VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_09-vv-00453 Package ID: USCOURTS-cofc-1_09-vv-00453 Petitioner: Jeremy Hodge Filed: 2009-07-15 Decided: 2023-10-27 Vaccine: hepatitis B Vaccination date: 2006-03-17 Condition: significant aggravation of preexisting neuroborreliosis Outcome: denied Award amount USD: AI-assisted case summary: Jeremy Hodge, born in 1987, filed a petition on July 15, 2009, through counsel Clifford Shoemaker, who filed the petition within 48 hours of being contacted by Mr. Hodge's mother and conservator, Erika Elson. The petition acknowledged a potential statute of limitations issue. Mr. Hodge alleged that hepatitis A and hepatitis B vaccinations administered on March 17, 2006, and a second hepatitis B dose on April 25, 2006, had caused or significantly aggravated his neurological condition. Mr. Hodge's background was complex. Around 2003, he was bitten by a tick and subsequently developed progressive fatigue, headaches, obsessive-compulsive disorder, and cognitive disturbances. By September 2004, his OCD symptoms were documented. He dropped out of school in the eleventh grade due to his symptoms, had never been employed, and was largely dependent on his mother. By 2007, evaluators identified possible nonspecified psychosis in addition to OCD, and he was described as unable to make a cogent medical history at emergency room visits. On the night of March 17, 2006, after his first hepatitis B vaccination, he experienced hot flashes, chills, and stabbing pains. On June 2, 2006, he was evaluated at Valley Presbyterian Hospital for dizziness, eye movement disturbances, balance issues, fatigue, and pain; his discharge diagnoses included dizziness and arthralgias-myalgias status post hepatitis vaccination. He did not obtain an MRI until February 2009, which revealed white matter hyperintensities consistent with possible demyelinating disease. The first phase of the case addressed the statute of limitations. Special Master Moran dismissed the petition on March 23, 2015, finding the claim untimely because the first symptoms appeared on June 2, 2006, more than 36 months before the July 15, 2009 filing. He rejected equitable tolling, characterizing petitioner's condition as OCD. The Court of Federal Claims, Judge Sweeney, vacated and remanded in September 2015, finding that the special master had substantially mischaracterized and minimized the medical records documenting the severity of petitioner's mental illness — including repeated diagnoses of nonspecified psychosis, possible schizoaffective disorder, inability to function independently, and near-total dependence on his mother. On remand, Special Master Moran issued a ruling on December 21, 2015, applying a stop-clock approach to equitable tolling and finding that Mr. Hodge was incapable of managing his own affairs from July 2007 through September 2008, a period sufficient to render the filing timely. The special master also directed the parties to brief whether the California Probate Court should appoint a guardian or conservator for Mr. Hodge, recognizing that any compensation would likely require a court-appointed representative to receive funds. In subsequent proceedings, Erika Elson was appointed conservator by the California Probate Court, and Renée Gentry of the Vaccine Injury Clinic at George Washington University Law School substituted as counsel. Petitioner's theory was reformulated as a significant aggravation claim under the Loving test: a tick bite in approximately 2003 caused Lyme disease, which progressed to neuroborreliosis, which in turn caused OCD; the hepatitis B vaccinations in 2006 then significantly aggravated the underlying neuroborreliosis. Petitioner's expert, Dr. Carlo Tornatore, opined that neuroborreliosis was a plausible diagnosis and that the vaccine may have aggravated the underlying autoimmune demyelinating disorder. An entitlement hearing was held on June 14-15, 2021, after years of record-gathering efforts were hampered by the absence of contemporaneous medical records from the critical 2003-2006 period. Special Master Moran denied entitlement on September 12, 2022. He identified two overarching problems: (1) the absence of medical records during the critical timeframes, and (2) the inconsistency of Ms. Elson's testimony, which she had provided many years after the relevant events. The primary failure was that petitioner had not established by preponderant evidence the predicate factual assumption underlying Dr. Tornatore's opinion — that Mr. Hodge had contracted Lyme disease before his 2006 vaccinations. The evidence supported a Lyme disease diagnosis only from 2009. Without that predicate, the expert's theory was built on an unestablished foundation, requiring denial under Burns v. Secretary of HHS, 3 F.3d 415 (Fed. Cir. 1993). The Court of Federal Claims, Judge Sweeney, granted the motion for review in March 2023, setting aside the special master's finding that Mr. Hodge had not contracted Lyme disease in 2003, and finding affirmatively that tick exposures and Lyme disease predated Mr. Hodge's OCD symptoms. The court remanded for ninety days for reconsideration of entitlement. On the second remand, Special Master Moran again denied entitlement, finding that petitioner failed to establish a medical theory for how the hepatitis B vaccine can significantly aggravate neuroborreliosis (Loving prong 4) and failed to show a logical sequence of cause and effect (Loving prong 5). The Court of Federal Claims denied the motion for review on October 12, 2023, sustaining the special master's decision and finding that the correct legal standard had been applied throughout. Theory of causation field: Hep A + Hep B vaccines March-April 2006 → alleged significant aggravation of neuroborreliosis/OCD (Loving test). Theory: tick bite 2003 → Lyme disease → neuroborreliosis → OCD; vaccine significantly aggravated. Dr. Tornatore: neuroborreliosis plausible; vaccine may aggravate. SOL issue: equitable tolling found (SM 2015 stop-clock; Hodge incapable July 2007-Sept 2008). Merits: denied Sept 12 2022 (no predicate = Lyme disease pre-2006 not established); CFC March 2023 remand (set aside Lyme finding); second remand denied (Loving prongs 4+5 unmet); CFC Oct 27 2023 AFFIRMED. 14-year case. Dates correct. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_09-vv-00453-0 Date issued/filed: 2015-04-20 Pages: 10 Docket text: PUBLIC DECISION (Originally filed: 03/23/2015) regarding 99 DECISION of Special Master. Signed by Special Master Christian J. Moran. (tpj) Copy to parties. -------------------------------------------------------------------------------- Case 1:09-vv-00453-MMS Document 100 Filed 04/20/15 Page 1 of 10 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS * * * * * * * * * * * * * * * * * * * * * * * * * JEREMY HODGE, * * Petitioner, * No. 09-453V * Special Master Christian J. Moran * Filed: March 23, 2015 v. * * SECRETARY OF HEALTH AND * Statute of limitations; equitable HUMAN SERVICES * tolling; mental illness; * obsessive-compulsive disorder Respondent. * (“OCD”). * * * * * * * * * * * * * * * * * * * * * * * * * Clifford J. Shoemaker, Shoemaker, Gentry & Knickelbein, Vienna, VA, for petitioner; Althea Walker Davis, Unites States Dep’t of Justice, Washington, DC, for respondent. PUBLISHED DECISION GRANTING MOTION TO DISMISS1 In this case under the National Vaccine Injury Compensation Program (“the Program”), Jeremy Hodge seeks compensation for injuries he alleges were caused by hepatitis A and B vaccinations administered on March 17, 2006, and April 15, 2006. The Secretary of Health and Human Services filed a motion to dismiss based on the Vaccine Act’s statute of limitations, 42 U.S.C. § 300aa-16(a)(2). The evidence indicates that Mr. Hodge filed outside the time permitted. Additionally, Mr. Hodge has not established that equitable tolling can be used to correct his untimely filed petition. Accordingly, this case is dismissed as untimely filed. 1 The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002), requires that the Court post this decision on its website. Pursuant to Vaccine Rule 18(b), the parties have 14 days to file a motion proposing redaction of medical information or other information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by the special master will appear in the document posted on the website. Case 1:09-vv-00453-MMS Document 100 Filed 04/20/15 Page 2 of 10 I. FACTUAL AND PROCEDURAL HISTORY A. Mr. Hodge’s Background Mr. Hodge was born in 1987. Exhibit 3. At the time of his birth, Mr. Hodge’s father had attention deficit disorder (ADD), and a grandparent possibly had obsessive-compulsive disorder (OCD). Exhibit 5 at 4. His great-grandfather and grandfather were both diagnosed with bipolar disorder. Exhibit 10 at 2. While on a camping trip to Big Sur, California in approximately 2005, Mr. Hodge was bitten by a tick. Afterwards, he developed progressive fatigue, headaches, OCD, and cognitive disturbances. Exhibit 7 at 22; see also exhibit 5 at 2 (indicating that Mr. Hodge’s OCD commenced at the age of seventeen). On March 17, 2006, Mr. Hodge, who was eighteen years old at the time, was seen by Dr. Rodriguez at the Noble Community Choice Provider Medical Group (“Noble Community”) for consistent headache and sinus pressure. Exhibit 5 at 2- 6. Mr. Hodge’s physical exam was normal, and upon Dr. Rodriguez’s request, Mr. Hodge received hepatitis A and B vaccinations at this visit. Id at 4-7. That night, according to an affidavit filed years later, Mr. Hodge became ill, experiencing hot flashes followed by chills and stabbing pains in his back, legs and arms. Exhibit 9 (Aff. of Erika Olsen) at 2. However, these symptoms dissipated the next day, and Mr. Hodge received his hepatitis B booster vaccination on April 25, 2006. Exhibit 1; exhibit 9. Mr. Hodge was evaluated at Valley Presbyterian Hospital emergency room on June 2, 2006, for complaints of balance issues, dizziness, eye movement disturbances, fatigue, and pain. Exhibit 6 at 1, 7-8. Mr. Hodge’s blood tests and CT scan were normal, and he was diagnosed with dizziness and “arthralgias- myalgias s[tatus] p[ost] hepatitis vaccination.” Id. at 6. His condition on discharge was improving and he was prescribed Meclizine to treat his dizziness. Id. On June 8, 2006, Mr. Hodge’s mother called Noble Community to complain about a neurologist who was unfamiliar with using Zoloft to treat OCD. Exhibit 5 at 4. She also expressed concern for Mr. Hodge’s loss of weight. Id. She indicated that she wanted an MRI, which Dr. Rodriguez later agreed to order. Id. However, an MRI was not performed in 2006 because, according to Mr. Hodge, he 2 Case 1:09-vv-00453-MMS Document 100 Filed 04/20/15 Page 3 of 10 lacked insurance to pay for an MRI. Pet’r’s Memo. In Supp. of Appl. of Equitable Tolling (“Pet’r’s Memo”), filed Jan. 30, 2014, at 10. On August 23, 2006, Mr. Hodge was evaluated at Encino-Tarzana Regional Medical Center for fatigue and numbness. Exhibit 4 at 12-13. At this evaluation, Mr. Hodge reported that these symptoms began intermittently since he received the hepatitis B vaccination four months prior. Id. at 4. After diagnostic tests, he was diagnosed with “diffuse paresthesias” and discharged. Id. at 12-13. On September 9, 2007, Mr. Hodge was evaluated for chest pain, OCD problems, and palpitations at West Hills Hospital and Medical Center. Exhibit 8 at 76. The physician’s notes stated “the mother almost controls the situation and provides the history,” because Mr. Hodge “appears to be unable to make a cogent history” of his condition and symptoms. Id. Mr. Hodge’s mother averred that Mr. Hodge had a long history of OCD and had been taking several psychotropic medications without benefit. Mr. Hodge was reported to have suffered from palpitations since starting to take Dextrostat for possible ADHD. Id. At this visit, Mr. Hodge’s mother maintained that Mr. Hodge had had a significant change in his personality for the past 18 months, which she attributed to the “hepatitis vaccinations.” Id. at 76-77. The evaluating physician stated that Mr. Hodge has an underlying psychological cause for his discomfort and that he has significant impairment due to his OCD. Id. In November 2007, physicians at the San Fernando Valley Community Mental Health Center Transitional Youth Outpatient Program assessed Mr. Hodge. During the evaluation, Mr. Hodge’s OCD symptoms were described in detail. Exhibit 10 at 2-3. Mr. Hodge’s medications included Lithium, Risperdal, and Ativan to control his symptoms with his response being characterized as fair. Mr. Hodge was scheduled to be seen two to three times a week to manage and to reduce his symptoms. Cognitive behavioral therapeutic interventions were designed to be used as part of the treatment. Id. at 59. Between November 2007 and January 2008, Mr. Hodge intermittently attended therapy and then stopped attending therapy at the clinic. Id. at 24, 26, 66. After he discontinued attending therapy on February 4, 2008, Mr. Hodge did not respond to attempts by the clinic to reach him. Id. at 8, 24. As a result, Mr. Hodge was discharged from the therapy at the clinic on September 16, 2008. Id. at 8. 3 Case 1:09-vv-00453-MMS Document 100 Filed 04/20/15 Page 4 of 10 On February 13, 2009, Mr. Hodge was seen in the emergency room at Olive View-UCLA Medical Center (“Olive View”) for chronic headaches with diffuse pain for the past year. Exhibit 7 at 8. Dr. Guzman-Marin ordered an MRI to find the cause of Mr. Hodge’s headaches and to rule out a mass or lesion. Mr. Hodge received this MRI on February 14, 2009. Exhibit 2 at 1-2. Dr. Tho-Anh Hoang, who reviewed the MRI, noted white matter hyperintensities, and suggested a follow-up investigation for suspected demyelinating disease. Id. On May 4, 2009, Mr. Hodge received another MRI of his brain. Exhibit 7 at 210-11. The MRI showed white matter hyperintensities in the periventricular, deep and subcortical white matter regions of the brain. Id. Mr. Hodge’s doctor suspected a demyelinating disease. Id. On August 4, 2009, Mr. Hodge was evaluated by Dr. Mishra, a neurologist at Olive View, for headaches, intermittent arm numbness, arm and back spasms, OCD problems, and bipolar disorder. Exhibit 7 at 45-46. Dr. Mishra ordered an MRI with multiple sclerosis (MS) protocol, multiple blood tests, and a lumbar puncture to determine if Mr. Hodge suffered from either MS, Lyme disease, or encephalitis. Id. The August 11, 2009 MRI showed “demyelinating plaques in the white matter of both hemispheres” of the brain, and strengthened the suspicion of a demyelinating disease. Id. at 65. To further test for Lyme disease, Mr. Hodge was seen by an infectious disease specialist, Dr. Dasher, on October 22, 2009. Exhibit 7 at 23-25. Dr. Dasher stated that Mr. Hodge had a non-specific cognitive disorder and referred Mr. Hodge for neurocognitive and psychological testing. Id. On November 17, 2009, a polymerase chain reaction test of the cerebrospinal fluid was also done to rule out Lyme disease and the result was negative. Id. at 173. Although evidence of Lyme disease had not been found in Mr. Hodge’s cerebrospinal fluid, a follow-up MRI done on April 13, 2010, demonstrated a stable FLAIR2 hyperintense foci in the brain most consistent with a history of Lyme disease. Id. at 132-33. 2 Fluid attenuated inversion recovery; a type of inversion recovery in MRI in which the signal from water is reduced by timing the delay of the inversion pulse. Stedman’s Medical Dictionary 740 (28th ed. 2006). 4 Case 1:09-vv-00453-MMS Document 100 Filed 04/20/15 Page 5 of 10 To further test for MS, on November 17, 2009, a lumbar puncture was done at Olive View. Id. at 174-75. Although the result was consistent with MS, further clinical tests were necessary to confirm the diagnosis. Id. A visual evoked potential study was done on December 23, 2009. The result was not determinative for MS. Exhibit 7 at 27-28. Over the course of the following three years, Mr. Hodge continued to see specialists for his suspected demyelinating disease. During this period, Mr. Hodge continued follow-up visits with the infectious disease clinic. Exhibit 7 at 10-11; exhibit 12 at 56, 61-63, 71. Mr. Hodge continued suffering from his central nervous system symptoms, which were treated with medication. Exhibit 12 at 21, 23-24, 39-45, 54. On August 23, 2013, the doctor whom Mr. Hodge retained in this litigation, Dr. Carlo Tornatore, opined that Mr. Hodge may be suffering from neuroborreliosis, a late manifestation of Lyme disease. Exhibit 18 (Dr. Tornatore’s report) at 2; see also exhibit 12 at 11(stating evidence “could be consistent with Lyme disease”); exhibit 7 at 24 (indicating evidence shows “possible Lyme dz [sic]”). Dr. Tornatore further opined that given the presumptive neuroborreliosis, the vaccine may have aggravated his underlying autoimmune demyelinating disorder. Id. B. Procedural History Represented by Mr. Clifford Shoemaker, Mr. Hodge filed the petition on July 15, 2009, alleging that he suffered “various injuries” after receiving hepatitis A and hepatitis B vaccinations in March and April of 2006. Pet. at 2, 5-6. The petition did not define the injuries for which Mr. Hodge was seeking compensation. The petition acknowledged a potential statute of limitations problem. Pet. at 2. In the initial status conference on September 3, 2009, the Secretary raised the statute of limitations problem and consistently reminded Mr. Hodge about this problem. Nevertheless, Mr. Hodge pressed forward. Between November 2009 and January 2012, Mr. Hodge filed medical records (exhibits 1-8, 10-12) and an affidavit from his mother (exhibit 9) in support of his claims, which are summarized above. Mr. Hodge did not submit an affidavit from himself. After Mr. Hodge appeared to have filed most of the relevant medical records, the Secretary filed a Rule 4 report and motion to dismiss the petition on 5 Case 1:09-vv-00453-MMS Document 100 Filed 04/20/15 Page 6 of 10 April 30, 2012. The Secretary contended that Mr. Hodge explained his symptoms but did not state a specific injury with a specific date of onset that resulted from the March and April 2006 vaccinations. Resp’t’s Mot. to Dismiss at 13, 18. Further, the Secretary contended that the petition was untimely because Mr. Hodge experienced various symptoms prior to July 15, 2006, 36 months before the petition was filed. Id. Mr. Hodge filed several motions for enlargement of time that were granted. Mr. Hodge filed more medical records on January 4, 2013 (exhibits 13-14), and again on June 25, 2013 (exhibits 15-17). During the status conferences, the Secretary continued to question the reasonable basis for this claim. See order dated June 27, 2013. On August 23, 2013, Mr. Hodge filed an export report from Dr. Tornatore. Exhibit 18 at 2. Dr. Tornatore opined that “the diagnosis of neuroborreliosis would not be unreasonable.” Id. Furthermore, Dr. Tornatore explained that the medical records show that the neuroborreliosis began in 2005. Id. at 2 (citing exhibit 12 at 11, 245-47; exhibit 7 at 22, 172-75, 204-05, 209, 213). Dr. Tornatore also maintained that Mr. Hodge’s dizziness and eye movement disturbances on June 2, 2006, evidenced a worsening of his “underlying autoimmune demyelinating disorder.” Id. Although Dr. Tornatore’s report filled some medical gaps in Mr. Hodge’ evidence, Mr. Hodge had not responded to the legal arguments in the Secretary’s motion to dismiss. On January 30, 2014, Mr. Hodge filed his memorandum, in which he argued that the running of the statute of limitations should be tolled because none of Mr. Hodge’s medical providers associated his symptoms with a vaccine injury. Pet’r’s Memo. at 1-2. Because of that fact, Mr. Hodge contended that he and his mother were duly diligent in pursuing his Program rights, but lacked a good faith basis to file a claim within three years of the onset of Mr. Hodge’s injury. Id. at 2. Mr. Hodge argued that his claim should be allowed under a “discovery rule,” under which the cause of action did not accrue until he had evidence that his vaccination could have potentially caused his injury. Id. at 4. On May 9, 2014, the Secretary filed a response to petitioner’s January 30, 2014 memorandum. The Secretary argued that this case does not merit equitable tolling because the Vaccine Act does not contain a discovery rule. Resp’t’s Resp., 6 Case 1:09-vv-00453-MMS Document 100 Filed 04/20/15 Page 7 of 10 filed May 9, 2014, at 1-2, 16 (citing Cloer v. Sec’y of Health & Human Servs., 654 F.3d 1322, 1337 (Fed. Cir. 2011) (en banc)). On October 1, 2014, Mr. Hodge filed a reply, asserting that his severe mental illness constituted an extraordinary circumstance that prevented a timely filing of the claim. Mr. Hodge further argued that he exercised due diligence in pursuing his claim. Thus, he asserted the doctrine of equitable tolling permits his action to continue. Pet’r’s Reply, filed Oct. 1, 2014, at 1-2, 7. With Mr. Hodge’s reply brief, the two issues are ready for adjudication. II. STATUTE OF LIMITATIONS The Vaccine Act limits the time in which a claim may be filed. The Vaccine Act states that In the case of … a vaccine set forth in the Vaccine Injury Table which is administered after October 1, 1988, if a vaccine-related injury occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such injury after the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset or of significant aggravation of such injury. 42 U.S.C. §§ 300aa-16(a)(2). Therefore, to be timely, a petitioner must file a Program petition within 36 months of the presentation of the first symptom of an alleged vaccine-related injury. “[T]he statute of limitations begins to run on a specific statutory date: the date of occurrence of the first symptom or manifestation of onset of the vaccine-related injury recognized as such by the medical profession at large.” Cloer, 654 F.3d at 1340. The cause of action accrues on the date when the first sign or symptom of injury appears, not when a petitioner knew or reasonably should have known about the injury or its cause. Id. at 1338-39. Furthermore, "a discovery rule cannot be read into the Vaccine Act statute of limitations." Id. at 1339. The Federal Circuit stated that equitable tolling under the Vaccine Act due to a petitioner’s “unawareness of a causal link between an injury and administration of a vaccine is unavailable.” Id. at 1345. 7 Case 1:09-vv-00453-MMS Document 100 Filed 04/20/15 Page 8 of 10 Here, it appears that Mr. Hodge is pursuing a claim that the vaccinations given to him in March and April 2006 significantly aggravated his neuroborreliosis. See exhibit 18 (Dr. Tornatore’s report) at 2.3 Further, Dr. Tornatore identified Mr. Hodge’s dizziness and eye movement disturbances on June 2, 2006, as a worsening of the underlying neuroborreliosis. Id. Because this manifestation occurred more than 36 months before the petition was filed, the case is untimely. Mr. Hodge does not dispute that his petition was not timely filed. Pet’r’s Memo. at 10-11. Mr. Hodge has asked the court to apply the doctrine of equitable tolling to correct his untimely filed petition. Id. at 1. III. EQUITABLE TOLLING According to Cloer, equitable tolling of the statute of limitations may occur in “extraordinary circumstances,” such as when a petitioner is the victim of fraud or duress, or when a procedurally deficient pleading was timely filed. Cloer at 1344-45 (citing Pace v. DiGuglielmo, 544 U.S. 408, 418 (2005); Irwin v. Dep't of Veterans Affairs, 498 U.S. 89, 96 (1990)). Equitable tolling may not apply simply because the statute of limitations deprives a petitioner of his or her claim. Cloer, 654 F.3d at 1344. Mr. Hodge does not allege either that the Secretary employed deception or trickery resulting in Mr. Hodge missing the deadline, or that he filed a defective pleading. Mr. Hodge argues that his mental illness fulfills the requirement of extraordinary circumstances. This is the only argument that warrants extensive discussion.4 3 Mr. Hodge has not amended his July 15, 2009 petition to incorporate information his attorney later obtained. 4 Mr. Hodge argues that the doctrine of equitable tolling should apply to him because he diligently pursued his rights in filing this claim. People pursue their claims diligently when they have filed within the statute of limitations period albeit in a defective manner. See Irwin, 498 U.S. at 96, 111; see also Cloer, 654 F.3d at 1344–45. Mr. Hodge did not file a defective pleading. In addition, Mr. Hodge argues that his family’s lack of insurance did not allow for further testing to diagnose a physiological injury or to allow Mr. Hodge’s medical providers to associate Mr. Hodge’s injuries with the onset of a vaccine injury. Pet’r’s Memo. at 8-11. This argument conflicts with the Federal Circuit’s holding that “equitable tolling under the Vaccine Act due to 8 Case 1:09-vv-00453-MMS Document 100 Filed 04/20/15 Page 9 of 10 In this jurisdiction, Barrett v. Principi established the controlling test for equitable tolling due to mental illness. The Federal Circuit held that one can establish extraordinary circumstance due to mental illness “by showing that [one’s] untimely filing was the direct result of a mental illness that rendered him incapable of rational thought or deliberate decision making, or incapable of handling his own affairs or unable to function in society.” Barrett v. Principi, 363 F.3d 1316, 1321 (Fed. Cir. 2004). The standard means that “a medical diagnosis alone or mere assertions of mental problems will not suffice.” Id.5 Courts should analyze requests for equitable tolling due to mental illness on a “case-by-case basis.” Dixon v. Shinseki, 741 F.3d 1367, 1377 (Fed. Cir. 2014). Mr. Hodge’s argument that his history of mental illness constitutes an extraordinary circumstance for the purposes of equitable tolling is unsubstantiated. As recounted above, Mr. Hodge has been diagnosed with and treated for OCD. He has also been referred for cognitive testing. But, as held in Barrett, “a medical diagnosis alone…will not suffice.” 363 F.3d at 1321. Mr. Hodge must also establish that the “mental illness rendered him incapable of ‘rational thought or deliberate decision making,’ or ‘incapable of handing [his] own affairs or unable to function [in] society.’” Barrett, 363 F.3d at 1321 (citations omitted). Mr. Hodge unawareness of a causal link between an injury and administration of a vaccine is unavailable.” Cloer, 654 F.3d at 1345. In a similar case, the petitioner missed the filing deadline and argued that her preexisting chronic illness and family difficulties constituted an extraordinary circumstance that should warrant equitable tolling. Anderson v. Sec’y of Health & Human Servs., No. 12-016V, 2013 WL 691003, at *4-5 (Fed. Cl. Spec. Mstr. Jan. 29, 2013). The special master ruled that the petitioner’s situation did not satisfy the extraordinary circumstance requirement for equitable tolling. Id. at *5 (citing Irwin, 498 U.S. at 96). 5 The Federal Circuit also stated that when one is represented by counsel, one must also demonstrate that “the mental illness impaired the attorney-client relationship.” Barrett, 363 F.3d at1321 (internal citations and quotations omitted). Mr. Hodge’s attorney, Mr. Shoemaker, has stated that he filed the petition within two days of being contacted by Mr. Hodge’s mother. Pet. at 2. 9 Case 1:09-vv-00453-MMS Document 100 Filed 04/20/15 Page 10 of 10 was given an opportunity to substantiate his claim that his inability to meet the limitations period was a direct result of his mental illness but failed to do so.6 Mr. Hodge acknowledges that when he received the vaccine, he was legally an adult and deemed by his mother to be competent. Pet’r’s Memo. at 8, 10. Furthermore, Mr. Hodge has not presented any evidence showing that he was the ward of a guardian. Id. Mr. Hodge has not satisfied his burden of demonstrating that the Vaccine Act’s statute of limitations should be equitably tolled. Thus, Mr. Hodge did not establish that his mental illness was an extraordinary circumstance that rendered him incapable of rational thought or deliberate decision-making. See Barrett, 373 F.3d at 1321. Nor did Mr. Hodge establish that his mental illness left him incapable of handling his own affairs or unable to function in society. Id. IV. CONCLUSION For the foregoing reasons, Mr. Hodge did not file this action within a time permitted by the statute of limitations. He has not established any circumstances that would justify tolling the statute of limitations on equitable grounds. Thus, the Secretary’s motion to dismiss is GRANTED. IT IS SO ORDERED. s/ Christian Moran. Christian Moran Special Master 6 For examples of cases from other jurisdictions rejecting a claimant’s mental illness as a justification for equitable tolling, see Vazquez-Rivera v. Figueroa, 759 F.3d 44 (1st Cir. 2014); Bartlett v. Dep’t of the Treasury (I.R.S.), 749 F.3d 1 (1st Cir. 2014); Lyons v. Potter, 521 F.3d 981 (8th Cir. 2008); Bove v. Shinseki, 25 Vet.App. 136, 144 (2011). 10 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_09-vv-00453-1 Date issued/filed: 2015-09-30 Pages: 18 Docket text: JUDGE VACCINE REPORTED OPINION reissuing 108 Opinion and Order for publication. Signed by Judge Margaret M. Sweeney. (kb1) -------------------------------------------------------------------------------- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 1 of 18 In the United States Court of Federal Claims No. 09-453V (Filed Under Seal: September 9, 2015) (Reissued for Publication: September 30, 2015)1 ************************************* J.H., * * Petitioner, * * Vaccine Act; Motion for Review; Statute of v. * Limitations; Equitable Tolling; Mental * Illness; Remand SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * ************************************* Clifford J. Shoemaker, Vienna, VA, for petitioner. Althea Walker Davis, United States Department of Justice, Washington, DC, for respondent. OPINION AND ORDER SWEENEY, Judge Petitioner J.H. filed a petition under the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”), 42 U.S.C. §§ 300aa-1 to -34 (2012), alleging that he was injured as a result of his hepatitis A and hepatitis B vaccinations. The special master dismissed the petition, holding that petitioner’s claim was barred by the statute of limitations and was not subject to equitable tolling. In his motion for review, petitioner concedes that his claim is time-barred, but contends that the special master erred in concluding that his mental illness did not warrant the application 1 Vaccine Rule 18(b), contained in Appendix B of the Rules of the United States Court of Federal Claims, affords each party fourteen days in which to object to the disclosure of (1) trade secrets or commercial or financial information that is privileged or confidential or (2) medical information that would constitute “a clearly unwarranted invasion of privacy.” Petitioner timely filed a motion to redact, and respondent filed a response. The court has reviewed the parties’ positions, and has determined that petitioner’s full name and the identities of certain family members–those included in the discussions of petitioner’s family history of mental illness–should not be disclosed in this Opinion and Order. Petitioner’s name is replaced with one or both of his initials, as appropriate, and the identities of his family members are replaced with bracketed ellipses (“[. . .]”). Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 2 of 18 of equitable tolling. For the reasons set forth below, the court grants petitioner’s motion for review and remands the case to the special master for further proceedings. I. BACKGROUND A. Petitioner’s Vaccinations and Subsequent Injuries Petitioner was born in 1987.2 Around 2005, petitioner was bitten by a tick and developed progressive fatigue, headaches, obsessive-compulsive disorder (“OCD”), and cognitive disturbances. On March 17, 2006, when he was eighteen years old, petitioner received a hepatitis A vaccination and his first hepatitis B vaccination. That night, he experienced hot flashes, chills, and stabbing pains in his back, legs, and arms, all of which dissipated the following day. Petitioner received his second hepatitis B vaccination on April 25, 2006. On June 2, 2006, he was evaluated at the Valley Presbyterian Hospital emergency room for balance issues, dizziness, eye movement disturbances, fatigue, and pain. His discharge diagnoses were dizziness and “arthralgias-myalgias [status post] hepatitis vaccination.” Six days later, at the request of petitioner’s mother, one of petitioner’s physicians agreed to order an MRI for petitioner. However, petitioner did not obtain an MRI at that time. In fact, petitioner did not obtain an MRI until February 14, 2009, after he went to the emergency room at Olive View-UCLA Medical Center (“Olive View”) with complaints of chronic headaches and diffuse pain for the past year. The MRI revealed white matter hyperintensities in petitioner’s brain, leading a neurologist to suggest the possibility of a demyelinating disease. Follow-up MRIs obtained on May 4, 2009, and August 11, 2009, strengthened the suspicion of a demyelinating disease. Over the following three years, petitioner continued to receive treatment for his possible demyelinating disease and associated central nervous system symptoms. B. Petitioner’s Mental Illness Petitioner’s medical records reveal a family history of mental illness.3 For example, his [. . .] suffers from attention deficit disorder, Ex. 5 at 2, Ex. 11 at 3, and bipolar disorder, Ex. 11 at 3; Ex. 14 at 521. His [. . .] is a hoarder, Ex. 7 at 37; Ex. 10 at 69; Ex. 14 at 442, and may suffer from depression, Ex. 10 at 69. His [. . .] suffers or suffered from bipolar disorder, id. at 2, 69; 2 The court derives the facts in this section, which pertain to petitioner’s vaccinations and subsequent neurological injuries, from the special master’s March 23, 2015 decision dismissing the case for lack of jurisdiction. See generally J.H. v. Sec’y of HHS, No. 09-453V, 2015 WL 1779274 (Fed. Cl. Spec. Mstr. Mar. 23, 2015). 3 The court derives the facts in this section, which pertains to petitioner’s mental illness, from the medical records and affidavits submitted by petitioner in support of his claims. -2- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 3 of 18 Ex. 14 at 442, 521, schizoaffective disorder, Ex. 10 at 69, and/or anxiety and mood swings, Ex. 7 at 37. His [. . .] suffered from bipolar disorder. Ex. 10 at 2. His [. . .] is or was a hoarder. Id. at 69. And, his [. . .] may have had Wilson disease.4 Ex. 14 at 521. The first reference in petitioner’s medical records to his mental health issues appears in a September 28, 2004 notation by an individual in his pediatrician’s office describing his mother’s report that a psychiatrist had given him a prescription for Adderall. Ex. 3 at 4. Then, sometime before March 21, 2005, petitioner developed OCD and was prescribed Zoloft to treat it. See id. (indicating that petitioner was taking Zoloft as of March 21, 2005); Ex. 5 at 3-4 (noting that Zoloft was used to treat petitioner’s OCD). He was seventeen years old at the time of his OCD diagnosis. Ex. 5 at 2; Ex. 7 at 45-46. Although petitioner’s OCD diagnosis is mentioned in these earlier medical records, it is not until July 2007 that his medical records indicate the full extent of his condition. On July 10, 2007, petitioner was assessed at the West Valley Mental Health Center. The record of that visit includes the following history: OCD: 2 yr hx of taping [sic], touching, counting. Stress [with] environment made it worse. Hx of depression. Took Zoloft (4 wks) made him worse. Prozac made him feel surreal. Racing thoughts [with] counting. No current SI. Not sleeping. Argumentative at times. No good sleeping. Naps during day. Sometimes sleeps too much. Very pale. + psychosis, seeing shadows. “It’s bad air, environmental.” Ex. 11 at 3; see also id. (noting that petitioner had been treated by a private psychiatrist, Dr. John Nassi). A mental status evaluation revealed impaired intellectual functioning, impaired memory, and impaired concentration. Id. at 7. The evaluator, a licensed medical health professional, identified two diagnoses: nonspecified psychosis and OCD. Id. at 8. A physician agreed with the diagnosis of nonspecified psychosis and noted that “OCD [versus] bipolar disorder” should be ruled out. Id. at 14. On September 9, 2007, petitioner went to the emergency room at West Hills Hospital and Medical Center (“West Hills”) with chest pains, heart palpitations, and OCD symptoms. Ex. 8 at 76; accord id. at 61 (noting a history of “severe OCD”). The emergency room physician noted that petitioner appeared incapable of providing his medical history: “The patient is [an] extremely vague historian. The mother almost controls his situation and provides the history. The patient really is less than forthcoming as far as descriptions and appears to be unable to make 4 Wilson disease is “a rare, progressive, autosomal recessive disease due to a defect in metabolism of copper. Accumulation of copper in the liver, brain, cornea, and other tissues results in liver poisoning, with cirrhosis in the liver and degenerative changes in the brain, particularly the basal ganglia.” Dorland’s Illustrated Medical Dictionary 545 (32d ed. 2012). -3- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 4 of 18 a cogent history as far as quality of his discomfort, or length of time.” Id. at 76. With respect to petitioner’s mental health, the physician wrote: The mother says the patient has had a long-standing history of OCD and that his brain is moving so quickly that he is almost paralyzed as far as being able to respond. He has had psychiatric intervention in the past. He was recently started on dextrostat for possible [attention deficit hyperactivity disorder]. . . . . On review the patient currently has been on several other psychotropic medications that . . . did not lead to any real improvement. The mother also relates that the child has had a significant change in his personality over the last 18 months. . . . . . . . . . . This is a 20-year-old gentleman who is having atypical chest pain. He has had this discomfort intermittently for 6 months. . . . I do believe that the patient may have an underlying psychological cause for this discomfort. He clearly has significant impairment due to his OCD. Id. at 76-77; cf. id. at 72-75 (reflecting that petitioner’s mother signed the discharge instructions). But cf. id. at 54-56 (reflecting that petitioner signed the admission paperwork). Beginning in November 2007, and for the following seven months, petitioner was treated at the San Fernando Valley Community Mental Health Center’s Transitional Youth Outpatient Program (“TYOP”). See generally Ex. 10. Petitioner’s initial assessment occurred on November 16, 2007. Id. at 2-7. The following medical history was provided: At age 17, client began to exhibit symptoms consistent with OCD, which included debilitating panic attacks. Client reports that he “counts everything,” to include words spoken, letters in words, scenes from TV. It is reported that anything “associated with a bad number, is contaminated.” Client will not touch anything metal due to “contamination,” and will not speak about his medications, past or present, as this contaminates them. Client engages in repetitive actions, which include his walking back and forth without purpose, and touching things numerous times, or tapping out rhythms in number sequences. Client further chants things in order, and engages in ritualized behaviors around mundane acts, such as brushing teeth, and getting into bed. Client reports intrusive thoughts, which take the form of violent thoughts and images, of “weapons in the air,” violence happening to self or family, and “enemies” in his head.” [sic] It is -4- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 5 of 18 reported that client is “scared of everything.” Client experiences racing thoughts, and paranoia, which is described as his being controlled. Id. at 2; see also id. at 59 (noting that petitioner’s symptoms “began about three yeas ago, and have become increasing[ly] worse over time”). In addition, the following psychiatric history was provided: Client has had no psychiatric hospitalizations, but it is reported that he has been taken to the emergency room of numerous hospitals, in an attempt to try and get him help for his severe symptoms. Client has been seen by private psychiatrists for medications, and also has been seen by private therapists. . . . . It is reported that there has been some improvement in client condition since beginning to take anti-psychotic medications, even though his symptoms persist. Client’s mother states that he has been much worse in the past. Id. at 2; accord id. at 59. At the time of this evaluation, petitioner was taking Risperdal, lithium, and Ativan. Id. at 3. A mental status evaluation revealed no impairments to petitioner’s intellectual functioning and memory, but did reveal issues with concentration. Id. at 6. The evaluator, a therapist, identified a primary diagnosis of OCD, and futher indicated that paranoid schizophrenia and a nonspecified psychotic disorder should be ruled out. Id. at 7, 59. After this initial assessment, petitioner was treated at TYOP by a psychiatrist, Dr. N. Jones, and a therapist, Jennifer West. In her initial evaluation of petitioner on December 7, 2007, Dr. Jones noted the following history: When asked what medications he has been on in past pt had to get up and leave room. Mother explained that pt feels that if we say the name of his medication, he thinks the medication will become contaminated. Pt has numerous counting rituals involving letters and words, and “if certain letters are in a word, he can’t say them”. Dx w OCD 3 yrs ago & this has worsened in the last yr. Pt states he has “very bad panic. Dozens of stuff. Depression. They’re really bad.” States that panic sxs “are really disruptive. It takes up a lot of time. If you want to do an activity, it would disrupt that.” States that he feels SOB, “sweats, heart palpitations, my mind kind of races”. Admits to impending sense of doom, nausea, dizziness. Sxs last for about 20 min. States that there are triggers, but he cannot recall what those are. Gets 5-25 panic attacks per day. Re: paranoia: “That goes along with the panic. You just get really worried about a lot of stuff, like OCD stuff. Images, numbers you gotta count, tapping on objects and walls and tables and chairs, you chant words, stuff really needs to be organized, there’s a lot symmetrical stuff. You can see weapons, bad people doing bad stuff, and -5- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 6 of 18 events that are bad.” States that he believes that images might become true b/c “It seems so real.” When asked about his prolonged latency when answering questions, he admitted to “doing rituals in my head”. “There are voices in my head . . . a couple years. They say bad things.” Admit[s] that they tell him to do bad things, “basically you just don’t listen.” Admits to feeling that “common, random people” are out to “physically harm” him. Id. at 70. With respect to petitioner’s medications, Dr. Jones noted: “In past has been on Zoloft, but developed agitation, racing thoughts & mood [lability]. Also on prozac w similar probs. Had been up to 3 mg a day of risperidone which helped for psychosis but mother felt it caused inc in OCD sxs & sedation.” Id. Dr. Jones provided an assessment of OCD and nonspecified psychotic disorder, and further indicated that schizoaffective disorder and bipolar disorder should be ruled out. Id. at 69. Ms. West began seeing petitioner four days after his initial assessment. Id. at 58. Shortly thereafter, on November 26, 2007, Ms. West indicated that petitioner was experiencing panic attacks five times per week and symptoms of psychosis–including paranoia and feelings of being controlled–daily. Id. at 55. The notes from Ms. West’s sessions with petitioner are replete with comments indicating that petitioner was unable to verbalize his thoughts and that petitioner continued to experience “prominent,” “severe,” and “debilitating” symptoms of anxiety, OCD, and psychosis, including panic attacks, hallucinations, paranoia, delusions, racing thoughts, ritualized behaviors, obsessive counting, repetitive actions, believing that things are contaminated, and depression. See generally id. at 9-57; see also id. at 22 (indicating that on February 15, 2008, petitioner “continued to struggle in producing answers about any activities in the recent past” and admitted “that his memory was poor”), 26 (indicating that on January 28, 2008, petitioner stated that it was “difficult for him to go out, as there [were] many ‘triggers’ to his anxiety”), 30 (indicating that on January 18, 2008, petitioner described his “recent problems as having a ‘sandstorm’ in his mind, adding that it creates problems with focus, memory, and thinking clearly”), 33 (indicating that on January 7, 2008, petitioner admitted not having “much of a sense of what time it is”). Indeed, by June 9, 2008, Ms. West reported that petitioner experienced symptoms of depression five times per week, hallucinations from twenty to thirty times per day, responses to compulsions from ten times per hour to ten times per day, and panic attacks seven times per day. Id. at 12. While attending therapy, petitioner continued to be seen by Dr. Jones. See generally id. at 60-68. Of particular note, Dr. Jones learned during a January 25, 2008 appointment that petitioner’s mother was adjusting petitioner’s medications in response to his varying reactions. See id. at 65 (“Pt is a 20 yo male w severe OCD and psychotic d/o [not otherwise specified] who cont to have depressive, psychotic and obsessive-compulsive sxs in context of mother self- adjusting doses & starting/stopping meds on own.”). In addition, during a February 1, 2008 appointment, Dr. Jones discussed with petitioner and his mother a voluntary admission at UCLA for an inpatient treatment program. Id. at 64. Dr. Jones made the appropriate arrangements with UCLA. Id. at 62, 64. However, on February 15, 2008, an official at UCLA advised Dr. Jones -6- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 7 of 18 that petitioner and his mother declined admission. Id. at 61. Although Dr. Jones and Ms. West discussed the importance of the admission with petitioner and his mother later that day, id. at 21- 22, 61, petitioner was never admitted to UCLA as an inpatient, id. at 17-19, 60. Petitioner’s last appointment at TYOP was on June 23, 2008. Id. at 9. Because the staff at TYOP was unable to reach petitioner or his mother for several months, TYOP discharged petitioner from its care on September 16, 2008. Id. at 8. In the meantime, on March 3, 2008, petitioner visited the emergency room at West Hills to be evaluated for near syncope and vomiting. See generally Ex. 8 at 27-52. His mother provided the relevant information to the emergency room staff, including that petitioner had been diagnosed with OCD. Id. at 32; see also id. at 28-31 (reflecting that petitioner’s mother signed the admission paperwork), 44-46 (reflecting that petitioner’s mother signed the discharge instructions). Then, on December 4, 2008, petitioner was evaluated at the West Hills emergency room for a rash on his left thigh and redness of his right eye. See generally id. at 2-26. Both he and his mother provided the relevant information to the emergency room staff, including that petitioner had psychiatric issues. Id. at 7; accord id. at 25 (noting a past medical history of bipolar disorder); see also id. at 3-6 (reflecting that petitioner initialed, and his mother signed, the admission paperwork), 17-20 (reflecting that petitioner’s mother signed the discharge instructions). As noted above, two months later, petitioner was seen at the Olive View emergency room with complaints of chronic headaches and diffuse pain for the past year. See generally Ex. 7 at 5- 8. Petitioner provided his medical history to the emergency room staff during this February 13, 2009 visit. Id. at 8. After he was discharged from the emergency room, petitioner was seen at Olive View on a regular basis as an outpatient at a number of clinics, including the neurology, infectious disease, and infectious disease-psychiatry clinics. See generally Ex. 7 (containing records dated February 2009 through July 2010), Ex. 12 (containing records dated May 2009 through December 2011), Ex. 14 (containing records dated February 2009 to October 2012). Petitioner had his initial evaluation with Dr. Robert J. Dasher, an Olive View psychiatrist, on October 22, 2009. Ex. 14 at 440. Petitioner reported, among other things, being foggy in his head and having memory issues over the last four to five years, and specifically noted that he could not remember some things that he used to remember. Id. at 441. A mental status examination revealed petitioner’s long-term memory to be impaired. Id. at 446. Dr. Dasher’s principal diagnosis was a nonspecified cognitive disorder, and he indicated that OCD and bipolar disorder should be ruled out.5 Id. at 447. 5 Dr. Dasher’s later diagnoses and assessments included: “mood instability” on January 7, 2010, Ex. 14 at 437; “OCD/bipolar” on August 5, 2010, id. at 426; “psychological and behavioral dysfunction” on September 30, 2010, id. at 422; “organic mania” on October 15, 2010, id. at 405; “organic mood/psychotic disorder” on January 27, 2011, id. at 399; “mania/psychosis” on March 8, 2011, id. at 395; “[v]ery difficult mood, psychotic and anxiety [symptoms]” on September 2, 2011, id. at 54; “an unusual psychiatric presentation with elements -7- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 8 of 18 As part of his initial treatment plan, Dr. Dasher ordered neurocognitive/psychological testing for petitioner. Id. at 440, 447. Petitioner underwent this testing sometime in late 2009. Id. at 29-31. Although the medical records submitted by petitioner do not contain the contemporaneous test results, the results are addressed in a February 2011 medical record discussing the results of retesting. Id.; see also id. at 401-02, 420 (noting that the retesting occurred in January 2011). The February 2011 record revealed the following information regarding the 2009 testing: The patient[’]s scores from psych/neuropsych testing in 2009 were compared to his scores from retesting in 2011 in order to evaluate areas of improvement and decline in cognitive functioning. . . . . In the language domain, a large discrepancy in the negative direction was seen in expressive vocabulary (word knowledge) with an average score in 2009 (50th %ile) but an impaired score in 2011 (<1st %ile). His object naming scores remained stable across time as both were impaired (<1st %ile). This stability was also seen in his scores on receptive vocabulary (hearing a word and choosing a picture that best matches it) which were average (27th %ile and 25th %ile, respectively). In phonemic fluency (generating a list of words that begin with a particular letter), a noticeable discrepancy in the positive direction across time was found between his impaired (1st %ile) score in 2009 and his low average (21st %ile) score in 2011. A similar pattern was found in his score on semantic fluency (generating a list of words belonging to a particular semantic category: animals) which was borderline (4th %ile) in 2009 and average (42nd %ile) in 2011. In the visual-spatial domain, the patient[’]s score in copying a complex figure was in the impaired range (<1st %ile) in both 2009 and 2011. His score in visual acuity/line closure decreased, though not significantly, from the average range in 2009 (42nd %ile) to the low average range in 2011 (23rd %ile). However, his score in 3D visuoconstruction improved somewhat, though not significantly, from a 2009 performance (9th %ile, low average) to 2011 (37th %ile, average). While almost all of the patient[’]s scores in the verbal memory domain were impaired in both assessments, the exception was his free recall score on a of both mania and psychosis” on October 7, 2011, Ex. 12 at 19; and “organic mood disorder” and “bouts of depression” on July 11, 2012, Ex. 14 at 105. In addition, Dr. Dasher noted on January 7, 2010, January 28, 2010, and July 11, 2012, that he could not rule out bipolar disorder. Id. at 105, 434. He further noted on July 11, 2012, that schizophrenia was unlikely. Id. at 105. -8- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 9 of 18 word list after being administered an interference list, where he showed significant improvement over time (<1st %ile/impaired in 2009; 25th %ile/average in 2011). A mixed pattern was found in the visual memory domain. Most of the patient’s scores were in the impaired range in both 2009 and 2011. However, his recognition of simple geometric figures was average in 2009 (37th %ile), but low average/within normal limits in 2011 (16th %ile) while his recognition of a complex figure in 2009 was impaired (<1st %ile), but low average in 2011 (14th %ile). In the executive functions domain, the patient had impaired scores at both times on behavioral inhibition, mental flexibility, complex problem solving, working memory, sustained attention/concentration, and learning from feedback. However, notable improvements were seen in both phonemic/letter and semantic/animals verbal fluency; his 2009 letters score was impaired (1st %ile), but improved to the low average range (21st %ile) in 2011. His semantic fluency score was borderline (4th %ile) in 2009, but average (42nd %ile) in 2011. Id. at 29-30. Overall, Dr. Dasher’s records reflect most of the same symptoms and the same severity of those symptoms that were reported in TYOP’s records. See, e.g., id. at 29-31, 54, 83, 90-93, 95-97, 100, 102-07, 395, 399, 401-10, 412-20, 422, 425-26, 431, 434, 437, 441-47, 489- 92, 506, 526-29; Ex. 7 at 14, 17, 20, 37; Ex. 12 at 3-4, 12-13, 17-20, 26, 33-34. Indeed, Dr. Dasher reported on December 9, 2011, that petitioner was “starting to stabilize from [a] very difficult several year course” of behavioral issues and psychosis. Ex. 12 at 4. In addition to the above diagnoses and assessments, the medical records reflect that petitioner experienced issues in other aspects of his life. For example, petitioner dropped out of school in eleventh grade due to his debilitating symptoms. See, e.g., Ex. 10 at 5 (“Client has completed the 10th grade, having stopped attending school due to the onset of symptoms, and anxiety so debilitating, he was unable to do the work necessary to stay in school.”); Ex. 14 at 443 (indicating that petitioner reported dropping out of school in eleventh grade due to confusion and an inability to think clearly). In addition, petitioner had no work history as of July 10, 2007, Ex. 11 at 6, and was unable to work as of October 22, 2009, Ex. 14 at 447; accord Ex. 12 at 18 (indicating that petitioner remained unable to work as of October 7, 2011). Moreover, Ms. West advised petitioner on November 28, 2007, that given his symptoms, it was not appropriate for him to become involved in activities with people his age. Ex. 10 at 52. An affidavit executed by petitioner’s mother on September 29, 2014, is consistent with the information contained in petitioner’s medical records. See Ex. 19. She reported that within one year of the tick bite, petitioner began exhibiting OCD symptoms and complaining of “spaciness and fogginess in his brain.” Id. at 1. Nevertheless, she explained, petitioner remained -9- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 10 of 18 active and social. Id. However, once petitioner received his hepatitis B vaccination in March 2006, his condition changed. Id. Petitioner’s mother reported: After the March 2006 shot . . . it was night and day. It was like he got hit by a bus. He got very very ill within the month after the shot. He deteriorated rapidly. . . . He had severe pain shooting up and down his spine. He was screaming in pain. His eyes were jittery and moving all over the place. This didn’t stop for the next year. He had to drop out of school–his independent study program. After the shot, he couldn’t do anything. Couldn’t do any of the things he loved. My son was wiped clean. Like his brain was scrambled. Within 6 months he declined rapidly. He didn’t know who he was. He forgot his past. . . . He was completely dependent on me. He couldn’t cook. I picked out his clothes. He could dress himself but could not bathe himself. . . .6 During that time J. never went to a doctor’s appointment by himself. He couldn’t drive himself. He still can’t drive. At those first doctor’s appointments right after the shot he was terrified and scared. He would tell them his symptoms but then as it progressed he stopped talking to the doctors. I communicated for him. It was too difficult for him. He couldn’t ask questions. He couldn’t process what doctors told him, or what anyone told him. He couldn’t follow them. Eventually, in the last couple of years he has been able to talk to his psychiatrist but he still insists I’m right there with him in appointments. He still has trouble following what people are saying and instructions. I administered all of his medications. I still do. The side effects of his medications make it hard for him to interact as well. I do all of his daily living things like cooking and laundry and driving. It’s difficult to get him in the shower. He will try to bathe himself but he doesn’t do a good job. I would describe him during those years of 2006 after the shot to 2009 as being completely mentally disabled. Completely incapacitated. It was like he reverted to childhood functionality. He couldn’t make decisions. Even simple decisions. If you asked him what he wanted to eat he would sit and stare. He couldn’t engage in any meaningful way. He was completely dependent on me. He is still completely dependent on me. Id. at 1-2 (footnote added); see also Ex. 7 at 46 (noting, in the record of an August 4, 2009 neurological evaluation, the following: “Pt was normal prior to age of 17, abrupt onset OCD-like 6 The first line of the second page of the affidavit is cut off and illegible. -10- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 11 of 18 behavior (counting, checking, etc) over 1 month, then onset of a mental ‘fogginess’/’detached from reality’ of [sic] insidious onset that has since waxed and waned with periods of ‘normalcy.’ By the age 19, mother states he has never been back to baseline psych level.”). C. Procedural History Petitioner filed his Vaccine Act petition on July 15, 2009, alleging injuries resulting from his hepatitis A and hepatitis B vaccinations.7 Although petitioner acknowledged that there might be a statute of limitations issue, he pursued his claim over the next four-and-one-half years by filing medical records. On April 30, 2012, after petitioner filed most of the relevant medical records, respondent filed her report pursuant to Vaccine Rule 4, which included a motion to dismiss the petition. In her motion to dismiss, respondent argued that the petition was untimely under the Vaccine Act because petitioner experienced symptoms of his injuries more than thirty- six months before filing the petition. On August 23, 2013, petitioner submitted an expert report from Dr. Carlo Tornatore. Dr. Tornatore opined that based on the medical records, a diagnosis of neuroborreliosis–a late manifestation of Lyme disease–“would not be unreasonable,” that the “neuroborreliosis began in 2005,” and that petitioner’s June 2, 2006 symptoms reflected a worsening of his “underlying autoimmune demyelinating disorder.” Five months later, petitioner filed a memorandum in response to the motion to dismiss in which he argued that the statute of limitations should be equitably tolled because despite his and his mother’s diligent efforts, extraordinary circumstances prevented him from filing a Vaccine Act petition within the thirty-six month limitations period. Respondent submitted a response to petitioner’s memorandum on May 9, 2014, and petitioner filed a reply on October 1, 2014. In a March 23, 2015 decision, the special master concluded that the petition was not timely filed and that petitioner had not established that the statute of limitations should be equitably tolled. He therefore granted respondent’s motion to dismiss. Petitioner timely filed a motion for review, and respondent submitted her response. The court heard argument on September 3, 2015, and is prepared to rule. II. DISCUSSION The United States Court of Federal Claims possesses jurisdiction to review the record of the proceedings before a special master, and upon such review, may: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision, 7 The court derives the procedural history in this section from the special master’s March 23, 2015 decision, J.H., 2015 WL 1779274, and the parties’ filings. -11- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 12 of 18 (B) set aside any findings of fact or conclusion 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. 42 U.S.C. § 300aa-12(e)(2); accord Vaccine Rule 27(c). In the instant case, petitioner contends that the special master both abused his discretion by substantially mischaracterizing his condition and acted contrary to law in applying the doctrine of equitable tolling to his circumstances. An abuse of discretion occurs when a “decision is based on clearly erroneous findings of fact, is based on erroneous interpretations of the law, or is clearly unreasonable, arbitrary or fanciful.” Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1460 (Fed. Cir. 1998) (en banc); accord Hendler v. United States, 952 F.2d 1364, 1380 (Fed. Cir. 1991) (“An abuse of discretion may be found when (1) the court’s decision is clearly unreasonable, arbitrary, or fanciful; (2) the decision is based on an erroneous conclusion of the law; (3) the court’s findings are clearly erroneous; or (4) the record contains no evidence upon which the court rationally could have based its decision.”), quoted in Murphy v. Sec’y of HHS, 30 Fed. Cl. 60, 61 (1993). It is well settled that under this standard, the court accords deference to the special master’s factual findings and fact- based conclusions. See, e.g., Whitecotton v. Sec’y of HHS, 81 F.3d 1099, 1108 (Fed. Cir. 1996) (“Congress desired the special masters to have very wide discretion with respect to the evidence they would consider and the weight to be assigned that evidence.”); Munn v. Sec’y of HHS, 970 F.2d 863, 871 (Fed. Cir. 1992) (emphasizing that “the probative value of the evidence” was within the special master’s purview as fact finder). It is not the court’s role to reweigh the evidence. See Hodges v. Sec’y of HHS, 9 F.3d 958, 961 (Fed. Cir. 1993) (“[O]n review, the Court of Federal Claims is not to second guess the Special Master[’]s fact-intensive conclusions; the standard of review is uniquely deferential for what is essentially a judicial process.”). In contrast, under the “not in accordance with law” standard, the court reviews the special master’s legal conclusions de novo. Saunders v. Sec’y of HHS, 25 F.3d 1031, 1033 (Fed. Cir. 1994). A. The Vaccine Act’s Statute of Limitations and Equitable Tolling Petitioner’s motion for review implicates the Vaccine Act’s statute of limitations. Under the Vaccine Act, a petition for compensation for a vaccine-related injury must be filed within “36 months after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of such injury.” 42 U.S.C. § 300aa-16(a)(2). The special master concluded that petitioner’s complaint was not timely filed because his claim–the significant aggravation of his neuroborreliosis–accrued no later than June 2, 2006, when he visited the Valley Presbyterian Hospital emergency room with dizziness and eye movement disturbances. Petitioner does not contest that conclusion. Rather, petitioner argues that the statute of limitations should be equitably tolled due to his mental illness. -12- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 13 of 18 The Vaccine Act’s statute of limitations can be equitably tolled. Cloer v. Sec’y of HHS, 654 F.3d 1322, 1344 (Fed. Cir. 2011) (en banc). “Generally, a litigant seeking equitable tolling bears the burden of establishing two elements: (1) that he has been pursuing his rights diligently, and (2) that some extraordinary circumstance stood in his way.” Pace v. DiGuglielmo, 544 U.S. 408, 418 (2005), cited in Cloer, 654 F.3d at 1344. The application of equitable tolling should be considered on a case-by-case basis, and a rigid invocation of mechanistic rules should be avoided. Holland v. Florida, 560 U.S. 631, 649-50 (2010); accord Arctic Slope Native Ass’n v. Sebelius, 699 F.3d 1289, 1295 (Fed. Cir. 2012). Overall, however, federal courts apply the equitable tolling doctrine “sparingly.” Irwin v. Dep’t of Veterans Affairs, 498 U.S. 89, 96 (1990), cited in Cloer, 654 F.3d at 1344. Although the United States Supreme Court has not addressed whether a statute of limitations can be equitably tolled due to mental illness, a number of federal appellate courts have concluded, in cases not involving the Vaccine Act, that equitable tolling is available in such circumstances. See Barrett v. Principi, 363 F.3d 1316, 1318-20 (Fed. Cir. 2004). For example, in Barrett v. Principi, the United States Court of Appeals for the Federal Circuit concluded that the 120-day period for appealing a decision of the Board of Veterans’ Appeals can be equitably tolled due to mental illness. Id. at 1317-21. It held: [T]o obtain the benefit of equitable tolling, a veteran must show that the failure to file was the direct result of a mental illness that rendered him incapable of “rational thought or deliberate decision making,” or “incapable of handling [his] own affairs or unable to function [in] society.” A medical diagnosis alone or vague assertions of mental problems will not suffice. Id. at 1321 (citations omitted). The special master applied the standard set forth in Barrett in analyzing petitioner’s equitable tolling argument.8 J.H., 2015 WL 1779274, at *6. B. The Special Master’s Characterization of Petitioner’s Condition Does Not Comport With the Medical Records Petitioner argues that the special master substantially mischaracterized his mental health condition in his decision, asserting that his medical records reflect a much more serious and complex condition than the OCD diagnosis noted by the special master. As explained below, petitioner is correct. 8 Although respondent emphasizes the fact that Barrett does not concern the Vaccine Act, neither she nor petitioner seeks review of the special master’s application of the standard set forth in Barrett to petitioner’s circumstances. And, as explained below, this case is being remanded to the special master for a full evaluation of the medical evidence presented by petitioner. Accordingly, the issue of whether the Barrett standard should be applied in Vaccine Act cases is not before the court. -13- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 14 of 18 1. The Special Master’s Recitation of the Facts Relating to Petitioner’s Mental Illness The special master included the following information regarding petitioner’s mental health condition in his recitation of facts: At the time of his birth, Mr. H.’s [. . .] had attention deficit disorder (ADD), and a [. . .] possibly had obsessive-compulsive disorder (OCD). Exhibit 5 at 4. His [. . .] and [. . .] were both diagnosed with bipolar disorder. Exhibit 10 at 2. While on a camping trip to Big Sur, California in approximately 2005, Mr. H. was bitten by a tick. Afterwards, he developed progressive fatigue, headaches, OCD, and cognitive disturbances. Exhibit 7 at 22; see also exhibit 5 at 2 (indicating that Mr. H.’s OCD commenced at the age of seventeen). . . . . On June 8, 2006, Mr. H.’s mother called Noble Community to complain about a neurologist who was unfamiliar with using Zoloft to treat OCD. Exhibit 5 at 4. . . . . . . . On September 9, 2007, Mr. H. was evaluated for chest pain, OCD problems, and palpitations at West Hills Hospital and Medical Center. Exhibit 8 at 76. The physician’s notes stated “the mother almost controls the situation and provides the history,” because Mr. H. “appears to be unable to make a cogent history” of his condition and symptoms. Id. Mr. H.’s mother averred that Mr. H. had a long history of OCD and had been taking several psychotropic medications without benefit. Mr. H. was reported to have suffered from palpitations since starting to take Dextrostat for possible ADHD. Id. At this visit, Mr. H.’s mother maintained that Mr. H. had had a significant change in his personality for the past 18 months, which she attributed to the “hepatitis vaccinations.” Id. at 76-77. The evaluating physician stated that Mr. H. has an underlying psychological cause for his discomfort and that he has significant impairment due to his OCD. Id. In November 2007, physicians at the San Fernando Valley Community Mental Health Center Transitional Youth Outpatient Program assessed Mr. H. During the evaluation, Mr. H.’s OCD symptoms were described in detail. Exhibit 10 at 2-3. Mr. H.’s medications included Lithium, Risperdal, and Ativan to control his symptoms with his response being characterized as fair. Mr. H. was scheduled to be seen two to three times a week to manage and to reduce his symptoms. Cognitive behavioral therapeutic interventions were designed to be used as part of the treatment. Id. at 59. Between November 2007 and January -14- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 15 of 18 2008, Mr. H. intermittently attended therapy and then stopped attending therapy at the clinic. Id. at 24, 26, 66. After he discontinued attending therapy on February 4, 2008, Mr. H. did not respond to attempts by the clinic to reach him. Id. at 8, 24. As a result, Mr. H. was discharged from the therapy at the clinic on September 16, 2008. Id. at 8. . . . . On August 4, 2009, Mr. H. was evaluated by Dr. Mishra, a neurologist at Olive View, for headaches, intermittent arm numbness, arm and back spasms, OCD problems, and bipolar disorder. Exhibit 7 at 45-46. . . . To further test for Lyme disease, Mr. H. was seen by an infectious disease specialist, Dr. Dasher,9 on October 22, 2009. Exhibit 7 at 23-25.10 Dr. Dasher stated that Mr. H. had a non-specific cognitive disorder and referred Mr. H. for neurocognitive and psychological testing. Id. Id. at *1-3 (footnotes added). Comparing this recitation of facts with the contents of the medical records–described earlier in this Opinion and Order, see supra Part I.B–reveals that the special master failed to discuss a number of relevant medical records and gave short shrift to many of the medical records he did address. Specifically, the special master did not mention: (1) petitioner’s July 10, 2007 visit to West Valley Mental Health Center, (2) the repeated diagnosis of a nonspecified psychosis, (3) petitioner’s treaters’ notations that a diagnosis of schizophrenia or schizoaffective disorder needed to be ruled out, (4) Dr. Dasher’s repeated notations that he was unable to rule out a diagnosis of bipolar disorder, a diagnosis that had also been raised by Dr. Jones, (5) the severity of petitioner’s symptoms, (6) the results of petitioner’s 2009 neurocognitive/psychological testing,11 (7) petitioner’s educational and work history, and (8) any evidence of petitioner’s 9 The medical records reflect that Dr. Dasher is a psychiatrist who works in Olive View’s infectious disease-psychiatry clinic. See, e.g., Ex. 7 at 67 (noting that petitioner was being “followed by psychiatry, Dr. Dasher”); Ex. 12 passim (containing records indicating that Dr. Dasher saw petitioner at the infectious disease-psychiatry clinic); Ex. 14 at 447 (containing Dr. Dasher’s name and signature above the line titled “Psychiatrist’s Name and Signature”). 10 Only one of these pages is a record created by Dr. Dasher. Ex. 7 at 23. The other two pages are records created by other physicians in August 2009 and January 2010. Id. at 24-25. The complete set of records from Dr. Dasher’s initial evaluation of petitioner on October 22, 2009, can be found in Exhibit 14 at pages 440 to 447. 11 The court recognizes that this testing occurred sometime between October 22, 2009, and December 31, 2009, after the filing of the petition. Nevertheless, the testing occurred no -15- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 16 of 18 ability or inability to function independently. And, the special master only briefly referred to petitioner’s extensive mental health records from TYOP and Olive View, which include the detailed records of Ms. West’s therapy sessions with petitioner and the comprehensive psychiatric treatment records from Dr. Jones and Dr. Dasher.12 Generally, the court presumes that a special master has reviewed all of the material in the record, regardless of whether it is mentioned in his or her decision. Hazlehurst v. Sec’y of HHS, 604 F.3d 1343, 1352 (Fed. Cir. 2010). Moreover, special masters are not required to discuss every piece of evidence or testimony in their decisions. See Maza v. Sec’y of HHS, 67 Fed. Cl. 36, 38 (2005) (“The Special Master need not discuss every item of evidence in the record so long as her decision makes clear that she considered the petitioners’ arguments.”); Snyder v. Sec’y of HHS, 36 Fed. Cl. 461, 466 (1996) (“The special master need not discuss every item of evidence in the record so long as the decision makes clear that the special master fully considered a party’s position and arguments on point.”), aff’d, 117 F.3d 545 (Fed. Cir. 1997); Murphy v. Sec’y of HHS, 23 Cl. Ct. 726, 734 n.8 (1991) (“The special master is not required to discuss every item of evidence when his decision reflects that he fully considered a party’s position and arguments on point.”), aff’d per curiam, 968 F.2d 1226 (Fed. Cir. 1992) (mem.). In this case, however, there is a substantial amount of relevant evidence that was not discussed by the special master. The special master’s failure to address this evidence indicates that he did not fully consider petitioner’s position and arguments regarding his mental illness. 2. The Special Master’s Analysis Premised on His Recitation of Facts Moreover, not only did the special master fail to consider all of the relevant evidence in his decision, but he unduly minimized the evidence that he did consider. Here is the special master’s analysis of petitioner’s equitable tolling argument, in its entirety: Mr. H.’s argument that his history of mental illness constitutes an extraordinary circumstance for the purposes of equitable tolling is unsubstantiated. As recounted above, Mr. H. has been diagnosed with and treated for OCD. He has also been referred for cognitive testing. But, as held in Barrett, “a medical diagnosis alone . . . will not suffice.” 363 F.3d at 1321. Mr. H. must also establish that the “mental illness rendered him incapable of ‘rational thought or deliberate decision making,’ or ‘incapable of handing [his] own affairs or unable to function [in] society.’” Barrett, 363 F.3d at 1321 (citations omitted). more than five-and-one-half months after the petition was filed, and therefore may provide some insight into petitioner’s condition at that time. 12 Although Dr. Dasher did not begin treating petitioner until after the petition was filed, his records contain information concerning petitioner’s mental health history, and are largely consistent with the mental health records from before the petition was filed. -16- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 17 of 18 Mr. H. was given an opportunity to substantiate his claim that his inability to meet the limitations period was a direct result of his mental illness but failed to do so. Mr. H. acknowledges that when he received the vaccine, he was legally an adult and deemed by his mother to be competent. Pet’r’s Memo. at 8, 10. Furthermore, Mr. H. has not presented any evidence showing that he was the ward of a guardian. Id. Mr. H. has not satisfied his burden of demonstrating that the Vaccine Act’s statute of limitations should be equitably tolled. Thus, Mr. H. did not establish that his mental illness was an extraordinary circumstance that rendered him incapable of rational thought or deliberate decision-making. See Barrett, 373 F.3d at 1321. Nor did Mr. H. establish that his mental illness left him incapable of handling his own affairs or unable to function in society. Id. J.H., 2015 WL 1779274, at *6 (footnote omitted). By condensing petitioner’s mental health condition into two short sentences (“Mr. H. has been diagnosed with and treated for OCD. He has also been referred for cognitive testing.”), the special master has impermissibly ignored and thereby mischaracterized the contents of the medical records before him. In sum, by failing to consider the full universe of medical records before him and by mischaracterizing the contents of the medical records that he did consider, the special master has abused his discretion. Remand is therefore appropriate.13 III. CONCLUSION For the reasons set forth above, the court GRANTS petitioner’s motion for review, VACATES the special master’s March 23, 2015 decision, and REMANDS the case to the special master for further proceedings. On remand, the special master shall (1) reevaluate petitioner’s equitable tolling argument based on the entire universe of medical records and the other evidence before him, and (2) file a new decision on respondent’s motion to dismiss.14 The special master is encouraged to seek additional fact evidence if he deems it necessary to determine petitioner’s mental health condition during the 2006 to 2009 time period. This evidence may include testimony or a report from one of petitioner’s current or previous treating 13 At oral argument, counsel for respondent, Althea Walker Davis, agreed that the case should be remanded to the special master for a full consideration of the records describing petitioner’s mental health condition. The court appreciates Ms. Davis’s high degree of professional commitment to carrying out the purposes of the Vaccine Act. 14 The special master shall not be bound by the court’s recitation of facts in this Opinion and Order, see supra Part I.B, because they are not findings of fact as contemplated by 42 U.S.C. § 300aa-12(e)(2)(B). -17- Case 1:09-vv-00453-MMS Document 116 Filed 09/30/15 Page 18 of 18 physicians or therapists. It may also include other psychiatric treatment records referred to in the medical records but not previously submitted by petitioner.15 IT IS SO ORDERED. s/ Margaret M. Sweeney MARGARET M. SWEENEY Judge 15 Such records may include those from Daniel’s Place, see Ex. 10 at 15, those from Dr. Nassi, a psychiatrist, see Ex. 11 at 3, and those from other psychiatrists and therapists, see Ex. 3 at 4; Ex. 5 at 3; Ex. 10 at 2. -18- ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_09-vv-00453-2 Date issued/filed: 2016-01-11 Pages: 41 Docket text: PUBLIC ORDER/RULING (Originally filed: 12/21/2015) regarding 141 Ruling on Entitlement. Signed by Special Master Christian J. Moran. (SP) Copy to parties. -------------------------------------------------------------------------------- Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 1 of 41 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS * * * * * * * * * * * * * * * * * * * * * * * * * JEREMY HODGE, * * No. 09-453V Petitioner, * Special Master Christian J. Moran * * Filed: December 21, 2015 v. * * Statute of limitations; equitable SECRETARY OF HEALTH AND * tolling; mental illness; HUMAN SERVICES, * obsessive-compulsive disorder * (“OCD”); remand. Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * Clifford J. Shoemaker, Shoemaker, Gentry & Knickelbein, Vienna, VA, for petitioner; Althea Walker Davis, United States Dep’t of Justice, Washington, DC, for respondent. PUBLISHED RULING FINDING EQUITABLE TOLLING1 In this case under the National Vaccine Injury Compensation Program (“the Vaccine Program”), Jeremy Hodge seeks compensation for injuries he alleges were caused by hepatitis A and B vaccinations administered on March 17, 2006, and April 15, 2006. The Secretary of Health and Human Services filed a motion to dismiss based on the Vaccine Act’s statute of limitations, 42 U.S.C. § 300aa- 16(a)(2). At this stage, there is no dispute that Mr. Hodge did not file his petition within the time permitted by the statute of limitations. 1 The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002), requires that the Court post this decision on its website. Pursuant to Vaccine Rule 18(b), the parties have 14 days to file a motion proposing redaction of medical information or other information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by the special master will appear in the document posted on the website. Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 2 of 41 To avoid the consequence of filing outside of the statute of limitations, Mr. Hodge argues that the running of the statute should be equitably tolled. In a March 23, 2015 decision, the undersigned rejected that argument. However, in an Opinion and Order issued on September 9, 2015, the Court vacated that decision and remanded for additional consideration. After additional consideration and additional evidentiary development, the undersigned concludes that Mr. Hodge has established that equitable tolling is appropriate. As discussed below, this conclusion is premised upon an analysis of several legal issues that are novel to the Vaccine Program. Procedural History Before describing events in Mr. Hodge’s case, it is important to set forth the background law regarding the time for filing petitions in the Vaccine Program because this law has influenced the actions taken by Mr. Hodge’s attorney, Mr. Clifford Shoemaker. The Vaccine Act provides the starting point for analyzing the timeliness of petitions. In 2009 (and now), the Vaccine Act stated that “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 the significant aggravation of such injury.” 42 U.S.C. § 300aa−16(a)(2). Before 2009, petitioners in other Vaccine Program cases had attempted to ameliorate the consequence of the 36-month statute of limitations by relying upon two closely related doctrines: the discovery rule and equitable tolling. As later explained by the Federal Circuit, “discovery rules look to the knowledge of a plaintiff to determine the date upon which the statute of limitations begins to run.” Cloer v. Sec’y of Health & Human Servs., 654 F.3d 1322, 1338 (Fed. Cir. 2011) (en banc). When petitioners invoked the discovery rule to explain that they did not file their petition within 36 months of an injury because they did not know about their potential claim, courts did not grant them relief. E.g., Goetz v. Sec’y of Health & Human Servs., 45 Fed. Cl. 340, 341 (1999). Unlike the discovery rule, which would modify when a cause of action accrues, equitable tolling extends the time for filing a petition. In 2001, the 2 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 3 of 41 Federal Circuit held that the Vaccine Act was not compatible with equitable tolling. Brice v. Sec’y of Health & Human Servs., 240 F.3d 1367, 1372 (Fed. Cir. 2001). As discussed below, the en banc Federal Circuit overruled this aspect of Brice while Mr. Hodge’s case was pending. Against this backdrop, Mr. Hodge’s mother, Erika Elson, conferred with Mr. Shoemaker on July 13, 2009. She informed Mr. Shoemaker that Mr. Hodge received a dose of the hepatitis A vaccine on March 17, 2006, and doses of the hepatitis B vaccine on March 17, 2006, and April 25, 2006. She apparently also told Mr. Shoemaker that after these vaccinations, Mr. Hodge “experienced various symptoms.” Pet., filed July 15, 2009, at ¶¶ 5-7. Two days after speaking with Ms. Elson, Mr. Shoemaker filed the petition without collecting medical records. He filed the petition “immediately because of potential statute of limitations problems.” Pet. ¶ 7. The petition was, thus, not very specific about the injury that the vaccinations allegedly caused, and merely asserted that a May 18, 2009 MRI2 suggested that Mr. Hodge suffered from a demyelinating disease. Pet. ¶ 9. At the first status conference, the parties discussed the potential statute of limitations problem, which Mr. Shoemaker had disclosed in the petition. Nevertheless, Mr. Shoemaker wanted to continue the case, suggesting that this case might be an appropriate vehicle to modify Brice.3 2 The petition states an MRI date of May 19, 2009, which is the date that the evaluating physician reviewed the results of the MRI. The accurate date is May 18, 2009, the date the MRI was performed on Mr. Hodge. For consistency, this ruling refers to the MRI as performed on May 18, 2009. 3 Mr. Shoemaker’s decision to represent Mr. Hodge was admirable. Mr. Shoemaker knew that Mr. Hodge’s case could be barred by the statute of limitations and that attempts to avoid the consequences of the statute of limitations had been rejected by the Federal Circuit. Thus, the task confronting Mr. Hodge to establish that the merits of his claim should be adjudicated were considerable. In addition, when Mr. Shoemaker decided to undertake this challenge, he knew that the Federal Circuit had held that special masters lacked the authority to award attorneys’ fees to petitioners whose cases were filed outside the statute of limitations. This ruling came in a 3 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 4 of 41 The parties agreed that Mr. Shoemaker should file medical records and he spent more than two years gathering them. In this phase of collecting records, the Federal Circuit issued its en banc opinion in Cloer. Two aspects of Cloer affect Mr. Hodge’s case. First, the Federal Circuit confirmed that the Vaccine Act does not include a discovery rule. Cloer, 654 F.3d at 1336-40. Second, overruling Brice, the Federal Circuit determined that the Vaccine Act permits equitable tolling. Id. at 1340-44. After Mr. Hodge’s medical records were filed, the Secretary evaluated them in her report. The Secretary premised her analysis on the idea that Mr. Hodge’s petition alleged that the vaccinations caused him a demyelinating disease. Resp’t’s Rep., filed April 30, 2012, at 13. The Secretary’s report also argued that the case should be dismissed due to untimeliness. Id. at 17-19. The next significant event was Mr. Hodge’s filing a report from a neurologist, Carlo Tornatore. This report had two purposes: (1) to define the injury for which Mr. Hodge was seeking compensation, and (2) to determine when the first sign or symptom of that injury arose. After reviewing the medical records, Dr. Tornatore determined that “the diagnosis of neuroborreliosis would not be unreasonable.”4 He stated that the onset of this disease was in 2005. Dr. Tornatore also added that after Mr. Hodge received the vaccinations, his neuroborreliosis second opinion from the Federal Circuit in the Brice case. Brice v. Sec’y of Health & Human Servs., 358 F.3d 865, 869 (Fed. Cir. 2004). In a second en banc decision in Cloer, the Federal Circuit overruled this Brice decision as well. Cloer v. Sec’y of Health & Human Servs., 675 F.3d 1358 (Fed. Cir. 2012) (en banc). Thus, as the law stood in 2009, Mr. Shoemaker agreed to take on a case that would require a significant amount of work (possibly an en banc appeal), for which it was possible, if not likely, he would not receive attorneys’ fees. Mr. Shoemaker’s willingness to put his client’s interests ahead of his own upholds the best traditions of the legal profession. 4 Dr. Tornatore’s diagnosis of neuroborreliosis means that Mr. Hodge is suffering from a manifestation of Lyme’s disease. See Dorland’s Illus. Med. Dictionary at 241, 1263 (32d ed. 2012). Dr. Tornatore’s diagnosis is consistent with the opinions of some treating doctors’ opinions that he suffered from Lyme’s disease. E.g., Exhibit 7 at 22, 28, 44; exhibit 14 at 3; exhibit 20 at 16. 4 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 5 of 41 became worse by June 2, 2006, when he experienced dizziness and eye movement disorders. Exhibit 18 at 2, citing exhibit 6 at 7. In the ensuing status conference, the parties discussed the significance of Dr. Tornatore’s report. Mr. Hodge recognized that Dr. Tornatore’s reliance on the June 2, 2006 dizziness and eye movement disorders placed the first manifestation of a vaccine-induced significant aggravation outside the statute of limitations. But, Mr. Hodge wanted to argue that equitable tolling should save his claim. Order, issued August 29, 2013. Mr. Hodge filed his brief approximately five months later. His primary argument was that doctors did not recognize his symptoms as manifestations of an injury caused by a vaccine. Pet’r’s Br., filed Jan. 30, 2014, at 1-2, 4. In passing, Mr. Hodge also mentioned that mental disability could serve as a basis for equitable tolling. Id. at 8. The Secretary did not agree with Mr. Hodge’s invocation of equitable tolling. With respect to mental disability, the Secretary argued that Mr. Hodge had not shown how his mental illness prevented him from filing a timely petition. Resp’t’s Resp., filed May 9, 2014, at 17. Mr. Hodge was permitted to have the last word as to the availability of equitable tolling. In his sur-reply, Mr. Hodge emphasized the extraordinary circumstances that prevented him from filing earlier and his diligence in pursuing his rights. Pet’r’s Sur-Reply, filed Oct. 1, 2014. A decision was issued on March 23, 2015. The decision found that based upon Dr. Tornatore’s report, Mr. Hodge had not filed his petition within the time permitted by the statute of limitations. In addition, the decision found that Mr. Hodge had not established that he was entitled to equitable tolling. 2015 WL 1779274. After Mr. Hodge filed a motion for review, the Court vacated the March 23, 2015 decision. The Court did not modify the finding that Mr. Hodge filed the case outside the statute of limitations. 123 Fed. Cl. 206, 216. However, the Court remanded for a more detailed assessment of the medical records especially with respect to Mr. Hodge’s mental status. Id. at 219. 5 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 6 of 41 The time for remand is set forth in the Vaccine Act: “The court may allow not more than 90 days for remands.” 42 U.S.C. § 300aa−12(e)(2). This provision is carried over into Vaccine Rule 28(b). Because the Court remanded the case on September 9, 2015, the time for remand was set to expire on December 9, 2015. After the remand, the parties were ordered to file briefs addressing legal and factual questions. Order, issued Sept. 14, 2015. The parties presented their arguments in a series of briefs that are discussed in the context of specific issues below. On October 16, 2015, Mr. Hodge filed more medical records. He also filed a report from Robert Dasher, a psychiatrist who treated him. Exhibit 22. The October 8, 2015 scheduling order required the Secretary to file a response to Dr. Dasher’s report on Friday, November 6, 2015. On that date, the Secretary filed two motions for enlargement of time. Mr. Hodge did not oppose either motion. The first (ECF entry 127) was directed to the Court, requesting an extension of time for the remand proceedings. The second (ECF entry 128) was directed to the special master, requesting an extension of time for the expert’s report. On Monday, November 9, 2015, the Court denied the Secretary’s motion to enlarge the time for remand. The Court reasoned that it cannot change a deadline set by statute. Order, issued Nov. 9, 2015, at 1, citing 1 James Wm. Moore, Moore’s Federal Practice ¶ 6.06[1][a] (3d ed. 2012). However, citing Paluck v. Sec’y of Health & Human Servs., 111 Fed. Cl. 160, 165-66 (2013), the Court added that “the Vaccine Act does not identify any consequence for a failure to act within the ninety-day remand period.” The Court concluded that “if both parties and the special master agree that additional time is necessary for the special master to comply with the court’s remand order, the court will fully support that common- sense agreement in the interest of justice.” Order, issued Nov. 9, 2015, at 2. The following day, a status conference was held to discuss the implications of the Court’s November 9, 2015 order. Mr. Hodge continued to consent for additional time for the Secretary to file a response to Dr. Dasher. Thus, the Secretary’s deadline was extended to November 20, 2015. Order, issued Nov. 10, 2015. 6 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 7 of 41 On November 20, 2015, the Secretary filed reports from Elizabeth LaRusso, a psychiatrist, and John Dunn, a neuropsychologist. These reports provided information about obsessive-compulsive disorder and opinions about Mr. Hodge’s mental health. On December 4, 2015, Mr. Hodge filed a reply. With the reply, he filed an additional affidavit from his mother, exhibit 26, contesting some of the factual assertions made by Dr. LaRusso and Dr. Dunn. With that submission, the matter is again ready for adjudication. Analysis The analysis follows the following structure. The first two sections are devoted to resolving questions of law: (1) whether petitioners in the Vaccine Program may invoke the doctrine of equitable tolling on the basis of mental incapacity, and (2) what petitioners relying upon a mental disability must establish to receive the benefits of equitable tolling. The following section considers the pleadings and facts of Mr. Hodge’s case and concludes that Mr. Hodge is entitled to equitable tolling. Based upon the finding that Mr. Hodge’s claim that he is mentally incapacitated, the final section requests briefs regarding Mr. Hodge’s ability to continue to function as the petitioner in his case. I. Availability of Equitable Tolling for Mental Illness There is no question that, as a general matter, the Vaccine Act permits equitable tolling. Cloer, 654 F.3d at 1340-44. Although the Secretary concedes this general point, the Secretary contends that “equitable tolling for mental illness is not available in Vaccine Program cases.” Resp’t’s Mem., filed Sept. 30, 2015 at 7.5 Cloer itself does not directly address this question. The petitioner, Dr. Melissa Cloer, sought equitable tolling “on the ground that she first became aware 5 After remand, the Secretary’s legal argument has matured into a prominent argument compared to the relatively tangential argument made earlier. See Resp’t’s Resp. to Pet’r’s Mot. for Rev., filed July 22, 2015, at 8 n.5. 7 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 8 of 41 of the causal link between her [multiple sclerosis] and the [hepatitis B] vaccine” after the statute of limitations had run. Cloer, 654 F.3d at 1344. The en banc Federal Circuit held that “unawareness of a causal link between an injury and administration of a vaccine” is not a basis for equitable tolling. Id. at 1345. Unlike Mr. Hodge, Dr. Cloer did not invoke mental illness as a reason for tolling the statute of limitations. In determining whether equitable tolling is available, the starting point is Irwin v. Department of Veterans Affairs, 498 U.S. 89, 95-96 (1990), in which the Supreme Court “established a presumption that all federal statutes of limitations are amenable to equitable tolling absent provision by Congress to the contrary.” Cloer, 654 F.3d at 1342. In a case the Federal Circuit cited involving equitable tolling, Barrett v. Principi, 363 F.3d 1316, 1319 (Fed. Cir. 2004), the Sixth Circuit stated “time limitations may be tolled on equitable grounds not inconsistent with the legislative purpose.” Cantrell v. Knoxville Community Development Corp., 60 F.3d 1177, 1179 (6th Cir. 1995). Citing the Vaccine Act, the Secretary argues that Congress did not intend for mental illness to be a basis for equitable tolling in the Vaccine Program. The Vaccine Act identifies three groups of people who may be petitioners in the Vaccine Program: “[(1)] any person who has sustained a vaccine-related injury, [(2)] the legal representative of such person if such person is a minor or is disabled, or [(3)] the legal representative of any person who died as the result of the administration of a vaccine set forth in the Vaccine Injury Table.” 42 U.S.C. § 300aa–11(b)(1)(A); but see Figueroa v. Secʼy of Health & Human Servs., 715 F.3d 1314, 1322-25 (Fed. Cir. 2013) (authorizing the legal representative of a person who died from non-vaccine related causes to file a petition for a vaccine- related injury). The Secretary’s argument regarding equitable tolling is based upon the second class: “the legal representative” of a vaccine-injured person who is “disabled.” The Secretary essentially argues that because Congress authorized the legal representative of a disabled person to file a petition, Congress did not want the disabled person to have the benefit of equitable tolling. In the Secretary’s words, the Vaccine Act “empowers the legal representative of a disabled person with the right and obligation to advance [a] Vaccine Act claim.” Resp’t’s Mem. at 9; accord Resp’t’s Br., filed Nov. 20, 2015, at 8 n.6, 10. 8 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 9 of 41 Mr. Hodge did not directly respond to the Secretary’s citation to the Vaccine Act. See Pet’r’s Mem., filed Oct. 16, 2015. This omission is unfortunate because the Secretary’s argument carries some force. Despite the lack of response from Mr. Hodge, the Secretary’s argument is not persuasive. The Secretary argument leaves unaddressed two questions. First, who is the “legal representative”? The Vaccine Act defines “legal representative” as “a parent or individual who qualifies as a legal guardian under State law.” 42 U.S.C. § 300aa–33(2). The Court of Federal Claims construed the term “legal representative” to mean that “parents are always viewed as the legal guardian of a son or daughter, whether or not they also qualify as such under state law.” Kennedy v. Secʼy of Health & Human Servs., 99 Fed. Cl. 535, 542 (2011), aff’d without op., 485 F. App’x 435 (Fed. Cir. 2012); cf. Bernhardt v. Sec'y of Health & Human Servs., 82 Fed. Cl. 290, 291 (2005) (determining only that a non-custodial parent possessed the right to sue on behalf of the child under Maryland law and refraining from determining the right apart from state law). Notably, Kennedy’s interpretation of “legal representative” came in the context of a case in which the parents of Michael Kennedy filed a petition while their son was a minor. Kennedy, 99 Fed. Cl. at 538. The question was whether Michael’s parents could continue to prosecuting Michael’s Vaccine Program claim after he turned 18 as “next friend.” The Court said that the parents could continue to act as petitioners because, in part, Michael was disabled. Id. at 542. Thus, Kennedy supplies some support for an argument that Mr. Hodge’s mother (Ms. Elson) could act as the “legal representative” of Mr. Hodge due to his disability. (In contrast, Ms. Elson could not have initiated the lawsuit in her capacity as Mr. Hodge’s “parent” because the Vaccine Act authorizes the parent of a minor to file suit and Mr. Hodge was not a minor when he was vaccinated.) However, it is not absolutely clear whether a person — even a mother — may file a Vaccine Program petition for a disabled person without first establishing his or her status as a “legal representative” under the pertinent state law. Spates v. Secʼy of Health & Human Servs., 76 Fed. Cl. 678, 681 n.1 (2007) (recognizing an ambiguity in “whether a parent is a legal representative per se, irrespective of state law, or whether a parent must simultaneously qualify as a legal guardian under state law to be a legal representative under the Act”). 9 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 10 of 41 If, for the sake of argument, it is assumed that Ms. Elson qualifies as Mr. Hodge’s “legal representative” without ever actually having been appointed as a legal representative, that answer only leads to the second question, which is even more difficult. The Secretary’s argument is that the Vaccine Act “empowers the legal representative of a disabled person with the right and the obligation to advance [a] Vaccine Act claim.” Resp’t’s Mem. at 9. The critical word is “obligation.” The Vaccine Act grants the “legal representative” a “right” to file a petition. But, saying there is a “right” to do something is not the same as saying there is an “obligation” to do it. On this point, Mr. Hodge cited two cases that address responsibility for initiating litigation when the injured person is an incapacitated adult for whom a legal guardian has not been appointed. The older case is Clifford ex rel. Clifford v. United States, 738 F.2d 977 (8th Cir. 1984). In October 1976, Allen Clifford was 24 years old and suffering from depression with suicidal tendencies. Physicians from the Veteran Administration prescribed a medication and Allen Clifford overdosed on that medication, leading to a coma. In January 1979, Mr. Clifford’s father, Dewey Clifford, was appointed as his son’s guardian. Shortly less than two years later, Mr. Clifford filed an administrative claim. The issue in litigation was whether the claim was timely filed. Reversing the district court, the Eighth Circuit held that the cause of action did not accrue in October 1976, when the alleged negligence took place. Instead, the Court of Appeals held that the cause of action accrued when the guardian was appointed for two reasons. First, the circuit court found significant that the complaint alleged that the defendant’s negligence prevented Allen Clifford from knowing he was harmed and from filing the lawsuit. The circuit court did not want to let the United States benefit from an alleged wrong. Second, “Allen was an emancipated adult, and neither his girlfriend nor his family had a legal duty to act on his behalf.” Id. at 979. Clifford was a basis for the second case Mr. Hodge cited: Miller v. Philadelphia Geriatric Center, 463 F.3d 266 (3d Cir. 2006). Henry Miller suffered from developmental delay throughout his life. “Despite this severe impairment, no one was ever appointed his legal guardian.” Id. at 268. In 1988, one of Henry’s 10 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 11 of 41 doctors prescribed medications. In October 1995, an attending physician at another hospital told Henry’s sister, Vicki Miller, that these medications were harming Henry. After Henry died in 1997, Ms. Miller initiated legal actions against various entities, including the United States. Id. at 269. The question on appeal was whether the two-year statute of limitations found in the Federal Tort Claims Act barred the causes of action. The government argued that the survivor claim accrued in October 1995 when Ms. Miller became aware of the injury. Ms. Miller argued for September 24, 1997, the date Henry Miller died. Id. at 272-73. A divided panel of the Third Circuit held that the later date was the date of accrual for the survivor claim. The Third Circuit explained: Miller argues that the District Court erred by looking to her rather than to the decedent as the proper person to whom the reasonable person standard of the FTCA discovery rule applies. We agree. The record is quite clear that, although Miller closely monitored her brother’s health and treatment, she was not his legal guardian. Even though she was not his legal guardian, the District Court nonetheless looked to Miller to determine when any lawsuit should have been filed. This was error. Miller would not have had the authority to file a suit on the decedent’s behalf while he was alive unless she was appointed his guardian. Id. at 273. Procedurally, neither Clifford nor Miller is entirely on all fours with Mr. Hodge’s case because both Clifford and Miller were concerned with when the cause of action should have been discovered pursuant to the Supreme Court’s decision in United States v. Kubrick, 444 U.S. 111 (1979). Because the discovery rule does not delay the start of the accrual of the statute of limitations for the Vaccine Act, Cloer, 654 F.3d at 1340, Mr. Hodge is not pursuing an argument based on when he discovered that the vaccines injured him. Nonetheless, Clifford and Miller illustrate the point that Ms. Elson lacked the authority to file a petition 11 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 12 of 41 for Mr. Hodge until she was appointed guardian.6 The Secretary did not address either Clifford or Miller. See Resp’t’s Br., filed Nov. 20, 2015. The Secretary’s interpretation of the Vaccine Act would create an unworkable system. An unappointed “legal representative” would be required to file a lawsuit on behalf of a disabled person whom he or she did not know he or she was representing. The text of the Vaccine Act does not suggest that Congress intended to limit the opportunities for disabled people to bring claims on their own behalf. The Secretary’s legal argument is not consistent with general principle of equity that underlie the equitable tolling doctrine. Consequently, petitioners in the Vaccine Program may invoke equitable tolling based upon mental illness. Whether Mr. Hodge’s request for equitable tolling fulfills the requirement of extraordinary circumstances must be analyzed according to the facts and evidence. II. Legal Standard The second legal question is: in cases involving a claim for equitable tolling due to mental incapacity, what must the claimant show? The parties agree that the starting point, at least, is Barrett. In Barrett, the Federal Circuit interpreted 38 U.S.C. § 7266(a), which establishes a 120-day deadline for an appeal from the Board of Veterans’ Appeals to the Court of Appeals for Veterans Claims, to allow for claims of equitable tolling based on mental illness. 363 F.3d at 1318. The Federal Circuit stated that to gain the benefit of equitable tolling, “a veteran must show that the failure to file was the direct result of mental illness that rendered him incapable of ‘rational thought or deliberate decision making,’ . . . or ‘incapable of handling [his] own affairs or unable to function [in] society.’” Id. at 1321 (citations omitted). 6 For additional views on whether the appointment of a guardian for a mentally incompetent adult should toll the running of the statute of limitations, see William M. Schrier, The Guardian or the Ward: For Whom Does the Statute Toll?, 71 B.U. L. Rev. 575 (1991). 12 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 13 of 41 The Secretary stated that Barrett “does establish the test for determining whether mental illness may toll the statute of limitations.” Resp’t’s Mem., filed Sept. 30, 2015, at 10 (capitalization changed without notation).7 Mr. Hodge describes Barrett as “instructive,” but believes that there should be a “totality of the circumstances” test. Pet’r’s Mem., filed Sept. 30, 2015, at 2. Mr. Hodge’s argument to add to the test set forth in Barrett is not necessary. The various factors that Mr. Hodge identifies, such as a lack of ability to communicate and lack of ability to complete life’s activities, are simply aspects of being “incapable of handling his own affairs.” When a claimant establishes that he is “incapable of handling his own affairs,” the claimant is entitled to equitable tolling. Significantly, a mentally ill person is not required under Barrett to demonstrate due diligence in pursuing legal remedies. The Federal Circuit was certainly aware that “due diligence” was a factor in claims for equitable tolling as the government had argued that equitable tolling was limited to two situations, including when the claimant has “actively pursued his judicial remedies.” Barrett, 363 F.3d at 1318, quoting Irwin, 498 U.S. at 96. However, the Federal Circuit did not incorporate any diligence requirement in defining what a person with a mental illness must show to gain the benefit of equitable tolling. Requiring mentally ill claimants to show both that they were not capable of rational decision-making and that they were diligent in pursuing their legal rights would be like attempting to fit a square peg into a round hole. A person whose mental illness is so debilitating that he (or she) cannot function in society is highly unlikely to be capable of filing any sort of petition. Conversely, any steps to advance the legal claim would likely be considered evidence that the person could handle his (or her) affairs. For these reasons, claimants for equitable tolling based 7 In the context of arguing whether equitable tolling for mental illness is consistent with the Vaccine Act, the Secretary attempted to distinguish Barrett, a case arising in the veterans’ context, from the present Vaccine Program case. This decision does not address Barrett in that context because the Vaccine Act answers the question. See section I above. 13 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 14 of 41 upon mental illness are not required to show diligence. They must fulfill only the standard set forth in Barrett.8 III. Facts The previous two sections addressed issues of law — whether the Vaccine Act permits equitable tolling based upon a disability and whether petitioners with a disability are required to show diligence in pursuing their legal rights. The remainder of the decision places these rulings in the context of Mr. Hodge’s case, both in terms of the pleadings and the evidence. A. Pleadings Before addressing the evidence related to whether Mr. Hodge lacked the capacity to manage his own affairs, the undersigned considers first the Secretary’s argument that would obviate this examination. The Secretary contends that Mr. Hodge has admitted that the reason he did not file his petition sooner was that he did not know that a vaccine injured him until July 2009. The legal basis for the Secretary’s argument is the declaration that “equitable tolling under the Vaccine Act due to unawareness of a causal link between an injury and administration of a vaccine is unavailable.” Cloer, 654 F.3d at 1345. 8 Mr. Hodge argues that he met any requirement for diligence. See Pet’r’s Mem., filed Oct. 20, 2015, at 6-9. He asserts that: “In the vaccine injury context, pursuing one’s rights means visiting health care facilities that are available to that particular petitioner.” Id. at 7. However, it is far from clear that for purposes of qualifying for equitable tolling, diligence in seeking medical attention qualifies as diligence in pursuing legal remedies. See Resp’t’s Br., filed Nov. 20, 2015, at 3 (“There is no basis to equate the pursuit of medical care with the pursuit of legal rights through reasonably diligent efforts to timely file a claim”). For one example of diligence in pursuing legal remedies that qualified for equitable tolling, see Mojica v. Sec’y of Health & Human Servs., 102 Fed. Cl. 96 (2011) (recognizing equitable tolling when petitioner’s attorney delivered the petition to an express mail service that lost the petition). 14 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 15 of 41 Both parties recognize this restriction for equitable tolling. See Pet’r’s Br., filed Dec. 4, 2015, at 1-2, Resp’t’s Br., filed Nov. 20, 2015, at 7. The factual basis for the Secretary’s argument is a series of statements Mr. Hodge made early in the litigation. See Resp’t’s Mem., filed October 1, 2014, at 3-7, Resp’t’s Br., filed Nov. 20, 2015, at 7. These statements begin with the petition: “Up until now [July 2009], doctors have told Jeremy and his mother that the symptoms he has been describing were probably due to mental issues, so they have had absolutely no reason to suspect that he has had a vaccine related injury.” Pet., filed July 15, 2009, at ¶ 9. The petition also explains that the event that alerted Ms. Elson to the possibility that a vaccine injured her son was an MRI conducted on May 18, 2009. Id.9; accord Pet’r’s Mem., filed Jan. 31, 2015, at 10 (the “MRI was crucial to the doctor’s determination that [Mr.] Hodge had an injury rather than a mere psychosis”). Three years after his petition was filed, Mr. Hodge continued to make statements that suggested his failure to file within the time the statute of limitations permitted was due to an unawareness that a vaccine caused his injury. When Mr. Hodge responded to the Secretary’s argument that his case should be dismissed due to an untimely filing, Mr. Hodge asserted that “none of the medical professionals who treated Jeremy objectively recognized his complaints of rapid eye-movement, numbness, dizziness, joint and back pain, headache, or behavior changes as a first symptom, onset, or sign of vaccine injury nor did they recognize a vaccine-induced aggravation of a pre-existing condition.” Pet’r’s Mem., filed 9 Medical records, which were collected after the petition was filed, show that there was suspicion that a vaccine caused an injury much earlier. In August 2006, Dr. Baca, at Encino- Tarzano Regional Medical Center, recorded that Mr. Hodge said his “symptoms have been evident intermittently since receiving hepatitis vaccine earlier this year.” Exhibit 4 at 13. Approximately one year later, in September 2007, a medical record again reflects that “The mother is concerned about possible side effects from previous hepatitis vaccinations.” Exhibit 8.5 at 72. Mr. Hodge used these statements to argue that “Ms. Elson was duly diligent in advocating for her son’s rights because she consistently expressed during each doctor visit that [Mr.] Hodge experienced severe health problems following the Hepatitis vaccinations.” Pet’r’s Mem., filed Jan. 15, 2015, at 9-10. 15 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 16 of 41 Jan. 30, 2014, at 1-2. Mr. Hodge repeated this later in his brief: none of Mr. Hodge’s various symptoms were indicative of a vaccine-related aggravation of a pre- existing condition to the medical profession at large because - despite Mrs. Elson’s efforts to emphasize to doctors that Hodge’s condition worsened following these vaccinations - Hodge’s various doctors continued to find unrelated diagnoses. . . . Only after Hodge’s MRI in 2009, three years after he received the vaccinations in 2006, did the doctors responsible for treating Hodge determine he even had an injury Id. at 6-7. Mr. Hodge again emphasized his lack of knowledge when he argued that before the 2009 MRI, he “was unaware and lacked evidence of his underlying neuroborreliosis to conclude the Hepatitis B vaccine caused a sequela of that condition.” Id. at 12. Thus, the clear thrust of Mr. Hodge’s initial response to the motion to dismiss was to argue for something like the discovery rule.10 He changed tack in his sur-reply. There, he argued for equitable tolling based upon his “due diligence in attempting to file his claim in spite of extraordinary circumstances.” Pet’r’s Reply, filed Oct. 1, 2014, at 4 (capitalization changed without notation). On remand, the Secretary, as noted above, cites some of these assertions as a basis for arguing that Mr. Hodge “admits that his petition was filed late because he was unaware that he may have suffered a vaccine-related injury.” Resp’t’s Mem., filed Oct. 1, 2015, at 5. If it were correct that Mr. Hodge’s lack of awareness caused him to miss the deadline for filing within the statute of limitations, then equitable tolling could not save his action. Cloer, 654 F.3d at 1345. In juxtaposition, Mr. Hodge argues that his “mental illness caused his untimely filing, not his lack of awareness of his injury.” Pet’r’s Mem., filed Oct. 10 In a single sentence of his brief, Mr. Hodge mentioned mental disability and cited Barrett. See Pet’r’s Mem., filed Jan. 31, 2014, at 8. 16 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 17 of 41 16, 2015, at 14 (capitalization changed without notation). However, the remainder of the section below this heading does not develop this argument very significantly. Mr. Hodge’s response to the Secretary’s arguments regarding statements in his petition is found later on pages 22-26. In that section, Mr. Hodge argued that the precedent controlling the interpretation of the statute of limitations that was effective on July 15, 2009, recognized a discovery rule. See id. at 22-26, citing Markovich v. Sec’y of Health & Human Servs., 477 F.3d 1353 (Fed. Cir. 2007). Markovich, however, did not endorse the discovery rule. In linking Markovich and the discovery rule, Mr. Hodge, as the Secretary stated, “misunderstands the holding.” Resp’t’s Br., filed Nov. 20, 2015, at 8 n.5. The parties’ arguments demonstrate a conundrum in the interplay between the discovery rule and equitable tolling for mental illness. See Garcia v. Brockway, 526 F.3d 456, 465 (9th Cir. 2008) (en banc) (differentiating discovery rule and equitable tolling but recognizing they are frequently confused); Oshiver v. Levin, Fishbein, Sedran & Berman, 38 F.3d 1380, 1388 (3d Cir. 1994) (application of the discovery rule and equitable tolling “invite confusion”); cf. Martinez v. United States, 333 F.3d 1295, 1319 (Fed. Cir. 2003) (en banc) (discussing equitable tolling and accrual rule). When Mr. Hodge thought that the discovery rule would delay the accrual of the statute of limitations, he made assertions that suggested that he did not know about his vaccine injury. See Pet. ¶ 9. After the en banc Federal Circuit held that the Vaccine Act was not consistent with the discovery rule in Cloer, the Secretary argues that Mr. Hodge is still trying to assert the discovery rule based upon initial pleadings. Resp’t’s Mem., filed Sept. 30, 2015, at 5. Mr. Hodge’s pleadings from before the motion for review can be seen as inconsistent with his current position. In his petition and in his argument against the motion to dismiss, he seems to have admitted that his lack of knowledge that a vaccine injured him caused him to delay filing his petition until after the May 2009 MRI. Pet. ¶ 9, Pet’r’s Mem., filed Jan. 30, 2014, at 1-2, 6-7, 12.11 However, not 11 Mr. Hodge attempted to explain the statements appearing in his 2009 petition by arguing that they were consistent with Markovich. While there are some questions about the soundness of this argument, Mr. Hodge can use Markovich to excuse only the statements made in 2009. Mr. Hodge has not attempted to explain why his arguments in his 2014 brief continued 17 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 18 of 41 all admissions constitute binding admissions. See Paice LLC v. Toyota Motor Corp. 504 F.3d 1293, 1312 (Fed. Cir. 2007) (finding that in a patent infringement case, the district court did not err in treating “the statement as merely an evidential admission — as opposed to a conclusive admission”). Rather than finding that Mr. Hodge’s claim for equitable tolling fails simply because his pleadings focused on the wrong legal theory, the undersigned will consider all the evidence. See 42 U.S.C. § 300aa−13. B. Medical Records and Expert Commentary on Them On remand, the parties have presented thorough accounts of Mr. Hodge’s medical history, emphasizing his mental condition. In addition, the parties retained individuals to offer opinions about Mr. Hodge’s competency. Before authoring their reports, Dr. Dunn and Dr. LaRusso reviewed Mr. Hodge’s medical records. Exhibit A at 1, exhibit C at 2-4. Their reports provide helpful information about Mr. Hodge’s mental status during the critical time from 2006 through July 2009. In contrast, Dr. Dasher did not identify what records he reviewed and did not cite any medical records.12 This lack of specificity limits the usefulness of Dr. Dasher’s report, although Dr. Dasher apparently treated Mr. Hodge at Olive View in mid-2008.13 The undersigned has reviewed the reports of Dr. Dasher, Dr. Dunn, and Dr. LaRusso. Their commentary upon Mr. Hodge’s symptoms are provided in the context of the following chronology. The recitation of Mr. Hodge’s history begins before his vaccination to provide context for later events. The review of the to be based upon his lack of knowledge, an argument that the en banc Federal Circuit rejected in Cloer in 2011. 12 Dr. Dasher states that Mr. Hodge has had a limited ability to perform daily activities and “[t]his process has been going on for years prior to seeing me by my review of his records.” Exhibit 22 at 1. 13 Dr. Dasher has explained the lack of records from his treatment of Mr. Hodge in mid- 2008 by noting that a fire destroyed medical records at Olive View. Exhibit 27. The undersigned has confirmed that in November 2008, the Sayre Fire destroyed a building at Olive View that housed medical records. Exhibits 1000-01. 18 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 19 of 41 medical history stops shortly after the petition was filed in July 2009, because events temporally distant from the date the petition was filed are not likely to provide information relevant to Mr. Hodge’s mental capacity in the time covered by the statute of limitations. 1. From Birth through Vaccinations Mr. Hodge was born on May 17, 1987. Exhibit 3. According to a record created in 2007, Mr. Hodge’s family had a “strong family [history of] mental illness.” Exhibit 11 at 3. This record states that Mr. Hodge’s father suffered from bipolar disorder and attention deficit disorder (ADD). Id.; see also exhibit 5 at 2. A grandmother was a “hoarder.” Exhibit 11 at 3; see also exhibit 5 at 2 (indicating a grandparent possibly had obsessive-compulsive disorder (OCD)). Another record states Mr. Hodge’s great-grandfather and grandfather were both diagnosed with bipolar disorder. Exhibit 10 at 2; see also exhibit 10 at 69 (slightly different family history of mental illness), exhibit 14 at 442. The medical records from Mr. Hodge’s pediatrician dating back to his early years recount relatively routine illnesses associated with childhood. See exhibit 3, passim. On September 28, 2004, when Mr. Hodge was 17 years old, Ms. Elson called the pediatrician to report that her son “was put on Adderall per psych.” Exhibit 3 at 4. The specific reason for Adderall was not given in the pediatrician’s record. According to records created years later, in December 2009, Mr. Hodge was bitten by a tick while hiking in Big Sur. Exhibit 7 at 22. The tick bite was not treated. Id. at 34. Later records tend to associate a decline in Mr. Hodge’s functioning with the tick bite. Id. at 22, 45-46; exhibit 13 at 15. At the age of 18, Mr. Hodge appeared at Noble Community Choice Provider Medical Group for an adolescent health maintenance exam. Exhibit 5 at 2. It appears that Mr. Hodge completed a “‘STAYING HEALTHY’ ASSESSMENT.” Id. at 5.14 In response to the question do you “[o]ften feel sad, down, or hopeless,” 14 The assessment consists of a series of questions to which one completing the assessment answers the question by placing a check in the box “no,” “yes,” or “skip.” 19 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 20 of 41 Mr. Hodge checked the box marked “yes.” Id. The doctor’s handwritten notes, which are difficult to read, indicate that Mr. Hodge was positive for OCD, which started at age 17 years. Id. at 2. The plan included vaccinations against hepatitis A and hepatitis B. Id. at 2, 7. On April 25, 2006, Mr. Hodge returned to Noble Community. Exhibit 5 at 3. The intake portion of the form indicates that Mr. Hodge was returning for follow-up. Id. The remainder of the form is difficult to understand. However, the plan for a second dose of the hepatitis B vaccination is clear. Id. at 3, 7. Dr. Dunn’s opinion is that Mr. Hodge did not lack capacity to function before he was vaccinated. Although Mr. Hodge had already been diagnosed with OCD, “this diagnosis does not equate to a lack of capacity.” Exhibit C at 6. 2. Alleged Initial Adverse Reaction to Vaccinations – June 2006 On June 2, 2006, Mr. Hodge and Ms. Elson appeared at the emergency department at Valley Presbyterian Hospital. Exhibit 6 at 1-12. Mr. Hodge’s chief complaint was “dizzy/eye movement disturbances.” Id. at 7. In addition to these problems, the history of present illnesses stated that Mr. Hodge had “back pain, joint + muscle aches and fatigue since receiving Hep B + A vaccinations 4 mos ago.” Id. Ms. Elson also reported that blood tests were done and they were normal. Id. The review of symptoms showed that Mr. Hodge was having frontal headaches and dizziness. Id. For the physical examination, Mr. Hodge was oriented x 3 with an intact memory. Id. However his affect was “flat,” not normal. Id. The doctor ordered a CT scan of the brain without contrast. Id. at 10. The result was normal. Id. At discharge, which occurred a few hours after admission, Mr. Hodge’s condition was reported as “improving” and “good.” Id. at 6. The doctor indicated that discharge instructions were given for Mr. Hodge to follow-up with his “PMD,” which may stand for “primary medical doctor.” Id. In addition, the doctor indicated that with respect to the continuity of care, “[significant other] demonstrates understanding.” Id. Additionally, the doctor noted in the end of visit summation that the “mother verbalyzed [sic] understanding.” Id. The diagnosis 20 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 21 of 41 was “1: Dizziness 2: Arthralgias – Myalgias [status post] Hepatitis Vaccination.” Exhibit 6 at 6. In this litigation, the doctor whom Mr. Hodge retained, Carlo Tornatore, opined that the dizziness and abnormal eye movements that were reported on June 2, 2006, constituted an aggravation of Mr. Hodges “underlying autoimmune demyelinating disorder.” Exhibit 18 at 2.15 Because these symptoms triggered the accrual of the statute of limitations, Mr. Hodge should have filed his petition by June 2, 2009. However, he did not file his petition until approximately six weeks later, on July 15, 2009. Thus, the statute of limitations bars his action unless Mr. Hodge can establish that he is entitled to equitable tolling due to his mental illness. As to Mr. Hodge’s mental capacity in June 2006, Dr. Dunn stated that “[t]here was no indication of significant cognitive or mental impairment that would indicate a lack of capacity.” Exhibit C at 6. Dr. LaRusso also opined that the record from this visit showed “no evident deficits in orientation or memory.” Exhibit A at 7. 3. Emergency Room Visit – August 2006 The next medical record reporting some information about Mr. Hodge’s mental status was created in August 2006. On August 23, 2006, accompanied by his mother, Mr. Hodge went to the emergency department at Encino-Tarzana Regional Medical Center. Exhibit 4. Mr. Hodge reported that he was feeling weak and tired. Id. at 4. Mr. Hodge also stated “‘it’s hard to feel my skin.’” Id. Ms. Elson stated that his problems “all started [after] Hepatitis vaccine.” Id. The intake nurse recorded that Mr. Hodge was “oriented x 3,” and “alert.” Id. His speech was “appropriate.” Id. Under psychological, the nurse checked “lethargic.” Id. Mr. Hodge had a score of 15 on the Glasgow Coma Scale. Id. at 5. The Glasgow Coma Scale assesses the response to stimuli in neurologically impaired people. Dorland’s at 1672. 15 Although Dr. Tornatore has opined that Mr. Hodge suffers from an "autoimmune demyelinating disorder," Mr. Hodge's treating doctors have not settled upon a diagnosis for him. 21 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 22 of 41 At Encino-Tarzana, Dr. Ralph M. Baca evaluated Mr. Hodge. Id. at 12-13. In addition to receiving a history from Mr. Hodge and his mother that was consistent with the history created by the intake nurse, Dr. Baca conducted a review of systems. Id. at 12. For psychiatric symptoms, Dr. Baca stated that Mr. Hodge “denies any depression, anxiety or hallucinations.” Id. After receiving results from laboratory studies, Dr. Baca discharged Mr. Hodge with an impression that he suffered from a “neuropathy, etiology uncertain.” Id. at 13. Dr. Baca recommended that Mr. Hodge follow-up with a private physician. Id. Dr. Dunn interpreted this record as indicating “an absence of severe impairment and show[ing] he had capacity.” Exhibit C at 7. This report was based, in part, on the Glasgow Coma Scale assessment that showed Mr. Hodge did not have altered or diminished consciousness at that time. Id. Dr. LaRusso stated Mr. Hodge’s mental capacity in this visit was reasonably similar to his capacity in the prior visit on June 2, 2006. Exhibit A at 7. There are no medical records created after Mr. Hodge’s discharge from Encino-Tarzana until July 10, 2007. See exhibit A at 2 (Dr. LaRusso’s assertion of no records), exhibit C at 8 (Dr. Dunn’s assertion of no records). However, Mr. Hodge’s attorney asserts that during this period, Mr. Hodge’s condition “declined rapidly.” Pet’r’s Mem., filed Sept. 30, 2015, at 16. 4. West Valley Mental Health Center – July 2007 On July 10, 2007, C. Collins, RN, completed a multipage “adult initial assessment” for West Valley Mental Health Center. Exhibit 11 at 3-8. Nurse Collins provided information that is helpful in determining Mr. Hodge’s mental state approximately one year after receiving the vaccinations. Mr. Hodge completed schooling through only the 10th grade. Id. at 3. He has no history of working. Id. at 6. He was living with his mother and grandmother. Id. His mother and father were separated with his father living in a nearby town. Id.; see also exhibit 10 at 59 (describing Mr. Hodge’s upbringing, education, and work history). 22 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 23 of 41 Mr. Hodge was being seen by a private psychiatrist, Dr. John Nasse. Exhibit 11 at 3. Dr. Nasse prescribed Xanax. Id.16 A family friend referred Mr. Hodge to West Valley Mental Health Center. Id. Nurse Collins recorded that Mr. Hodge’s presenting problem was a two-year history of OCD that presented as “taping, cutting, [and] counting.” Exhibit 11 at 3. The remainder of Nurse Collins’s notes provides additional details. [History] of depression. Took Zoloft (4wks) made him worse, Prozac made him feel suicidal, Racing thoughts [with] counting. No current SI [suicidal ideation]. Not sleeping, argumentative at times. No good sleeping, naps during day, sometimes sleeps too much. Very pale (+), psychosis, seeing [illegible]. “It’s bad air, environmental.” Id. Nurse Collins completed a mental status evaluation in which she described him as “not stable.” Exhibit 11 at 7. The form for the mental status evaluation is divided into 3 columns with different components and an associated list of words. The following words are circled: General Description Grooming and Hygiene: Disheveled Eye Contact: Erratic Motor Activity: Restless Speech: Soft, Slowed, Poverty of Content Interactional Style: Guarded / Suspicious Orientation: Disoriented: Time Intellectual Functioning: Impaired Memory: Impaired, Remote Fund of Knowledge: Average 16 Mr. Hodge was not successful in attempting to obtain records from Dr. Nasse. Pet’r’s Status Rep., filed Nov. 12, 2015. 23 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 24 of 41 Mood and Affect Mood: Irritable, Anxious, Known stressor Affect: Constricted, Blunted, Flat Perceptual Disturbances Hallucinations: Visual, Auditory, other Self-Perceptions: Ideas of reference Perceptual Disturbances Hallucinations: Visual, Auditory, other Self-Perceptions: Ideas of reference Thought Process Disturbances Associations: Loose Concentration: Impaired, Thought blocking, Clouding of Consciousness, Fragmented Abstractions: Concrete Judgements: Impaired between moderate and severe Insight: Impaired between moderate and severe Serial 7’s: Poor Thought Content Disturbance Delusions: Persecutory, Paranoid Ideations: Suspicious, Magical thinking Behavioral Disturbances: Display of anger, Antisocial Suicidal / Homicidal: Denies Ideation only Passive: Isolated, Withdrawn Other: No words circled Id. Nurse Collins diagnosed him with “psychosis NOS” and “OCD.” Id. at 8. Mr. Hodge’s Global Assessment of Functioning (“GAF”) was 30. Id. She recommended him for a medical evaluation and case management. Id. As part of this process, a physician reviewed Mr. Hodge’s chart. Dr. Shanthi Kesham also diagnosed Mr. Hodge with a psychotic disorder NOS and OCD. Id. at 14. She prescribed Xanax and Seroquel. Id. at 15. 24 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 25 of 41 Although the intake information from West Valley Mental Health Center was very thorough, information about actual treatment seems sparse. There is a single page of progress notes, indicating that Mr. Hodge had not returned for further services and the case was closed on January 8, 2008. Exhibit 11 at 13. Dr. Dunn indicated that the visit to West Valley “was in response to a recent escalation of symptoms and a psychotic break Mr. Hodge experienced.” Exhibit C at 8. Dr. Dunn noted that Mr. Hodge was prescribed an antipsychotic medication and an anti-anxiety medication that he had not taken previously. Id. In Dr. Dunn’s opinion, around July 10, 2007, “Mr. Hodge became severely impaired and lacked capacity.” Id. Dr. LaRusso explained that a GAF of 30 meant that “Behavior is considerably influenced by delusions or hallucinations OR serious impairment in communication or judgment OR inability to function in almost all areas.” Exhibit A at 7. Dr. LaRusso stated that by July 2007, Mr. Hodge “is experiencing a significant psychiatric decompensation.” Id. 5. Emergency Department Visit at West Hills Hospital – September 2007 On September 9, 2007, Mr. Hodge went to the emergency department at West Hills Hospital and Medical Center. Exhibit 8 at 53-78. He was complaining about pain in his chest that was radiating to his left arm and a sore throat. Id. at 57. His past medical history included OCD and depression. Id. The typed report authored by the emergency room physician, Alan Kuban, indicates that the chest pain was not particularly significant. Exhibit 8 at 76-77. However, Dr. Kuban also comments on Mr. Hodge’s mental health. Dr. Kuban indicated that: The patient is [an] extremely vague historian. The mother almost controls the situation and provides the history. The patient really is less than forthcoming as far as descriptions and appears to be unable to make a cogent history as far as quality of his discomfort, or length of time. 25 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 26 of 41 The mother says the patient has a long-standing history of OCD and that his brain is moving so quickly that he is almost paralyzed as far as being able to respond. He has had psychiatric intervention in the past. He was recently started on dextrostat for possible ADHD.[17] He has noted palpitations however since that time. * * * The mother also relates the child has had a significant change in his personality over the last 18 months. She believes this may be related to previous hepatitis vaccinations. . . . No primary physician. Id. With respect to medical decision-making, Dr. Kuban stated that Mr. Hodge “clearly has significant impairment due to his OCD.” Id. at 77. Dr. Kuban recommended follow-up with a neurologist, possibly at Olive View Medical Center. He provided instructions and documents to Ms. Elson. Id. at 75, 78. Dr. Dunn provided relatively little analysis of the record from West Hills. Dr. Dunn stated: “While he presented as significantly impaired on 9/9/07, and required assistance from his mother with respect to providing a history of his condition, he was assessed as alert, fully oriented, and with ‘cognitive/safety/judgment’ intact.” Exhibit C at 10. On the other hand, Dr. LaRusso stated that Dr. Kuban’s note does not reflect a “mental status/cognitive exam.” Exhibit A at 8. 6. San Fernando Transitional Youth – November 2007 through February 2008 Approximately two months later, Mr. Hodge and his mother met with Theresa Kieldgaard, a program manager at the transitional youth outpatient service of San Fernando Valley Community Mental Health Center (“Transitional Youth”). 17 Through his attorney, Mr. Hodge stated that Dr. Nasse prescribed dextrostat. But, again, Dr. Nasse’s records have not been obtained. Pet’r’s Status Rep., filed Nov. 12, 2015. 26 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 27 of 41 Exhibit 10. The form for “adult initial assessment” matched the form used at West Valley Mental Health Center and the information contained on both forms is similar. Compare exhibit 11 at 3-8 with exhibit 10 at 2-7. Ms. Kieldgaard stated: “It is reported that there has been some improvement in client condition since beginning to take anti-psychotic medications, even though his symptoms persist. Client’s mother states that he has been much worse in the past.” Exhibit 10 at 2. Ms. Kieldgaard’s initial assessment, which occurred on November 16, 2007, provided the following information about Mr. Hodge’s current status. Client reports that he “counts everything,” to include words spoken, letters in words, scenes from TV. It is reported that anything “associated with a bad number, is contaminated.” Client will not touch anything metal due to “contamination,” and will not speak about his medications, past or present, as this contaminates them. Client engages in repetitive actions, which include his walking back and forth without purpose, and touching things numerous times, tapping out rhythms in number sequences. Client further chants things in order, and engages in ritualized behaviors around mundane acts, just brushing teeth, and getting into bed. Client reports intrusive thoughts, which take the form of violent thoughts and images, of “weapons in the air,” violence happening to self or family, and “enemies” in his head. It is reported that client is “scared of everything.” Id. Consistent with the conclusions that other mental health professionals had reached, Ms. Kieldgaard diagnosed Mr. Hodge as suffering from obsessive- compulsive disorder. Id. at 7. She also wanted to rule out schizophrenia (paranoid type) and psychotic disorder NOS. Id. At intake, Mr. Hodge’s GAF was 27. Id. The plan was for Mr. Hodge to be seen on an outpatient basis in therapy two or three times per week. Id. at 7, 59. A psychiatrist would also see Mr. Hodge in the next three to four weeks. Id. at 7. 27 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 28 of 41 In accord with the plan, Mr. Hodge started to see a therapist, Jennifer West, on November 20, 2007. Exhibit 10 at 57. Ms. West saw Mr. Hodge multiple times each week between November 20, 2007 and February 28, 2008. See exhibit 10, passim. Also as part of the plan, Mr. Hodge saw a psychiatrist on December 7, 2007. Id. at 70. Dr. Jones obtained a history that is basically in accord with the records summarized above. Like Ms. Kieldgaard, Dr. Jones stated that Ms. Elson told Dr. Jones that Mr. Hodge “feels that if we say the name of his medication, he thinks the medication will become contaminated.” Id. Apparently, Dr. Jones asked Mr. Hodge why there was a prolonged latency in answering questions and Mr. Hodge “admitted to ‘doing rituals in my head.’” Id. at 70. Dr. Jones assigned Mr. Hodge a score of 41-50 on the GAF. Id. at 69. Dr. Jones prescribed various medications, although there was a disagreement among Dr. Jones, Mr. Hodge, and his mother about the best course of medication. Exhibit 10 at 69-70. Mr. Hodge continued to see Dr. Jones during December 2007. Dr. Jones eventually increased the dose of Luvox to100 mg every morning and 50 mg at bedtime as treatment for the OCD and depressive symptoms. Id. at 67. Dr. Jones also noted that Ms. Elson required “much education [regarding Mr. Hodge’s] illness and treatment.” Id. at 68. By the end of December, Dr. Jones stated that Mr. Hodge “[s]tates that he is for the most part great” and that “the rituals have decreased, the mood has improved and even the psychotic stuff has decreased.” Id. at 67. Dr. Jones also noted that Mr. Hodge’s mood was “better,” he was well groomed, and had good eye contact. Id. In January 2008, Mr. Hodge seemed to be having trouble. At the January 3, 2008 visit, Dr. Jones was unable to see Mr. Hodge and spoke only with Ms. Elson. Id. at 66. Dr. Jones stated that Ms. Elson told Dr. Jones that Mr. Hodge “was doing okay on the SSRI, but then all of the sudden he just plummeted.” Id. Ms. Elson reduced the dosage of Luvox to 25 mg per morning. Id. Ms. Elson spoke to Dr. Jones alone about concerns with program manager and left without bringing Mr. Hodge in to see Dr. Jones. Id. Ms. Elson later called stating she no longer wanted Mr. Hodge to receive care at the facility. Dr. Jones expressed willingness to continue care and urged Ms. Elson to continue with medication and therapy. Id. 28 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 29 of 41 Until January 25, 2008, Dr. Jones had noted compliance as “full.” However, during this visit, he noted “MOTHER SELF-ADJUSTS all meds.” Id. at 65. Dr. Jones states that Ms. Elson had discontinued Luvox “[n]ow OCD has gotten worse.” Id. Dr. Jones discontinued Lithium due to Ms. Elson “self-adjusting this med which could be dangerous.” Id. Dr. Jones stated that Mr. Hodge “cont[inues] to have depressive, psychotic and obsessive-compulsive [symptoms] in context of mother self-adjusting doses & starting/stopping meds on own.” Id. By February 2008, Dr. Jones was recommending that Mr. Hodge be admitted to an inpatient service at UCLA. See exhibit 10 at 22, 61, 64. On February 28, 2008, Ms. Elson, Ms. West, and senior people at Transitional Youth met to discuss “issues that have arisen between client’s mother and staff at Transitions.” Ms. Elson stated that she intended for her son to start treatment at UCLA next week. Exhibit 10 at 18. However, Ms. Elson informed Ms. West on April 23, 2008, that Mr. Hodge had not started at UCLA. Id. at 17. Again, Dr. LaRusso translated Mr. Hodge’s numeric GAF scores into words. The GAF of 27 from November 16, 2007 meant that “Behavior is considerably influenced by delusions or hallucinations OR serious impairment in communication or judgment OR inability to function in almost all areas.” Exhibit A at 2; accord exhibit C at 13. The GAF rating from Dr. Jones on December 7, 2007 meant that Mr. Hodge had “Serious symptoms (e.g. suicidal ideation, severe obsessional rituals, frequent shoplifting) OR any serious impairment in social, occupational, or school functioning (e.g. no friends, unable to keep a job).” Id. Dr. LaRusso commented that both “suggest significant impairment.” Id. However, Dr. LaRusso also noted that while in Transitional Youth, Mr. Hodge’s “team had the capacity to determine [potentially missing word] even when his psychiatric symptoms caused impairment.” Exhibit A at 2. Examples of Mr. Hodge displaying the ability to make decisions included signing forms consenting to treatment and permitting his mother to participate, attending and acting appropriately at a holiday party, and declining to being admitted to the hospital on February 15, 2008. Id. at 2-3. Dr. Dunn’s analysis was similar to Dr. LaRusso’s analysis. Like Dr. LaRusso, Dr. Dunn began with the GAF score from November 16, 2007. Dr. Dunn, then, opined that treatment in the following year, which extended beyond 29 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 30 of 41 the services provided at Transitional Youth, “was effective and resulted in significant improvement.” Exhibit C at 13. 7. Miscellaneous Visits – March 2008 through February 2009 Mr. Hodge went to the emergency department on March 8, 2008, at West Hills Hospital & Medical Center because he felt faint while eating dinner. Exhibit 8 at 47. As part of the doctor’s neurologic examination, the doctor recorded that Mr. Hodge “answers all my questions appropriately.” Id. at 48. “He obeys my command appropriately.” Id. The doctor believed the fainting was related to medications that Mr. Hodge was taking for his OCD. Id. Although Dr. Dunn quoted from this report, he did not separately analyze it. See exhibit C at 21. Dr. LaRusso mentioned that during this visit, Mr. Hodge was asked to authorize a release of medical records from another facility. Exhibit A at 3. In May 2008, Ms. Elson returned to Transitional Youth to discuss whether Mr. Hodge should continue to receive services. Exhibit 10 at 14-15. Mr. Hodge did meet with Ms. West four times in June. Id. at 9-10, 12-13. In the last session, Ms. West recorded that Mr. Hodge “resisted answering certain questions, reluctantly explaining that responding specifically about some things ‘triggers’ ‘panic,’ and that this is because it ‘taints’ or ‘contaminates’ certain places/things. [Mr. Hodge] has limited insight as to the nature and reality of these obsessions and delusions.” Exhibit 10 at 9. This June 23, 2008 appointment was the last time that Ms. West saw Mr. Hodge. Id. at 8. On December 4, 2008, Mr. Hodge again went to the emergency department at West Hill. Exhibit 8 at 1-26. He had a rash on his left thigh and a lesion on his left eyelid, neither of which required medical intervention. Id. at 26. Dr. LaRusso noted that Mr. Hodge “was able to sign in to accept treatment and to decline an Advanced Directive.” Exhibit A at 4. Dr. Dunn remarked that his overall care level was “1” meaning the person “typically has their full mental capacities.” Exhibit C at 23, citing exhibit 8 at 13. 30 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 31 of 41 8. Olive View - UCLA Medical Center – February 2009 and May 2009 Mr. Hodge went to a different emergency department, this time the one associated with Olive View - UCLA Medical Center, on February 13, 2009. Exhibit 14 at 372-78; exhibit 7 at 5-8, 213. Mr. Hodge was complaining about headaches for one year and also seizure-like activity for six months. Id. at 372. On this date, blood was drawn for laboratory tests. Exhibit 7 at 213. A note from the triage nurse states that Mr. Hodge was referred for an MRI. Exhibit 14 at 376; see also exhibit 7 at 8 (indicating that Mr. Hodge’s mother requested a neurology follow-up and an MRI). Although the records are not entirely clear, it appears that Mr. Hodge was discharged with “ACI” (presumably, after care instructions) and referred to follow up with the next available appointment in the neurology clinic. Id. at 371. However, it appears that an MRI was not performed in February 2009. Ms. Elson’s September 29, 2014 affidavit describes that MediCal – Medicaid refused to cover an MRI, although Ms. Elson is not specific about when the denial happened. Exhibit 19 at 2. Eventually, Mr. Hodge underwent an MRI on May 18, 2009. Exhibit 2.18 The MRI was performed in the absence of any clinical history. The interpreting doctor, Thu-Anh Hoang, detected multiple lesions in Mr. Hodge’s brain. Id. at 1. Dr. Hoang “suspect[ed] the presence of demyelinating disease, in the absence of adequate clinical history.” Id. at 2.19 18 When Mr. Hodge had a repeat MRI done on August 11, 2009, the doctor compared the results to the May 18, 2009 MRI. Exhibit 7 at 65. The use of the May 18, 2009 MRI as a basis for comparison supports a finding that the May 18, 2009 MRI was the first MRI performed on Mr. Hodge. 19 The version of the May 18, 2009 MRI that appears in exhibit 2 was printed on July 8, 2009, and states that Mr. Hodge was admitted on 02/14/09. The report of the May 18, 2009 MRI also appears as pages 210-11 of exhibit 7. The version in exhibit 7 was printed on July 2, 2010, and indicates Mr. Hodge was admitted on 06/17/10. 31 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 32 of 41 These records received little attention from Dr. Dunn and Dr. LaRusso. See exhibit A at 4, exhibit C at 24. 9. Filing the Petition – July 15, 2009 The May 18, 2009 MRI prompted the filing of the pending petition. See Pet., filed July 15, 2009. According to the petition, Ms. Elson received the results shortly before July 13, 2009. Id. ¶¶ 7, 9. Then, on July 13, 2009, Ms. Elson contacted Mr. Hodge’s attorney, who submitted the petition two days later. Id. ¶ 7. The petition also asserts that until they received the results of the May 18, 2009 MRI, Mr. Hodge and Ms. Elson “had absolutely no reason to suspect that he has had a vaccine related injury.” Id. ¶ 9. 10. Post-Petition Medical Records After May 18, 2009, it appears that the next significant encounter with medical personnel occurred on August 1, 2009, when Mr. Hodge returned to the emergency department at Olive View. Exhibit 14 at 369-70.20 Mr. Hodge was complaining of chest pain on his left side, which Mr. Hodge’s mother reported he was experiencing on and off for two years. Id. at 369. The triage nurse also recorded that Mr. Hodge was seeing a “neurologist for headaches, dizziness, muscle aches, numbness to arms and [abnormal] MRI.” Id. (capitalization changed without notation). Mr. Hodge went to the neurology clinic a few days later. Exhibit 7 at 45-46. The chief complaint was recorded as: 22 [year old] [male] referred for headaches from Midvalley – Dr. Munoz. Pt. was normal prior to age of 20 The Secretary asserted that Mr. Hodge was at Olive View on June 3, 2009. Resp’t’s Rep. at 8, citing exhibit 7 at 81. The problem is that although the laboratory studies presented on this page do say “Adm: 06/03/09,” the reports also indicate that the blood was collected about one year later on 06/24/2010. Id. On the other hand, there is a negative test for antibodies for Borrelia burgdorferi, the causative agent for Lyme disease, that was drawn on June 18, 2009. Id. at 204. Other laboratory tests were conducted on blood drawn on July 23, 2009. Id. at 194. 32 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 33 of 41 17, abrupt onset of OCD-like behavior (counting, checking, etc) over 1 month, then onset of a mental “fogginess” / “detachment from reality” of insidious onset that has since waxed and waned with periods of “normalcy.” By the age 19, mother states he has never been back to baseline psych level always somewhat detached/ wierd [sic]. At age 18½ had routine hep B vaccine, then that night had stabbing spinal back pain [with] neg CT head. Age 19, pt [complained of] “arm/neck/back” muscle and skin “tightness” [with] spams of gradual onset (intermittent). Also has a numbness of mainly arm that is somewhat persistent but is intermittently exacerbated. + tick exposure in North Cal [with] neighbor [with] Lyme [disease]. Mother convinced [symptoms] [secondary to] hep vaccine. Id. at 46. The report also contains a summary of the results from a mental status examination. “Mr. Hodge was oriented to person, place, time, and situation. His mood was normal, but his affect was blunted. He had difficulty with serial 7’s, and he displayed slight perseverations.” Id. at 46. The author (probably Dr. Mishra) was aware of an MRI and testing for Lyme disease. The author ordered various tests including another MRI. Id. Both Dr. Dunn and Dr. LaRusso included information from this appointment in their reports, but neither provided any opinion about Mr. Hodge’s ability to function in early August 2009. See exhibit A at 4, exhibit C at 25. A more significant record came from Dr. Dasher on October 22, 2009. The chief complaint included “‘Fog in head, memory issues, joint pains throughout body’ [for] 4-5 years” and “some new onset OCD [symptoms] – incredible urge to touch, count.” Exhibit 14 at 441. Dr. Dasher also completed a mental status exam. For most categories, Mr. Hodge was normal. His mood was anxious and angry, but he denied being depressed. His obsessions were touching and counting. He denied delusions and 33 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 34 of 41 auditory hallucinations. There was a question about visual hallucinations. Id. at 446. Dr. Dasher determined that Mr. Hodge’s GAF was currently 45 and 60 within the past year. Dr. Dasher recommended neurocognitive / personality testing. Id. at 447. According to Dr. Dunn,21 a GAF score of 60 does not indicate severe impairment or lack of capacity. Dr. Dunn concludes that for approximately one year before Dr. Dasher’s assessment, which was on October 22, 2009, Mr. Hodge was competent. Exhibit C at 25. In contrast, Dr. Dasher’s report in this litigation indicates that when Dr. Dasher has been able to observe Mr. Hodge, Mr. Hodge has not been capable of handling his own affairs. Exhibit 22 at 2 (point 3). Dr. Dasher’s October 22, 2009 report is the most recent contemporaneously created record that bears upon Mr. Hodge’s capacity from 2006 to July 2009. 11. Evaluation The expert reports, which the parties did not submit until after the Court remanded the case, were very helpful in understanding Mr. Hodge’s capacity. Dr. Dasher’s opinion is that Mr. Hodge was generally not capable of managing his affairs, at least in the time that Dr. Dasher was treating Mr. Hodge. Exhibit 22. Dr. LaRusso opined that “Mr. Hodge suffered a period of significant psychiatric decompensation beginning on July 7, 2007. . . . There was some improvement in his condition with therapeutic treatment, and his records show he had a level of impairment but retained a level of capacity to make decisions.” Exhibit A at 6. Dr. Dunn concluded that just before July 10, 2007, “Mr. Hodge became severely impaired and lacked capacity. This period of incompetency lasted for approximately one year, until the middle of 2008.” Exhibit C at 27. The opinions of Dr. LaRusso and Dr. Dunn that Mr. Hodge lacked capacity for approximately one year is sufficient to find that Mr. Hodge is entitled to 21 Dr. LaRusso did not address Dr. Dasher’s GAF score of 60. 34 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 35 of 41 equitable tolling. Thus, the undersigned refrains from making any factual findings regarding Mr. Hodge’s capacity from April 2006, when he received the first vaccinations, through the end of June 2007, which is shortly before he was evaluated at West Valley. The undersigned also refrains from making any factual findings regarding Mr. Hodge’s capacity after September 2008, which corresponds to the approximate date at which Dr. Dasher scored Mr. Hodge’s GAF as 60. The determination that approximately one year of impaired capacity suffices to entitle Mr. Hodge to equitable tolling is based, in part, on the amount of time by which Mr. Hodge filed late. Based upon Mr. Hodge’s visit to Valley Presbyterian Hospital (exhibit 6 at 1-12), Dr. Tornatore opined that Mr. Hodge’s mental condition was substantially worse on June 2, 2006. Exhibit 18. Thus, Mr. Hodge should have filed his petition by June 3, 2009. 42 U.S.C. § 300aa−16(a)(2). He actually filed on July 15, 2009, which is 42 days later. The parties largely overlooked the significance of the duration of impairment. Mr. Hodge simply argued that he lacked capacity throughout the time from April 2006 through July 2009. Pet’r’s Br., filed Oct. 16, 2015, at 16. Consistent with her argument that equitable tolling for mental illness is not compatible with the Vaccine Act (see section I above), the Secretary stated that during this one-year period, an unappointed guardian could have filed a petition for Mr. Hodge. Resp’t’s Br., filed Nov. 20, 2015, at 10 n.7. Stronger guidance comes from the Federal Circuit’s opinion in Checo v. Shinseki, 748 F.3d 1373 (Fed. Cir. 2014), a case that the Secretary cited. There, Ms. Checo sought veterans’ benefits. However, on July 6, 2011, the Board of Veterans’ Appeals denied her request. On this date, Ms. Checo was homeless, and apparently remained homeless until September 27, 2011, when she communicated a new address to the Department of Veterans Affairs. She received a copy of the Board’s adverse decision on October 6, 2011, which was within the time permitted to file an appeal. However, she did not file the appeal until December 7, 2011, 33 days later. Checo, 748 F.3d at 1375. The Federal Circuit accepted the parties’ contention that the period of equitable tolling should be measured with a “‘stop-clock’ approach.” Id. at 1380. Under the stop-clock approach, “the clock measuring the 120-day appeal period is 35 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 36 of 41 ‘stopped’ during the extraordinary circumstance period and starts ticking only when the period is over.” Id. at 1379. As a case arising from a claim for veterans benefits, Checo has different factual underpinnings than a case from the Vaccine Program. Nevertheless, Checo is a case from the Federal Circuit. Moreover, the reasoning of the “stop-clock approach” is persuasive.22 Thus, the undersigned will also use the stop-clock approach to Mr. Hodge’s case.23 Therefore, the essential chronology should be restated as follows: On June 2, 2006, Mr. Hodge’s claim accrued and the clock representing the 36-month statute of limitations started ticking. By July 2007, approximately 13 months of time on the statute of limitations clock had expired and approximately 23 months of time remained. On July 10, 2007, this clock was stopped because Mr. Hodge was unable to manage his own affairs. In September 2008, the statute of limitations clock began ticking again. By July 2009, 10 more months had elapsed, but 13 months remained. Therefore, Mr. Hodge filed his petition within the time permitted by the statute of limitations as adjusted for equitable tolling. 22 This approach is also consistent with 28 U.S.C. § 2501, stating that a petition may be filed within three years after the disability ends if the person was under legal disability at the time the claim accrued. 23 An alternative approach would be to require people lacking mental capacity to manage their affairs to establish that the incapacity lasted the entire period covered by the statute of limitations. See Checo, 748 F.3d at 1379-80; MacLennan v. Provident Life & Acc. Ins. Co., 676 F. Supp. 2d 57, 63 (D. Conn. 2009). The Secretary has not made this argument and, therefore, it is not considered. 36 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 37 of 41 Consequently, Mr. Hodge’s case will proceed to the merits of evaluating whether the hepatitis A and hepatitis B vaccinations caused him any harm. IV. Issues Implicated by Mr. Hodge’s Status as the Petitioner Mr. Hodge’s claim for equitable tolling based upon a lack of capacity differs from other claims for equitable tolling based upon an isolated problem. Mojica, 102 Fed. Cl. 96, illustrates a more traditional example of equitable tolling. There, the petitioners’ attorney sent a petition through an overnight delivery service that lost the petition. After an unusual series of procedural events (id. at 97-98), the Court of Federal Claims recognized that the petitioners’ case qualified as an “extraordinary circumstance” for which equitable tolling was appropriate. Id. at 101. Significantly, after the case was allowed to proceed, the reason for the late filing and extraordinary circumstance justifying equitable tolling was no longer an issue. Mr. Hodge’s case is different in the sense that according to him, his mental illness has lasted throughout this case.24 This leads to two questions about Mr. Hodge’s status as the petitioner when the case was originally filed and his continued ability to act as the petitioner. As discussed earlier, the Vaccine Act identifies three people who qualify as petitioners. 42 U.S.C. § 300aa−11(b)(1)(A). In filing his petition, Mr. Hodge appears to have represented himself as a “person who has sustained a vaccine- related injury,” which is listed first. Notably, Mr. Hodge did not take advantage of the statute’s second category of people who qualify as petitioners: “the legal representative of such person if such person is a minor or is disabled.” When the petition is brought by the legal representative of a disabled person, “the petition must also be accompanied by documents establishing the authority to file the petition in a representative capacity or a statement explaining when such documentation will be available.” Vaccine 24 Mr. Hodge recognized that before receiving the vaccinations in 2006, he had been prescribed Adderall and diagnosed with obsessive compulsive disorder. Pet’r’s Mem., filed Oct. 16, 2015, at 15. Mr. Hodge implies that before the vaccinations, he could function as Mr. Hodge asserts that “Following the second vaccination, he became incapable of rational thought.” Id. 37 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 38 of 41 Rule 2(c)(2)(C). According to the Rules of the Court of Federal Claims, “an incompetent person who does not have a duly appointed representative may sue by a next friend or by a guardian ad litem.” Rule 17(c)(2) of the Rules of the Court of Federal Claims. In advancing his claim for equitable tolling, Mr. Hodge seems to admit that he was disabled. Mr. Hodge states he “was not capable of rational thought, deliberate decision [making], and unable to function in society when the petition was filed in July of 2009.” Pet’r’s Mem., filed Oct. 16, 2015, at 15-16. Petitioner further admits that this disability runs through the present day “render[ing] him incapable of rational thought, deliberate decision-making and unable to function in society.” Pet’r’s Mem., filed Dec. 4, 2015, at 12. The petitioner’s characterization of himself as unable to function in society is consistent with Dr. Dasher’s most recent report. Exhibit 27. Thus, it would appear that Mr. Hodge’s petition should have been brought on his behalf by a next friend or guardian ad litem. A remedy for this potential problem is found in RCFC 17.25 When an incompetent person does not have a representative (meaning a general guardian or conservator), a “court must appoint a guardian ad litem — or issue another appropriate order — to protect” the incompetent person. RCFC 17(c)(2). The Court of Federal Claims found that a special master’s orders to the parents of an incompetent (but unrepresented) adult constituted “an appropriate order.” Kennedy, 99 Fed. Cl. at 543. Here, the undersigned proposes that Mr. Hodge should have a general guardian or conservator appointed for him through the California Probate Court. The reasons for this proposal are several. Mr. Hodge’s claim for equitable tolling is premised on his lack of ability to manage his own affairs. Thus, someone must watch out for him. A potential choice in this litigation is to assume that Mr. Shoemaker, who represents Mr. Hodge as an attorney, is advancing Mr. Hodge’s best interests. However, the duties of an attorney differ from the duties of a 25 Special masters in the Vaccine Program may use RCFC 17. Kennedy v. Sec’y of Health & Human Servs., 99 Fed. Cl. 535, 542 (2011), subsequent decision aff’d, 485 F. App’x 435 (Fed. Cir. 2012). 38 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 39 of 41 guardian ad litem. McCaslin v. Radcliff, 168 F.R.D. 249, 256 (D. Neb. 1996), aff'd without opinion, 141 F.3d 1169 (8th Cir. 1998). In addition, although Kennedy states “the Special Master could have appointed the parents as ‘next friends’ or guardians ad litem,” 99 Fed. Cl. at 542, the Federal Circuit has not confirmed the extent of a special master’s authority. Special masters must heed the limits to their authority. See Patton v. Sec’y of Health & Human Servs., 25 F.3d 1021, 1026 (Fed. Cir. 1994) (“the Office of Special Masters owes its existence to and derives its powers from the Vaccine Act”). This caution seems especially appropriate here because the California Probate Court is a tribunal whose duties include appointing guardians or conservators. The California Probate Court, therefore, has extensive experience with determining who should act as an incompetent person’s guardian or conservator. The California Probate Court also has a system to oversee the performance of the guardian or conservator. These features make the California Probate Court a better forum to determine who should act for Mr. Hodge. Finally, the California Probate Court’s appointment of an appropriate representative for Mr. Hodge may expedite resolution of this matter. Assuming that the special master could and did appoint a next friend, the next friend probably could not receive the compensation. See Neilson v. Colgate-Palmolive Co., 199 F.3d 642, 656 (2d Cir. 1999) (noting that after district court appointed a guardian ad litem, the district court did not have to delay approving a settlement for appointment of general guardian); Noe v. True, 507 F.2d 9, 12 (6th Cir. 1974) (describing duties of guardian ad litem). In the Vaccine Program, the Secretary universally (or nearly universally) conditions payments to a minor’s parents on the parents’ status as guardians appointed by the local probate court. See, e.g., Sucher v. Secʼy of Health & Human Servs., No. 07-58V, 2012 WL 1030028 (Fed. Cl. Spec. Mstr. March 2, 2012) (awarding cost for surety bond required for appointment of conservator); Stewart v. Secʼy of Health & Human Servs., No. 06-287V, 2011 WL 5330388 (Fed. Cl. Spec. Mstr. Oct. 17, 2011) (awarding compensation for establishing guardianship). Thus, if Mr. Hodge succeeds in his goal of receiving compensation through the Vaccine Program, he will, in all likelihood, be required to have a general 39 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 40 of 41 guardian or conservator appointed for him.26 Under these circumstances, involving the California Probate Court earlier, rather than later, may be a more efficient path. Both parties ARE ORDERED to file briefs addressing the advisability of an order requiring Mr. Hodge to request an appropriate action by the California Probate Court. Needless to say, Mr. Shoemaker should present the views of his client, Mr. Hodge, which may (or may not) align with the views of his mother. The parties shall file supplemental briefs on this issue in 30 days. Conclusion As developed on remand, Mr. Hodge’s argument for equitable tolling presents several complicated legal issues. These include: 1. Whether the Vaccine Act permits equitable tolling for mental disability or does the Vaccine Act’s provision that a legal representative of a disabled person may file a petition preclude the use of equitable tolling for disability? 2. Must petitioners who are claiming equitable tolling for mental disability establish diligence in pursuing their legal rights to file a claim? 3. For claims of mental disability, must petitioners establish that the disability impaired their functioning for the entire period covered by the statute of limitations? These are questions of law for which there is little (or no) appellate guidance. As the case law around equitable tolling develops, the conclusions reached in this decision may need to be revisited. In addition to these challenging issues of law, Mr. Hodge’s case involves questions of fact. The primary factual determination is that Mr. Hodge was not capable of managing his affairs from July 2007 through September 2008. Pursuant 26 Due to the issues involving the statute of limitations and equitable tolling, the parties have not presented any expert reports addressing whether the hepatitis vaccinations in 2006 harmed Mr. Hodge in some way. Thus, this ruling should not be interpreted as providing any guidance as to whether Mr. Hodge will be found entitled to compensation. 40 Case 1:09-vv-00453-MMS Document 142 Filed 01/11/16 Page 41 of 41 to a “stop-clock” approach to equitable tolling, this period of disability is sufficient to find that Mr. Hodge is entitled to equitable tolling. Finally, because Mr. Hodge has stated that he is disabled, the California Probate Court may wish to appoint a guardian for him. The parties are instructed to file briefs within 30 days on this topic. This ruling is intended to answer the Court’s remand. As such, the Clerk’s Office is instructed to transmit it to the presiding judge. See Vaccine Rule 28.1(a). However, this ruling does not constitute a “decision” as that term of art is used in the Vaccine Program. See Currie v. Secʼy of Health & Human Servs., No. 02- 838V, 2003 WL 23218074 (Fed. Cl. Spec. Mstr. Nov. 26, 2003). IT IS SO ORDERED. s/ Christian J. Moran Christian J. Moran Special Master 41 ================================================================================ DOCUMENT 4: USCOURTS-cofc-1_09-vv-00453-5 Date issued/filed: 2022-10-04 Pages: 58 Docket text: PUBLIC DECISION (Originally filed: 9/12/2022) regarding 376 DECISION of Special Master Signed by Special Master Christian J. Moran. (jmw) Service on parties made. -------------------------------------------------------------------------------- Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 1 of 58 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS * * * * * * * * * * * * * * * * * * * * * * * * * JEREMY HODGE, * No. 9-453V by his conservator ERIKA ELSON, * * Special Master Christian J. Petitioner, * Moran * * Filed: September 12, 2022 v. * * Obsessive-compulsive disorder SECRETARY OF HEALTH * (“OCD”); hepatitis B vaccine; AND HUMAN SERVICES, * Lyme disease; neuroborreliosis; * demyelination; burden of proof; Respondent. * significant aggravation; * collection of medical records; * entitlement. * * * * * * * * * * * * * * * * * * * * * * * * * Renee J. Gentry, Vaccine Injury Clinic, George Washington Univ. Law School, Washington, DC, for Petitioner; Althea W. Davis, United States Dep’t of Justice, Washington, DC, for Respondent. PUBLISHED DECISION DENYING ENTITLEMENT1 I. Introduction For the many reasons discussed below, this is an unfortunate and unusual case. This case has been pending for over a decade, due in large part to disputes 1 The E-Government Act, 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services), requires that the Court post this decision on its website. This posting will make the decision available to anyone with the internet. Pursuant to Vaccine Rule 18(b), the parties have 14 days to file a motion proposing redaction of medical information or other information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by the special master will appear in the document posted on the website. 1 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 2 of 58 regarding equitable tolling and evidentiary problems, discussed below in sections II.A and III. The petitioner’s claim is complex: Erika Elson alleges that (1) her son, Jeremy Hodge, developed Lyme disease in 2003; (2) the untreated bacterial infection progressed to a central nervous system disorder known as neuroborreliosis; (3) the Lyme disease / neuroborreliosis in turn caused him to develop obsessive-compulsive disorder (“OCD”); (4) then, the 2006 hepatitis B vaccine(s) significantly aggravated his condition. More details regarding the petitioner’s position and the respondent’s rebuttals are discussed below in section II.B. A recitation of the available evidence follows in section III, forming the basis for fact finding in section IV. A primary issue pervading this case is the absence of records during the critical periods of time. It is the petitioner’s burden to present preponderant evidence supporting his or her claims. Determining whether certain assertions in this case are true (on a more likely than not basis) is extremely difficult without making inferences and guesses. While special masters may draw plausible inferences, it is improper to be arbitrary or capricious when determining facts. Hines v. Sec’y of Health & Hum. Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991). Guesswork is inappropriate. Ultimately, it is the special master’s task to determine whether assertions in a particular case are more likely than not to be true. Here, the petitioner has fallen short of supplying preponderant evidence to support assertions that are essential to her claim. A secondary (and intimately related) issue regards the testimony from Ms. Elson. Due to the absence of objective, contemporaneously created records, Ms. Elson has attempted to fill in the evidentiary gaps by providing testimony many years after the subject events took place. However, human memory is seldom perfect, and recall becomes less robust over time. To be sure, testamentary evidence is valuable and must be considered. However, a persistent problem with this case, revealed below in section III.A.4 and III.B. 3, and discussed in section IV, is that Ms. Elson’s testimony has been inconsistent. Generally speaking, when a case participant asserts incongruous statements, fact-finders are justified in being skeptical of the accuracy of the speaker’s statements. Camery v. Sec'y of Health & Hum. Servs., 42 Fed. Cl. 381, 391 (1998) (noting “testimony that is inconsistent with medical records must be consistent, clear, cogent and compelling to outweigh the medical records prepared for the purpose of diagnosis and treatment.”); Caron v. Sec’y of Health & Hum. Servs., 136 Fed. Cl. 360, 377-78 (2018). Furthermore, when documents are lacking and inconsistent testimony permeates the record, fact- 2 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 3 of 58 finders have the unenviable chore of deciding between two (or more) versions of events. A tertiary problem is that the experts have developed their opinions based upon the rough sketch that the limited record evidence provides. Clinicians and expert witnesses often work with incomplete pictures. They are tasked with developing hypotheses and theories about what happened, what is happening, and what will happen in the future. This necessarily involves making inferences and assumptions. Although the experts have provided theories about Mr. Hodge’s life, they have built their versions of events upon shaky foundations. Before considering the experts’ theories, the special master must make findings of facts. The uncertainty involved in examining an incomplete record does not prevent a special master from making factual determinations on a more likely than not basis. In re Claims for Vaccine Injuries Resulting in Autism Spectrum Disorder or a Similar Neurodevelopmental Disorder, 2004 WL 1660351, at *8 (Fed. Cl. July 16, 2004) (“in legal factfinding, if there is no evidence, the factual issue simply is resolved against the party having the ‘burden of proof.’”). However, doing so judiciously is challenging. To illustrate the difficult task, imagine an unfinished puzzle featuring lots of blue puzzle pieces with wisps of white. To some, it may appear to be a sky with clouds; to others, it looks like an ocean with sea foam. Occasional unconnected red pieces could be part of a plane or the side of a sailboat. To build their cases, petitioners must preserve, produce, and present the puzzle pieces that paint their portrait. It is insufficient to build a blue border, depict disjointed red dots, and declare the puzzle represents a sky with an airplane – the petitioner must present preponderant evidence to persuade the special master that the puzzle is more likely than not what they claim it to be. In other words, the dots need to be connected and the border must persuasively resemble a sky and not an ocean. The above issues are defining characteristics of this case. In the Vaccine Program, many cases succeed or fail based upon the contemporaneously created medical records. Unfortunately, for a multitude of reasons discussed below, records during critical timeframes do not exist in this case. Petitioners may still succeed even without stellar records. But, for the reasons detailed below, the testimony necessary to rescue petitioner’s case is not persuasive enough to establish pertinent facts. Without a solid foundation of facts, much of the expert testimony becomes moot. 3 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 4 of 58 In this case, petitioner’s expert, Dr. Carlo Tornatore, assumes that Mr. Hodge suffered from Lyme disease before Mr. Hodge developed OCD. However, petitioner has not established that predicate with preponderant evidence. II. Case Overview A. Procedural History The duration of this case is unusual, and the recitation of events during its pendency is, accordingly, lengthy as well. For approximately six years, the parties focused on determining whether the case could proceed because the statute of limitations appeared to bar the claim. Part of this process, which is described in section II.A.1 below, involved the gathering of medical records. Eventually, the undersigned found that the doctrine of equitable tolling allowed the case to proceed. The next stage concerned the development of opinions as to whether the 2006 vaccinations caused Mr. Hodge’s OCD to worsen. As discussed in section II.A.2 below, this stage ended when an entitlement hearing was cancelled to allow Ms. Elson to obtain additional records about Mr. Hodge’s health in 2005 and 2006. Section II.A.3 below recounts some of the efforts to obtain this information. Ideally, all records about Mr. Hodge’s health and well-being should have been gathered from schools, doctors, and counselors much closer to when the petition was filed in 2009, not a decade later. After these efforts ended and the experts reviewed the material, the case proceeded to an entitlement hearing on June 14-15, 2021. The parties then filed briefs, making the case ready for adjudication. 1. Petition through December 21, 2015 Ruling Finding Equitable Tolling2 Represented by Mr. Clifford Shoemaker, the petitioner filed the petition on July 15, 2009, alleging that Mr. Hodge suffered “various injuries” after receiving hepatitis A and hepatitis B vaccines in March and April of 2006. Pet. at 2, 5-6. In July 2009, the petitioner was identified as Jeremy Hodge, although whether Mr. Hodge engaged Mr. Shoemaker and whether he possessed the capacity to retain an attorney appeared unclear. 2 The December 21, 2015 ruling regarding equitable tolling sets out the procedural history relevant to the statute of limitations and equitable tolling issues in more detail. 2015 WL 9685916. 4 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 5 of 58 Mr. Shoemaker stated that Mr. Hodge’s mother (Ms. Elson) contacted Mr. Shoemaker less than 48 hours before Mr. Shoemaker filed the petition. Mr. Shoemaker was filing the petition as quickly as possible “to stop the running of the statute of limitations.” Pet. ¶ 11. Mr. Shoemaker further explained that he possessed only two medical records: the vaccination record and the results of a May 19, 2009 MRI.3 Id. Mr. Shoemaker filed those documents as exhibits 1 and 2 on November 3, 2009. In the absence of other medical records, Mr. Shoemaker stated that Mr. Hodge “experienced various symptoms that will be described in subsequently filed affidavits from the Petitioner, his mother and perhaps other witnesses. Presumably, many of these symptoms will also be found in medical records.” Pet. ¶ 6. On behalf of petitioner, Mr. Shoemaker sought and received authorization to serve subpoenas to gather medical records. See Pet’r’s Mot., filed July. 15, 2009; Order Granting Mot., issued Aug. 31, 2009. It is not readily apparent whether Mr. Shoemaker served subpoenas on Valley Care, the institution where Mr. Hodge was allegedly diagnosed with OCD, or Dr. John Nasse, a doctor who provided mental health services to Mr. Hodge. See Resp’t’s Post Hearing Br. at 32 n.20. The petition acknowledged a potential statute of limitations problem. Pet. ¶ 7. In the initial status conference on September 3, 2009, the Secretary raised the statute of limitations problem and consistently reminded petitioner about this problem. Nevertheless, Mr. Shoemaker pressed forward on behalf of Mr. Hodge / Ms. Elson. Between November 2009 and January 2012, the petitioner filed medical records (exhibits 1-8, 10-12) and an affidavit from his mother (exhibit 9) in support of the claims, which are summarized below. Mr. Hodge did not submit an affidavit from himself. After Mr. Hodge appeared to have filed most of the relevant medical records, the Secretary filed a Rule 4 report and motion to dismiss the petition on April 30, 2012. The Secretary identified some problems with the medical records that remain unresolved ten years later. For example: • The psychologist or psychiatrist who prescribed Zoloft in March 2005 was not identified. Resp’t’s Rep. at 2, citing exhibit 3 at 4. 3 Although the record states the “D/T” (likely Date of Treatment) was May 18, 2009, the date of study is listed as May 19, 2009. The parties use the May 19, 2009 date. To avoid confusion, the undersigned will refer to this MRI as occurring on May 19, 2009. See exhibit 2 and exhibit 7 at 210-211. 5 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 6 of 58 • Dr. Rodriguez’s handwritten notes from March 17, 2006 and June 8, 2006 were not entirely legible. Resp’t’s Rep. at 2 n.2, citing exhibit 5 at 2, and Resp’t’s Rep. at 4, citing exhibit 5 at 4. • The psychologist or psychiatrist whom Mr. Hodge was seeing in April 2006 was not identified. Resp’t’s Rep. at 3, citing exhibit 5 at 3. • A lack of clarity about the neurologist whose treatment in June 2006 displeased Ms. Elson. Resp’t’s Rep. at 4, citing exhibit 5 at 3. • Any VAERS report that Dr. Rodriguez may have submitted in June 2006. Resp’t’s Rep. at 4, citing exhibit 5 at 4.4 • The person (possibly a psychiatrist) who prescribed Inositol that Mr. Hodge was taking in August 2006. Resp’t’s Rep. at 5, citing exhibit 4 at 15. The Secretary additionally explained that this list related to the timeliness of filing the petition. The Secretary stated: The parties have discussed previously the incompleteness of petitioner’s medical records. However, given the potential that this claim is untimely, and the possibility that petitioner may not be entitled to attorneys’ fees and costs, respondent has attempted to limit any requests for additional records to those needed to determine whether petitioner’s claim is timely. Respondent reserves the right, however, to request that petitioner provide complete records from all care providers for the relevant time periods both before and after his March and April, 2006 vaccinations. Resp’t’s Rep. at 18 n.14. Beyond identifying these deficiencies among the records Mr. Hodge had filed, the Secretary raised two arguments against compensation. First, the Secretary maintained that the petition was filed beyond the time permitted by the statute of limitations. Second and briefly, the Secretary contended that Mr. Hodge had not submitted evidence to show a vaccination caused any injury, and thus the Althen factors had not been satisfied. Id. at 17-20. 4 In an affidavit filed in 2021, Ms. Elson stated that she never filed a VAERS report. Exhibit 86 at 25. 6 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 7 of 58 At the undersigned’s direction, the Secretary formally requested medical records. Resp’t’s Status Rep., filed May 21, 2012. In response, Mr. Shoemaker stated that counsel was working with Mr. Hodge’s mother, who would be sending counsel medical records and contact information. Pet’r’s Status Rep., filed July 20, 2012.5 Months later, no additional records had been filed. Mr. Shoemaker represented that he had not been able to speak with Ms. Elson because she was caring for Mr. Hodge. Mr. Shoemaker represented that he would send requests for records later that week. Pet’r’s Status Rep., filed Oct. 25, 2012.6 Pursuant to an order, Mr. Hodge filed medical records on January 4, 2013. Exhibits 13-14. Mr. Shoemaker discussed the efforts to obtain more records, of which the most important concerned the diagnosis and treatment for Mr. Hodge’s OCD. For this problem, Mr. Shoemaker seemed to be relying upon Ms. Elson’s work: Counsel has spoken to the Petitioner’s mother and she told Counsel that she was unsure of the name of the provider. She told Counsel that she drove by the building that the provider was at and they are no longer there. She said she would place a call into the County to see if the records exist anymore. Pet’r’s Status Rep., filed Jan. 31, 2013. It appeared that despite some outstanding requests for records, Mr. Hodge may have produced medical records sufficient for him to respond to the Secretary’s pending motion to dismiss due to untimeliness. The undersigned directed Mr. Hodge to obtain a report from an expert addressing three questions. These questions were: (1) what is a proper diagnosis for Mr. Hodge? (2) when did Mr. 5 Mr. Shoemaker’s associate, Sabrina Knickelbein, signed these status reports on behalf of Mr. Shoemaker. See Rule 83.1(c)(2) of the Rules of the Court of Federal Claims (authorizing one member of the bar to sign for counsel of record). 6 Medical records produced later showed that Mr. Hodge was in counseling with Dr. Dasher around this time. See exhibit 14.2 at 106. 7 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 8 of 58 Hodge begin to suffer from that disease? and (3) whether any additional treatment and/or testing is appropriate for Mr. Hodge? Order, issued April 24, 2013.7 Mr. Shoemaker filed a status report regarding outstanding medical records requests on May 6, 2013. Counsel reported that he spoke to Ms. Elson, reviewed the file, and she indicated that all of the records for Dr. Rodriguez had been filed, thus they would no longer pursue that request. Counsel also continued to seek records from Greg Nelson, a dermatologist. On August 23, 2013, Mr. Hodge filed an export report from Dr. Tornatore. Exhibit 18. Dr. Tornatore opined that “the diagnosis of neuroborreliosis would not be unreasonable.” Id. at 2. Furthermore, with the information available at that time, Dr. Tornatore opined that the medical records showed that the neuroborreliosis began in 2005. Id. at 2. Dr. Tornatore also stated that some of Mr. Hodge’s reported symptoms (dizziness and eye movement disturbances on June 2, 2006), evidenced a worsening of his “underlying autoimmune demyelinating disorder.” Id. Although Dr. Tornatore’s report filled some gaps in Mr. Hodge’s evidence, Mr. Hodge had not responded to the legal arguments in the Secretary’s motion to dismiss. The parties developed their legal arguments in briefs. See Pet’r’s Memo, filed Jan. 30, 2014; Resp’t’s Resp., filed May 9, 2014; Pet’r’s Sur-Reply, filed Oct. 1, 2014. With Mr. Hodge’s Sur-Reply, he submitted an affidavit from Ms. Elson. Exhibit 19. The undersigned granted the Secretary’s motion to dismiss based upon two rulings. First, the undersigned determined that Mr. Hodge filed his petition after the statute of limitations elapsed. Second, the undersigned found that Mr. Hodge did not establish his mental illness justified equitable tolling. Decision, 2015 WL 1779274 (Mar. 23, 2015). This decision, however, did not lead to a judgment. Mr. Hodge filed a motion for review. The Court vacated the aspect of the March 23, 2015 decision concerning equitable tolling and remanded for additional consideration. Opinion and Order, 123 Fed. Cl. 206 (2015). On remand, the parties filed additional evidence regarding Mr. Hodge’s mental capacity. See, e.g., exhibit 20 (records from Dr. Glenn Mathisen and Dr. Wendy Clough, contemplating potential problems Mr. Hodge might have been 7 During the status conferences held to discuss the collection of medical records, the Secretary continued to question the reasonable basis for this claim. See orders dated June 27, 2013; April 24, 2013. 8 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 9 of 58 experiencing, including Lyme disease and other issues); exhibit 21 (affidavit from Ms. Elson); exhibit 22 (report of Robert Dasher, a psychologist who treated Mr. Hodge); exhibit A (report of Elizabeth LaRusso, a psychiatrist the Secretary retained); exhibit C (report of John Dunn, a neuropsychologist the Secretary retained). Mr. Hodge filed another affidavit from his mother, who challenged some factual assertions made by Dr. LaRusso and Dr. Dunn. Exhibit 26. The undersigned found that Mr. Hodge qualified for equitable tolling. Ruling, 2015 WL 9685916 (Dec. 21, 2015). The undersigned held, as a matter of law, that the Vaccine Act authorized equitable tolling for mental illnesses.8 The undersigned also held that to be entitled to equitable tolling, a claimant must establish that he is “incapable of handling his own affairs.” Id. at *8, quoting Barrett v. Principi, 363 F.3d 1316, 1321 (Fed. Cir. 2004). Based upon the evidence, the undersigned found that Mr. Hodge’s mental illness deprived him of the ability to handle his own affairs, justifying equitable tolling. Id. at *24. Finally, the undersigned suggested that the finding that Mr. Hodge could not handle his own affairs implied that Mr. Hodge should not be the petitioner in this case. Id. at *24. 2. Development of Expert Opinions and Initial Scheduling of Entitlement Hearing 9 The December 21, 2015 ruling allowed the case to proceed. The first task was to resolve who should be the petitioner. Mr. Shoemaker stated that Ms. Elson intended to become the conservator for Mr. Hodge through the California Probate Court. Pet’r’s Status Rep., filed Jan. 20, 2016. On October 4, 2016, Mr. Shoemaker filed an order appointing Ms. Elson conservator. Exhibit 28. Based upon this order, Mr. Shoemaker sought to amend the caption.10 Once the identity of the petitioner was resolved, the parties proceeded to develop evidence related to causation in earnest. An October 24, 2016 order structured the next steps. The Secretary suggested obtaining updated medical records and Mr. Shoemaker was agreeable. In retrospect, Mr. Shoemaker should 8 The Federal Circuit later agreed with this holding. K.G. v. Sec’y of Health & Hum. Servs., 951 F.3d 1374, 1381 (Fed. Cir. 2020). 9 The December 21, 2015 ruling regarding equitable tolling sets out the procedural history relevant to the statute of limitations and equitable tolling issues in more detail. 2015 WL 9685916. 10 The caption was officially modified on November 9, 2016. 9 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 10 of 58 have done more to obtain records, such as school records and medical records, created before 2006 and around the time of the vaccinations in 2006. However, it appears that by 2016, all participants (including the undersigned) had failed to appreciate that the petitioner should gather more information about Mr. Hodge’s health before and shortly after the vaccinations. In any event, Mr. Shoemaker wanted to obtain a report from Dr. Tornatore in which Dr. Tornatore could explain how the vaccinations significantly aggravated Mr. Hodge’s pre-existing OCD. To further this process, the undersigned proposed a set of instructions for preparation of expert reports. Order, issued Oct. 24, 2016. These instructions directed the experts to present opinions regarding the expected course of OCD. Final Instructions, issued Nov. 22, 2016, ¶ 4.b. The petitioner, now Ms. Elson, filed Dr. Tornatore’s report on January 23, 2017. Exhibit 29. In presenting this report, Dr. Tornatore did not address the expected course of OCD. See id. The next day, Ms. Elson filed two more medical records. Exhibits 31-32. Ms. Elson added another set of medical records on February 17, 2017. Exhibit 33. Ms. Elson filed an amended petition on March 6, 2017. The amended petition was short, barely more than one page. Based on Dr. Tornatore’s report, the amended petition alleged that the 2006 vaccinations significantly aggravated Mr. Hodge’s neuroborreliosis. Am. Pet., filed March 6, 2017, ¶ 6.11 Dr. Tornatore’s report suggested that records from a psychiatrist or psychologist who treated Mr. Hodge might be necessary. Accordingly, Ms. Elson was directed to file a status report regarding records from a psychiatrist or psychologist. Order, issued Feb. 13, 2017. Ms. Elson, in turn, represented that the “petitioner has filed all of his psychiatrist and psychologist records.” Pet’r’s Status Rep., filed March 15, 2017. In retrospect, again, the undersigned should not have accepted this two- sentence status report. The undersigned should have demanded that Ms. Elson and/or Mr. Shoemaker submit an affidavit describing efforts to obtain records from a psychiatrist and/or psychologist. See Vaccine Rule 2(c)(2)(B)(1); Guidelines, Section II, Chapter 3, paragraph B.13. However, the undersigned accepted the representation of Mr. Shoemaker. 11 Around this time, the undersigned awarded attorneys’ fees and costs on an interim basis. Interim Fees Decision, 2017 WL 1315716 (March 9, 2017). The undersigned issued a second decision awarding interim attorneys’ fees and costs on May 3, 2017. Second Interim Fees Decision, 2017 WL 2333626 (May 3, 2017). 10 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 11 of 58 On August 4, 2017, the Secretary responded to Dr. Tornatore’s report by submitting a report from Arun Venkatesan. Exhibit E. Dr. Venkatesan opined that the course of OCD waxes and wanes. Thus, any worsening of Mr. Hodge’s OCD after the 2006 vaccinations reflects a natural course of OCD, which he opined was not caused by the vaccinations. This case was then scheduled for a one-day hearing on November 5, 2018. Order, issued Sept. 21, 2017. This order encouraged Ms. Elson to attend the hearing. On December 18, 2017, Ms. Elson filed a supplemental report from Dr. Tornatore, which was approximately two pages. Exhibit 34. Dr. Tornatore did not address topics listed in the August 9, 2017 order, such as the expected course of OCD. Accordingly, Ms. Elson was barred from introducing testimony from Dr. Tornatore about these topics in the forthcoming hearing. Order, issued Dec. 22, 2017. In anticipation of the November 5, 2018 hearing, the undersigned directed the parties to file briefs and other material, such as updated medical records. Order, issued March 23, 2018. This order again encouraged Ms. Elson’s participation in the hearing. Id. at 10 n.6. The March 23, 2018 order referenced the December 22, 2017 order limiting Dr. Tornatore’s testimony. After being reminded about the December 22, 2017 order, Ms. Elson sought reconsideration of the order restricting Dr. Tornatore’s testimony to the topics on which he had opined. Pet’r’s Mot. filed April 30, 2018. With her motion, Ms. Elson submitted another report from Dr. Tornatore. Exhibit 35. The Secretary stated that he would not be prejudiced by consideration of this report. Resp’t’s Resp., filed June 13, 2018. In the absence of an objection from the Secretary, Dr. Tornatore’s April 30, 2018 report was accepted. Order, issued June 19, 2018. After receiving enlargements of time, Ms. Elson filed her brief on June 28, 2018. Before and in conjunction with this submission, Ms. Elson also filed medical records and medical articles. The Secretary filed his brief on August 15, 2018. Based upon the parties’ arguments, a lengthy and substantive status conference was held on September 7, 2018. The undersigned advised that the hearing should be extended from one day to two days. Based upon the availability of the attorneys, Dr. Tornatore, and Dr. Venkatesan, the hearing was rescheduled for January 10-11, 2019. Order, issued Sep. 17, 2018. 11 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 12 of 58 In the September 7, 2018 status conference, the undersigned also suggested that Ms. Elson should testify. Mr. Shoemaker represented that rather than testifying orally at a hearing, Ms. Elson could present a comprehensive affidavit. In addition, the undersigned ordered Ms. Elson to file a series of documents, including Mr. Hodge’s school records, a list of payments from any insurance company, and records from Dr. Nasse. Order, issued Sept. 7, 2018. To ensure that Ms. Elson’s affidavit was comprehensive, the undersigned propounded a series of questions for her to answer. Order, issued Sept. 13, 2018; see also 42 U.S.C. § 300aa–12(d)(3)(B)(iii) (authorizing special master to require the testimony of any person). Ms. Elson began to submit additional documents. The collection of school records, unfortunately, contained relatively little useful information because the school systems did not retain all records. See exhibits 58, 60-61. Attempts to obtain medical records were also sometimes unsuccessful. See exhibits 62, 64. One notable example of a missing records were records from the doctor who provided mental counseling to Mr. Hodge, Dr. Nasse. Exhibit 70. Ms. Elson requested additional time to file her comprehensive affidavit. See Pet’r’s Mot., filed Oct. 9, 2018; Pet’r’s Mot., filed Oct. 22, 2018; Pet’r’s Mot., filed Nov. 6, 2018. Ms. Elson finally submitted her comprehensive affidavit on November 26, 2018. Exhibit 71. This affidavit generally did not answer many questions put forth in the September 13, 2018 order. Although the undersigned had anticipated that Dr. Tornatore and Dr. Venkatesan would review any additional documents and present supplemental reports before the hearing starting on January 10, 2019 (see order, issued Oct. 24, 2018), this task was not possible. Ms. Elson had not collected many documents. For example, Ms. Elson had not obtained documents from the insurance company showing a list of payments to doctors who had treated Mr. Hodge. See Pet’r’s Mot. for Subpoena, filed Oct. 26, 2018. This list could have identified doctors whom Ms. Elson did not recall. Without a complete set of documents describing Mr. Hodge’s condition before and around the time of his vaccinations in 2006, the undersigned reluctantly cancelled the hearing. Order, issued Nov. 28, 2018. 3. Attempts to Gather More Factual Materials Through Entitlement Hearing After the hearing was cancelled, Mr. Shoemaker intensified efforts to obtain medical records. Mr. Shoemaker submitted motions to authorize him to subpoena various institutions that possessed either medical records or school records for Mr. Hodge. This process garnered little useful information. See, e.g., exhibit 72. 12 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 13 of 58 Efforts to obtain information from the insurance company that paid for Mr. Hodge’s medical care were especially protracted. Repeatedly, Mr. Shoemaker seemed to be close to receiving useful information only to learn later that his request was misdirected. See, e.g., Pet’r’s Status Rep., filed July 12, 2019. Mr. Shoemaker was replaced as Ms. Elson’s counsel of record by Renee Gentry on October 30, 2019. Ms. Gentry continued to represent Ms. Elson and continued the process of attempting to gather information from an insurance company about payments to doctors. See Pet’r’s Status Rep., filed Jan. 6, 2020. The persistence of Mr. Shoemaker and Ms. Gentry eventually led to a list of medical providers. Ms. Gentry filed a list on February 27, 2020 as exhibit 80. From this list, Ms. Gentry intended to seek additional records. However, by this time, the coronavirus pandemic had caused delays in obtaining records from medical facilities. Eventually, some potential sources of information responded that they did not have information. See exhibit 82. The parties determined that by August 2020, Ms. Gentry and Ms. Elson had exhausted all possible sources of written information about Mr. Hodge. Thus, the parties were directed to provide the material that Mr. Shoemaker and Ms. Gentry had discovered to the experts the parties had retained. Order, issued Aug. 25, 2020. The recently produced material did not affect the opinions of either Dr. Tornatore or Dr. Venkatesan. Dr. Tornatore took the opportunity to restate his opinions and to reorganize his presentation in a comprehensive report. Exhibit 83. Dr. Venkatesan wrote four sentences. Exhibit I. The undersigned, again, attempted to mark the case down for a hearing. As a preliminary step, Ms. Elson was to determine whether she would testify at a hearing because her participation would influence the duration of the hearing. Order, issued Nov. 12, 2020. Ms. Elson stated that she did not want to testify live. Instead, she wanted to file an updated affidavit. Pet’r’s Status Rep., filed Dec. 14, 2020. Ms. Elson’s request to submit an affidavit was granted. However, the undersigned noted that Ms. Elson had not responded to the questions posed to her in the September 13, 2018 order. Answering those questions could be important. In addition, information about Mr. Hodge’s functioning in the years since Ms. Elson’s previous affidavit would not be likely to affect whether the vaccinations in 2006 harmed Mr. Hodge. Order, issued Dec. 23, 2020. 13 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 14 of 58 The December 23, 2020 order also set out deadlines for scheduling a two- day hearing as well as the submission of briefs before the hearing. A mutually convenient time for a hearing was found to be June 14-15, 2021. Thus, a hearing was ordered for those dates. Order, issued Jan. 22, 2021. Ms. Elson filed her affidavit on February 3, 2021. Exhibit 86. Ms. Elson appeared to make a good-faith effort to answer all the questions set forth in the September 13, 2018 order, although she did not address all questions entirely. Ms. Elson’s affidavit was considered, and its contents are set forth in the recitation of evidence below. Ms. Elson submitted her brief on February 24, 2021. Following the submission of Ms. Elson’s affidavit and her brief, the undersigned issued a series of orders to clarify the record. For example, Ms. Gentry drafted and filed two affidavits regarding how medical records were collected. Exhibits 87-88. The Secretary declined to explore settlement. Resp’t’s Status Rep., filed March 24, 2021. The same day, the Secretary filed his brief, arguing Ms. Elson was not entitled to compensation. Ms. Elson addressed some of those arguments. Pet’r’s Reply, filed April 26, 2021. In his brief, the Secretary requested that Ms. Elson testified orally at the upcoming hearing. Resp’t’s Pre-Hearing Br. at 43. In response, Ms. Elson stated that she “will make herself available to testify should the Court require it[,]” although Ms. Elson questioned whether her testimony in 2021 could add to what she had stated in her affidavits and what is contained in the medical records. Pet’r’s Status Rep., filed April 1, 2021. Based upon the lack of objection from Ms. Elson as well as the undersigned’s previously expressed interest in obtaining testimony from Ms. Elson, the undersigned scheduled time for Ms. Elson to testify. Order, issued April 15, 2021. On June 14 and 15, 2021, a hearing was held. Ms. Elson testified at the hearing, as did Dr. Tornatore and Dr. Venkatesan. On June 17, 2021, the parties were ordered to file post-hearing briefs. Ms. Elson filed her post-hearing brief on September 20, 2021. Respondent filed his post-hearing brief on December 3, 2021. On February 1, 2022, Ms. Elson submitted a reply brief. On February 10, 2022, to address remaining issues and clarify the parties’ positions on several matters, the undersigned scheduled an oral argument and provided a list of questions for the parties to prepare to address. The oral argument was held on March 17, 2022. At this point, it was evident the parties had exhaustively stated their positions and that no more evidence would be uncovered to fill in the gaps. 14 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 15 of 58 B. A Brief Summary of the Parties’ Positions This section contains a condensed recitation of the parties’ positions, highlighting the major points of contention between the parties. The position statements below are derived from the post-hearing briefs. A more comprehensive explanation of the evidence and arguments follows in subsequent sections. 1. Petitioner’s Position According to Ms. Elson, her attorneys, and Dr. Tornatore, the facts of this case are as follows. Mr. Hodge was healthy and happy prior to 2003. See, e.g., Pet’r’s Post Hearing Br., at 4. Mr. Hodge was 15-16 years old during that year. At some point in 2003, during a camping trip, Mr. Hodge was bitten by a tick carrying Borrelia Burgdorferi, the pathogenic spirochete (spiral-shaped bacteria) which can cause Lyme disease and neuroborreliosis (a Borrelia infection of the central nervous system with neurologic manifestations).12 Id. at 4, 8, 48. As such, Mr. Hodge developed Lyme disease. Subsequently, the Lyme disease progressed to neuroborreliosis and caused Mr. Hodge to develop OCD. Id. at 4-5. Despite the Lyme disease and Lyme-induced OCD, Mr. Hodge lived a mostly normal life. Id. at 5. Difficulties with OCD were manageable. On March 17, 2006, Mr. Hodge received the hepatitis A and B vaccines. Symptoms suggestive of an adverse reaction followed, including fatigue, stabbing pains, and uncontrollable eye movements. Id. at 6. Mr. Hodge returned to the same clinic to receive a hepatitis B booster vaccine on April 25, 2006. After the second shot, “[a]ll hell broke loose.” Id. (quoting Ms. Elson, Tr. at 150). A host of problems followed, indicating his psychiatric symptoms had been significantly aggravated. See, e.g., Pet’r’s Post Hearing Br. at 6-7, 17, 23, 26. He went to emergency rooms multiple times in 2006, indicating a radical change in his health. Id. at 9-11. He continued to seek treatment, though he had less encounters with medical professionals in 2007 and 2008. Id. at 11-12. In 2009, Mr. Hodge received MRIs of his brain that indicated the presence of a demyelinating condition. Id. at 12. Bloodwork performed in 2009 also indicated he had Lyme disease. Id. at 13. Mr. Hodge had many hospital visits in 2009 that elucidated underlying heath concerns. Id. at 13-15. Mr. Hodge and his mother continued to see doctors between 2010 and 2016 seeking clarification and 12 In the parties’ briefs and in some medical records, the phrase “neurolyme” is occasionally used. It seems this term is being used interchangeably with “neuroborreliosis.” 15 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 16 of 58 treatment. Id. at 15-16. Ms. Elson became Mr. Hodge’s conservator in 2016. Id. at 18. In sum, Mr. Hodge developed Lyme-induced OCD in 2003, which was manageable until the 2006 hepatitis B vaccinations significantly aggravated his underlying condition. Id. at 17-18. 2. Respondent’s Responses The Secretary disputes many aspects of Ms. Elson’s version of events, as well as the sufficiency and reliability of the evidence proffered. The Secretary argues petitioner has not shown the subject vaccinations can or did cause a significant aggravation of neuroborreliosis. Resp’t’s Post Hearing Br. at 5. This aspect of the Secretary’s position concerns the medical theories that correspond to the Althen prongs. Id. at 53-66. Fact issues are also raised. The Secretary argues that the evidence does not support findings that (a) Mr. Hodge suffered neuroborreliosis prior to the 2006 vaccinations, (b) Mr. Hodge suffered vaccine-induced demyelination, or (c) Mr. Hodge’s condition was significantly aggravated by the vaccines. Id. at 5-6, 31-53. Other fact discrepancies are addressed as well. The Secretary notes the petitioner’s burden to produce records supporting her claims. Id. at 26-28. In the Secretary’s view, Mr. Hodge’s condition after the vaccines is consistent with the natural course of OCD.13 Id. at 6. But, the Secretary also argues the burden of proof has not shifted to him because the petitioner has not presented a prima facie case. Id. at 66-67. In sum, the Secretary disputes nearly all aspects of petitioner’s position. The factual evidence is insufficient and unreliable; the medical theories are not well supported; and in the alternative, the series of events is better explained by the natural course of Mr. Hodge’s pre-existing condition. III. Recitation of Evidence As discussed above, the evidence in this case is less than ideal. The peculiar circumstances compel a particular presentation; a chronological discussion is more 13 The Secretary argues “[w]hile is unknown when Mr. Hodge may have contracted Lyme disease, no neurological manifestations occurred for at least three years after his 2006 vaccinations.” Resp’t’s Post Hearing Br. at 43. The Secretary’s expert witness, Dr. Venkatesan, opined that Mr. Hodge likely had neuroborreliosis in 2009, and the Secretary argues that the medical records do not support that diagnosis prior to 2009. Id. at 48; Tr. at 442-43. 16 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 17 of 58 complicating than clarifying under the conditions of this case. Much of the evidence regarding what may have happened in a given year is derived from testimony provided years later. For example, there are no records created in 2003 that illuminate the events of that year, but plenty of testimony has been generated discussing what may have happened in 2003. If this evidence had been reliable, consistent, and developed in a timely fashion, the undersigned would have presented the evidence in a chronological order. However, under these circumstances, the evidence is recited and evaluated based upon the source from which it was derived. Contemporaneously created medical records receive a rebuttable presumption of validity. In contrast, although testamentary evidence must be considered, it does not receive the same presumption of validity. Curcuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Furthermore, special masters are not required to accept party assertions as facts, particularly when there is reason to doubt the veracity of a given claim. During the course of litigation, Ms. Elson was involved in creating numerous affidavits. At a macro level, they tell a similar story. However, there are significant inconsistencies regarding several facts. For reference, Ms. Elson’s affidavits are listed below. Exhibit Number Filing Date ECF # Exhibit 9 January 14, 2011 33 Exhibit 19 October 1, 2014 97 Exhibit 21 October 16, 2015 124 Exhibit 26 December 4, 2015 135 Exhibit 71 November 26, 2018 245 Exhibit 86 February 3, 2021 335 An additional problem is that the parties’ briefs make statements contradicted by the records that they rely upon. See, e.g., footnotes 36 and 39. Due to these problems, the undersigned has spent additional time independently reviewing all evidence to understand Mr. Hodge’s health during critical times. The evidence below is divided into events before the subject vaccinations and events contemporaneous with and after the vaccinations. Sections III.A and III.B. Within these categories, evidence gleaned from medical and school records merit their own sub-sections. Next, testamentary evidence is summarized, which at times corroborates, contradicts, and compliments the medical records. The subsequent section concerns expert commentary, which necessarily relies on the 17 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 18 of 58 facts and assertions from the preceding sections. After the recitation of evidence, findings of facts are reached in Section IV.14 A. Mr. Hodge’s Health and Condition(s) Before the 2006 Vaccinations The following section concerns Mr. Hodge’s health prior to the 2006 vaccinations. Information is derived from (1) medical records; (2) school records; (3) statements and evidence regarding missing and unavailable records; (4) testimony, including affidavits and oral statements; and (5) expert commentary. 1. Medical Records Jeremy Hodge was born on May 15, 1987. Exhibit 3.1 at pdf 4. The medical records from Mr. Hodge’s pediatrician, Dr. Lawrence Menzer, recount relatively routine illnesses associated with childhood. See exhibit 3.1 and 3.2, passim.15 Mr. Hodge received routine childhood immunizations in the late 1980s and early 1990s. Exhibit 3.1 at pdf 4; exhibit 1. Though the handwritten descriptions are difficult to read, each entry is clearly stamped with a date of the visit. Mr. Hodge’s parents regularly took him to Dr. Menzer’s office. These include more than 10 visits in 1987, more than 10 visits in 1988, about 5 visits in 1989, about 4 visits in 1990, about 3 visits in 1991, about 5 visits in 1992, about 4 visits in 1993, and at least 1 visit each in 1994, 1995, and 1996. Exhibit 3.1, passim. Some words and phrases are legible, such as “sick,” “fever,” “cough,” “stuffy nose,” “viral syndrome,” “bad cold,” “tongue hurts.” It appears Dr. Menzer referred Mr. Hodge to Dr. Greg Nelson, a dermatologist, in 1996, when Mr. Hodge was 9 years old. A letter dated July 18, 14 However, out of necessity, some fact-finding occurs within each section. For example, the undersigned states his interpretations of difficult to decipher handwritten medical records, blurring the line between reciting evidence and finding facts about the content of the evidence. 15 Unfortunately, much of Dr. Menzer’s notes are handwritten. The parties and the undersigned have struggled to decipher the content. See, e.g., Pet’r’s Pre- Hearing Br., filed June 28, 2018 (summarizing events between 2004 and 2006 with one sentence); Resp’t’s Rep., filed Apr. 30, 2012, at 2 (skipping over content in recitation of facts). Some information is readily intelligible; other content is unlikely to ever be decoded. This is one among many examples of suboptimal records. 18 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 19 of 58 1996 states Mr. Hodge was evaluated three days prior by Dr. Nelson. The letter states: “Jeremy was bothered by a rash on the bottom of his feet that has been present for several years. The mother feels that the use of his high topped shoes has aggravated this. In reality, this rash, although prominent is entirely asymptomatic.” Exhibit 3.2 at pdf 5; exhibit 15 (duplicate of Dr. Nelson’s note). The dermatologist’s impression was granuloma annulare, and Mr. Hodge was given an ointment for treatment.16 As explained in the introduction and elsewhere in this decision, an unfortunate issue in this case is the absence of medical records and other notes describing contemporaneous events. There are no available doctors’ notes or other records between July 1996 and March 2004 that document Mr. Hodge’s health. See also Resp’t’s Post Hearing Br. at 6 n.4 (arguing Mr. Hodge was seen by other care providers during this period, despite the lack of available records). This eight- year gap makes it difficult to understand Mr. Hodge’s health before the 2006 vaccinations. As discussed below, 2003 is an important year in the context of this litigation. However, the testimony utilized to fill this gap is unreliable. See supra section IV. After the gap, some medical records exist that elucidate Mr. Hodge’s health when he was 17 years old. The difficult to decipher handwritten notes from Dr. Menzer indicate that on March 10, 2004, Mr. Hodge was evaluated for “sinus pressure x 2 mo.”17 Exhibit 3.1 at pdf 5. It seems a diagnosis of nasal allergies was probably written. The subsequent note on the page suggests Mr. Hodge returned on April 19, 2004; it appears sinus pressure and nasal discharge are discussed, and amoxicillin may have been prescribed, but the rest of the note is incomprehensible. Id. The next recorded date is September 7, 2004, which seems to read: “Per mom would like Rx for Zyrtec – D, called in Rx: 0/1 tab PO 1-2 times/day #30.” Id. The next line in Dr. Menzer’s notes is dated September 28, 2004. It appears to state: “Per mom was given Amox 500 mg near the weekend by Dr. on call – 16 The Secretary stated granuloma annulare is a chronic skin disease that manifests as a rash with reddish bumps arranged in a circle or ring, that is sometimes itchy and occasionally associated with diabetes and thyroid disease. Resp’t’s Rep. at 2 n.1. This assertion was not discussed by the experts subsequently retained to opine in this case. 17 The rest of the note is too difficult to decode. See infra n.15. 19 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 20 of 58 sinus inf. – doing better per mom. Also mom said he was put on Adderall per psych. Advised px will call back to schedule yp.” Records from the Ojai Village Pharmacy suggest Dr. Nasse prescribed Risperdal on September 27, 2004, and Adderall on September 28, 2004. See exhibit 23.18 Dr. Menzer’s notes continue with the next visit on March 21, 2005. Only a portion of this note is legible. It appears to state: “sore throat, jaw pain, now stomach pains. Was taking Zoloft, now off last 2 days . . .” Exhibit 3.1 at pdf 6. Dr. Menzer appears to have written much during this visit, but neither parties’ brief successfully deciphers the difficult to read text. This note also marks the end of Mr. Hodge’s records from Dr. Menzer’s office. The next medical record is on March 17, 2006, the date of the first hepatitis B vaccination. That medical record and subsequent medical records are discussed below in section III.B.1. 2. School Records Information about Mr. Hodge’s schooling was sparse due to when Ms. Elson collected those records. Ms. Elson attempts to fill the gaps via testimony, discussed below in section III.A.4 and III.B.3. Mr. Hodge attended various schools throughout his childhood. Some of the records have been produced, others have been destroyed or are no longer available. See supra section III.A.3. The available and legible school records from before the 2006 vaccinations are recited below.19 Little information exists about Mr. Hodge’s education and functioning during K-5. See exhibit 58. He attended Herrick Elementary School for kindergarten through second grade. Id. at pdf 4. One early school record stated that in second grade, Mr. Hodge’s skills were below grade level. Exhibit 61 at 3. But, this notation is relatively isolated as only a few school records include grades 18 The specific reason for Adderall was not given in the pediatrician’s record or the pharmacy record. 19 The school records that were discovered and provided have some problems. Like many of the medical records, they are difficult to read due to handwritten notes, smudging, and suboptimal copying quality. Additionally, they are incomplete: some years have available grades, most years do not have grades. Thus, using grades as a proxy for Mr. Hodge’s functioning and/or mental health is difficult. 20 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 21 of 58 or teachers’ comments.20 He attended Knollwood School for third through fifth grade. Exhibit 58 at 4. No further information is available. Some of the school records from the Los Angeles Unified School District were provided. See exhibit 61. Starting when he was in sixth grade (1999-2000), Mr. Hodge changed schools frequently. See also exhibit 74 (records supplied by Ventura Unified School District); exhibit 76 (some duplicates provided by Los Angeles Unified School District). For sixth grade, Mr. Hodge attended two schools. The first was Voyager Charter School and the second was Homestead School. At both schools, his grades were all “P’s” for passing. Exhibit 61 at pdf 9. In seventh grade, Mr. Hodge started at City of Angels School. For the first semester, he earned three A’s, one B, and one C, and one grade that cannot be read with certainty. Exhibit 61 at pdf 6. The records indicate he did not finish the second semester at this institution.21 Although an affidavit fills in some of the gaps and is discussed below, no other records existed discussing eighth grade. In ninth grade (2003-2004), Mr. Hodge again attended the City of Angels School. Exhibit 61 at pdf 7. He received all A’s and one B. Id. Mr. Hodge would have been 16-17 years old during ninth grade. School records do not exist regarding Mr. Hodge’s schooling between tenth and twelfth grade. Information about his education during those years is provided via affidavits from Ms. Elson and is discussed below. 3. Unavailable Records / Unsuccessful Records Requests Ms. Elson and her attorneys attempted to get records to fill in the gaps at various points. Unfortunately, not all attempts were successful. As such, some alleged events do not have any corroborating contemporaneous records. In the fall of 2018, Mr. Hodge’s attorney attempted to get several records that either did not exist or no longer existed. The unavailable records regarding events prior to 2006 are recounted below. 20 Furthermore, this record is difficult to read. 21 An affidavit, discussed below in section III.A.4, revealed that Mr. Hodge did an independent study program through Somis Union School District. No records were available from that institution. Exhibit 71 at 1-2; see also exhibit 60; Tr. at 165. 21 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 22 of 58 One example was school records, including transcripts and IEP documents, from Nordhoff High School. Exhibit 60. The school’s registrar stated she was unable to locate records of Jeremy Hodge and could not confirm that he was a student at Nordhoff High School. Id. The registrar stated that the school retained transcripts and IEPs of any students within the Ojai Unified School district (with the exception of Chaparral High School) and that all records would have been retained with no intention of destruction. Id. If other school records existed, they were destroyed. See exhibit 77. Mr. Hodge’s attorneys also requested records from John Nasse, the doctor that prescribed Adderall to Mr. Hodge. In a handwritten note, Dr. Nasse certified that Mr. Hodge was his patient “on + off for a year between 2000 [and] 2003”. See exhibit 70. Dr. Nasse wrote Mr. Hodge “was being treated for ‘OCD’”. Id. However, Dr. Nasse claimed the records were destroyed a couple years before the records request. Id. Records for a facility called “Valley Care” were never discovered or filed. See exhibit 72, exhibit 88. Valley Care is where Mr. Hodge allegedly was first diagnosed and treated for OCD. Notably, there are no medical records provided from 2003. 4. Testimony The following section is divided into two subparts. First, events from before 2006 are extracted from the six affidavits Ms. Elson submitted. Next, Ms. Elson’s oral testimony given during the hearing about details from before 2006 is summarized. a) Ms. Elson’s Affidavits22 The affidavits describe events before 2006, contemporaneous with the vaccines, and events after 2006. As previously discussed, this section (III.A.4.a) only recounts the content describing events before Mr. Hodge was vaccinated in 2006. (i) Affidavit # 1 (exhibit 9) Ms. Elson submitted her first affidavit on January 14, 2011. See exhibit 9. This date is approximate 2.5 years after the petition was filed. She recounts that Mr. Hodge “was at all times before his vaccination, extremely healthy.” Id. at pdf 22 Ms. Elson was the only percipient witness to submit affidavits. Mr. Hodge did not submit any affidavits. 22 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 23 of 58 3. She notes allergies, symptoms of sinus congestion, clogging, and headaches. Id. Ms. Elson sought allergy testing and medication to help with his symptoms. Id. at pdf 3-4. She recounts that Dr. Rodriguez prescribed Nasonex and Amoxicillin. Notably, this initial affidavit makes no mention of OCD or ritualized behaviors. It generally portrays Mr. Hodge as completely healthy prior to the 2006 vaccinations. (ii) Affidavit #2 (exhibit 19) Ms. Elson submitted her next affidavit on October 1, 2014. In this filing, more details are alleged about Mr. Hodge’s health prior to 2006. The affidavit begins: “While we do not know the exact trip where Jeremey likely contracted Lyme disease, we would go camping all the time at Big Sur, near my grandparents’ house. . . . On our last trip there was a large amount of ticks everywhere.” Exhibit 19 at 1. She recounts that there were “always ticks on the pets, and there were lots of deer and there were ticks on everything.” Id. She recalls that Mr. Hodge had a bull’s-eye rash on his leg at the end of the (unspecified) trip.23 She alleged “[w]ithin a year of that he began exhibiting OCD hoarder symptoms and complained of spaciness and fogginess in his brain.” Id.24 Although this affidavit maintains Mr. Hodge was active and participating in normal childhood activities (hiking, riding bikes, swimming, playing video games), it implicitly acknowledges he was not perfectly healthy. In contrast with the prior affidavit, this filing alleged Mr. Hodge developed Lyme disease, had “OCD hoarder symptoms” and was experiencing brain fog before the vaccinations. (iii) Affidavit #3 (exhibit 21) In the next affidavit, filed on October 16, 2015, Ms. Elson alleged more details about her son’s health pre-vaccination. Petitioner prevailed on a motion for review, and at the time of this affidavit’s filing, Ms. Elson was trying to support a finding in favor of equitable tolling. She stated: “Jeremy’s OCD developed around age 16. Before about May 2006, my son acted on his OCD symptoms but he could participate in his life.” 23 This affidavit does not state in what year or at what age Mr. Hodge allegedly developed the rash and/or Lyme disease. 24 Similarly, the affidavit does not state in what year or at what age Mr. Hodge allegedly began experiencing OCD symptoms. 23 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 24 of 58 Exhibit 21 at pdf 3. She noted the same hobbies as in the prior affidavit. In this affidavit, Ms. Elson adds: Before the vaccine he engaged in various rituals; he avoided walking in circles—circles were bad. He avoided certain numbers—numbers were scary. He walked up and down the stairs numerous times until ‘he felt like he had done it the right number.’ He chanted words in certain rituals and patterns. Jeremy turned the TV on and off; on and off; on and off. Same with the stove—he would turn it on and off; on and off in these rituals. His feelings told him the appropriate number of turns, of clicks, of trips he needed to take up and down the stairs. Although Jeremy struggled with OCD he didn’t hallucinate like he did after the vaccine. His habits were pure obsessions where he had to perform his rituals in the appropriate numbers but his OCD did not consume his life. Id. Ms. Elson continues by discussing Mr. Hodge toward the end of 2005. She stated that he was on track to get his GED at that time, but he could not attend school with the rest of his peers and instead took classes through an independent study program. Id. She further alleged that due to “his condition, ordinary high school overwhelmed him.” Id. (iv) Affidavit #4 (exhibit 26) This affidavit (filed December 4, 2015) is not relevant for this portion of the decision. (v) Affidavit #5 (exhibit 71) Ms. Elson filed another affidavit on November 26, 2018. See exhibit 71. This affidavit provides more details and includes references to exhibits. She fills in some details about which schools Mr. Hodge attended between kindergarten and sixth grade. Id. at 1. She notes that they moved to Ventura when Mr. Hodge was in seventh grade, and Mr. Hodge attended two schools that year: City of Angels Junior High and then an independent study through Somis Union School District.25 Ms. Elson acknowledged that records supporting this assertion do not exist. Id. at 1-2; see exhibit 60. She stated he did independent study at the 25 Based on the information provided, the move and seventh grade would have been between fall 2000 and spring 2001. 24 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 25 of 58 Homestead School for eighth grade. Exhibit 71 at 2. She stated he attended ninth grade at the City of Angels school. Id. Ms. Elson recalled that on April 30, 2003, they moved to Canoga Park and the two lived there subsequently. She stated: “I don’t remember when Jeremy had the tick bite that resulted in the bull’s-eye rash on his leg, but I think it was shortly before we moved to [Canoga Park]. It was some time after the move when he started having OCD symptoms.” Id at 2. Ms. Elson next states that she took Jeremey to Valley Care, where he was prescribed Prozac and then Zoloft, and was seen by treaters there on and off for about six months. Id. She stated he had OCD symptoms, but they did not interfere with his daily life. Jeremey continued at City of Angels for tenth grade and received good grades. Id.; see also exhibit 61. Ms. Elson states “Clearly, Jeremy’s OCD was not causing any problems with his school work.” Exhibit 71 at 2. She notes that she took Jeremy to Dr. Menzer in March of 2004 for sinus pressure. Id.; see infra section III.A.1. Ms. Elson states Mr. Hodge did independent studies throughout the school district for eleventh grade, differentiating this from home schooling. She recalls that he reported to a facility called Opportunities for Learning on Ventura Boulevard in Encino. Id. However, “Jeremy decided to drop out of high school and work on getting his GED[.]” Id. Ms. Elson states that on March 17, 2006 (the date of the first hepatitis vaccination), Jeremey “did have OCD, and he was somewhat depressed, but he was active and enjoying” previously discussed activities.” Id. at 3. She compared him to the character from the TV series Monk, stating he had OCD but could live his life. Id. (vi) Affidavit #6 (exhibit 86) The final affidavit was filed on February 3, 2021. This lengthy affidavit featured specific questions posed by the undersigned. Though a majority of the questions were answered, at times the responses to multiple questions were condensed into a single response. Ms. Elson testified that she generally relied on her memory when creating the prior affidavits, but also referred to some exhibits. Exhibit 86 at 1. 25 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 26 of 58 She discussed her family health history. Exhibit 86 at 2-5. She stated that her husband had head injuries, resulting in personality change. The two separated when Jeremy was 16; Ms. Elson and Jeremy moved away around 2003. Id. at 4-5. Ms. Elson was asked questions regarding her employment. See id. at 5-6. She recalled working on and off, waitressing, working in movie theatres, and modeling before Jeremy was born. Id. at 5. Ms. Elson could not recall the specifics of the odd jobs she worked between 2004 and 2009. Id. at 6.26 She discussed the activities she enjoyed. Id. at 6-7. Next, Mr. Hodge’s schooling was recounted. Id. at 7-9. Ms. Elson listed the schools he attended for K-5. Id. at 7-8. She affirmed he went to Voyager Charter School and the Homestead School for sixth grade, which he completed in June of 2000. Id. at 8. Next, he attended City of Angles Junior High and did independent study through Somis Union School District for seventh grade. Id. For eighth, he did independent study again at Homestead. He returned to City of Angels for ninth and tenth grade. Eleventh grade involved independent study through the school district and Opportunities for Learning in Encino. Id.27 The next portion of the affidavit concerned Mr. Hodge’s activities and interests. Id. 9-10. Ms. Elson recounted Mr. Hodge enjoyed hiking, riding bikes, numerous sports, WWE wrestling events, and playing video games with friends. He enjoyed being outdoors. He performed one or more of these activities almost every day. Id. at 10. The following section of the affidavit involves questions about Mr. Hodge’s health between 2003 and March 17, 2006. Id. at 10-13. Ms. Elson recounts that during this period, he did not have any problems related to his sense of touch, he did not have excessive or unusually frequent headaches. Id. at 10. He slept easily and did not have problems walking. Id. at 11. When asked if professionals other than Dr. Menzer provided Jeremy any medical care, Ms. Elson wrote: “I can’t remember. He may have seen professionals for OCD, perhaps Dr. Nasse.” Id. 26 In response to the question of where she was employed, she wrote: “I don’t remember specifics. It was a long time ago.” She also could not recall her earnings or identify any work colleagues, co-workers, or supervisors. These responses call into question Ms. Elson’s ability to recall other specific details during that timeframe. 27 Some school records were obtained and filed, as noted in the affidavit. See exhibit 58 and exhibit 61. Good grades were noted in tenth grade. Exhibit 61 at 7. Other records were found to be unavailable. See infra section III.A.3. 26 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 27 of 58 She assessed Dr. Menzer as a good doctor. She recalled that Dr. Nasse prescribed the Adderall in 2004, and stated she did not give the medication to Jeremy as prescribed. Id. at 12. She stated Mr. Hodge was first diagnosed with OCD at Valley Care and his symptoms started sometime after their move on April 30, 2003. Id. at 12-13. She reported the OCD was apparent due to his various rituals. Id. at 13. In this affidavit, she states Valley Care treated him with Prozac and then switched him to Zoloft. Id. b) Oral Testimony In addition to the affidavits, Ms. Elson testified during the June 14, 2021 hearing. She reviewed her affidavits and some of the records in preparation. Tr. at 144. When asked to described Mr. Hodge’s general health from birth to age 16, she stated he was “very healthy.” Id. She testified that during a camping trip with lots of ticks, Mr. Hodge received a bull’s-eye rash and subsequently developed OCD symptoms. Tr. at 144-45. She recalled the OCD symptoms started at around age 16 and he received an OCD diagnosis at age 17. Tr. at 145. Despite the symptoms, she insisted his life was “very normal.” Tr. at 146. However, he had to quit school in eleventh grade because Ms. Elson and Mr. Hodge had moved several times and “the OCD made him work a little bit slower because he would get caught up counting” and with “ritualistic behavior.” Id. His rituals included “[a] lot of checking[.]” Id. This included turning lights, faucets, and the oven on and off, going up and down the stairs, and avoid cracks in the sidewalks. Tr. at 146-47. On a bad day, Mr. Hodge would spend about 20% of his day consumed by OCD symptoms. On good days, it was not noticeable. Tr. at 147. She recalled Mr. Hodge getting OCD treatment at Valley Care, but could not remember the name of the doctor that diagnosed him. Tr. at 147. She stated he was on Prozac during this time period. Id. Ms. Elson estimated she took Mr. Hodge to Valley Care about four or five times between 2003 and 2004. Tr. at 202. During cross-examination, Ms. Elson was asked about whether Mr. Hodge was seeing other doctors or receiving other treatment at around age 16 when the OCD symptoms purportedly started. Tr. at 161. Ms. Elson responded: “It’s kind of hard to remember. Everything is so – just such a blur now. I may have, about that time, gone to Dr. Nasse, but other than that, I’m sorry, I don’t remember.” Id. She could not recall, without checking her notes, what grade Mr. Hodge was in when she separated from her husband. Tr. at 165-66. “The dates are very fuzzy for me right now. It’s just been so long.” Tr. at 166. 27 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 28 of 58 After being reminded that Mr. Hodge was placed on Adderall in 2004, Ms. Elson noted that Mr. Hodge took Adderall only one time. Tr. at 163. She stated she did not fill the prescription. Tr. at 170. She could not remember if Dr. Nasse prescribed any other medication, and thought Mr. Hodge saw him only twice. Tr. at 167. She recalled Mr. Hodge taking Zoloft for a couple of weeks in 2005. Tr. at 170. But, it was “hard to remember all the medications.” Tr. at 171. Respondent’s counsel asked Ms. Elson if she had any recollection of the month or year that the Big Sur camping trip took place. She responded: “I know it was not – I know it wasn’t – maybe spring. I’m literally guessing. . . . It would have been like summer or spring, something like that.” Tr. at 192-93. She proceeded to say Mr. Hodge was about 14 or 15 years old on that trip (which would be between 2001 and 2002). Tr. at 193. 5. Expert Commentary The petitioner submitted several expert reports. Most of the content of these reports focus on Mr. Hodge’s health in 2006 and beyond. Some opinions were generated about Mr. Hodge’s health prior to the 2006 vaccinations. However, these opinions were based on the medical records and affidavits available to Dr. Tornatore at the time of each report. a) Dr. Tornatore’s First Expert Report Ms. Elson filed Dr. Tornatore’s first expert report on August 23, 2013. Exhibit 18. This report largely focused on records from 2009, three years after Mr. Hodge’s hepatitis vaccinations, as limited records were available to him at this time. Based on medical records from 2009, in which doctors attempted to understand Mr. Hodge’s past and had to rely on histories provided by Mr. Hodge and Ms. Elson, Dr. Tornatore opined that Mr. Hodge began experiencing “some symptoms (progressive fatigue, headaches, memory disturbances, myalgias)” in 2005. Id. at pdf 4. Working with the records available to him at that time, he estimated the neuroborreliosis onset was in 2005. Id. These are the only aspects of Mr. Hodge’s pre-vaccination health discussed in this report. b) Dr. Dasher’s Expert Opinion The next report submitted by Ms. Elson was from Dr. Robert Dasher, a psychiatrist. Exhibit 22. This report was filed on October 16, 2015. It does not address Mr. Hodge’s pre-vaccination health history, as it predates his care and treatment of Mr. Hodge. Thus, this report will be discussed in the section regarding health after the 2006 vaccines. 28 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 29 of 58 c) Dr. Tornatore’s Second Report Ms. Elson filed Dr. Tornatore’s next report on January 23, 2017. Exhibit 29. By this time, petitioner’s counsel had developed the evidence a little more, but not substantially. The only pre-vaccination health history discussed in this report is Mr. Hodge’s March 10, 2004 visit to Dr. Menzer, in which he complained of sinus pressure for two months. Id.; see exhibit 3. Again, based on the information available at that time, Dr. Tornatore opined that Mr. Hodge “contracted Lyme disease in 2005” and developed symptoms of OCD shortly thereafter. Exhibit 29 at 7. Most of this report contains commentary on Mr. Hodge’s health after his 2006 vaccinations and medical theories regarding his condition. See generally id. d) Dr. Tornatore’s Third and Fourth Reports Ms. Elson filed supplemental reports authored by Dr. Tornatore on December 18, 2017 (exhibit 34) and April 30, 2018 (exhibit 35). Due to the issues the being litigated at the time of these reports, the reports do not discuss Mr. Hodge’s health before the 2006 vaccinations. e) Dr. Tornatore’s Fifth Report The fifth and final report from Dr. Tornatore was filed on October 26, 2020. Exhibit 83. Although this report is more comprehensive, the only pre-vaccination medical record discussed is the March 10, 2004 record from Dr. Menzer. Id. at 1, passim. Within the report, the March 10, 2004 record serves as a baseline of comparison. Dr. Tornatore notes that Mr. Hodge did not have subjective reports of neurologic symptoms or objective testing supporting neurologic issues on that date. The remainder of the report considers evidence from the date of the first vaccination onward. f) Oral Testimony During the hearing, Dr. Tornatore did not testify much about events prior to the 2006 vaccinations. His assertions about what may have happened prior to 2006 depend on the spare medical records and the testimony provided by Ms. Elson. Based on the March 17, 2006 medical record (exhibit 5 at 2), Dr. Tornatore opined Mr. Hodge was diagnosed with OCD in 2005. Tr. at 15. He further opined that Mr. Hodge had neuroborreliosis, which caused the OCD. Id. at 16-17. When asked when Mr. Hodge developed neuroborreliosis, Dr. Tornatore relied upon later created medical records and Ms. Elson’s affidavits. Id. at 21. He opined “it sounds like there was a trip where they were camping and it sounds like multiple people in the family were exposed to ticks. And so it clearly was somewhere perhaps in that time. Maybe it was after that.” Id. Based on the notation that Mr. 29 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 30 of 58 Hodge had OCD when he was 17, Dr. Tornatore opined the neuroborreliosis must have started earlier in order to cause the OCD. Id. at 21-22. “It’s hard to know . . . when that [tick] exposure was, but it clearly preceded the documented OCD . . . .” Id. at 23. Aside from the affidavits, Dr. Tornatore reached his opinion that Mr. Hodge had neuroborreliosis by utilizing MRIs and spinal fluid data from 2009, discussed below, along with medical literature. Tr. at 16-17. B. Mr. Hodge’s Health During and After the Vaccinations The following section concerns Mr. Hodge’s health from the date of the first vaccination onward. Information is derived from (1) medical records; (2) statements and evidence regarding missing and unavailable records; (3) testimony from affidavits and oral statements; and (4) expert commentary. 1. Medical Records The following sections recite the pertinent (available) medical records concerning Mr. Hodge’s health following his vaccinations in 2006. a) Mr. Hodge’s Health in 2006 (i) First hepatitis B vaccination On March 17, 2006, at the age of 18, Mr. Hodge appeared at Noble Community Choice Provider Medical Group (“Noble Clinic”) for an adolescent health maintenance exam. Exhibit 5 at 2. The treating doctor was Jorge Rodriguez. Someone told Dr. Rodriguez that Mr. Hodge was feeling pressure in his face. One line reads: “(+) OCD started at 17yrs.” Id. Another line states: “mother [unintelligible] at cognitive therapy.” Id. The record also states: “[Family] [history]: . . . father = ADD, grandmother = ? OCD”. Id.28 Physical exams and a neurologic assessment from this visit were all documented as normal. Id. Mr. Hodge weighed 159 pounds. Id. Dr. Rodriguez’s assessment of Mr. Hodge included allergic rhinitis, OCD, and possibly sinusitis. He prescribed Amoxil and some other medication. At this March 17, 2006 appointment, Mr. Hodge received the hepatitis A and hepatitis B vaccinations. Id. at 2, 7. 28 As with other medical records in this case, this record contains difficult to read handwriting. Some aspects are illegible. 30 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 31 of 58 A “‘STAYING HEALTHY’ ASSESSMENT” was completed at this visit. Id. at 5. Generally, it discloses healthy habits. However, “Yes” was marked next to the question about whether Mr. Hodge “Often feel[s] sad, down, or hopeless[.]” Id. The assessment form also notes that medication was used “sometimes” to sleep, relax, calm down, feel better, or lose weight, with “OCD” added in for context. Id. at 6. Additional questions or concerns about health were noted, which included “sinus pain, allergies?” Id. (ii) Second hepatitis B vaccination The next medical record is from April 25, 2006, when Ms. Elson brought Mr. Hodge back to the Noble Community Clinic for a follow-up visit. Exhibit 5 at 3. The intake notes suggest Mr. Hodge was seeing a psychiatrist or psychologist, though the doctor’s name is not legible. Id. The note states Mr. Hodge was on Zoloft, his mom did not want him taking that drug, and that his mom was concerned about toxoplasmosis. Id.29 Samples were taken, which were negative for toxoplasma AB IgG. Id. at 10. He weighed 155 pounds at this visit. Id. at 3. Subjective complaints from the April 25, 2006 visit included uncontrollable eye movement, neck pain, facial pressure, and itchiness. Id. at 3. However, abnormal neurologic findings do not appear to have been documented on this medical record. (iii) Valley Presbyterian – June 2006 Mr. Hodge’s next visit to a hospital was thirty-eight days later, on June 2, 2006. He presented to the Valley Presbyterian Hospital emergency room. Exhibit 6 at 7. The chief complaint was “Dizzy / Eye movement disturbances.” Id. The history of present illnesses section states that complaints included “back pain, joint + muscle aches and fatigue since receiving Hep B & A vaccinations 4 [months] ago. Blood tests done = normal per mother.” Id. The review of systems indicated problems with fatigue, nasal discharge, bone/joint pain, back pain, headaches, dizziness, and frontal room spins. Id. The physical examination memorializes that Mr. Hodge was “Oriented X 3” with memory intact, and that he was well nourished. Id. A flat affect was noted. An additional note was added that Mr. 29 Much of the notes from this visit are illegible. See also Pet’r’s Post Hearing Br. at 9 (acknowledging that the record cannot be deciphered completely). 31 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 32 of 58 Hodge had a negative vertical/horizontal nystagmus test.30 Id. The neurological examination was within normal limits. Id. At this June 2, 2006 visit, Mr. Hodge received a CT brain scan without contrast enhancement. Id. at 4, 10. The record notes a history of headaches. The impression note for the CT scan was “Normal.” Id. at 4. A diagnosis from the visit was that Mr. Hodge had neurological problems without specifying the nature of those neurologic problems. Id. at 2. Impression notes listed “dizziness” and “arthralgias – myalgias s[tatus]/p[ost] Hepatitis vaccination.” Id. at 6. Mr. Hodge was discharged that day, with his condition “Improving” and “Good.” Id. He was given Meclizine.31 Id. Ms. Elson called the Noble Clinic on June 8, 2006. Exhibit 5 at 4. The phone note appears to read: Mother called and was very upset about neurologist and according to mother neurologist was very rude and didn’t know Zoloft was used for OCD and she did not trust him. Mom concerned about vit. B deficiency and was pushing for MRI for Jeremy. Informed mom will do MRI request and get CT scan fr[om] Valley Presbyterian. [Three illegible words]. Informed mother will report to VAERS if [illegible] vaccine related adverse effect. Id.32 (iv) Encino/Tarzana – August 2006 More than two months passed before Mr. Hodge’s next medical appointment. On August 22 and 23, 2006, Mr. Hodge presented to the emergency department at Encino/Tarzana Regional Medical Center. Exhibit 4 at 2-15.33 On 30 Nystagmus is “an involuntary, rapid, rhythmic movement of the eyeball, which may be horizontal, vertical, rotatory, or mixed.” Dorland’s at 1289. 31 Respondent stated this is a medication for dizziness and nausea. See Resp’t’s Post Hearing Br. at 10. 32 This difficult to read note was mostly deciphered by petitioner. See Pet’r’s Post Hearing Br. at 10. 33 In referencing this exhibit, petitioner wrote as though there was no August 22, 2006 visit, only a visit on August 23, 2006. Pet’r’s Post Hearing Br. at 10. 32 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 33 of 58 August 22, 2006, he was evaluated by Dr. Ralph Baca and complained of diffuse paresthesias. Id. at 12. The note memorialized that “[t]he patient state[d] these symptoms have been evident intermittently since receiving [the] hepatitis vaccine earlier this year. The mother also state[d] that she [was] concerned that the patient, her son, appears more jaundiced, and also complains of dizziness associated with generalized weakness.” Id. Mr. Hodge denied any depression, anxiety, or hallucinations. Id. Mr. Hodge’s eyes were examined and normal at that time. Id. at 13. A chemistry panel, thyroid study, and urinalysis were ordered, with normal results. Id. He was discharged as stable. The diagnostic impression was “Neuropathy, etiology uncertain.” Id. Mr. Hodge returned to the emergency department the next day, August 23, 2006. Id. at 2. The record notes Mr. Hodge stated, “it’s hard to feel my skin” and indicates his “mom state[d] it all started p[ost] Hepatitis vaccine.” Id. at 4. OCD was recorded under medical/social history. Id. The neurological assessment listed Mr. Hodge was alert and oriented “x 3”. Id. Mr. Hodge weighed 160 pounds at this visit and the record states his skin color was normal rather than pale, flushed, or jaundiced. Id. (v) UCLA – November 2006 Mr. Hodge’s next encounter with medical professionals was on November 3, 2006, when he arrived at the UCLA emergency room. Exhibit 67 at 1-10; see also exhibit 32 at 26-35 (duplicate). The chief complaint was decreased sensation to skin for seven to eight months, as well as facial pain and inability to relax. The review of systems indicated he had depression but did not have weight loss. Exhibit 67 at 2. The discharged impression was OCD and numbness. Id. at 3. The record indicates Mr. Hodge was awaiting a psych evaluation, but left prior to being assessed. Id. at 5. (vi) Mr. Hodge’s Health in 2007 – 2008 The parties stated that between November 2006 and July 2007, there are no available medical records. See Pet’r’s Post Hearing Br. at 11; Resp’t’s Post Hearing Br. at 11. However, a more thorough search for records also led to the discovery of medical records from the emergency department of Providence Saint Joseph Respondent treated the record as referencing two visits, August 22 and August 23, 2006. Resp’t’s Post Hearing Br. at 10-11. It is possible that the reference to August 22, 2006 in the record was a mistake and that there was only one visit. It is also possible there were back-to-back visits. 33 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 34 of 58 Medical Center on June 20, 2007.34 Mr. Hodge was seen for “depression, numbness to both hands.” Exhibit 65 at 2. The chief complaint was “[Patient] has multiple psychological problems x ‘months’ [complains of] physical ‘pain.’ Sudden onset on & off x ‘months.’” Id. The history of present illness recounts his history of problems: “Mother states that over the last year, he has had numerous symptoms including headache and chest pain, his Adam’s apple appears to be large, shortness of breath, numbness and tingling in his extremities, weight loss, difficulty eating, back pain, and uncontrollable fits. She describes this and many numerous somatic complaints.” Id. at 5. The June 20, 2007 record notes Mr. Hodge’s vitals and states Mr. Hodge was “a well-developed, well-nourished male.” Id. The history of present illness also presents Ms. Elson’s account of her efforts to obtain medical care. Mother states that she has been to many emergency departments and clinics. Labs have been done, which showed no abnormalities. She states that approximately 1 year ago he had a head CT, which showed no abnormalities. Otherwise, she is here requesting a neurologic evaluation and MRI. She states that she has not been able to receive any authorizations from her insurance. . . . The patient himself denies any acute complaint at this time. Id. Upon examination, the doctor from the emergency room, Lawrence E. Wells, recorded Mr. Hodge was “in no acute distress. He [was] awake, alert, and oriented to person, place, and time. . . He [was] able to ambulate up and down the hallway without any difficulty whatsoever.” Id. Dr. Wells stated that he “advised the mother that [Mr. Hodge’s] symptoms appeared to be somatic signs of severe major depression and anxiety.” Id. at 6. Dr. Wells also “strongly advised the mother that she needs to follow up at one of the County Facilities if she is unable 34 Despite the presence of the Providence Saint Joseph exhibit, Ms. Elson asserted, “From November 2006 to July 2007 no medical records are available.” Pet’r’s Post Hearing Br. at 11. 34 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 35 of 58 to follow up with a neurologist and I have told the mother than my suspicion is that the patient has somatization of his psychological problems.” Id.35 On July 10, 2007, Mr. Hodge presented to West Valley Mental Health Center for an Adult Initial Assessment. Exhibit 11 at 2-12, 14-16. Under Presenting Problem / Chief Complaint, the form states: [History]: OCD: 2 [year] [history] of tapping, touching, counting, stress [with] environment made it worse. [History] of depression. Took Zoloft (4 [weeks]) made him worse, Prozac made him feel suicidal, racing thoughts [with] counting. No current S[uicidal] I[deation]. Not sleeping, argumentative at times. No good sleeping, naps during day. Sometimes sleeps too much. Very pale (+) psychosis, seeing shadows. ‘It’s bad air, environmental.’ Id. at 3. The form states Mr. Hodge had only completed 10th grade. It additionally notes Mr. Hodge’s dad had bipolar and ADD, and that his grandmother was a hoarder, suggesting a “strong family h[istory] [of] mental illness.” Id. Under medical history, the record indicates no problem with “weight/appetite ch[an]g[e]”. Id. at 4. The record indicates he was taking Xanax, prescribed by Dr. Nasse. Id. at 3, 5. The diagnostic summary stated Mr. Hodge had a history of psychosis and OCD since age 16. Id. at 8. Medical case management was recommended. Id. He did not return for treatment. Id. at 13. The next available medical record is from West Hills Hospital and Medical Center on September 9, 2007. Exhibit 8 at 76. Mr. Hodge was evaluated by Dr. Alan Kuban. Dr. Kuban wrote that Mr. Hodge was brought in by his mother “for evaluation of chest pain, OCD problems, [and] palpitations.” Id. Dr. Kuban observed Mr. Hodge was a vague historian and that Ms. Elson “almost control his situation and provides the history.” Id. Ms. Elson related that Mr. Hodge had been complaining of chest pain for over 6 months and had intermittent throat infections. Id. Dr. Kuban noted Ms. Elson also conveyed that Mr. Hodge had “a significant change in his personality over the last 18 months. She believes this may be related to previous hepatitis vaccinations.” Id. at 76-77. Dr. Kuban opined Mr. Hodge 35 At Ms. Elson’s request, Dr. Wells obtained an imaging study of Mr. Hodge’s sinuses, which was normal. Exhibit 65 at 7. Other than mentioning that Ms. Elson was requesting an MRI, Dr. Wells’s note does not discuss whether an MRI was appropriate. See exhibit 65. 35 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 36 of 58 “clearly has significant impairment due to his OCD.” Id. at 77. He recommended a neurologic consultation.36 Id. Mr. Hodge received mental health therapy at San Fernando Valley Community Mental Health Center (“Transitional Youth”) on a somewhat regular basis between November 2007 and February 2008. See exhibit 10. He received psychotherapy treatment, as well as numerous medications, including Risperdal, Lithium, Ativan, and Fluoxetine. Id. at 3, 59, 65. An initial assessment was that he suffered from OCD. Id. at 9. Concerns were expressed about the medications and services provided. See generally id. Attendance became less frequent in the spring and summer of 2008. After no contact for several months, on September 16, 2008, Transitional Youth closed Mr. Hodge’s case file. Exhibit 10 at 8. The Pfeiffer Treatment center performed a urinalysis for Mr. Hodge in March 2008. See exhibit 57. Malabsorption and low histamine levels were reported. Id. at 2. Diet and nutrition changes were recommended. Id. at 7, passim.37 Mr. Hodge arrived at the West Hills Hospital emergency room on December 4, 2008, with a chief complaint of a lesion on his left thigh and left eyelid. Exhibit 8 at 25. Past medical history listed him as bipolar, and suggests he was taking Risperdal and lithium at that time. Id. The treater considered the left thigh rash to be consistent with ringworm. Id. He was discharged in a stable condition. (vii) Mr. Hodge’s Health in 2009 – MRIs and Lyme Disease Diagnosis Mr. Hodge was seen at Olive View / UCLA Medical Center (“Olive View”) in February 2009. Exhibit 7 at 8. Chronic headaches were reported. Id. at 5-8. Under the neurologic assessment, the record notes Mr. Hodge was oriented, and his gait was within normal limits, though sensory issues were discussed.38 Id. at 8. 36 Citing to exhibit 8 at page 77, respondent’s post hearing brief states that a neurologic consultation was not recommended. Resp’t’s Post Hearing Br. at 13. This assertion is inaccurate. See exhibit 8 at 77 (“I do recommend neurologic consultation”). 37 Subsequent testing in February 2009 showed high levels of kryptopyrrole in Mr. Hodge’s urine. 38 Unfortunately, the handwritten notes on this copy of the medical record are largely illegible. 36 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 37 of 58 Though the handwriting is difficult to discern, it appears follow-up with neurology and an MRI were ordered. Id. On May 19, 2009, an MRI was performed on Mr. Hodge’s brain at the Olive View. Exhibit 2 at pdf 3-4; exhibit 7 at 210-211. The study’s findings note: Multiple white matter hyperintensities are seen in the periventricular, deep and subcortical white matter, one of which on FLAIR axial image 14 of series 4 has its long axis parallel to the long axis of the ventricles, I suspect the presence of demyelinating disease although the patient is a young male rather than a young female. Evaluation with contrast was not requested and not done and no history is provided. The differential diagnosis for the above white matter hyperintensities does include gliosis, migraine headaches, collagen vascular disease, vasculitis or ischemic change which would be too early in this patient. The brainstem is unremarkable. Exhibit 2 at pdf 3-4.39 The interpreting doctor’s impression was “demyelinating disease, in the absence of adequate clinical history” with “a wide differential diagnosis.” Id. at pdf 4. The doctor recommended a follow-up exam with contrast using a multiple sclerosis (“MS”) protocol. Id. On June 5, 2009, Mr. Hodge had blood drawn and analyzed for further diagnostics. Exhibit 7 at 209. It was notable for B. Burgdorferi IgG IFA with a 1:80 titer, a borderline positive result. Id. B. Burgdorferi IgM was <1:10. Id. These results suggested Mr. Hodge had Lyme disease. However, subsequent western blot testing on June 18, 2009 was negative for B. Burgdorferi IgG. Id. at 204. Additional serology tests were conducted by Dr. Mathisen on September 10, 2009. Exhibit 63 at 1. The results were negative / inconclusive. Id. Mr. Hodge was evaluated by a neurologist, Dr. Shri Mishra, at Olive View on August 4, 2009. Exhibit 7 at 45-46. He had “nonspecific complaints (headache, intermittent arm numbness, neck/back spasms)” and the doctor also noted psychiatric [disorders] included OCD behavior, bipolar vs. schizoaffective [disorder] all of varying onsets starting at age 17.” Id. at 45. The chief complaint / 39 Citing to exhibit 2, petitioner’s post hearing brief states that Mr. Hodge received this MRI on February 14, 2009. Pet’r’s Post Hearing Br. at 8. This assertion is inaccurate. 37 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 38 of 58 history of present illness section discussed Mr. Hodge’s medical history.40 The record states Mr. Hodge “was normal prior to age of 17, abrupt onset OCD-like behavior (counting, checking, etc) over 1 month, then onset of a mental ‘fogginess’ / ‘detachment from reality’ of insidious onset that has since waxed and waned with periods of ‘normalcy’.” Id. at 46. It further states Mr. Hodge received his routine hepatitis B vaccine at 18.5 and that he experienced subsequent stabbing pain, and muscle and skin tightness with spasms of gradual onset. The record recounts a tick exposure, and that Ms. Elson was convinced the symptoms were secondary to the vaccine. Id. The assessment notes differential diagnoses, including “MS, Lyme d[isease], post vaccination demyelinating d[isease], other demyelinating d[isease].” Id. at 45. The doctor ordered an MRI with MS protocol as well as a lumbar puncture and blood tests to rule out “MS, Lyme, other encephalitis, etc[.]” Id. On August 11, 2009, Mr. Hodge received another brain MRI, with and without contrast, so that it could be evaluated for MS and compared to the May 19, 2009 MRI. Exhibit 7 at 65-66. The doctor’s impression was “[b]ilateral demyelinating plaques again noted on today’s exam. Plaques also present at callosal septal interface (inferior surface or [sic] corpus callosum). No abnormal enhancement.” Id. at 65. No new abnormalities were appreciated. Id. at 65. Mr. Hodge had a CT scan of his sinuses on September 17, 2009. Id. at 64. The findings were unremarkable.41 On October 19, 2009, Mr. Hodge had a PET scan of his brain for “suspected neurolyme.” Id. at 178. The findings included “diffusely decreased metabolic activity in the cerebral cortex and basal ganglia” with non-specific distribution. Id. Additionally, “apparent hypermetabolism” was observed “near the midline in the region of the parietal lobes, [which] likely corresponds with area of prominent gyral folds seen on MRI.” Id. On October 22, 2009, Mr. Hodge was evaluated at Olive View by psychiatrist Robert Dasher. Id. at 23. Dr. Dasher’s assessment was that Mr. Hodge had a cognitive disorder, but he could not provide further specification. Id. He proposed neuro-psychological testing and a follow-up visit in three weeks. 40 Given that Mr. Hodge had not seen Dr. Mishra before, it seems likely that this history was provided by Ms. Elson, rather than being derived from Dr. Mishra’s review of records. 41 The parties did not comment on this scan in their briefs, and the findings seem to be of little relevance. 38 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 39 of 58 Mr. Hodge was evaluated again at Olive View on November 13, 2009, as an outpatient in the ophthalmology clinic. Id. at 9. The assessment noted Mr. Hodge had an “MRI concerning for demyelinating lesions.” Id. It further stated “[no] clinical evidence of optic nerve involvement [for either eye]. No evidence of intraocular inflammation, infection, given ?history of chronic Lyme disease.” Id. On November 17, 2009, Mr. Hodge underwent a lumbar puncture. Id. at 173-75. The cerebrospinal fluid (“CSF”) contained more than 5 well defined oligoclonal bands. Id. The report stated the bands “indicate abnormal synthesis of gammaglobulins in the central nervous system.” Id. The interpreter found this evidence supportive of a MS diagnosis, but noted other clinical and laboratory data was necessary for clarification. Id. B. burgdorferi was not detected in the CSF sample. Id. at 173. On December 11, 2009, Mr. Hodge was evaluated by Dr. Glenn Mathisen, an infectious disease specialist. Exhibit 14 at 3. Mr. Hodge’s medical history was recounted. Dr. Mathisen opined that the neuropsychiatric testing demonstrated cognitive deficits that were not compatible with standard psychiatric diagnoses such as schizophrenia or affective disorders. Id. Dr. Mathisen’s assessment states the following: Neuropsychiatric disorder: [patient’s] symptoms are compatible with chronic neurolyme as described in literature. He has a positive peripheral serology (ELISA) but does not meet CDC criteria by Western Blot. [Patient] and family are aware of this but still strongly wish IV therapy. Multiple sclerosis is the other possibility but is not completely supported by clinical course, MRI and LP results. I believe that a course of antibiotic therapy is reasonable and plan to repeat tests (MRI; PET scan; neuropsychiatric testing) following completion of therapy. Depending upon [patient’s] response, may also give 6 month course of doxycycline after initial [reaction] with ceftriaxone. [Patient] and family member are fully aware of the potential benefits and risks of this course and have decided to go ahead with treatment. Id. On December 17, 2009, Mr. Hodge had a follow-up visit with Dr. Dasher. Exhibit 7 at 37. Dr. Dasher’s assessment was “OCD-like” symptoms associated with anxiety and “possible Lyme” disease with neurological symptoms. Id. 39 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 40 of 58 On December 22, 2009, Mr. Hodge presented to the emergency department at Olive View with a body rash and a week of fevers. Id. at 3. The recent antibiotics PICC line was noted. Id. The rash resolved within a day. Id. at 68. Diagnoses included a ceftriaxone or other drug induced rash and “less likely” a Jarisch-Herxheimer reaction. Id. When he was evaluated the following day, December 23, 2009, Mr. Hodge underwent visual evoked potential testing. Id. at 27. The results were normal and interpreted as not supporting an MS diagnosis. Id. Dr. Mishra conducted EMG testing, and the study was normal, not supporting a polyneuropathy. Id. at 29-31. Dr. Mathisen evaluated Mr. Hodge again on December 31, 2009. His assessment remained “possible Lyme disease” but noted “[d]iagnosis is not proven as CSF serology has been negative.” Id. at 21.42 (viii) Mr. Hodge’s Health from 2010 to the Present The parties dedicated relatively little attention to medical records from 2010 to the present. See Pet’r’s Post Hearing Br. at 15-16; Resp’t’s Post Hearing Br. at 19-21. The undersigned has reviewed the medical records from 2010 onward and determined that they are unlikely to provide information regarding Mr. Hodge’s pre-vaccination condition(s) and whether the vaccines caused any sequelae. Nevertheless, a summary of these records is as follows. Mr. Hodge had follow-up visits with Dr. Mathisen and Dr. Dasher between January 2010 and March 2012. See exhibit 7 and exhibit 12. Via referral from Dr. Mathisen, Mr. Hodge was evaluated by Dr. Wendy Clough on January 11, 2010. Exhibit 13 at 4-7. She concurred with Dr. Mathisen’s assessment, stating “most likely [Mr. Hodge] does have Lyme disease.” Id. at 4. Dr. Clough wondered whether Mr. Hodge’s hospitalization in December 2009 was due to a reaction to the ceftriaxone or treatment of the Lyme disease. Id. at 5, 7. In late January 2010, Dr. Mathisen started treating Mr. Hodge with IV penicillin. Exhibit 7 at 19. Subsequently, on February 25, 2010, Dr. Mathisen assessed Mr. Hodge as improving, with increased mental sharpness and “better OCD.” Id. at 15. On May 12, 2010, Mr. Hodge had a normal EMG and nerve conduction Exhibit 12 at 245-47. Exhibit 7 at 32-33. He had a normal EEG study on May 17, 2010, with no evidence of a seizure disorder or brain dysfunction identified. Exhibit 7 at 32-33. Mr. Hodge was started on Doxycycline along with the IV 42 Some of the handwriting in this note is difficult to read. 40 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 41 of 58 penicillin treatment. Id. at 11. The penicillin treatment was discontinued in June 2010. Id. at 10. An MRI from April 14, 2011 found some lesions in the left frontal lobe had increased and there were two or three new punctate lesions in the frontal gyrus. Exhibit 12 at 11. “Differential considerations remain the same but this could be compatible with Lyme disease given patient history.” Id. An MRI was performed in January of 2012. Exhibit 14 at 252-53. There was not much change from the April 2011 MRI. Id. at 253. The interpreting doctor thought the results were most consistent with known history of Lyme disease. Id. Mr. Hodge began seeing Dr. Kevin Pimstone, a new primary care doctor, in May 2014. Exhibit 32 at 56-58. Dr. Pimstone provided a recitation of Mr. Hodge’s history. Id. at 63. Dr. Pimstone’s impression was neurocognitive decline in addition to OCD symptoms and depression since age 19, possible Lyme disease, abnormal MRI consistent with “possibly demyelinating disease versus Lyme disease,” and elevated Epstein-Barr antibody, among others. Id. at 64. Mr. Hodge returned to Dr. Pimstone on numerous occasions and was referred to various specialists throughout 2014 and 2015. See, e.g., id. at 285, 689, 781, 1361, 1481, 1559, 1590, 1643, 2008. A neurologist, Dr. Giesser, evaluated Mr. Hodge on January 20, 2015, as he was experiencing numbness in his hands and feet, heat sensitivity, difficulty thinking, and auditory/visual hallucinations at that time. Id. at 781. In 2015, Mr. Hodge was evaluated by Dr. James Landen. See exhibit 33. Assessments included psychosis, bipolar disorder, and tardive dyskinesia symptoms. Id. at 1. His reactions to various medications were recounted. See id., passim. In 2018, Mr. Hodge was taking to the emergency department of West Hills Hospital and treated for “chest pain of unclear etiology.” Exhibit 59. 2. Unavailable Records / Unsuccessful Records Requests The following recites the unsuccessful records requests from facilities that may have treated Mr. Hodge from 2006 onward. Records were requested from Noble Community Medical Associates of LA. A verification letter revealed the facility had a flood in early 2017, in which records, including Mr. Hodge’s, were destroyed. Exhibit 64. 41 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 42 of 58 A records request was sent to Step Up / Daniel’s Place, a mental health support center. The facility indicated they did not have any records indicating Mr. Hodge was enrolled in their mental health services. Exhibit 62. Despite the existence of some records from Transitional Youth, discussed above, the records department later stated Mr. Hodge was never in one of their programs. See exhibit 82. In 2018, records were requested from Valley Coordinated Children’s Services within the Los Angeles County Department of Mental Health. The records requested were destroyed due to the department’s retention policy. Exhibit 72.43 For similar reasons, records from West Valley Mental Health were destroyed. Exhibit 81.44 3. Testimony Ms. Elson’s recollections of events after the 2006 vaccinations are noted below. a) Ms. Elson’s Affidavits The following section recites the remainder of Ms. Elson’s affidavits. The remainder concerns Mr. Hodge’s health from the date of the first hepatitis vaccination (March 17, 2006) onward. (i) Affidavit #1 Ms. Elson recalls that on the evening of March 17, 2006, “[Mr. Hodge] became violently ill with chills followed by hot flashes and stabbing pains that felt like electric shocks up his spine, his legs, and his arms.” Id. at pdf 4. Ms. Elson thought he caught the flu. He improved over the next few days and still felt tired, but his symptoms did not seem too alarming. Id. After the second booster vaccination on April 25, 2006, Mr. Hodge’s “health declined rapidly” as he “complained of horrible fatigue, numbness in his arms, and stiffness throughout his body. He was unable to concentrate for any length of time. He left school . . . .” Id. Next, she recalled rushing Mr. Hodge to the ER at Valley Presbyterian Hospital on June 2, 2006, due to complaints of terrible body pain, stiffness, and 43 It is possible Mr. Hodge was treated at this facility prior to 2006. 44 Some records from West Valley were provided and are discussed above. This implies the West Valley records are incomplete. 42 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 43 of 58 numbness throughout his body. “He was in a ‘fog’ where he could not remember things happening around him.” Id. She claims he lost his health insurance because he was deemed to have a pre-existing condition. Subsequently, she recalls he received a brain MRI at Olive View, which revealed an undiagnosed demyelinating condition and evidence of at least five oligoclonal bands. Id. at pdf 4-5. The suspicion at that time was MS. (ii) Affidavit #2 Regarding the events of 2006 onward, the next affidavit continues: After the March 2006 shot he shot [sic] it was night and day. It was like he got hit by a bus. He got very very ill within the month after the shot. He deteriorated rapidly. He went to the emergency room within a week. He had severe pain shooting up and down his spine. He was screaming in pain. His eyes were jittery and moving all over the place. That didn’t stop for the next year. He had to drop out of school. Exhibit 19 at 1. She claims that after “the shot” (it is unclear whether this refers to the first or second hepatitis B vaccination), “he couldn’t do anything. Couldn’t do any of the things he loved. [Mr. Hodge] was wiped clean. Like his brain was scrambled.” Id. Ms. Elson reported that his health declined rapidly within six months. She alleged: “He didn’t know who he was. He forgot his past. He was urinating and defecating in his pants. He would go days without eating. He dropped to 90 pounds.” She recalled the doctors’ visits that followed, in which Mr. Hodge was scared. “He would tell them his symptoms but then as it progressed he stopped talking to the doctors. I communicated for him. It was too difficult for him.” Id. at 2. She described him as “completely mentally disabled” between 2006 and 2009. Regarding insurance Ms. Elson stated they Mr. Hodge on MediCal – Medicaid. However, “[t]hey refused to cover MRIs. He was constantly refused medical care. He was denied an MRI numerous times. We requested MRIs in every emergency room we were in and were denied. Easily 12-14 times we asked for MRIs and were told no.” Id. (iii) Affidavit #3 This affidavit makes numerous claims regarding Mr. Hodge’s functioning after his 2006 vaccinations. Ms. Elson testified before 2006, Mr. Hodge engaged 43 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 44 of 58 in some OCD rituals, discussed above. She testified that after the 2006 vaccinations, his OCD rituals consumed his entire life. Exhibit 21 at 3. She stated Mr. Hodge was on track to get his GED toward the end of 2005, but could not attend school with the rest of his peers and his OCD caused him to fall too far behind to keep up with ordinary classes. Id. She testified his symptoms and rituals became so severe during the summer of 2006 that he could not attend any classes. Id. Ms. Elson alleged that after the April vaccine, Mr. Hodge could not form full, coherent sentences and he instead screamed phrases like “I don’t even know who I am” and “I can’t feel anything.” Id. She noted rapid eye fluttering during the summer of 2006. She alleged he could not sleep for days at a time, and could not properly use the restroom for multiple years. Id. at 3-4. “The hallucinations started during the summer of 2006.” Id. at 4. She recalled he said angels, demons, and people screamed at him; the hallucinations were sometimes comforting, other times scary, and persisted for years. Id. Ms. Elson alleged Mr. Hodge “tried to burn down [their] house the summer of 2006–more than once.” Id. She wrote that he would turn on the gas stove and put paper and other objects, including his own hand, into the flames. She reportedly feared he would burn the house down. Ms. Elson stated Mr. Hodge “could not feed himself for several years after the vaccine. He weighed 160 pounds around August of 2006. By 2007 he weighed approximately 90 pounds.” Id. She alleged he went days without eating or drinking water, and at other times, “took jars of salt and dumped them on his food.” Id. at 4. She alleged he was “afraid to leave the house” but also that “[m]ost days of the week, between 2006 and 2009, he would not come inside the house and [she] had to sleep outside in [her] car watching him.” Id. Ms. Elson alleged that Mr. Hodge lost insurance because of his preexisting OCD, and without insurance, “every facility shooed us away.” Id. After obtaining MediCal-Medicaid, she started taking him to Transitional Youth. He became secretive about his hallucinations. Id. She recalled holistic/nutritional approaches with Pfeiffer, which were to no avail. She next recalls that a volunteer psychiatrist at Daniel’s Place (a free mental health services clinic) told them Mr. Hodge was too much work, so they stopped going there after one visit. Id. at 5. She reported 44 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 45 of 58 that things “remained pretty constant until about [2013] when the Risperdol [sic] started to work.” Id.45 The general theme of this affidavit was the Mr. Hodge had regressed in extreme ways. Ms. Elson alleged he could not eat or drink, comprehend basic sentences, engage in personal hygiene, wear clothing, or properly use the restroom. She alleged the only “activity” he could do was go aimlessly biking for miles into the woods or into the middle of the highway. He ceased to do the activities that were normal for him prior to 2006. Additionally, “[h]e can’t remember most of what has happened to him since 2006.” Id. at 5. (iv) Affidavit #4 The purpose of the third affidavit was straightforward and responsive to statements made by experts retained by the Secretary. Dr. LaRusso and Dr. Dunn implied that because Mr. Hodge signed consent forms, he had mental capacity. Ms. Elson wrote Affidavit #3 to clarify that “in many cases [she] signed for Jeremy” (emphasis in original). Exhibit 26 at 1. She continued, noting Mr. Hodge “would not and could not do certain things. . . . [She] would talk for him at the doctors’ offices. [She] would give his history etc. . . . He was in no way capable of handling his own affairs or make deliberate decisions.” Id. (v) Affidavit #5 In this affidavit, Ms. Elson recounts that “[w]ithin days” of the March 17, 2006 vaccines, Mr. Hodge “starting having headaches, dizziness, shooting pains up and down his back, and numbness in his arms. After a while, he also developed these weird eye movements that he couldn’t control.” Exhibit 71 at 3. She reported he could no longer play basketball. The two returned to Noble Community Medical Center on April 25, 2006. She wrote that she told the doctor about the problems Mr. Hodge was having. Id. The symptoms got worse after the second shot. She alleged they could not wait for a neurologist appointment, so she took Mr. Hodge to Valley Presbyterian on June 2, 2006. She then defers to the medical records to describe what was experienced before receiving the 2009 MRI. She also incorporated her prior affidavits into this affidavit. Id. She also provides some amendments: 45 A pharmacy record shows Mr. Hodge was prescribed Risperdal as early as 2004. See exhibit 23. 45 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 46 of 58 However, there are a couple of corrections. In Exhibit 19, I described the things as if there was only one shot given in March of 2006. Reviewing the records of the visits for March 16, 2006 and April 25, 2006 has helped me to describe what I remember after each of those shots better. Id. At this point in time, Ms. Elson’s recollection was that Mr. Hodge only saw Dr. Nasse a couple of times after the 2006 vaccines, and not before that point. “It is really hard to remember things from so long ago, but getting the records that the Special Master asked us to get has helped.” Id. at 4. Ms. Elson reiterated that Mr. Hodge had bad mood swings, provided incoherent communications, and could not participate in any of the activities he used to enjoy. Id. She likened his condition to dementia. (vi) Affidavit #6 In the final affidavit, Ms. Elson responded to specific questions posed by the undersigned. The following subsection concerns events from the date of first hepatitis vaccination onward. A “‘Staying Healthy’ Assessment” form was completed at Noble Community Clinic on March 17, 2006. Ms. Elson reported that she filled out the form. Exhibit 86 at 12.46 On the form, she positively indicated that Mr. Hodge “often feel[s] sad, down, or hopeless,” and explained this was due to his OCD. Id. Ms. Elson indicated Mr. Hodge saw Dr. Nasse after the March 17, 2006 vaccination. Id. at 13. Other than OCD and being somewhat depressed, his “mental health was still pretty normal after the first vaccine.” Id. Between the two vaccinations, Mr. Hodge “experienced headaches and shooting pains up and down his back, and numbness in his arms.” Id. After the second vaccine, “he couldn’t feel his arms, legs, and skin” and “he experienced severe rapid eye movement.” Id. She reported the symptoms continued to get worse, that Mr. Hodge began to tire easily and that his mental health deteriorated. Id. at 14. Though she could not recall specifically when the uncontrollable eye movements began, she stated she knows it got really bad after the second vaccine. Id. “[I]t was constant and progressively worse for at least a year.” Id. “All the doctors that saw Jeremy saw it after Noble Community Clinic.” 46 The assessment consists of a series of questions to which one completing the assessment answers the question by placing a check in the box “no,” “yes,” or “skip.” 46 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 47 of 58 Id. She also stated he had severe spine and neck pain, and lost sensation in his lower legs and arms. Id. at 15. Similarly, she reported he had coordination and balance issues, and experienced sporadic pain for years. Id. When asked whether Mr. Hodge was seeing a psychiatrist or psychologist during the summer of 2006, Ms. Elson wrote: “I don’t remember. To the best of my knowledge, he was only seeing the people that gave him the Prozac and Zoloft.” Id. at 14. She alleges they were denied MRIs due to not having private insurance. Id. at 15-16. Ms. Elson recalled that they went to Valley Presbyterian instead of the Noble Clinic in June 2006 because they could not wait for a neurologist appointment and she did not trust Noble. Id. at 16. When asked about the medical record indicating Mr. Hodge denied having pain at that visit, she guessed that the notation might be an error. Id. at 17. When asked what the doctor’s recommendations were after discharge, she reported it was to go to a neurologist and get an MRI, and that she remembers subsequently going to “at least four or five times to an ER near [them].” Id. at 18. Between June 3, 2006 and August 21, 2006, Ms. Elson “think[s]” there were living at her mom’s place in Encino. Id. She stated that during this time, his OCD “was still there, but the focus was on other problems, so OCD wasn’t at forefront of concerns. It seemed like it wasn’t as bad, but it came back with a vengeance later on.” Id. She recalled making one or two visits to Encino-Tarzana, and that Mr. Hodge had been having abnormal eye movements and dizziness problems in the days leading up to that visit. Id. at 19. She reportedly asked for an MRI but they could not provide one. Id. at 20. They did not follow instructions to follow-up with a private doctor due to an inability to obtain insurance. Id. However, Mr. Hodge did have insurance through Health Net for their visit to UCLA Medical Center on November 3, 2006. Id. She reported his OCD was “about the same as before” at this visit. Id. She alleged that she “begged for an MRI, but they refused.” Id. at 21. The discharge plan was to follow-up with a private doctor or county or community clinic. Ms. Elson could not remember whether they did so or not. Id. She also did not have much recollection of what they did for Thanksgiving in 2006. Id. When asked what emergency rooms they visited between August 2006 and July 2007, Ms. Elson wrote: “We went to West Valley ER Hospital 6-7 times, 47 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 48 of 58 Valley Presbyterian, Encino, UCLA, Northridge Hospital, Ventura County ER, St. Joseph’s Hospital Burbank, Pfeiffer Treatment Center outreach.” Id. at 23.47 Ms. Elson alleged that it was after the July 10, 2007 visit to West Valley that Mr. Hodge’s mental health significantly deteriorated. Id. at 22. “He started to go through psychosis and had crippling fear. He would stay in the corner shaking, believing house was evil.” Id. at 23. On September 9, 2007, Mr. Hodge went to West Hills Hospital. See exhibit 8. The record states Mr. Hodge “was recently started on dextrostat for possible ADHD.” Id. at 76. Ms. Elson alleged Dr. Nasse prescribed the medication. Exhibit 86 at 24. “He had a bad reaction to it. When he took it, I had to chase Jeremy up the street.” Id. She stated Dr. Nasse diagnosed him with possible ADHD but could not remember when. Id. The affidavit also asked Ms. Elson to recall when she began investigating potential causes for Mr. Hodge’s condition(s). She reported she started her research about six months before contacting Mr. Shoemaker. Id. at 26. Additionally, she noted: “Every single doctor after Olive View said that it was a strong possibility that vaccine triggered autoimmune reaction. Even at UCLA I Was told that it was a possibility.” Id. b) Oral Testimony The undersigned was present for the June 14, 2021 hearing and has reviewed the transcripts on multiple occasions. Due to fact findings explained below in Section IV, a full recitation of Ms. Elson’s oral testimony during the hearing is not necessary. Nonetheless, a brief summary follows. Ms. Elson testified that after the first shot, Mr. Hodge’s eyes started fluttering and he complained of spinal pain and itching. Tr. at 149. Though the two allegedly told Dr. Rodriguez about the eye fluttering, it was not reflected in the medical record. Id. Then, “[a]ll hell broke loose” after the second hepatitis vaccine. Id. at 150. She testified she requested an MRI “[e]very time” they went to an emergency room, but was denied until 2009 because they had Medi-Cal / Medicaid. Id. She testified his eye fluttering got worse after the second vaccine and he experienced horrible pain, weakness, and dizziness. Id. at 151. Similarly, she 47 It seems that West Valley is a mental health treatment center, not an emergency room. See exhibit 11. If there is a West Valley emergency room, records from that facility were not filed. 48 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 49 of 58 alleged his personality changed and his ritualistic behavior became constant. Id. She stated she reported all of these symptoms when she took him to the hospitals. Id. On cross-examination, she professed to not recalling several details. Id. at 183-188, 193-194. 4. Expert Commentary For the reasons discussed below, a full recitation of the experts’ commentary on Mr. Hodge’s condition after the 2006 vaccinations is not necessary. The relevant portions of Dr. Tornatore’s opinions are explained below in Section V. Dr. Tornatore’s testimony mirrored Ms. Elson’s statements. He noted that numbness and tingling followed the vaccines and were suggestive of a neurologic vaccine injury. Tr. at 25. He postulated the vaccines caused autoimmune demyelination, which aggravated the neuroborreliosis (which he characterized as an underlying autoimmune inflammatory condition). Id. at 26-27. In his opinion, the reported eye fluttering was a neurological manifestation of vaccine injury. Id. at 27. In assessing Mr. Hodge’s clinical picture, Dr. Tornatore assumes Mr. Hodge’s OCD was a manifestation of neurolyme. Id. at 34, 39. This assumption, coupled with the 2009 MRI and spinal fluid, forms the foundation of his significant aggravation theory. Id. at 34. But for exposure to Lyme disease via the tick bite, Dr. Tornatore opined, Mr. Hodge would not have OCD. Id. at 42. However, Dr. Tornatore acknowledged that “when [ ] the actual infection happen[ed] . . . is very difficult to discern from the records.” Id. at 34. Nonetheless, he maintained confidence that neuroborreliosis preceded the vaccinations and that the vaccines triggered additional inflammatory responses via molecular mimicry. Id. at 34-36. IV. Findings of Fact The recitation of evidence above forms the foundation of this case. Having considered all of the evidence, the undersigned now presents his findings of fact. A. Standards for Adjudication A petitioner is required to establish her case by a preponderance of the evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence standard requires a “trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the judge of the fact's existence.” Moberly v. Sec'y of Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations 49 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 50 of 58 omitted). Proof of medical certainty is not required. Bunting v. Sec'y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). Distinguishing between “preponderant evidence” and “medical certainty” is important because a special master should not impose an evidentiary burden that is too high. Andreu v. Sec'y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed. Cir. 2009) (reversing special master's decision that petitioners were not entitled to compensation); see also Lampe v. Sec'y of Health & Hum. Servs., 219 F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec'y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (disagreeing with dissenting judge's contention that the special master confused preponderance of the evidence with medical certainty). Medical records generally warrant consideration as trustworthy evidence. Curcuras, 993 F.2d at 1528. However, because medical records are not always complete and accurate regarding a patient’s condition(s), it may be appropriate for a special master to credit a petitioner’s lay testimony to fill in gaps. Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378 (Fed. Cir. 2021). Nonetheless, special masters are expected to consider the record as a whole and determine how the evidence preponderates. See Britt v. Sec’y of Health & Hum. Servs., No. 17- 1352V, 2021 WL 4282596, at *1-5 (Fed. Cl. Spec. Mstr. Aug. 27, 2021) (discussing the creation of and standards for evaluating medical records). Furthermore, special masters may assess the credibility of an individual offering testimony. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009). B. Ms. Elson’s testimony is generally not reliable In addition to the medical records created contemporaneously with the hospital visits, the undersigned has also considered all of the affidavits and testimony provided by Ms. Elson. At times, the claims made by Ms. Elson are contradicted by the medical records. In other circumstances, the testimony is contradicted by other statements she has made. Ms. Elson also seems to have used hyperbole in some of her statements. Taken as a whole, the undersigned finds that Ms. Elson’s testimony does not carry the burden of persuasion on various facts. As acknowledged by Ms. Elson, “[i]t is really hard to remember things from so long ago[.]” Exhibit 71 at 4; see also exhibit 86 (affidavit in which Ms. Elson stated she could not remember various details). Here, it seems more likely than not that Ms. Elson’s memories were shaped by information in the medical records, which she obtained years after the incidents in question. See Reusser v. Sec’y of Health & Hum. Servs., 28 Fed. Cl. 516, 523 (1993) (noting documentation recorded by a disinterested person soon after the event at issue is generally more 50 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 51 of 58 reliable than recollection of a party to a lawsuit many years later). Indeed, in the fifth affidavit, Ms. Elson amended testimony from her second affidavit. See exhibit 71 at 3 (“Reviewing the records of the visits from March 16, 2006 and April 25, 2006 has helped me to describe what I remember after each of those shots better”). This reliance on records, as opposed to an independent recollection corroborated by the medical records, tends to undermine her credibility as a fact witness. See Reusser, 28 Fed. Cl. at 523. Ms. Elson made numerous statements that are in conflict with the medical records and that are contradicted by her own testimony. Examples are provided below to illustrate why it is difficult to credit her testimony. In the fifth affidavit, filed on November 26, 2018, Ms. Elson recalled Mr. Hodge only began seeing Dr. Nasse after the 2006 vaccinations. Exhibit 71 at 3.48 However, in the sixth affidavit, filed on February 3, 2021, Ms. Elson stated Dr. Nasse prescribed Mr. Hodge Adderall in September of 2004. Exhibit 86 at 11. Additionally, Dr. Nasse submitted a note indicating he no longer had records for Mr. Hodge. In that note, Dr. Nasse stated he saw Mr. Hodge “on + off for a year between 2000 & 2003.” Exhibit 70. These conflicting remarks tend to suggest Ms. Elson’s recollection of events is unreliable. Another example of a dubious assertion made by Ms. Elson is that within six months of the 2006 vaccinations, Mr. Hodge “dropped to 90 pounds.” Exhibit 19 at 1. This claim was later amended: “He weighed 160 pounds around August of 2006. By 2007 he weighed approximately 90 pounds.” Exhibit 21 at 4. However, these claims are not supported by the existing medical records. The March 17, 2006 medical record from the Noble Clinic indicates Mr. Hodge weighed 159 pounds on the date of the first hepatitis vaccination. Exhibit 5 at 2. At the next hospital visit in April 2006, his weight was roughly comparable, at 155 pounds. Id. at 3. The next medical record was generated on June 2, 2006. Although Mr. Hodge’s weight was not recorded here, the note indicates he was well nourished and well hydrated, and there are no notations that suggest otherwise. Exhibit 6 at 7. The medical record from August 23, 2006 states Mr. Hodge weighed 160 pounds. Exhibit 4 at 4. Though his weight was not recorded at the next visit on November 3, 2006, the review of systems indicates he was not experiencing weight loss. Exhibit 67 at 2. As noted above, there is a lack of medical records between November 3, 2006 and June of 2007. The next available medical record is from June 20, 2007, and it memorializes that Mr. Hodge was “a well-developed, well- 48 The full quote is: “To the best of my recollection, Jeremy only saw him a couple times after the vaccines and not before the vaccines.” 51 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 52 of 58 nourished male.” Exhibit 65 at 5. The July 10, 2007 record from West Valley recorded that Mr. Hodge did not have a weight or appetite change problem. Exhibit 11 at 4. In light of these medical records, the undersigned is skeptical that Mr. Hodge experienced extreme weight loss (nearly 70 pounds) that went unnoticed by the doctors. It seems more likely that Ms. Elson was either misremembering or exaggerating a problem. This undercuts her credibility. Furthermore, the third affidavit contains statements that seem incongruous with other statements within the affidavit. For example, she stated that “[i]f he wasn’t riding his bike in front of cars on the street he was afraid to leave the house.” Exhibit 21 at 4. At the same time, she stated “[m]ost days of the week, between 2006 and 2009, he would not come inside the house and I had to sleep outside in my car watching him.” Id. It is difficult to reconcile these assertions. She also claimed Mr. Hodge “had no understanding” of what it meant when she told him to eat. Id. It seems more likely that Ms. Elson was using hyperbole when making some of these statements. These types of claims seem to exaggerate circumstances and makes it difficult for the undersigned to credit her testimony. See Heath v. Sec’y of Health & Hum. Servs., No. 08-86V, 2011 WL 4433646, at *5 (Fed. Cl. Spec. Mstr. Aug. 25, 2011) (declining to credit the testimony of a fact witness due, in part, to “a tendency to exaggerate”); Watson v. Sec’y of Health & Hum. Servs., No. 91-1354V, 1992 WL 42927, at *6 (Cl. Ct. Spec. Mstr. Feb. 18, 1992) (declining to credit testimony of a vaccinee’s mother when the special master found “her susceptible to exaggeration, and really unsure about exactly what happened when”). Another example of unreliable testimony involves Ms. Elson’s contention that Mr. Hodge began experiencing severe hallucinations during the summer of 2006. Exhibit 21 at 4. Dr. Baca’s medical records from 2006 note Mr. Hodge denied any hallucinations. Exhibit 4 at 12. When asked about Dr. Baca’s notation that Mr. Hodge denied hallucinations, Ms. Elson indicated that she probably stepped in, but the doctors ignored her complaint. Tr. at 215-16. According to Dr. Tornatore, a report of hallucinations constitutes a medical emergency. Tr. at 279- 80. Thus, it seems unlikely that Dr. Baca would have ignored a report of hallucinations that came from Mr. Hodge or his mother. Cf. Tr. at 280, 404 (both discussing how doctors solicit histories from or about potentially delusional patients). Furthermore, during the hearing, Ms. Elson recalled that Mr. Hodge was 14 or 15 years old on the camping trip in question, which would have been 2001 or 2002. Tr. at 193. At other times, Ms. Elson alleged the tick bit occurred in 2003. See, e.g., Pet’r’s Post Hearing Br. at 4; exhibit 71 at 2. Even in this November 26, 52 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 53 of 58 2018 affidavit, Ms. Elson avers: “I don’t remember when Jeremy had the tick bite that resulted in the bulls-eye rash on his leg, but I think it was shortly before we moved.” Exhibit 71 at 2 (emphasis added). This assertion seems more like a guess. To be clear, the undersigned does not intend to suggest that Ms. Elson testified with any intentional dishonesty. The circumstances in this case, especially in how her original counsel of record did (and did not) collect records, placed Ms. Elson in a difficult position of trying to describe events that occurred many years earlier. The flaws in Ms. Elson’s testimony described above are set forth to explain why her testimony is not reliable. Because her testimony is not reliable, the undersigned cannot rest a finding of fact upon it. See Vaccine Rule 8(b)(1) (directing special masters to consider “reliable” evidence). C. Mr. Hodge had OCD prior to 2006 There are no contemporaneous medical records establishing Mr. Hodge’s OCD diagnosis in the years prior to the 2006 vaccinations. See infra section III.A; Resp’t’s Post Hearing Br. at 27. Records may have existed, but they were not filed and are unavailable. See, e.g., exhibit 72. Dr. Menzer’s records from 2004 and 2005 do not mention OCD. See exhibit 3. Dr. Nasse could not produce his records, though in the brief note he provided many years later, he suggested he may have treated Mr. Hodge on and off for a year between 2000 and 2003 for “OCD”. Exhibit 70 (quotation marks in original). This is insufficient to establish a diagnosis, as it provides no further information and the assertion of treatment between 2000 and 2003 is inconsistent with pharmacy records that show he prescribed Mr. Hodge Adderall and Risperdal in 2004. Exhibit 23. However, there is some evidence suggesting Mr. Hodge developed OCD around age 16-17 (i.e. between 2003 and 2004). Though Dr. Nasse’s note is not without issues, it does provide some support that Mr. Hodge had OCD prior to 2006. Ms. Elson testified that Mr. Hodge developed OCD symptoms after the camping trip in question, but the symptoms were not causing any problems with his school work. Exhibit 71 at 2 (affidavit). The earliest support in the available medical records comes from the March 17, 2006 visit to Dr. Rodriguez when Mr. Hodge received the first hepatitis vaccination. Exhibit 5 at 2. However, it seems this history was provided by Ms. Elson and does not reflect an independent assessment of Dr. Rodriguez. Nonetheless, the Secretary concedes that Mr. Hodge had OCD prior to the 2006 vaccinations. See Resp’t’s Post Hearing Br. at 33. Because of this 53 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 54 of 58 agreement, the undersigned finds that persuasive evidence supports a finding that Mr. Hodge had OCD before he was vaccinated. See exhibit 5 at 2. D. Although Mr. Hodge had Lyme disease in 2009, the evidence does not persuasively show Mr. Hodge had Lyme disease or neuroborreliosis prior to 2006 or prior to developing OCD Ms. Elson argued that in 2003, Mr. Hodge was bitten by a tick carrying B. Burgdorferi and subsequently developed Lyme disease and neuroborreliosis. Pet’r’s Post Hearing Br. at 4, 8, 48. This assertion was derived from Ms. Elson’s fifth affidavit, which was filed on November 26, 2018. See exhibit 71. Ms. Elson’s statement, made fifteen years after the alleged event, is as follows: “I don’t remember when Jeremy had the tick bite that resulted in the bulls-eye rash on his leg, but I think it was shortly before we moved to [Canoga Park]. It was some time after the move when he started having OCD symptoms.” Id. at 2. The move to Canoga Park was in the Spring of 2003. Exhibit 71 at 2. Accordingly, it became petitioner’s position that Mr. Hodge was bitten by ticks and developed Lyme disease in 2003.49 Given the finding that Ms. Elson is not reliable in section IV.B, the undersigned cannot accept the assertion that Mr. Hodge was bitten by ticks during a camping trip in 2003 or that he developed Lyme disease in 2003. Mr. Hodge did develop Lyme disease at some point. Indeed, some medical records in 2009 suggest a B. Burgdorferi infection. See exhibit 7 at 209 (discussing a B. Burgdorferi IgG IFA with a 1:80 titer, a borderline positive result), exhibit 7 at 21 (Dr. Mathisen opining a “possible Lyme disease” diagnosis), and 49 Ms. Elson did mention tick bites, a bull’s-eye rash, and camping trips to Big Sur before the fifth affidavit. These topics were discussed in the second affidavit, but without specificity. She wrote: “While we do not know the exact trip where Jeremy likely contracted Lyme disease, we would go camping all the time at Big Sur, near my grandparents’ house. There were always ticks on the pets, and there were a lot of deer and there were ticks on everything. On our last trip there was a large amount of ticks everywhere. In the sleeping bags and on the dogs. At the end of that trip Jeremy had a bulls-eye rash on his leg.” Exhibit 19 at 1 (filed October 1, 2014). It is unclear as to what timeframe these statements refer. Indeed, Ms. Elson stated she did not know on which trip Mr. Hodge “likely” contracted Lyme disease. Id. A medical record from 2009 also mentions possible tick exposure. Exhibit 7 at 44. However, this record does not contain any persuasive information about the time of the camping. 54 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 55 of 58 exhibit 13 at 4 (Dr. Clough assessing Mr. Hodge as likely having Lyme disease); c.f. exhibit 7 at 204 (noting subsequent western blot testing on June 18, 2009 was negative for B. Burgdorferi IgG) and exhibit 63 at 1 (inconclusive / negative serology tests in September 2009). The Secretary’s expert indicated Mr. Hodge likely had Lyme disease by December 2009. Tr. at 442-43. Thus, the undersigned accepts this premise (that Mr. Hodge had Lyme disease in December of 2009), as it is undisputed. However, a finding that Mr. Hodge suffered from Lyme disease in 2009 does not mean that Mr. Hodge suffered from Lyme disease six years earlier in 2003. The medical records discussing Lyme disease start in 2009. The only evidence supporting a Lyme disease diagnosis prior to 2006 is derived from statements made by Ms. Elson. Although Dr. Tornatore assumes Mr. Hodge had Lyme disease in 2003, the basis for that assumption comes from Ms. Elson’s testimony. It is not wholly implausible that Mr. Hodge had Lyme disease before 2006. But, in light of the above findings, the undersigned cannot credit that assertion because it is not sufficiently persuasive. As such, it is difficult to find that Mr. Hodge contracted Lyme disease in 2003 as opposed to some other year. He may have developed Lyme disease in 2006 or 2007, or earlier. However, it is the petitioner’s burden to prove facts by the preponderance of evidence. Here, that burden has not been met. V. Analysis A. Explanation of petitioner’s theory and Dr. Tornatore’s opinion Dr. Tornatore’s complex opinion can be divided into a series of steps. First, Dr. Tornatore asserted that years before the vaccinations, Mr. Hodge contracted B. Burgdorferi. Pet’r’s Post Hearing Br. at 28; Tr. at 22-23. This opinion derived from Ms. Elson’s testimony that Mr. Hodge was bitten by a tick and developed a bull’s-eye rash at around the age 14 or 15 (in 2003). Pet’r’s Post Hearing Br. at 27. Dr. Tornatore also relied on Dr. Mathisen’s assessment in reaching this conclusion. Petitioner also points to the May 19, 2009 MRI and the spinal tap results as support that Mr. Hodge suffered from neuroborreliosis. Pet’r’s Post Hearing Br. at 27-28. From a starting point that Mr. Hodge suffered from Lyme disease years before the vaccination, Dr. Tornatore made additional assumptions about Mr. Hodge’s condition. In Dr. Tornatore’s version of events, the spirochete took up residence in Mr. Hodge’s nervous system and caused persistent inflammation as the immune system attempted to eradicate the spirochete. Then, the persistent infection or immune activation resulting from the infection manifested as OCD. 55 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 56 of 58 Pet’r’s Post Hearing Br. at 28-29; Tr. at 22-23. Dr. Tornatore testified that the first evidence of neuroborreliosis was Mr. Hodge’s initial presentation of OCD. Id.; Tr. at 23. Petitioner further maintains that Mr. Hodge’s Lyme-induced OCD was relatively mild. Pet’r’s Post Hearing Br. at 30. These assertions and assumptions about Mr. Hodge’s health before the vaccination are the foundation for the remainder of Dr. Tornatore’s opinion. Dr. Tornatore opines that the hepatitis B vaccines significantly aggravated Mr. Hodge’s OCD. The mechanism is molecular mimicry. Id. at 48, 52-57. B. Dr. Tornatore’s assumption of facts is incongruous with the fact findings The factual assertions upon which Dr. Tornatore relies are inconsistent with the facts that the undersigned determined to be more likely than not true. The primary unsubstantiated assumption concerns when Mr. Hodge developed Lyme disease. A lesser unsubstantiated assumption is that Mr. Hodge’s OCD before the vaccinations in 2006 was mild. In light of the fact finding, there is not preponderant evidence to show Mr. Hodge developed Lyme disease before 2009. As such, Dr. Tornatore’s opinion cannot be credited. However, Numerous cases in the Vaccine Program have recognized that a special master may reject the opinion from an expert that assumed a set of facts not supported by the record. Among these cases, a leading precedent is Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993). In Burns, the vaccinee’s mother alleged that her son, Ryan, became fussy and did not want to eat after his first DPT vaccine, and began to experience staring spells and excessive drooling the day after the second DPT vaccination. Burns v. Sec’y of Health & Hum. Servs., No. 90-953V, 1992 WL 365410, *2 (Fed. Cl. Spec. Mstr. Nov. 6, 1992). Ms. Burns testified Ryan’s behavior changed dramatically following the second DPT vaccination, but the alleged symptoms were not corroborated by the contemporaneous medical records. Id. Ryan received his third DPT shot a few months later. Ryan’s next hospital visit was a few months later and the records from that visit did not document staring spells or possible seizures. Nearly a year later, Ryan was hospitalized, which was the first medically documented seizure episode. Id. at *3. He received a fourth DPT vaccine a few months later and Ms. Burns testified he had a high fever. Id. at *4. The petitioner’s expert assumed Ryan’s seizures started the day after his second DPT vaccine and was exacerbated by the fourth shot. Id. at *6. However, the special master discounted the expert’s opinion, which was largely reliant on Ms. 56 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 57 of 58 Burns’s testimony, after finding Ms. Burns’s testimony was contradicted by multiple contemporaneous medical records. Id. at *6-7. The Federal Circuit held that the special master did not err by accepting the contemporaneous medical records over the testimony of a fact witness. Burns, 3 F.3d at 417. In reaching this conclusion, the Federal Circuit recognized that the petitioner presented inconsistent affidavits and professed to the difficulties of remembering specific dates from events that happened long ago. Id. Moreover, the Federal Circuit also ruled that the special master did not err in rejecting the opinion from the expert the petitioner had retained. The Federal Circuit explained: “The special master concluded that the expert based his opinion on facts not substantiated by the record. As a result, the special master properly rejected the testimony of petitioner’s medical expert.” Id. Special masters have followed Burns and its reasoning in multiple cases. Examples include: Kreizenbeck v. Sec’y of Health & Hum. Servs., No. 08-209, 2018 WL 3679843, at *32 (Fed. Cl. Spec. Mstr. June 22, 2018) (“Dr. Boles placed too much emphasis on Mrs. Kreizenbeck’s uncorroborated allegations of C.J.K.’s vaccine reaction in opining that proof of exacerbation was established, further diminishing the reliability of his opinion”), mot. for rev. denied, 141 Fed. Cl. 138 (2018), aff’d on non-relevant ground, 945 F.3d 1362 (Fed. Cir. 2020); Hirmiz v. Sec’y of Health & Hum. Servs., No. 06-371V, 2014 WL 4638375, at *8 (Fed. Cl. Spec. Mstr. Aug. 26, 2014) (finding an opinion from petitioners’ expert, Dr. Oleske, was unpersuasive because he “based his opinion on a plainly flawed assumption as to the time of onset of J.H.’s neurological symptoms”), mot. for rev. denied, 119 Fed. Cl. 209, 217 (2014), aff’d without opinion, 618 Fed. App’x 1033 (Fed. Cir. 2015); Milik v. Sec’y of Health & Hum. Servs., No. 01-064V, 2014 WL 6488735, at *16 (Fed. Cl. Spec. Mstr. Oct. 29, 2014) (“Dr. Souayah based his testimony on a clearly flawed assumption as to the time of the onset of A.M.’s neurological dysfunction, his causation opinion can be readily dismissed for that reason alone.”), mot. for rev. denied, 121 Fed. Cl. 68, 84 (2015), aff’d, 822 F.3d 1367, 1381 (Fed. Cir. 2016). Notably, in each of those cases, an appellate authority agreed with the reasoning of the special master. In a non-precedential opinion, the Federal Circuit stated that the special master correctly relied upon a Supreme Court opinion, Brooke Group Ltd. v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993), for the proposition that “[w]hen an expert assumes facts that are not supported by a preponderance of the evidence, a finder of fact may properly reject the expert’s opinion.” Dobrydnev v. Sec’y of Health & Hum. Servs., 556 Fed. App’x 976, 982-93 (Fed. Cir. 2014). 57 Case 1:09-vv-00453-MMS Document 377 Filed 10/04/22 Page 58 of 58 Ms. Elson’s case is comparable to those cases in that she has not established the predicate assumptions underlying an expert’s opinion. Without the necessary showing, analyzing other aspects of the expert’s opinion is unnecessary. For example, Dr. Tornatore’s opinion presupposes that Mr. Hodge suffered from Lyme disease before he was vaccinated in 2006.50 But, determining whether preponderant evidence supports Ms. Elson’s argument that a hepatitis B vaccine can aggravate Lyme disease (Althen prong 1 / Loving prong 4) would be an entirely hypothetical construct. See Lombardi v. Sec’y of Health & Hum. Servs., 656 F.3d 1343, 1353 (Fed. Cir. 2011) (stating in a causation-in-fact case, that the Vaccine Act “places the burden on the petitioner to make a showing of at least one defined and recognized injury”). VI. Conclusion The undersigned does not doubt that Ms. Elson and Mr. Hodge have had a difficult decade. The records demonstrate that Mr. Hodge has suffered severely, and that Ms. Elson has cared for her son during trying times. However, petitioners bear the burden of proving facts in order to demonstrate entitlement. Here, for the above stated reasons, the evidentiary record does not sufficiently show certain predicate facts. Without the predicate facts to support her claim, Ms. Elson has failed to prove entitlement. The Clerk’s Office is instructed to enter judgment in accord with this decision unless a motion for review is filed. Information about filing a motion for review, including deadlines, is available through the Vaccine Rules, found on the website of the Court of Federal Claims. IT IS SO ORDERED. s/ Christian J. Moran Christian J. Moran Special Master 50 While the evidence supports a finding that Mr. Hodge suffered Lyme disease in 2009, there is not preponderance evidence that Mr. Hodge suffered Lyme disease in 2006. 58 ================================================================================ DOCUMENT 5: USCOURTS-cofc-1_09-vv-00453-6 Date issued/filed: 2023-03-22 Pages: 23 Docket text: JUDGE VACCINE REPORTED OPINION reissuing 383 Opinion and Order for publication. Signed by Senior Judge Margaret M. Sweeney. (kb1) -------------------------------------------------------------------------------- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 1 of 23 In the United States Court of Federal Claims No. 09-453V (Filed Under Seal: March 7, 2023) (Reissued for Publication: March 22, 2023)1 *************************************** JEREMY HODGE, by his conservator * ERIKA ELSON, * * Petitioner, * Vaccine Act; Motion for Review; * Consideration of the Record as a Whole; v. * Failure to Evaluate Relevant, Reliable * Evidence; Factual Predicate for Petitioner’s SECRETARY OF HEALTH AND HUMAN * Theory of Causation; Remand SERVICES, * * Respondent. * *************************************** Renée J. Gentry, Washington, DC, for petitioner. Bridget A. Corridon and Althea Walker Davis, United States Department of Justice, Washington, DC, for respondent. OPINION AND ORDER SWEENEY, Senior Judge Petitioner Erika Elson filed an amended petition under the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”), 42 U.S.C. §§ 300aa-1 to -34, alleging that her son’s neurological issues were significantly aggravated by his hepatitis A and hepatitis B vaccinations. The special master determined that petitioner did not establish a necessary factual predicate for her theory of causation and therefore failed to prove that she was entitled to compensation. Petitioner seeks review of that decision, arguing that the special master did not consider the record as a whole as required by the Vaccine Act. As explained in more detail below, the court grants petitioner’s motion for review, sets aside certain fact findings and legal conclusions made by the special master, makes its own findings of fact, and remands the case to the special master to reevaluate petitioner’s entitlement to compensation. 1 Vaccine Rule 18(b), included in Appendix B of the Rules of the United States Court of Federal Claims, affords each party fourteen days in which to object to the disclosure of (1) trade secrets or commercial or financial information that is privileged or confidential or (2) medical information that would constitute “a clearly unwarranted invasion of privacy.” Neither party objected to the public disclosure of any information included in this opinion. Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 2 of 23 I. BACKGROUND A. Procedural History Jeremy Hodge, in his individual capacity, filed a petition for compensation under the Vaccine Act on July 15, 2009, alleging unspecified injuries arising from his hepatitis A and hepatitis B vaccinations.2 Over the following few years, Mr. Hodge filed various medical records in support of his claim. After he indicated that all of his medical records had been filed, respondent moved to dismiss the petition on the ground that it was filed beyond the applicable limitations period. Thereafter, Mr. Hodge filed additional medical records and an expert report from Carlo Tornatore, M.D. that addressed his diagnosis and the onset of his symptoms. The parties then briefed the issue of whether equitable tolling applied in this case due to Mr. Hodge’s mental health issues, and Mr. Hodge submitted an affidavit from his mother. On March 23, 2015, the special master dismissed the petition as untimely. Mr. Hodge filed a motion for review, which the undersigned granted on September 9, 2015. The case was remanded to the special master with instructions to reevaluate Mr. Hodge’s equitable tolling argument based on the entirety of the record and then issue a new decision on respondent’s motion to dismiss. During the remand period, Mr. Hodge filed additional medical records, two expert reports from Robert Dasher, M.D., and two affidavits from his mother, while respondent filed expert reports from Elizabeth M. LaRusso, M.D., and John T. Dunn, Ph.D. On December 21, 2015, the special master issued a decision in which he concluded that the statute of limitations should be equitably tolled and directed the parties to address whether a guardian should be appointed on behalf of Mr. Hodge. The following year, Mr. Hodge’s mother was appointed his conservator, and in that capacity she was substituted as the petitioner in this case. On March 6, 2017, after filing additional medical records and another expert report from Dr. Tornatore, petitioner filed an amended petition to specify her son’s injury: a significant aggravation of his preexisting neuroborreliosis. Thereafter, respondent filed an expert report from Arun Venkatesan, M.D., Ph.D., and petitioner filed two additional expert reports from Dr. Tornatore. The parties also filed prehearing briefs in anticipation of an entitlement hearing. After receiving the prehearing briefs, the special master issued an order on September 13, 2018, in which he directed petitioner to obtain and file additional medical records from providers mentioned in the existing medical records and propounded a twelve-page, single-spaced list of questions for petitioner to answer in writing. Four days later, the special master issued another order directing petitioner to obtain and file her social security file and eleven other sets of records (school records, medical records, and youth sports records). Petitioner filed the records 2 The court limits its recitation of the case’s procedural history and recounting of the contents of the medical records, school records, affidavits, and expert reports to the information relevant to the resolution of petitioner’s motion for review. A fuller account of the case’s factual and procedural history can be found in the special master’s decision. See generally Hodge v. Sec’y of HHS, No. 09-453V, 2022 WL 4954672, at *2-9, *12-32 (Fed. Cl. Spec. Mstr. Sept. 12, 2022). -2- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 3 of 23 she was able to obtain and, on November 26, 2018, another affidavit. The special master, dissatisfied with petitioner’s production (of both the requested records and the contents of the affidavit), issued an order on November 28, 2018, in which he cancelled the upcoming entitlement hearing, indicated his intent to instead hold a fact hearing focused on Mr. Hodge’s condition before and after his hepatitis A and hepatitis B vaccinations, stated that such a hearing would not be scheduled until the identified records had been produced, directed petitioner’s counsel to seek authorization to issue subpoenas to obtain these records, further directed petitioner’s counsel to be prepared to submit an affidavit describing the efforts made to obtain these records, explained that updated expert reports reflecting any new information would likely be necessary, and indicated that a new entitlement hearing would then need to be scheduled. The special master acknowledged that the delay his requests would cause was contrary to the efficient resolution of claims contemplated by Congress in enacting the Vaccine Act, but stated his belief that such a delay was better than deciding the case without relevant factual information. Eventually, on August 16, 2020, petitioner filed a statement indicating that all of the records requested by the special master, to the extent they existed, had been filed. Thereafter, she filed another expert report from Dr. Tornatore and respondent filed another expert report from Dr. Venkatesan. Petitioner subsequently advised the special master that she did not want to testify during the yet-to-be-scheduled entitlement hearing,3 and instead proposed filing another affidavit, which she did on February 3, 2021. In this affidavit, she directly answered the questions originally propounded by the special master in September 2018. In a March 25, 2021 order, the special master indicated that he was inclined to order petitioner to testify during the entitlement hearing. In response, petitioner again indicated her objections to testifying, but stated that she would make herself available if required by the special master. The special master treated the latter statement as petitioner indicating her willingness to testify and thus incorporated petitioner’s testimony into the hearing schedule, along with the testimony of Dr. Tornatore and Dr. Venkatesan. The special master held the entitlement hearing on June 14-15, 2021. The parties then filed posthearing briefs from September 2021 to February 2022, and the special master heard argument in March 2022. Six months later, on September 12, 2022, the special master issued his decision. At the outset of his decision, the special master summarized petitioner’s theory of causation: [Petitioner] alleges that (1) her son, Jeremy Hodge, developed Lyme disease in 2003; (2) the untreated bacterial infection progressed to a central nervous system disorder known as neuroborreliosis; (3) the Lyme disease / neuroborreliosis in turn caused him to develop obsessive-compulsive disorder (“OCD”); (4) then, the 2006 hepatitis B vaccine(s) significantly aggravated his condition. 3 By this point in time, the special master’s plan to conduct separate fact and expert hearings had been abandoned. -3- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 4 of 23 Hodge, 2022 WL 4954672, at *1. He then identified three issues presented by this case: (1) “the absence of records during the critical periods of time”; (2) the inconsistency of petitioner’s testimony, provided “many years after the subject events took place,” that was meant to “fill in the evidentiary gaps”; and (3) the experts’ “develop[ment of] their opinions based upon the rough sketch that the limited record evidence provides.” Id. at *1-2. With respect to second issue, the special master found that petitioner’s testimony, “[a]t times,” was contradicted by the medical records, inconsistent, and hyperbolic. Id. at *33. He therefore found petitioner’s testimony unreliable, and held that it could not form the basis for any finding of fact. With respect to the third issue, he remarked that Dr. Tornatore’s opinion was premised on Mr. Hodge suffering from Lyme disease before he developed OCD, but that petitioner had “not established that predicate with preponderant evidence.” Id. at *2. He therefore held that petitioner did not establish her entitlement to compensation. The special master’s decision contains a lengthy recounting of much of the factual evidence in the record, including Mr. Hodge’s medical and school records, petitioner’s affidavits, the reports of petitioner’s experts, and the oral testimony elicited from petitioner and Dr. Tornatore during the entitlement hearing.4 The court briefly summarizes the evidence relevant to the resolution of petitioner’s motion for review.5 B. Information Included in Mr. Hodge’s Medical Records Mr. Hodge was born on May 15, 1987. His pediatric records reflect a number of normal childhood illnesses and injuries through July 8, 1996, when he was nine years old. There are no medical records from that date until March 10, 2004, when he visited his pediatrician with a two- month history of sinus pressure. Mr. Hodge’s mental health issues are first referenced in a September 28, 2004 notation by an individual in his pediatrician’s office describing petitioner’s report that a psychiatrist had given Mr. Hodge a prescription for Adderall. This notation is supported by pharmacy records 4 The special master’s recounting omits discussion of certain records, which the court addresses below. It also includes a few inaccuracies. For example, the special master erroneously indicated that Mr. Hodge was in the ninth grade from 2003 to 2004 and was sixteen- to-seventeen years old at the time. Compare Hodge, 2022 WL 4954672, at *14 (“In ninth grade (2003-2004), Mr. Hodge again attended the City of Angels School. . . . Mr. Hodge would have been 16-17 years old during ninth grade.”), with Pet’r’s Ex. 61 at 6-7 (reflecting that Mr. Hodge’s ninth grade year began in October 2002, and that his first two (of six) semesters in senior high school ended in January 2004 and June 2004, respectively). As another example, the special master implies that Shri Mishra, M.D. recorded Mr. Hodge’s chief complaint, history of present illness, and assessment during an August 4, 2019 visit, even though the medical record reflects that this information was recorded by another physician. Compare Hodge, 2022 WL 4954672, at *24, with Pet’r’s Ex. 7 at 45-46. Further inaccuracies are noted later in this decision. 5 The court derives its summary from the special master’s decision and petitioner’s affidavits. Additional details from the medical records are set forth in the court’s discussion of petitioner’s motion for review. -4- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 5 of 23 indicating that John Nasse, M.D. prescribed Adderall for Mr. Hodge that same day (Dr. Nasse also prescribed Risperdal for Mr. Hodge the previous day).6 A March 21, 2005 pediatric record indicates that Mr. Hodge had been taking Zoloft, and medical records from the spring of 2006 indicate that the Zoloft was being used to treat OCD, which Mr. Hodge developed when he was seventeen years old. On March 17, 2006, when he was eighteen years old, Mr. Hodge received a hepatitis A vaccination and his first hepatitis B vaccination. Mr. Hodge received his second hepatitis B vaccination on April 25, 2006. On June 2, 2006, he was evaluated at the Valley Presbyterian Hospital emergency room for balance issues, dizziness, eye movement disturbances, fatigue, and pain. His discharge diagnoses were dizziness and arthralgias-myalgias following the hepatitis vaccination. Six days later, at petitioner’s request, one of Mr. Hodge’s physicians agreed to request an MRI for Mr. Hodge. However, Mr. Hodge did not obtain an MRI at that time. In fact, Mr. Hodge did not obtain an MRI until May 19, 2009. The MRI revealed white matter hyperintensities in Mr. Hodge’s brain, leading a neurologist to suggest the possibility of a demyelinating disease, among other potential diagnoses. A blood test on June 5, 2009, revealed the presence of antibodies for Borrelia burgdorferi, suggestive of Lyme disease, but subsequent testing for those antibodies had negative or inconclusive results. The record from a neurology examination on August 4, 2009, includes the first mention of a tick exposure in the section describing the history of Mr. Hodge’s illness. That record further indicates that Mr. Hodge had psychiatric disorders, including OCD, of various onsets starting at age seventeen, and that the onset of his OCD-like behavior occurred abruptly over the course of one month. On December 11, 2009, an infectious disease specialist indicated that Mr. Hodge’s symptoms were consistent with chronic neuroborreliosis. C. Petitioner’s Written and Oral Testimony Petitioner submitted several affidavits to expand upon the information described in the medical records and fill in gaps where no relevant records exist. In her first affidavit, filed on January 14, 2011, petitioner stated that Mr. Hodge “was at all times before his vaccination, extremely healthy. He was kind, happy-go-lucky, and excelled in athletics.” Pet’r’s Ex. 9 ¶ 6. She reported, however, that Mr. Hodge began to suffer from allergy-like symptoms at age sixteen, leading them to seek medical treatment. Petitioner stated that the physician who examined Mr. Hodge on March 17, 2006, Jorge Rodriguez, M.D., noted that Mr. Hodge had not yet received his hepatitis A and hepatitis B vaccinations, and had them administered that day. She then recounted: 6 Petitioner submitted a handwritten note, dated November 24, 2018, from Dr. Nasse in which Dr. Nasse explained that his records had been destroyed in a fire a couple of years before the records request. Nevertheless, he certified that Mr. Hodge was his patient on-and-off for a year between 2000 and 2003, and was being treated for OCD. The conflict between this certification and the September 2004 prescriptions he wrote for Mr. Hodge is not explained. -5- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 6 of 23 14. The same evening he became violently ill with chills followed by hot flashes and stabbing pains that felt like electric shocks up his spine, his legs, and his arms. 15. We thought he had caught the flu. 16. He was somewhat better the following day, yet still felt hot. 17. Days [passed] and he still felt tired, but his symptoms did not seem too alarming. 18. On April 25, 2006, I took Jeremy back to Dr. Rodriguez for a Hepatitis B booster vaccination. 19. After that vaccination, my son’s health declined rapidly. 20. He complained of horrible fatigue, numbness in his arms, and stiffness throughout his body. He was unable to concentrate for any length of time. He left school and has not returned to his studies. Id. ¶¶ 14-20. Petitioner did not mention OCD or describe any ritualized behaviors in this affidavit, nor did she mention Mr. Hodge’s Lyme disease diagnosis.7 Petitioner’s second affidavit, filed on October 1, 2014, provides additional detail regarding Mr. Hodge’s health prior to the vaccinations at issue: While we do not know the exact trip where Jeremy likely contracted Lyme disease, we would go camping all the time at Big Sur, near my grandparents’ house. There were always ticks on the pets, and there were a lot of deer and there were ticks on everything. On our last trip there was a large amount of ticks everywhere. In the sleeping bags and on the dogs. At the end of that trip Jeremy had a bulls-eye rash on his leg. Back then there was not much information about Lyme disease so we just treated it topically. He had some flu-like symptoms but we never thought much of it. Within a year of that he began exhibiting OCD hoarder symptoms and complained of spaciness and fogginess in his brain. However before the hepatitis b vaccination in March of 2006 Jeremy was a young man getting ready to finish school and start his new life. He loved going to wrestling events with his family. Before the vaccine he would play video 7 Presumably, these topics were not addressed because the theory of causation at that time was that Mr. Hodge developed a demyelinating disease from his hepatitis A and hepatitis B vaccinations. See, e.g., Pet’r’s Ex. 9 ¶¶ 25-27 (stating that an MRI revealed lesions on Mr. Hodge’s brain that indicated “a yet undiagnosed demyelinating condition”). -6- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 7 of 23 games with friends. He loved hiking, riding bikes, swimming. He was very active. He could drive and go out with friends. Pet’r’s Ex. 19 at 1. She also expanded upon Mr. Hodge’s condition postvaccination: After the March 2006 shot . . . it was night and day. It was like he got hit by a bus. He got very very ill within the month after the shot. He deteriorated rapidly. He went to the emergency room within a week. He had severe pain shooting up and down his spine. He was screaming in pain. His eyes were jittery and moving all over the place. That didn’t stop for the next year. He had to drop out of school – his independent study program. Id.; see also Pet’r’s Ex. 71 ¶ 19 (explaining that she erroneously attributed Mr. Hodge’s deterioration in health to a single vaccination rather than the multiple vaccinations he received on two dates). She expanded on this information in a third affidavit, filed on October 16, 2015: Jeremy’s OCD developed around age 16. Before about May 2006, my son acted on his OCD symptoms but he could participate in his life. In the years before and leading up to his 2006 vaccination he played video games, skateboarded, wrestled. He did engage in rituals but they didn’t consume his entire life like they did for the next seven or eight years following the vaccine. . . . . Toward the end of 2005 Jeremy was on track to get his GED. At that time, he could not attend school with the rest of his peers. He took classes through an independent study program. His OCD made him fall too far behind in school to keep up with ordinary classes. Because of his condition, ordinary high school overwhelmed him. His rituals, obsessions, and compulsions became so severe during the summer of 2006 that attending any classes whatsoever was a pipe dream. Pet’r’s Ex. 21 at 1; see also Pet’r’s Ex. 71 ¶ 19 (explaining that she erroneously stated that Mr. Hodge wrestled; rather, he liked to attend WWE wrestling events). Petitioner’s fifth affidavit was submitted in response to the special master’s order propounding a list of questions for her to answer.8 Petitioner did not directly answer the questions posed by the special master, but did address some of the questions’ subject matter, such as Mr. Hodge’s educational history. After recounting Mr. Hodge’s educational history through the ninth grade, she stated: 7. I don’t remember when Jeremy had the tick bite that resulted in the bulls-eye rash on his leg, but I think it was shortly before we moved to De Soto Avenue [on 8 The contents of petitioner’s fourth affidavit are not relevant to the issues now before the court. -7- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 8 of 23 April 30, 2003]. It was some time after the move when he started having OCD symptoms. 8. I took Jeremy to Valley Care on Victory Boulevard, and they prescribed medication for him to take. First they tried Prozac, and then they switched to Zoloft. Jeremy saw them off and on for about six months. 9. While Jeremy had OCD symptoms, they did not interfere with his daily life. He continued to do well in school, and he continued to enjoy hiking, riding bikes, swimming, going to WWE wrestling events, shows, and even opera. He also enjoyed playing video games with friends. 10. Jeremy attended City of Angels for tenth grade. His report card for tenth grade shows that he received all A’s the first semester (which ended January 30, 2004), and he received 4 A’s and one B the second semester (which ended June of 2004[)]. . . . Clearly, Jeremy’s OCD was not causing any problems with his school work. Pet’r’s Ex. 71 ¶¶ 7-10; see also id. ¶¶ 12-13 (indicating that Mr. Hodge did independent study through his school district for eleventh grade, that after the eleventh grade he dropped out of school to pursue his GED, and that he wanted to attend a local community college). She also described Mr. Hodge’s condition on the date of his hepatitis A and first hepatitis B vaccinations: On March 17, 2006, I took Jeremy to the Noble Community Medical Center. It is important to understand what Jeremy was like on that day. He did have OCD, and he was somewhat depressed, but he was active and enjoying all of the activities described in paragraph 9 above. The best analogy I can come up with is watching the TV series about Monk. He has OCD, but it does not prevent him from living his life. That was Jeremy. He had a life. Id. ¶ 14. Petitioner directly responded to the questions posed by the special master in her sixth affidavit, and her answers to the questions relevant to her motion for review were consistent with the contents of her fifth affidavit. In addition to providing extensive written testimony, petitioner testified during the entitlement hearing in June 2021. The special master summarized petitioner’s testimony regarding Mr. Hodge’s prevaccination condition, placing particular emphasis on her inability to remember certain details regarding events that occurred more than fifteen years previously: When asked to described Mr. Hodge’s general health from birth to age 16, she stated he was “very healthy.” She testified that during a camping trip with lots of ticks, Mr. Hodge received a bull’s-eye rash and subsequently developed OCD symptoms. She recalled the OCD symptoms started at around age 16 and he received an OCD diagnosis at age 17. Despite the symptoms, she insisted his life was “very normal.” However, he had to quit school in eleventh grade because Ms. Elson and Mr. Hodge had moved several times and “the OCD made him -8- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 9 of 23 work a little bit slower because he would get caught up counting” and with “ritualistic behavior.” . . . . On a bad day, Mr. Hodge would spend about 20% of his day consumed by OCD symptoms. On good days, it was not noticeable. She recalled Mr. Hodge getting OCD treatment at Valley Care, but could not remember the name of the doctor that diagnosed him. She stated he was on Prozac during this time period. . . . During cross-examination, Ms. Elson was asked about whether Mr. Hodge was seeing other doctors or receiving other treatment at around age 16 when the OCD symptoms purportedly started. Ms. Elson responded: “It’s kind of hard to remember. Everything is so – just such a blur now. I may have, about that time, gone to Dr. Nasse, but other than that, I’m sorry, I don’t remember.” She could not recall, without checking her notes, what grade Mr. Hodge was in when she separated from her husband. “The dates are very fuzzy for me right now. It’s just been so long.” After being reminded that Mr. Hodge was placed on Adderall in 2004, Ms. Elson noted that Mr. Hodge took Adderall only one time. She stated she did not fill the prescription. She could not remember if Dr. Nasse prescribed any other medication, and thought Mr. Hodge saw him only twice. She recalled Mr. Hodge taking Zoloft for a couple of weeks in 2005. But, it was “hard to remember all the medications.” Respondent’s counsel asked Ms. Elson if she had any recollection of the month or year that the Big Sur camping trip took place. She responded: “I know it was not – I know it wasn’t – maybe spring. I’m literally guessing. . . . It would have been like summer or spring, something like that.” She proceeded to say Mr. Hodge was about 14 or 15 years old on that trip (which would be between 2001 and 2002).9 Hodge, 2022 WL 4954672, at *18 (footnote added) (citations omitted). The special master then summarized petitioner’s testimony regarding Mr. Hodge’s postvaccination condition: Ms. Elson testified that after the first shot, Mr. Hodge’s eyes started fluttering and he complained of spinal pain and itching. Though the two allegedly told Dr. Rodriguez about the eye fluttering, it was not reflected in the medical record.10 Then, “[a]ll hell broke loose” after the second hepatitis vaccine. She 9 Mr. Hodge’s fifteenth birthday was on May 15, 2002, and therefore he also would have been fifteen years old in 2003. 10 Contrary to the special master’s assertion, Dr. Rodriguez’s “subjective” notes from Mr. Hodge’s April 25, 2006 visit provide: “Pt gets itchy after [illegible], pt gets uncontrollable eye movements[.] Pt also complaining of back pain[.]” Pet’r’s Ex. 5 at 3. -9- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 10 of 23 testified she requested an MRI “[e]very time” they went to an emergency room, but was denied until 2009 because they had Medi-Cal / Medicaid. She testified his eye fluttering got worse after the second vaccine and he experienced horrible pain, weakness, and dizziness. Similarly, she alleged his personality changed and his ritualistic behavior became constant. She stated she reported all of these symptoms when she took him to the hospitals. On cross- examination, she professed to not recalling several details. Id. at *31-32 (footnote added). Having set forth the background relevant to petitioner’s motion for review, the court is prepared to address the merits of that motion. II. DISCUSSION A. Standard of Review The United States Court of Federal Claims (“Court of Federal Claims”) has jurisdiction to review the record of the proceedings before a special master, and upon such review, may: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision, (B) set aside any findings of fact or conclusion 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. 42 U.S.C. § 300aa-12(e)(2). The standards set forth in § 300aa-12(e)(2)(B) “vary in application as well as degree of deference. . . . Fact findings are reviewed . . . under the arbitrary and capricious standard; legal questions under the ‘not in accordance with law’ standard; and discretionary rulings under the abuse of discretion standard.” Munn v. Sec’y of HHS, 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). In this case, petitioner’s sole enumerated objection to the special master’s decision is that the special master improperly raised her burden of proof by separately assessing and rejecting each piece of evidence under the preponderance-of-evidence standard rather than evaluating all of the evidence in the record as a whole. This approach, she argues, is not in accordance with law. When faced with such a contention, the Court of Federal Claims reviews the special master’s application of the law de novo. Rodriguez v. Sec’y of HHS, 632 F.3d 1381, 1384 (Fed. Cir. 2011). -10- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 11 of 23 B. The Special Master Did Not Consider All of the Evidence in the Record Petitioner, in support of her contention that the special master did not consider the record as a whole when determining that she had not established by a preponderance of evidence that Mr. Hodge’s Lyme disease predated his development of OCD, maintains: In his analysis, the Special Master reviews the pieces of circumstantial evidence regarding the Big Sur camping trip individually, relying substantially on [petitioner’s] six affidavits (including the final affidavit addressing 13 pages of questions from the special master issued several years after the fact) filed over the period of more than a decade, as well as her testimony at hearing in 2021 – nearly two decades after the events in question. The Special Master then critiques every variation in [petitioner’s] affidavits and testimony with respect to when the camping trip at Big Sur occurred. He further criticizes and dismisses every medical record that references the tick-bite exposure trip as being insufficient. He does both without acknowledging that [petitioner’s] statements in her affidavits and testimony consistently report the tick-bite exposure camping trip occur[ing] before her son’s diagnosis of OCD and prior to the first Hepatitis b vaccination and that the medical records at the time support this statement. Nevertheless, he dismisses each one individually as lacking persuasive information. Pet’r’s Mot. 15 (footnotes and citations omitted). Respondent counters that the special master appropriately considered all of the evidence in the record in concluding that petitioner had not established that Mr. Hodge suffered from Lyme disease in 2003, before he developed OCD and before he was vaccinated against hepatitis A and hepatitis B. Under the Vaccine Act, a petitioner is entitled to compensation “if the special master . . . finds on the record as a whole . . . that the petitioner has demonstrated by a preponderance of the evidence” the necessary elements of a vaccine-caused “illness, disability, injury, condition, or death,”11 and if there is not a preponderance of evidence that the “illness, disability, injury, condition, or death” is due to factors unrelated to the administration of the vaccine. 42 U.S.C. § 300aa-13(a)(1). Further, when determining the weight to be given any “diagnosis, conclusion, judgment, test report, report, or summary” set forth in the medical records, the special master “shall consider the entire record and the course of the injury, disability, illness, or condition . . . .” Id. § 300aa-13(b)(1). This “statutory instruction to consider the entire record[] is consistent with the purpose of the Vaccine Act, which established ‘a no-fault compensation 11 The necessary elements include: (1) that the vaccine in question is set forth in the Vaccine Injury Table (“Table”); (2) that the vaccine was received in the United States or in its trust territories; (3) that the injured person either sustained an injury as a result of the administration of a Table-designated vaccine for a period of more than six months after the administration of the vaccine, suffered illness, disability, injury, or condition from the vaccine that resulted in inpatient hospitalization and surgical intervention, or died from the administration of the vaccine; and (4) that the petitioner has not previously collected an award or settlement of a civil action for damages arising from the alleged vaccine-related injury or death. 42 U.S.C. § 300aa-11(c)(1). -11- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 12 of 23 program “designed to work faster and with greater ease than the civil tort system.”’” Moriarty v. Sec’y of HHS, 844 F.3d 1322, 1331-32 (Fed. Cir. 2016) (quoting Bruesewitz v. Wyeth LLC, 562 U.S. 223, 228 (2011)). Precedent of the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) provides guidance on what is necessary to satisfy the requirements of 42 U.S.C. § 300aa-13(a)(1) and 42 U.S.C. § 300aa-13(b)(1). For example, in Golub v. Secretary of Health & Human Services, the Federal Circuit criticized the special master for “treat[ing] each element of the evidence individually, discrediting each piece of evidence in turn, without considering the totality of the evidence.” 243 F.3d 561 (Fed. Cir. 2000) (per curiam) (unpublished table decision). It relied, in part, on its earlier decision in Jay v. Secretary of the Department of Health & Human Services, in which it held that the special master, in concluding that the petitioners had not established that their child suffered from an encephalopathy, “los[t] sight of the forest for the trees” because the testimony of the petitioners’ expert reflected that the child, after his vaccination, exhibited symptoms consistent with an encephalopathy and then “died well-within the [Vaccine Act’s] time frame for an encephalopathy.” 998 F.2d 979, 983-84 (Fed. Cir. 1993). Ten years later, in Cedillo v. Secretary of Health & Human Services, the Federal Circuit approved the special master’s separate evaluation of each piece of evidence, remarking: “In the Special Master’s careful and thorough opinion, he considered, weighed, and stated his reasons for rejecting or discounting each item of evidence in which the petitioners relied.” 617 F.3d 1328, 1345 (Fed. Cir. 2010). In Snyder v. Secretary of Health & Human Services, it concluded that the special master properly “examin[ed] the record in its entirety” when he found that the respondent’s evidence showed that the children’s seizure disorders were caused by a factor unrelated to the DTaP vaccine, observing that the special master “did the analysis necessary to decide the Secretary had the stronger case based on testimony and the intellectual strength of the evidence, as well as the arguments presented.” 553 F. App’x 994, 1000, 1003 (Fed. Cir. 2014) (unpublished decision). And most recently, in Paluck v. Secretary of Health & Human Services, the Federal Circuit held that “the special master failed in his duty to consider ‘the record as a whole’” by “placing undue emphasis on the relatively insignificant variations” in some of a particular provider’s records, thereby “giv[ing] short shrift to the evidence” of the child’s condition reflected in the entirety of that provider’s records. 786 F.3d 1373, 1382-83 (Fed. Cir. 2015). What all of this case law indicates is that a special master must not focus on individual pieces of evidence at the expense of determining what is depicted by the record as a whole, and that to the extent that a special master evaluates each piece of evidence on its own merits, he or she should ensure that all relevant evidence is so evaluated. In setting forth his findings of fact, the special master in this case accepted the “undisputed” proposition “that Mr. Hodge had Lyme disease in December of 2009,” but declined to find that Mr. Hodge had Lyme disease prior to that date, explaining: [A] finding that Mr. Hodge suffered from Lyme disease in 2009 does not mean that Mr. Hodge suffered from Lyme disease six years earlier in 2003. The medical records discussing Lyme disease start in 2009. The only evidence supporting a Lyme disease diagnosis prior to 2006 is derived from statements made by [petitioner]. Although Dr. Tornatore assumes Mr. Hodge had Lyme -12- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 13 of 23 disease in 2003, the basis for that assumption comes from [petitioner’s] testimony. It is not wholly implausible that Mr. Hodge had Lyme disease before 2006. But, in light of the above findings [that petitioner’s testimony was unreliable because petitioner “made numerous statements that are in conflict with the medical records and that are contradicted by her own testimony,”12] the undersigned cannot credit that assertion because it is not sufficiently persuasive. Hodge, 2022 WL 4954672, at *36; accord id. at *35 (“Given the finding that [petitioner] is not reliable . . . , the undersigned cannot accept the assertion that Mr. Hodge was bitten by ticks during a camping trip in 2003 or that he developed Lyme disease in 2003.”), *37 n.50 (“While the evidence supports a finding that Mr. Hodge suffered Lyme disease in 2009, there is not preponderan[t] evidence that Mr. Hodge suffered Lyme disease in 2006.”). In other words, because the special master found “numerous” “flaws” in petitioner’s testimony, id. at *34, he refused to credit any of her statements. It is axiomatic that special masters have great discretion in assessing the credibility of witnesses and determining what weight their testimony should be afforded. See, e.g., Andreu v. Sec’y of HHS, 569 F.3d 1367, 1379 (Fed. Cir. 2009); Pafford v. Sec’y of HHS, 451 F.3d 1352, 1359 (Fed. Cir. 2006); Lampe v. Sec’y of HHS, 219 F.3d 1357, 1360 (Fed. Cir. 2000); Munn, 970 F.2d at 871. But upon declaring a fact witness to be lacking in credibility and rejecting the witness’s testimony as unreliable, a special master cannot ignore other evidence in the record that is consistent with, but does not depend on, that witness’s testimony. To do so would be a violation of the Vaccine Act’s mandate to consider the entire record. Here, the special master rejected petitioner’s written and oral testimony that Mr. Hodge was bitten by a tick and developed Lyme disease in 2003. In doing so, he made a single, passing reference in a footnote to other evidence in the record that might support petitioner’s testimony: He stated that “[a] medical record from 2009 also mentions possible tick exposure,” but maintained that “this record does not contain any persuasive information about the time of the camping.” Hodge, 2022 WL 4954672, at *35 n.49 (citing Pet’r’s Ex. 7 at 44). He did not reference any other medical record. Yet there are at least five separate medical records dated from August 2009––shortly after presence of antibodies for B. burgdorferi were detected in Mr. Hodge’s blood––to January 2010 that implicitly associate the presence of those antibodies to the onset of Mr. Hodge’s OCD around 2004, and more than one record that explicitly states that Mr. Hodge’s Lyme disease predated his OCD symptoms. Set forth below are the portions of these and other medical records that relate to the timing of Mr. Hodge’s tick exposures, contraction of Lyme disease, and development of OCD:13 12 This quotation is from earlier in the special master’s decision. See Hodge, 2022 WL 4954672, at *34. 13 Many of the quoted notes are handwritten. The court retains the original abbreviations, punctuation, and grammar, but makes one alteration for an obvious misspelling and omits irrelevant comments. -13- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 14 of 23 • August 4, 2009, Olive View-UCLA Medical Center (“Olive View”) neurology department, resident physician’s notes on Mr. Hodge’s chief complaint and the history of his illness: Pt was normal prior to age of 17, abrupt onset of OCD-like behavior (counting, checking, etc) over 1 month, then onset of a mental “fogginess”/“detachment from reality” of insidious onset that has since waxed and waned with periods of “normalcy.” By the age 19, mother states he has never been back to baseline psych level––always somewhat detached/[weird]. At age 18 1/2 had routine hep B vaccine, then that night had stabbing spinal/back pain ¯c neg CT head, Age 19, pt c/o “arm/neck/back” muscle and skin “tightness” ¯c spasms of gradual onset (intermittent). . . . tick exposure in NorCal ¯c neighbor ¯c Lyme Dx. Mother convinced sx’s 2/2 Hep vaccine Pet’r’s Ex. 7 at 46; see also id. at 45 (setting forth the resident physician’s assessment: “22 y/o M ¯c . . . psychiatric d/o including OCD behavior, bipolar vs. schizoaffective d/o all of varying onsets starting at age 17.”). • August 4, 2009, Olive View neurology department, attending physician’s assessment: 22 yr old male ¯c hx of behavioral problem starting at age 17. Pt has hx of tick bite? Exposure to northern California Lyme? Pt had hx of fever neck sinus symptoms. Pt examined He has normal gen physical & neurological exam. . . . Imp. → Hx of Lyme? Id. at 45. • September 24, 2009, Olive View infectious disease outpatient clinic, physician’s “subjective” notes: 22 yo ♂ ¯c ? Lyme disease, had characteristic EM rash after went camping, on back of calf 3 yrs ago. Then 6 wks after rash, had “OCD” type symptoms. Was given amoxicillin for a squirrel bite, then 2 months amox for ? sinusitis. . . . Went camping a few times prior. Pet’r’s Ex. 14 at 457. • September 29, 2009, Olive View neurology department, a different resident physician’s notes on Mr. Hodge’s chief complaint and the history of his illness: “pt ¯c OCD sxs, ‘bad mood swings’, hx of hallucinations, pt ¯c hx of tick bite at Monterey County, CA, pt ¯c chronic HA, pt never Rx’ed for lyme -14- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 15 of 23 dx.” Pet’r’s Ex. 7 at 44; see also id. at 43 (noting, in the resident physician’s assessment and plan, that Mr. Hodge was “ past lyme disease exposure”14). • October 22, 2009, Olive View initial psychiatric evaluation, psychiatrist’s assessment: “22 y/o ♂ ¯c 4-5 yr hx of cognitive sx’s assoc ¯c high exposure to Lyme disease.” Pet’r’s Ex. 14 at 447. • December 3, 2009, Olive View infectious disease outpatient clinic, physician’s “subjective” notes: Pt was in his normal state of health until ~4 yrs ago, when family noted the onset of OCD and cognitive disturbances. Pt reportedly had exposure to tick bites while camping in Big Sur. Mother also states she recalls rash on L leg. Over past few years, patient has been plagued by progressive fatigue, headaches, memory disturbances, myalgias which have left him unable to function. Pet’r’s Ex. 7 at 22. • December 11, 2009, Olive View infectious disease outpatient clinic, physician’s notes: “24 yr old male with . . . chronic neuropsychiatric syndrome (depression; obsessive compulsive disorder; changes in cognition) and hx of possible Lyme disease 4-5 years PTA while living in Big Sur area (+ hx of tick bites; + hx of rash Rxed ¯c short course of antibiotics).” Pet’r’s Ex. 14 at 3. • December 17, 2009, Olive View psychiatric/infectious disease outpatient clinic, psychiatrist’s assessment: “OCD-like sx’s assoc ¯c anxiety – Possible Lyme ¯c neuro Ψ sx’s - Can’t exclude 1° cause.” Pet’r’s Ex. 7 at 37; see also id. (indicating that Mr. Hodge was being “followed for possible neurolyme with neuropsychiatric sxs”). • December 22, 2009, Olive View, physician’s notes on the history of Mr. Hodge’s illness: “22-yo man with a history of possible Lyme disease 4-5 years ago who subsequently developed new obsessive compulsive symptoms (concerns about contamination, incessant counting) and changes in cognition . . . .” Pet’r’s Ex. 14 at 5; see also id. at 9 (indicating, in a December 23, 2009 record made by a different physician, that Mr. Hodge was being followed for “neuropsychiatric disorders as complication of his lyme disease”), 12 (indicating, in another record dated December 23, 2009, from a third physician, that Mr. Hodge had a “hx of likely lyme disease 5 years ago, untreated then”). 14 There appear to be two letters immediately following the word “exposure” (perhaps “VT”) that are double underscored, but it is difficult to ascertain precisely what they are. -15- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 16 of 23 • December 31, 2009, Olive View infectious disease outpatient clinic, physician’s “subjective” notes: “22 y/o ♂ being followed by ID for unexplained neurologic/cognitive deficits ¯c MRI evidence of demyelination in setting of possible tick bite.” Pet’r’s Ex. 7 at 21. • January 11, 2010, private infectious disease specialist’s notes on the history of Mr. Hodge’s illness: [T]he patient and his mother recall that the patient had spent a great deal of time visiting in Monterey County near Salinas and also in the Big Sur area because his grandparents were there. At age 17, the patient and the rest of his family had camped out at Big Sur. The patient’s mother recalls that there were ticks all over them, their dog, and their belongings at that time. Approximately 2 months after that trip, the patient developed severe muscle aches and fatigue. The patient also may have had some rashes, which his mother believes could have been of the bull’s eye type. Six months after the camping trip, the patient suddenly developed OCD and in fact has not really been normal since that time, although it is noted he did have the major breakdown starting 2 years ago [around the time of his hepatitis B vaccination]. . . . The patient and his mother stated he was angry, agitated, and had hallucinations. The patient was followed at a mental health clinic, but no specific diagnosis other than the OCD was found . . . . Finally, a brain MRI was done and lesions were found. . . . In the meantime, the patient’s mother had found out that other people in the area of Big Sur and also Monterey County, where the patient had been, had contracted Lyme disease, and she became concerned about this. Pet’r’s Ex. 13 at 5. The special master does not mention four of the medical records excerpted above in his decision: the medical records dated September 29, 2009, and December 3, 2009, and the two medical records dated December 23, 2009. Additionally, for all but two of the remaining medical records excerpted above––those dated August 4, 2009, and December 17, 2009––the special master only describes portions of the records not quoted by the court. Given his decision to assess whether one medical record included persuasive evidence regarding the timing of Mr. Hodge’s camping trip and possible tick exposures, it is unclear why the special master would not similarly assess the other medical records that referenced these key events. The special master’s failure to discuss these other medical records is problematic because they bear several hallmarks of reliability. First, the notes in these medical records regarding Mr. Hodge’s tick exposures and OCD reflect information that was conveyed to the physicians closer in time to the relevant events, and at a time when it made sense to convey that information to the -16- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 17 of 23 physicians (in the wake of the detection of antibodies for B. burgdorferi in Mr. Hodge’s blood).15 Second, the notes reflect information that was conveyed to the physicians well before petitioner or Dr. Tornatore linked Mr. Hodge’s Lyme disease and OCD to his alleged vaccine-caused injury.16 Thus, petitioner and Mr. Hodge were not motivated by this litigation when recounting Mr. Hodge’s history of tick exposures and OCD, but instead by the need to provide the physicians with information relevant to the newly discovered presence of antibodies for B. burgdorferi in Mr. Hodge’s blood. And third, the medical history reflected in these notes is generally consistent, even though it is evident from the distinct manners in which the information was recorded that petitioner and Mr. Hodge were required to recount the relevant events numerous times to numerous physicians. Overall, while it is true that many of the notes in these medical records regarding Mr. Hodge’s tick exposures and OCD were likely derived from information provided by petitioner, there is every reason to believe that they portray a substantially accurate picture of Mr. Hodge’s health in the years leading up to his hepatitis A and hepatitis B vaccinations. Indeed, the special master did not find that the statements that petitioner likely made to these physicians in 2009 and early 2010 were not credible; his credibility determination was limited to petitioner’s testimony, which she first offered by way of affidavit in October 2014. At bottom, the special master’s failure to consider these medical records when determining whether it was more likely than not that Mr. Hodge’s tick exposures and Lyme disease predated his OCD symptoms violates the Vaccine Act’s mandate to consider the record as a whole, and therefore his conclusion on this issue was not in accordance with law. Further, because the special master did not consider all of the relevant evidence in the record, his fact findings regarding the timing of Mr. Hodge’s exposure to ticks, contraction of Lyme disease, and development of OCD symptoms are arbitrary and capricious. See Hines v. Sec’y of HHS, 940 F.2d 1518, 1528 (Fed. Cir. 1991) (observing that under the “highly deferential” arbitrary and capricious standard, reversible error is “extremely difficult to demonstrate” when “the special master has considered the relevant evidence of record” (emphasis added)). Consequently, 15 Petitioner asserts that Mr. Hodge’s tick exposures and rash predated his OCD symptoms, which he began to exhibit when he was sixteen years old (in the 2003-2004 time period). Antibodies for B. burgdorferi were detected in Mr. Hodge’s blood on June 5, 2009. The excerpted medical records are dated from August 4, 2009, to January 11, 2010, and the first time petitioner testified regarding Mr. Hodge’s tick exposures and OCD was in her October 1, 2014 affidavit. 16 In the original petition, filed on July 15, 2009, just forty days after antibodies for B. burgdorferi were detected in Mr. Hodge’s blood, petitioner suggested only that the hepatitis A and hepatitis B vaccines caused a demyelinating disease; the theory of significant aggravation is not even suggested. Further, petitioner’s first affidavit, signed on January 13, 2011, and filed the following day, does not mention Lyme disease or OCD. The first evidence that petitioner considered Mr. Hodge’s alleged vaccine-caused injury to be related to his Lyme disease and OCD was Dr. Tornatore’s August 23, 2013 expert report identifying the illness suffered by Mr. Hodge and the onset of the symptoms of that illness. Petitioner did not provide testimony regarding Mr. Hodge’s tick exposures and OCD until the submission of her second affidavit on October 1, 2014. -17- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 18 of 23 pursuant to 42 U.S.C. § 300aa-12(e)(2)(B), the court sets aside the special master’s conclusion–– and the findings of fact underlying that conclusion––that petitioner did not satisfy her burden to prove, by a preponderance of evidence, that Mr. Hodge contracted Lyme disease in 2003.17 C. Consideration of the Record as a Whole The question of when Mr. Hodge contracted his Lyme disease is critical to petitioner’s case because her theory of causation, as espoused by Dr. Tornatore, is premised on Mr. Hodge’s 17 Notably, the special master found petitioner to not be a credible witness because, “[a]t times,” her testimony was in conflict with the medical records, internally inconsistent, and hyperbolic; he then provided several examples of these “flaws.” Hodge, 2022 WL 4954672, at *33-34. In this decision, the court sets aside only one aspect of this determination—that petitioner’s testimony concerning the sequence of Mr. Hodge’s tick exposures, contraction of Lyme disease, and exhibition of OCD symptoms was not credible. Nevertheless, a few comments regarding some of the “flaws” identified by the special master are warranted. First, it seems unfair to rely on Dr. Nasse’s statement that he treated Mr. Hodge sometime between 2000 and 2003 to criticize petitioner for her inconsistent statements regarding the treatment dates, since Dr. Nasse’s statement is itself contradicted by pharmacy records indicating that Dr. Nasse prescribed Risperdal and Adderall for Mr. Hodge in September 2004. Second, there are notes in a few medical records from 2007, unmentioned by the special master, that provide some support for petitioner’s claim that Mr. Hodge experienced significant weight loss (albeit not to the magnitude petitioner describes in her affidavits). See, e.g., Pet’r’s Ex. 65 at 5 (indicating, in a medical record dated June 20, 2007, that petitioner reported “weight loss, difficulty eating” “over the last year”); Pet’r’s Ex. 10 at 3 (indicating, in a medical record dated November 16, 2007, that Mr. Hodge “lost significant weight, between 25-30 pounds in recent months”). Third, unlike the special master, the court does not find it “difficult to reconcile” petitioner’s assertions in her third affidavit regarding Mr. Hodge switching between being afraid to leave the house and refusing to go in the house, especially in light of her comment later in the same affidavit that a medication helps Mr. Hodge sleep so that her “entire life isn’t consumed with chasing him down in the streets––that is, when he isn’t afraid to wear clothes or leave the house.” Pet’r’s Ex. 21 at 3. Given the manifestation of his illness, as described in the medical records, it seems quite likely that Mr. Hodge’s behavior could shift from one extreme to the other. Fourth, the special master ascribes more precision to petitioner’s references to particular years and ages than is warranted by the record. He recounts petitioner’s oral testimony that the pivotal camping trip occurred when Mr. Hodge was fourteen or fifteen years old, concludes that it therefore would have occurred in 2001 or 2002, and then offers petitioner’s written testimony that the trip occurred in 2003 as a reason for discrediting her testimony. However, Mr. Hodge turned fourteen years old on May 15, 2001, and was fifteen years old from May 15, 2002, to May 14, 2003. Accordingly, there is no actual conflict between petitioner’s oral and written testimony. -18- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 19 of 23 OCD being a manifestation of neuroborreliosis. Given this fact, there are two paths available to the court: (1) remand the case to the special master to consider the record as a whole and redetermine whether petitioner has satisfied her burden to establish that Mr. Hodge’s tick exposures and Lyme disease predated his OCD symptoms,18 42 U.S.C. § 300aa-12(e)(2)(C); or (2) make its own findings of fact on this issue and, if necessary, remand the case for further proceedings, id. § 300aa-12(e)(2)(B). To ensure that this 2009 case is not delayed any longer than necessary, the court opts to take the latter path. To establish entitlement to compensation under the Vaccine Act, a petitioner alleging a vaccine-caused injury must prove causation by a preponderance of evidence. Id. § 300aa- 13(a)(1) (citing 42 U.S.C. § 300aa-11(c)(1)). The burden of showing something by a “preponderance of the evidence,” the most common standard in the civil law, “simply requires the trier of fact ‘to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the [judge] of the fact’s existence.’” Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers Pension Tr. for S. Cal., 508 U.S. 602, 622 (1993) (quoting In re Winship, 397 U.S. 358, 371-72 (1970) (Harlan, J., concurring) (alterations in original)), quoted in Moberly v. Sec’y of HHS, 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010). When determining whether preponderant evidence exists to establish a fact, the court, like the special master, weighs the relevant evidence in light of the “entire record and the course of the injury, disability, illness, or condition . . . .” 42 U.S.C. § 300aa-13(b)(1); see also id. § 300aa-13(a)(1) (requiring fact findings to be based “on the record as a whole”). Further, the court must be mindful that there is “no basis for presuming that medical records are accurate and complete . . . as to all physical conditions” because “[a]lthough a patient has a ‘strong motivation to be truthful’ when speaking to his physician, that does not mean he will report every ailment he is experiencing, or that the physician will accurately record everything he observes.” Kirby v. Sec’y of HHS, 997 F.3d 1378, 1383 (Fed. Cir. 2021) (citation omitted); accord id. (“[P]hysicians may enter information incorrectly and ‘typically record only a fraction of all that occurs.’” (quoting Shapiro v. Sec’y of HHS, 101 Fed. Cl. 532, 538 (2011))); see also La Londe v. Sec’y of HHS, 110 Fed. Cl. 184, 203 (2013) (describing reasons why symptoms may not appear in a medical record, such as a petitioner’s failure to recount an observed symptom, a physician’s failure to record all information conveyed by a petitioner, and a petitioner’s faulty recollection of events), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). Additionally, “the absence of a reference to a condition or circumstance is much less significant than a reference which negates the existence of the condition or circumstance.” Kirby, 997 F.3d at 1383 (quoting Shapiro, 101 Fed. Cl. at 538). 18 The special master has already found that Mr. Hodge had OCD prior to his 2006 hepatitis A and hepatitis B vaccinations. Hodge, 2022 WL 4954672, at *34-35. -19- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 20 of 23 With these standards in mind, the court finds that when looking at the record as a whole, there is a preponderance of evidence that Mr. Hodge exhibited symptoms of OCD by September 28, 2004. This evidence includes: (1) records from the Los Angeles Unified School District reflecting that Mr. Hodge did not return to high school for the eleventh grade in the fall of 2004, when he was seventeen years old, Pet’r’s Ex. 61 at 7; (2) the September 27-28, 2004 pharmacy record indicating that Dr. Nasse prescribed Risperdal and Adderall for Mr. Hodge, who was seventeen years old at the time, Pet’r’s Ex. 23; (3) the March 21, 2005 medical record indicating that Mr. Hodge, who was seventeen years old at the time, had been taking Zoloft until two days prior, Pet’r’s Ex. 3 at 4; (4) the March 17, 2006 medical record indicating that Mr. Hodge’s OCD started when he was seventeen years old (between May 15, 2004, and May 14, 2005), Pet’r’s Ex. 5 at 2; (5) the August 4, 2009 medical record indicating that Mr. Hodge experienced an “abrupt onset of OCD-like behavior” at age seventeen (between May 15, 2004, and May 14, 2005), Pet’r’s Ex. 7 at 46; accord id. at 45; (6) the October 22, 2009 medical record indicating that Mr. Hodge had a four-to- five year history of cognitive symptoms, which would place those symptoms in the 2004-2005 time period, Pet’r’s Ex. 14 at 447; and (7) the December 11, 2009 medical record indicating that Mr. Hodge had a “chronic neuropsychiatric syndrome (depression; obsessive compulsive disorder; changes in cognition)” four-to-five years prior, which would place that syndrome in the 2004-2005 time period, id. at 3. Only two pre-2010 medical records suggest different dates for the onset of Mr. Hodge’s OCD. See Pet’r’s Ex. 7 at 22 (a December 3, 2009 medical record suggesting an onset date around 2005); Pet’r’s Ex. 14 at 457 (a September 24, 2009 medical record suggesting an onset date around 2006). Furthermore, petitioner consistently testified that Mr. Hodge’s OCD symptoms manifested before September 28, 2004. See Pet’r’s Ex. 21 at 1 (indicating that Mr. Hodge’s “OCD developed around age 16,” in other words, between May 15, 2003, and May 14, 2004); Pet’r’s Ex. 71 ¶ 10 (implying that Mr. Hodge had OCD during tenth grade, in other words, between the fall of 2003 and the spring of 2004); Hr’g Tr. 145 (testifying that Mr. Hodge showed symptoms of OCD at age sixteen––in other words, between May 15, 2003, and May 14, 2004–– and was diagnosed with OCD at age 17). At no time did petitioner testify that Mr. Hodge first exhibited OCD symptoms after September 28, 2004. -20- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 21 of 23 In addition, the court finds that when looking at the record as a whole, there is a preponderance of evidence that Mr. Hodge’s tick exposures and resulting Lyme disease predated his OCD symptoms. This evidence includes several medical records indicating that Mr. Hodge exhibited OCD symptoms after contracting Lyme disease: (1) the September 24, 2009 medical record indicating that Mr. Hodge developed a rash after camping, which was followed by OCD-like symptoms six weeks later, Pet’r’s Ex. 14 at 457; (2) the December 22, 2009 medical record indicating that Mr. Hodge developed OCD symptoms after contracting “possible Lyme disease,” id. at 5; and (3) the January 11, 2010 medical record indicating that Mr. Hodge camped at Big Sur, developed muscle aches and fatigue approximately two months later, and then developed OCD four months after that, Pet’r’s Ex. 13 at 5. The evidence also includes medical records that more generally associate Mr. Hodge’s OCD with his tick exposures and/or Lyme disease: (1) the October 22, 2009 medical record indicating that Mr. Hodge had a four-to- five year history of cognitive symptoms that were associated with a “high exposure” to Lyme disease, Pet’r’s Ex. 14 at 447; (2) the December 3, 2009 medical record indicating that Mr. Hodge’s family noted an onset of OCD, that Mr. Hodge purportedly had an exposure to ticks while camping in Big Sur, and that petitioner recalled a rash on Mr. Hodge’s left leg, Pet’r’s Ex. 7 at 22; and (3) the December 11, 2009 medical record indicating that Mr. Hodge had a “chronic neuropsychiatric syndrome,” along with “possible Lyme disease,” a “history of tick bites,” and a “history of rash” four-to-five years prior, Pet’r’s Ex. 14 at 3. There are no pre-2010 medical records indicating that Mr. Hodge’s OCD symptoms predated his tick exposures or Lyme disease. Furthermore, petitioner consistently testified that Mr. Hodge exhibited OCD symptoms after his tick exposures and subsequent bull’s-eye rash. See Pet’r’s Ex. 19 at 1 (stating that “[w]ithin a year of” developing “a bulls-eye rash on his leg” at the conclusion of a camping trip, Mr. Hodge “began exhibiting OCD hoarder symptoms”); Pet’r’s Ex. 71 ¶ 7 (stating that they moved on April 30, 2003, and indicating petitioner’s belief that Mr. Hodge “had the tick bite that resulted in the bulls-eye rash on his leg” shortly before they moved, and began to exhibit OCD symptoms “some time after” they moved); Hr’g Tr. 145 (testifying that the tick exposure and “bull’s-eye rash” predated Mr. Hodge’s OCD symptoms). In short, upon considering the record as a whole, including Mr. Hodge’s medical and school records and petitioner’s testimony, the court finds that (1) Mr. Hodge exhibited symptoms of OCD by September 28, 2004, and (2) Mr. Hodge’s tick exposures and subsequent Lyme -21- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 22 of 23 disease predated his OCD symptoms. These findings negate the special master’s determination that Dr. Tornatore’s expert opinion was based on facts not established by petitioner and therefore could not be credited. They also negate the special master’s determination that any further analysis of petitioner’s theory of causation, including whether “a hepatitis B vaccine can aggravate Lyme disease,” was unnecessary. Hodge, 2022 WL 4954672, at *37. Consequently, petitioner’s entitlement to compensation must be resolved anew. And while the court is authorized to make the necessary fact findings and legal conclusions, 42 U.S.C. § 300aa- 12(e)(2)(B), the special master, given his familiarity with the experts’ opinions and the medical and scientific evidence supporting those opinions, is better positioned to assess petitioner’s theory of causation in the first instance. See Munn, 970 F.2d at 870 (“[T]he key decision maker in the first instance is the special master.”); Sword v. United States,19 44 Fed. Cl. 183, 188-89 (1999) (“[E]ven more than ordinary fact-finders, this Court has recognized the unique ability of Special Masters to adjudge cases in the light of their own acquired specialized knowledge and expertise. . . . A fact-finder, especially one with specialized experience such as a Special Master, can accept or reject opinion testimony, in whole or in part. . . . [T]he Special Master evaluates the testimony in light of the entire record, based on reasonable inferences born of common experience or the product of special expertise.” (citations omitted)). Thus, the court will remand the case to the special master with instructions to reevaluate petitioner’s entitlement to compensation in accordance with 42 U.S.C. § 300aa-13. III. CONCLUSION Under the Vaccine Act, special masters are required to consider all of the evidence in the record, and when a special master violates this mandate, the reviewing court must set aside the findings of fact and conclusions of law affected by that violation and may then issue its own fact findings and legal conclusions. Here, the special master disregarded substantial, reliable evidence in the record that supported petitioner’s later testimony regarding the sequence of events: that prior to his hepatitis A and hepatitis B vaccinations, Mr. Hodge was exposed to ticks, then developed a rash indicative of Lyme disease, and then exhibited symptoms of OCD. Consequently, the court sets aside the special master’s conclusion––and the findings of fact underlying that conclusion––that petitioner did not satisfy her burden to prove, by a preponderance of evidence, that Mr. Hodge contracted Lyme disease in 2003. Additionally, to avoid further delay in this matter, the court issues its own fact findings regarding the sequence of events, concluding that petitioner has established, by a preponderance of evidence, that Mr. Hodge exhibited symptoms of OCD by September 28, 2004, and that his tick exposures and subsequent Lyme disease predated his OCD symptoms. Finally, the court remands the case to the special master to reevaluate petitioner’s entitlement to compensation in light of the court’s fact findings. On remand, the special master shall not require the submission of any additional evidence or legal argument unless this prohibition would result in erroneous findings of fact or conclusions of law. Indeed, the record already appears to be complete since it includes all of Mr. Hodge’s existing, relevant medical 19 Although the respondent in all Vaccine Act cases is the Secretary of the Department of Health and Human Services, 42 U.S.C. § 300aa-12(b)(1), the respondent in Sword is identified as the United States. -22- Case 1:09-vv-00453-MMS Document 385 Filed 03/22/23 Page 23 of 23 and school records; petitioner’s oral and written testimony; expert reports and testimony addressing petitioner’s theory of causation; and legal memoranda and oral argument addressing petitioner’s entitlement to compensation. Ultimately, the decision regarding how to resolve entitlement is within the province of the special master, but given the extent of the information presently in the record, the special master may likely only need to issue a new decision on entitlement. In sum, the court GRANTS petitioner’s motion for review; SETS ASIDE the special master’s conclusion that petitioner did not establish that Mr. Hodge contracted Lyme disease in 2003 and the findings of fact made in support of that conclusion; FINDS that Mr. Hodge exhibited symptoms of OCD by September 28, 2004, and that the tick exposures and Lyme disease predated Mr. Hodge’s OCD symptoms; and REMANDS the case, for a period not to exceed ninety days, to the special master to reevaluate petitioner’s entitlement to compensation. IT IS SO ORDERED. s/ Margaret M. Sweeney MARGARET M. SWEENEY Senior Judge -23- ================================================================================ DOCUMENT 6: USCOURTS-cofc-1_09-vv-00453-8 Date issued/filed: 2023-10-27 Pages: 13 Docket text: JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) reissuing 390 Opinion and Order. Signed by Senior Judge Margaret M. Sweeney. (kb1) -------------------------------------------------------------------------------- Case 1:09-vv-00453-MMS Document 392 Filed 10/27/23 Page 1 of 13 In the United States Court of Federal Claims No. 09-453V (Filed Under Seal: October 12, 2023) (Reissued for Publication: October 27, 2023)1 *************************************** JEREMY HODGE, by his conservator * ERIKA ELSON, * * Petitioner, * * v. * * SECRETARY OF HEALTH AND HUMAN * SERVICES, * * Respondent. * *************************************** Renée J. Gentry, Washington, DC, for petitioner. Bridget A. Corridon, United States Department of Justice, Washington, DC, for respondent. OPINION AND ORDER SWEENEY, Senior Judge Petitioner Erika Elson filed an amended petition under the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”), 42 U.S.C. §§ 300aa-1 to -34, alleging that her son’s neurological issues were significantly aggravated by his hepatitis A and hepatitis B vaccinations. The special master determined that petitioner did not satisfy her burden of establishing entitlement to compensation. Petitioner moves for review of that decision, arguing that the special master improperly raised her burden of proof. As explained in more detail below, the court denies petitioner’s motion. 1 Vaccine Rule 18(b), included in Appendix B of the Rules of the United States Court of Federal Claims, affords each party fourteen days in which to object to the disclosure of (1) trade secrets or commercial or financial information that is privileged or confidential or (2) medical information that would constitute “a clearly unwarranted invasion of privacy.” Neither party objected to the public disclosure of any information included in this opinion. Case 1:09-vv-00453-MMS Document 392 Filed 10/27/23 Page 2 of 13 I. BACKGROUND Unfortunately, this case has, for a number of reasons, spent an uncharacteristically long time in the Vaccine Program without a final resolution.2 It is fair to say that no one involved in this case takes any pleasure from this fact. However, petitioner’s motion for review is directed solely to the substance of the special master’s most recent decision on entitlement. Consequently, the court will forgo a lengthy recitation of the case’s procedural history and focus on the facts necessary to resolve the motion currently before it. Jeremy Hodge was born on May 15, 1987.3 His medical records reflect a number of normal childhood illnesses and injuries through July 8, 1996, when he was nine years old. There are no medical records from that date until March 10, 2004, when he visited a pediatrician. Notably, by September 28, 2004, when he was seventeen years old, Mr. Hodge began to exhibit symptoms of obsessive-compulsive disorder (“OCD”).4 During a doctor’s visit on March 17, 2006, Mr. Hodge received a hepatitis A vaccination and his first hepatitis B vaccination. He returned to the clinic on April 25, 2006. Among his complaints were uncontrollable eye movements, and the treating physician referred Mr. Hodge to a neurologist.5 Mr. Hodge also received his second hepatitis B vaccination during this visit. On June 2, 2006, Mr. Hodge was evaluated at an emergency room for balance issues, dizziness, eye movement disturbances, fatigue, and pain. The medical provider noted impressions of dizziness and arthralgias-myalgias following the hepatitis vaccination, and the diagnosis at discharge was neurological problems.6 Six days later, at petitioner’s request, one of 2 Those reasons are described in prior decisions in this case. See, e.g., Hodge v. Sec’y of HHS, 164 Fed. Cl. 633, 635-36 (2023) (setting forth a concise recitation of the case’s procedural history); Hodge v. Sec’y of HHS, No. 09-453V, 2023 WL 4186513, at *1-10 (Fed. Cl. Spec. Mstr. May 24, 2023) (setting forth a fuller recounting of the case’s procedural history). 3 Unless otherwise noted, the facts are taken from the special master’s decision. See generally Hodge, 2023 WL 4186513, at *14-42. 4 The court made this fact finding in its prior decision, based on the preponderant evidence in the record. See Hodge, 164 Fed. Cl. at 647-48 (recounting the evidence in support of this fact finding). 5 In her motion for review, petitioner twice asserts that the special master “failed to note” the referral to the neurologist. Mot. 3 n.3, 18 n.33. This assertion is incorrect; the special master references the referral several times in his decision. See Hodge, 2023 WL 4186513, at *41, *70, *72. 6 In her motion for review, petitioner twice asserts that the special master “leaves out the diagnosis of ‘Neurological Problems.’” Mot. 3 n.5, 19 n.35. This assertion is incorrect; the special master noted the diagnosis in his fact findings on the precise page identified by petitioner. See Hodge, 2023 WL 4186513, at *24. -2- Case 1:09-vv-00453-MMS Document 392 Filed 10/27/23 Page 3 of 13 Mr. Hodge’s physicians agreed to request an MRI for Mr. Hodge. However, Mr. Hodge did not obtain an MRI at that time. In fact, Mr. Hodge did not undergo an MRI until May 19, 2009. The MRI revealed white matter hyperintensities in Mr. Hodge’s brain, leading a neurologist to suggest the possibility of a demyelinating disease, among other potential diagnoses. A blood test on June 5, 2009, revealed the presence of antibodies for Borrelia burgdorferi, suggestive of Lyme disease, but subsequent testing for those antibodies had negative or inconclusive results. On December 11, 2009, an infectious disease specialist indicated that Mr. Hodge’s symptoms were consistent with chronic neuroborreliosis. Preponderant record evidence reflects that Mr. Hodge was exposed to ticks and contracted Lyme disease before he began to exhibit symptoms of OCD in 2004.7 Mr. Hodge, in his individual capacity, filed a petition for compensation under the Vaccine Act on July 15, 2009, alleging unspecified injuries arising from his hepatitis A and hepatitis B vaccinations. His mother was subsequently appointed as his conservator and substituted as the petitioner in this case. Thereafter, on March 6, 2017, petitioner filed an amended petition to specify her son’s injury: a significant aggravation of his preexisting neuroborreliosis. Petitioner filed several expert reports from Carlo Tornatore, M.D., along with supporting medical literature. Dr. Tornatore posited that Mr. Hodge’s chronic neuroborreliosis was aggravated by the hepatitis B vaccinations, which caused an autoimmune demyelinating event that manifested neurologically as abnormal eye movements. Dr. Tornatore acknowledged, however, that the May 2009 MRI showing demyelination did not establish that Mr. Hodge suffered from a demyelinating event in March or April 2006, and that none of Mr. Hodge’s treating physicians in 2006 considered Mr. Hodge’s symptoms to be a demyelinating event. Respondent filed two expert reports and supporting medical literature from Arun Venkatesan, M.D., Ph.D., who disagreed with Dr. Tornatore’s conclusion that the hepatitis B vaccinations administered to Mr. Hodge caused a demyelinating event. Petitioner and both experts testified during a two-day entitlement hearing, and the parties provided the special master with extensive written and oral argument on entitlement issues. On September 12, 2022, the special master issued his initial entitlement decision. He concluded that petitioner had not established a necessary factual predicate for her theory of causation and therefore could not prove entitlement to compensation. Petitioner timely moved for review. In a March 7, 2023 decision, the undersigned granted the motion, set aside certain fact findings and legal conclusions made by the special master, made its own findings of fact, and remanded the case to the special master to reevaluate petitioner’s entitlement to compensation. The special master issued his decision on remand on May 24, 2023. The decision contains a comprehensive recounting of the factual evidence in the record—including Mr. Hodge’s medical and school records, petitioner’s affidavits, the expert reports, the medical 7 The court made this fact finding in its prior decision. See Hodge, 164 Fed. Cl. at 648 (recounting the evidence in support of this fact finding). -3- Case 1:09-vv-00453-MMS Document 392 Filed 10/27/23 Page 4 of 13 literature, and the oral testimony elicited from petitioner and the experts during the entitlement hearing—and the parties’ contentions. After considering the record evidence in light of the applicable legal standards, the special master concluded that petitioner did not satisfy her burden of establishing that Mr. Hodge’s injuries were caused by his vaccinations. Petitioner timely moved for review, and respondent filed a response. Neither party requested oral argument and the court deems such argument unnecessary. II. DISCUSSION A. Standard of Review The United States Court of Federal Claims (“Court of Federal Claims”) has jurisdiction to review the record of the proceedings before a special master, and upon such review, may: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision, (B) set aside any findings of fact or conclusion 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. 42 U.S.C. § 300aa-12(e)(2). The standards set forth in § 300aa-12(e)(2)(B) “vary in application as well as degree of deference. . . . Fact findings are reviewed . . . under the arbitrary and capricious standard; legal questions under the ‘not in accordance with law’ standard; and discretionary rulings under the abuse of discretion standard.” Munn v. Sec’y of HHS, 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). Here, petitioner’s sole enumerated objection to the special master’s decision, articulated pursuant to Vaccine Rule 24(a), is that the special master improperly elevated her burden of proof “by explaining away or dismissing virtually every argument and piece of evidence offered in” her case.8 Mot. 2, 10. This method of analysis, she argues, is “legal error.” Id.; accord id. at 8 In the “Relevant Caselaw” section of her motion, petitioner also contends that the special master “improperly reject[ed] her expert’s testimony based on his ‘demeanor’ and ‘credibility,’” Mot. 9, but she does not revisit this contention in her motion’s legal argument section except in a footnote: “Throughout his decision, the Special Master paints Dr. Tornatore’s testimony as lacking credibility due to his ‘demeanor’. He has an entire breakout section on Dr. Tornatore’s ‘demeanor’. . . . He uses this ‘demeanor’ evaluation to give Dr. Tornatore’s testimony less weight. Petitioner asserts this is also legal error.” Mot. 16 n.30. Although the court need not entertain arguments raised in footnotes, see SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1320 (Fed. Cir. 2006), it observes that the special master’s commentary on Dr. Tornatore’s “demeanor” is limited to Dr. Tornatore’s testimony regarding (1) a portion of the special master’s significant aggravation analysis not being challenged by petitioner, see Hodge, -4- Case 1:09-vv-00453-MMS Document 392 Filed 10/27/23 Page 5 of 13 10 (“[T]he Special Master once again erroneously extracts each piece of evidence from the whole and rejects each one as not individually meeting the preponderance standard in a manner that is not in accordance with the law.”). When faced with such a contention, the Court of Federal Claims reviews the special master’s application of the law de novo. Rodriguez v. Sec’y of HHS, 632 F.3d 1381, 1384 (Fed. Cir. 2011). B. Legal Standards Petitioner’s objection relates to the special master’s determination that petitioner did not satisfy her burden of proving that the hepatitis B vaccinations Mr. Hodge received caused the significant aggravation of his preexisting neuroborreliosis. There is an established framework for assessing such claims: A petitioner must prove by preponderant evidence that the vaccination caused significant aggravation by showing: (1) the person’s condition prior to administration of the vaccine, (2) the person’s current condition (or the condition following the vaccination if that is also pertinent), (3) whether the person’s current condition constitutes a “significant aggravation” of the person’s condition prior to vaccination, (4) a medical theory causally connecting such a significantly worsened condition to the vaccination, (5) a logical sequence of cause and effect showing that the vaccination was the reason for the significant aggravation, and (6) . . . a proximate temporal relationship between the vaccination and the significant aggravation. W.C. v. Sec’y of HHS, 704 F.3d 1352, 1357 (Fed. Cir. 2013) (alteration in original) (quoting Loving v. Sec’y of HHS, 86 Fed. Cl. 135, 144 (2009)). These six factors are collectively referred to as the Loving test. At issue in this case are the final three prongs of the Loving test, which “correspond to the three-part inquiry articulated in Althen v. Secretary of Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005).” Sharpe v. Sec’y of HHS, 964 F.3d 1072, 1081 (Fed. Cir. 2020). Under Loving prong 4, a petitioner is “required to present a medically plausible theory demonstrating that a vaccine ‘can’ cause a significant worsening of” the condition at issue. Id. at 1083. To make this showing, “a petitioner must provide a reputable medical or scientific explanation that pertains specifically to the petitioner’s case, although the explanation need only be ‘legally probable, not medically or scientifically certain.’” Broekelschen v. Sec’y of HHS, 618 F.3d 1339, 1345 (Fed. Cir. 2010) (quoting Knudsen v. Sec’y of HHS, 35 F.3d 543, 548-49 (Fed. Cir. 1994)). Loving prong 5 requires a petitioner “to show that the vaccinations ‘did’ cause a 2023 WL 4186513, at *47-48 (discussing a part of the significant aggravation analysis for which the special master found in petitioner’s favor), cited in Mot. 16 n.30; and (2) a single aspect of an ultimately nondispositive portion of the special master’s significant aggravation analysis, see id. at *67 n.81. Consequently, assuming petitioner’s contention were accurate, it would have no bearing on the outcome of her motion for review. -5- Case 1:09-vv-00453-MMS Document 392 Filed 10/27/23 Page 6 of 13 worsening of the” condition at issue. Sharpe, 964 F.3d at 1085. And, Loving prong 6 requires a petitioner to establish that the significant aggravation “occurred within a timeframe for which, given the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation-in-fact.” de Bazan v. Sec’y of HHS, 539 F.3d 1347, 1352 (Fed. Cir. 2008). A failure to establish Loving prong 4—that the vaccination can cause the significant aggravation—or Loving prong 5—that the vaccination did cause the significant aggravation—is necessarily fatal to a petitioner’s case. Causation under the Vaccine Act can be established with circumstantial evidence––in other words, with medical records or medical opinion. Althen, 418 F.3d at 1279-80 (citing 42 U.S.C. § 300aa-13(a)(1)); see also Knudsen, 35 F.3d at 548 (observing that the “‘logical sequence of cause and effect’ must be supported by a sound and reliable medical or scientific explanation” (citing Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993); Jay v. Sec’y of HHS, 998 F.2d 979, 984 (Fed. Cir. 1993))). A petitioner “need not produce medical literature or epidemiological evidence to establish causation,” but “where such evidence is submitted, the special master can consider it in reaching an informed judgment as to whether a particular vaccination likely caused a particular injury.” Andreu v. Sec’y of HHS, 569 F.3d 1367, 1379 (Fed. Cir. 2009). But see LaLonde v. Sec’y of HHS, 746 F.3d 1334, 1341 (Fed. Cir. 2014) (“In Vaccine Act cases, petitioners must proffer trustworthy testimony from experts who can find support for their theories in medical literature in order to show causation under the preponderance of the evidence standard. The level of specificity of such support may vary from circumstance to circumstance.”). Moreover, to say that proof in the form of epidemiological studies or well-established medical experience is not mandatory does not mean that the special masters in Vaccine Act cases are precluded from inquiring into the reliability of testimony from expert witnesses. Weighing the persuasiveness of particular evidence often requires a finder of fact to assess the reliability of testimony, including expert testimony, and . . . the special masters have that responsibility in Vaccine Act cases. Moberly v. Sec’y of HHS, 592 F.3d 1315, 1325 (Fed. Cir. 2010). Finally, as set forth in the Vaccine Act, when reaching a conclusion on causation, special masters must consider the record as a whole. 42 U.S.C. § 300aa-13(a)(1), (b)(1); accord Moriarty v. Sec’y of HHS, 844 F.3d 1322, 1330 (Fed. Cir. 2016). In doing so, they must ensure that they do not focus on individual pieces of evidence at the expense of determining what is depicted by the entirety of the record. See, e.g., Paluck v. Sec’y of HHS, 786 F.3d 1373, 1382- 83 (Fed. Cir. 2015) (holding that “the special master failed in his duty to consider ‘the record as a whole’” by “placing undue emphasis on the relatively insignificant variations” in some of a particular provider’s records, thereby “giv[ing] short shrift to the evidence” of the child’s condition reflected in the entirety of that provider’s records); Snyder v. Sec’y of HHS, 553 F. App’x 994, 1000, 1003 (Fed. Cir. 2014) (unpublished decision) (concluding that the special master properly “examin[ed] the record in its entirety” when he found that the respondent’s evidence showed that the children’s seizure disorders were caused by a factor unrelated to the vaccine, observing that the special master “did the analysis necessary to decide the Secretary had -6- Case 1:09-vv-00453-MMS Document 392 Filed 10/27/23 Page 7 of 13 the stronger case based on testimony and the intellectual strength of the evidence, as well as the arguments presented”); Cedillo v. Sec’y of HHS, 617 F.3d 1328, 1345 (Fed. Cir. 2010) (approving the special master’s separate evaluation of each piece of evidence, and remarking that “[i]n the Special Master’s careful and thorough opinion, he considered, weighed, and stated his reasons for rejecting or discounting each item of evidence in which the petitioners relied”); Golub v. Sec’y of HHS, 243 F.3d 561 (Fed. Cir. 2000) (per curiam) (unpublished table decision) (criticizing the special master for “treat[ing] each element of the evidence individually, discrediting each piece of evidence in turn, without considering the totality of the evidence”). C. Loving Prong 4 The special master concluded that petitioner demonstrated Mr. Hodge’s condition prior to the administration of the hepatitis B vaccinations (Loving prong 1); Mr. Hodge’s current condition (Loving prong 2); and that Mr. Hodge’s current condition is worse than it was prior to the vaccinations, in other words, that there was a significant aggravation of Mr. Hodge’s condition (Loving prong 3). Because these conclusions were in her favor, petitioner understandably does not object to them. Rather, petitioner contends that the special master erroneously elevated her burden of proof with respect to the final three Loving prongs, primarily focusing on Loving prong 4. With respect to that prong, petitioner argues that the special master’s “primary error,” Mot. 10, was that he “failed to consider the cumulative impact” of the evidence in the record in determining whether she had satisfied her burden of proof, id. at 17. In support of this argument, she contends that the special master conflated her theory of causation (that the hepatitis B vaccinations aggravated Mr. Hodge’s existing neuroborreliosis and triggered “an immune response characterized by autoimmune inflammation that ultimately resulted in autoimmune demyelination”) with the biological mechanism that was proposed to explain how the purported immune response could have been triggered (“molecular mimicry”). Id. at 11. Consequently, she asserts, “rather than view evidence regarding molecular mimicry as circumstantial evidence in support of the theory, [the special master] drew a bright line and found that [her] failure to prove the biological mechanism was failure to prove her theory of causation.”9 Id. at 17. Relatedly, petitioner also argues that the special master erred by “examin[ing] and dismiss[ing] every single article” she submitted as “insufficient,” preventing her “use of circumstantial evidence in support of her case” and “instead requiring direct proof.” Id. at 18. It is undisputed that petitioner is not required to prove the specific biological mechanism leading to the significant aggravation of Mr. Hodge’s injuries. Stone v. Sec’y of HHS, 676 F.3d 9 Petitioner contends that the special master “did so by relying on the erroneous interpretation that Boatmon raised Petitioner’s burden of proof by conflating biologically plausible theory with biological mechanism.” Mot. 17 (citing Hodge, 2023 WL 4186513, at *53). Petitioner is incorrect. The special master did not cite Boatmon v. Secretary of HHS, 941 F.3d 1351 (Fed. Cir. 2019), as setting forth the applicable standard in this case. Rather, he referenced Boatmon when describing respondent’s position on the applicable legal standard. Indeed, in the very next paragraph of his decision, the special master sets forth the correct legal standard, which is identical to the one propounded by petitioner. -7- Case 1:09-vv-00453-MMS Document 392 Filed 10/27/23 Page 8 of 13 1373, 1384 (Fed. Cir. 2012); Simanski v. Sec’y of HHS, 671 F.3d 1368, 1384 (Fed. Cir. 2012). Indeed, [i]t is not necessary for a petitioner to point to conclusive evidence in the medical literature linking a vaccine to the . . . injury, as long as the petitioner can show by a preponderance of the evidence that there is a causal relationship between the vaccine and the injury, whatever the details of the mechanism may be. Simanski, 671 F.3d at 1384. Nor is it disputed that petitioner is entitled to rely on circumstantial evidence to establish that Mr. Hodge’s injuries can be caused by the hepatitis B vaccination. See, e.g., Althen, 418 F.3d at 1279-80; Knudsen, 35 F.3d at 548. The special master correctly articulated petitioner’s burden: He quoted the three-prong Althen test, recognized that all three prongs must be satisfied by a preponderance of the evidence, and reiterated the statement from Broekelschen that the first Althen prong—Loving prong 4—is satisfied with “a reputable medical or scientific explanation pertain[ing] specifically to the petitioner’s case” that is “legally probable, not medically or scientifically certain.” Hodge, 2023 WL 4186513, at *53 (quoting Bull v. Sec’y of HHS, 156 Fed. Cl. 329, 336 (2021)). And, as set forth below, there is no indication that the special master elevated that burden by requiring petitioner to definitively establish with direct proof that the hepatitis B vaccination can cause an autoimmune demyelination via molecular mimicry. As explained by the special master, petitioner’s expert, Dr. Tornatore, opined that neuroborreliosis is an autoimmune demyelinating disease, that the hepatitis B vaccinations triggered an autoimmune demyelination in Mr. Hodge that aggravated his underlying demyelinating disease, and that it was “biologically plausible for the hepatitis B vaccine to cause autoimmune demyelination” through a mechanism known as molecular mimicry. Id. at *56-59 (quoting Pet’r’s Ex. 29 at 10); see also id. at *59-60 (recounting Dr. Tornatore’s explanation that the antigens in the hepatitis B vaccine may share homology with myelin basic protein, and thus upon vaccination, antibodies are triggered that can cross-react against the hepatitis B virus and myelin). Consequently, the special master first evaluated whether petitioner had established that neuroborreliosis is an autoimmune demyelinating disease and then turned to the question of whether a hepatitis B vaccination could cause or aggravate an autoimmune demyelinating disease. With respect to the first inquiry, the special master reviewed the opinions of Dr. Tornatore and respondent’s expert, Dr. Venkatesan, along with two articles relied upon by Dr. Tornatore. He noted at the outset that the evidence was mixed. For example, he observed that in the Hildenbrand article, “autoimmune reaction via molecular mimicry” was listed as one “putative mechanism[]” for Lyme neuroborreliosis central nervous system injury, but that “the authors seem to dismiss, as speculation, molecular mimicry because ‘T-cell lines demonstrate only weak cross-reactivity between myelin basic protein and B burgdor[f]eri.’” Id. at *57 (quoting Pet’r’s Ex. 42 at 1083). The special master then remarked that in the Ramesh article, the authors demonstrated that infection with the B. burgdorferi spirochete “leads to inflammation and inflammation can be harmful,” but noted that they did not use the term “autoimmunity” and that Dr. Venkatesan “persuasively explained[] the presence of immune cells does not necessarily mean that an injury’s etiology is autoimmune.” Id. Finally, the special master highlighted Dr. -8- Case 1:09-vv-00453-MMS Document 392 Filed 10/27/23 Page 9 of 13 Tornatore’s recognition that “researchers are considering multiple mechanisms, not just autoimmunity, as ways to explain how neuroborreliosis develops.” Id. After assessing the relevant body of evidence, the special master determined that petitioner did not establish “that neuroborreliosis is an autoimmune condition.” Id. at *58. Petitioner complains that the special master “rejected” each article relied upon by Dr. Tornatore, Mot. 12, and asserts that the articles support the proposition that neuroborreliosis is an autoimmune disease. Petitioner also identifies another piece of supportive evidence that she claims is significant (without actually contending that the special master disregards it): that Dr. Tornatore posited in one of his expert reports “that even after the [B. burgdorferi] infection ha[s] been treated with antibiotics, ongoing injury to the nervous system may occur as a result of the immune cascade that was triggered.” Id. However, it is apparent from the special master’s analysis that he considered the evidence offered in support of the proposition that neuroborreliosis is an autoimmune demyelinating disease—including Dr. Tornatore’s theory concerning the immune cascade, see Hodge, 2023 WL 4186513, at *57 n.70—and found it insufficient for petitioner to satisfy her burden. Consequently, petitioner’s contention that the special master legally erred in his analysis of the first inquiry under Loving prong 4 is not well- founded.10 Because the theory of causation advanced by Dr. Tornatore was premised on neuroborreliosis being an autoimmune demyelinating disease, petitioner’s failure to satisfy her burden of proof on that element necessarily means that she cannot prevail on her claim that the hepatitis B vaccinations significantly aggravated Mr. Hodge’s neuroborreliosis. Moreover, this failure renders petitioner’s criticism of the special master’s analysis of the second inquiry, which focuses on whether a hepatitis B vaccination can cause or aggravate an autoimmune demyelinating disease, moot. Nevertheless, for the sake of completeness, the court will address it. To assess petitioner’s contention that the hepatitis B vaccination can, in fact, cause or aggravate an autoimmune demyelinating disease, the special master reviewed the entire record before him, but concentrated on the evidence that petitioner identified as being the most supportive of her contention. He began by describing Dr. Tornatore’s opinion that the hepatitis B vaccination could cause autoimmune demyelination via molecular mimicry, and then analyzed the five articles that Dr. Tornatore relied upon in forming his opinion. Petitioner addresses four of these articles in her motion for review: the Matsui, Bogdanos, Comenge and Girard, and Waisbren articles. 10 Petitioner, in a footnote, also lodges an extensive objection to the special master’s statement that “Dr. Venkatesan has a stronger background in Lyme disease because he works at a center for studying Lyme disease.” Hodge, 2023 WL 4186513, at *57, quoted in Mot. 12 n.13. The court reiterates that it need not entertain arguments raised in footnotes, see SmithKline Beecham, 439 F.3d at 1320, but observes that a special master’s findings as to the credibility of an expert’s testimony are entitled to a high degree of deference, see Porter v. Sec’y of HHS, 663 F.3d 1242, 1250-51 (Fed. Cir. 2011) (summarizing precedent indicating that such credibility determinations are virtually unreviewable). -9- Case 1:09-vv-00453-MMS Document 392 Filed 10/27/23 Page 10 of 13 First, with respect to the Matsui article, the special master noted that the authors described the experiences of a patient diagnosed with recurring episodes of demyelinating transverse myelitis who carried hepatitis B surface antigens and myelin basic protein in his cerebrospinal fluid, and postulated that “the persistence of [hepatitis B virus] components including [hepatitis B surface] antigen in the [cerebrospinal fluid]/[central nervous system] of the patient may contribute to the recurrent demyelinating lesion formation in the [central nervous system].” Id. at *61 (quoting Pet’r’s Ex. 51 at 237). The special master discounted this article because it was a case report regarding a single individual, and noted another shortcoming: there is no indication that the patient at issue received a hepatitis B vaccination. The special master next described the contents of the Bogdanos article. The authors searched for amino acid “similarities between the small hepatitis B virus surface antigen (SHBsAg), and the [multiple sclerosis]-autoantigens myelin basic protein (MBP) and myelin oligodendrocyte glycoprotein (MOG) that could serve as targets of immunological cross- reactivity.” Id. (quoting Pet’r’s Ex. 48 at 217). They found that 60% of serum samples from individuals vaccinated against hepatitis B “had SHBsAg/MOG double reactivity on at least [one] occasion,” id. (quoting Pet’r’s Ex. 48 at 217), but as the special master observed, they did not draw a definitive conclusion: “In view of the observed SHBsAg/MOG cross-reactivity, the vaccine’s possible role as a trigger for the induction and/or maintenance of viral/self cross- reactivity through molecular mimicry must be further investigated.” Id. at *62 (quoting Pet’r’s Ex. 48 at 223). Indeed, as recognized by the special master and acknowledged by Dr. Tornatore, the authors reported that none of the vaccinated individuals “reported symptoms of demyelinating disorders,” id. (quoting Pet’r’s Ex. 48 at 222); accord id. (“All of the vaccinees were free of autoimmune phenomena before vaccination and remain free of any adverse reactions during the follow up.” (quoting Pet’r’s Ex. 48 at 222-23)). The final two articles addressed by petitioner—the Comenge and Girard article and the Waisbren article—were published in 2006 and 2008 in a journal titled Medical Hypotheses. The special master explained that the authors of the first article “appear to summarize some research that, in their view, supports their hypothesis that the ‘hepatitis B vaccine . . . has a marked potential to induce auto-immune hazards, neurological as well as non-neurological,’” due to a hypothesized effect of the vaccine manufacturing process, and “end by suggesting that the potential benefits of vaccination against hepatitis B be reevaluated.” Id. (quoting Pet’r’s Ex. 50 at 84). He then explains that the author of the second article “appears to hypothesize that the hepatitis B vaccine when given to a person who already is infected with the Epstein-Barr virus may develop multiple sclerosis via molecular mimicry,” and “proposes two experiments to test this hypothesis[.]” Id. Addressing both articles, the special master remarks that they presented hypotheses, not experimental data, and thus “it is difficult to deem either . . . article as meriting much evidentiary weight.” Id. The special master then addressed the articles as a whole. He observed that the most recent article was published in 2008, the Bogdanos and Waisbren articles suggested the need for further investigation, and another article (the Oldstone article published in 2005) characterized molecular mimicry as a hypothesis. The special master stated that he was not persuaded by Dr. Tornatore’s explanation for the lack of subsequent investigations into whether the hepatitis B vaccine could cause an autoimmune demyelinating disease—that there would be no reason for -10- Case 1:09-vv-00453-MMS Document 392 Filed 10/27/23 Page 11 of 13 such investigations because “once it’s been demonstrated, it’s very hard to get something published if . . . there’s data already out there,” id. at *63 (quoting Hr’g Tr. 255)—because given the evidence in the record, it was “difficult to credit” Dr. Tornatore’s “oral testimony that a causal link between the hepatitis B vaccine and demyelination has been ‘demonstrated.’” id. Ultimately, he concluded: [T]he undersigned is mindful that petitioners do not have to prove any aspect of their cases with certainty. But, even at a lower level of proof, the evidence [petitioner] has produced does not meet her burden. She has not presented evidence of sufficient quantity and quality to show that the hepatitis B vaccine can aggravate a demyelinating condition. Id. Petitioner objects to the special master’s analysis of the second inquiry. She explains why the Matsui, Bogdanos, Comenge and Girard, and Waisbren articles are supportive of her theory of causation notwithstanding the special master’s criticisms. She further notes Dr. Tornatore’s opinion that neuroborreliosis is similar to the demyelinating disease of multiple sclerosis and that another special master concluded in another case that the hepatitis B vaccination can cause multiple sclerosis. And, she emphasizes respondent’s concessions that (1) neuroborreliosis symptoms can be aggravated by external triggers and (2) the basis of some autoimmune disease can be explained by molecular mimicry. Petitioner asserts that had the special master applied the correct burden of proof, he would have found that this evidence, when examined as a whole, amounts to preponderant proof that the hepatitis B vaccination can cause or aggravate an autoimmune demyelinating disease. Petitioner’s argument is not persuasive. The special master articulated the proper legal standard, reviewed the evidence in the record—including the evidence highlighted by petitioner in addition to the articles, see id. at *55-56, *57 n.70, *58 n.73—in light of that standard, and concluded, based on the totality of that evidence, that petitioner did not satisfy her burden of proof. In short, petitioner has not established that the special master’s analysis of Loving prong 4 was not in accordance with law.11 D. Loving Prongs 5 and 6 Having concluded that the special master did not legally err in analyzing Loving prong 4, the court must deny petitioner’s motion for review. Nevertheless, it will address petitioner’s 11 Petitioner does not contend that the special master’s fact findings were arbitrary and capricious. Had she advanced such an argument, she would have found it difficult to prevail since that standard imposes a high bar: “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.” Hines v. Sec’y of HHS, 940 F.2d 1518, 1528 (Fed. Cir. 1991); accord Lampe v. Sec’y of HHS, 219 F.3d 1357, 1360 (Fed. Cir. 2000) (“The arbitrary and capricious standard of review is difficult for an appellant to satisfy with respect to any issue . . . .”). -11- Case 1:09-vv-00453-MMS Document 392 Filed 10/27/23 Page 12 of 13 additional, albeit abbreviated, challenges to the special master’s conclusions under Loving prongs 5 and 6.12 With respect to Loving prong 5, petitioner objects that despite ruling that she had satisfied her burden of demonstrating the existence of a significant aggravation of Mr. Hodge’s condition postvaccination under Loving prong 3, the special master concluded that “the evidence, viewed in its entirety, does not persuasively support that the hepatitis B vaccine significantly worsened an underlying neuroborreliosis manifesting as OCD.” Mot. 18 (quoting Hodge, 2023 WL 4186513, at *64); see also Hodge, 2023 WL 4186513, at *82-83 (providing a “synopsis” of the special master’s findings and conclusions under Loving prong 5). Specifically, petitioner complains that the special master “dismisses medical record evidence of neurological symptoms,” including notations in April 25 and June 2, 2006 medical records; disregards neurological symptoms identified by Dr. Tornatore; and “rejects the evidence of several treating doctors.” Mot. 18-19. However, a review of the special master’s decision reflects that the special master carefully considered all of the evidence identified by petitioner in her motion, along with other evidence in the record, in determining whether she could satisfy her burden of proof under Loving prong 5. See Hodge, 2023 WL 4186513, at *64-83. In other words, petitioner has not established that the special master’s analysis of Loving prong 5 was not in accordance with law.13 Petitioner’s criticism of the special master’s analysis of Loving prong 6 fares no better. In his decision, the special master observed that the “timing prong actually contains two parts,” and that “[a] Petitioner must show the ‘timeframe for which it is medically acceptable to infer causation’ and [that] the onset of the disease (or aggravation) occurred in this period.” Id. at *83 (quoting Shapiro v. Secʼy of HHS, 101 Fed. Cl. 532, 542 (2011), aff’d mem., 503 F. App’x 952 (Fed. Cir. 2013)). He concluded that petitioner “established the first part of this element” and that had she “presented preponderant evidence that the uncontrollable eye movements” were “neurologic in origin,” such “eye movements were noted within the time for which an inference of causation is appropriate.” Id. In other words, petitioner would have established the second 12 Petitioner devotes one paragraph to each prong in her motion for review. Mot. 18-19. 13 Petitioner’s complaint that the special master “dismisse[d]” or “reject[ed]” certain evidence might be construed as an argument that the special master improperly weighed the evidence in the record. Because petitioner did not explicitly raise such an argument, she has waived it. See SmithKline Beecham, 439 F.3d at 1319 (“[A]rguments not raised in the opening brief are waived.”). Even if she did advance such an argument, she would have found it difficult to prevail because special masters “have very wide discretion” in determining what evidence to consider and “the weight to be assigned that evidence.” Whitecotton v. Sec’y of HHS, 81 F.3d 1099, 1108 (Fed. Cir. 1996); accord Koehn v. Sec’y of HHS, 773 F.3d 1239, 1244 (Fed. Cir. 2014). Consequently, on review, the Court of Federal Claims does “not reweigh the factual evidence, assess whether the special master correctly evaluated the evidence, or examine the probative value of the evidence.” Porter, 663 F.3d at 1249; Hodges v. Sec’y of HHS, 9 F.3d 958, 961 (Fed. Cir. 1993) (holding that “on review, the Court of Federal Claims is not to second guess the Special Master[’]s fact-intensive conclusions”); Hines, 940 F.2d at 1527 (“[A]rguments as to the weighing of evidence . . . do not demonstrate reversible error.”). -12- Case 1:09-vv-00453-MMS Document 392 Filed 10/27/23 Page 13 of 13 part of the timing prong if she had proven that Mr. Hodge’s abnormal eye movements were a neurological symptom. The special master did not, as petitioner contends, conclude that petitioner “failed to prove the second component of Prong [6],” Mot. 19; rather, he concluded that her failure to satisfy her burden on Loving prong 5 rendered the second component of Loving prong 6 irrelevant. The court identifies no legal error in the special master’s reasoning or conclusion. III. CONCLUSION In short, petitioner has not demonstrated that the special master required her to satisfy a heightened burden of proof to establish causation under the final three prongs of the Loving test. Rather, applying the proper legal standard to the record as a whole, the special master concluded that petitioner had not offered preponderant evidence that the hepatitis B vaccination can significantly aggravate neuroborreliosis, as required under Loving prong 4. Furthermore, contrary to petitioner’s contention, the special master carefully reviewed the entirety of the record in determining that petitioner had not satisfied her burden of proof under Loving prong 5. The court recognizes that petitioner and Mr. Hodge have suffered tremendously in the time since Mr. Hodge received his hepatitis B vaccinations, and that petitioner strongly believes that those vaccinations caused the significant deterioration of Mr. Hodge’s condition. However, under the Vaccine Act, this court’s review is limited. When the sole objection presented is that the special master applied the wrong legal standard and therefore acted contrary to law, the court’s inquiry necessarily ends if it concludes that the special master applied the correct legal standard. Such is the case here. Accordingly, the court DENIES petitioner’s motion for review and SUSTAINS the decision of the special master. The clerk is directed to enter judgment accordingly. IT IS SO ORDERED. s/ Margaret M. Sweeney MARGARET M. SWEENEY Senior Judge -13-