J. v. Secretary of Health and Human Services ( 2022 )


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  •             In the United States Court of Federal Claims
    OFFICE OF SPECIAL MASTERS
    Filed: March 30, 2022
    * * * * * * * * * * * * * *  *
    W.J., by his parents and legal guardians,
    *
    R.J. and A.J.,                *                     UNPUBLISHED
    *
    Petitioners,        *                     No. 21-1342V
    *
    v.                            *                     Special Master Nora Beth Dorsey
    *
    SECRETARY OF HEALTH           *                     Dismissal Decision; Measles, Mumps,
    AND HUMAN SERVICES,           *                     and Rubella (“MMR”) Vaccine;
    *                     Encephalopathy; Statute of Limitations;
    Respondent.         *                     Equitable Tolling.
    *
    * * * * * * * * * * * * * * *
    R.J. and A.J., pro se, Staten Island, NY, for petitioners.
    Sarah B. Rifkin, U.S. Department of Justice, Washington, DC, for respondent.
    DECISION1
    I.     INTRODUCTION
    On May 7, 2021, R.J. and A.J. (“petitioners”) filed a petition, on behalf of their minor
    child, W.J., pursuant to the National Vaccine Injury Compensation Program (“Vaccine Act” or
    “the Program”), 42 U.S.C. § 300aa-10 et seq. (2012).2 Petitioners generally allege that their
    minor child, W.J., suffered from a chronic encephalopathy Table claim and/or a cause-in-fact or
    significant aggravation of pre-existing cerebral and immunological damage, including immune-
    1
    Because this Decision contains a reasoned explanation for the action in this case, the
    undersigned is required to post it on the United States Court of Federal Claims’ website in
    accordance with the E-Government Act of 2002. 
    44 U.S.C. § 3501
     note (2012) (Federal
    Management and Promotion of Electronic Government Services). This means the Decision will
    be available to anyone with access to the Internet. In accordance with Vaccine Rule 18(b),
    petitioners have 14 days to identify and move to redact medical or other information, the
    disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the
    undersigned agrees that the identified material fits within this definition, the undersigned will
    redact such material from public access.
    2
    The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
    Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 
    100 Stat. 3755
    , codified as amended,
    42 U.S.C. §§ 300aa-10 to -34 (2012). All citations in this Decision to individual sections of the
    Vaccine Act are to 42 U.S.C. § 300aa.
    1
    related blood disorders, severe eczema, and many other allergies as a result of a measles, mumps,
    and rubella (“MMR”) vaccination administered on February 24, 2005. Petition at 1 (ECF No. 1).
    Respondent filed a Motion to Dismiss in conjunction with his Rule 4(c) Report on August
    2, 2021, stating, “[t]he petition in this case was [] filed beyond the relevant statutory limitations
    period, and petitioners have not provided a basis for the extraordinary remedy of equitable
    tolling,” and therefore the petition should be dismissed. Respondent’s Rule 4(c) Report (“Resp.
    Rept.”), filed Aug. 2, 2021, at 12 (ECF No. 15); Resp. Motion to Dismiss (“Resp. Mot.”), filed
    Aug. 2, 2021 (ECF No. 16). The undersigned agrees. Petitioners have failed to provide
    evidence to show why their case should not be dismissed.
    Based on the reasons set forth below, the undersigned GRANTS respondent’s motion to
    dismiss and DISMISSES petitioners’ case for failure to file a timely action pursuant to Section
    16(a)(2) of the Vaccine Act.
    II.    PROCEDURAL HISTORY
    Petitioners filed their claim on May 7, 2021, on behalf of their minor child, W.J. Petition
    at 1. Petitioners alleged W.J. suffered from chronic encephalopathy and immunological issues as
    a result of an MMR vaccination administered on February 24, 2005. Id. Petitioners filed a
    compact disc of medical records along with the petition. Petitioners’ Exhibits (“Pet. Exs.”) 1-29.
    On May 13, 2021, the case was assigned to the undersigned. Notice of Reassignment
    dated May 13, 2021 (ECF No. 9). An initial status conference was held on June 3, 2021, and the
    undersigned raised the threshold question of the statute of limitations. Order dated June 3, 2021,
    at 1 (ECF No. 14). The undersigned ordered respondent to file a Rule 4(c) Report and Motion to
    Dismiss, and to set a briefing schedule for petitioners to file a response. Id.
    Respondent filed a Motion to Dismiss and Rule 4(c) Report on August 2, 2021. Resp.
    Rept.; Resp. Mot. In September and October 2021, petitioners filed medical records, medical
    literature, and a response to respondent’s motion to dismiss. Pet. Exs. 30-72; Pet. Response to
    Resp. Mot. (“Pet. Response”), filed Sept. 30, 2021 (ECF No. 22). Respondent filed a reply to
    petitioners’ response on October 28, 2021. Resp. Reply, filed Oct. 28, 2021 (ECF No. 27).
    This matter is now ripe for adjudication.
    III.   PARTIES’ CONTENTIONS
    A.      Petitioners’ Contentions
    Petitioners first allege that the MMR vaccine was inappropriately administered to W.J. in
    contravention of the vaccine’s warnings due to W.J.’s Xq28 chromosomal duplication. Petition
    at 3. Petitioners contend “[m]any chromosomal aberrations cause immunodeficiencies” and the
    MMR vaccine was contraindicated for individuals with “[p]rimary and acquired
    immunodeficiency states.” Id. The MMR vaccine insert also cautions against vaccination “to
    persons with a history of cerebral injury.” Id. Petitioners state the MMR vaccine “significantly
    2
    aggravated [W.J.’s] pre-existing immunodeficiency, stemming from his Xq28 duplication.” Id.
    Additionally, petitioners allege that W.J.’s “chronic encephalopathy and immunodeficiency
    issues were either directly caused by the administration of the MMR vaccine, or that the MMR
    vaccine significantly aggravated pre-existing cerebral and immunological damage caused by
    [W.J.’s] chromosomal aberration.” Id. at 3-4, 11.
    Second, petitioners allege W.J. suffered from thrombocytosis,3 lymphocytopenia,4
    lymphocytosis,5 monocytosis,6 granulocytopenia,7 severe eczema, and “many other allergies”
    that his “physicians offered no cause or diagnosis for.” Petition at 4-8. They state “[o]ver the
    course of some seven years that followed the administration of [W.J.’s] MMR vaccine, [W.J.’s]
    immune system struggled with no less than four immuno-related blood disorders . . . and a
    several years long battle with severe eczema, and many other allergies.” Id. at 8. Petitioners
    state that because W.J.’s physicians found no cause for his conditions, “in the absence of any
    evidence to the contrary, [] the many immuno-related adverse events were caused by the MMR
    vaccine administration to [W.J.] on February 24, 2005.” Id. at 20.
    Third, petitioners allege W.J. had an extremely high mumps antibody count on April 18,
    2014, which “may be indicative of an unusual and chronic allergic reaction to the MMR
    vaccine.” Petition at 8.
    Petitioners also allege that W.J. was admitted to the emergency room on June 22, 2007,
    for a swollen jaw and face, and a high fever. Petition at 8. His blood test showed a high white
    blood cell count and high lymphocyte, monocyte, and granulocyte counts. Id. at 9. Petitioners
    state W.J.’s “symptoms during this hospitalization were very similar to mumps, which may point
    to some adverse chronic reaction to the MMR vaccine.” Id.
    3
    Thrombocytosis is “an increase in the number of circulating platelets; called also
    thrombocythemia.” Thrombocytosis, Dorland’s Online Med. Dictionary,
    https://www.dorlandsonline.com/dorland/definition?id=49877 (last visited Feb. 3, 2022).
    4
    Lymphocytopenia is the “reduction in the number of lymphocytes in the blood.”
    Lymphocytopenia, Dorland’s Online Med. Dictionary, https://www.dorlandsonline.com/
    dorland/definition?id=29030 (last visited Feb. 3, 2022).
    5
    Lymphocytosis is the “excess of normal lymphocytes in the blood or in any effusion.”
    Lymphocytosis, Dorland’s Online Med. Dictionary, https://www.dorlandsonline.com/dorland/
    definition?id=29034 (last visited Feb. 3, 2022).
    6
    Monocytosis is the “increase in the proportion of monocytes in the blood.” Monocytosis,
    Dorland’s Online Med. Dictionary, https://www.dorlandsonline.com/dorland/definition?
    id=31969 (last visited Feb. 3, 2022).
    7
    Granulocytopenia is the “reduction in the number of granular leukocytes in the blood.”
    Granulocytopenia, Dorland’s Online Med. Dictionary, https://www.dorlandsonline.com/dorland/
    definition?id=20930 (last visited Feb. 3, 2022).
    3
    Fifth, petitioners contend W.J. suffered from an encephalopathy Table injury after MMR
    vaccine administration. Petition at 10. “Prior to the administration of the MMR vaccine on
    February 24, 2005, [W.J.’s] medical records indicate no developmental delays or any other
    indication of mental incapacitation.” Id. Petitioners allege that “[a]fter the administration of the
    MMR vaccine, [W.J.’s] developmental delays soon began to surface.” Id. “The table injury
    timeframe for [W.J.’s] MMR injury is the fifteen days between February 24, 2005 and March 11,
    2005.” Id. at 11.
    Sixth, petitioners allege equitable tolling of the statute of limitations is warranted.
    Petition at 12. Petitioners state W.J.’s encephalopathy is an “extraordinary circumstance” that
    tolls the statute of limitations in cases under the Vaccine Act and cite K.G. v. Secretary of Health
    & Human Services, 
    951 F.3d 1374
     (Fed. Cir. 2020) for support. Petitioners contend the Federal
    Circuit in K.G. held “that equitable tolling under the Vaccine Act applied to an adult who was
    mentally incapacitated for some five years. . . . It stands to reason, then, that the same should
    apply to a minor with permanent brain damage.” 
    Id. at 13
    . Petitioners also state they exercised
    reasonable diligence in bringing this matter. 
    Id. at 14
    . W.J. was diagnosed with autism and they
    “had no basis for questioning” his diagnosis. 
    Id. at 15
    . However, petitioners state “that vaccines
    do sometimes cause or enhance autism-like symptoms.” 
    Id. at 16
    . Petitioners cite Paluck v.
    Secretary of Health & Human Services, 
    786 F.3d 1373
    , 1379 (Fed. Cir. 2015) where “K.P. won a
    favorable judgment based on his parents’ amply supported allegation that he was a child
    ‘suffering from both a mitochondrial disorder and autism who experienced developmental
    regression following vaccination.’” 
    Id.
    Petitioners discovered W.J.’s genetic aberration on March 19, 2019 and “soon came to
    the conclusion that because of the Xq28 duplication, [W.J.], in spite of his autism-like
    symptoms, either might not be autistic at all or that the Xq28 duplication is a cause of his
    autism.” 
    Id. at 17
    . They allege that they realized in light of the genetic mutation, the MMR
    vaccine should not have been administered, and that the MMR vaccine caused W.J.’s permanent
    injury. 
    Id. at 18
    . W.J.’s parents assert that they exercised reasonable diligence and “the statute
    of limitations in this matter began to toll no earlier than March 19, 2019, when [W.J.’s] parents
    were first informed of his Xq28 duplication.” 
    Id.
    Petitioners also allege “[t]o consider equitable tolling for K.G.’s drug and alcohol
    induced mental incapacity, but not for [W.J.’s] congenital genetically-caused mental incapacity,
    would be disability discrimination in violation of [W.J.’s] Fourteenth Amendment rights.”
    Petition at 18. Petitioners cite Justice Marshall’s concurring in part opinion in City of Cleburne,
    Tex. v. Cleburne Living Ctr., 
    473 U.S. 432
     (1985) for support.
    Finally, petitioners allege that the K.G. standard—“that the proper analysis of equitable
    tolling based on mental incapacity in the Vaccine Act context must consider both extraordinary
    circumstances and diligence”—applies in this matter. Petition at 19.
    B.      Respondent’s Contentions
    Respondent contends petitioners filed their claim for compensation “after the expiration
    of the statutorily prescribed limitations period set forth in Section 16(a)(2) of the Vaccine Act.”
    4
    Resp. Reply at 1. Further, respondent asserts that “petitioners have not demonstrated the
    extraordinary circumstances necessary to equitably toll the Act’s statute of limitations.” 
    Id.
    Specifically, respondent states “[s]ymptoms of W.J.’s alleged injury began to manifest
    before March 2006, when W.J. was diagnosed with a speech delay. Therefore, to comply with
    Section 16(a)(2) of the Vaccine Act, petitioners needed to file a petition on W.J.’s behalf by
    March 2009.” Resp. Reply at 2. Respondent states that petitioners argue for the application of
    the discovery rule, “suggesting that the Act’s statute of limitations should not have begun
    running until March 2019, when they conceived of a possible connection between W.J.’s autism
    and the MMR vaccine. The Federal Circuit has held that there is no explicit or implied discovery
    rule under the Vaccine Act.” Id. at 3. “Accordingly, [respondent contends that] the statutory
    filing period began to run in 2006, when W.J. experienced the first symptoms of his autism
    spectrum disorder—not in 2019, when petitioners devised a purported connection between
    W.J.’s symptoms and the MMR vaccine.” Id.
    Regarding equitable tolling, respondent states, “petitioners have not shown a diligent
    pursuit of W.J.’s rights or extraordinary circumstances.” Resp. Reply at 4. “The Federal Circuit
    has expressly held that equitable tolling is not a substitute for the discovery rule and is not
    available simply because the application of the statute of limitations would otherwise deprive a
    petitioner of his claim.” Id. “W.J.’s age and incapacity are not bases for equitable tolling.” Id.
    Respondent claims K.G. does not support petitioners’ position. First, “K.G. was an incapacitated
    adult.” Id. at 5. “Her relationship with her appointed guardian became strained and was later
    terminated.” Id. “Accordingly, during the relevant time period, K.G. had no one to act on her
    behalf and was incapable of filing a claim under the Vaccine Act; for this reason, the Court
    found that equitable tolling was appropriate in her case.” Id. Respondent alleges, “[u]nlike
    K.G., W.J. was an infant at the time of his vaccination, and his parents (the petitioners) were
    entirely capable of filing a claim on his behalf.” Id. Respondent also argues that “[t]aken to its
    logical conclusion, petitioners’ equitable tolling argument would essentially mean that the three-
    year statute of limitations is irrelevant in all cases involving young children who cannot file
    claims on their own behalf. This is not what the Vaccine Act contemplates.” Id.
    Lastly, the respondent asserts that petitioners have not provided a procedural basis for
    their assertions. “Procedurally, petitioners have not demonstrated a basis for equitable tolling,
    and their claim should be dismissed as untimely.” Resp. Reply at 6. To the extent that
    petitioners are asserting an injury based on their child’s condition of autism, the respondent
    points out that “[s]ubstantively, it is important to note that the theory of MMR vaccines causing
    autism has been thoroughly evaluated and repeatedly rejected by the courts.” Id.
    IV.    FACTUAL SUMMARY8
    8
    The factual summary is abbreviated to provide relevant information. Additionally, complete
    medical records were not filed. The records that have been filed, however, are sufficient for the
    purposes of this Decision.
    5
    W.J. was born on February 8, 2004. Pet. Ex. 1 at 1. He was a healthy, full-term infant,
    with no significant neonatal problems apart from meconium which was suctioned at birth. Pet.
    Ex. 5 at 1; Pet. Ex. 13.
    W.J. received several childhood vaccinations, including influenza (“flu”) vaccines from
    Dr. Stephen Borchman. Pet. Ex. 2 at 1. W.J. received his first hepatitis B vaccine on February
    8, 2004, his second hepatitis B vaccine on May 12, 2004, and his third hepatitis B vaccine on
    August 23, 2004. Id. He also received his diphtheria-tetanus-acellular pertussis (“DTaP”)
    vaccinations in April, June, and August 2004, August 2005, and February 2009. Id. The
    Haemophilus influenzae type B (“hib”) vaccines were given at the same time as DTaP in April,
    June, and August 2004. Id. W.J. received his pediatric pneumococcal (“PCV7”) and polio
    (“IPV”) vaccinations in 2004, 2005, and 2009. Id. MMR vaccinations were administered on
    February 24, 2005 and March 15, 2008. Id. Flu vaccines were given in 2007, 2008, and 2010.
    Id. No adverse reaction to any of the vaccines was noted in the medical records.
    On March 7, 2006, Dr. Ann Marie Abbondante examined W.J. and diagnosed him with a
    “speech delay.” Pet. Ex. 6 at 13. W.J. then underwent an audiology evaluation on June 26,
    2006, which revealed adequate hearing. Pet. Ex. 8 at 1. Dr. Abbondante ordered a blood test
    performed on March 9, 2006 that showed high platelet levels (424, normal range is 140-400) and
    low lymphocyte levels (3,276, normal range is 4,400-10,500). Pet. Ex. 9 at 1. Dr. Abbondante
    did not diagnose W.J. with encephalopathy or any immunodeficiencies.
    On January 5, 2007, W.J. was diagnosed with Autism and Pervasive Developmental
    Delay following a psychological evaluation at Words ‘N Motion Pediatric Multi-Disciplinary
    Diagnostic Evaluation and Treatment Center by Psychologist D. Jeanne Romeo. Pet. Ex. 39 at
    17.
    W.J. presented to Dr. John Wells, pediatric neurologist, for a neurologic evaluation on
    January 24, 2007. Pet. Ex. 13 at 1. Dr. Wells stated W.J.’s developmental delays and language
    disorder required intensive therapeutic programs. Id. At that time, Dr. Wells considered
    ordering an MRI and genetic testing depending on W.J.’s progress. Id. Dr. Wells did not
    diagnosis W.J. with encephalopathy.
    From June 22 to June 25, 2007, W.J. was hospitalized with a fever and swollen glands.
    Pet. Ex. 12 at 11. W.J. presented in the emergency room with swelling in the jaw and neck,
    runny nose, and a moderately-sore throat. Id. at 9. His white blood cell count was consistent
    with a bacterial infection, and he was admitted to the hospital with a diagnosis of cervical
    lymphadenitis.9 Id. at 11, 18. Three days later, he was discharged with antibiotics. Id. at 11.
    Bloodwork performed on July 3, 2007, showed W.J. had an elevated white blood count (11.9,
    normal range is 4.8-10.8), elevated platelet count (548), as well as high monocyte (0.6, normal
    range is 0.11-0.59) and lymphocyte numbers (5.9, normal range is 1.2-3.4). Pet. Ex. 10 at 7.
    9
    Cervical lymphadenitis is the “enlarged, inflamed, and tender cervical lymph nodes, seen in
    certain infectious diseases of children, such as acute infections of the throat.” Cervical
    Lymphadenitis, Dorland’s Online Med. Dictionary, https://www.dorlandsonline.com/dorland/
    definition?id=87515 (last visited Feb. 3, 2022).
    6
    W.J. was not diagnosed with encephalopathy at any time during this hospitalization.
    Additionally, W.J. was not diagnosed with any immunodeficiencies.
    W.J. attended yearly follow-up visits with Dr. Borchman from February 2009 to February
    2014. Pet. Ex. 7 at 3-11. On February 21, 2011, W.J. presented to Dr. Borchman for a follow up
    of strep throat. Id. at 5. Dr. Borchman noted W.J.’s moderate to severe autism diagnosis. Id.
    W.J. also received his first hepatitis A vaccine. Id. No adverse reaction to the vaccine was
    noted. During these years, W.J. was not diagnosed with encephalopathy or immunodeficiencies.
    On February 20, 2012, W.J. returned to Dr. Borchman for atopic dermatitis. Pet. Ex. 7 at
    7. Dr. Borchman again noted W.J.’s moderate to severe autism, and a past history of lead
    poisoning. Id.; Pet. Ex. 10 at 9. Dr. Borchman assessed W.J. for “unstable atopic dermatitis”
    and ordered heavy metal testing to rule out lead poisoning, plus allergy testing. Pet. Ex. 7 at 7.
    Dr. Borchman explained to petitioners there was a lack of data associating autism spectrum
    disorders with diet. Id. W.J.’s blood work showed he had numerous abnormal reactions to a
    variety of allergens and had an elevated platelet count (496). Pet. Ex. 10 at 11.
    On February 19, 2014, W.J. returned to Dr. Borchman for eczema and rhinitis. Pet. Ex. 7
    at 10. W.J. had numerous environmental allergies, and Dr. Borchman documented that his
    parents “refuse[] any steroid nasal sprays” and medications. Id. Dr. Borchman also expressed
    his concern with W.J.’s mother’s refusal to use prescription steroid creams or any medications to
    control W.J.’s allergies. Id. at 10-11. W.J.’s mother agreed to return to W.J.’s immunologist,
    Dr. Russo, and to restart allergy and eczema medications. She refused the diphtheria, pertussis,
    and tetanus (“DPT”) vaccine. Id. at 11.
    On April 4, 2014, W.J. underwent a variety of lab tests, including genetic screening,
    ordered by Dr. Maya Klein. Pet. Ex. 11 at 1-10. Testing showed a normal blood panel, normal
    platelet count, and normal levels of heavy metals. Id. at 1-3. W.J. exhibited high antibodies to
    the mumps virus (71.2, negative range <9.0), and the records noted that “[a] positive result
    generally indicates past exposure to Mumps virus or previous vaccination.” Id. W.J. also had
    elevated antibodies to the Streptococcus B virus (210, negative range 0-170), herpes virus
    (17.66, negative range, <0.76), and pneumonia virus (118, indeterminate range 100-320), noting
    “[v]alues >100 may indicate a recent infection . . . and need to be confirmed.” Id. at 4, 6, 8.
    Genetic testing revealed a MTHFR homozygous A1298C mutation.10 Id. at 4, 6, 8.
    W.J. presented to Dr. Maria Del Pilar Trelles-Thorne for a psychiatric evaluation on July
    9, 2018. Pet. Ex. 71 at 59. Dr. Trelles-Thorne performed a comprehensive evaluation to help
    10
    MTHFR is “a common, autosomal recessive, inborn error of folate metabolism caused by
    mutation in the MTHFR gene (locus: 1p36.3), which encodes the enzyme. The chief
    biochemical finding is homocystinuria with normal levels of plasma methionine.” Methylene
    Tetrahydrofolate Reductase (MTHFR) Deficiency, Dorland’s Online Med. Dictionary,
    https://www.dorlandsonline.com/dorland/definition?id=30976 (last visited Jan. 21, 2022).
    “Clinical manifestations, age of onset, and severity are highly variable; characteristics include
    signs of neurologic damage ranging from psychiatric symptoms to fatal developmental delay,
    microcephaly, ectopia lentis, and thrombosis.” Id.
    7
    petitioners manage W.J.’s irritability, mood swings, and poor sleep. Id. Dr. Trelles-Thorne
    prescribed Risperdal.11 Id. at 60.
    W.J. returned to Dr. Trelles-Thorne on January 30, 2019, for medication management of
    irritability and disruptive behaviors. Pet. Ex. 71 at 32. Dr. Trelles-Thorne ordered a number of
    medications for W.J. and noted his autism spectrum disorder diagnosis. Id. at 33-34.
    On February 22, 2019, W.J. underwent genetic testing that revealed he had a duplication
    on the Xq28 chromosome of “uncertain clinical significance—likely benign.” Pet. Ex. 14 at 1.
    On February 11, 2021, Dr. Trelles-Thorne saw W.J. for psychopharmacology evaluation.
    Pet. Ex. 71 at 2. W.J. was noted to have autism spectrum disorder and unspecified bipolar
    disorder. Id. Dr. Trelles-Thorne changed W.J.’s dosage of lithium.12 Id. at 3. The records do
    not indicate that Dr. Trelles-Throne ever diagnosed W.J. with encephalopathy or any
    immunodeficiency disorder.
    Although the petitioners allege that the MMR vaccination administered to W.J. on
    February 24, 2005 caused encephalopathy as well as a number of immunodeficiencies, the
    medical records do not include a diagnosis of encephalopathy or immunodeficiency disorder.
    See Petition at 1.
    V.     LEGAL FRAMEWORK
    A.      Vaccine Act Statute of Limitations
    Section 16(a)(2) of the Vaccine Act governs claims resulting from vaccines administered
    after October 1, 1988, and reads,
    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.
    11
    Risperdal is a trademark name for risperidone, “a benzisoxazole derivative used as an
    antipsychotic agent.” Risperdal, Dorland’s Online Med. Dictionary,
    https://www.dorlandsonline.com/dorland/definition?id=43964 (last visited Jan. 20, 2022);
    Risperidone, Dorland’s Online Med. Dictionary, https://www.dorlandsonline.com/dorland/
    definition?id=43965 (last visited Jan. 20, 2022).
    12
    Lithium carbonate, the carbonate salt of lithium, is “used as a mood stabilizer in treatment of
    acute manic and hypomanic states in bipolar disorder and in maintenance therapy to reduce the
    intensity and frequency of subsequent manic episodes.” Lithium Carbonate, Dorland’s Online
    Med. Dictionary, https://www.dorlandsonline.com/dorland/definition?id=87087 (last visited Jan.
    21, 2022).
    8
    § 16(a)(2). Therefore, claims resulting from vaccines administered after October 1, 1988 must be
    filed within 36 months of the first symptom or manifestation of onset of the alleged vaccine-related
    injury. The statute of limitations begins to run from the onset of the first objectively cognizable
    symptom, whether or not that symptom is sufficient for diagnosis. Carson v. Sec’y of Health &
    Hum. Servs., 
    727 F.3d 1365
    , 1369 (Fed. Cir. 2013). Special masters have appropriately
    dismissed cases that were filed outside the limitations period, even by a single day or two. See,
    e.g., Spohn v. Sec’y of Health & Hum. Servs., No. 95-0460V, 
    1996 WL 532610
     (Fed. Cl. Spec.
    Mstr. Sept. 5, 1996) (dismissing case filed one day beyond the 36-month limitations period),
    aff’d, 
    132 F.3d 52
     (Fed. Cir. 1997); Cakir v. Sec’y of Health & Hum. Servs., No. 15-1474V,
    
    2018 WL 4499835
    , at *4 (Fed. Cl. Spec. Mstr. July 12, 2018).
    B.      Motion to Dismiss
    Although the Vaccine Act and the Vaccine Rules contemplate case dispositive motions,
    the dismissal procedures included within the Vaccine Rules do not specifically include a
    mechanism for a motion to dismiss. See §§ 12(d)(2)(C)-(D); Vaccine Rule 8(d); Vaccine Rule
    21. However, Vaccine Rule 1 provides that for any matter not specifically addressed by the
    Vaccine Rules, the special master may regulate applicable practice consistent with the rules and
    the purpose of the Vaccine Act. Vaccine Rule 1(b). Vaccine Rule 1 also provides that the Rules
    of the Court of Federal Claims (“RCFC”) may apply to the extent they are consistent with the
    Vaccine Rules. Vaccine Rule 1(c).
    Accordingly, there is a well-established practice of special masters entertaining motions
    to dismiss in the context of RCFC 12(b)(6), which allows the defense of “failure to state a claim
    upon which relief can be granted” to be presented via motion. See, e.g., Herren v. Sec’y of
    Health & Hum. Servs., No. 13-1000V, 
    2014 WL 3889070
     (Fed. Cl. Spec. Mstr. July 18, 2014);
    Bass v. Sec’y of Health & Hum. Servs., No. 12-135V, 
    2012 WL 3031505
     (Fed. Cl. Spec. Mstr.
    June 22, 2012); Guilliams v. Sec’y of Health & Hum. Servs., No. 11-716V, 
    2012 WL 1145003
    (Fed. Cl. Spec. Mstr. Mar. 14, 2012); Warfle v. Sec’y of Health & Hum. Servs., No. 05-1399V,
    
    2007 WL 760508
     (Fed. Cl. Spec. Mstr. Feb. 22, 2007).
    Under RCFC 12(b)(6), a case should be dismissed “when the facts asserted by the
    claimant do not entitle him to a legal remedy.” Extreme Coatings, Inc. v. United States, 
    109 Fed. Cl. 450
    , 453 (2013) (quoting Lindsay v. United States, 
    295 F.3d 1252
    , 1257 (Fed. Cir. 2002)). In
    considering a motion to dismiss under RCFC 12(b)(6), allegations must be construed favorably
    to the pleader. 
    Id.
     (citing Scheuer v. Rhodes, 
    416 U.S. 232
    , 236 (1974)). However, the pleading
    must “contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is
    plausible on its face.’” Golden v. United States, 
    137 Fed. Cl. 155
    , 169 (2018) (quoting Ashcroft
    v. Iqbal, 
    556 U.S. 662
    , 678 (2009)); see also Bell Atlantic Corp. v. Twombly, 
    550 U.S. 544
    , 570
    (2007).
    “To determine whether a complaint states a plausible claim for relief, the court must
    engage in a context-specific analysis and ‘draw on its judicial experience and common sense.’”
    Golden, 137 Fed. Cl. at 169 (quoting Iqbal, 
    556 U.S. at 679
    ). However, “Rule 12(b)(6) does not
    countenance . . . dismissals based on a judge’s disbelief of a complaint’s factual allegations.”
    Neitzke v. Williams, 
    490 U.S. 319
    , 327 (1989). Nonetheless, on a motion to dismiss, courts “are
    9
    not bound to accept as true a legal conclusion couched as a factual allegation.” Papasan v.
    Allain, 
    478 U.S. 265
    , 286 (1986). In assessing motions to dismiss in the Vaccine Program,
    special masters have concluded that they “need only assess whether the petitioner could meet the
    Act’s requirements and prevail, drawing all inferences from the available evidence in petitioner’s
    favor.” Herren, 
    2014 WL 3889070
    , at *2; see also Warfle, 
    2007 WL 760508
    , at *2.
    C.      Doctrine of Equitable Tolling
    The Federal Circuit has held that the doctrine of equitable tolling can apply to Vaccine
    Act claims in limited circumstances. See Cloer v. Sec’y of Health & Hum. Servs., 
    654 F.3d 1322
    , 1340-41 (Fed. Cir. 2011). The Federal Circuit determined equitable tolling on the basis of
    mental incompetence is available in Vaccine Act cases. K.G., 951 F.3d at 1381. However, lack
    of knowledge of an actionable claim is not a basis for equitable tolling. Id. at 1380 (citing Cloer,
    
    654 F.3d at 1344-45
    ).
    To establish that equitable tolling of a statute of limitations is appropriate, a claimant
    must prove (1) he pursued his rights diligently and (2) an extraordinary circumstance prevented
    him from timely filing the claim. K.G., 951 F.3d at 1379 (citing Menominee Indian Tribe v.
    United States, 
    136 S. Ct. 750
    , 755 (2016). In K.G., the Federal Circuit determined “the proper
    analysis of equitable tolling based on mental incapacity in the Vaccine Act context must consider
    both extraordinary circumstances and diligence.” Id. at 1381. All relevant facts and
    circumstances must be considered when determining whether a claimant pursued his rights
    diligently. Id. at 1382. “It is possible, for instance, that a reasonable amount of diligence for an
    individual with memory loss or hallucinations would equate to no diligence for an able-minded
    individual.” Id. Additionally, “[a] claimant need only establish diligence during the period of
    extraordinary circumstances to meet this test.” Id. (citing Checo v. Shinseki, 
    748 F.3d 1373
    ,
    1380 (Fed. Cir. 2014)).
    To show extraordinary circumstances, “a Vaccine Act claimant must show that [his]
    failure to file was the direct result of a mental illness or disability that rendered [him] incapable
    of rational thought, incapable of deliberate decision making, incapable of handling [his] own
    affairs, or unable to function in society.” K.G., 951 F.3d at 1381. However, “[a] medical
    diagnosis alone or vague assertions of mental problems are insufficient” to establish
    extraordinary circumstances. Id. at 1381-82.
    Under the provisions of the Vaccine Act, a petition seeking compensation on behalf of a
    minor may only be filed by the minor’s “legal representative,” § 11(b)(1)(A), a term which the
    Act defines as “a parent or an individual who qualifies as a legal guardian under State law.” §
    33(2).
    D.      Equal Protection Under the Fourteenth Amendment
    The Equal Protection Clause of the Fourteenth Amendment to the Constitution, and
    through the Due Process Clause of the Fifth Amendment, implicitly forbids most discriminations
    by the Federal Government against individuals. Bolling v. Sharpe, 
    347 U.S. 497
     (1954). A
    potential violation of equal protection arises whenever the Government treats one group
    10
    differently than it treats another while it pursues some social goal. Black v. Sec’y of Health &
    Hum. Servs., 
    33 Fed. Cl. 546
    , 554 (1995), aff’d sub nom. Black v. Sec’y of Health & Hum.
    Servs., 
    93 F.3d 781
     (Fed. Cir. 1996). Legislation, which classifies people into favored and
    nonfavored groups based upon race, is subject to “strict scrutiny.” Palmore v. Sidoti, 
    466 U.S. 429
     (1984); Loving v. Virginia, 
    388 U.S. 1
     (1967); Anderson v. Martin, 
    375 U.S. 399
     (1964).
    However, under the Vaccine Program, the Vaccine Act’s limitation period is rationally
    related to the dual legitimate legislative purposes undergirding the Vaccine Act: (1) the settling
    of claims quickly and easily, and (2) the protecting of manufacturers from uncertain liability
    making “production of vaccines economically unattractive, potentially discouraging vaccine
    manufacturers from remaining in the market.” Cloer v. Sec’y of Health & Hum. Servs., 
    85 Fed. Cl. 141
    , 151-52 (2008) (quoting Brice v. Sec’y of Health & Hum. Servs., 
    240 F.3d 1367
    , 1368
    (Fed. Cir. 2001)), rev’d on other grounds, 
    603 F.3d 1341
     (Fed. Cir. 2010), aff’d on rehearing en
    banc, 
    654 F.3d 1322
     (Fed. Cir. 2011).
    VI.    DISCUSSION
    A.       Applicable Statute of Limitations in the Vaccine Program
    1.     Alleged Injuries in the Petition
    Petitioners allege that W.J. sustained injuries, including “chronic encephalopathy and
    immunodeficiency issues,” resulting from adverse effects of the MMR vaccination received on
    February 24, 2005. Petition at 3. Petitioners allege that W.J.’s “chronic encephalopathy and
    immunodeficiency issues were either directly caused by the administration of the MMR vaccine,
    or that the MMR vaccine significantly aggravated pre-existing cerebral and immunological
    damage caused by [W.J.’s] chromosomal aberration.” Id. at 4. Petitioners also alleged that W.J.
    suffered from thrombocytosis, lymphocytopenia, lymphocytosis, monocytosis, granulocytopenia,
    severe eczema, and “many other allergies” that his “physicians offered no cause or diagnosis
    for;” an extremely high mumps antibody count on April 18, 2014, which “may be indicative of
    an unusual and chronic allergic reaction to the MMR vaccine;” and an emergency room visit for
    a swollen jaw and face and high fever, and “symptoms during this hospitalization were very
    similar to mumps, which may point to some adverse chronic reaction to the MMR vaccine.”
    Petition at 4-9. Finally, petitioners allege W.J. suffered a chronic encephalopathy Table Claim.
    Id. at 11.
    a.      Petitioners’ Table Claim
    The Vaccine Injury Table defines chronic encephalopathy as a condition that “occurs
    when a change in mental or neurologic status, first manifested during the applicable Table time
    period as an acute encephalopathy or encephalitis, persists for at least 6 months from the first
    symptom or manifestation of onset or of significant aggravation of an acute encephalopathy or
    encephalitis.” 
    42 C.F.R. § 100.3
    (d)(1)(i). Acute encephalopathy, for children less than 18
    months of age, that presents without a seizure “is indicated by a significantly decreased level of
    consciousness that lasts at least 24 hours.” 
    42 C.F.R. § 100.3
    (c)(2)(i)(A)(1). Typical symptoms
    of encephalopathy include, but do not in themselves demonstrate an acute encephalopathy or a
    11
    significant change in either mental status or level of consciousness, “[s]leepiness, irritability
    (fussiness), high-pitched and unusual screaming, poor feeding, persistent inconsolable crying,
    bulging fontanelle, or symptoms of dementia.” 
    42 C.F.R. § 100.3
    (c)(2)(i)(C). Exclusionary
    criteria for encephalopathy include, “[a]n underlying condition or systemic disease shown to be
    unrelated to the vaccine (such as malignancy, structural lesion, psychiatric illness, dementia,
    genetic disorder, prenatal or perinatal central nervous system (CNS) injury).” 
    42 C.F.R. § 100.3
    (c)(2)(ii)(A). The time period for first symptom or manifestation of onset or of significant
    aggravation of encephalopathy is between 5 and 15 days after MMR vaccine administration. 
    42 C.F.R. § 100.3
    (a)(III)(B).
    Petitioners alleged, “[p]rior to the administration of the MMR vaccine on February 24,
    2005, [W.J.’s] medical records indicate no developmental delays or any other indication of
    mental incapacitation.” Petition at 10. “After the administration of the MMR vaccine, [W.J.’s]
    developmental delays soon began to surface.” 
    Id.
     Petitioners cited W.J.’s March 7, 2006
    doctor’s appointment where he was diagnosed with speech delay as evidence of his
    developmental delays.
    Petitioners claim,
    Given the before and after circumstantial evidence in the record, and based on the
    record as a whole, the Special Master should find that “the first symptom or
    manifestation of onset” of [W.J.’s] chronic encephalopathy, or the “significant
    aggravation” of a pre-existing encephalopathy, occurred within the fifteen-day
    time period described in the Vaccine Injury Table, “even though the occurrence of
    such symptom or manifestation within the time period was not recorded.” 42
    U.S.C. § 300aa-13(b)(2).
    Petition at 11.
    “The symptoms associated with an acute encephalopathy are neither subtle nor
    insidious.” Blake v. Sec’y of Health & Hum. Servs., No. 03-31V, 
    2014 WL 2769979
    , at *6
    (Fed. Cl. Spec. Mstr. May 21, 2014) (quoting Waddell v. Sec’y of Health & Hum. Servs., No.
    10-316V, 
    2012 WL 4829291
    , at *6 (Fed. Cl. Spec. Mstr. Sept. 19, 2012)). Acute and chronic
    encephalopathy is a serious injury that can necessitate hospitalization. Miller v. Sec’y of Health
    & Hum. Servs., No. 02-235V, 
    2015 WL 5456093
    , at *37 (Fed. Cl. Spec. Mstr. Aug. 18, 2015).
    W.J. has never been diagnosed with acute or chronic encephalopathy, nor have any of his
    treating physicians suspected the condition or noted either conditions as a differential diagnosis
    in the medical records. Therefore, in assessing all inferences from the available evidence in
    petitioner’s favor, the undersigned finds that W.J. did not suffer from encephalopathy and does
    not fulfill the criteria for an encephalopathy Table claim.
    However, even if petitioners were able to establish W.J. suffered an encephalopathy
    Table injury, petitioners filed their claim beyond the statute of limitations. W.J. received the
    MMR vaccine on February 24, 2005. In order for the encephalopathy Table claim to apply,
    W.J.’s injury would have to have manifested between 5 and 15 days after MMR vaccine
    12
    administration, or by March 11, 2005. Therefore, petitioners had 36 months from March 11,
    2005 to file a Table claim in the Vaccine Program, or by March 11, 2008. Petitioners did not file
    their petition until May 7, 2021, and thus any Table claim is time-barred.
    b.       Cause-In-Fact Injuries
    i.      Chronic Encephalopathy
    First, in regard to W.J.’s “chronic encephalopathy” claim, W.J. medical records do not
    include a diagnosis of or reference to encephalopathy or chronic encephalopathy by his treating
    physicians. W.J. was seen by multiple physicians to review his developmental progress,
    including Dr. Abbondante on March 7, 2006 who diagnosed him with speech delay, psychologist
    Romeo who diagnosed him with autism on January 5, 2007, and Dr. Wells who conducted a
    neurologic evaluation on January 24, 2007. None of W.J.’s treating physicians diagnosed or
    mentioned encephalopathy.
    There is no evidence in W.J.’s medical records establishing that he was diagnosed with
    chronic encephalopathy. Thus, the undersigned finds that petitioners have failed to provide
    evidence with regard to the injury or condition of encephalopathy.
    W.J. received the MMR vaccination at issue on February 24, 2005. W.J.’s medical
    records show W.J. was diagnosed “speech delay” on March 7, 2006, and with autism spectrum
    disorder on January 5, 2007. Pet. Ex. 6 at 13; Pet. Ex. 39 at 17. Even if petitioners were able to
    establish W.J. suffered a chronic encephalopathy injury, petitioners filed their claim beyond the
    statute of limitations. Assuming the date of diagnosis for either condition (speech delay or autism
    spectrum disorder) was the first symptom or manifestation of the alleged vaccine-related injury,
    petitioners would have been required to file their petition prior to March 7, 2009 or January 5,
    2010. Petitioners did not file their petition until May 7, 2021, and thus their claim is time-barred.
    ii.      Immunodeficiency Issues
    In regard to W.J.’s “immunodeficiency issues” claim, petitioners alleged that W.J.’s
    blood tests on March 9, 2006, June 23, 2007, July 3, 2007, April 13, 2007, February 12, 2012,
    and April 8, 2014 “demonstrate[d] that his immune system suffered from irregularities for
    several years after the administration of the MMR vaccine.” Petition at 4. However, the blood
    tests do not constitute evidence of a diagnosis of an immunodeficiency disorder. And the
    medical records do not contain any evidence that W.J. was diagnosed with an immunodeficiency
    disorder.
    First, petitioners allege W.J. struggled with thrombocytosis. Petition at 4. Petitioners
    state W.J.’s blood sample collected on March 9, 2006 showed a high platelet count at 424
    (normal range 140-400). 
    Id.
     They state lab results were “indicative of a blood disorder known
    as thrombocytosis.” 
    Id.
     Petitioners then point to a blood samples drawn on July 3, 2007 and
    February 20, 2012, which again showed a high platelet counts (548 and 469, respectively).
    However, on April 4, 2014, W.J. had a normal platelet count. W.J.’s abnormal platelet counts
    13
    occurred during periods when he was ill. Further, none of W.J.’s physicians diagnosed him with
    thrombocytosis.
    Similarly, from blood samples collected on March 9, 2006, April 13, 2007, and July 3,
    2007, petitioners state these lab results showed an “indication” of blood disorders known as
    “lymphocytopenia or lymphopenia,” “lymphocytosis,” “monocytosis,” and “granulocytopenia, a
    form of immunosuppression.” Petition at 5-7. Again, these blood tests were drawn when W.J.
    was ill with a viral or bacterial infection. Most importantly, W.J.’s treating physicians did not
    diagnose W.J. with an abnormal immune illness due to these lab results.
    Petitioners also alleged that W.J. suffered from eczema and “many other allergies,” and
    stated “[t]here is research pointing to eczema as an autoimmune disease.” Petition at 8.
    Additionally, petitioners stated W.J.’s April 2014 lab results indicated he had high mumps
    antibodies that “may be indicative of an unusual and chronic allergic reaction to the MMR
    vaccine.” 
    Id.
     However, the lab results state that “[a] positive result generally indicates past
    exposure to Mumps virus or previous vaccination.” Pet. Ex. 11 at 3.
    Finally, petitioners stated W.J.’s hospitalization on June 22, 2007 showed a high white
    blood count as well as high lymphocyte, monocyte, and granulocyte counts. 
    Id. at 8-9
    .
    Petitioners allege that W.J.’s “symptoms during this hospitalization were very similar to mumps,
    which may point to some adverse chronic reaction to the MMR vaccine.” 
    Id. at 9
    . However, the
    petitioners provide no evidence to suggest that W.J. had any adverse reaction to the MMR
    vaccine.
    W.J. was never diagnosed with an immunodeficiency disorder and petitioners’ own
    statements and beliefs are not evidence of a diagnosis of an immunodeficiency disease or
    disorder. W.J.’s physicians did not associate his illnesses with an immunodeficiency disorder or
    with the MMR vaccine, or any of W.J.’s vaccinations. During his hospitalization in June 2008,
    his physicians noted his white blood cell count was consistent with a bacterial infection and he
    was diagnosed of cervical lymphadenitis. However, W.J. was not diagnosed with an
    immunodeficiency disease or disorder. Overall, there is no evidence in W.J.’s medical records
    establishing that he was diagnosed with an immunodeficiency disorder.
    Even if petitioners were able to establish W.J. suffered from an immunodeficiency
    disorder, petitioners filed their claim beyond the statute of limitations. The records show W.J.
    received a number of blood tests that showed, at various times, high platelet count (March 9,
    2006), low absolute lymphocyte count (March 9, 2006), high lymphocyte count (April 13, 2007),
    high monocyte count (April 13, 2007), and low granulocyte count (April 13, 2007). Dr.
    Borchman diagnosed W.J. with unstable atopic dermatitis on February 20, 2012, and diagnosed
    eczema and rhinitis on February 19, 2014. Thus, petitioners’ allegations that W.J.’s immune
    system struggled with “no less than four immuno-related blood disorders: granulocytopenia,
    lymphocytopenia, lymphocytosis, and monocytosis, and a several years long battle with severe
    eczema, and many other allergies” is untimely.
    In order to have filed a timely petition for thrombocytosis and lymphocytopenia,
    petitioners would have needed to assert these alleged injuries before March 9, 2009, 36 months
    14
    after the 2006 blood test. For the lymphocytosis, granulocytopenia, and monocytosis allegations,
    petitioners would have needed to assert these alleged injuries before April 13, 2010, 36 months
    after the 2007 blood test. For the eczema and “many other allergies” claims, petitioners would
    have needed to assert these alleged injuries before February 20, 2015, 36 months after Dr.
    Borchman’s exam and allergy testing. Assessing all inferences from the available evidence in
    petitioner’s favor, petitioners’ claims are time-barred.
    Additionally, even if W.J.’s hospitalization on June 22-24, 2007 and high mumps count
    on April 8, 2014, were caused by the MMR vaccination, petitioners were required to file their
    petition prior to June 24, 2010 and April 8, 2017, respectively. Petitioners did not file their
    petition until May 7, 2021. As filed, the onset of W.J.’s claim, in order to be timely under the
    Vaccine Act, would have had to occur on or after May 7, 2018. Thus, their claim is time-barred.
    c.      Significant Aggravation Injuries
    Petitioners argue W.J.’s “chronic encephalopathy and immunodeficiency issues were
    either directly caused by the administration of the MMR vaccine, or the MMR vaccine caused
    ‘significant aggravation’ of pre-existing cerebral and immunological damage caused by [W.J.’s]
    Xq28 duplication, a chromosomal aberration.” Petition at 2. As discussed above, petitioners
    failed to provide evidence that the MMR vaccine caused-in-fact W.J.’s alleged injuries.
    As set forth earlier, there is no factual support in the contemporaneous medical records to
    support chronic encephalopathy or immunodeficiency disorder occurred after vaccination.
    Because there is no evidence, petitioners’ significant aggravation claims fail as well.
    Petitioners argue that the MMR vaccine caused significant aggravation of pre-existing
    cerebral and immunological damage caused by W.J.’s Xq28 duplication. However, petitioners
    have failed to provide any evidence to suggest vaccination or the Xq28 chromosomal duplication
    significantly or was any way associated with W.J.’s alleged injuries. Genetic testing on February
    22, 2019, revealed the Xq28 chromosome duplication was “of uncertain clinical significance—
    likely benign.” Pet. Ex. 14 at 1. None of W.J.’s physicians have documented that W.J.’s
    vaccinations or his genetic testing was associated with his alleged injuries.
    Further, as discussed above, even if petitioners were able to establish the MMR vaccine
    significantly aggravated W.J.’s pre-existing injuries, petitioners filed their claim beyond the
    statute of limitations.
    2.     Equitable Tolling
    The Vaccine Act required petitioners to file their claim on behalf of W.J. under the
    Vaccine Act within 36 months of the onset of the earliest symptom or manifestation of an injury.
    See Markovich v. Sec’y of Health & Hum. Servs., 
    447 F.3d 1353
    , 1357 (Fed. Cir. 2007) (holding
    that “either a ‘symptom’ or a ‘manifestation’ of onset of a vaccine-related injury is the first event
    objectively recognizable as a sign of a vaccine injury by the medical profession at large”).13
    13
    For cases that have been dismissed for failure to file within the prescribed statute of
    15
    The petition was filed on May 7, 2021. In order for petitioners’ vaccine claim to be
    timely, W.J. would have had to experience the initial onset of his vaccine-related injuries, as pled
    in the petition, on or after May 7, 2018. Any claims for injuries that manifested prior to May 7,
    2018, are time-barred.
    However, petitioners assert equitable tolling of the statute of limitations is warranted in
    this matter. For equitable tolling to apply, petitioners must prove two elements: (1) they pursued
    their rights diligently, and (2) an extraordinary circumstance prevented them from timely filing
    the claim. K.G., 951 F.3d at 1379. In K.G., the court allowed equitable tolling for the period of
    K.G.’s mental incapacity and held equitable tolling is available to mentally incapacitated
    individuals under the Vaccine Act. Id. In that case, petitioner, an adult, alleged the flu vaccine
    caused chronic inflammatory demyelinating polyneuropathy (“CIDP”) in 2011. Id. at 1376.
    “During the same period, K.G. succumbed to alcoholism, spent months in the hospital, and
    developed amnesia. In Spring 2014, an Iowa state court declared K.G. incapable of caring for
    herself and, against K.G.’s will, appointed K.G.’s sister as her guardian.” Id. K.G. regained her
    mental faculties by May 2016 and filed a claim in the Vaccine Program for her alleged vaccine
    injury in January 2018. Id.
    Unlike K.G., W.J. was an infant at the time of his vaccination, and the petitioners, W.J.’s
    parents, were capable of filing a claim on his behalf. W.J.’s parents have not filed any evidence
    to suggest that they were incapacitated in any way during any time frame relevant to their
    petition. While the Court in K.G. confirmed an equitable tolling right for incapacitated
    individuals, nothing in the decision negated a legal representative’s rights and responsibilities
    under the Vaccine Act. A legal representative is “a parent or an individual who qualifies as a
    legal guardian under State law.” § 33(2). The Vaccine Act expressly permits a legal
    representative to file a petition for compensation on behalf of a minor. § 11(b)(1)(A).
    Therefore, petitioners had the right and responsibility to bring a timely claim on W.J.’s behalf.
    The decision in K.G. did not alter this provision.
    W.J.’s “mental incapacity” does not serve as an “extraordinary circumstance.”
    Petitioners, as W.J.’s legal representatives as his parents, had the ability to file a petition 36
    months from the onset of the earliest symptom or manifestation of W.J.’s injury. The same is
    true for all petitions brought on behalf of all minors. Parents or other legal representatives must
    file the petition on behalf of a minor within the applicable statute of limitations.
    3.      The Discovery Rule
    limitations, see Villalobos ex rel. A.D. v. Sec’y of Health & Hum. Servs., No. 20-96V, 
    2020 WL 5797865
     (Fed. Cl. Spec. Mstr. Sept. 2, 2020); Palencia ex rel. C.A.P. v. Sec’y of Health & Hum.
    Servs., No. 20-180V, 
    2020 WL 5798504
     (Fed. Cl. Spec. Mstr. Sept. 2, 2020); Edoo v. Sec’y of
    Health & Hum. Servs., No. 13-302V, 
    2014 WL 1381341
     (Fed. Cl. Spec. Mstr. Mar. 19, 2014);
    Boettcher v. Sec’y of Health & Hum. Servs., No. 17-1402V, 
    2018 WL 2925043
     (Fed. Cl. Spec.
    Mstr. May 2, 2018).
    16
    Petitioners argue that it was not until genetic testing on March 19, 2019 which revealed
    that W.J. had a chromosomal aberration known as Xq28 duplication, that they believed that the
    MMR vaccine should not have been administered to him. Petition at 17-18. The petitioners
    assert “the statute of limitations in this matter began to toll no earlier than March 19, 2019, when
    [W.J.’s] parents were first informed of his Xq28 duplication.” 
    Id. at 18
    .
    Essentially, petitioners argue for the application of a discovery rule, suggesting that the
    Act’s statute of limitations should not have begun running until March 19, 2019. The Federal
    Circuit has held that there is no explicit or implied discovery rule under the Vaccine Act. Cloer,
    
    654 F.3d at 1337
    . The date of the occurrence of the first symptom or manifestation of onset
    “does not depend on when a petitioner knew or reasonably should have known anything adverse
    about [the] condition.” 
    Id. at 1339
    . Nor does it depend on when a petitioner knew or should
    have known of a connection between an injury and a vaccine. 
    Id. at 1338
     (“Congress made the
    deliberate choice to trigger the Vaccine Act statute of limitations from the date of occurrence of
    the first symptom or manifestation of the injury for which relief is sought, an event that does not
    depend on the knowledge of a petitioner as to the cause of an injury.”); see also Markovich, 477
    F.3d at 1358 (“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.”). Accordingly, the statutory filing
    period was not tolled until March 19, 2019, when petitioners learned of W.J.’s test results.
    4.      Fraud
    Petitioners claim they were unable to file a claim on behalf of W.J. because the
    government fraudulently concealed the connection between vaccines and autism. Petition at 17.
    However, the petitioners did not file any evidence to suggest that the government was
    fraudulently concealing the connection between vaccines and autism. Furthermore, petitioners
    failed to show how respondent’s alleged concealment prevented them from filing a petition on
    behalf of W.J. At the time W.J. was vaccinated and later diagnosed with autism the Vaccine
    Program was conducting an Omnibus Autism Proceeding (“OAP”), which included more than
    5,100 petitions filed under the Vaccine Act alleging that vaccines caused autism. See Snyder v.
    Sec’y of Health & Hum. Servs., No. 01-162V, 
    2009 WL 332044
    , at *4 n.12 (Fed. Cl. Spec. Mstr.
    Feb. 12, 2009), aff’d, 
    88 Fed. Cl. 706
     (2009). Petitioners could have filed a petition during that
    timeframe, but did not do so.
    Petitioners also cite Paluck, 
    786 F.3d 1373
     to emphasize that “that vaccines do
    sometimes cause or enhance autism-like symptoms.” Petition at 16. The Court in Paluck held
    that the parents of K.P. demonstrated “by preponderance of evidence that their son’s existing
    mitochondrial disorder was significantly aggravated by his receipt of vaccines within medically
    acceptable time, and thus he was entitled to compensation under National Childhood Vaccine
    Injury Act.” 786 F.3d at 1373. K.P. demonstrated significant developmental delays when he
    was nine months old and underwent evaluations that showed he had gross motor delays. Id. at
    1375. K.P. received an MMR vaccine and pneumococcal vaccines at his one-year well baby
    visit, and two days later had a high temperature. Id. at 1376. After a series of tests and a three
    weeklong hospitalization, K.P. was subsequently diagnosed with an unspecified mitochondrial
    disorder “most likely present from the time of K.P.’s birth.” Id. The petitioners in Paluck
    17
    showed by preponderant evidence, the first sign of neurodegeneration was within 23 days of
    vaccines, and the findings of his pediatrician, neurologist, and speech therapist, as well as MRI
    exams, showed K.P.’s rapid, progressive neurodegeneration as predicted by his expert’s medical
    theory. Id. at 1379.
    Here, petitioners did not show W.J. has a mitochondrial disorder. W.J. was assessed with
    speech delay over a year after the MMR vaccine at issue was administered and was diagnosed
    with autism two years later. Petitioners failed to provide any evidence linking W.J.’s speech
    delay or autism diagnosis to the MMR vaccination, how the government contributed to
    obstructing petitioner’s ability to file a petition on behalf of W.J., or how W.J.’s condition is
    similar to that of K.P.’s in Paluck. Additionally, the Paluck case did not involve the issues of the
    statute of limitations or equitable tolling.
    Petitioners have the burden of establishing the timely filing of their claim, and they have
    failed to provide evidence that their petition was filed within “36 months after the date of
    occurrence of the first symptom or manifestation of onset . . . of such injury” as required by the
    Vaccine Act. Because petitioners have alleged injury onset in 2006 (diagnosis of speech delay),
    and at the latest, 2012 (eczema and allergies), the undersigned, in assessing all inferences from
    the available evidence in petitioner’s favor, finds it appropriate to dismiss the case for failure to
    establish that the petition was timely filed.
    5.      Petitioner’s Autism Diagnosis
    In the OAP, three special masters conducted separate proceedings in test cases involving
    the two theories of autism causation. All found petitioners had not provided preponderant
    evidence of causation. See Hazlehurst v. Sec’y of Health & Hum. Servs., No. 03-654V, 
    2009 WL 332306
     (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d sub nom. Hazlehurst ex rel. Hazlehurst v.
    Sec’y of Health & Hum. Servs., 
    88 Fed. Cl. 473
     (2009), aff’d sub nom. Hazlehurst v. Sec’y of
    Health & Hum. Servs., 
    604 F.3d 1343
     (Fed. Cir. 2010); Cedillo v. Sec’y of Health & Hum.
    Servs., 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); Mead ex rel. Mead v. Sec’y of Health & Hum.
    Servs., No. 03-215V, 
    2010 WL 892248
     (Fed. Cl. Spec. Mstr. Mar. 12, 2010); King ex rel. King
    v. Sec’y of Health & Hum. Servs., No. 03-584V, 
    2010 WL 892296
     (Fed. Cl. Spec. Mstr. Mar.
    12, 2010); Dwyer ex rel. Dwyer v. Sec’y of Health & Hum. Servs., No. 03-1202V, 
    2010 WL 892250
     (Fed. Cl. Spec. Mstr. Mar. 12, 2010); Snyder, 
    2009 WL 332044
    .
    Here, petitioners state, “[b]ased on his symptoms and behaviors, [W.J.] was diagnosed by
    his physician as having autism. . . . Indeed, [W.J.] does have several autism-like symptoms.”
    Petition at 15. Petitioners assert respondent’s denial “of any connection between vaccines and
    autism can be misleading because they serve to obscure any connection between vaccines and
    injuries resulting in autism-like symptoms, if not autism proper, in children.” 
    Id. at 16
    . “Since
    the cause of autism is unknown, the postulation that vaccines may sometimes cause autism-like
    symptoms, rather than autism proper in children, cannot be ruled out.” 
    Id.
    Petitioners further state respondent’s “categorical denials have the effect of misleading
    and discouraging parents with children who have autism-like symptoms from even thinking that
    18
    the symptoms might have been caused by a vaccine.” Petition at 16. Petitioners argue that
    “[r]espondent’s assertions that hard science has ruled out any connection between vaccines and
    autism-like symptoms can amount to a ‘fraudulent defense’ to any claims suggesting otherwise,
    warranting equitable tolling in some cases. Holmberg v. Armbrecht, 
    327 U.S. 392
    , 397
    (1946).”14 
    Id.
    Equity will not lend itself to such fraud and historically has relieved from it. It
    bars a defendant from setting up such a fraudulent defense, as it interposes against
    other forms of fraud. And so this Court long ago adopted as its own the old
    chancery rule that where a plaintiff has been injured by fraud and remains in
    ignorance of it without any fault or want of diligence or care on his part, the bar of
    the statute does not begin to run until the fraud is discovered, though there be no
    special circumstances or efforts on the part of the party committing the fraud to
    conceal it from the knowledge of the other party.
    This equitable doctrine is read into every federal statute of limitation. Holmberg
    v. Armbrecht, 
    327 U.S. 392
    , 396-397 (1946) (Internal citations and quotation
    marks omitted).
    Petition at 17.
    Petitioners then assert that after genetic testing, a chromosomal aberration, Xq28
    duplication, was discovered. Petition at 17. Petitioners believe the Xq28 duplication impaired
    [W.J.’s] immune system and caused his mental incapacities, and he “might not be autistic at all
    or that the Xq28 duplication is a cause of his autism.” 
    Id.
     Finally, petitioners state, “because of
    the Xq28 duplication, the MMR vaccine should not have been administered to [W.J.] at all, and
    that it probably significantly aggravated his congenital chromosomal aberration.” Id. at 18.
    Petitioners, however, do not provide any evidence to support their contentions that
    respondent’s actions prevented them from filing a timely claim in the thirty-six months after W.J.
    first began to show signs of autistic spectrum disorder or how the fraudulent defense pertains to
    this case. Around the time of W.J.’s vaccination and autism diagnosis, more than 5,100 petitions
    were filed under the Vaccine Act alleging that vaccines caused autism. See Snyder, 
    2009 WL 332044
     at *4 n.12.
    There is no evidence here to suggest that fraud or concealment prevented petitioners from
    timely filing claims on behalf of W.J. for allegations of autism following vaccination. Thus, the
    undersigned does not agree that respondent’s “categorical denials” had the “effect of misleading
    and discouraging parents with children who have autism-like symptoms” from filing petitions, or
    that this claim warrants “equitable tolling” based on any assertion of fraud. Petition at 16.
    14
    Petitioners cite Holmberg v. Armbrecht, an equity case where shareholders and creditors of the
    Southern Minnesota Joint Stock Land Bank of Minneapolis sued the defendant for fraudulently
    concealing his shareholder interest, which delayed petitioners from bringing suit. 
    327 U.S. 392
    ,
    393 (1946).
    19
    Therefore, in assessing all inferences from the available evidence in petitioner’s favor,
    petitioners have failed to show respondent’s actions prevented them from filing a timely petition.
    6.      Petitioner’s Fourteenth Amendment Claim
    Petitioners contend, “[t]o consider equitable tolling for K.G.’s drug and alcohol induced
    mental incapacity, but not for [W.J.’s] congenital genetically-caused mental incapacity, would be
    disability discrimination in violation of [W.J.’s] Fourteenth Amendment rights.” Petition at 18.
    Petitioners cite City of Cleburne, 
    473 U.S. 432
    , stating disparate treatment between neuro-
    normal and mentally incapacitated individuals violates the Fourteenth Amendment’s Equal
    Protection clause. 
    Id.
     “The equal protection clause of the Fourteenth Amendment dictates that
    [W.J.] receive the same consideration for equitable tolling that was offered to K.G.” Id. at 19.
    But petitioners fail to comprehend that they, as parents and legal representatives of W.J., had the
    right and responsibility to timely file a petition. They have not asserted that they have any
    disability or mental incapacity. Thus, their argument based on the Fourteenth Amendment fails.
    Further, under the Vaccine Program, the Vaccine Act’s limitation period is rationally
    related to the dual legitimate legislative purposes undergirding the Vaccine Act: (1) the settling
    of claims quickly and easily, and (2) the protecting of manufacturers from uncertain liability
    making “production of vaccines economically unattractive, potentially discouraging vaccine
    manufacturers from remaining in the market.” See Cloer, 
    85 Fed. Cl. 141
     (2008) (quoting Brice,
    
    240 F.3d at 1368
    ).
    Highlighting in Cloer that the “neutral” nature of the 36-month statute of limitations
    “treats all petitioners equally,” the Federal Circuit appears to have affirmed, without overt
    discussion, the Court of Federal Claims’ use of rational basis review to conclude that the
    statutorily prescribed limitations period is rationally related to the “legitimate legislative
    purposes undergirding the Vaccine Act.” Cloer, 85 Fed. Cl. at 151-52 (quoting Brice, 
    240 F.3d at 1368
    ). See 
    id.
     (“[T]here can be no question that applying the Vaccine Act’s limitation period
    is rationally related to the dual legitimate legislative purposes undergirding the Vaccine Act: (1)
    the settling of claims quickly and easily, and (2) the protecting of manufacturers from uncertain
    liability [that makes the] ‘production of vaccines economically unattractive, [and] potentially
    discourag[es] vaccine manufacturers from remaining in the market.’”) (internal footnote
    omitted). The Court of Federal Claims further stated in Cloer that “Congress is not obligated to
    extend the coverage of the Vaccine Act . . . to all person[s] suffering a vaccine-related injury.”
    
    Id.
     at 150 (citing Leuz v. Sec’y of Health & Hum. Servs., 
    63 Fed. Cl. 602
    , 608 (2005)).
    The petitioners have not shown that they fall within a protected class of persons. The
    claims of all petitioners, regardless of the alleged injury, must be evaluated consistent with the
    terms of the Vaccine Act, provided the claimants have met the threshold requirement of filing the
    petition within the time limit prescribed by the statute. Here, petitioners have failed to file within
    the appropriate time frames set forth under the statute.
    VII    CONCLUSION
    It is clear from the medical records that W.J. has struggled with illness, and the
    20
    undersigned has great sympathy for what he and his parents have endured due to his illness. The
    undersigned’s decision, however, cannot be decided based upon sympathy, but rather on the
    evidence and law.
    Accordingly, for all the reasons stated above, in assessing all inferences from the
    available evidence in petitioner’s favor, the undersigned GRANTS respondent’s motion to
    dismiss and this case is dismissed for failure to timely file the petition within the statute of
    limitations. In the absence of a timely filed motion for review pursuant to Vaccine Rule 23, the
    Clerk of Court SHALL ENTER JUDGMENT in accordance with this Decision.
    IT IS SO ORDERED.
    s/Nora Beth Dorsey
    Nora Beth Dorsey
    Special Master
    21