations “does not depend on the knowledge of a petitioner as to the cause of an
injury.” Id. at 1338. In Cloer, the Federal Circuit held that “a discovery rule cannot be
read into the Vaccine Act statute of limitations.” Id. at 1339.

       Prior to its decision in Cloer, the Federal Circuit, in Markovich explained the
differences between “symptom” and “manifestation of onset,” as those words are used
in the Vaccine Act. Markovich, 477 F.3d at 1357. A “symptom” may be associated with
more than one condition, and it may be difficult for a lay person to connect a symptom

25
 Tyler received a varicella vaccination on August 12, 1999, when he was about two years and nine
months old. Pet. Ex. 10.
26
   “[Tyler] had several push buttons for episodes of anger outbursts, staring, headaches, episodes of
forgetfulness, and perseveration. None of these episodes showed any epileptic correlates.” Pet. Ex. 13,
p. 4. During the February 14, 2001 visit with Dr. So, Ms. Speights reported that most of Tyler’s starring
spells seemed to occur after anger outbursts. Id., p. 2.


                                                   10
with a particular injury. Id. “Manifestation of onset,” on the other hand, is an event more
clearly associated with an injury. Id. Neither a symptom nor the manifestation of onset
requires a doctor’s definitive diagnosis of a condition. Id. at 1358 (quoting Brice, 36
Fed. Cl. at 477 (1996)). The earlier of the two, however, will trigger the statute of
limitations. Markovich, 477 F.3d at 1357; see also Cloer, 654 F.3d at 1335 (“The
analysis and conclusion in Markovich is correct. The statute of limitations in the
Vaccine Act begins to run on the date of occurrence of the first symptom or
manifestation of onset .”).27

        Although equitable tolling of the statute of limitations is permitted in Vaccine Act
cases, petitioners must establish specific circumstances to justify its application. Cloer,
654 F.3d at 1344-45. The Federal Circuit has noted that appropriate circumstances
include incidents of fraud or duress or where a procedurally defective petition was timely
filed. Id.

B. Findings of Fact and Conclusions of Law.

        Under Cloer, a determination of a petition’s timeliness requires the identification
of the first symptom or manifestation of onset of the alleged vaccine injury. This
determination, however, has been made more difficult in Tyler’s case because of the
ambiguity in petitioner’s pleadings addressing the alleged injury. Because the second
amended petition refers to developmental regression (without explicit mention of autism
or an ASD), as well as CMC, I will assess the timeliness of the petition for the claims of
developmental delay or regression and CMC separately.

        In light of the November 3, 2003 filing date, the first symptom or manifestation of
onset of Tyler’s developmental delay or regression and/or his CMC may not have
occurred before November 3, 2000. Likewise, petitioner’s significant aggravation claim
is subject to the same three-year time period. That is, the “change for the worse” in
Tyler’s developmental delay and/or CMC disorder must have occurred on or after
November 3, 2000 for the petition to be considered timely. See § 33(4) (defining
“significant aggravation”).

                1. The Developmental Delay, Regression Claim, or Autism Claim.

        Petitioner claims that the triggering date for application of the statute of
limitations is August 8, 2001, when Tyler was diagnosed with “speech loss as being a
form of autism.” Pet. Resp. to Mot. to Dismiss at 3.




27
   Petitioner’s reliance on Setnes was not reasonable as Setnes was effectively overruled by Cloer, and,
in any event, does not constitute binding precedent. Hanlon v. Sec’y, HHS, 40 Fed. Cl. 625, 630 (1998)
(noting that decisions of special masters and judges of the Court of Federal Claims constitute persuasive,
but not binding authority); see also Guillory v. Sec’y, HHS, 59 Fed. Cl. 121, 124 (2003) (“The special
master and this court are bound . . . by the decisions of the . . . Federal Circuit.”), aff’d, 104 Fed.Appx.
712 (Fed. Cir. 2004).

                                                     11
       I find that the first symptom of Tyler’s speech delay occurred by 18 months of
age (around May, 1998), when his speech development appeared to have plateaued.
Tyler had approximately the same number of words at this point as he had at 12 months
of age. Pet. Ex. 4, pp. 9-12. There is no indication in the medical records that Tyler’s
pediatrician or his parents were concerned at this point in time. However, according to
Ms. Speights’s own statement, she was concerned shortly after this point. In her words,
“Tyler was quite vocal until about 20 months of age” (Pet. Ex. 13, p. 2), placing onset of
speech regression at around July, 1998. Although this statement was recorded in a
medical history provided in February, 2001, Ms. Speights dated the regression in Tyler’s
speech to his DTaP vaccination (referred to by her as his “DaPT” vaccination). Id. The
vaccination records reflect administration of Tyler’s only DTaP vaccination on June 19,
1998, when he was 19 months old. Tyler’s speech delay was formally diagnosed in
November and December 1999. Pet. Exs. 4, p. 16; 26, pp. 59, 71. In September, 2000,
Ms. Speights reported to Tyler’s pediatrician that he had been having problems with
speech for the previous 16 months, placing onset around May, 1999. Pet. Ex. 8, p. 9.

        Regardless of the date used, both Ms. Speight’s dating and the pediatric records
reflect the first symptoms of speech delay in the spring or summer of 1998. Even using
the initial diagnosis date (December,1999), Tyler’s speech delay had manifested nearly
year too soon for a claim based on speech delay to be timely.

      Tyler’s speech delay later led, in part, to his autism diagnosis.28 The medical
records also reflect behavioral symptoms consistent with autism (finicky eating and
sensory integration concerns) in September, 2000. Pet. Ex. 8, p. 7. Moreover, three
medical records from September, 2000, including a report by petitioner herself, reflect
concerns about autism or PDD. Id., pp. 7-9. These references were made about 10
months too soon for this claim to be considered timely.

       I thus hold that a vaccine injury claim for developmental delay, regression, or, to
the extent Tyler’s autism remains a claimed injury, autism spectrum disorder, is time-
barred.

                2. The CMC Claim.

        Petitioner claims that the triggering date for application of the statute of
limitations is November 3, 2000, the date Tyler was diagnosed with CMC. Pet. Br. at 7.
According to petitioner, November 3, 2000, is the date by which she “knew or should
have known that the vaccines injured Tyler,” and thus that her petition was timely filed
on November 3, 2003. Id. Unfortunately, it is not the diagnosis date that triggers the
running of the statute of limitations; it is the date of the first symptom or manifestation of
onset.

28
   Speech delay is often the first symptom of autism noticed by caregivers, usually between 18-24 months
of age. See White v. Sec’y, HHS, No. 04-337V, 2011 WL 6176064, at *5, *7-8 (Fed. Cl. Spec. Mstr. Nov.
22, 2011); see also Carson v. Sec’y, HHS, 727 F.3d 1365, 1370 (Fed. Cir. 2013) (“[I]t was not arbitrary
and capricious for the Chief Special Master to find that severe speech delay . . . was the first objectively
recognizable symptom of autism.”).

                                                    12
        I find that the first symptom of Tyler’s CMC was the thrush he exhibited on
January 21, 1997, at his well-baby checkup. Pet. Ex. 4, p. 1; see also Pet. Ex. 13, p. 2
(“The mother recalls that Tyler used to have frequent bouts of thrush since 2 weeks of
age.”). Thrush is commonly recognized as a symptom of immune system disorders,
including CMC. See DORLAND’S at 1924; see also supra note 19. I thus hold that
petitioner’s claim that Tyler’s vaccines caused his CMC is time-barred, as the first
symptom of his CMC occurred more than three years before November 3, 2000.

         3. The Significant Aggravation Claim.

       Petitioner claims that Tyler suffered an injury, or in the alternative, suffered an
aggravation of a medical condition due to the multiple vaccines he received. Second
Am. Pet. at 5. Specifically, petitioner asserts that, following Tyler’s CMC diagnosis, his
physicians determined that his CMC was being aggravated by his vaccinations. Pet. Br.
at 6; Second Am. Pet. at 3 (citing Pet. Ex. 8, p. 11).29

       Tyler received his last vaccine on August 12, 1999, according to the medical
records filed. Pet. Ex. 10. His medical records do not show a worsening of his CMC
following his final vaccination, nor did petitioner reference any medical records to
support her claim. Tyler’s condition, as is paradigmatic of chronic diseases, was
persistent. On September 26, 2000, Tyler’s doctor noted his “problem [with] yeast” (Pet.
Ex. 8, p. 9), a problem that, according to Ms. Speights’s own report, had frequently
manifested since Tyler was two weeks of age (Pet. Ex. 13, p. 2). Thus, any claim that a
vaccination aggravated Tyler’s CMC is time-barred.

        Although petitioner did not specifically allege that Tyler’s vaccinations
significantly aggravated his developmental delay, any such claim also would be time-
barred. Tyler’s medical records do not show a worsening of his developmental delay
following his final vaccination on August 12, 1999. On December 8, 1999, nearly four
months after Tyler’s final vaccination, and nearly a year before the earliest date by
which a significant aggravation claim could be considered timely, speech delay was
noted in his pediatric records (Pet. Ex. 4, p. 16), but, as noted above, speech delays
were present prior to this vaccination (see, e.g., Pet. Ex. 8, p. 9 (Ms. Speights’s own
report on September 26, 2000, that speech problems had been present for 16 months)).
Thus, any claim that a vaccination aggravated Tyler’s developmental delay is time-
barred.




29
  On December 6, 2001, Tyler’s doctor noted, “[b]ecause of neurological workup and dx [diagnosis] of
[CMC] hold shots for now.” Pet. Ex. 8, p. 11. Petitioner relies on this notation to support her significant
aggravation claim. Such statements, however, do not necessarily “support an inference that the treaters
believed there was a logical link between vaccination and injury.” Rickard v. Sec’y, HHS, No. 09-729V,
2011 WL 1979601, at *12 (Fed. Cl. Spec. Mstr. Apr. 11, 2011). I note that the physician who diagnosed
Tyler’s CMC categorically stated that Tyler’s CMC “was not induced by immunization.” Pet. Ex. 15, p. 47

                                                    13
        4. Equitable Tolling.

       In her response to my April 12, 2013 order to show cause, petitioner argues that
she “was not aware that the [Vaccine Program] existed at the time Tyler received his
vaccines.” Pet. Show Cause Resp. at 2. She adds that Tyler’s physicians never
provided her with information about the Program as they were legally obligated to do,
and that the documents she was given at the time of Tyler’s vaccinations did not
mention the Vaccine Program. Id. at 2-3. Petitioner asserts that had she been
adequately informed, she would have filed her petition sooner. 30 Id.

      As discussed below, petitioner’s equitable tolling argument lacks factual support.
Moreover, even assuming that petitioner’s assertions are factually correct, to apply
equitable tolling under these circumstances would contravene the intent of Congress, as
evidenced by the legislative history of the Vaccine Act. Petitioner has failed to point to
any other circumstances that justify equitable tolling.

                a. A Lack of Factual Support for Equitable Tolling.

        Petitioner’s Exhibit 39 contains copies of Vaccine Information Statements [“VIS”]
for the polio (two pages), DTP (two pages), hepatitis B (four pages), and Hib (one page)
vaccines. Pet. Ex. 39, pp. 1-9. The Hib VIS is dated 1990, and the other three VIS are
dated 1992.31 Id. Petitioner states that she received these VIS at the time Tyler
received his vaccinations.32 Pet. Show Cause Resp. at 3. Petitioner adds, however,

30
  Petitioner raised these arguments as the basis for retracting her February 15, 2013 motion for a
decision dismissing her petition. On May 13, 2013, petitioner filed copies of vaccine information
pamphlets which she claims she received at the time of Tyler’s vaccinations. Pet. Ex. 39; Pet. Show
Cause Resp. at 3. Petitioner wishes for the court to consider the arguments in favor of equitable tolling
she raised on May 13, 2013.
31
   More current versions of the VIS may have been available between 1996 and 1998, when Tyler
received those vaccines. The Centers for Disease Control [“CDC”] states on its website that “VIS are
updated only when they need to be. For instance, a VIS would be updated if there were a change in
ACIP [Advisory Committee on Immunization Practices] recommendations that affect the vaccine’s
adverse event profile, indications, or contradictions.” CDC, VIS Frequently Asked Questions,
http://www.cdc.gov/vaccines/hcp/vis/about/vis-faqs.html (last visited Oct. 17, 2013) [hereinafter “VIS
FAQ”].
32
  The medical records confirm that petitioner received vaccine information materials at the time of Tyler’s
vaccinations. The record of Tyler’s vaccinations contains the following statement:

        I have been provided a copy of the appropriate Centers for Disease Control and
        Prevention Vaccine Information Material(s) and have read, or have had explained to me,
        information about the diseases and the vaccines listed below. I have had a chance to
        ask questions that were answered to my satisfaction. I believe I understand the benefits
        and risks of the vaccines cited, and ask that the vaccine(s) listed below be given to me or
        to the person named above (for whom I am authorized to make this request).

Below this statement is a multicolumn table, containing vaccination details, such as the type of vaccine
and date of administration. Two columns are titled “Vaccine Information Materials Publ. Date” and
“Parent/Guardian Initials.” For each of the 13 vaccinations listed on the form, a checkmark was made in

                                                    14
that the materials she received did not contain information about the Vaccine Program.
Id. at 2-3.

          Enacted in 1986, the Vaccine Act mandates that the Secretary of Health and
Human Services “develop and disseminate vaccine information materials for distribution
by health care providers to the legal representatives of any child . . . receiving a [Table
vaccine],” and that “[s]uch materials shall be published in the Federal Register” following
“notice to the public and 60 days of comment.” § 26(a)-(b). Currently, and prior to the
earliest publication date of the VIS petitioner filed, the materials disseminated by the
Secretary must contain “a statement of the availability of the National Vaccine Injury
Compensation Program” (§ 26(c)), which took effect on October 1, 1988 (§ 1 (“Effective
Date”)).

        A review of the Federal Register suggests that at least two of the four VIS
petitioner received at the time of Tyler’s vaccinations contained information about the
Vaccine Program.33 On October 15, 1991, a “final rule” concerning the information a
health care provider who administers a polio and/or DTP vaccine must provide to a
vaccinee or his parent was published in the Federal Register. Included in the required
information was the following language: “Get Information About Possible Help: A U.S.
government program provides compensation for some persons injured by vaccines. For
more information, call this toll-free number . . . OR contact: The U.S. Claims Court.”34
Vaccine Information Materials, 56 Fed. Reg. 51798-01 (Oct. 15, 1991).

       The polio and DTP VIS petitioner filed appear to be incomplete. As published in
the Federal Register, the final drafts of the polio and DTP VIS, each contain 12
sections. The final three sections are titled: “Get Information About Possible Help,”
“What Vaccines Does Your State Require?,” and “Vaccine Administration Record.”

the vaccine materials column and a checkmark and/or the initials “KS” or “GS” were written in the
parent/guardian column. Pet. Ex. 5, p. 2.
33
   The hepatitis B and Hib vaccines were not added to the Vaccine Injury Table until August 6, 1997.
National Vaccine Injury Compensation Program (VICP): Effective Date Provisions of Coverage of Certain
Vaccines to the Vaccine Injury Table, 63 Fed. Reg. 25777-01 (May 11, 1998). Notice of proposed
vaccine information materials for those vaccines, including proposed language identifying the Vaccine
Program, was published on September 3, 1998. Proposed Vaccine Information Materials for Hepatitis B,
Haemophilus influenzae type b (Hib), Varicella (Chickepox), and Measles, Mumps, Rubella (MMR)
Vaccines, 63 Fed. Reg. 47026-01. Tyler received his final hepatitis B and Hib vaccines in 1997. Pet. Ex.
5, p. 2. Thus, the hepatitis B and Hib VIS petitioner received at the time of Tyler’s vaccinations may not
have contained information about the Program.
34
   According to the CDC, “[t]he date for a new VIS’s required use is announced when the final draft is
published in the Federal Register. Ideally, providers will begin using a new VIS immediately.” The CDC
recognizes, however, that “[a] provider might be reluctant to discard existing stocks of a VIS when a new
edition is published.” VIS FAQ. I point out that the polio and DTP VIS petitioner filed were published after
the final draft containing information about the Vaccine Program was published in the Federal Register.
Additionally, even if the health care provider who administered Tyler’s polio and DTP vaccinations failed
to discard expeditiously stocks of VIS that did not reflect the 1991 final rule, it is unlikely that that provider
would have been distributing such VIS in 1998, when Tyler received his final polio and DTP vaccines.


                                                       15
Vaccine Information Materials, 56 Fed. Reg. 51798-01 (emphasis added). The
photocopies of the polio and DTP VIS petitioner filed contain sections 1-3 and 5-9.35
The photocopies, however, do not contain sections 10-12. Based on the layout of the
VIS filed, the last three sections of the final drafts would have been printed on a third
page of the 1992 polio and DTP statements. Compare Vaccine Information Materials,
56 Fed. Reg. 51798-01, with Pet. Ex. 39, pp. 1-4.

       In light of the Secretary’s 1991 final rule regarding polio and DTP VIS, the 1992
polio and DTP VIS petitioner filed, and the dates on which Tyler received those
vaccines, it is likely that petitioner received information that referenced the Vaccine
Program at the time of Tyler’s vaccinations. Petitioner’s argument that she had not
been adequately informed of the Program and thus that equitable tolling is warranted
lacks factual support.

                 b. Legislative Intent of the Vaccine Act.

       Assuming arguendo that the VIS petitioner received from Tyler’s physicians did
not provide information about the Vaccine Program, equitable tolling is nevertheless not
warranted. The Vaccine Act’s legislative history indicates that equitable tolling should
not be applied, even if a petitioner did not receive the Program information required by §
26(d).

       The first version of the Vaccine Act, introduced in the Senate, provided an
exception to the statutory limitations period for a petitioner who “demonstrates that he or
she was not informed [of the Program] as required by [the Vaccine Act].” S. 2117, 98th
Cong. § 2115(b) (1983). This exception, however, was omitted from the final bill.
S. 1744, 99th Cong. § 2116 (1986) (enacted). Congress clearly considered, and
rejected, this proposed exception.

        Congress’s decision to omit from the Vaccine Act an exception to the statute of
limitations for petitioners who were not informed of the Program evinces its intent to
hold the uninformed to the 36-month limitations period.36 This is consistent with the use
of objective events, rather than subjective knowledge, found in § 16, to start the 36-
month clock running. Thus, equitably tolling the statute of limitations for a petitioner
whose physician did not inform her of the Vaccine Program would contravene
Congressional intent.


35
  The final drafts of the polio and DTP VIS in the Federal Register contain identical sections (section 4)
concerning “When Should Your Child Get the Polio/DTP Vaccine and Other Vaccines,” which includes a
table of the “Recommended Schedule of Vaccinations for All Children.” Vaccine Information Materials, 56
Fed. Reg. 51798-01. This section does not appear on the copies of the VIS petitioner filed. Due to the
table, this section may have been moved to the end of the VIS for formatting purposes.
36
  This reasoning is analogous to that used by the Federal Circuit in Cloer, where the Court, based on
Congress’s abandonment of a discovery rule that had been included in prior versions of the bill,
concluded that the legislative history clearly established Congressional intent to reject a discovery rule.
Cloer, 654 F.3d at 1327.

                                                     16
                                      IV. Conclusion.

        For the reasons set forth above, petitioner’s causation-in-fact and significant
aggravation claims were not filed within the Vaccine Act’s 36-month statute of
limitations. Additionally, there is no basis for applying equitable tolling to this case.
Therefore, this case is dismissed as untimely filed. The clerk is directed to enter
judgment accordingly.


IT IS SO ORDERED.
                                           s/Denise K. Vowell
                                           Denise K. Vowell
                                           Chief Special Master




                                              17
