VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_12-vv-00742 Package ID: USCOURTS-cofc-1_12-vv-00742 Petitioner: Sydney Rich Filed: 2012-11-01 Decided: 2016-12-16 Vaccine: influenza Vaccination date: 2010-09-26 Condition: Acute Disseminated Encephalomyelitis (ADEM) Outcome: denied Award amount USD: AI-assisted case summary: Sydney Rich filed a petition on November 1, 2012, alleging that an influenza vaccine she received on September 26, 2010, caused her to develop Acute Disseminated Encephalomyelitis (ADEM). Petitioner was born on May 13, 1992, and was a freshman at the University of Oklahoma in the fall of 2010. She had a history of asthma but was otherwise healthy. She had received influenza vaccinations annually for the five years prior to 2010 without reported adverse reactions. Petitioner alleged that a few weeks after her September 26, 2010, flu vaccination, she began experiencing fatigue, lethargy, headaches, dizziness, and leg weakness. Her roommate, Caramia Enrich, and her co-worker, Aurora Tapia, corroborated these alleged symptoms, stating they began in October and November 2010 and worsened over time. Petitioner's mother, Heather Rich, also stated that her daughter complained of fatigue and headaches a few weeks after the vaccination. However, Petitioner sought medical attention on three occasions during the fall of 2010. On October 8, 2010, she saw her pediatrician, Dr. Colleen Dooley, complaining of difficulty breathing at night and increased use of her inhaler. Dr. Dooley diagnosed an asthma exacerbation and prescribed medication. Petitioner did not report leg heaviness or difficulty walking to Dr. Dooley at this visit. On October 23, 2010, Petitioner returned to Dr. Dooley, again complaining of asthma symptoms. Her mother accompanied her and attributed the symptoms to asthma. Medical records from this visit noted increased asthma symptoms and continued medication. On November 10, 2010, Petitioner visited her college's medical center, reporting coughing, difficulty breathing, fever, night sweats, sore throat, headache, earache, wheezing, and muscle aches. The medical record from this visit, signed by Dr. Stephanie Parker, noted no nausea, vomiting, or diarrhea, and no other complaints beyond those checked on the intake form. Petitioner testified that she had experienced dizziness, light-headedness, weakness, and nausea prior to this visit and felt like she was going to pass out, but she did not report these specific symptoms to the medical personnel. The medical records from all three visits focused on respiratory and asthma-related issues. Petitioner was hospitalized on December 27, 2010, with wheezing, dyspnea, shortness of breath, and chest tightness. Her neurological examination at that time was normal, and she denied weakness or fatigue. She was diagnosed with community-acquired pneumonia, pneumothorax, and asthma exacerbation. Her condition worsened, leading to intubation. On January 6, 2011, an MRI revealed findings consistent with ADEM and hypoxic injury. On January 7, 2011, she was diagnosed with suspected ADEM and began treatment. A sputum test later revealed H1N1 Influenza, and she was treated with Tamiflu. She also received Intravenous Immunoglobulin (IVIG) treatment. By February 17, 2011, her condition stabilized, and she was transferred to a rehabilitation facility with diagnoses including acute demyelinating encephalomalacia with paralysis and quadriparesis, respiratory failure, and critical care myopathy. She was discharged home on March 25, 2011, requiring ongoing care and a wheelchair. Two treating physicians, Dr. Jenny Le and Dr. William Schueler, later attributed her condition to H1N1 Influenza. Petitioner's expert, Dr. David Siegler, noted that a three-month latency period between vaccination and ADEM was long and that he had not found a case report with such a latency. He stated that his theory of causation was dependent on the oral history of neurological symptoms developing a few weeks post-vaccine. Respondent's expert, Dr. Michael Kohrman, concluded that the flu vaccine was "very unlikely" to be the cause of Petitioner's ADEM, citing the lack of documented neurological problems in medical records prior to hospitalization and the negative temporal relationship. He opined that H1N1 infection, bronchitis, or pneumonia were more likely causes. An onset hearing was held on October 30, 2014, to determine the date of the first symptom or manifestation of ADEM. Special Master Lisa Hamilton-Fieldman issued a Finding of Fact on September 16, 2015, concluding that Petitioner's ADEM symptoms began on or after December 27, 2010, concurrently with or shortly after her hospitalization for pneumonia and pneumothorax. The Special Master found that Petitioner's medical records did not support the testimony of Petitioner and her witnesses regarding earlier neurological symptoms, and that Petitioner had not reported such symptoms during her earlier medical visits. The Special Master found it implausible that Petitioner, who was familiar with seeking medical care for her asthma, would not have reported severe neurological symptoms if she had experienced them. On June 30, 2016, Special Master Hamilton-Fieldman issued a decision dismissing the petition, finding that Petitioner failed to present a prima facie case for entitlement. She concluded that Petitioner had not demonstrated a logical sequence of cause and effect or a proximate temporal relationship between the vaccination and her ADEM, as both experts agreed that a three-month latency period was not consistent with causation, and treating physicians attributed her ADEM to H1N1. Petitioner moved for review by the Court of Federal Claims. On December 16, 2016, Judge Elaine D. Kaplan of the Court of Federal Claims sustained the Special Master's dismissal. The Court found that the Special Master's decision was supported by the evidence in the record and was not arbitrary, capricious, an abuse of discretion, or contrary to law. The Court noted that medical records are generally considered trustworthy and contemporaneous evidence, and that the Special Master appropriately relied on the absence of reported neurological symptoms in the medical records. The Court found that the Special Master's rejection of Petitioner's explanations for not reporting symptoms was not arbitrary or capricious. The Court affirmed that the Special Master's determination of the onset date was reasonable and that Petitioner failed to demonstrate causation. Interim attorneys' fees were awarded to Petitioner's counsel during the litigation. The petition was ultimately denied. Theory of causation field: Sydney Rich, born May 13, 1992, received an influenza vaccine on September 26, 2010. She alleged this caused Acute Disseminated Encephalomyelitis (ADEM). Petitioner's witnesses and she herself claimed neurological symptoms began a few weeks after vaccination, in October/November 2010. However, contemporaneous medical records from three visits in Fall 2010 (Oct 8, Oct 23, Nov 10) documented only respiratory and asthma-related complaints, with no mention of neurological symptoms. Petitioner's ADEM diagnosis occurred after hospitalization on December 27, 2010, with onset determined by Special Master Lisa Hamilton-Fieldman to be on or after that date, establishing a latency period of at least three months. Both Petitioner's expert, Dr. David Siegler, and Respondent's expert, Dr. Michael Kohrman, agreed that a three-month latency period between vaccination and ADEM onset is not medically plausible for causation. Treating physicians attributed Petitioner's ADEM to H1N1 Influenza. Special Master Hamilton-Fieldman dismissed the petition on June 30, 2016, finding Petitioner failed to establish a prima facie case under the Althen test, specifically lacking a logical sequence of cause and effect and a proximate temporal relationship. Judge Elaine D. Kaplan of the Court of Federal Claims sustained the dismissal on December 16, 2016, finding the Special Master's decision was supported by the record and not arbitrary or capricious, particularly regarding the reliance on contemporaneous medical records and the determination of the onset date. Interim attorneys' fees were awarded. The petition was denied. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_12-vv-00742-0 Date issued/filed: 2015-04-16 Pages: 2 Docket text: PUBLIC DECISION (Originally filed: 03/26/2015) regarding 76 DECISION Interim Fees Stipulation. Signed by Special Master Lisa Hamilton-Fieldman. (jb) Copy to parties. -------------------------------------------------------------------------------- Case 1:12-vv-00742-EDK Document 79 Filed 04/16/15 Page 1 of 2 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 12-742V Filed: March 26, 2015 * * * * * * * * * * * * * * * * UNPUBLISHED SYDNEY RICH, * * Special Master Hamilton-Fieldman Petitioner, * * Decision on Interim Attorneys’ Fees v. * and Costs; Reasonable Amount * Requested to Which Respondent SECRETARY OF HEALTH * Does Not Object. AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * Andrew D. Downing, Van Cott & Talamante, PLLC, Phoenix, AZ, for Petitioner. Sarah C. Duncan, United States Department of Justice, Washington, D.C., for Respondent. DECISION1 On November 1, 2012, Sydney Rich (“Petitioner”) filed a petition pursuant to the National Vaccine Injury Compensation Program.2 42 U.S.C. §§ 300aa-1 to -34 (2006). Petitioner alleged that she suffered from Acute Disseminated Encephalomyelitis (“ADEM”) as a result of the administration of an influenza (“flu”) vaccine on September 26, 20103. On October 30, 2014, an onset hearing was held. A decision regarding onset is pending. 1 Because this decision contains a reasoned explanation for the undersigned’s action in this case, the undersigned intends to post this ruling on the website of the United States Court of Federal Claims, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). As provided by Vaccine Rule 18(b), each party has 14 days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). 2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-1 to -34 (2006) (Vaccine Act or the Act). All citations in this decision to individual sections of the Vaccine Act are to 42 U.S.C.A. § 300aa. 3 A hearing was conducted on June 24, 2013 and the undersigned found that Petitioner received the influenza vaccination on September 26, 2010. Order, ECF No. 35. 1 Case 1:12-vv-00742-EDK Document 79 Filed 04/16/15 Page 2 of 2 On March 24, 2015, the parties filed a stipulation of fact concerning interim attorneys’ fees and costs stating that they had agreed on a reasonable amount of attorneys’ fees and costs that have been incurred by Petitioner’s counsel to date. Respondent maintains her objection to any award of interim attorneys’ fees and costs. Nevertheless, the parties agree to the reasonableness of the revised total of interim attorneys’ fees and costs as set forth in paragraph 6 of the joint stipulation. The undersigned finds that Petitioner is entitled to an award of interim attorney’s fees and costs under the unique facts and circumstances of this case. See Butler v. Sec’y, HHS, No. 02- 1051, 2012 WL 4458203 (Fed. Cl. Spec. Mstr. June 25, 2012) (awarding interim attorneys’ fees and costs over respondent’s objection); Shaw v, Sec’y, HHS, 609 F.3d 1372, 1375 (Fed. Cr. 2010) (holding that “[w]here the claimant establishes that the cost of litigation has imposed an undue hardship and that there exists a good faith basis for the claim, it is proper for the special master to award interim attorneys’ fees”). The undersigned finds that paragraph 6 of the stipulation is reasonable and adopts it as the decision of the Court in awarding interim fees and costs, on the terms set forth therein. Accordingly, the undersigned hereby awards: 1. A lump sum of $45,358.69 in the form of a check jointly payable to Petitioner, Petitioner’s attorney, Andrew D. Downing, and Van Cott & Talamante; and 2. A lump sum of $4,771.31 in the form of a check jointly payable to Petitioner, Petitioner’s attorney, Andrew D. Downing, and Hennelly & Steadman PLC. In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the court SHALL ENTER JUDGMENT in accordance with the terms of the parties’ stipulation.4 IT IS SO ORDERED. s/ Lisa Hamilton-Fieldman Lisa Hamilton-Fieldman Special Master 4 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of notice renouncing the right to seek review. 2 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_12-vv-00742-1 Date issued/filed: 2015-10-07 Pages: 15 Docket text: PUBLIC DECISION (Originally filed: 09/16/2015) regarding 80 Findings of Fact & Conclusions of Law. Signed by Special Master Lisa Hamilton-Fieldman. (jb) Copy to parties. -------------------------------------------------------------------------------- Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 1 of 15 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 12-742V E-Filed: September 16, 2015 * * * * * * * * * * * * * * * * SYNDEY RICH, * UNPUBLISHED * Petitioner, * Special Master Hamilton-Fieldman * v. * * Finding of Fact; Influenza (“Flu”) Vaccine; * Acute Disseminated Encephalomyelitis SECRETARY OF HEALTH * (“ADEM”); Timing of Onset of Symptoms; AND HUMAN SERVICES, * Contemporaneous Medical Records Versus Respondent. * Testimony. * * * * * * * * * * * * * * * * Andrew Downing, Van Cott & Talamante, PLLC, Phoenix, AZ, for Petitioner. Sarah Duncan, United States Department of Justice, Washington, DC, for Respondent. FINDING OF FACT1 On November 1, 2012, Sydney Rich (“Petitioner”) filed a petition pursuant to the National Vaccine Injury Compensation Program2 (the “Program”). Petitioner alleged that, as a 1 Because this finding of fact contains a reasoned explanation for the action in this case, the undersigned intends to post this order on the United States Court of Federal Claims’ website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 and note (2006)). In accordance with Vaccine Rule 18(b), a party has 14 days to identify and move to delete medical or other information that satisfies the criteria in § 300aa-12(d)(4)(B). Further, consistent with the rule requirement, a motion for redaction must include a proposed redacted decision. If, upon review, the undersigned agrees that the identified material fits within the requirements of that provision, such material will be deleted from public access. 2 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-10 et seq. (hereinafter Vaccine Act or the Act). Hereafter, individual section references will be to 42 U.S.C. § 300aa of the Act. 1 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 2 of 15 result of receiving an influenza (“flu”) vaccination on September 26, 20103, she developed Acute Disseminated Encephalomyelitis (“ADEM”). 4 See Petition (Pet.) at 1, ECF No. 1. The matter is before the undersigned at this time for a fact ruling on the question of the timing of ADEM symptom onset. The undersigned conducted a fact hearing on October 30, 2014, at which Petitioner, her mother, Heather Rich, her college roommate, Caramia Enrich, and her former supervisor, Aurora Tapia-Contreras, testified. See Transcript (“Tr.”) at 3. Respondent asserted that Petitioner’s medical records do not show complaints consistent with ADEM until after Petitioner was hospitalized for pneumonia and a pneumothorax5 on December 27, 2010, and that the undersigned should therefore find that symptom onset of Petitioner’s allegedly vaccine-caused ADEM is on or after that date. Rule 4(c) Report, ECF No. 37, at 9-10. Petitioner conceded that her medical records were primarily focused on her pulmonary complaints, and that they do not affirmatively reflect any neurological problems prior to Petitioner’s admission to the hospital on December 27, 2010. See generally Petitioner’s Pre- Hearing Submission, ECF No. 61. However, Petitioner asserted that she has presented evidence in the form of affidavits and hearing testimony to rebut the presumptive accuracy of the medical records. Petitioner stated that her evidence shows that she was experiencing symptoms such as dizziness, nausea, lightheadedness, weakness, difficulty with word finding, heaviness in her limbs, and pain in her legs prior during the fall of 2010, and that she had reasonable explanations for why those symptoms were not discussed with any of her medical providers. Id.; Pet. Ex. 1 at 2-3; Pet. Ex. 16 at 1-2; Pet. Ex. 3 at 1-2; Pet. Ex. 4 at 7; Pet. Ex. 15 at 2. 3 Because written records were missing, Respondent questioned whether Petitioner actually received the vaccine alleged to have caused her injury. See Order, April 25, 2013. A fact hearing was held on June 24, 2013 about this issue and the undersigned issued an “Order and Ruling on Facts Pertaining to Petitioner’s Receipt of a Covered Vaccination” on July 26, 2013 [hereinafter “Order and Ruling”]. That Order concluded that Petitioner received the influenza vaccine on September 26, 2010, as stated in the Petition. Order and Ruling at 10; ECF No. 35. 4 ADEM is an inflammation involving the brain and spinal cord. Dorland’s: Dorland’s Illustrated Medical Dictionary, 613 (32nd. ed. 2012). The typical cause is an acute viral infection and “it is believed to be a manifestation of an autoimmune attack on the myelin of the central nervous system.” Id. The symptoms “appear rapidly, beginning with encephalitis-like symptoms such as fever, fatigue, headache, nausea, and vomiting.” Furthermore, many patients experience neurological symptoms including confusion, visual blurring, weakness, and drowsiness. See Acute Disseminated Encephalomyelitis (ADEM), Cleveland Clinic, last reviewed on August 22, 2014, available at: http://my.clevelandclinic.org/services/neurological_institute/mellen-center-multiple- sclerosis/diseases-conditions/hic-acute-disseminated-encephalomyelitis. 5 A pneumothorax is “an accumulation of air or gas in the pleural space.” Dorland’s: Dorland’s Illustrated Medical Dictionary, 1476 (32nd ed. 2012). 2 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 3 of 15 Based on the record as a whole, the undersigned finds that the symptoms of Petitioner’s ADEM began on or after her December 27, 2010 hospitalization for pneumonia and pneumothorax. I. Procedural History On November 1, 2012, Petitioner filed a Petition alleging that a flu vaccination administered in 2010 caused Petitioner to develop ADEM. Pet. at 1-4. This case was initially assigned to Special Master Denise Vowell; the case was transferred to the undersigned on March 4, 2013. See Notices of Assignment, filed November 1, 2012 and March 4, 2013. Following the filing of Petitioner’s medical records and affidavits, the undersigned determined that a fact hearing regarding whether Petitioner received the vaccine in question was necessary. See Order, ECF No. 22, at 1. A video conference fact hearing took place in Washington, DC on June 24, 2013. Tr. at 1-7. On July 26, 2013, the undersigned made a determination that “Petitioner … has established by preponderant evidence that she received the influenza vaccination at Memorial Christian Church in Oklahoma City, Oklahoma on September 26, 2010.” Order and Ruling on Facts Pertaining to Petitioner’s Receipt of a Covered Vaccination [hereinafter “Order and Ruling”], ECF No. 35, at 10. The undersigned also noted that Petitioner had begun to suffer from symptoms, including fatigue and weakness, shortly after receiving the vaccination in September 2010; however, she had a positive H1N1 test after she was hospitalized for ADEM in January 2011. Id. On September 10, 2013, Respondent filed a Rule 4(c) Report in which she denied that Petitioner had presented a reputable medical theory, evidence of “a logical sequence of cause and effect,” or evidence of a “medically appropriate temporal relationship” between Petitioner’s vaccine and her alleged injury. Rule 4 Report, ECF No. 37, at 9-10. Respondent identified a dearth of documented neurological symptoms in the medical records prior to Petitioner’s hospitalization for pneumonia and pneumothorax on December 27, 2010,, and she articulated a theory of alternative causation. Id. at 10-11. Respondent did not believe that this case was appropriate for compensation. Id. at 11. During a status conference that took place on September 19, 2013, the undersigned discussed the status of the case with the parties, who agreed to explore settlement while simultaneously preparing for a trial. See Order, ECF No. 38. Petitioner filed an expert report from Dr. David Siegler on December 9, 2013. Pet. Ex. 18, ECF No. 39. Between the filing of Petitioner’s expert report and Respondent’s expert report, Petitioner identified missing medical records and filed them on July 28, 2014. Pet. Ex. 23, ECF No. 52. On September 5, 2014, Respondent filed an expert report from Dr. Michael Kohrman. Respondent’s Exhibit (“Resp. Ex.”) A, ECF No. 55. Following a status conference that took place on September 16, 2014, the parties agreed that the date of onset was still in contention and agreed that an onset hearing be held. See Order, ECF No. 56. On October 9, 2014, Petitioner filed a Pre-Hearing Submission. Petitioner’s Pre-Hearing Submission, ECF No. 61. Petitioner alleged that her symptoms began earlier than January 7, 2011, when she was diagnosed with ADEM. Id. at 1. She stated that circumstantial evidence, 3 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 4 of 15 including testimony and affidavits, show that Petitioner began to show symptoms of ADEM “within weeks of receiving the influenza vaccination on September 26, 2010.” Id. at 6. An Onset Hearing took place on October 30, 2014 in Oklahoma City, Oklahoma. See Order, ECF No. 63. I. The Record a. Medical Records Petitioner filed several medical records from various treating physicians. Petitioner had a pre-existing diagnosis, as early as 2004, of asthma, for which she was prescribed a variety of medication including Pulmicort, Singulair, Symbicort, Advair, and Albuterol. See Pet. Ex. 4 at 51; see generally Pet. Ex. 4. However, Petitioner did not always take the prescribed medication. See Pet. Ex. 4 at 15, 16. Pulmonary testing conducted in 2004, 2006, and 2010 consistently indicated that Petitioner had a pulmonary obstruction and low vital capacity. Pet. Ex. 4 at 30, 47-48, 60. Otherwise, Petitioner appeared healthy and was followed frequently by her pediatrician, Dr. Colleen Dooley. See generally Pet. Ex. 4. Petitioner received flu vaccines in 2005, 2006, 2007, 2008, and 2009, and she did not report any adverse reactions to these flu vaccines. Pet. Ex. 4 at 37-38, 42. On September 26, 2010, Petitioner received the flu vaccine at issue. Order and Ruling at 10. About two weeks after vaccination, on October 8, 2010, Petitioner went to her pediatrician, Dr. Dooley, because she was having trouble breathing at night and was unable to get Advair, her asthma medication. Pet. Ex. 4 at 8. She was “using inhaler ‘a lot.’” Id. Although her mother often accompanied her to medical appointments, Tr. at 20, the records reflect that Petitioner was “unaccompanied” at this visit.” Id. Dr. Dooley’s impression was that Petitioner was having an exacerbation of her asthma and she prescribed asthma medication, in addition to giving Petitioner some samples. Id. Petitioner went to Dr. Dooley again on October 23, 2010; her mother was at this visit. Pet. Ex. 4 at 7. During the visit, Petitioner again complained about her asthma and she stated that she could not afford her medication. Id. Dr. Dooley’s impression was that Petitioner was suffering from asthma and prescribed her prednisone and Singulair. Id. The medical records from Dr. Dooley do not document that Petitioner complained of symptoms of fatigue, heavy legs, difficulty concentrating, or dizziness. See generally Pet. Ex. 4. Another visit with Dr. Dooley was not noted until April 8, 2011.6 See Pet. Exs. 5, 6. On November 10, 2010, Petitioner visited the on-campus health center at the University of Oklahoma, where she lived and attended school, with complaints of coughing and trouble breathing. See generally Pet. Ex. 15. On the Center’s symptom checklist, Petitioner reported that she had a fever, night sweats, a sore throat, a headache and ear ache/pain, a cough that was interfering with her sleep, and muscle aches, but that her symptoms were “somewhat improving”. Id. at 2. Exam notes documented wheezing, a red pharynx, and mucus and sinus issues; a Doctor of Osteopathic Medicine at the health center, Stephanie Parker, diagnosed 6 Petitioner’s affidavit states that she “ended up going to the doctor in Oklahoma City” after the November 10, 2010 clinic visit, but no records of such a visit were provided. Pet. Ex. 1 at 2. 4 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 5 of 15 Petitioner with bronchitis and asthma. Id. Petitioner was given a nebulizer treatment at the clinic, after which she felt “better” according to L. Cushman, R.N. Id. Petitioner was sent home with albuterol for additional nebulizer treatments, and antibiotics. Id. Again, the records do not document symptoms of extreme fatigue, “heaviness,” dizziness, difficulty concentrating, or sensitivity to light. On December 27, 2010, Petitioner presented to the emergency room at Integris Baptist Medical Center with “wheezing, dyspnea7 . . . shortness of breath, [and] chest tightness starting yesterday.” Pet. Ex. 5 at 9. She denied weakness or fatigue; her neurologic examination was normal. Id. at 47-49.She reported that she had had a recent upper respiratory infection (“URI”), a runny nose, and congestion, and that the onset of symptoms had been one day prior. Id. The physician noted that she was experiencing a severe asthma exacerbation; however, she appeared alert and oriented, despite being in moderate distress and anxious. Id. at 10. Dr. John Huff noted that Petitioner had a computerized tomography (“CT”) scan in the emergency room that “show[ed] an extensive right upper lobe pneumonia as well as trace anterior right upper lobe pneumothorax.” Id. at 46-47. Petitioner was admitted to the intensive care unit (“ICU”) and was given antibiotics, corticosteroids, and bronchodilators. Id. at 50. Her diagnoses included community-acquired pneumonia, right small pneumothorax, asthma exacerbation, a left lower lobe pulmonary nodule, allergic rhinitis, and hypoxemia8. Id. at 49-50. Influenza, both type A and B, was ruled out through a laboratory test performed on December 27, 2010. Id. at 390. The following day, on December 28, 2010, a right chest tube was placed for her pneumothorax. Pet. Ex. 5 at 374. As the pneumothorax began to resolve, Petitioner continued to have trouble breathing and she was intubated. Id. at 41, 362. A bronchoscopy was performed on December 29, 2010 and “showed severe bronchitis.” Id. at 41. Petitioner’s condition continued to worsen. Pet. Ex. 5 at 41-42. Following the bronchoscopy, “[t]ube feeding was initiated. She had decreased responsiveness over the next few days. Her sedatives were decreased; however, she continued to have decreased mental status.” Id. The results of neurological exams were “extremely abnormal,” as was an MRI of her cervical spine. Id. It was noted that the findings of her MRI “were consistent with acute disseminated encephalomyopathy.” Id. A brain MRI conducted on January 6, 2011 showed, among other things, an “[a]cute infarction of the splenium of the corpus callosum with areas of diffusion restriction, T2 alteration, and abnormal contrast enhancement within pons . . . cervical spine cord may relate to hypoxic injury. Additional considerations include demyelinating process or vasculitis.” Pet. Ex. 5 at 368. A physician who saw Petitioner to manage her tracheostomy tube, Dr. Maplani, interpreted her results to show “an acute infarction of the corpus callosum with involvement of the pons in the right cerebellum. She had progression of the cervical spine ischemic injury and now has a high spinal cord injury as a result.” Pet. Ex. 7 at 8. 7 Dyspnea is defined as “breathlessness or shortness of breath; difficult or labored respiration.” Dorland’s: Dorland’s Illustrated Medical Dictionary, 582 (32nd ed. 2012). 8 Hypoxemia is “deficient oxygenation of the blood.” Dorland’s: Dorland’s Illustrated Medical Dictionary, 908 (32nd ed. 2012). 5 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 6 of 15 Petitioner was examined by infectious disease specialist Aline Brown, M.D., on January 7, 2011. Pet. Ex. 5 at 173. Dr. Brown’s diagnosis was ADEM “which is usually post- infectious.” Id. She recommended a sputum test, laboratory results from which showed a positive H1N19 result as of January 7, 2011. Id. at 42; Pet. Ex. 17 at 1-3. Petitioner was started on Tamiflu, in addition to the many medications she was already taking. Id. She started on a four day course of Intravenous Immunoglobulin (“IVIG”) treatment on January 13, 2011. Id. at 42. When doctors attempted to wean her from the ventilator, she was unable to be weaned and a tracheostomy was performed. Id; Pet. Ex. 22 at 1. The chest tube was discontinued on February 8, 2011, after doctors determined that her pneumothorax had resolved, and her ventilator was discontinued the next day. Pet Ex. 5 at 42. Several physicians attributed her condition to the H1N1 virus, for which she tested positive for on January 7, 2011. Pet. Ex. 17 at 2. Dr. William B. Schueler, a professor at the University of Oklahoma Health Sciences Center, opined that Petitioner had “some paralysis secondary to the swine flu in January 2011.” Pet. Ex. 6 at 24. Another physician, Dr. Jenny Lee, opined that Petitioner had an asthma exacerbation that “turned into bronchitis and then pneumonia. This in turn was complicated by a ‘collapsed lung’ which required a chest tube and intubation and ventilator assistance (Dec. 28, 2010). During her recovery she contracted the ‘swine flu’ (Jan 2011) which turned into encephalitis.” Pet. Ex. 6 at 27. On February 17, 2011, Petitioner was transferred to Jim Thorpe Rehabilitation (“Jim Thorpe”), where she remained until March 25, 2011. Id. at 28, 42. Her discharge diagnoses, as reported on her discharge summary from Integris Baptist Medical Center, were: acute hypoxemic respiratory failure, community-acquired pneumonia, H1N1 influenza, asthma exacerbation, right pneumothorax, hypertension, acute disseminated encephalomyelitis, central hypothermia, critical illness myopathy10, anxiety, mild protein-calorie malnutrition, and mild oropharyngeal dysphagia11. Id. at 40-43. Petitioner continued to receive treatment from home health aides following her discharge from Jim Thorpe. See generally Pet. Ex. 6. She continues to require a wheelchair, as seen at the onset hearing, and she requires assistance for many activities of daily living. Tr. at 5; Pet. at 4. 9 H1N1 is a seasonal flu virus with several severe complications such as pulmonary and cardiac conditions. See John G. Barlett, MD, 2009 H1N1 Influenza – Just the Facts: Clinical Features and Epidemiology, Medscape, last reviewed on November 23, 2009, available at: http://www.medscape.com/viewarticle/709540_4; see also H1N1 (originally referred to as Swine Flu), Flu.gov, available at: http://www.flu.gov/about_the_flu/h1n1/. 10 Critical illness myopathy is defined as “severe muscle weakness, hypotonia, and depressed tendon reflexes of many different muscles . . . in some it may be a complication of therapy with corticosteroids or neuro-muscular blocking agents, but in others the cause is unknown.” Dorland’s: Dorland’s Illustrated Medical Dictionary, 1224 (32nd ed. 2012). 11 Dysphagia is defined as “difficulty in swallowing”; oropharyngeal dysphagia refers to “difficulty initiating the swallowing process.” Dorland’s: Dorland’s Illustrated Medical Dictionary, 579 (32nd ed. 2012). 6 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 7 of 15 b. Affidavits In addition to the medical records, Petitioner filed several affidavits. Petitioner’s own Affidavit was filed on December 5, 2012. See Pet. Ex. 1, ECF No. 5-1. In this affidavit, Petitioner stated that a few weeks after vaccination12, she would get “fatigued easily.” Pet. Ex. 1 at 2. Additionally, she stated that she was lethargic, fatigued, and frequently had headaches. Id. She explained that she didn’t tell her mother about her health because she suspected that her mother would make her return home from her on-campus housing and go to the doctor. Id. at 2. However, one day she felt dizzy, light-headed, weak, and nauseous and she told her mother, who urged her to come home. Id. After seeking treatment at the on-campus health center, she stated that her symptoms continued, but she didn’t tell her mother. Id. Petitioner filed an affidavit authored by her college roommate, Caramia Testa, on December 5, 2012. See Pet. Ex. 3, ECF No. 5-3. Ms. Testa recounted that Petitioner was healthy and active prior to vaccination, but that “[a] few weeks after getting the flu shot, Sydney started showing symptoms of something being wrong.” Id. at 1. The specific symptoms she discussed included fatigue and headaches. Id. at 1-2. Ms. Testa noted a particular occasion, Halloween 2010, where Petitioner appeared ill and fatigued. Id. at 2. The affidavit describes that she thought Petitioner’s symptoms seemed to worsen until the semester ended and Sydney was hospitalized. Id. at 2-4. Petitioner also filed an affidavit from witness Aurora Tapia.13 See Pet. Ex. 24, ECF No. 60. Ms. Tapia affirmed that she “specifically recall[ed] when Sydney got her flu shot,” and that she “recall[ed] her symptoms starting shortly thereafter.” Pet. Ex. 24 at 1. According to Ms. Tapia, Petitioner’s symptoms included headaches, dizziness, fatigue, and acting different than usual; she specified that these symptoms started in late October of 2010 and into November of 2010. Id. at 1. She indicated that she was responsible for training Petitioner at Panera Bread, their mutual place of employment, and she noticed Petitioner was slow to complete tasks following receipt of the vaccine at issue here. Id. Finally, Petitioner filed an affidavit authored by her mother, Heather Rich, on May 2, 2013. Pet. Ex. 16, ECF No. 23. According to Ms. Rich, Petitioner received the flu vaccination on September 26, 2010, and Petitioner’s symptoms, including fatigue, headaches, and trouble sleeping, began “[a] couple of weeks later.” Id. at 1. Other symptoms Ms. Rich noted included trouble speaking in complete sentences, weakness, lack of energy, and headaches. Id. at 1-2. Ms. Rich believed that these symptoms were attributable to Petitioner’s asthma. Id. at 2. c. Testimony i. Sydney Rich Petitioner testified as to the date of onset of her symptoms at the hearing 12 In her affidavit, Petitioner never gives a date, or range or dates, for the onset of her symptoms. See Pet. Ex. 1, ECF No. 5-1. 13 Aurora Tapia testified under the name Aurora Tapia-Contreras at the hearing. Tr. at 73. 7 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 8 of 15 on October 30, 2014. She explained that, prior to vaccination, she was involved with a sorority at the University of Oklahoma and felt healthy. Tr. at 129-31. Although she used her rescue inhaler a few times during the move-in process, this was not abnormal, as she regularly used her rescue inhaler a couple of times a week. Tr. at 130. Petitioner stated that her first symptom was “feeling tired” and it began a few weeks after vaccination, in mid-October. Tr. at 137-38, 162. Petitioner clarified that when she said she was “feeling tired,” her “body started feeling heavier than it did [before she experienced this symptom]” and her legs were heavy. Tr. at 137, 162-63. The next symptoms she began to experience were headaches and dizziness and she recalled that these began in early to mid- November. Tr. at 139, 162. Although she attempted to use her rescue inhaler and experienced some initial relief, it did not continue to alleviate her symptoms. Tr. at 138-39. Petitioner explained that after experiencing the first symptoms, she never improved and her symptoms worsened over time. Tr. at 165. Counsel attempted to clarify the specific time of onset; Petitioner specifically recalled having symptoms during Halloween of 2010. Tr. at 139-40. The symptoms she remembered included being exhausted, feeling “heavy”, having difficulty breathing and headaches. Id. She stated that while experiencing these symptoms, she spoke to her mother but didn’t tell her mother about her ailments because she was afraid she would be forced to seek medical treatment. Tr. at 140-41. One of her last symptoms, being bothered by light, began “[l]ate November into December.” Tr. at 145. By the finals period, at the beginning of December 2010, Petitioner was “exhausted all the time. [Her] body felt so heavy. [She] was tired. [She] was having trouble breathing. [She] was having headaches, dizziness on a daily basis. And [she] couldn’t hardly focus at all.” Tr. at 158. A couple of weeks before she was hospitalized, on December 27, 2010, she felt unusually irritable and emotional. Tr. at 159-60. Until this time, however, she was still able to function. Tr. at 160. She could still drive; she could carry things. Id. Petitioner was questioned about her doctors’ visits. She stated that she visited her primary care physician, Dr. Colleen Dooley, on October 8, 2010, without her mother. Tr. at 142. She explained that she didn’t discuss the symptoms she was experiencing and that she was given asthma medication, but didn’t take it. Tr. at 142-43. She went back to Dr. Dooley with her mother on October 23, 2010, and was given more medication, which she finally did take. Tr. at 143. She went to the on-campus infirmary on November 10, 2010. Tr. at 146. In between these appointments, Petitioner testified that her symptoms were worsening, that “it was so hard to function,” and that she “was so scared.” Id. Even then, however, she did not discuss these symptoms with the medical personnel at either Dr. Dooley’s office or at the on-campus health center. Tr. at 146-52. When given a checklist at the on-campus health center, however, Petitioner checked the boxes for muscle aches and headaches, which she explained she was experiencing at the time. Tr. at 151-52. Petitioner testified that her reasoning for not discussing her other symptoms was that she believed her symptoms were asthma related, and that she “just thought [she] was going to get better.” Tr. at 169-70, 172. She was also worried that the doctor would prescribe steroids for her, which would cause her to gain weight. Tr. at 178. The mental symptoms Petitioner was experiencing were discussed at the hearing as well. Petitioner stated that she experienced trouble focusing at work and that it took her longer to 8 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 9 of 15 finish tasks than it did before vaccination, but she didn’t think “it was bad enough that [her] job would be in trouble.” Tr. at 154, 186. She was still able to carry her belongings, drive a car, and get in and out of bed, although it became increasingly more difficult. Tr. at 157, 160. Petitioner testified that many individuals, including her mother, co-workers, and friends, were concerned about her health; she also testified that she was concerned about her own health. Tr. at 180. Despite their concerns and her own, Petitioner did not discuss her symptoms with medical professionals because “[she] was just naive. [She] was stupid. . . [she] was just a stupid teenager.” Tr. at 180. During the onset hearing, Petitioner stated, multiple times, that she did not report her specific symptoms because she attributed them to her asthma. See, e.g., Tr. at 188. ii. Heather Rich Heather Rich, Petitioner’s mother, was the first to testify at the onset hearing; she also testified at the previous fact hearing.14 Ms. Rich testified that her daughter was healthy in the fall of 2010, aside from the asthma she controlled using medication; however, Ms. Rich testified that Petitioner was not always compliant with taking her prescribed medication. Tr. at 12; 14. Ms. Rich explained that Petitioner had asthma problems “probably every couple of months” and used a breathing machine to treat these flare-ups. Tr. at 32. Ms. Rich stated that the symptoms Petitioner usually experiences when in distress due to asthma include trouble breathing, coughing, and wheezing. Tr. at 32-33. Typically, she described, “when [Petitioner] was at her worst she would do two breathing treatments, and she would be fine. It opened her right up.” Tr. at 62. Ms. Rich stated that she had a good relationship with her daughter, and that although Petitioner lived on-campus at the University of Oklahoma, they spoke daily on the phone. Tr. at 17. Petitioner called her mother a “helicopter mom” and testified that Ms. Rich was heavily involved in her daughter’s life. Tr. at 62. Ms. Rich explained that she saw Petitioner weekly because Petitioner came home on the weekends to work at Panera Bread, a local restaurant. Tr. at 17. The Rich home had “a couple of levels” and Ms. Rich did not notice Petitioner having trouble with the steps when she was home, although she clarified that they were not often in the house at the same time. Tr. at 38-39. The symptoms of Petitioner’s ADEM began, according to Ms. Rich, around the “first part of October.” Tr. at 18. Ms. Rich explained that after vaccination, Petitioner called her mother with complaints of headaches and lack of energy. Id. They spoke about seeing a doctor, but Petitioner “made the comment that she would be fine, that she should probably take her [asthma] medication.” Id. Ms. Rich testified that Petitioner told her that she “was having trouble walking to class … her legs were tired … and … felt heavy,” which prompted a visit to her primary care physician, Dr. Dooley, on October 23, 2010. Tr. at 19-20. During this visit, Ms. Rich attended the appointment and gave a history to the physician’s office as “[she] tended to talk for Sydney a lot.” Tr. at 20. The symptoms, such as trouble walking and headaches, were not discussed at this appointment, because Ms. Rich stated that she “thought it was just asthma.” Tr. at 21-22, 14 A fact hearing was held on June 24, 2013, to determine whether Petitioner received a flu vaccination. The transcript for the June 24, 2013 will be cited as “Tr. June.” The transcript from the current hearing will be cited as “Tr.”. 9 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 10 of 15 41. Ms. Rich did not notice any changes in Petitioner’s balance, but she did notice that Petitioner “wasn’t like herself.” Tr. at 41. Ms. Rich informed the Court that when Petitioner’s symptoms continued, Ms. Rich urged her to see at doctor. Tr. at 24. Petitioner agreed to go to an on-campus health center at the end of November. Tr. at 24. The symptoms Ms. Rich recalled that Petitioner had complained of trouble with her legs, headaches, trouble sleeping, and weakness. Tr. at 24-25. When they spoke on the phone, Ms. Rich said that Petitioner “was kind of slurring her words a little bit.” Tr. at 25. Ms. Rich explained that the first symptoms she noticed that weren’t typical for an asthma exacerbation, including slurred speech and the inability to walk to class. Tr. at 40. Following finals, which Petitioner struggled to complete, she returned home for Christmas break. Tr. at 26-27. During the break, Ms. Rich noticed that Petitioner seemed “different.” Tr. at 27-28. Ms. Rich received a phone call from Petitioner on December 27, 2010, stating that something was wrong and that she needed to be transported to the emergency room. Tr. at 28-29. Again, Ms. Rich gave medical personnel a history and again she noted that she “tend[s] to speak up for Sydney.” Tr. at 30. iii. Aurora Tapia-Contreras Aurora Tapia-Contreras, Petitioner’s supervisor at Panera Bread, testified second at the onset hearing. She stated that she met Petitioner in January of 2009 at their mutual place of employment and “became friends right off the bat.” Tr. at 73-74. Ms. Tapia-Contreras noted that Petitioner began to take shorter, weekend-only shifts after school started, but she did not notice any physical or mental shortcomings related to her job performance. Tr. at 75-76. In October 2010, Ms. Tapia-Contreras noted that Petitioner complained that she was not feeling well, and particularly that she complained of headaches, dizziness, and fatigue. Tr. at 77. She first noticed Petitioner’s breathing troubles in mid-November. Tr. at 89. Furthermore, Ms. Tapia-Contreras noted that Petitioner’s “mental process was kind of slow” and she had trouble understanding job-related tasks. Tr. at 79. When discussing her physical performance, Ms. Tapia-Contreras explained that the job was physical and required Petitioner to stand; however, she did not notice any physical deficits. Tr. at 84-85. As Petitioner continued to experience worsening symptoms, Ms. Tapia-Contreras felt that she needed to cover for Sydney’s inadequate performance; Ms. Tapia-Contreras explained that she told Petitioner to seek medical treatment “all the time.” Tr. 80-83. iv. Caramia Enrich15 Caramia Enrich, Petitioner’s high school friend and freshman year roommate, testified. Mrs. Enrich stated that, prior to vaccination, Petitioner did not appear to have any trouble walking, any dizziness, or any headaches. Tr. at 98-99. She remembers Petitioner getting the vaccination 15 Caramia filed an affidavit on December 5, 2012 using her maiden name, Caramia Testa. At the hearing, on October 30, 2014, Caramia was married and testified under her married name, Caramia Enrich. 10 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 11 of 15 and recounted that she noted Petitioner’s health changing in October 2010. Tr. at 100. The first symptom she noticed was fatigue, at the beginning of October. Tr. at 108, 115. In particular, she remembered that Petitioner was excited about a trick-or-treat event on Halloween, but that at the end of the event, Petitioner “was completely drained,” which was uncharacteristic of Petitioner’s behavior. Tr. at 100-01. She explained that, contrary to testimony in her own affidavit, Petitioner had complained of dizziness and leg pain immediately preceding Halloween. Tr. at 101, 122. The leg pain, as clarified by Mrs. Enrich, was “not like a shooting pain. What she had said was, like, heavy.” Tr. at 122. Mrs. Enrich stated that Petitioner’s symptoms worsened in November of 2010 and that “[t]owards November, she was really tired all the time, really fatigued and complaining more about heavy arms and legs and so forth. And I saw more of the dizziness and headaches.” Tr. at 103. Although Petitioner complained of dizziness, Mrs. Enrich does not remember Petitioner losing her balance or stumbling. Tr. at 103. Mrs. Enrich recounted that Petitioner spoke to her mother frequently and that “[s]he would talk about how she felt tired . . . [b]ut she was usually pretty quiet about symptoms and so forth.” Tr. at 121. Ms. Enrich mentioned that sound and light seemed to bother Petitioner. Tr at 105. Petitioner would take the stairs to their sixth floor dormitory room; Ms. Enrich stated that Petitioner was still using the stairs to reach the sixth floor at the end of October. Tr. at 115-16. Mrs. Enrich explained that Petitioner’s speech wasn’t slurred, but she seemed incoherent at times and would “easily los[e] her train of thought.” Tr. at 117-18. Petitioner’s trip to the on-campus health facility was discussed, and Ms. Enrich recalled that Petitioner wanted to discuss the symptoms she had been experiencing including “how she felt tired at the time, and [that] she really thought her asthma was kicking up.” Tr. at 118-19. Petitioner purportedly told Mrs. Enrich that the doctors thought she might have bronchitis or the flu. Tr. at 104. The last time Mrs. Enrich saw Petitioner before her hospitalization was the day before Christmas break. Tr. at 110. II. The Applicable Legal Standards A petitioner must prove, by a preponderance of the evidence, the factual circumstances surrounding her claim. 42 U.S.C. §300aa-13(a)(1)(A). To meet the preponderance of the evidence standard, the special master must “believe the existence of a fact is more probable than its nonexistence before [she] may find in favor of the party who has the burden to persuade the [special master] of the fact’s existence.” In re Winship, 397 U.S. 358, 371-72 (1970) (Harlan, J., concurring, quoting F. James, Civil Procedure, at 250-51 (1965)). In determining whether a petitioner is entitled to compensation under the Vaccine Act, a special master must consider the record as a whole. 42 U.S.C. §300aa-13(a)(1). The special master may not make a finding based on the claims of a petitioner that are not substantiated by medical records or medical opinion. Id. The process of finding facts pursuant to the Vaccine Act begins with analyzing the medical records. 42 U.S.C. §300aa-11(c)(2). As set forth in 42 U.S.C. §300aa-13(b)(1)(A), a special master shall consider “all . . . relevant medical or scientific evidence contained in the record,” including “any diagnosis, conclusion, medical judgment . . . 11 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 12 of 15 regarding the nature, causation, and aggravation of petitioner’s illness, disability, injury, condition, or death.” To resolve factual issues, the special master must weigh the evidence presented, which may include contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special master must decide what weight to give evidence including oral testimony and contemporaneous medical records). “Medical records, in general, warrant consideration as trustworthy evidence.” Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Records created contemporaneously with the events they describe are presumed to be accurate, as individuals seeking treatment will likely report the circumstances relating to their symptoms and history accurately to ensure their doctors have all the information necessary to treat their malady. Cucuras, 993 F.2d at 1527-28. Similarly, doctors recording their patients’ histories are paying particular attention to record such histories accurately so that they will be aware of all of the patient’s aliments in order to effectively treat them. Id. Therefore, particular attention should be paid to contemporaneous medical records and opinions of treating physicians. Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006); Cortez v. Sec’y of Health & Human Servs., No. 09-176V, 2012 WL 4829301, at *6 (Fed. Cl. Spec. Mstr. Aug. 31, 2012). When considering the weight to be given to oral testimony versus contemporaneous records, “[i]t has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight.” Murphy v. Sec’y of Health & Human Servs., 23 Cl.Ct. 726, 733 (1991), aff’d, 968 F.2d 1226 (Fed. Cir.), cert. denied sub nom. Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“Where such testimony is in conflict with contemporaneous documents we can give it little weight, particularly when the crucial issues involve mixed questions of law and fact.”) Records that are clear, consistent, and complete should be accorded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). To overcome the presumptive accuracy of the written medical records through testimony, the testimony must be “consistent, clear, cogent, and compelling.” Sanchez v. Sec’y of Health & Human Servs., No. 11-685, 2013 WL 1880825, at *3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998). III. Discussion “Petitioner alleges that shortly after having received the influenza vaccine on September 26, 2010, she began to experience the onset of neurological symptomology that was subsequently diagnosed as ADEM.” Petitioner’s Pre-Hearing Submission, ECF No. 61, at 1. That “neurological symptomology” allegedly included “unprecedented symptoms [of] extreme fatigue, headaches, lack of concentration, dizziness, and feeling nauseous.” Id. at 2; see also Pet. Ex. 1; Pet. Ex. 24. 12 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 13 of 15 At hearing, Petitioner testified that she was experiencing this multitude of symptoms before her visits with Dr. Dooley and with the on-campus health center, but that she did not report these symptoms to the medical professionals. Tr. at 142-43, 147-48, 150-51. Petitioner gave several reasons for not telling her physician about these symptoms--that she thought the symptoms were related to her asthma, tr. at 169; that the doctors would put her on steroids, which had caused her to gain weight in the past, Tr. at 178; and that her mother “would make [her] move back home.” Tr. at 165, 171; Pet. Ex. 1 at 2. She also stated that she thought she “was going to get better.” Tr. at 146-47. However, the medical histories provided during Petitioner’s medical visits, both to Dr. Dooley and to the on-campus health center, consistently reflect that her symptoms in the fall of 2010 were related to her asthma and her developing bronchitis/ pneumonia, and not to ADEM. On October 8, 2010, about two weeks after receiving the vaccine, Petitioner made her first visit to a medical professional post-vaccination. She was unaccompanied by her mother, who otherwise tended to speak for her. Pet. Ex. 4 at 8. Petitioner’s chief complaint was that she was “having trouble breathing at night and hasn’t been able to get Advair [asthma medication].” Pet. Ex. 4 at 8. Petitioner did not complain of fatigue, “heaviness,” dizziness, sensitivity to light, difficulty remembering things, or completing tasks. Petitioner was given samples of several asthma medications, id., which she did not take. Tr. at 142-143. Petitioner saw Dr. Dooley again on October 23, 2010; again her chief complaint was “asthma--worse when [she] comes home.” Pet. Ex. 4 at 7. Again, nothing about heaviness, lack of concentration, dizziness, headaches, or nausea. The impression of the treating professional was asthma, and Petitioner was again treated with asthma medication. Id. This time, she was also given the steroid Prednisone. Id. On November 10, 2010, Petitioner saw a medical professional, Stephanie A. Parker, D.O., at the University of Oklahoma Health Services Center. Pet. Ex. 15 at 1. Upon checking in, Petitioner filled out intake forms, including a checklist of symptoms on which she was to mark the symptoms she was experiencing. Id. at 2. Petitioner stated that her worst symptoms were coughing and trouble breathing, but she also indicated that she was experiencing fever, night sweats, sore throat, headache, ear ache/pain, cough, wheezing, and muscle aches. Id. She stated that her symptoms started five days prior and that they were “somewhat improving.” Id. Petitioner stated in her affidavit that in early November 2010, she felt dizzy, lightheaded, weak, and nauseous, which prompted her to call her mother and make an appointment with the on-campus health center. Pet. Ex. 1 at 2. At the hearing, Petitioner testified that she was confused, dizzy, having trouble walking coupled with heavy legs, and had blurry vision prior to her November 10 appointment. Tr. at 147-51. The records from the health center reflect none of those concerns. Petitioner had three separate opportunities to tell someone at the clinic about these symptoms: when she filled out the intake sheet, when she spoke with the doctor, and when she spoke with the nurse after the first nebulizer treatment, but she did not avail herself of those opportunities. The focus of that visit, as had been the focus of her earlier medical visits, was exclusively her difficulty breathing and related issues. 13 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 14 of 15 Petitioner did not see another medical professional until she went to the emergency room at Integris Baptist Hospital on December 27, 2010. Petitioner presented to the emergency room with shortness of breath, chest tightness, wheezing, and dyspnea which started one day prior. Pet. Ex. 5 at 9. Even then, Petitioner “denie[d] weakness, fatigue,” “denie[d] nausea,””denie[d] muscle pain or weakness,” Id at 48-49, and her responsiveness did not begin to decline until several days after her admission for pneumonia, pneumothorax, and hypoxemia. Id. at 41. Petitioner was familiar with doctors, as she had had asthma, a chronic illness, since childhood and would go to the doctor occasionally for a flare-up of asthma or to refill an asthma related medication prescription. Tr. at 126-27. Therefore, she was familiar with the practice of visiting a physician and reporting symptoms, particularly when prompted. She continued this practice when she went to college: she went to the doctor three times that first semester, and she reported the symptoms from which she was suffering so that they could be treated. The undersigned is not persuaded that Petitioner would not be forthcoming with her doctors, particularly if the symptoms were as unprecedented, persistent and severe as has been described. The undersigned finds that Petitioner reported the symptoms she was experiencing, related to the severe pulmonary illness for which she was eventually hospitalized. Petitioner’s medical records clearly document her worsening medical condition throughout the fall of 2010, but the worsening condition that they document is pulmonary. Petitioner has not put forward evidence sufficient to refute the contemporaneous medical records, which firmly support the onset of the symptoms of ADEM concurrently with or shortly after Petitioner’s hospitalization for pneumonia, pneumothorax and hypoxemia, on or after December 27, 2010. The undersigned has carefully reviewed the record. Consistent with the foregoing discussion, the undersigned finds that the symptoms of ADEM began concurrently with or shortly after Petitioner’s hospitalization for pneumonia, pneumothorax and hypoxemia, on or after December 27, 2010. 14 Case 1:12-vv-00742-EDK Document 81 Filed 10/07/15 Page 15 of 15 IV. Conclusion The undersigned has carefully reviewed the record. Consistent with the foregoing discussion, the undersigned finds that the symptoms of ADEM began concurrently with or shortly after Petitioner’s hospitalization for pneumonia, pneumothorax and hypoxemia, on or after December 27, 2010. Petitioner may now proceed with her claim. The parties are ordered to provide this ruling to any expert whom they retain for the purpose of litigating that claim. The undersigned is unlikely to find persuasive expert opinion that is inconsistent with these findings of fact. See Burns, 3 F.3d at 417 (special master did not abuse his discretion in refraining from conducting a hearing when the petitioner’s expert “based his opinion on facts not substantiated by the record”). The parties shall also contact my chambers no later than September 25, 2015 to schedule a telephonic status conference in this case to discuss next steps. IT IS SO ORDERED. s/Lisa D. Hamilton-Fieldman Lisa D. Hamilton-Fieldman Special Master 15 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_12-vv-00742-2 Date issued/filed: 2016-07-21 Pages: 11 Docket text: PUBLIC DECISION (Originally filed: 6/30/2016) regarding 91 DECISION of Special Master Signed by Special Master Lisa Hamilton-Fieldman. (pn) Copy to parties. -------------------------------------------------------------------------------- Case 1:12-vv-00742-EDK Document 92 Filed 07/21/16 Page 1 of 11 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 12-742V Filed: June 30, 2016 * * * * * * * * * * * * * * * SYDNEY RICH, * UNPUBLISHED * Petitioner, * Special Master Hamilton-Fieldman * v. * Vaccine Act Entitlement; * Causation-in-Fact; Influenza (“Flu”) SECRETARY OF HEALTH * Vaccine; Acute Disseminated AND HUMAN SERVICES, * Encephalomyelitis (“ADEM”). * Respondent. * * * * * * * * * * * * * * * * Andrew Downing, Van Cott & Talamante, PLLC, Phoenix, AZ, for Petitioner. Sarah Duncan, United States Department of Justice, Washington, DC, for Respondent. DECISION1 On November 1, 2012, Sydney Rich (“Petitioner”) filed a petition pursuant to the National Vaccine Injury Compensation Program (“Program”).2 Petitioner alleged that she developed Acute Disseminated Encephalomyelitis (“ADEM”)3 because she received the 1 Because this decision contains a reasoned explanation for the undersigned’s action in this case, the undersigned intends to post this decision on the website of the United States Court of Federal Claims, in accordance with the purposes espoused in the E-Government Act of 2002. See 44 U.S.C. § 3501 (2012). Each party has 14 days to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). 2 The National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (2012) (“Vaccine Act”), governs the Program. 3 ADEM is a form of inflammation involving the brain and spinal cord. Encephalomyelitis, 1 Case 1:12-vv-00742-EDK Document 92 Filed 07/21/16 Page 2 of 11 Influenza (“Flu”) Vaccine on September 26, 2010. Pet. at 1, ECF No. 1. Petitioner now moves for judgment on the record, claiming that she has “satisfied her prima facie case for entitlement” and therefore deserves compensation. Mot. for J. on the Administrative R. at 8, ECF No. 88 (hereinafter “Mot.”). After reviewing the record, the undersigned disagrees and therefore dismisses the petition. I. FACTUAL BACKGROUND On May 13, 1992, Petitioner was born. Pet’r’s Ex. 1 at 1, ECF No. 5-1. As early as 2004, a physician diagnosed Petitioner with asthma. Pet’r’s Ex. 4, Part 1 at 51, ECF No. 5-4. Although she was prescribed a variety of medications, she did not always take what she was prescribed. See id. at 15-16. Petitioner underwent pulmonary testing in 2004, 2006, and 2010, all of which revealed a pulmonary obstruction and low vital capacity. Id. at 30, 47-48, 60. Otherwise, Petitioner was healthy and frequently evaluated by her pediatrician, Dr. Colleen Dooley. See generally id. In 2005, 2006, 2007, 2008, and 2009, Petitioner received the Flu vaccine without any reported adverse reactions. Id. at 37-38, 42. On September 26, 2010, Petitioner received the Flu vaccine that underscores the instant claim. Order and Ruling on Facts at 10, ECF No. 35. Roughly two weeks after the vaccination, on October 8, Petitioner visited Dr. Dooley, complaining that it was difficult to breath at night and she had been unable to acquire her asthma medication. Pet’r’s Ex. 4 at 8. She reported using her inhaler “‘a lot.’” Id. Typically, Heather Rich, Petitioner’s mother, accompanied Petitioner on her medical visits; however, Petitioner’s mother did not attend this visit. Id. In the end, Dr. Dooley felt that Petitioner experienced an exacerbation of her asthma, and prescribed her medication and samples. Id. In an affidavit, Petitioner reported that she started to experience fatigue, lethargy, and headaches around this time. Pet’r’s Ex. 1 at 2, ECF No. 5-1. She admitted that she did not tell her mother about these symptoms, explaining that she feared that if she did so, her mother would force her to leave on-campus housing at the University of Oklahoma (where she attended acute disseminated, Dorland’s Illustrated Medical Dictionary (32nd ed. 2012) (hereinafter “Dorland’s”). Usually, an acute viral infection causes ADEM. Id. The medical community believes that ADEM is “a manifestation of an autoimmune attack on the myelin of the central nervous system.” Id. Symptoms of ADEM “appear rapidly, beginning with encephalitis-like symptoms such as fever, fatigue, headache, nausea, and vomiting,” id.; and many patients also experience neurological symptoms, including confusion, blurred vision, weakness, and drowsiness. Acute Disseminated Encephalomyelitis (ADEM), Cleveland Clinic, (Aug. 22, 2014), http://my.clevelandclinic.org/services/neurological_institute/mellen-center-multiple- sclerosis/diseases-conditions/hic-acute-disseminated-encephalomyelitis. 2 Case 1:12-vv-00742-EDK Document 92 Filed 07/21/16 Page 3 of 11 college), return home, and go to the doctor. Id. In addition, she worried that the doctor would prescribe her steroids, which she hoped to avoid due to previous experiences with weight gain. Id. Petitioner’s college roommate, Caramia Enrich,4 filed an affidavit in support of Petitioner’s recollection. See generally Pet’r’s Ex. 3, ECF No. 5-3. Enrich recalled that when Petitioner arrived at college, she was “very vibrant” and “quite healthy”; however, “[a] few weeks after the flu shot,” Enrich continued, Petitioner “started showing symptoms of something being wrong,” including fatigue, headaches, feelings of heaviness, pain and weakness in her legs, and lethargy. Id. at 1-2. Of particular note, Enrich remembered that Petitioner’s “symptoms were present before Halloween, 2010, because [Petitioner] had been very excited for the children to come and trick-or-treat in the dorms but was exhausted from the event.” Id. Enrich recounted that Petitioner’s symptoms worsened until Petitioner was hospitalized over winter recess. Id. at 2. At the end of her affidavit, she concluded, “[t]here is no question that [Petitioner’s] symptoms started in October of 2010, within just a few weeks after she received the flu shot.” Id. Aurora Tapia-Contreras,5 Petitioner’s former coworker at Panera Bread, also filed an affidavit in support of this narrative. See generally Pet’r’s Ex. 24, ECF No. 60-1. Tapia- Contreras recalled, (a) “[b]efore [Petitioner] received her flu shot, [Petitioner] was super healthy,” (b) “when [Petitioner] got her flu shot,” and (c) Petitioner’s “symptoms starting shortly thereafter.” Id. at 1. Beginning in late October to early November, 2010, Tapia-Contreras observed Petitioner “complaining of headaches” and “experiencing dizziness,” remembering that she was “very fatigued” and “not herself.” Id. In particular, Tapia-Contreras explained that she “was responsible for training [Petitioner] on various tasks” and Petitioner became slow and struggled to perform at work throughout November 2010. Id. On multiple occasions, Tapia- Contreras stated, she suggested that Petitioner visit a doctor; however, she indicated that Petitioner stubbornly refused because Petitioner believed that her condition would improve, even though her symptoms worsened. Id. In closing, Tapia-Contreras concluded that “[t]here is no question that [Petitioner’s] symptoms of headaches, dizziness and brain fog started in October of 2010 and progressively worsened throughout November and December, 2010.” Id. at 2. Petitioner’s mother, like Petitioner, Enrich, and Tapia-Contreras, also filed an affidavit in support of Petitioner’s recollection. See generally Pet’r’s Ex. 16, ECF No. 23. Petitioner’s mother reported that Petitioner began “complaining of fatigue, headaches, and trouble sleeping” a couple of weeks after the vaccination. Id. at 1. She also remembered that Petitioner had 4 Although Enrich filed her affidavit as “Caramia Testa,” she clarified before the Court that she was subsequently married and changed her last name. Tr. at 94-95, ECF No. 66. 5 While Tapia-Contreras’s affidavit lists her name as “Aurora Tapia,” the undersigned assumes that the name she provided in the hearing before the Court is the correct one. Tr. at 73. 3 Case 1:12-vv-00742-EDK Document 92 Filed 07/21/16 Page 4 of 11 trouble speaking in complete sentences, was absent from numerous classes, and had recurring headaches. Id. at 1-2. The next documented medical visit (after October 8, 2010) occurred on October 23, 2010, when Petitioner revisited Dr. Dooley, albeit now accompanied by her mother. Pet’r’s Ex. 4 at 7. Petitioner repeated her complaints about asthma and an inability to afford her medication. Id. As before, Dr. Dooley observed that Petitioner suffered from asthma and prescribed her prednisone and Singulair. Id. Notably, the medical records document no complaints of fatigue, heavy legs, difficulty concentrating, or dizziness. See generally id. A little more than two weeks later, on November 10, Petitioner went to the on-campus health center at the University of Oklahoma, complaining of coughing and difficulty breathing. Pet’r’s Ex. 15 at 2, ECF No. 20-1. Petitioner reported night sweats, a fever, a sore throat, a headache, an earache, a cough that interfered with her sleep, and muscle aches; that being said, she noted that her symptoms were “somewhat improving.” Id. Examination revealed wheezing, a red pharynx, mucus, and sinus issues, and a physician diagnosed Petitioner with bronchitis and asthma. Id. Petitioner responded positively when the physician administered a nebulizer treatment. Id. The treating physician sent her home with additional nebulizer treatments and antibiotics. Id. Like those from the October 28 visit, medical records from the November 10 visit show no symptoms of fatigue, feelings of heaviness, dizziness, difficulty concentrating, or light sensitivity. See generally id. But in her affidavit, Petitioner claimed that she visited the on- campus health center because she felt “nauseous,” “light headed,” “extremely weak,” and “like she was going to pass out.” Pet’r’s Ex. 1 at 2. She also asserted that she informed her mother about her condition, who urged her to come home. Id. After roughly one-and-a-half months, on December 27, Petitioner traveled to the emergency room at Integris Baptist Medical Center because she experienced “wheezing, dyspnea,[6] . . . shortness of breath, [and] chest tightness starting yesterday.” Pet’r’s Ex. 5, Part 1 at 9, ECF No. 6-1. Yet, she explicitly denied suffering from fatigue or night sweats, and a treating physician noted that she was “alert and oriented to person, place, time, and situation,” and her neurological exam was normal; although she did report a recent upper respiratory infection. Id. at 10, 48-49. A computerized tomography scan showed “extensive right upper lobe pneumonia as well as trace anterior right upper lobe pneumothorax.” Id. at 46-47. A different lab test ruled out Influenza (types A and B). Pet’r’s Ex. 5, Part 9 at 390, ECF No. 6-9. Ultimately, she was admitted to the Intensive Care Unit; diagnosed with community acquired pneumonia in her right upper lobe, a small right pneumothorax, asthma exacerbation, a nodule 6 Dyspnea is “breathlessness or shortness of breath,” or “difficult or labored respiration.” Dyspnea, Dorland’s. 4 Case 1:12-vv-00742-EDK Document 92 Filed 07/21/16 Page 5 of 11 on her left lower pulmonary lobe, allergic rhitinis, and hypoxemia7; and given antibiotics, corticosteroids, and bronchodilators. Pet’r’s Ex. 5, Part 1 at 49-50. The next day, physicians implanted a “Stan French Right Chest Tube” for her pneumothorax. Pet’r’s Ex. 5, Part 8 at 374, ECF No. 6-8. After Petitioner continued to experience difficulty breathing, she was intubated. Pet’r’s Ex. 5, Part 1 at 41. A subsequent bronchoscopy revealed “severe bronchitis,” and physicians initiated tube feeding. Id. Over the next week, her condition worsened. Id. MRIs of the brain and cervical spine yielded “extremely abnormal” results, consistent with ADEM, id., as well as “[a]cute infarction of the splenium or the corpus callosum with areas of diffusion restriction, T2 alteration, and abnormal contrast enhancement within the pons, inferior right cerebellar hemisphere, medulla, and cervical spine cord, [which] may relate to hypoxic injury,” Pet’r’s Ex. 5, Part 8 at 368. On January 7, 2011, Dr. Aline Brown, an infectious disease specialist, diagnosed Petitioner with ADEM. Pet’r’s Ex. 5, Part 4 at 173, ECF No. 6-4. Dr. Brown ordered a sputum test, Pet’r’s Ex. 5, Part 1 at 42, which ultimately revealed H1N1 Influenza,8 Pet’r’s Ex. 17 at 3, ECF No. 30-1. As a result, she started Petitioner on a ten-day course of Tamiflu. Pet’r’s Ex. 5, Part 1 at 42. Six days later, on January 13, Petitioner began a four-day course of Intravenous Immunoglobulin treatment. Id. When physicians were unable to wean her from her ventilator thereafter, they performed a tracheostomy and a variety of other related treatments over the next few weeks. Id. Eventually, by February 9, Petitioner’s pneumothorax resolved, and the physicians discontinued her chest tube and ventilator. Id. After about a week of additional improvement, Petitioner was transferred to Jim Thorpe Rehabilitation. Id. Evaluating Petitioner’s condition in hindsight, two of her treating physicians attributed her hospitalization to H1N1 Influenza. Dr. William B. Schueler, Assistant Professor in the Department of Neurosurgery at the University of Oklahoma Health Sciences Center, noted that Petitioner “unfortunately had some paralysis secondary to the swine flu in January of 2011.” Pet’r’s Ex. 6 at 24, ECF No. 7-1. Dr. Jenny Le indicated that Petitioner “had an asthma exacerbation in 2010 that turned into bronchitis and then pneumonia,” which “in turn was complicated by a ‘collapsed lung’ which required a chest tube and intubation and ventilator 7 Hypoxemia is a deficiency in the “oxygenation of the blood.” Hypoxemia, Dorland’s. 8 H1N1 Influenza, also known as Swine Flu (because it was initially transmitted by direct contact with pigs), is a type of seasonal flu virus and the source of a 2009 pandemic. H1N1 Flu Virus (Swine Flu), WebMD, http://www.webmd.com/cold-and-flu/flu-guide/h1n1-flu-virus-swine-flu (last visited June 26, 2016). 5 Case 1:12-vv-00742-EDK Document 92 Filed 07/21/16 Page 6 of 11 assistance”; as she recovered, “she contracted the ‘swine flu’ . . . which turned into encephalitis.” Id. at 27. Petitioner stayed at Jim Thorpe until she was discharged on March 25, 2011. Pet’r’s Ex. 5, Part 1 at 28. Upon her discharge, physicians diagnosed her with acute demyelinating encephalomalacia with paralysis and quadriparesis, respiratory failure with community-acquired pneumonia, asthma, critical care myopathy,9 neuropathic pain, a seizure disorder, obesity, atopic dermatitis, a lazy eye, anemia, anxiety, and depression. Id. Following her discharge, Petitioner continued to receive home treatment from health aides. See generally Pet’r’s Ex. 6. To this day, Petitioner must use a wheelchair to move about and requires assistance to complete many of the activities of daily life. Pet. at 4, ECF No. 1. II. PROCEDURAL HISTORY After the petition was filed, the case was assigned to Special Master Denise Vowell. See Notice of Assignment, ECF No. 2. On March 4, 2013, the case was transferred to the undersigned. See Order Reassigning Case, ECF No. 18. After Petitioner filed medical records and affidavits, the undersigned scheduled a fact- hearing regarding whether Petitioner actually received the alleged vaccine. See Order (Apr. 25, 2013) at 1, ECF No. 22. On June 24, 2013, the undersigned conducted that hearing via video conference in Washington, DC. See Minute Entry (Apr. 17, 2013). On July 26, 2013, the undersigned concluded that Petitioner “established by preponderant evidence that she received the influenza vaccination at Memorial Christian Church in Oklahoma City, Oklahoma on September 26, 2010.” Order and Ruling on Facts at 10. The undersigned made “no determination of any kind as to whether Petitioner’s alleged damages [were] the result of an adverse reaction to her influenza vaccination.” Id. On September 10, 2013, Respondent filed a Rule 4(c) Report. Rule 4(c) Report, ECF No. 37. Respondent claimed that Petitioner failed to present a prima facie case for entitlement under Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir. 2005), as she provided neither a reputable medical theory of causation, evidence of a logical sequence of cause and effect, nor a temporally appropriate relationship between the vaccination and her ADEM. Id. at 9-10. As to the latter two points, Respondent identified a dearth of documented neurological symptoms in Petitioner’s medical records prior to her hospitalization for pneumonia and pneumothorax in December 2010. 9 Critical care myopathy is a condition featuring “severe muscle weakness, hypotonia, and depressed tendon reflexes of many different muscles,” which “in some may be a complication of therapy with corticosteroids or neuro-muscular blocking agents, but in others the cause is unknown.” Critical Illness Myopathy, Dorland’s. 6 Case 1:12-vv-00742-EDK Document 92 Filed 07/21/16 Page 7 of 11 Id. at 9-1. Furthermore, Respondent argued, it was more likely that Petitioner’s H1N1 infection, not her vaccination, caused her ADEM. Id. at 11. During a September 19, 2013 status conference, the undersigned discussed the case with the parties, who agreed to explore the possibility of settlement while preparing for further litigation. Scheduling Order (Sept. 19, 2013) at 1, ECF No. 38. On December 9, Petitioner filed an expert report from Dr. David Siegler. See Pet’r’s Ex. 18, ECF No. 39-1. On September 5, 2014, Respondent filed an expert report from Dr. Michael Kohrman. See Resp’t’s Ex. A, ECF No. 55-1. Of note, both experts agreed that determining the first symptom or manifestation of onset of Petitioner’s ADEM was crucial to adjudicating her claim. See Pet’r’s Ex. 18 at 1; Resp’t’s Ex. A at 10. Dr. Siegler noted that Petitioner’s “3 month interval from vaccine to ADEM admission [was] long” and that he had “not yet found an ADEM case report of a known latency that long.” Pet’r’s Ex. 18 at 1. Dr. Kohrmann, meanwhile, opined that “[n]one of the literature indicates that a three month period between the flu vaccine and the onset of ADEM is a biologically plausible time period to infer causation.” Resp’t’s Ex. A at 10. During a September 16, 2014 status conference, the parties agreed that a hearing was needed to determine the date of first symptom or manifestation of onset of Petitioner’s ADEM. See Scheduling Order (Sept. 18, 2014), ECF No. 56. Citing the affidavits from herself, her mother, Enrich, and Tapia-Contreras, Petitioner alleged that her first symptoms arose “within weeks of receiving the influenza vaccination on September 26, 2010.” Pet’r’s Prehearing Submissions at 6, ECF No. 61. Citing Petitioner’s medical records, Respondent countered that Petitioner’s symptoms did not arise until at least December 27, 2010, when she was hospitalized for pneumonia and pneumothorax, and when she first reported neurological complaints. Resp’t’s Rule 4(c) Report at 9-10. On October 30, 2014, the undersigned presided over an onset hearing in Oklahoma City, Oklahoma. See Minute Entry (Nov. 3, 2014). Petitioner, her mother, Enrich, and Tapia- Contreras, all testified at the hearing, largely reiterating the attestations in their affidavits. See generally Tr. Despite their testimony, the undersigned concluded that Petitioner’s first symptom or manifestation of onset of ADEM “began concurrently with or shortly after Petitioner’s hospitalization for pneumonia, pneumothorax, and hypoxemia, on or after December 27, 2010.” Rich v. Sec’y of HHS, No. 12-742V, 2015 U.S. Claims LEXIS 1288, at *36 (Fed. Cl. Spec. Mstr. Sep. 16, 2015). The undersigned found that Petitioner’s medical records did not support the affiants’ testimony that Petitioner began to experience symptoms of ADEM in late October to early November. Id. at *34. The undersigned observed that Petitioner visited physicians on 7 Case 1:12-vv-00742-EDK Document 92 Filed 07/21/16 Page 8 of 11 three occasions, beginning in mid-October, before she eventually entered the emergency room on December 27, 2010; but none of the medical records from these visits note the symptoms of ADEM that the affiants would later describe. Id. at *32-33. Moreover, the undersigned noted, at the November 10 visit to the on-campus health clinic, “Petitioner had three separate opportunities to tell someone at the clinic about these symptoms: when she filled out the intake sheet, when she spoke with the doctor, and when she spoke with the nurse after the first nebulizer treatment, but she did not avail herself of those opportunities.” Id. at *34. Instead, the undersigned explained, that visit, like those before it, exclusively focused on “her difficulty breathing and related issues.” Id. at *34. The undersigned rejected Petitioner’s suggestion that, even though she experienced symptoms of ADEM, she omitted mention of them during these three visits: Petitioner was familiar with doctors, as she had had asthma, a chronic illness, since childhood and would go to the doctor occasionally for a flare-up of asthma or to refill an asthma related medication prescription. Therefore, she was familiar with the practice of visiting a physician and reporting symptoms, particularly when prompted. She continued this practice when she went to college: she went to the doctor three times that first semester, and she reported the symptoms from which she was suffering so that they could be treated. The undersigned is not persuaded that Petitioner would not be forthcoming with her doctors, particularly if the symptoms were as unprecedented, persistent and severe as has been described. The undersigned finds that Petitioner reported the symptoms she was experiencing, related to the severe pulmonary illness for which she was eventually hospitalized. Id. at 34-35 (citation omitted). After the undersigned’s finding of fact, the undersigned offered Petitioner an opportunity to submit a supplemental expert report. Scheduling Order (Nov. 6, 2015), ECF No. 84. In response, Petitioner submitted a letter from Dr. Siegler. Letter from pediatric neurologist, Dr. David Siegler, ECF No. 85-1. While maintaining that Petitioner’s claim of “flu vaccine-induced ADEM is medically plausible,” Dr. Siegler explained, his theory “linking her flu vaccine with her ultimate diagnosis of ADEM is dependent on the oral history of multiple neurologic symptoms developing a few weeks post-vaccine and persisting through her admission to Baptist Hospital in December 2010.” Id. Because the undersigned’s aforementioned finding of fact forecloses this “oral history,” Dr. Siegler continued, it “prevents [him] offering an opinion on causation in [Petitioner’s] claim.” Id. 8 Case 1:12-vv-00742-EDK Document 92 Filed 07/21/16 Page 9 of 11 Petitioner now moves for judgment on the record. See generally Mot. While positing in her motion that she “satisfied her prima facie case for entitlement,” Petitioner offers no specific argument in favor of causation; rather, she spends virtually the entire brief challenging the undersigned’s finding of fact. Id. at 3-9. Respondent counters that Petitioner has established neither “a proximate temporal relationship between the vaccination and her injury” nor “a logical sequence of cause and effect showing that the vaccination was the reason for her injury.” Resp. to Mot. for J. on the Administrative R.at 16, 22, ECF No. 90 (hereinafter “Resp.”). As to the former, Respondent points out that both parties’ experts agreed that there is no evidence to suggest that it is biologically possible for a latency period of three months to separate vaccination and the onset of ADEM; and here, given the undersigned’s finding of fact, the parties are faced with just such a latency period. Id. at 21. Regarding the latter, Respondent emphasizes that Petitioner never addressed the possibility of H1N1 as an alternative cause of her ADEM, despite records from at least two treating physicians linking H1N1 and her ADEM. Id. at 22-23. Accordingly, Respondent argues, Petitioner is not entitled to compensation under the Program and her claim ought to be dismissed. III. LEGAL STANDARD To receive compensation under the Vaccine Act, a petitioner must demonstrate either that (1) she suffered a “Table injury,” that is, she received a vaccine and developed an injury in the manner specified by the Vaccine Injury Table, see 42 U.S.C. § 300aa-14 (2012); or (2) she suffered an injury that was in-fact caused by her receipt of a vaccine covered by the Act, see 42 U.S.C. § 300aa-11(c)(1)(C) (2012). When, as here, the petitioner does not allege a Table injury, she must prove the latter by a preponderance of the evidence. Althen v. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). The Federal Circuit has set forth a three-pronged inquiry to determine when the petitioner has established a causal link between a vaccine and an injury. Id. at 1278. Under Althen, the petitioner must provide: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” Id. Under the first prong, the petitioner’s theory must show that the vaccine received can cause the alleged injury. Pafford v. Sec’y of HHS, 451 F.3d 1352, 1356 (Fed. Cir. 2006) (internal quotation marks omitted). The medical theory set forth by the petitioner need only be “legally probable, not medically or scientifically certain.” Knudsen v. Sec’y of HHS, 35 F.3d 543, 548-49 (Fed. Cir. 1994). If the petitioner proffers a medical opinion to support the theory alleged, the 9 Case 1:12-vv-00742-EDK Document 92 Filed 07/21/16 Page 10 of 11 basis for the opinion and the reliability of that basis must be considered in determining how much weight to afford the offered opinion. Broekelschen v. Sec’y of HHS, 618 F.3d 1339, 1347 (Fed. Cir. 2010). To satisfy Althen’s second prong, the petitioner must prove that the vaccine received did cause the alleged injury. Capizzano v. Sec’y of HHS, 440 F.3d 1317, 1326 (Fed. Cir. 2006). The petitioner may satisfy her burden by presenting circumstantial evidence, and reliable medical opinions from experts, as well as treating physicians; she is not required to offer “epidemiologic studies, rechallenge, the presence of pathological markers or genetic disposition, or general acceptance in the scientific or medical communities to establish a logical sequence of cause and effect.” Id. at 1325-26. Ultimately, the “logical sequence of cause and effect must be informed by sound and reliable medical or scientific explanation.” Knudsen, 35 F.3d at 548 (internal quotation marks omitted). As to Althen’s third prong, it helps to establish the connection between the causal theory of the first prong and the more fact-based cause and effect arguments of the second. De Bazan v. Sec’y of HHS, 539 F.3d 1347, 1352 (Fed. Cir. 2008). In short, the petitioner must demonstrate “that the onset of symptoms occurred within a timeframe for which, given the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation-in-fact.” Id. If the petitioner satisfies all three prongs by a preponderance of the evidence, she establishes a prima facie case entitling her to compensation. Walther v. Sec’y of HHS, 485 F.3d 1146, 1149 (Fed. Cir. 2007). At that point, the burden shifts to Respondent to prove (by a preponderance of the evidence) that factors unrelated to the administration of the vaccine actually caused the alleged injury. Walther, 485 F.3d at 1151. Stated differently: if, after presenting a prima facie case, “the evidence is seen in equipoise, then the government has failed in its burden of persuasion and compensation must be awarded.” Knudsen, 35 F.3d at 550. IV. ANALYSIS After reviewing the record, the undersigned concludes that Petitioner has failed to present a prima facie case entitling her to compensation. Specifically, Petitioner has not made the necessary showings under Althen’s second or third prongs.10 In both his initial and supplemental expert reports, Dr. Siegler affirmed that he knew of no credible medical evidence to suggest that a three-month latency period between a vaccination and the onset of ADEM is consistent with causation, and Dr. Kohrmann concurred. Furthermore, as Respondent aptly notes, at least two of Petitioner’s treating physicians ascribed her ADEM to her H1N1, not the vaccination. In sum, 10 The undersigned makes no finding as to Althen’s first prong. 10 Case 1:12-vv-00742-EDK Document 92 Filed 07/21/16 Page 11 of 11 Petitioner has not demonstrated, by a preponderance of the evidence, that the vaccination caused her injury.11 V. CONCLUSION For these reasons, the undersigned concludes that Petitioner is not entitled to compensation under the Program. Therefore, the petition is DISMISSED. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court is directed to enter judgment herewith.12 /s/ Lisa D. Hamilton-Fieldman Lisa D. Hamilton-Fieldman Special Master 11 To the extent Petitioner’s brief is an invitation for the undersigned to reconsider her finding of fact, the undersigned declines the invitation. The undersigned remains convinced that Petitioner’s contemporaneous medical records, documenting three separate visits, present a more accurate picture of Petitioner’s medical history than the recollections of Petitioner, her mother, and her friends. 12 Pursuant to Vaccine Rule 11(a), the parties can expedite entry of judgment by filing a notice renouncing the right to seek review by a United States Court of Federal Claims judge. 11 ================================================================================ DOCUMENT 4: USCOURTS-cofc-1_12-vv-00742-3 Date issued/filed: 2016-12-16 Pages: 17 Docket text: PUBLIC DECISION (Originally filed: 12/01/2016) regarding 99 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Judge Elaine D. Kaplan. (bh) Copy to parties. -------------------------------------------------------------------------------- Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 1 of 17 In the United States Court of Federal Claims No. 12-742V (Filed: December 1, 2016 | Reissued for Publication: December 16, 2016)* ) SYDNEY RICH, ) ) Petitioner, ) Keywords: Vaccine Act; ) Contemporaneous Medical Records; v. ) Althen Test; Arbitrary and Capricious. ) SECRETARY OF HEALTH AND HUMAN ) SERVICES, ) ) Respondent. ) ) Andrew D. Downing, Van Cott & Talamante, PLLC, Phoenix, AZ, for Petitioner. Sarah C. Duncan, Trial Attorney, Torts Branch, Civil Division, U.S. Department of Justice, with whom were Gabrielle M. Fielding, Assistant Director, Catharine E. Reeves, Acting Deputy Director, C. Salvatore D’Alessio, Acting Director, and Benjamin C. Mizer, Principal Deputy Assistant Attorney General, for Respondent. OPINION AND ORDER KAPLAN, Judge. This case is before the Court on Petitioner Sydney Rich’s motion to review the special master’s decision denying compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (Vaccine Act). Ms. Rich alleged that an influenza vaccination caused her to develop acute disseminated encephalomyopathy (ADEM).1 On June 30, 2016, a * Pursuant to Vaccine Rule 18(b), this opinion was initially filed on December 1, 2016, and the parties were afforded 14 days to propose redactions. The parties did not propose any redactions. Accordingly, this opinion is reissued in its original form for publication, with the exception of one minor change in the caption for section VI.B. The original caption read “Liability Determination.” The revised caption reads “Entitlement Determination.” 1 Also known as acute disseminated encephalomyelitis, this is an inflammation of both the brain and spinal cord characterized by, among other things, the destruction, removal, or loss of the myelin sheath of nerves. See Dorland’s Illustrated Medical Dictionary (Dorland’s) 486, 613 (32d ed. 2012). It manifests in neurologic deficits. J. Nicholas Brenton, MD et al., Acute Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 2 of 17 special master denied compensation, concluding that Ms. Rich failed to demonstrate that the vaccination caused her injury. Ms. Rich then moved for review in this Court on July 29, 2016. For the reasons set forth below, the special master’s decision is supported by the evidence in the record and is not arbitrary, capricious, an abuse of discretion, or contrary to law. The Court, therefore, SUSTAINS the decision. BACKGROUND The facts relevant to Ms. Rich’s motion for review are set forth in detail in the special master’s Finding of Fact, issued September 16, 2015, and in her decision on the merits, issued June 30, 2016. The Court has reviewed the special master’s Finding of Fact in detail and concludes that it accurately reflects the testimony of the witnesses and the documentary evidence in the record. What follows is a summary of that testimony and documentary evidence. I. Testimony of Ms. Rich and Her Witnesses Regarding the Decline in Her Health Following Her Vaccination Ms. Rich was born on May 13, 1992. Pet.’s Ex. 1 ¶ 1, ECF No. 5-1. In the fall of 2010, she was a freshman at the University of Oklahoma and was living on campus in a dormitory. Id. ¶ 2. Ms. Rich had previously been diagnosed with asthma but was otherwise healthy. Id. ¶ 3. On September 26, 2010, Ms. Rich received an influenza vaccination at Memorial Christian Church in Oklahoma City. Order & Ruling on Facts at 10, ECF No. 35.2 According to the testimony of Ms. Rich and her witnesses, summarized below, her health took a turn for the worse in the months following her vaccination. A. Ms. Rich’s Testimony Ms. Rich submitted a declaration and also testified at the onset hearing held in the case. She stated that “a few weeks after” she received the vaccination, “in mid-October,” she began to notice that she was becoming fatigued “easily.” Pet.’s Ex. 1 ¶ 6; Tr. of Hr’g (Tr.) 137–38, October 30, 2014, ECF No. 66. In addition, she was sleeping in “later and later,” was taking afternoon naps, and “just never seemed to have any energy.” Pet.’s Ex. 1 ¶¶ 6–7; Tr. 137–38. Ms. Rich stated that her condition continued to worsen through October, and that, beginning in early to mid-November, she started to wake up every day with a headache. Tr. 139. She also started to experience dizziness. Id. By the beginning of December, according to Ms. Rich, she was constantly exhausted, having trouble breathing, suffering from headaches and dizziness, experiencing difficulty focusing, and her eyes had become sensitive to light. Id. at 157–58. She Disseminated Encephalomyelitis, Medscape (Dec. 30, 2015), http://emedicine.medscape.com/article/1147044-overview. 2 Ms. Rich had also received influenza vaccinations on an annual basis the preceding five years, beginning in 2009. Finding of Fact at 4, ECF No. 80. 2 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 3 of 17 also suffered from a sensation of heaviness in her legs and was having difficulty walking. See id. at 155, 162–63. In her declaration, Ms. Rich states that on the morning of December 27, 2010, while at home on winter break, she woke up early feeling unwell and called in sick to her employer. Pet.’s Ex. 1 ¶ 13. According to Ms. Rich, she was “dizzy, had a throbbing headache, couldn’t breathe, and felt nauseous.” Id. She called her mother, who was at work, and she took Ms. Rich to the emergency room at the Integris Baptist Medical Center. Id. As described in greater detail below, Ms. Rich was admitted to the hospital where her condition worsened and where, on January 7, 2011, she was diagnosed with ADEM. B. Testimony of Caramia Enrich Ms. Rich’s roommate at the time, Caramia Enrich,3 also submitted a declaration and testified at the onset hearing. She stated that a few weeks after Ms. Rich received the flu shot, she began to display signs of fatigue and to report that she was experiencing headaches and feeling sick. Pet.’s Ex. 3 ¶ 6, ECF No. 5-3. Ms. Enrich testified that Ms. Rich “started complaining a lot about . . . being very tired from the walk” across campus and that “she’d talk about how her legs would feel heavy.” Tr. 100. Ms. Enrich recalled that on Halloween, Ms. Rich had struggled to hand out candy to children who were trick-or-treating in the dormitory. Tr. 100– 01. Sometime after Halloween, she observed that Ms. Rich’s symptoms were getting worse, and included complaints of pain and weakness in her legs. See Pet.’s Ex. 3 ¶¶ 6–7; see also Tr. 102– 03. Ms. Enrich testified that by the end of the fall semester, Ms. Rich was complaining that light bothered her eyes and that she was “very fatigued all the time.” Tr. 105. She observed that “as soon as she would come in, she would just go to bed,” and that “it was really, really affecting her every day.” Id. C. Testimony of Aurora Tapia Aurora Tapia,4 Ms. Rich’s friend and co-worker at Panera Bread, also stated that Ms. Rich began to complain of headaches, dizziness, and fatigue in October and November 2010. Pet.’s Ex. 24 ¶¶ 2–3, ECF No. 60-1; see also Tr. 77. During this time period, she observed Ms. Rich’s performance at work begin to suffer; according to Ms. Tapia, Ms. Rich was becoming slower and was incorrectly performing tasks that she had previously mastered. Pet.’s Ex. 24 ¶ 4; see also Tr. 79. She characterized Ms. Rich as suffering from a “brain fog” beginning in October 2010. Pet.’s Ex. 24 ¶ 7. In other words, Ms. Tapia stated, Ms. Rich had an “inability to mentally process what [she was] doing.” Tr. 82. Ms. Tapia testified that from October to December of 2010, Ms. Rich’s condition progressively worsened and that she “was not her normal self.” Tr. 81. 3 Ms. Rich’s roommate married between the time she submitted her statement and when she testified at the onset hearing; her maiden name, as seen on that statement, was Testa. See Tr. 94– 95. 4 Ms. Tapia testified under the name of Aurora Tapia-Contreras at the onset hearing. Tr. 73. 3 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 4 of 17 D. Heather Rich’s Testimony Ms. Rich’s mother, Heather Rich, testified that she spoke to her daughter almost every day during the fall of 2010. See Tr. 12–13, 17. She recalled that a few weeks after her daughter received the flu shot, she began to complain of headaches, weakness, and a lack of energy. Pet.’s Ex. 16 ¶¶ 5–10, ECF No. 23-1. She testified that Ms. Rich was reporting headaches “all the time” and that she told her mother that “she was tired a lot.” Tr. 18. Ms. Rich also testified that near the time of her daughter’s November 10th visit to the college infirmary (described below), her daughter told her that she had been “unable to go to class . . . [and unable to] walk across the campus.” Tr. 24. Ms. Rich’s mother also recalled that at this time, her daughter was “slurring her words a little bit . . . [and] having trouble a little bit with getting her sentences out.” Tr. 25. II. Medical Care Sought During Fall 2010 During the fall of 2010, Ms. Rich sought medical care on three occasions. First, on October 8, 2010, approximately two weeks after she received her vaccination, Ms. Rich attended an appointment with her pediatrician, Dr. Colleen Dooley. Pet.’s Ex. 4 at 8, ECF No. 5-4. Ms. Rich reported to Dr. Dooley that she was having trouble breathing at night, that she had been using her inhaler “a lot,” and that she had been unable to obtain Advair, one of the medications she had been prescribed for her asthma. Id. Although she was experiencing heaviness in her legs by October 8, Ms. Rich testified, she did not report it to Dr. Dooley because she “didn’t think it was a big deal,” she “related it back to [her] asthma,” and she just thought she was “tired.” Tr. 143. Dr. Dooley’s impression based on her examination of Ms. Rich was that she was experiencing an exacerbation of her asthma. Pet.’s Ex. 4 at 8. She gave Ms. Rich a new prescription for Advair, a prescription for Singulair, samples of both medications, and a sample of what appears from Dr. Dooley’s handwritten notes to be “ProAir.” Id. Dr. Dooley instructed Ms. Rich to return to the clinic if she did not improve. Id. On October 23, 2010, Ms. Rich again visited Dr. Dooley. Id. at 7. She testified that she did so at the insistence of her mother, to whom she had been complaining of fatigue and difficulty breathing. Tr. 141. Her mother accompanied Ms. Rich to the appointment and, according to Ms. Rich, provided “most of the history about what was wrong with [her] and why [she was] there.” Id. Specifically, Ms. Rich testified, her mother told the doctor that “she [Heather Rich] thought it was my asthma.” Tr. 141–42. Ms. Rich did not tell Dr. Dooley during this appointment that her legs were feeling heavy or that she was having difficulty walking across campus. Tr. 142. The chief complaint recorded in the medical records for the October 23 appointment was “Asthma – worse when comes home.” Pet.’s Ex. 4 at 7. The doctor’s notes indicate that Ms. Rich was continuing to use her inhaler “a lot” and had increased symptoms of asthma over the previous two weeks. Id. Dr. Dooley continued to prescribe medications for asthma, including Prednisone, Singulair, and Albuterol. See id. On November 10, 2010, Ms. Rich again sought medical care, this time at her college’s medical center. Pet.’s Ex. 15, ECF No. 20-1. According to Ms. Rich, she visited the infirmary at 4 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 5 of 17 her mother’s urging. Tr. 147; see also Pet.’s Ex. 1 ¶ 10. She testified that between her October 23 visit with Dr. Dooley, and her visit to the infirmary, she “was getting to the point where it was so hard to function, and [she] didn’t want to tell anyone about it because [she] didn’t want them to worry.” Tr. 146. She stated “it was really bad” and that she “was so tired, and [her] body felt so heavy . . . like [she] was going to pass out every time [she] would go to class.” Id. Ms. Rich testified that she was “so scared” but that she “just kept thinking [she] was going to get better.” Tr. 146–47. In her declaration, Ms. Rich similarly explained that “one day as I was walking back to my dorm after class I got dizzy and, for the first time in my life, I felt like I was going to pass out.” Pet.’s Ex. 1 ¶ 10. She stated that she was “light headed and extremely weak” and “felt nauseous.” Id. Ms. Rich noted that “I was able to make it back to my dorm, but I was scared.” Id. Therefore, she called her mother, who wanted her to come home. Id. But Ms. Rich “didn’t think [she] could drive that far, so [she] made an appointment at the on-campus medical clinic.” Id. At that visit to the clinic on November 10, 2010, Ms. Rich listed her worst symptom as “Coughing & trouble breathing” on the intake form she filled out upon arriving. Pet.’s Ex. 15 at 2. The intake form also presented a list of symptoms and Ms. Rich was asked to check all that applied to her condition. Id. She checked fever, night sweats, sore throat, headache, ear ache/pain, cough, wheezing, and muscle aches. Id. She wrote that her symptoms had started five days previously and characterized them as “improving somewhat” since then. Id. As noted, in her statement Ms. Rich said that she was feeling dizzy, light-headed, weak, and nauseous prior to making the November 10, 2010 appointment and that she had almost passed out while walking back to her dorm after class. Pet.’s Ex. 1 ¶ 10. She did not, however, report these symptoms or this incident to the medical personnel at the infirmary. See Pet.’s Ex. 15; see also Tr. 147–48. Nor did she report the chronic fatigue, heaviness in her legs, slurred speech, or mental processing difficulties which she, her roommate, her co-worker, and/or her mother testified she had been experiencing during the mid-October to early November time period. See Pet.’s Ex. 15; see also Tr. 147–48. Ms. Rich testified that she did not see a doctor at the college infirmary and only saw a physician’s assistant. Tr. 147. However, the medical record documenting the visit is signed and stamped by Dr. Stephanie Parker. Pet.’s Ex. 15 at 2. Dr. Parker recorded that Ms. Rich had “[n]o N/V/D or any other c/o” other than what was checked on the intake form.5 See id. Ms. Rich was 5 N/V/D stands for nausea-vomiting-diarrhea. N/v/d, Dictionary.com, http://www.dictionary.com/browse/n-v-d (last visited Nov. 29, 2016). C/O stands for “complains of.” Medical Definition of C/O, Merriam-Webster, http://www.merriam- webster.com/medical/c/o (last visited Nov. 29, 2016). Further down the note, in the physical examination section, Dr. Parker also wrote “+PND,” which stands for paroxysmal nocturnal dyspnea, shortness of breath that wakes a patient during the night. See Vaskar Mukerji, Dyspnea, Orthopnea, and Paroxysmal Nocturnal Dyspnea, National Center for Biotechnology Information (1990), https://www.ncbi.nlm.nih.gov/books/NBK213/. 5 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 6 of 17 diagnosed with bronchitis and asthma, was provided a nebulizer treatment at the clinic, was prescribed home medications, and was instructed that she should follow-up as needed.6 Id. III. December Hospitalization and ADEM Diagnosis Ms. Rich ultimately completed the semester and returned home for winter break. Pet.’s Ex. 1 ¶ 12. On the afternoon of December 27, 2010, however, she went to the emergency room, reporting wheezing, dyspnea, shortness of breath, and chest tightness, starting the previous day. Pet.’s Ex. 5 Part 1 at 9, ECF No. 6-1. No musculoskeletal or neurologic symptoms were recorded at that time. See id. The physical examination revealed that Ms. Rich was “[a]lert and oriented to person, place, time, and situation,” and “[n]o focal neurological deficit [was] observed.” Id. at 10. In the emergency room, the medical personnel concluded that she was experiencing status asthmaticus and hypoxemia.7 She was admitted to the intensive care unit (ICU), provided medications and breathing treatment, and scheduled for diagnostic tests. Id. at 10–11. Dr. John Edward Huff evaluated Petitioner in the ICU. Id. at 46. Ms. Rich reported to Dr. Huff that she had experienced sudden and increasing shortness of breath with wheezing beginning the prior evening. Id. He noted that Ms. Rich had been diagnosed with bronchitis three weeks previously, but that she reported having recovered from it. Id. Dr. Huff also noted that CT scans performed in the emergency room revealed pneumonia and a pneumothorax.8 Id. at 46–47. According to Dr. Huff’s report, Ms. Rich reported fever, chills, shortness of breath, dyspnea, cough with sputum production, wheezing, asthma, and pleuritic chest pain. Id. at 48. She denied weakness, fatigue, and night sweats. Id. Dr. Huff diagnosed community-acquired pneumonia in the right upper lobe, right small pneumothorax, asthma exacerbation, left lower lobe pulmonary nodule, allergic rhinitis, and hypoxemia. Id. at 49–50. Ms. Rich’s respiratory status continued to decline and she was ultimately intubated. Id. at 41. Over the next few days, she also became less responsive. Id. On January 6, 2011, Ms. Rich underwent a brain MRI. Pet.’s Ex. 5 Part 8 at 48–49, ECF No. 6-8. It revealed, inter alia, an acute infarction of the splenium of the corpus callosum9 with areas of diffusion restriction, T2 6 Dr. Parker used the abbreviation “prn,” which comes from the Latin pro re nata and stands for “as needed.” PRN, Merriam-Webster, http://www.merriam-webster.com/dictionary/prn (last visited Nov. 29, 2016). 7 Status asthmaticus is a particularly severe episode of asthma that does not respond adequately to ordinary therapeutic measures. Dorland’s 1767. Hypoxemia is an oxygen deficiency in the blood. Id. at 908. 8 A pneumothorax is an accumulation of air or gas in the pleural space of the lungs. Dorland’s 1476. 9 The corpus callosum is an arched mass of white matter in the brain. Dorland’s 417. The splenium is its posterior subsection. Id. An infarction is the formation of an area of cell death due to blood deficiency. See id. at 934, 961, 1235. Acute means having a short and relatively severe course. Id. at 24. 6 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 7 of 17 alteration, and abnormal contrast enhancement within the pons, inferior right cerebellar hemisphere, medulla, and cervical spine, which possibly related to hypoxic injury. Id. at 50. Based on these results, she was started on prophylactic seizure medication. Pet.’s Ex. 5 Part 1 at 41. On January 7, 2011, doctors added a diagnosis of “suspect[ed] ADEM” and began a course of Solumedrol. Pet.’s Ex. 5 Part 4 at 20, ECF No. 6-4. Dr. Aline Brown noted that it “appears most likely [Petitioner] has ADEM which is usually post infectious.” Id. at 21. As a result, she ordered a “sputum DTX” test. Id. Also on January 7, 2011, Ms. Rich underwent a cervical spine MRI. Pet.’s Ex. 5 Part 8 at 50. This test revealed, inter alia, a “probable evolving early subacute ischemic infarct of the upper cervical cord with restricted diffusion and minimal enhancement,” mild expansion of the upper cervical cord due to edema, and evolving small subacute infarcts in the posterior fossa. Id. Her cervical condition was later described as a “progression of cervical spine ischemic injury” with a “high spinal cord injury.” Pet.’s Ex. 5 Part 1 at 52. The findings were considered “consistent with acute disseminated encephalomyopathy.” Id. at 41. Ms. Rich’s “sputum DTX” test came back positive for H1N1,10 and she was put on Tamiflu. Id. at 41–42. On January 13, 2011, she also began an IVIG11 treatment for ADEM, and doctors noticed slight improvement. Id. at 42, 53. However on January 17, 2011, Ms. Rich underwent a tracheostomy because she was unable to wean from the ventilator. Id. at 42. Petitioner then began to develop myopathy.12 Id. Dr. Travis Kanaly diagnosed critical illness myopathy and prescribed gabapentin. Id. By February 17, 2011, Ms. Rich’s condition had begun to stabilize and she was discharged to an inpatient rehabilitation facility. Id.; see also id. at 53. At that time, her diagnoses were 1) acute demyelinating encephalomalacia with paralysis and quadriparesis13; 2) respiratory failure with community-acquired pneumonia, treated, and a long history of asthma, now with a tracheostomy; 3) critical care myopathy; 4) neuropathic pain on gabapentin; 5) seizure disorder on Keppra; 6) obesity; 7) atrophic dermatitis; 8) lazy eye; 9) anemia; and 10) anxiety and depression. Id. at 55. Ms. Rich was discharged home from the rehabilitation facility on March 25, 2011. Id. at 28. Doctors noted that she was dependent on others for movement, feeding, and self-care, and 10 H1N1 is a human seasonal flu virus which also circulates in pigs and was originally referred to as the “swine flu.” H1N1 – Swine Flu, Flu.Gov, http://www.flu.gov/about_the_flu/h1n1/ index.html (last visited Nov. 29, 2016). 11 IVIG stands for intravenous immunoglobulin, a treatment for autoimmune conditions. Noah S. Scheinfeld et al., Intravenous Immunoglobulin, Medscape (Feb. 3, 2016), http://emedicine.medscape.com/article/210367-overview. 12 Myopathy is a disease of the muscle. Dorland’s 1224. 13 Quadriparesis is a weakness in all four limbs. See Dorland’s 1565, 1906. 7 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 8 of 17 would require home health care, physical and occupational therapy, and a wheelchair. See id. at 29–30. IV. Subsequent Medical Care Ms. Rich received home health care and therapy after she was discharged from the hospital. See generally Pet.’s Ex. 6, ECF No. 7-1. In February 2012, she began care with Dr. Jenny Le at the University of Oklahoma’s internal medicine clinic. Id. at 26. In describing Ms. Rich’s medical history, Dr. Le stated that she “had an asthma exacerbation in 2010 that turned into bronchitis and then pneumonia,” and that, “[d]uring her recovery, she contracted the ‘swine flu’ (Jan 2011) which turned into encephalitis.” Id. at 27. On April 4, 2012, Ms. Rich was seen by Dr. William Schueler, a physician at the University of Oklahoma’s Department of Neurosurgery. Id. at 22. Dr. Schueler described Ms. Rich’s present illness as “swine flu back in January 2011” which left her “paralyzed from the neck down.” Id. He reiterated that connection in his assessment and plan, stating that Petitioner “unfortunately got paralysis secondary to swine flu.” Id. at 23. Currently, Ms. Rich continues to use a wheelchair and suffers from ongoing paralysis. Pet.’s Ex. 1 ¶¶ 29, 31. V. Expert Opinions Early on in the proceedings, and prior to the onset hearing, Ms. Rich submitted a report from Dr. David J. Siegler, dated December 8, 2013. Pet.’s Ex. 18, ECF No. 39-1. Dr. Siegler is board-certified in neurology. See Pet.’s Ex. 19 at 2, ECF No. 39-2. He was asked to provide an opinion as to whether the flu vaccine Ms. Rich received on September 26, 2010 was “causally- related to her subsequent development of diagnosed Acute Disseminated Encephalomyelitis 3 months post-vaccine.” Pet.’s Ex. 18 at 1. Dr. Siegler reviewed Ms. Rich’s medical records, the sworn statements of Ms. Rich, her mother, and her roommate, and the relevant medical literature. Id. He stated that it was challenging to establish a cause and effect relationship between the vaccine and the ADEM that Ms. Rich developed because of 1) “the long latency” between her September 2010 vaccination and December 2010 diagnosis; 2) the “paucity of medical records during the interval”; 3) “the present day lack of available diagnostic tests to confirm vaccines as causative in vaccine adverse events”; and 4) “the extremely rare occurrences of vaccine-induced demyelinating disorders.” Id. Nonetheless, Dr. Siegler identified several factors that might support a diagnosis of “influenza vaccine-induced ADEM.” Id. These included, in particular, “the timing of onset of neurologic symptoms shortly following receipt of the vaccine (as reported in compelling statements by [Ms. Rich], her roommate, Caramia, and [Ms. Rich’s] mom and established in court documents[)].” Id. Dr. Siegler believed that these statements were “compelling in description of signs and symptoms (fatigue, weakness, leg pain, dizziness and headaches) and 8 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 9 of 17 which the court notes as having started a few weeks after [having] been injected with the influenza vaccination.” Id. at 2.14 “If we accept the validity of [the statements],” he observed: [T]hen we have a pattern of CNS symptom development “a few weeks” after the vaccine including: Sydney’s report of “fatigue, excessive sleepiness, weakness and dizziness.” Caramia’s report of “something being wrong” including getting “fatigued easily” and having “trouble making it up the stairs” with “headaches and complaining that she felt sick.” She reported that Sydney “progressively got worse” including “her backpack felt very heavy, she complained of pain and weakness in her legs and her limbs felt []heavy.[] She seldom left the room. She stayed in bed and watched TV.” Ms. Rich[’s mother] reported Sydney developed fatigue, headaches and trouble sleeping a few weeks following the vaccine. If these statements are accepted as valid observations, then the statements indicate that several weeks following her influenza vaccine, Sydney developed constitutional symptoms (fatigue, insomnia), CNS symptoms (headaches, dizziness) and PNS symptoms (leg weakness and leg pain). Id. The government submitted a report prepared by Dr. Michael H. Kohrman, dated September 2, 2014. Resp’t’s Ex. A, ECF No. 55-1. Dr. Kohrman is board-certified in neurology with a subspecialty of clinical neurophysiology. Resp’t’s Ex. B at 2, ECF No. 55-2. He highlighted the “normal neurological examination” that was conducted when Ms. Rich was admitted to the hospital on December 27, 2010, as well as the lack of documented neurologic problems in medical records dated October 8, October 25, and November 10, 2010. Resp’t’s Ex. A at 8.15 He identified the first neurologic problem as having occurred January 4, 2011, when the hospital documented Petitioner as “lethargic.” Id. Dr. Kohrman also noted that when admitted, Ms. Rich tested negative for acute H1N1 infection, but then tested positive on January 7, 2011. Id. He concluded that the “H1N1 infection, bronchitis or pneumonia infections are likely, to a reasonable degree o[f] medical certainty, the cause of [Ms. Rich’s] ADEM.” Id. at 9. Because Ms. Rich received the flu vaccine in September, but there were no documented neurological 14 At the time Dr. Siegler wrote this letter, the special master had not yet issued any findings with respect to symptoms or onset. See Finding of Fact. Further, as discussed below, the special master did not conclude that such symptoms were present in the weeks after the vaccination. See id. Thus when Dr. Siegler stated “which the court notes,” he could only have been referring to a passing reference in the special master’s Order and Ruling on Facts Pertaining to Petitioner’s Receipt of a Covered Vaccination, ECF No. 35, at page ten, in which the special master appears to simply restate Ms. Rich’s contention that she “began to suffer fatigue, weakness, dizziness, and headaches only a few weeks” after receiving the vaccination. 15 Dr. Kohrman refers to the second visit to Dr. Dooley in October 2010 as having taken place October 25, 2010, rather than October 23, 2010. See Resp’t’s Ex. A at 3, 8. 9 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 10 of 17 problems until her hospitalization, and because there was a “lack of a close temporal relationship between Sydney’s illness and vaccination,” Dr. Kohrman concluded the flu vaccine was “very unlikely” to be the cause of Ms. Rich’s ADEM. Id. VI. The Special Master’s Decision A. Onset Finding The parties requested an onset hearing to determine when Ms. Rich’s ADEM symptoms began. See Orders, ECF Nos. 56, 58; see also ECF Nos. 72–73. That hearing was held on October 30, 2014, in Oklahoma City. Order, ECF No. 62. On September 16, 2015, the special master issued a Finding of Fact. ECF No. 80. In that decision, the special master rejected Ms. Rich’s assertion that “shortly after having received the influenza vaccine on September 26, 2010, she began to experience the onset of neurological symptomology that was subsequently diagnosed as ADEM,” specifically “extreme fatigue, headaches, lack of concentration, dizziness, and feeling nauseous.” Finding of Fact at 12 (quoting Pet.’s Pre-Hr’g Submission at 1–2, ECF No. 61). The special master relied upon “the contemporaneous medical records throughout the fall of 2010,” which she noted reflected symptoms “related to [Petitioner’s] asthma and [] developing bronchitis/pneumonia, and not to ADEM.” Id. at 13. She discredited the testimony of Ms. Rich and her witnesses because she found it implausible that, if Ms. Rich were suffering the severe fatigue, weakness, leg heaviness, chronic headaches, and dizziness about which they testified, she would not have reported those symptoms during the three medical consultations she sought during that time. See id. at 14. For example, the special master explained, although Ms. Rich testified that “she was confused, dizzy, having trouble walking coupled with heavy legs, and had blurry vision prior to her November 10 appointment” at the college infirmary, “[t]he records from the health center reflect none of those concerns.” Id. at 13. She noted that Ms. Rich “had three separate opportunities to tell someone at the clinic about these symptoms: when she filled out the intake sheet, when she spoke with the doctor, and when she spoke with the nurse after the first nebulizer treatment, but she did not avail herself of those opportunities.” Id. “The focus of that visit,” the special master observed, “as had been the focus of her earlier medical visits, was exclusively her difficulty breathing and related issues.” Id. Further, the special master noted, when Ms. Rich reported to the emergency room on December 27, 2010, she “presented . . . with shortness of breath, chest tightness, wheezing, and dyspnea which started one day prior” and affirmatively denied weakness, fatigue, nausea, and muscle pain or weakness. Id. at 14 (citing Pet.’s Ex. 5 at 9, 48–49). “[H]er responsiveness did not begin to decline,” the special master observed, “until several days after her admission for pneumonia, pneumothorax, and hypoxemia.” Id. at 14. The special master found that in light of her history of asthma, “Petitioner was familiar with doctors,” as well as “with the practice of visiting a physician and reporting symptoms, particularly when prompted.” Id. “She continued this practice when she went to college: she went to the doctor three times that first semester, and she reported the symptoms from which she was suffering so that they could be treated.” Id. The special master, accordingly, was “not 10 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 11 of 17 persuaded that Petitioner would not be forthcoming with her doctors, particularly if the symptoms were as unprecedented, persistent and severe as has been described.” Id. Based on the foregoing, the special master concluded that while Ms. Rich’s “medical records clearly document her worsening condition throughout the fall of 2010,” “the worsening condition that they document is pulmonary.” Id. She found that Ms. Rich failed to “put forward evidence sufficient to refute the contemporaneous medical records, which firmly support the onset of the symptoms of ADEM concurrently with or shortly after Petitioner’s hospitalization for pneumonia, pneumothorax and hypoxemia, on or after December 27, 2010.” Id. B. Entitlement Determination After the special master issued her onset finding, the parties moved for judgment on the administrative record. ECF Nos. 88, 90. At the special master’s invitation, Ms. Rich submitted a November 30, 2015 letter written by Dr. Siegler to supplement his conclusions in light of the special master’s onset finding. See Pet.’s Ex. 28, ECF No. 85-1. Dr. Siegler reiterated his belief that flu vaccine-induced ADEM is “medically plausible” and that the witness statements supported the development of neurological symptoms in the weeks after the vaccination. Id. at 1. However, he concluded that based upon the special master’s decision discrediting the testimony of Ms. Rich and her witnesses regarding the “multiple neurologic symptoms” which developed a few weeks after she received the vaccine, he could not offer an opinion on causation in Ms. Rich’s case. See id. The special master issued her decision on June 30, 2016. See Rich v. Sec’y of HHS, No. 12-742V, 2016 WL 3996334 (Fed. Cl. Office of the Special Masters June 30, 2016). Relying upon the earlier fact-finding, the special master concluded that Ms. Rich failed to present a prima facie case and was not entitled to compensation. Id. at *8. Specifically, the special master concluded that Ms. Rich failed to make the necessary showings under prongs two and three of the inquiry set forth in Althen v. Secretary of Health and Human Services, 418 F.3d 1274 (Fed. Cir. 2005), that there was: 1) “a logical sequence of cause and effect showing that the vaccination was the reason for the injury” and 2) “a proximate temporal relationship between vaccine and injury.” 2016 WL 3996334, at *7–*8. She observed that Ms. Rich’s expert, Dr. Siegler, “affirmed that he knew of no credible medical evidence to suggest that a three-month latency period between a vaccination and the onset of ADEM is consistent with causation,” and that the government’s expert, Dr. Kohrman, “concurred.” Id. at *8. Additionally, the special master noted that “at least two of Petitioner’s treating physicians ascribed her ADEM to her H1N1, not the vaccination.” Id. In short, the special master concluded that Ms. Rich did not “demonstrate[], by a preponderance of the evidence, that the vaccination caused her injury.” Id. VII. This Action On July 29, 2016, Ms. Rich moved for review in this Court. Pet.’s Mot. for Review (Pet.’s Mot.), ECF No. 93. Oral argument was held on November 16, 2016. See Order, ECF No. 98. 11 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 12 of 17 DISCUSSION I. Jurisdiction and Standard of Review Congress established the National Vaccine Injury Compensation Program in 1986 to provide a no-fault compensation system for vaccine-related injuries and deaths. Figueroa v. Sec’y of HHS, 715 F.3d 1314, 1316–17 (Fed. Cir. 2013). The Vaccine Act is remedial legislation that should be construed in a manner effectuating its underlying spirit and purpose. Id. A petition seeking compensation under the Vaccine Act is filed in the Court of Federal Claims, after which the Clerk of Court forwards it to the chief special master for assignment to a special master. 42 U.S.C. § 300aa-11(a)(1). The special master to whom the petition is assigned “issue[s] a decision on such petition with respect to whether compensation is to be provided under the [Vaccine Act] Program and the amount of such compensation.” Id. § 300aa- 12(d)(3)(A). The Vaccine Act grants the Court of Federal Claims jurisdiction to review the record of the proceedings before a special master, and authority, upon such review, to: 1) Uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision; 2) 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 3) Remand the petition to the special master for further action in accordance with the Court’s direction. 42 U.S.C. § 300aa-12(e); see also Vaccine Rule 27. On review of the special master’s decision, the court applies the arbitrary and capricious standard to factual findings and the “not in accordance with law” standard to legal rulings. Moberly ex rel. Moberly v. Sec’y of HHS, 592 F.3d 1315, 1321 (Fed. Cir. 2010). The court’s scope of review is a narrow one. The court “do[es] not reweigh the factual evidence, assess whether the special master correctly evaluated the evidence, or examine the probative value of the evidence or the credibility of the witnesses,” because those “are all matters within the purview of the fact finder.” Porter v. Sec’y of HHS, 663 F.3d 1242, 1249 (Fed. Cir. 2011) (citing Broekelschen v. Sec’y of HHS, 618 F.3d 1339, 1345 (Fed. Cir. 2010)). As long as a special master’s finding is based on evidence in the record that is “not wholly implausible,” the Court must uphold it. Id. at 1249 (quoting Cedillo v. Sec’y of HHS, 617 F.3d 1328, 1338 (Fed. Cir. 2010)). “[T]he standard of review is uniquely deferential” to special masters’ decisions; if a 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. Milik v. Sec’y of HHS, 822 F.3d 1367, 1376 (Fed. Cir. 2016) (quoting Hodges v. Sec’y of HHS, 9 F.3d 958, 961 (Fed. Cir. 1993) (internal citations omitted)). 12 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 13 of 17 II. Merits To secure compensation under the Vaccine Act, a petitioner must prove by a preponderance of the evidence that the injury at issue was caused by a vaccine. See 42 U.S.C. §§ 300aa-11(c)(1), -13(a)(1). Where a petitioner sustains an injury in association with a vaccine listed in the Vaccine Injury Table, causation is presumed. Broekelschen, 618 F.3d at 1341–42 (citing 42 U.S.C. § 300aa-11(c)(1)(C)(i) and Andreu v. Sec’y of HHS, 569 F.3d 1367, 1374 (Fed. Cir. 2009)). Where, as in this case, the injury is not listed in the Table, “the petitioner may seek compensation by proving causation in fact.” Id. (citing Moberly, 592 F.3d at 1321). “Once the petitioner has demonstrated causation, she is entitled to compensation unless the government can show by a preponderance of the evidence that the injury is due to factors unrelated to the vaccine.” Id. (citing Doe v. Sec’y of HHS, 601 F.3d 1349, 1351 (Fed. Cir. 2010) and 42 U.S.C. § 300aa-13(a)(1)(B)). The Federal Circuit has established a three-pronged test for proving causation in non- Table injury cases. Althen, 418 F.3d at 1278. Under that test, to demonstrate that a vaccination caused the petitioner’s injury, he or she must provide: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” Id. In this case, the special master found that the onset date for Ms. Rich’s ADEM was on or after December 27, 2010. Finding of Fact at 15. In other words, the special master concluded that there was a delay of at least three months between Ms. Rich’s receipt of the influenza vaccination and the injury about which she complains (ADEM). As the special master noted, both of the medical experts in the case agreed that they “knew of no credible medical evidence to suggest that a three-month latency period between a vaccination and the onset of ADEM is consistent with causation.” See Rich, 2016 WL 3996334, at *8. Therefore, the special master concluded that Ms. Rich failed to meet both Althen’s second prong, requiring a showing that the vaccine caused the alleged injury, and Althen’s third prong, requiring that there be an appropriate temporal relationship between vaccine and injury to support the petitioner’s theory of causation. Id. In her motion for review, Ms. Rich does not dispute that—if the special master’s onset determination is correct—the evidence does not support a finding that her ADEM was caused by the vaccination. See Pet.’s Mot. at 2–3. Her challenge is focused therefore on whether that determination was arbitrary and capricious and/or based on a misapplication of relevant legal standards. See id. She contends that the special master “disregarded all of the factual testimony presented by multiple witnesses as to [the] date of onset of [her] neurological symptoms.” Pet.’s Mem. of Objs. (Pet.’s Mem.) at 4, ECF No. 94. Ms. Rich further argues that “to prove that a disorder first appeared within a particular time period, the petitioner does not have to prove that a symptom or manifestation was observed by a physician and contemporaneously recorded within that time period—which is what [the special master] is requiring.” Id. at 5 (emphasis in original). In short, Ms. Rich contends, the special master “set[] forth a rule that places too much importance on contemporaneous medical records and not enough deference to witness testimony.” Id. at 17. 13 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 14 of 17 Ms. Rich’s arguments lack merit. First, as the Federal Circuit has recognized, “[m]edical records, in general, warrant consideration as trustworthy evidence” because “[t]he records contain information supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions.” Cucuras v. Sec’y of HHS, 993 F.2d 1525, 1528 (Fed. Cir. 1993); see also Canuto v. Sec’y of HHS, No. 2016-2096, 2016 WL 5746370, at *3 (Fed. Cir. Oct. 4, 2016) (per curiam) (concluding special master correctly attributed more weight to medical records than later-filed affidavits because medical records are impartial and trustworthy). Indeed, “[w]ith proper treatment hanging in the balance, accuracy has an extra premium” in the preparation of medical records. Cucuras, 993 F.2d at 1528. Further, medical records are considered reliable because they are “generally contemporaneous to the medical events.” Id. Thus, it was entirely appropriate for the special master to rely upon the absence of neurological symptoms in the medical records compiled during the fall of 2010 as a basis for determining when those symptoms first occurred. Further, the special master did not discredit Ms. Rich’s testimony or that of her witnesses solely because neurological symptoms were not noted or observed or recorded by her treating physicians in her medical records. See Pet.’s Mem. at 17 (arguing that “[t]he absence of a reference to specific symptoms in a medical record does not conclusively establish the absence of symptoms during that time frame” (citing Murphy v. Sec’y of HHS, 23 Cl. Ct. 726, 733 (1991), aff’d, 968 F.2d 1226 (Fed. Cir. 1992))). She discredited Ms. Rich’s testimony and that of her witnesses because—as Ms. Rich acknowledges and the medical records confirm—during the fall of 2010, Ms. Rich never reported or complained about neurological symptoms to any of the medical professionals with whom she sought treatment. The special master concluded that it was Ms. Rich’s failure to report these symptoms—not merely the fact that they were not observed or noted by medical personnel—which undermined her contention that she was experiencing such symptoms in the months following her receipt of the influenza vaccination. As the special master found, between the time of vaccination on September 26, 2010, and the time of Ms. Rich’s hospitalization on December 27, 2010, Ms. Rich sought medical care on at least three separate occasions: twice in October 2010 and once in November 2010. Pet.’s Exs. 4, 15. With respect to the November 2010 visit to the college infirmary, Ms. Rich had alleged that prior to making the appointment, she was feeling dizzy, light-headed, weak, and nauseous. Pet.’s Ex. 1 ¶ 10. She further stated that in the time period before she sought care at the infirmary, her symptoms had gotten “to the point where it was hard to function, as she felt so tired and her body felt so heavy, that she felt like she would pass out every time she went to class.” Pet.’s Mem. at 10. Indeed, as described above, Ms. Rich testified that the reason she went to the college infirmary was because she had almost passed out as she walked across campus, an incident which she stated caused her to become “so scared.” See Tr. 146–47; see also Pet.’s Ex. 1 ¶ 10. But when Ms. Rich went to the infirmary, where she was diagnosed with bronchitis, she did not report this allegedly frightening incident or the chronic weakness, fatigue, nausea, dizziness and headaches she was allegedly experiencing and had been experiencing since at least mid-October. Pet.’s Ex. 15 at 2; see also Tr. 147–48. Rather, she reported fever, night sweats, sore throat, headache, ear ache/pain, cough, wheezing, muscle aches, and difficulty breathing, and she denied any other symptoms, including nausea. See Pet.’s Ex. 15 at 2. In addition, she 14 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 15 of 17 indicated that these symptoms were acute in nature, reporting that they had started in the previous five days and that they were improving “somewhat.” Id. Similarly, Ms. Rich did not report any weakness, nausea, headache, fatigue or other neurological symptoms to her pediatrician during the two visits she paid to her in October. Pet.’s Ex. 4 at 7–8. Ms. Rich’s only complaints during those visits related to her asthma and difficulty breathing. Id. Finally, Ms. Rich did not report neurological symptoms when she presented to the emergency room on December 27, 2010. Pet.’s Ex. 5 Part 1 at 9–11. The records from the emergency room reflect only the breathing difficulties noted above. See id. In addition, the physical examination conducted by the emergency room physicians appears to refute the notion that she was neurologically impaired at the time of her admission: the record of that examination states that Ms. Rich was “[a]lert and oriented to person, place, time, and situation,” and that “[n]o focal neurological deficit [was] observed.” Id. at 10. In addition, she denied suffering from weakness or fatigue when admitted. Id. at 48. And, Ms. Rich was not diagnosed with ADEM by a medical professional until January 7, 2011, eleven days after she entered the hospital. Pet.’s Ex. 5 Part 4 at 20. Further, several doctors attributed her ADEM to H1N1. Pet.’s Ex. 6 at 22–23, 27. It was the special master’s view that if the neurological symptoms about which Ms. Rich and her witnesses testified were present to such a severe and persistent degree during the months of October, November, and into December, then Ms. Rich would have reported those symptoms to medical professionals during at least one of the four times she sought their assistance. As the special master observed: Petitioner was familiar with doctors, as she had had asthma, a chronic illness, since childhood and would go to the doctor occasionally for a flare-up of asthma or to refill an asthma related medication prescription. Tr. at 126–27. Therefore, she was familiar with the practice of visiting a physician and reporting symptoms, particularly when prompted. She continued this practice when she went to college: she went to the doctor three times that first semester, and she reported the symptoms from which she was suffering so that they could be treated. The undersigned is not persuaded that Petitioner would not be forthcoming with her doctors, particularly if the symptoms were as unprecedented, persistent and severe as has been described. The undersigned finds that Petitioner reported the symptoms she was experiencing, related to the severe pulmonary illness for which she was eventually hospitalized. Finding of Fact at 14. In light of these considerations, the special master rejected Ms. Rich’s various explanations for her failure to disclose her neurological symptoms. These included, but were not limited to, the following: 1) that “she (mistakenly) related [all of her symptoms] back to her asthma”; 2) that she “just thought she was going to get better and did not feel it was important”; 3) that “she was never asked about the problem with her legs or dizziness”; 4) that she “felt that 15 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 16 of 17 if she got [her breathing problems] addressed and it was treated, and her asthma got better, then the rest of the symptoms would go away as well”; 5) that she was afraid that if she told the doctors her symptoms, she would be prescribed medication that would make her gain weight; and 6) that she did not communicate the symptoms during her October 23 visit with Dr. Dooley because her mother spoke for her when she accompanied her to the doctor’s office and she related all of her daughter’s symptoms to her asthma. Pet.’s Mem. at 9, 11–12, 15, 18–19. The special master’s rejection of these explanations as unpersuasive and her decision not to credit the testimony of Ms. Rich’s witnesses were not arbitrary or capricious. The inference she drew from Ms. Rich’s failure to report any of her neurological symptoms to medical personnel—that she was not experiencing them at the time she sought medical treatment—was not an unreasonable, much less a “wholly implausible” one. This Court is mindful of the Federal Circuit’s instruction in Porter that it is outside the authority of the reviewing court to “reweigh the factual evidence, assess whether the special master correctly evaluated the evidence, or examine the probative value of the evidence or the credibility of the witnesses” for “these are all matters within the purview of the fact finder.” 663 F.3d at 1249. Therefore, and for the reasons set forth above, the Court must reject as unavailing Ms. Rich’s arguments that the special master failed to give sufficient weight to the testimony of Ms. Rich and her witnesses when she determined that the symptoms of ADEM did not begin until shortly after Ms. Rich was hospitalized on December 27, 2010. Ms. Rich’s final argument is based on the statement in the special master’s decision that “Petitioner’s medical records clearly document her worsening condition throughout the fall of 2010 but the worsening condition that they document is pulmonary.” Finding of Fact at 14. Seizing upon this observation, Ms. Rich argues that the special master erred by offering her opinion about whether Ms. Rich’s symptoms were pulmonary or neurological. Pet.’s Mem. at 20–22. According to Ms. Rich, in determining the onset date of Ms. Rich’s ADEM, the special master should have simply specified the dates on which Ms. Rich developed particular symptoms and then allowed the medical experts to determine whether those symptoms were neurological or pulmonary. See id. This final argument is unpersuasive. The special master’s statement that Ms. Rich’s worsening condition was “pulmonary” not neurological was not a medical diagnosis; it was a short-hand way of restating her conclusion that Ms. Rich did not experience the neurological symptoms about which she testified but which were not reflected in her medical records. These included fatigue, lethargy, chronic headaches, dizziness, leg pain, weakness and other symptoms that she and her expert Dr. Siegler had already identified as “neurological” symptoms of ADEM. The special master characterized the decline in Ms. Rich’s health as due to respiratory (or “pulmonary”) causes because the symptoms reflected in her records consisted of difficulty breathing, wheezing, and the like. In other words, the special master found that the symptoms that were reflected in Ms. Rich’s medical records were the only ones that she was experiencing during the relevant period. And, as Dr. Siegler himself acknowledged, once Ms. Rich’s testimony and that of her witnesses was discredited by the special master, the non-neurological symptoms reflected in the medical records could not support a finding of causation. 16 Case 1:12-vv-00742-EDK Document 101 Filed 12/16/16 Page 17 of 17 In short, the special master’s onset determination in this case was not arbitrary or capricious or contrary to law. Therefore, her conclusion that Ms. Rich failed to demonstrate a causal relationship between her vaccination and the ADEM she developed must be sustained. CONCLUSION The special master’s decision of June 30, 2016, finding no liability, is SUSTAINED. IT IS SO ORDERED. s/ Elaine D. Kaplan ELAINE D. KAPLAN Judge 17