VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-01342 Package ID: USCOURTS-cofc-1_21-vv-01342 Petitioner: W.J. Filed: 2021-05-07 Decided: 2022-03-30 Vaccine: MMR Vaccination date: 2005-02-24 Condition: chronic encephalopathy Outcome: dismissed Award amount USD: AI-assisted case summary: On May 7, 2021, R.J. and A.J., parents and legal guardians of minor W.J., filed a petition for vaccine injury compensation on behalf of their child. They alleged that W.J. suffered from chronic encephalopathy and immunodeficiency issues, including immune-related blood disorders, eczema, and allergies, as a result of receiving the measles, mumps, and rubella (MMR) vaccine on February 24, 2005. They further claimed the vaccine either directly caused these injuries or significantly aggravated pre-existing cerebral and immunological damage related to W.J.'s Xq28 chromosomal duplication. The respondent, the Secretary of Health and Human Services, filed a motion to dismiss, arguing the petition was filed beyond the 36-month statutory limitations period and that no basis for equitable tolling existed. The Special Master, Nora Beth Dorsey, granted the motion to dismiss, finding the petition untimely. The Special Master noted that W.J. was diagnosed with a speech delay on March 7, 2006, and with autism and pervasive developmental delay on January 5, 2007. These diagnoses, occurring well before the petition filing date, were considered the first symptoms or manifestations of the alleged injuries. The Special Master determined that even if the alleged injuries could be proven, the petition was time-barred. The Special Master also rejected the petitioners' arguments for equitable tolling, stating that as W.J.'s legal representatives, his parents had the responsibility to file a timely claim and that W.J.'s alleged incapacity did not constitute an extraordinary circumstance to warrant tolling. The court also found no evidence of fraudulent concealment by the respondent that prevented timely filing. The petitioners appealed this decision. On July 7, 2022, Judge Kathryn C. Davis of the U.S. Court of Federal Claims issued a memorandum opinion and order affirming the Special Master's decision. The court found that the Special Master did not err in raising the statute of limitations issue sua sponte, nor did she misapply the legal standard in ruling on the equitable tolling arguments. The court agreed that the petition was filed outside the 36-month limitations period, which begins from the first symptom or manifestation of the injury. The court also affirmed the rejection of equitable tolling, noting that the parents, as legal representatives, had the right and responsibility to file a timely claim on behalf of their minor child. The court concluded that the Special Master's decision was not arbitrary and capricious, an abuse of discretion, or otherwise not in accordance with law, and therefore denied the motion for review, upholding the dismissal. Theory of causation field: Petitioners alleged that W.J., who received the MMR vaccine on February 24, 2005, suffered from chronic encephalopathy and immunodeficiency issues, including blood disorders, eczema, and allergies. They claimed these conditions were either directly caused by the vaccine or significantly aggravated pre-existing damage related to his Xq28 chromosomal duplication. The Special Master dismissed the petition as untimely, finding that W.J.'s speech delay diagnosis on March 7, 2006, and autism diagnosis on January 5, 2007, occurred outside the 36-month statute of limitations. The court affirmed this dismissal, agreeing that the petition was filed beyond the statutory period and that equitable tolling was not warranted, as the parents, as legal representatives, had the responsibility to file a timely claim. The public decision does not describe the specific mechanism of causation or name any medical experts. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_21-vv-01342-0 Date issued/filed: 2022-03-30 Pages: 21 Docket text: PUBLIC DECISION (Originally filed: 2/16/2022) regarding 29 DECISION of Special Master. Signed by Special Master Nora Beth Dorsey. (mca) Service on parties made. (Main Document 38 replaced on 3/30/2022 to add reissued for publication stamp) (sw). Petitioner served copy via e-mail on 3/30/2022 (sw). -------------------------------------------------------------------------------- Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 1 of 21 REISSUED FOR PUBLICATION MAR 30 2022 OSM U.S. COURT OF FEDERAL CLAIMS 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 2 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 3 of 21 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). 5Lymphocytosis 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 4 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 5 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 6 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 7 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 8 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 9 of 21 § 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 10 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 11 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 12 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 13 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 14 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 15 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 16 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 17 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 18 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 19 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 20 of 21 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 Case 1:21-vv-01342-KCD Document 38 Filed 03/30/22 Page 21 of 21 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 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_21-vv-01342-1 Date issued/filed: 2022-07-07 Pages: 21 Docket text: PUBLIC DECISION (Originally filed: 6/21/22) regarding 40 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Judge Kathryn C. Davis. (zlj) Service on parties made. Petitioners served copy via e-mail (sw). -------------------------------------------------------------------------------- Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 1 of 21 IN THE UNITED STATES COURT OF FEDERAL CLAIMS NOT FOR PUBLICATION ______________________________________ ) W.J., by his parents and legal guardians, ) R.J. and A.J., ) ) Petitioners, ) No. 21-1342V ) v. ) Filed: June 21, 2022 ) SECRETARY OF HEALTH AND ) Reissued: July 7, 20221 HUMAN SERVICES, ) ) Respondent. ) ______________________________________ ) MEMORANDUM OPINION AND ORDER Petitioners R.J. and A.J. seek review of a decision dismissing their request for vaccine injury compensation on behalf of their child, W.J. Petitioners filed their petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10 et seq. (the “Vaccine Act”), alleging W.J. suffered chronic encephalopathy (a Table injury) and immunodeficiency issues, including immune-related blood disorders, eczema, and allergies, as a result of receiving the measles, mumps, and rubella (“MMR”) vaccine in February 2005. Petitioners claim the vaccine either directly caused the asserted injuries or significantly aggravated W.J.’s pre-existing cerebral and immunological damage. The Special Master dismissed the claims as untimely under the Vaccine Act’s statute of limitations. For the reasons discussed below, the Special Master’s decision to grant Respondent’s 1 The Court issued this opinion under seal on June 21, 2022, and directed the parties to file any proposed redactions by July 6, 2022. On July 5, 2022, Petitioners requested the Court redact the case caption, as approved by the Special Master, but did not propose further redactions. See ECF No. 42. As such, the Court reissues the opinion publicly in full, with revisions to the case caption and first sentence of the text to protect the identity of Petitioners. Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 2 of 21 Motion to Dismiss was not arbitrary and capricious, an abuse of discretion, or otherwise not in accordance with law. Accordingly, the Court DENIES Petitioners’ Motion for Review. I. BACKGROUND A. Factual History Petitioners alleged that W.J. was born a healthy, full-term infant on February 4, 2004, without significant neonatal problems. Pet. Ex. 1 at 1, ECF No. 1-2. He received routine vaccinations throughout his childhood, including influenza, hepatitis B, diphtheria-tetanus- acellular pertussis, Haemophilus influenzae type B, pediatric pneumococcal, polio, and MMR. Pet. Ex. 2 at 1, ECF No. 1-2. His MMR vaccines were administered on February 24, 2005, and March 15, 2008, without record of adverse reactions. Id. On March 7, 2006, at the age of two, doctors diagnosed W.J. with a speech delay. Pet. Ex. 6 at 13, ECF No. 1-2. W.J.’s blood tests showed high platelet levels and low lymphocyte levels. Pet. Ex. 9 at 1, ECF No. 1-2. Subsequent audiologic evaluation in June 2006 revealed adequate hearing. Id. The following year, on January 5, 2007, doctors diagnosed W.J. with autism and pervasive developmental delay. Pet. Ex. 39 at 17, ECF No. 20-1. Pediatric neurologists determined that W.J.’s developmental delays and language disorder required intensive therapeutic programs. Pet. Ex. 13 at 1, ECF No. 1-2. Over the next 15 years, W.J. presented to doctors for various physical and psychological ailments. From June 22 to 25, 2007, he was hospitalized with a fever and swollen glands consistent with a bacterial infection. Pet. Ex. 12 at 11, ECF No. 1-2. On February 20, 2012, he was assessed by doctors for “unstable atopic dermatitis” and tested for lead poisoning. Pet. Ex. 7 at 7, ECF No. 1-2. On February 19, 2014, he returned for treatment of severe eczema and rhinitis, conditions that the treating physician noted had gone untreated over the objections of W.J.’s healthcare 2 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 3 of 21 providers. Id. at 10. W.J.’s behavioral problems, including irritability, mood swings, and poor sleep, prompted doctors to perform a comprehensive psychiatric evaluation on July 19, 2018. Pet. Ex. 71 at 59, ECF No. 1-2. Following this evaluation, doctors attempted to manage W.J.’s behaviors over the next three years with antipsychotic medications. Id. at 3. In February 2019, genetic testing revealed that W.J. has an MTHFR homozygous A1298C mutation and duplication of the Xq28 chromosome of uncertain clinical significance. Pet. Ex. 11 at 4, 6, 8, ECF No. 1-2; Pet. Ex. 14 at 1, ECF No. 1-2. Based on a review of the medical records, the Special Master found that at no point did doctors diagnose W.J. with encephalopathy or immunodeficiency disorder. See Decision Den. Comp. at 8, ECF No. 29. B. Procedural History On May 7, 2021, Petitioners filed a claim for vaccine injury compensation on behalf of W.J. See Pet., ECF No. 1. According to Petitioners, the MMR vaccine was inappropriately administered to W.J. in contravention of the vaccine’s warnings because of W.J.’s Xq28 chromosomal duplication. Id. ¶ 17. As a result, Petitioners contend that W.J. has chronic encephalopathy and immunodeficiency issues caused either directly by the vaccine or by its significant aggravation of the pre-existing damage related to his chromosomal abnormality. Id. ¶ 19. They further contend these injuries led to several bouts of immune-related blood disorders and an infection resembling mumps that resulted in hospitalization. See id. ¶¶ 21–64. On June 3, 2021, the Special Master held an initial status conference, during which she raised the issue of the statute of limitations. See Order dated June 3, 2021, at 1, ECF No. 14. Before addressing the merits of the claims, she directed Respondent to file a Rule 4(c) Report and Motion to Dismiss. Id. at 4–5. In accordance with this direction, Respondent moved to dismiss, 3 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 4 of 21 contending Petitioners filed their claims beyond the 36-month statute of limitations and that no basis for equitable tolling applied. See Resp’t’s Mot. to Dismiss, ECF No. 16. Respondent asserted that W.J.’s injuries, if they did exist, began to manifest by March 2006 when he was diagnosed with a speech delay. See Resp’t’s Rule 4(c) Report at 8, ECF No. 15. Accordingly, Respondent argued that the Vaccine Act required Petitioners to file a claim by no later than March 2009. Id. The Special Master granted Respondent’s Motion to Dismiss for failure to file a timely action under the Vaccine Act. ECF No. 29 at 2. Although the Special Master discussed the merits of Petitioners’ claims throughout the decision, she dismissed the claims solely on the basis of the statute of limitations. Id. at 21. The Special Master explained that even if Petitioners were able to establish a viable Table Claim, cause-in-fact injury, or significant aggravation injury, their petition was filed beyond the Vaccine Act’s 36-month filing period, which begins to run upon “the first symptom or manifestation of onset or of the significant aggravation of such injury.” Id. at 8–9 (citing 42 U.S.C. § 300aa-16(a)(2)). Because Petitioners based their Table Claim on the MMR vaccine administered on February 24, 2005, and a Table Claim must manifest within 15 days of vaccination, the Special Master found they were required to file that claim no later than March 11, 2008. Id. at 12. Likewise, if W.J.’s speech delay—the alleged first manifestation of his chronic encephalopathy—was diagnosed on March 7, 2006, Petitioners were required to file the claim for a cause-in-fact injury by March 7, 2009.2 Id. at 13. Similarly, the Special Master found that Petitioners were required to file a cause-in-fact injury claim related to any immunodeficiency issues by March 9, 2009, at the earliest, or April 8, 2017, at the latest. Id. at 14–15 (calculating 2 The Special Master also noted that if W.J.’s autism diagnosis on January 5, 2007, was a first symptom or manifestation of the alleged chronic encephalopathy, the filing period expired on January 5, 2010. ECF No. 29 at 13. 4 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 5 of 21 36-month filing period based on abnormal blood tests on March 9, 2006, and April 13, 2007; unstable atopic dermatitis diagnosis on February 20, 2012; hospitalization on June 22–24, 2007; and high mumps count on April 8, 2014). She applied the same standard to the significant aggravation claim, finding it time-barred for the same reasons. Id. at 15. The Special Master also rejected Petitioners’ equitable tolling arguments. Id. at 16, 17–18. Although W.J. was an infant when he received the MMR vaccine, she held Petitioners, as his parents, retained the ability to file a claim on his behalf. Id. at 16. The Special Master therefore concluded that W.J.’s mental incapacity was not an extraordinary circumstance warranting equitable tolling. Id. She also determined that the doctrine of fraudulent concealment did not apply because Petitioners failed to plead facts demonstrating Respondent’s alleged fraudulent conduct prevented them from timely pursuing compensation. Id. at 17–18. On March 14, 2022, Petitioners filed a Motion for Review of the Special Master’s decision. See Pet’rs’ Mot. for Review, ECF No. 36; Pet’rs’ Mem. of Obj., ECF No. 36-1. Petitioners challenge several aspects of the decision, including that the Special Master raised the statute of limitations issue sua sponte during the initial status conference and applied a purportedly incorrect legal standard to the motion. ECF No. 36-1 at 6. On April 14, 2022, Respondent responded to Petitioner’s motion. See Resp’t’s Resp. to Pet’rs’ Mot. for Review, ECF No. 39. It argues that the Special Master acted within her discretion by addressing timeliness as a potential threshold bar to recovery and properly applied both the standard of review and the case law governing equitable tolling. Id. at 12, 14. II. LEGAL STANDARDS A. Review of a Special Master’s Decision This Court has jurisdiction to review a special master’s decision upon the timely request 5 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 6 of 21 of either party. 42 U.S.C. § 300aa-12(e)(2). Under the Vaccine Act, a court deciding a motion for review may: (A) uphold the findings of fact and conclusions of law of the special master’s decision, (B) set aside any findings of fact and conclusions of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or (C) remand the petition to the special master for further action in accordance with the court’s direction. Id. §§ 300aa-12(e)(2)(A)–(C). The Court employs “a highly deferential standard” when reviewing a special master’s decision. Hines v. Sec’y of Health & Hum. Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991); Munn v. Sec’y of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992) (holding that findings of fact receive “great deference” under an “arbitrary and capricious” standard, legal conclusions are reviewed under the “not in accordance with law” standard, and discretionary rulings are reviewed for “abuse of discretion”). If the special master has “considered the relevant evidence of record, drawn plausible inferences[,] and articulated a rational basis for the decision,” reversible error will be “extremely difficult” to demonstrate. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000); see Hayman v. United States, No. 02-725V, 2005 WL 6124101, at *2 (Fed. Cl. May 9, 2005). On a motion for review, it is not the Court’s role “to reweigh the factual evidence.” Doe 93 v. Sec’y of Health & Hum. Servs., 98 Fed. Cl. 553, 565 (2011) (citing Lampe, 219 F.3d at 1360). Rather, “the probative value of the evidence [and] the credibility of the witnesses . . . are all matters within the purview” of the special master as fact finder. Id. The Court should not substitute its judgment for that of the special master even though it may have reached a different conclusion. Johnson v. Sec’y of Health & Hum. Servs., 33 Fed. Cl. 712, 720 (1995). This deference notwithstanding, when the matter for review is whether the special master’s decision was in accordance with law—i.e., when a question of law is at issue—the court reviews the decision de 6 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 7 of 21 novo. Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1277–78 (Fed. Cir. 2005). B. Motion to Dismiss Standard A motion to dismiss for failure to state a claim upon which relief may be granted “is appropriate when the facts asserted by the claimant do not entitle him to a legal remedy.” Lindsay v. United States, 295 F.3d 1252, 1257 (Fed. Cir. 2002). It is well established that a complaint “must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)); Cary v. United States, 552 F.3d 1373, 1376 (Fed. Cir. 2009). A “plausible” complaint “does not need detailed factual allegations,” but rather only enough “to raise a right of relief” beyond mere speculation. Twombly, 550 U.S. at 555. When reviewing a motion to dismiss for failure to state a claim, the Court may consider all allegations in the complaint and may also consider “matters incorporated by reference or integral to the claim, items subject to judicial notice, [and] matters of public record.” A & D Auto Sales, Inc. v. United States, 748 F.3d 1142, 1147 (Fed. Cir. 2014) (citation omitted); see Terry v. United States, 103 Fed. Cl. 645, 652 (2012). “[A]ll well-pled factual allegations” should be assumed by the court as true and “all reasonable inferences [should be made] in favor of the nonmovant.” United Pac. Ins. Co. v. United States, 464 F.3d 1325, 1327–28 (Fed. Cir. 2006). But “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements” are insufficient to prevent dismissal. Iqbal, 556 U.S. at 678. 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 v. Sec’y of Health 7 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 8 of 21 & Hum. Servs., No. 13-1000V, 2014 WL 3889070, at *2 (Fed. Cl. Spec. Mstr. July 18, 2014); see also Warfle v. Sec’y of Health & Hum. Servs., No. 05-1399V, 2007 WL 760508, at *2 (Fed. Cl. Spec. Mstr. Feb. 22, 2007). III. DISCUSSION Petitioners raise nine objections to the Special Master’s decision dismissing Petitioners’ claims as untimely under the statute of limitations. These objections fall roughly into three categories. First, Petitioners contend the Special Master violated separation-of-powers principles by sua sponte ordering Respondent to file a motion to dismiss at the initial status conference. ECF No. 36-1 at 6. Second, they allege the Special Master erred in rejecting their equitable tolling arguments because she allegedly applied the wrong legal standard for reviewing a motion to dismiss. Id. at 10–11. Petitioners base this argument on the Special Master’s alleged disbelief and rejection of their pleaded facts, which they argue demonstrate extraordinary circumstances and fraudulent concealment that warrants the tolling of the statute of limitations. Id. Finally, Petitioners contend the Special Master’s decision went beyond the scope of Respondents’ dismissal request and improperly ruled on the merits of Petitioners’ claims. Id. at 8. Having considered the arguments and record, the Court rejects Petitioners’ objections and finds the Special Master acted rationally, within her discretion, and in accordance with law in finding Petitioners’ claims time-barred by the statute of limitations. The issue of timeliness was apparent from the face of the Petition, and the Special Master did not force Respondent to adopt a particular legal strategy or position. Further, the Special Master applied the correct legal standard for a motion to dismiss by rejecting legal conclusions and determining that the pleaded facts, even accepted as true, did not justify equitable tolling. Moreover, regardless of whether the Special Master’s decision included merits-type rulings, the sole basis of the decision was properly limited 8 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 9 of 21 to the statute of limitations question. Accordingly, the Special Master’s decision is upheld. A. The Special Master Did Not Violate Separation of Powers. Petitioners first object to the Special Master raising the statute of limitations sua sponte during the initial status conference. Id. at 6. They contend that by directing the parties to brief the issue of timeliness, the Special Master violated the separation of powers or, at the least, created the appearance of impropriety by ordering Respondent to take a particular legal position and preemptively endorsing that position. Id. at 8. Respondent responds that there is nothing improper about a judge or special master raising a threshold, dispositive issue before reaching the merits of a party’s claim. ECF No. 39 at 8. The relevant exchange at the initial status conference is brief enough to reproduce in full. On June 3, 2021, the Special Master addressed the parties as follows: THE COURT: Okay. So I know you probably are aware of this based on the petition, there is a statute of limitations issue that we will need to address since that’s a threshold issue, that is, if the statute of limitations has expired, then the case will be dismissed because it can no longer be brought. And I think that is something we probably need to deal with sooner rather than later so that we don’t use a lot of your time, energy, and money and the Court’s time and energy litigating a case where the statute of limitations has expired. And by talking about this I’m not diminishing in any way the experiences and the difficulty that your family has had. I just don’t want to lead you to have any unrealistic expectations about how the case may proceed. So I think the best course of action . . . is probably for [Respondent] to file a Rule 4 report with any motion to dismiss or other legal filing with regard to the statute of limitations. And then I can ask [Petitioner] to file any reply or response which he may wish to do so, and then I can rule on that issue. [Respondent], what are your thoughts about that plan? [RESPONDENT’S COUNSEL]: Yes, Special Master, that sounds like an appropriate plan. THE COURT: [Petitioner], does that plan -- is that plan acceptable with you? 9 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 10 of 21 [PETITIONER]: That sounds fair. Yes. Tr. at 4:6–5:9, ECF No. 19. Following the initial status conference, the parties submitted full briefing, which the Special Master subsequently reviewed. ECF No. 29 at 2. In her decision, the Special Master noted that she “ordered” Respondent to file a Rule 4(c) Report and Motion to Dismiss on the issue of the statute of limitations. Id. Petitioners characterize the exchange at the status conference as a significant violation of judicial propriety because it showed the Special Master’s desire to dismiss the case. ECF No. 36- 1 at 8. They argue that her decision “is irreparably tainted by . . . separation-of-powers concerns” because of the so-called general principle that “she who orders the motion to be filed must not adjudge that motion’s merit.” Id. However, based on the relevant portion of the transcript, there is no evidence that the Special Master acted improperly by ordering briefing on the statute of limitations. The issue of timeliness was originally raised by Petitioners—not the Special Master— in the equitable tolling section of the Petition. See ECF No. 1 ¶¶ 80–121. The Special Master did not abuse her discretion or act contrary to law by recognizing that a patent statute of limitations question could be outcome determinative and deciding that it would be prudent to address the issue at as early a stage as possible. Cf. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2018) (endorsing use of summary judgment motion “at an early stage of the proceedings” where a party believes “that no material facts are in dispute and they will prevail as a matter of law”). By addressing the threshold timeliness issue before the merits, the Special Master efficiently used judicial resources to save the parties time, energy, and money litigating untimely claims, which is consistent with the goals of the Vaccine Act and applicable rules. See 42 U.S.C. § 300aa-12(d)(2)(A); see R. 3(b)(2), Rules of the U.S. Court of Federal Claims, app. B (“Vaccine Rules”). 10 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 11 of 21 Nor does the transcript reflect that the Special Master ordered Respondent to take a particular position on the statute of limitations or otherwise display bias in favor of dismissal on that basis. The Special Master raised the issue at the status conference by explaining it was likely “the best course of action” for Respondent to file “any motion to dismiss or other legal filing with regard to the statute of limitations.” ECF No. 19 at 4:22–25. Although the Special Master could have first inquired whether Respondent intended to raise a timeliness argument and then—having confirmed its intent—ordered briefing, that she reasonably anticipated Respondent’s position does not rise to the level of an abuse of discretion. See Cottingham on Behalf of K.C. v. Sec’y of Health & Hum. Servs., 971 F.3d 1337, 1345 (Fed. Cir. 2020) (“An abuse of discretion occurs if the decision is clearly unreasonable, arbitrary, or fanciful; is based on an erroneous conclusion of law; rests on clearly erroneous fact findings; or involves a record that contains no evidence on which the [special master] could base [her] decision.”). And the Special Master’s “best course of action” statement most naturally indicates her determination that it was procedurally efficient to resolve the statute of limitations question first, as opposed to suggesting a particular legal argument would improve Respondent’s chance of obtaining dismissal. Notwithstanding the briefing order, the substance and scope of the legal arguments Respondent eventually made was entirely up to it, including whether the statute of limitations barred the claims, equitable tolling was warranted, or some other issue should be addressed before or contemporaneous with the issue of timeliness. Moreover, the Special Master solicited any objections from Petitioners (they posed none), id. at 5:9, and afforded Petitioners ample opportunity to be heard in opposition to the motion. See Kreizenbeck, 945 F.3d at 1366 (holding that, in reviewing the method of adjudicating a petitioner’s claim, the material inquiry is whether the special master “afford[ed] each party a full and fair opportunity to present its case and create a record sufficient to allow review of [her] decision”). 11 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 12 of 21 The Special Master then considered the literature and evidence provided by Petitioners and based her decision squarely on the pleaded facts and relevant law. ECF No. 29 at 2. As such, the Court finds that the Special Master did not abuse her discretion in directing the parties to brief the statute of limitations issue following the initial status conference. The Special Master’s decision should not be overturned on this ground. B. The Special Master Did Not Misapply the Legal Standard In Ruling on Petitioners’ Equitable Tolling Arguments. Petitioners next object to the Special Master’s rejection of their equitable tolling arguments. ECF No. 36-1 at 14–19. They contend the Special Master erred by failing to accept the pleaded facts as true for purposes of ruling on the motion to dismiss. Id. at 5. According to Petitioners, had the Special Master properly construed all reasonable inferences in their favor, she would have determined that the statute of limitations should be tolled because of extraordinary circumstances and the doctrine of fraudulent concealment. Id. at 7. Respondent responds that although special masters may not disregard well-pleaded facts when ruling on a motion to dismiss, the rules do not require they accept legal conclusions as true purely because they are couched as factual assertions. ECF No. 39 at 15. Respondent argues that the role of the special master is to draw reasonable inferences from the provided evidence and to determine if a viable claim exists by applying the law to such evidence and inferences. Id. Although the Vaccine Act and the Vaccine Rules contemplate case-dispositive motions, they do not expressly include a mechanism for a motion to dismiss. See 42 U.S.C. §§ 300aa-12(d)(2)(C)–(D); Vaccine R. 8(d) (providing that “[t]he special master may decide a case on the basis of a written motion[,] . . . [which] may include a motion for summary judgment,” but not specifically mentioning a motion to dismiss). However, Vaccine Rule 1 provides that for any matter not specifically addressed by the Vaccine Rules, the special master “may regulate 12 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 13 of 21 applicable practice, consistent with these rules and with the purpose of the Vaccine Act, to decide the case promptly and efficiently.” See Vaccine R. 1(b). Vaccine Rule 1 also provides that the Rules of the United States Court of Federal Claims (“RCFC”) may apply to the extent they are consistent with the Vaccine Rules. Vaccine R. 1(c). Accordingly, there is a well-established practice of special masters’ entertaining motions to dismiss under RCFC 12(b)(6), which provides for dismissal based on “failure to state a claim upon which relief can be granted.” See, e.g., Herren, 2014 WL 3889070, at *1; Bass v. Sec’y of Health & Hum. Servs., No. 12-135V, 2012 WL 3031505, at *5 (Fed. Cl. Spec. Mstr. June 22, 2012). This includes in cases where Respondent raised a statute of limitations argument. See, e.g., Clubb v. Sec’y of Health & Hum. Servs., 136 Fed. Cl. 255, 263 (2018); J.H. v. Sec’y of Health & Hum. Servs., 123 Fed. Cl. 206, 215 (2015). Section 300aa-16 of the Vaccine Act provides a limitations period for claims arising from vaccines administered after October 1, 1988. It reads: [I]f a vaccine-related injury occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such injury after the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of such[.] 42 U.S.C. § 300aa-16(a)(2). The Federal Circuit has held that the Vaccine Act’s limitations period begins to run from the onset of the “first event objectively recognizable as a sign of a vaccine injury by the medical profession at large,” Carson v. Sec’y of Health & Hum. Servs., 727 F.3d 1365, 1368 (Fed. Cir. 2013) (quoting Markovich v. Sec’y of Health & Hum. Servs., 477 F.3d 1353, 1360 (Fed. Cir. 2007)), even if the symptom did not result in a diagnosis at the time or was not appreciated until after a doctor definitively diagnosed the injury, id. at 1369–70. Special Masters have regularly dismissed cases filed outside the limitations period, even if by only a single day. 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 limitations period), aff’d, 132 13 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 14 of 21 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) (dismissing case filed two months beyond the limitations period). 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). To establish that equitable tolling is appropriate, claimants must prove: (1) they pursued their rights diligently; and (2) an extraordinary circumstance prevented them from timely filing their claim. K.G. v. Sec’y of Health & Hum. Servs., 951 F.3d 1374, 1379 (Fed. Cir. 2020) (citing Menominee Indian Tribe v. United States, 577 U.S. 250, 255 (2016)); see Baldwin Cnty. Welcome Ctr. v. Brown, 466 U.S. 147, 151 (1984) (“One who fails to act diligently cannot invoke equitable principles to excuse that lack of diligence.”). Extraordinary circumstances exist when the “failure to file was the direct result of a mental illness or disability that rendered [the claimant] incapable of rational thought, incapable of deliberate decision making, incapable of handling [his or her] own affairs, or unable to function in society.” K.G., 951 F.3d at 1381. But “[a] medical diagnosis alone or vague assertions of mental problems are insufficient” to establish extraordinary circumstances. Id. at 1381–82. To determine whether a mentally incapacitated claimant has demonstrated reasonable diligence, the Court must consider “all relevant facts and circumstances,” including whether he or she had a legal guardian and the significance of that relationship. Id. at 1382 (holding that a court should evaluate the significance of a legal guardian based on a number of factors, including “the nature and sophistication of the guardian (parent, lawyer, family member, or third-party), the timing of the institution of the guardianship (before or after the vaccination, for example), . . . the extent to which the claimant’s mental incapacity interferes with her relationship and communication with her guardian, [and] the quality and nature 14 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 15 of 21 of the guardian’s relationship with the claimant . . . .”). The doctrine of fraudulent concealment may also toll a statute of limitations where, “assuming due diligence on the part of the plaintiff . . . the misconduct in question ‘has been concealed, or is of such character as to conceal itself.’” Simmons Oil Corp. v. Tesoro Petroleum Corp., 86 F.3d 1138, 1142 (Fed. Cir. 1996) (citing Bailey v. Glover, 88 U.S. 342, 349–50 (1874)). However, “a mere failure to come forward with facts that would provide the plaintiff with a basis for suit does not constitute fraudulent concealment.” Id. The Court has not located any caselaw applying this doctrine to a petition for compensation brought pursuant the Vaccine Act, nor do Petitioners cite cases on the matter of whether it applies in this context. Petitioners argue that the Special Master misapplied the legal standard on a motion to dismiss by disregarding several of their factual assertions “simply because she didn’t believe them.” ECF No. 36-1 at 10. As an example, they note their allegation that W.J. has been unable to communicate for much of his life and is cerebrally incapacitated, which prevented them from fully assessing his injury from the MMR vaccine in time to file a claim. Id. at 14–15. They also reference at length the facts surrounding the Omnibus Autism Proceeding (“OAP”) as evidence that Respondent concealed the link between the MMR vaccine and autism, which they assert discouraged them from filing a claim. Id. at 15–18. The Special Master ultimately rejected their arguments on equitable tolling, finding that “W.J.’s ‘mental incapacity’ does not serve as ‘an extraordinary circumstance,’” ECF No. 29 at 16, and that the fraudulent concealment claim failed due to lack of evidence, id. at 18. Petitioners point to the Special Master’s statement that she formed “inferences from the available evidence” as an example of her alleged legal error because, according to Petitioners, “[e]vidence should not be a factor” when determining whether a party states a viable claim for relief at the pleadings stage. ECF No. 36-1 at 11. 15 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 16 of 21 The record reflects that the Special Master acted in accordance with law in dismissing Petitioners’ equitable tolling arguments. The basis for Petitioners’ disagreement on this issue apparently stems from a misunderstanding of the role of a special master in ruling on a motion to dismiss. When determining if a petition states a viable claim for relief, special masters are not bound to accept legal conclusions as true. Only well-pleaded facts are presumed to be true. See Hill v. Sec’y of Health & Hum. Servs., No. 19-384V, 2020 WL 7231990, at *2 (Fed. Cl. Spec. Mstr. Nov. 13, 2020) (citing Papasan v. Allain, 478 U.S. 265, 286 (1986)); United Pac. Ins., 464 F.3d at 1327–28. A petition need only state a plausible claim for relief to survive a motion to dismiss, and special masters are tasked with applying the law to the pleaded facts to determine whether a case should move forward. Iqbal, 556 U.S. at 678. Although Petitioners may have alleged that extraordinary circumstances existed because of W.J.’s inability to communicate and that Respondent concealed information by contesting the link between vaccines and autism, the Special Master concluded that the sum of these alleged facts did not as a matter of law warrant equitable tolling. In reaching her decision, she assessed “all inferences from the available evidence” but, as Petitioners fail to note, she did so “in petitioner’s favor.” ECF No. 29 at 15 (emphasis added). First, in considering whether the statute of limitations should be tolled because of extraordinary circumstances, the Special Master rejected Petitioners’ arguments because—as a minor—the law required W.J.’s parents to file a claim on his behalf regardless of his mental capacity. The Special Master distinguished the circumstances of the instant case from those presented in K.G. In K.G., the Federal Circuit held that equitable tolling may apply in a case involving a vaccine injury suffered by an adult claimant who subsequently became incapacitated due to alcoholism, hospitalization, and amnesia. K.G., 951 F.3d at 1379. The Special Master 16 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 17 of 21 explained that, although 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.” ECF No. 29 at 16 (citing K.G., 951 F.3d at 1379). Put another way, the Special Master accepted Petitioners’ facts as true—that W.J. had a mental incapacity—but still concluded that these facts did not amount to extraordinary circumstances under the legal principles elucidated in K.G. because Petitioners retained the right to sue on his behalf. See id. This is not an erroneous application of the standard of review for a motion to dismiss pursuant to RCFC 12(b)(6). Petitioners argue that an injured party’s relationship to their legal guardian is only one factor to be considered under the extraordinary circumstances analysis. ECF No. 36-1 at 15 (citing K.G., 951 F.3d at 1382). According to Petitioners, even if they were required to sue on W.J.’s behalf, they were unable to because his mental capacity and inability to communicate interfered with their ability to assess the basis of the claim. Id. Petitioners correctly state the law but, as Respondent noted in its Rule 4(c) Report, the Special Master must “analyze[] the facts to determine whether [the] legal guardianship alleviated the extraordinary circumstance” of the petitioner’s mental incapacity. ECF No. 15 at 9 (quoting K.G., 951 F.3d at 1381). In this case, even though Petitioners attempt to thread their argument through W.J.’s speech delay, the Special Master considered all facts in the record and found that this did not amount to extraordinary circumstances. See K.G., 951 F.3d at 1382 (“[T]he reasonable diligence inquiry must also be based on a consideration of all relevant facts and circumstances.” (emphasis added)). The Special Master found that, as in any vaccine case involving a child, “[t]he Vaccine Act expressly permits a legal representative to file a petition for compensation on behalf of a minor,” and W.J.’s injuries objectively manifested prior to the expiration of the statute of limitations. ECF No. 29 at 16. Given the “great deference” afforded to the Special Master in applying the law to the facts of the 17 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 18 of 21 case, the Court does not find that her ruling on extraordinary circumstances (or the lack thereof) was arbitrary and capricious. Munn, 970 F.2d at 870. Second, in considering whether the statute of limitations should be tolled under the doctrine of fraudulent concealment, the Special Master rejected Petitioners’ arguments because the facts (accepted as true) did not demonstrate how the alleged fraud prevented them from seeking compensation. Petitioners argued that Respondent “fostered and promoted the scientific finding” that there is no link between the MMR vaccine and autism. ECF No. 1 ¶ 100. Petitioners assert that they included “hard evidence of a link between vaccines and autism” in the form of recent cases involving families who obtained compensation for their child’s autism on the basis of a vaccine injury. ECF No. 36-1 at 12. But the framing of this narrow issue is important. For purposes of the Motion to Dismiss, the relevant question before the Special Master was not whether there is a link between vaccines and autism. The relevant question was whether Petitioners alleged facts demonstrating they were misled by Respondents such that equitable tolling is appropriate because Respondent engaged in fraud. See Holmberg v. Armbrecht, 327 U.S. 392, 396–97 (1946) (noting that fraudulent concealment requires the claimant be misled “without any fault or want of diligence”). Accepting the pleaded facts as true, the Special Master observed that during the period in which Petitioners contended they were misled by Respondent, over 5,100 petitions alleging that vaccines caused autism were filed under the Vaccine Act in the OAP. ECF No. 29 at 19. In other words, their argument was significantly undercut by the fact that Respondent’s position to the contrary did not dissuade or prevent thousands of other claimants with similar claims from filing suit. Fraud also typically requires a showing of intent on behalf of the defrauder to make a false or misleading statement. See XpertUniverse Inc. v. Cisco Sys., Inc., 597 F. App’x 630, 635 (Fed. 18 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 19 of 21 Cir. 2015). The fact that a special master awarded compensation, or Respondent agreed to settle, a vaccine-related injury claim involving autism does not raise such an inference. Indeed, the Petitioner disavowed any allegation that Respondent engaged in intentional fraud. ECF No. 1 ¶ 103. Based on these facts, as well as evidence that the first symptom or onset of W.J.’s injury occurred at the earliest in 2006 (again, accepting Petitioners’ allegations as true), the Special Master properly concluded that Petitioners had sufficient time both before and after the OAP to seek compensation.3 Id. Lastly, the Court need only briefly address Petitioners’ arguments regarding the Fourteenth Amendment.4 Petitioners claim that denying equitable tolling in this case would be discriminatory against W.J. on the basis of his disability because courts have not denied such relief to other individuals who suffered from drug- and alcohol-based mental incapacity (for example, in K.G.).5 ECF No. 1 ¶ 114. The Special Master disagreed, holding that Petitioners—who as W.J.’s parents had the right and responsibility to seek compensation on his behalf—did not demonstrate they were members of a protected class of persons. ECF No. 29 at 20. Moreover, the Special Master correctly noted that the Vaccine Act’s limitations period does not establish any classifications 3 In their response to the Motion to Dismiss, Petitioners argued that they did not discover Respondent’s fraud until they received W.J.’s genetic testing results in March 2019 and were put on notice of the potential claim. Pet’rs’ Mem. of Law in Opp’n to Resp’t’s Mot. to Dismiss at 17, ECF No. 22. The Special Master correctly characterized this argument as raising the discovery rule. ECF No. 29 at 17. She also correctly rejected it. The Federal Circuit made clear in Cloer that a claim under the Vaccine Act accrues when the first symptom or manifestation of onset occurs, not when the petitioner learned of the alleged cause of his or her injury. 654 F.3d at 1338. 4 Although Petitioners listed an objection based on this ground, they did not include any substantive argument in their Motion for Review. 5 It should be noted that the Federal Circuit did not hold that equitable tolling in fact applied in K.G.’s case. Rather, the Court remanded the case to the special master “to consider all of the relevant facts in the first instance, with the purposes of the Vaccine Act in mind,” “under the standard set out in this opinion.” K.G., 951 F.3d at 1382. 19 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 20 of 21 (suspect or otherwise) but rather treats all vaccine-injury claimants equally. Id. (citing Cloer v. Sec’y of Health & Hum. Servs., 85 Fed. Cl. 141, 151–52 (2008), rev’d on other grounds, 603 F.3d 1341. Whether a claimant has established that equitable tolling applies is likewise not dependent on any particular classification of claimants. See K.G., 951 F.3d at 1382. That the Special Master found the facts and circumstances of this case not to warrant equitable tolling and to be distinguishable from K.G. does not amount to an equal protection violation. Petitioners’ argument on review is squarely a disagreement with the Special Master’s application of the established case law. The Special Master did not “disbelieve” pleaded facts on this point; she merely rejected Petitioners’ interpretation of the law. Id. In sum, the Court finds that the Special Master correctly applied the legal standard for a motion to dismiss under RCFC 12(b)(6) in denying equitable tolling of Petitioners’ claims. Thus, there is no cause for reversal on this ground. C. Any Merits-Type Rulings Do Not Provide a Basis to Set Aside the Decision. Petitioners’ final objection relates to the scope of the Special Master’s decision. They claim the Special Master went beyond the stated grounds of the Motion to Dismiss (i.e., the statute of limitations question) by finding that Petitioners had not proven their factual allegations of injury. ECF No. 36-1 at 9–10. The Court agrees with Respondent that to the extent the Special Master made rulings on the merits of Petitioners’ underlying claims, those rulings did not serve as a basis for her dismissal decision. See ECF No. 39 at 14. Rather, the decision repeatedly held that—even if Petitioners were able to establish their claims—the Petition was time-barred and that no equitable tolling applied. See ECF No. 29 at 12–13, 14, 15, 16, 18. And it in no uncertain terms concluded that the case must be “dismissed for failure to timely file the petition within the statute of limitations.” Id. at 21. Accordingly, as the rulings were not necessary to the Special Master’s 20 Case 1:21-vv-01342-KCD Document 43 Filed 07/07/22 Page 21 of 21 statute-of-limitations analysis and did not affect the stated basis for dismissal, Petitioners have not shown that any legal error resulted.6 IV. CONCLUSION For the reasons set forth above, Petitioners have not shown that the Special Master’s decision dismissing their claims on the basis of the statute of limitations was arbitrary and capricious, an abuse of discretion, or otherwise not in accordance with law. Accordingly, the Special Master’s decision is affirmed, and Petitioners’ Motion for Review (ECF No. 36) is DENIED. Under Vaccine Rule 30(a), the Clerk is directed to enter judgment accordingly. SO ORDERED. Dated: June 21, 2022 /s/ Kathryn C. Davis KATHRYN C. DAVIS Judge 6 As such, the Court need not address whether the substance of these rulings were arbitrary and capricious because such a determination would not save Petitioners’ otherwise untimely claims. 21