VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-00936 Package ID: USCOURTS-cofc-1_17-vv-00936 Petitioner: Mary Orloski Filed: 2017-07-13 Decided: 2020-04-27 Vaccine: influenza Vaccination date: 2014-10-23 Condition: acute disseminated encephalomyelitis Outcome: denied Award amount USD: AI-assisted case summary: Mary Orloski filed a petition on July 13, 2017, alleging that the influenza vaccine she received on October 23, 2014, and the tetanus-diphtheria-acellular-pertussis (Tdap) vaccine she received on November 18, 2015, caused her to develop acute disseminated encephalomyelitis (ADEM). Petitioner, a 58-year-old woman, reported experiencing visual disturbances shortly after the flu vaccine and later developed tingling and numbness in her extremities after both vaccinations. Her treating neurologist, Dr. Alexandra Degenhardt, diagnosed her with ADEM, citing a temporal relationship between the vaccinations and her symptoms. However, other treating physicians, Dr. David Preston and Dr. Haatem Reda, offered alternative diagnoses or questioned the ADEM diagnosis. Dr. Preston attributed many of Petitioner's symptoms to anxiety and panic disorder, while Dr. Reda suggested Multiple Sclerosis (MS) was more likely based on neuroimaging. Respondent's expert, Dr. Subramaniam Sriram, opined that Petitioner did not meet the criteria for ADEM, citing her age, lack of encephalopathy, and the timeline of her symptoms. Dr. Sriram also concluded that Petitioner's MRI images were inconsistent with a CNS demyelinating disease and more likely represented patterns seen in chronic migraines. The Special Master denied the claim, finding that Petitioner failed to establish a medical theory of causation (Althen Prong 1), a logical sequence of cause and effect (Althen Prong 2), and a proximate temporal relationship (Althen Prong 3). The Special Master noted deficiencies in Dr. Degenhardt's reports, including a lack of specific causation mechanisms, temporal considerations, and supporting medical literature, as well as inadequate demonstration of her qualifications. The medical literature submitted by Petitioner was also found insufficient to establish causation. The Special Master found that Petitioner's immediate symptom onset was inconsistent with typical timelines for vaccine-induced ADEM and that her diagnosis of ADEM was not definitively supported by the record, especially given the conflicting opinions from other physicians and the lack of mandatory encephalopathy. The United States Court of Federal Claims reviewed the Special Master's decision. The Court denied Petitioner's motion for review and sustained the Special Master's decision, agreeing that Petitioner failed to meet her burden of proof under the three prongs of the Althen test. The Court found that the Special Master appropriately considered the evidence, including Dr. Degenhardt's opinions, and did not abuse her discretion in declining to hold an evidentiary hearing. The claim was dismissed for insufficient proof. Theory of causation field: Mary Orloski, age 58, filed a claim alleging that her influenza vaccine on October 23, 2014, and/or her Tdap vaccine on November 18, 2015, caused acute disseminated encephalomyelitis (ADEM). Petitioner's treating neurologist, Dr. Alexandra Degenhardt, diagnosed ADEM, citing a temporal relationship between the vaccinations and symptoms including visual disturbances and extremity tingling/numbness. However, other physicians, Dr. David Preston and Dr. Haatem Reda, questioned this diagnosis, suggesting anxiety or MS. Respondent's expert, Dr. Subramaniam Sriram, opined that Petitioner did not meet ADEM criteria, citing her age, lack of encephalopathy, and symptom timeline, and found MRIs inconsistent with demyelinating disease. The Special Master denied the claim, finding Petitioner failed to establish Althen Prong 1 (medical theory of causation), Prong 2 (logical sequence of cause and effect), and Prong 3 (proximate temporal relationship). Deficiencies in Dr. Degenhardt's reports regarding causation mechanism, temporal aspects, qualifications, and supporting literature were noted. Medical literature submitted by Petitioner was deemed insufficient to establish causation, and immediate symptom onset was found inconsistent with typical ADEM timelines. The Court of Federal Claims affirmed the Special Master's decision, finding Petitioner did not meet her burden of proof under the Althen prongs. The claim was dismissed for insufficient proof. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_17-vv-00936-0 Date issued/filed: 2020-01-13 Pages: 19 Docket text: PUBLIC DECISION (Originally filed: 10/31/2019) regarding 47 DECISION of Special Master. Signed by Special Master Herbrina Sanders. (rs) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 1 of 19 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: October 31, 2019 * * * * * * * * * * * * * * * * * * * * * * * * * MARY ORLOSKI, * No. 17-936V * Petitioner, * Special Master Sanders * v. * * Ruling on the Record; Influenza (“flu”) SECRETARY OF HEALTH * Vaccine; Tetanus-diphtheria-acellular- AND HUMAN SERVICES, * pertussis (“Tdap”) Vaccine; Acute * Disseminated Encephalomyelitis (“ADEM”) Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * Verne E. Paradie, Jr., Paradie, Sherman, et al., Lewiston, ME, for Petitioner. Robert P. Coleman, III, United States Department of Justice, Washington, DC, for Respondent. DECISION1 On July 13, 2017, Mary Orloski (“Petitioner”) filed a petition for compensation in the National Vaccine Injury Compensation Program (“the Program”).2 Pet. 1, ECF No. 1. Petitioner alleged that the influenza (“flu”) vaccine she received on October 23, 2014, and the tetanus- diphtheria-acellular-pertussis (“Tdap”) vaccine she received on November 18, 2015, caused her to develop acute disseminated encephalomyelitis (“ADEM”).3 Id. The information in the record, however, does not show entitlement to an award under the Program. I. Procedural History Petitioner filed her petition along with one exhibit consisting of medical records on July 1 This decision shall be posted 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 (2012)). 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 National Childhood Vaccine Injury Act of 1986, Pub L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). 3 Acute disseminated encephalomyelitis is defined as “an acute or subacute encephalomyelitis or myelitis characterized by perivascular lymphocyte and mononuclear cell infiltration and demyelination . . . . It is believed to be a manifestation of an autoimmune attack on the myelin of the central nervous system.” Dorland’s Illustrated Medical Dictionary 613 (32nd ed. 2012) [hereinafter “Dorland’s”]. Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 2 of 19 13, 2017. See Pet. at 1; Pet’r’s Ex. 1, ECF Nos. 1-1, 1-2, 1-3, 1-4.4 Petitioner filed her first statement of completion on October 10, 2017. ECF No. 10. Respondent filed his Rule 4(c) report on April 23, 2018, in which he argued that the petition should be dismissed because Petitioner did not present “a reliable theory of causation, logical sequence of cause and effect, or appropriate temporal relationship.” Resp’t’s Report at 9, ECF No. 22. I ordered Petitioner to file an expert report and supporting medical literature by July 16, 2018. See Non-PDF Order, docketed June 6, 2018. On July 16, 2018, Petitioner filed one exhibit consisting of seven pages of medical records from Dr. Alexandra Degenhardt, a neurologist. Pet’r,’s Ex. 3, ECF No. 29. Petitioner did not file a formal expert report or supporting medical literature by the July 16, 2018 deadline. See docket. On July 17, 2018, Chambers contacted Petitioner via email regarding her missed deadline. See Informal Comm., docketed July 17, 2018. Petitioner replied in a status report that “[i]f [Petitioner’s Exhibit 3 was] insufficient and the Court require[d] something more formal . . . Petitioner would request additional time to inquire of Dr. Degenhardt.” ECF No. 30. I ordered Respondent to file a status report by August 16, 2018, indicating whether, based on Petitioner’s Exhibit 3, his position as to litigation or settlement had changed. Non-PDF Order, docketed July 17, 2018. On August 15, 2018, Respondent filed a status report indicating that he “intend[ed] to continue to contest entitlement in this case.” ECF No. 31. I then ordered Petitioner to file a formal expert report and supporting medical literature by October 22, 2018. ECF No. 32. The order required Petitioner to submit an expert report that specifically included discussions of the expert’s qualifications, pertinent facts from Petitioner’s medical records, background on Petitioner’s alleged disease or injury, a theory of causation, and any non-vaccine potential causes. Id. On October 2, 2018, Petitioner filed an expert report from Dr. Degenhardt. Pet’r’s Ex. 4, ECF No. 33. The report consisted of one page of text in which Dr. Degenhardt stated “there is a clear temporal relationship between the vaccinations [administered to Petitioner] and [Petitioner’s] symptoms, so the most consistent diagnosis is ADEM.” Id. at 1. Dr. Degenhardt did not include her qualifications, an overview of ADEM, a synopsis of pertinent medical facts, nor a causation theory of any kind. See id. Petitioner did not file any pieces of supporting medical literature. On October 15, 2018, I again ordered Petitioner to file a formal expert report by no later than November 14, 2018. ECF No. 34. In the order, I noted that Petitioner’s Exhibit 4 “d[id] not adequately address any of the topics listed in the August 21, 2018 [o]rder.” Id. Petitioner filed a status report on October 17, 2018, wherein she stated that she “ha[d] chosen to submit medical opinions and records from her treating physician, which state[d] that the logical sequence of cause and effect show[ed] that the vaccination was the most likely reason for Petitioner’s injuries, and which Petitioner maintains supports her claim for compensation.” Id. at 2. Petitioner also indicated that she “d[id] not anticipate submitting any further reports from non-treating ‘experts.’” Id. 4 Petitioner re-filed Exhibits 1(a)–(f) on February 19, 2018, because the original filings “were not properly labeled and numbered . . . .” ECF No. 15 at 1. Petitioner filed a motion to strike the original exhibits on February 21, 2019, see ECF No. 16, which I granted, ECF No. 17. 2 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 3 of 19 On October 18, 2018, Chambers contacted Respondent to inquire how he wished to proceed in light of Petitioner’s status report. See Informal Comm., docketed Oct. 18, 2018. Respondent indicated that he did not intend to file a responsive expert report. Id. I ordered the parties to appear for a status conference on November 13, 2018. See Non- PDF Order, docketed Nov. 7, 2018. During the status conference, Petitioner clarified her position regarding how the case should proceed and requested additional time to supplement the record with medical literature and other evidence related to her causation theory. ECF No. 36. I ordered Petitioner to file any such evidence by December 13, 2018. Id. On December 12, 2018, Petitioner filed the present motion for ruling on the record, ECF No. 37, along with five exhibits consisting of additional medical records, two pieces of medical literature, and an affidavit, Pet’r’s Ex. 5–10, ECF Nos. 38-1–38-6; ECF No. 38-7. On December 16, 2018, Respondent filed a status report “request[ing an] opportunity to respond to [P]etitioner’s filings with an expert report[.]” ECF No. 39. Respondent filed an expert report from Dr. Subramaniam Sriram and one piece of medical literature on March 27, 2019. Resp’t’s Ex. A, C, ECF Nos. 43-1, 43-3. Respondent did not file a direct response to Petitioner’s motion, although Respondent’s expert report encompassed many of the arguments commonly found in a formal response. On April 3, 2019, Chambers contacted Petitioner to inquire whether she intended to file a responsive expert report. See Informal Comm., docketed Apr. 3, 2019. Petitioner responded that she did not anticipate filing an additional expert report but requested twenty-one days to file a response. I ordered Petitioner to file a response by April 24, 2019. Non-PDF Order, docketed Apr. 3, 2019. Petitioner filed a reply brief on April 24, 2019, ECF No. 44,5 along with a second affidavit and two photographs purporting to show an injection site reaction. ECF No. 44; Pet’r’s Exs. 11–12, ECF Nos. 45-2–45-3; ECF No. 45-1. Neither party has filed any additional evidence. This matter is now ripe for adjudication. II. Factual Background A. Relevant Medical History Petitioner worked as a registered nurse and a certified clinical document specialist prior to receiving the vaccinations at issue in this case. Pet’r’s Aff. ¶ 2(i), ECF No. 38-7. Petitioner received the flu vaccine at issue in this case on October 23, 2014, at approximately 7:00 AM. Pet’r’s Ex. 1(c) at 37. At approximately 8:30 AM that morning, Petitioner began experiencing visual disturbances where she “felt that she could not see out of both eyes.” Id. These visual disturbances completely resolved after approximately twenty minutes. Id. At approximately 9:50 AM, Petitioner presented to the emergency room and saw Rob Boudewijn, PA-C, for treatment related to these disturbances. Id. Petitioner told PA-C Boudewijn that she “[was] quite convinced 5 In her reply, Petitioner mostly reiterated her arguments contained in her original motion, aside from citing to an additional Vaccine Program case which she argues “is nearly identical” to hers. Pet’r’s Reply at 14; see also Mondello v. Sec’y of Health and Human Servs., No. 15-972V, 2018 WL 947449 (Fed. Cl. Spec. Mstr. Jan. 24, 2018). 3 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 4 of 19 that [the visual disturbances were] an allergic reaction to the flu shot.” Id. However, PA-C Boudewijn disagreed and “had a long discussion with [Petitioner] that [his] suspicion for [the visual disturbances] being an allergic reaction due to the flu shot [was] extremely low.” Id. at 38. PA-C Boudewijn released Petitioner with directions to follow-up with her primary care physician (“PCP”). Id. On December 5, 2014, Petitioner presented to her PCP, Charles Burger, M.D., to “discuss her [post-traumatic stress disorder (“PTSD”)] and [the effect] set off by her reaction to the flu vac[cination].” Pet’r’s Ex. 1(f) at 3. Petitioner noted that her PTSD had been life-long and related to issues within her family. Id. Dr. Burger arranged a psychiatric referral for Petitioner and discussed medication options but did not prescribe any due to Petitioner’s “fear of . . . [selective serotonin reuptake inhibitors].” Id. On January 22, 2015, Petitioner presented to David Breer, M.D., a psychiatrist. Pet’r’s Ex. 7 at 1. Petitioner “denie[d] any significant worsening of her symptoms” resulting from her long-standing anxiety and depression but “describe[d] significant recent physical symptoms[,] which ha[d] contributed to [Petitioner’s] feelings of anxiety and being overwhelmed by stress.” Id. Petitioner reported a variety of symptoms, including “frequent episodic severe head pain when lying down associated with facial twitching, apnea, stuttering, difficulty breathing, and noise in her ears . . . .” Id. Petitioner also reported a history of “ocular respiratory reaction to [the] flu vaccine” and “numbness and tingling of hands and feet with ciprofloxacin.6” Id. Dr. Breer assessed Petitioner with depression and anxiety disorder and scheduled a follow-up appointment to continue treatment. Id. at 3. Petitioner’s next relevant medical appointment occurred on November 11, 2015, when she presented to a new PCP, Dr. David Preston, M.D., to establish care. Pet’r’s Ex. 1(a) at 71. Petitioner voiced four main concerns to Dr. Preston: atrial arrhythmia, arthritis, poor sleep possibly related to anxiety, and clinical lynch syndrome.7 Id. at 71–72. An examination revealed that Petitioner’s range of motion (“ROM”) in her neck was “limited.” Id. at 72. Petitioner did not mention any neurological complaints. See id. During this appointment, Petitioner received the Tdap vaccine at issue in this case. Id. at 73. Based on Petitioner’s limited neck ROM, Dr. Preston concluded that she “ha[d] a degenerative [neck] disease[.]” He referred Petitioner to physical therapy (“PT”) and discussed treatment options for her other concerns. Id. The medical record does not contain any mention of Petitioner’s alleged reaction to the flu vaccine. Petitioner presented for her first PT session on December 10, 2015. Pet’r’s Ex. 1(b) at 40. Petitioner reported that her neck pain had begun over five years prior without trauma. Id. She attended eight sessions over the next two months and was discharged from PT on February 5, 2016. Id. at 39. On February 23, 2016, Petitioner presented to Dr. Preston for a follow-up and stated that PT had been “quite helpful for her chronic neck pain.” Id. at 67–68. However, Petitioner reported a new problem—“intermittent tingling and numbness of the toes of both feet.” Pet’r’s Ex. 1(a) at 68. Petitioner also reported experiencing, over a longer, undefined period of time, tingling and numbness in her hands, although “she [could not] remember which fingers [were] affected but it seem[d] to be both palms.” Id. Dr. Preston assessed the tingling in Petitioner’s toes and feet as “consistent with an early sensory peripheral neuropathy,” and the 6 Ciprofloxacin is “a fluoroquinolone antibacterial effective against many gram-positive and gram- negative bacteria . . . .” Dorland’s at 362. 7 Lynch syndrome is “hereditary nonpolyposis colorectal cancer.” Dorland’s at 1838. 4 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 5 of 19 tingling in Petitioner’s hands as “most consistent with carpal tunnel syndrome.”8 Id. at 69. Petitioner declined referral to a neurologist and specific treatment for the tingling in her feet. Id. She did agree to try wrist splints at night to attempt to control the tingling in her hands. Id. Petitioner retuned to Dr. Preston on March 2, 2016, for a follow-up for her peripheral neuropathy. Id. at 64. Petitioner stated that her symptoms had worsened since her last visit and now “involve[d] the whole plantar surface of the foot and even going up a little bit on the ankle bilaterally.” Id. Petitioner stated, “that she fe[lt] this may be an autoimmune process, possibly related to the [Tdap] shot that [she received in] November.” Id. Dr. Preston noted that because Petitioner’s symptoms were “fluctuating [in] nature” and involving her hands “simultaneously with the feet[,]” the totality of her symptoms “would possibly argue against a peripheral neuropathy and more toward[] an anxiety reaction.” Id. at 66. Dr. Preston referred Petitioner for a neurology consult with Robert Stein, M.D. Id. Petitioner presented to Dr. Stein on April 20, 2016. Pet’r’s Ex. 5 at 1. Petitioner reported that she “has had headaches on a daily basis for over 15 years.” Id. Petitioner also reported that “[o]ne and a half hours after receiving [a] flu shot [in October 2014,] she developed shortness of breath and blurring of her eye site [(sic),]” which “improved within 2-1/2 hours.” Id. Petitioner stated that “[s]he made the diagnosis of oculorespiratory syndrome.”9 Id. Petitioner also stated that “she developed tingling sensation in her feet and hands and arms and legs[,]” and for the first time, stated that these symptoms developed “[w]ithin the next several days [after receiving the flu vaccine.]” Id. Id. Petitioner noted that this tingling “persisted for [six] weeks until [it] nearly resolved” and left Petitioner “with a residual tingling in the feet[,] which was constant[,] and episodic paresthesias10 in the hands.” Id. Petitioner then discussed the Tdap vaccination she received in November 2015. She stated that “[s]oon after this injection, she noted the paresthesias and a burning sensation intensifying in her feet[,]” which eventually “[s]pread up all [four] of her extremities.” Id. Petitioner reported that “[s]ince that time, she feels these paresthesias have become more intense and somewhat wider spread in her extremities.” Id. Petitioner also complained of weakness in her hands, difficulty swallowing, blurry vision in both eyes, a tremor at rest in her right hand, and intermittent fatigue. Id. at 2. Dr. Stein assessed Petitioner with paresthesias, which he “suspect[ed] . . . represent[ed] most likely [a] peripheral neuropathic dysfunction.” Id. at 4. Dr. Stein clarified that Petitioner “appear[ed] to have a sensory length- dependent small fiber neuropathy.” Id. Dr. Stein also assessed Petitioner with “migraine-like events” and right hemifacial spasm. He noted that “[multiple sclerosis (“MS”) 11] as the etiology 8 Carpal tunnel syndrome is “an entrapment neuropathy characterized by pain and burning or tingling paresthesias in the fingers and hand, sometimes extending to the elbow. Symptoms result from compression of the median nerve in the carpal tunnel.” Dorland’s at 1824. 9 Oculorespiratory syndrome is “a usually transient syndrome of bilateral red eyes and upper respiratory symptoms, including cough, wheezing, chest discomfort, sore throat, and occasionally facial edema, following [flu] vaccination.” Steadman’s Medical Dictionary 1907 (28th ed. 2006). 10 Paresthesia is defined as “an abnormal touch sensation, such as burning, prickling, or formication, often in the absence of an external stimulus.” Dorland’s at 1383. 11 Multiple sclerosis is “a disease in which there are foci of demyelination throughout the white matter of the central nervous system, sometimes extending into the grey matter . . . . The course of the disease is usually prolonged, so that the term multiple also refers to the remissions and relapses that occur over the period of many years.” Dorland’s at 1680. For a definition of central nervous system, see infra note 13. 5 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 6 of 19 would seem unlikely although the syndrome did start at age of 44.” Id. On July 14, 2016, Petitioner presented to Dr. Degenhardt, a neurologist, for a consultation. Pet’r’s Ex. 1(b) at 58. Dr. Degenhardt reviewed Petitioner’s history of symptoms and noted that “within [forty-eight] hours” after Petitioner received the flu vaccine in October of 2014, Petitioner developed “tingling and numbness in the arms and legs . . . [, which] rose up the legs to the knees and elbows.” Id. This tingling and numbness “took another [six] weeks to resolve.” Id. Dr. Degenhardt also noted that “within [twenty-four] hours” after Petitioner received the Tdap vaccine in November of 2015, “she felt ill again” and developed “tingling[,] . . . numbness[,] . . . [and] burning in [her] arms and legs.” Id. Dr. Degenhardt reviewed an MRI of Petitioner’s brain and noted “mild to moderate round (slightly larger than punctuate) T2 hyperintensities[,] which are nonspecific. No confluent lesions.” Id. at 60. After a physical examination, Dr. Degenhardt assessed Petitioner as having “[n]oninfectious [ADEM].” Id. at 61. Dr. Degenhardt stated “[a]lthough there is very little on [Petitioner’s] brain MRI to diagnose ADEM, the mild cognitive and visual changes with the presentation[] suggests some degree of central [nervous system (“CNS”)]12 as well as peripheral13 syndrome. The peripheral syndrome is most consistent with a [Guillain-Barré syndrome (“GBS”)14] like presentation following two vaccines[.]” Id. at 61. Dr. Degenhardt ruled out chronic inflammatory demyelinating polyneuropathy (“CIDP”)15 because “after so many months, [Petitioner’s condition] appears to be a stuttering chronic autoimmune condition.” Id. Dr. Degenhardt recommended treatment with either “[o]ne day of IVIG or [three] days of lower dose steroids” and told Petitioner to “avoid[] these specific vaccines.” Id. On August 5, 2016, Petitioner returned to Dr. Preston for a follow-up. Pet’r’s Ex.1(a) at 61. After reviewing Petitioner’s encounter with Dr. Degenhardt, Dr. Preston stated he “believe[d] much of [Petitioner’s] symptoms could be attributed to anxiety and panic disorder, including paresthesias, which is fairly classic for hyperventilation. Nonetheless, [he] would defer to Dr Degenhardt for her neurological diagnoses.” Id. at 62. 12 The central nervous system is “the part of the nervous system consisting of the brain and spinal cord.” Dorland’s at 1859. When both the brain and spinal cord become inflamed, it is called “encephalomyelitis.” Id. at 613. ADEM and MS are types of encephalomyelitis. See id; see also id. at 1680. 13 Peripheral nerves are “any nerve outside the [CNS].” Dorland’s at 1253. A peripheral neuropathy (also known as a “polyneuropathy”) is a “neuropathy of several peripheral nerves simultaneously . . . .” Id. at 1491. Both CIDP and GBS are considered peripheral neuropathies. See id. 14 Guillain-Barré syndrome is a “rapidly progressive ascending motor neuron paralysis of unknown etiology, frequently seen after an enteric or respiratory infection. . . . It begins with paresthesias of the feet, followed by flaccid paralysis of the entire lower limbs, ascending to the trunk, upper limbs, and face . . . .” Dorland’s at 1832. 15 Chronic inflammatory demyelinating polyneuropathy is “a slowly progressive, autoimmune type of demyelinating polyneuropathy characterized by progressive weakness and impaired sensory function in the limbs and enlargement of the peripheral nerves, usually with elevated protein in the cerebrospinal fluid. It occurs most commonly in young adults, particularly males, and is related to [GBS]. Presenting symptoms often include tingling or numbness in the digits, weakness of the limbs, hyporeflexia or areflexia, fatigue, and abnormal sensations.” Dorland’s at 1491. 6 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 7 of 19 Petitioner underwent an MRI of her cervical spine on September 9, 2016. Id. at 37. The MRI revealed “mild multilevel cervical spondylosis16 most pronounced at C4-5 but no appreciable stenosis,17” and “no intrinsic cord abnormality . . . .” Id. Petitioner also underwent an EMG on this date. Pet’r’s Ex. 1(c) at 47. The results revealed “an essentially normal study.” Id. On September 12, 2016, Petitioner presented to Dr. Degenhardt for a follow-up. Pet’r’s Ex. 1(a) at 28. Petitioner complained of “pressure on the front of her head[] and often on the top of her head . . . [, which was] exacerbated by computers and driving . . . [and could] also be associated with odors.” Id. Petitioner also complained of daily headaches, which had occurred for over five years. Id. Dr. Degenhardt noted that these headaches “[were] complicating her presentation and c[ould] produce cognitive issues.” Id. at 30. Regarding Petitioner’s “[p]ossible ADEM – like reaction to vaccination,” Dr. Degenhardt noted that it was “[v]ery atypical to have prolonged associated symptoms[;] however, [Petitioner] ha[d] a mildly elevated protein[,] which [was] abnormal and [could] indicate[] inflammation.” Id. Therefore, Dr. Degenhardt ordered “[t]esting for other autoimmune antibody mediated encephalopathies with [the] Mayo Clinic.” Id. Petitioner underwent a battery of tests for different autoantibodies and proteins, all of which returned negative. Pet’r’s Ex. 1(a) at 5; Pet’r’s Ex. 1(d) at 68–72. Of note, an autoimmune encephalopathy evaluation found “[n]o informative autoantibodies . . . .” Id. at 69. On December 5, 2016, Petitioner returned to Dr. Degenhardt for a follow-up. Id. at 20. Dr. Degenhardt definitively diagnosed Petitioner with ADEM because “[n]europsychology testing18 confirm[ed] . . . a CNS process[,]” and Petitioner “ha[d] a mildly elevated protein[,] which [was] abnormal and [could] indicate[] inflammation. The timing also coincide[d] with [Petitioner’s] history and presentation.” Id. at 22. Dr. Degenhardt stated that although “[t]here is an overlap with ADEM and GBS, and ADEM and MS[,] . . . the diagnosis is most consistent with ADEM currently.” Id. Dr. Degenhardt also noted that Petitioner was experiencing a “rare and . . . atypical presentation [of ADEM].” Id. Petitioner presented to Haatem Reda, M.D., at the Department of Neurology at Massachusetts General Hospital on January 12, 2017, for a second opinion regarding her ADEM diagnosis. Pet’r’s Ex. 1(b) at 43. After reviewing Petitioner’s symptoms and MRI results from the years 2008, 2009, and 2016, Dr. Reda stated “if [Petitioner] does have [a CNS] demyelinating disease, it predates the vaccination in 2014 and the symptoms she developed at that time. The differential diagnosis still includes prior [ADEM], though [MS] would be more likely on 16 Spondylosis is “1. [stiffening] of a vertebral joint[; and] 2. Degenerative spinal changes due to osteoarthritis.” Dorland’s at 1754. 17 Spinal stenosis is “narrowing of the vertebral canal, nerve root canals, or intervertebral foramina of the lumbar spine caused by encroachment of bone upon the space; symptoms are caused by compression of the cauda equina and include pain, paresthesias, and neurogenic claudication.” Dorland’s at 1770. 18 Petitioner did not provide records of this testing. However, the National Institute of Health defines a neuropsychological assessment as “a performance-based method to assess cognitive functioning . . . used to examine the cognitive consequences of brain damage, brain disease, and severe mental illness.” Philip D. Harvey, Clinical Applications of Neuropsychological Assessment, 14(1) DIALOGUES CLIN. NEUROSCI. 91, 91 (2012) (filed as Court’s Ex. A, ECF No. 46-1). 7 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 8 of 19 neuroimaging grounds.” Id. at 45; see also Not. of Filing on Compact Disk, ECF No. 40. Dr. Reda concluded “[a]t this point, given clinical and radiographic stability, I would not recommend initiating empiric immunomodulatory therapy, unless [Petitioner] develops new symptoms, signs, and/or imaging findings suggestive of CNS inflammatory disease.” Id. On February 16, 2017, Petitioner returned to Dr. Degenhardt for an “MS follow-up.” Pet’r’s Ex. 1(a) at 7. Petitioner reported “feeling a little better.” Id. Despite Dr. Reda’s conclusion that MS was the more likely diagnosis, Dr. Degenhardt reiterated her conclusion that Petitioner’s “[cerebrospinal fluid (“CSF”)19] findings [were] more consistent with ADEM than with MS.” Id. at 11. Petitioner had another follow-up appointment with Dr. Degenhardt on May 4, 2017. Id. at 2. Petitioner reported being “around 85% close to [her] baseline.” Id. Dr. Degenhardt restated that “[n]europsychology testing confirms findings that support a CNS process. There continues to be a mild processing delay with recall and learning since the ADEM. With improved rest, reduced stress, and improved sleep, [Petitioner] appears to be improving and functioning close to her prior level.” Id. The last medical records Petitioner submitted are from a June 5, 2018 follow up with Dr. Degenhardt. Pet’r’s Ex. 3 at 1. Petitioner reported experiencing “[t]ingling and burning on [her] left leg” and noted that that leg “will drag.” Id. She also reported experiencing “tingling in both palms[,]” and Dr. Degenhardt reaffirmed her diagnosis of ADEM. Id. Petitioner also noted “an occasional skin reaction in the region of her prior vaccin[ations].” Id. at 6. Dr. Degenhardt reviewed pictures, which Petitioner stated depicted her Tdap vaccination site from November 18, 2015, and the same site sometime in July of 2016. Id. Dr. Degenhardt noted that this was an “unusual” reaction. Id. Dr. Degenhardt opined that “perhaps . . . [it was] a reaction to an adjunct [(sic)]in the vaccine that . . . remain[ed] in the location of the injection.” Id. Dr. Degenhardt prescribed anti-inflammatory cream to control these reactions. Id. B. Petitioner’s Affidavit & Personal Office Visit Notes On December 12, 2018, Petitioner filed an affidavit to provide testimony that she “would have offered” if “there been an evidentiary hearing . . . .” Pet’r’s Aff. ¶ 2. In her affidavit, Petitioner noted that “immediately after [her] flu vaccination in October of 2014, [she] experienced respiratory tightness and visual disturbances and was unable to see out of both eyes.” Id. at ¶ 2(a). She explained that these “symptoms resolved” quickly, but that “over the next few days, [she] began to experience tingling and numbness in [her] toes that quickly ascended up [her] left calf and both hands up to [her] elbows.” Id. at ¶¶ 2(c)–(d). Petitioner stated that she reported these symptoms to her physician’s office via telephone, because she “thought [she] had [GBS].” Id. at ¶ 2(e)–(f). However, her physician “dismissed [her] complaint[]” and told her that “if [she] had GBS[, she] would know it.” Id. at ¶ 2(g). Petitioner was unable to obtain a record of this call, 19 Cerebrospinal fluid is “[t]he fluid that flows in and around the hollow spaces of the brain and spinal cord, and between two of the meninges (the thin layers of tissue that cover and protect the brain and spinal cord).” CEREBROSPINAL FLUID, National Dictionary of Cancer Terms, National Cancer Institute (last visited Oct. 10, 2019), retrieved from https://www.cancer.gov/publications/ dictionaries/cancer-terms/def/cerebrospinal-fluid. 8 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 9 of 19 because “the practice has been closed and sold twice.” Id. at ¶ 2(h). Petitioner further alleged that “[w]ithin [twenty-four] hours” of her Tdap vaccination on November 18, 2015, she “had a marked escalation and intensification of neurological symptoms: numbness, tingling, paresthesia in calves and forearms, left leg weakness, [and] severe pain at the right arm injection site . . . .” Id. at ¶ 2(t). She stated that she “returned to Dr. Preston within [forty-eight] hours” and “[h]e found abnormal findings on [a] neuro[logical] exam[] and made a referral to a neurologist.” Id. at ¶ 2(u). However, Petitioner noted that “[i]t was difficult to obtain a timely neurological consult [because] the wait time was 8 months . . . .” Id. at ¶ 2(v). Instead, she “pursued a more timely appointment[,]” which she found with Dr. Stein on April 20, 2016. Id. at ¶ 2(w). Petitioner stated that “given [her] experience with medical providers, as an R.N., and [c]ertified [c]linical [d]ocumentation [s]pecialist, [she is] a thorough historian with regard to [her] . . . medical appointments.” Id. at ¶ 2(i). She explained that she “retain[ed] almost all of [her] office visit and diagnostic reports[] and compile[d] a written summary of [her] own recollection of what occur[ed] at the visits.” Id. In addition, she stated that “for most of [her] doctor appointments since December 2014, [her] spouse (also an R.N.) accompanie[d her] into the exam room[] to act as a scribe to accurately record issues discussed during the visit.” Id. She filed a copy of what she described as “notes of [her] primary care appointment on December 2, 2014.”20 Id. at ¶ 2(k); Pet’r’s Ex. 10. The note is dated “12.2.14” and has “to Charles Burger” hand-written on the top. Pet’r’s Ex. 10. The note describes “enormous physical sleep difficulties” because of “endless twitching, apnea, [and] heart irregularity” when Petitioner slept on her right side, as well as “pain deep inside [her] head through [her] [left] eardrum” when she slept on her left side. Id. The note also contains the following description of symptoms that Petitioner stated occurred after her flu shot: Since flu shot[,] [t]ingling, heart racing, weakness, apprehension. . . . waxing and waning, much less now. Unremitting anxiety with this . . . again, much better now. Episodic swallowing difficulty[.] Fingers and toes tingling; especially evident when I [am] awake, at times traveling up to forearms and shins. Toes feel like corks. Waxing and waning exacerbation of eyesight difficulties. Id. Petitioner also wrote that she was “[c]onvinced [that] this is tied to [an] immune reaction . . . . triggered by allergens and stress.” Id. Petitioner did not file a record of this December 2, 2014 office visit, because “the practice has been closed and sold twice” and she has therefore been unable “to obtain a record” of this appointment. Pet’r’s Aff. ¶¶ 2(h), 2(j). III. Expert Review 20 Although Petitioner did not file a record of this office visit, she did file medical records from an office visit with Dr. Burger that occurred on December 5, 2014. See Pet’r’s Ex. 1(f) at 3. It is unclear if the December 2, 2014 visit Petitioner referenced in her affidavit and note actually occurred on December 5, 2014, or if she had appointments with Dr. Burger on both December 2nd and 5th of that year. However, there is no mention in the December 5, 2014 office records of a visit that occurred on December 2, 2014. See id. 9 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 10 of 19 A. Petitioner’s Expert, Alexandra Degenhardt, M.D., M.M.S.C. Petitioner submitted three filings from Dr. Degenhardt, which she entitled “expert reports.” See Pet’r’s Exs. 3–4, 8, ECF Nos. 29-1, 33-1, 38-4. The first consisted of seven pages of medical records from an office visit Dr. Degenhardt had with Petitioner on June 5, 2018. See Pet’r’s Ex. 3. Aside from these office notes, Dr. Degenhardt’s first report did not provide any additional information regarding Petitioner’s claim. Petitioner submitted a second document from Dr. Degenhardt on October 2, 2018. Pet’r’s Ex. 4. It consisted of a one-page letter which reads in full: [Petitioner] was seen by myself several times for symptoms that were most consistent with acute disseminated encephalomyelitis (ADEM) following vaccinations. ADEM can affect a discrete part, or multiple areas of the central nervous system, and at times portion[s] of the peripheral nervous system. Please see my office notes of 7/2016, 12/2016 and 2/2017 where Ms[.] Orloski's presentation and symtpoms (sic.) are detailed. I do not know if it is a[n] adjuvant in the vaccine that she is reacting to, as it occured (sic) after both a flu shot [on] 10/2014 and a tetanus shot [administered on] 11/2015, or if it is the actual superantigen. However, there is a clear temporal relationship between the vacciantions [(sic.)] and her symptoms, and so the most consistent diagnosis is ADEM. Id. No additional information was provided. Petitioner submitted Dr. Degenhardt’s third and final filing on December 12, 2018. Pet’r’s Ex. 8. It again consisted of a one-page letter which reads: As is commonly known in medicine and public health, vaccinations can cause [ADEM]. [Petitioner] clearly had reactions to her vaccinations and was seen by medical providers at the time. These specific dates were 10/23/2014 . . . and 11/18/15 . . . and she has documentation that she was seen by medical providers for reactions [to the vaccinations she received at those visits]. The neurological symptoms that I have seen [Petitioner] for [are] most consistent with recurrent symptoms of ADEM – mild left leg weakness, numbness on the left and mild cognitive issues. Her testing including CSF [were] supportive. She also saw another neurologist Dr. Reda at Mass General Hospital who agreed that the diagnosis was ADEM. [Petitioner] has documentation of that as well. Therefore, I . . . diagnosed [Petitioner] with ADEM as a reaction to her vaccinations. Id. No additional information was provided. B. Respondent’s Expert, Subramaniam Sriram, M.D. 10 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 11 of 19 Respondent submitted one expert report authored by Dr. Sriram on March 6, 2019, along with his curriculum vitae and one piece of supporting medical literature. Resp’t’s Exs. A–C, ECF Nos. 43-1–43-3. Dr. Sriram is a Professor of Neurology and Microbiology Immunology and head of the Multiple Sclerosis Clinic at the University of Vanderbilt Medical Center. Resp’t’s Ex. A at 1. He holds board certifications in Internal Medicine and Neurology. Id. He sees approximately 1,450 MS patients each year, of which 1,200 are in the outpatient setting and 250 are in the inpatient setting. Id. Dr. Sriram also conducts research on the causes and treatments of MS and “provide[s] consultation and care [for] patients with clinical features consistent with other demyelinating diseases of the [CNS].” Id. Dr. Sriram opined that Petitioner’s diagnosis is “uncertain.” Id. at 4. He noted that “[t]he only objective finding [was] a mild left[-]sided weakness of uncertain etiology[,]” which “was first noted by Dr. Degenhardt on . . . July 14[,] 2016.” Id. at 5. This symptom “was not apparent when Dr. Stein examined [Petitioner] on April 4[,] 2016.” Id. Therefore, Dr. Sriram argued that the onset of weakness was likely subsequent to April of 2016, which was over sixteen months post- flu vaccination and six months post-Tdap vaccination. Id. Dr. Sriram provided a table listing the criteria for the diagnosis of ADEM, which he created from an article by Krupp, Banwell, and Tenembaum. Id. (citing Resp’t’s Ex. C21 at 1–2). On one side of the table, Dr. Sriram listed the following criteria used to diagnose ADEM: (1) “onset before the age of 10”; (2) “[a] first clinical event with a presumed inflammatory or demyelinating cause, with acute or subacute onset that affects multifocal areas of the CNS; the clinical presentation must be polysymptomatic and must include encephalopathy”; (3) “behavioral change occurs, e.g., confusion, excessive irritability, lethargy or coma”; and (4) “a mostly monophasic disease”. Id. at 6 (emphasis in original). On the other side of the table, Dr. Sriram compared that criteria to Petitioner’s presentation and argued that Petitioner did not meet any of the listed criteria: (1) “[Petitioner] was 58 years-old”; (2) Petitioner experienced “[n]o change in level of consciousness . . . and there was no encephalopathy”; (3) Petitioner did not exhibit any behavioral changes “at the time of diagnosis”; and (4) Petitioner’s “symptoms have spanned more than three years.” Therefore, Dr. Sriram “disagree[d] with the diagnosis of ADEM.” Id. at 5. Dr. Sriram argued that “[t]he [MRI] images are not consistent with a diagnosis of [a] CNS demyelinating disease, either acute (ADEM) or subacute chronic (MS).” Id. Dr. Sriram examined all of Petitioner’s submitted brain and C-spine MRIs from the years 2008 to 2016 and concluded that “they do not show any progression of the punctuate lesions seen in the subcortical white matter.” Id. He noted that “the conclusion of the [MRI] report state[d] that ‘[l]ow grade white matter disease present on May 5[,] 2016[,] [was] not significantly changed from 2009.’” Id. (quoting Pet’r’s Ex. 1(c) at 9). Therefore, Dr. Sriram believed that they “are more likely patterns seen in patients with chronic migraine[s], which [Petitioner] suffered from.” Id. Dr. Sriram also argued that Petitioner’s immediate visual symptoms after receiving the flu vaccine were “inconsistent with the time line necessary for the development of an autoimmune response.” Id. at 6. He explained that ADEM “is a T cell[-]mediated autoimmune inflammatory demyelinating disease of the CNS.” Id. Dr. Sriram wrote that “the accepted process for the 21 Lauren B. Krupp, Brenda Banwell, and Silvia Tenembaum, Consensus Definitions Proposed for Pediatric Multiple Sclerosis and Related Disorders, 68 NEUROLOGY S2 (2007). 11 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 12 of 19 development of autoimmune demyelination[]” is the “recruitment, amplification[,] and migration of the autoimmune T cells to the brain” after an “immune sensitization in the peripheral lymphoid organs[.]” Id. Therefore, Dr. Sriram opined that “[t]he pre-requisite[ timeframe] for T cell activation and migration to the CNS [is] 7–10 days.” Id. He argued that “[i]f the vaccine [induced] the autoimmune response, it is unlikely that a neurological event [could] occur within one hour of the receipt of the vaccine[,]” and “it is also very unlikely that the autoimmune response [would] resolve in a matter of hours.” Id. Therefore, Dr. Sriram concluded that it was his “opinion and to a fair degree of medical certainty that the neurological symptoms suffered by [Petitioner] were not related to the receipt of her flu or Tdap vaccine[s].” Id. at 7. IV. Petitioner’s Motion for a Ruling on the Record Petitioner filed her motion for a ruling on the record on December 12, 2018. ECF No. 37. Petitioner conceded in her motion that “she ha[d] not submitted a hired expert opinion explaining the exact biological mechanism as to how vaccinations can cause ADEM.” Id. at 7. However, Petitioner argued that an expert opinion of that kind is unnecessary because her immediate symptom onset, Dr. Degenhardt’s opinion, and submitted medical literature are “sufficient to meet Petitioner’s burden to establish prong one of Althen.” Id. at 8. Specifically, Petitioner stated that “[m]edical and scientific literature, case studies, and case reports suggest that a wide variety of inflammatory diseases temporally associated with the administration of various vaccines, have been reported in the literature.” Id. at 9 (citing Pet’r’s Ex. 6 at 1). Petitioner submitted two pieces of medical literature in support of her motion. See Pet’r’s Exs. 6, 9, ECF Nos. 38-1, 38-5. The first is authored by Karussis and Petrou.22 In the introduction, the authors state that “[t]he vast majority of post-vaccination CNS demyelinating syndromes[] are related to the [flu] vaccination[,]” although they explained that “this could be attributed to the high percentage of the population that received the vaccine . . . .” Pet’r’s Ex. 6 at 1. The authors explained that “[u]sually the symptoms of the CNS demyelinating syndrome appear [a] few days following the immunization (mean: 14.2 days)[,] but there are cases where the clinical presentation was delayed (more than [three] weeks or even up to [five] months post-vaccination).” Id. The authors provided a brief overview of post-vaccination ADEM. Id. at 2–3. They wrote that “ADEM can occur in any age but is mainly a disease of children and young adults[,] with a mean age of onset of [five]–[six] years[,] and [the disease has] a higher incidence in males.” Id. at 2. They also explain that, while “[t]he clinical presentation [of ADEM] . . . is widely variable,” “[e]ncephalopathy, [which] occur[s] in up to [seventy-four percent] of patients, is considered mandatory for a definitive diagnosis.” Id. The authors list the varicella, rubella, smallpox, and flu vaccines as “common causes of post-vaccination ADEM.” The authors also provide two hypotheses for how vaccination can cause ADEM. The first is molecular mimicry where “antigens of viral origin cross-react with myelin components . . . and in a secondary manner induce a hyperergic reaction[] that leads to the development of disseminated demyelination.” Id. The second is T-cell activation where “vaccination may activate in a non- 22 Dimitrios Karussis & Panayiota Petrou, The Spectrum of Post-vaccination Inflammatory CNS Demyelinating Syndromes, AUTOIMMUNITY REV. (2013). 12 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 13 of 19 specific way distinct clones of anti-myelin T cells and that suppressor or regulatory cells that are aimed to control this abnormal reactivity are compromised or malfunctioning.” Id. The authors did not make a determination on the viability of either hypothesis. See id. The second article, authored by Yuan et al.,23 is a case report describing a twelve-year-old child who developed ADEM after receiving the Hepatitis B virus (“HBV”) vaccine. Pet’r’s Ex. 9 at 1. The only mention in this article of the vaccines Petitioner received is as follows: “Post[- ]vaccination ADEM has been associated with several vaccines such as . . . [the Tdap] . . . [and flu] . . . vaccine[s].” Id. at 2–3. Petitioner further argues that “there are numerous instances in the Vaccine Program in which . . . petitioner[s] ha[ve] established a plausible causation theory, including the plausibility of different vaccines, including the flu vaccine to cause ADEM or similar [CNS] neurological injuries.” Id. at 10 (quoting Taylor v. Sec’y of Health and Human Servs., No. 13-700V, 2018 WL 2050857, at *23 (Fed. Cl. Spec. Mstr. Mar 9, 2018). Petitioner also cites to another Vaccine Program case, Caruso v. Sec’y of Health and Human Services, No. 15-200V, 2017 WL 5381154, at *14 (Fed. Cl. Spec. Mstr. Oct. 18, 2017), for the proposition that “there is ample existing [Vaccine] Program authority (backed up by reliable scientific and medical evidence) that certain vaccines, including the flu vaccine, are reasonably associated with ADEM.” Petitioner concluded that “[i]n most of the cases in which the Court has denied ADEM claims, it is because a petitioner has failed to establish prong two or three of Althen, not one.” ECF No. 37 at 11. To establish Althen prongs two and three, Petitioner argues that “the medical records . . . clearly support [her] claim that she became immediately ill after receipt of the flu vaccination and then again immediately following the Tdap vaccination.” Id. Therefore, Petitioner continues, “[g]iven the immediate onset of symptoms not once, but twice, the records could not more clearly establish a temporal link to reactions to both vaccinations.” Id. However, Petitioner claims that if the medical records are “not enough to meet Petitioner’s burden in this matter, her treating neurologist[] Dr. Degenhardt has opined that Petitioner’s injuries are likely the result of reactions to both the [flu] and Tdap vaccinations.” Id. at 12. V. The Applicable Legal Standard To receive compensation under the Vaccine Act, Petitioner must demonstrate either that: (1) she suffered a “Table injury” by receiving a covered vaccine and subsequently developing a listed injury within the time frame prescribed by the Vaccine Injury Table set forth at 42 U.S.C. § 300aa-14, as amended by 42 C.F.R. § 100.3; or (2) that she suffered an “off-Table injury,” one not listed on the Table as a result of her receipt of a covered vaccine. See 42 U.S.C. §§ 300aa- 11(c)(1)(C); Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1319-20 (Fed. Cir. 2006). Petitioner does not allege a Table injury in this case; thus, she must prove that her injury was caused-in-fact by a Table vaccine. 23 Jun-liang Yuan et al., Acute Disseminated Encephalomyelitis Following Vaccination Against Hepatitis B in a Child: A Case Report and Literature Review, CASE REPORTS IN NEUROLOGICAL MEDICINE (2016). 13 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 14 of 19 To establish causation-in-fact, Petitioner must demonstrate by a preponderance of the evidence that the vaccine was the cause of the injury. 42 U.S.C. § 300aa-13(a)(1)(A). Petitioner is required to prove that the vaccine was “not only a but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321–22 (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)). In the seminal case of Althen v. Secretary of the Department of Health and Human Services, the Federal Circuit set forth a three-pronged test used to determine whether a petitioner has established a causal link between a vaccine and the claimed injury. See 418 F.3d 1274, 1278–79 (Fed. Cir. 2005). The Althen test requires the petitioner to set forth: “(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. at 1278. To establish entitlement to compensation under the Program, Petitioner is required to establish each of the three prongs of Althen by a preponderance of the evidence. See id. Under the first Althen prong, Petitioner must offer a scientific or medical theory that answers in the affirmative the question “can the vaccine[] at issue cause the type of injury alleged?” See Pafford v. Sec’y of Health & Human Servs., No. 01-0165V, 2004 WL 1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004), aff’d, 64 Fed. Cl. 19 (2005), aff’d, 451 F.3d 1352 (Fed. Cir. 2006). To satisfy this prong, a petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or scientifically certain.” Id. at 548–49. However, as the Federal Circuit has made clear, “simply identifying a ‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of proof.” LaLonde v. Sec’y of Health and Human Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014) (citing Moberly, 592 F.3d at 1322). Rather, “the statutory standard of preponderance of the evidence requires a petitioner to demonstrate that the vaccine more likely than not caused the condition alleged.” Id. A petitioner is not required to present medical literature or epidemiological studies to prove her burden. Grant v. Sec’y of Health and Human Servs., 956 F.2d 1144, 1149 (Fed. Cir. 1992); Andreu v. Sec’y Health & Human Servs., 569 F.3d 1367, 1380 (Fed. Cir. 2009). However, to the extent medical literature and epidemiological studies are provided, the special master will consider them when deciding whether the petitioner has met her burden of proof. Special masters, despite their expertise, are not empowered by statute to conclusively resolve what are essentially thorny scientific and medical questions, and thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.” Andreu, 569 F.3d at 1380. But this does not negate or reduce a petitioner’s ultimate burden to establish his overall entitlement to damages by preponderant evidence. W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted). Under Althen’s second prong, petitioners must demonstrate that the vaccine actually did cause the alleged injury in a particular case. See Pafford, 2004 WL 1717359, at *4; Althen, 418 F.3d at 1279. The second Althen prong requires proof of a logical sequence of cause and effect, usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; 14 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 15 of 19 Andreu, 569 F.3d at 1380; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Health Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). A petitioner does not meet this obligation by showing only a temporal association between the vaccination and the injury; instead, the petitioner “must explain how and why the injury occurred.” Pafford, 2004 WL 1717359, at *4 (emphasis in original). In Program cases, contemporaneous medical records and the opinions of treating physicians are favored. Capizzano, 440 F.3d at 1326 (citing Althen, 418F.3d at 1280). This is because “treating physicians are likely to be in the best position to determine whether ‘a logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.’” Id. In addition, “[m]edical records, in general, warrant consideration as trustworthy evidence. The records contain information supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions. With proper treatment hanging in the balance, accuracy has an extra premium. These records are also generally contemporaneous to the medical events.” Cucuras v. Sec’y of Health and Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). While a special master must consider these opinions and records, they are not “binding on the special master or court.” 42 U.S.C. § 300aa-13(b)(1). Rather, when “evaluating the weight to be afforded to any such . . . [evidence], the special master . . . shall consider the entire record . . . .” Id. Under the third prong of Althen, a petitioner must show that the timing of the injury fits with the causal theory. See Althen, 418 F.3d at 1278. For example, if the petitioner’s theory involves a process that takes several days to develop after vaccination, an injury that occurred within a day of vaccination would not be temporally consistent with that theory. Conversely, if the theory is one that anticipates a rapid development of a reaction post-vaccination, the development of the alleged injury weeks or months post vaccination would not be consistent with that theory. Causation-in-fact cannot be inferred from temporal proximity alone. See Grant, 956 F.2d at 1148; Thibaudeau v. Sec’y of Health & Human Servs., 24 Cl. Ct. 400, 403–04 (1991); see also Hasler v. United States, 718 F.2d 202, 205 (6th Cir. 1983) (“Without more, [a] proximate temporal relationship will not support a finding of causation.”). VI. Discussion A. Althen Prong One Petitioner failed to meet her burden under Althen prong one. As Petitioner acknowledges, “she has not submitted a hired expert opinion explaining the exact biological mechanism as to how vaccinations24 can cause ADEM.” Pet’r’s Mot. for Ruling on the Rec. at 7. Petitioner argues instead “that no such opinion is necessary[,] because” the evidence she submitted is enough to meet her burden. She cites to the following evidence to satisfy Althen prong one: (1) Dr. Degenhardt’s opinion that the vaccinations caused her alleged ADEM; (2) the medical literature contained in the record; and (3) her immediate onset after receiving both vaccinations. None of 24 Petitioner mistakes the burden that she must meet under Althen prong one. Her burden is not to show that any vaccination could cause ADEM, but rather that the flu and/or Tdap vaccines could cause ADEM. Furthermore, Petitioner does not necessarily have to provide the specific biological mechanism of a causation theory. She must, however, identify a “sound and reliable medical” theory relevant to her vaccination and alleged condition. Knudsen, 35 F.3d at 548. 15 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 16 of 19 these, whether taken separately or in the aggregate, are sufficient to meet the preponderant standard. Dr. Degenhardt’s assertions do not provide preponderant evidence under Althen prong one for numerous reasons. First, her assertions are superficial. Dr. Degenhardt did not present a theory of causation to apply to Petitioner’s case. After a thorough reading of her “expert reports,” it is unclear which vaccination Dr. Degenhardt believes caused Petitioner’s ADEM, or if she believes it was both. Nowhere in Dr. Degenhardt’s reports did she discuss a mechanism for how the Tdap vaccine or the flu vaccine—or a combination of both—could cause ADEM. She did not discuss what an appropriate temporal relationship would be for the flu or Tdap vaccines to be linked to the development of ADEM. She also did not discuss ADEM’s relationship to the wild viruses that Petitioner’s vaccines protect against. And although not a requirement, Dr. Degenhardt did not cite to any medical literature or epidemiological studies to support her contention that these vaccines can cause ADEM. Furthermore, Dr. Degenhardt’s assertions are afforded substantially less weight because, notwithstanding her role as a treating neurologist, she did not provide her qualifications to opine on Petitioner’s case. Dr. Degenhardt did not file a curriculum vitae or résumé. She did not state whether she is board-certified in immunology, neurology, or any other area that is pertinent to Petitioner’s claim. It is unclear whether Dr. Degenhardt has published any articles discussing issues pertinent to Petitioner’s case in peer-reviewed journals or whether she has testified in any medico-legal matters. It is also unclear whether Dr. Degenhardt holds any research or academic positions outside of her neurological practice or has any experience treating patients with ADEM. Without this information, it is difficult to assess the authority and reliability of Dr. Degenhardt’s conclusions. Petitioner had numerous opportunities to provide information in support of Dr. Degenhardt’s conclusions. See ECF Nos. 32, 34. On October 22, 2018, I gave Petitioner detailed instructions on what information she should include in her expert reports. See ECF No. 32. After Petitioner submitted Dr. Degenhardt’s second report on October 15, 2018, I alerted her that the filing did not comply with my instructions, and I gave her an additional opportunity to submit a proper expert report. See ECF No. 34. Despite these opportunities, Petitioner failed to adequately support Dr. Degenhardt’s assertions. Therefore, her opinions and reports are not persuasive evidence to meet Petitioner’s burden under Althen prong one. Although she was not required to submit medical articles in support of her claim, see Andrue, 569 F.3d at 1380, Petitioner argues that the two articles she submitted along with her motion for a ruling on the record support her argument under Althen prong one. These articles are also insufficient, however, to meet Petitioner’s burden, because they do not specifically address how the vaccines Petitioner received can cause her alleged injury. While the Karussis and Petrou article does briefly discuss molecular mimicry and T cell activation, two theories widely considered to explain vaccine-induced ADEM, the authors do not conclude whether either hypothesis is viable. Petitioner also did not identify which theory from this article she is advancing in this case. In addition, although the authors list the flu vaccine as a “common cause[] of post- vaccination ADEM[,]” it is unclear how this statement comports with another statement in the article that “despite a close temporal relation[hip] to vaccinations, there is no concrete evidence of 16 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 17 of 19 a clear pathogenic correlation” between vaccinations and ADEM.” Pet’r’s Ex. 6 at 3. The Yuan et al. article is a case report documenting a twelve-year-old child’s development of ADEM after receiving the HBV vaccine. Petitioner never attempts to explain how the HBV vaccine is analogous to either the flu or Tdap vaccines. She also did not discuss how the characteristics of the child in the case report—a twelve-year-old male—is analogous to her characteristics—a fifty- eight-year-old female. The child in this case report also has a confirmed ADEM diagnosis, whereas Petitioner diagnosis is differential at best. Therefore, these pieces of medical literature are not persuasive evidence to meet Petitioner’s burden under Althen prong one. Lastly, Petitioner argues that her immediate onset of symptoms after both the flu and Tdap vaccinations is supportive of a finding under Althen prong one. However, without additional preponderant evidence, this argument is misplaced. Petitioner is correct that evidence used to establish one Althen prong may be used to satisfy another. See Cappizano, 440 F.3d at 1326. However, the Court has stated that “a proximate temporal association alone does not suffice to show a causal link between the vaccination and the injury.” Grant, 956 F.2d at 1148. Therefore, the onset of Petitioner’s symptoms taken with her other filings cannot meet her burden under prong one. Importantly, Petitioner has not articulated an appropriate temporal association under her causation theory. In fact, one of the articles she submitted proposed a timeframe of approximately two weeks for symptom development post vaccination. The authors also described cases where onset occurred later than this period. Petitioner did not explain why her alleged immediate onset of symptoms is medically acceptable, how it is consistent with her filed literature, or how it supports her argument under this prong. Therefore, this evidence is insufficient to meet her burden under prong one. For these reasons, Petitioner has failed to meet her burden under Althen prong one. B. Althen Prong Two Petitioner cannot meet her burden under Althen prong two, because she did not provide a causation theory under prong one to apply to her symptoms. Furthermore, she did not establish a logical sequence of cause and effect, supported by her medical records, to show that her vaccinations actually caused her alleged ADEM. Aside from Dr. Degenhardt’s unsupported assertions, Petitioner only argues that the temporal onset of her ADEM symptoms supports Althen prong two. The parties dispute, however, whether Petitioner’s ADEM diagnosis is definitive, and Petitioner has not provided preponderant evidence that she suffers from this condition. Dr. Degenhardt’s diagnosis is differential, and she did not support her diagnosis with a discussion of the medical records. Aside from conclusory statements and superficial citations to records from her office visits with Petitioner, Dr. Degenhardt’s filings do not adequately explain why she believed Petitioner suffered from ADEM nor what criteria she used to diagnose Petitioner with ADEM. While Dr. Degenhardt referred to “neuropsychology testing” in Petitioner’s medical records, she did not provide any explanation for how she used this type of testing to assess Petitioner with ADEM. The National Institute of Health characterizes this type of testing as a behavioral assessment used to diagnose mental illness. See Court’s Ex. A at 1. Dr. Degenhardt did not provide any medical literature to show that neuropsychological testing can be used to 17 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 18 of 19 diagnose a neurological disorder. Dr. Degenhardt also did not discuss the opinions of two of Petitioner’s other treaters, Dr. Reda and Dr. Preston, nor the opinion of Respondent’s expert, Dr. Sriram, none of whom diagnosed Petitioner with ADEM. Petitioner is correct that opinions of treating physicians are afforded significant consideration by the Court. Pet’r’s Mot. for Ruling on the Record at 12. However, I must consider the entire record when assessing a treating physician’s opinion. Cucuras, 993 F.2d at 1528. When taking the entire record into account, Dr. Degenhardt’s opinion that Petitioner was suffering from vaccine-induced ADEM is not persuasive. Petitioner saw multiple treaters with differing opinions. Dr. Preston concluded that most of Petitioner’s symptoms related to her longstanding anxiety, see Pet’r’s Ex. 1(b) at 66, while Dr. Reda concluded that Petitioner’s diagnosis was more likely MS based off neuroimaging grounds, not ADEM, see Pet’r’s Ex. 1(b) at 45. Taken in total, these results are indeterminate, but it is noteworthy that Dr. Degenhardt provides the least support for her conclusions. In fact, while Dr. Sriram did not provide an explanation for Petitioner’s symptoms, he also discussed Petitioner’s record, and he used medical literature to support his conclusions. Dr. Sriram provided a chart contrasting Petitioner’s presentation with the criteria for diagnosing ADEM and concluded that Petitioner did not meet any of the listed criteria. See Resp’t’s Ex. A at 5. Petitioner did not disagree with the diagnostic criteria nor provide evidence that she met any of the listed criteria. Furthermore, Petitioner’s own medical literature contradicts her alleged ADEM diagnosis. The article by Karussis and Petrou explains that encephalopathy “is considered mandatory for a definitive [ADEM] diagnosis.” Pet’r’s Ex. 6 at 2. Petitioner provided no evidence that she developed an encephalopathy, and Dr. Degenhardt did not explain how she made an ADEM diagnosis in the absence of this finding. For those reasons, I find that Petitioner has not provided preponderant evidence that she suffers from ADEM or that her symptoms were caused by her vaccines. Therefore, Petitioner has not met her burden under Althen prong two. C. Althen Prong Three It is difficult to ascertain whether there was an appropriate temporal relationship between Petitioner’s vaccines and her alleged injury, because neither Petitioner nor Dr. Degenhardt clearly defined the applicable onset window. Petitioner argues that her immediate onset is evidence of an appropriate temporal relationship. However, the article by Karussis and Petrou places the appropriate symptom onset for CNS demyelinating disorders at days, with a mean symptom onset of two weeks. Pet’r’s Ex. 6 at 1. Petitioner did not provide an explanation for why the temporal relationship discussed in this article is wrong or provide any support to show that her immediate onset is appropriate. Furthermore, Dr. Sriram’s expert report provides persuasive evidence that Petitioner’s symptom onset is inconsistent with vaccine-induced ADEM under any causation theory. Dr. Sriram argued that vaccine-induced ADEM would require at least seven-to-ten days from the date of vaccination to develop. Resp’t’s Ex. A at 6. Although Dr. Sriram did not provide medical literature directly supporting this contention, his impressive credentials make him credible on this topic. As a professor of neurology and immunology and head of the MS Clinic at Vanderbilt University Medical Center, he is qualified to opine on an appropriate temporal relationship in this 18 Case 1:17-vv-00936-LKG Document 52 Filed 01/13/20 Page 19 of 19 case. Petitioner did not provide any evidence to refute this timeframe, either through Dr. Degenhardt’s reports or additional medical literature. I find Petitioner’s filed medical literature and Dr. Sriram persuasive. I therefore find that Petitioner did not establish with preponderant evidence that she developed vaccine-induced ADEM after she received her flu and Tdap vaccines. Accordingly, Petitioner has not met her burden under Althen prong three. VII. Conclusion For the foregoing reasons, Petitioner’s claim is hereby DISMISSED for insufficient proof. The Clerk of Court is directed to enter judgment accordingly.25 IT IS SO ORDERED. s/Herbrina D. Sanders Herbrina D. Sanders Special Master 25 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of a notice renouncing the right to seek review. 19 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_17-vv-00936-1 Date issued/filed: 2020-04-27 Pages: 22 Docket text: **RE-DOCKETED 57 TO CORRECT FILING ERROR** JUDGE VACCINE REPORTED OPINION on Motion for Review. Signed by Judge Lydia Kay Griggsby. (jt1) Service on parties made. Modified on 4/27/2020 - corrected document error(jt1). -------------------------------------------------------------------------------- Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 1 of 22 In the United States Court of Federal Claims No. 17-936V Filed Under Seal: March 17, 2020 Reissued: April 27, 2020* ) MARY ORLOSKI, ) ) Petitioner, ) ) National Childhood Vaccine Injury Act, v. ) 42 U.S.C. § 300aa–1 to –34; Acute ) Disseminated Encephalomyelitis; Althen SECRETARY OF HEALTH AND ) Prong One; Althen Prong Two; Althen HUMAN SERVICES, ) Prong Three. ) Respondent. ) ) Verne E. Paradie, Jr., Counsel of Record, Paradie, Sherman, Walker & Worden, Lewiston, ME, for petitioner. Robert P. Coleman III, Trial Attorney, Heather L. Pearlman, Assistant Director, Catharine E. Reeves, Deputy Director, C. Salvatore D’Alessio, Acting Director, Joseph H. Hunt, Assistant Attorney General, Torts Branch, Civil Division, United States Department of Justice, Washington, DC, for respondent. MEMORANDUM OPINION AND ORDER GRIGGSBY, Judge I. INTRODUCTION Petitioner, Mary Orloski, seeks review of the October 31, 2019, decision of the special master (the “October 31, 2019, Decision”) denying her claim for compensation under the National Childhood Vaccine Injury Act (the “Vaccine Act”), 42 U.S.C. § 300aa–1 to –34. Petitioner alleges that the influenza vaccine, and/or the tetanus-diphtheria-acellular-pertussis * This Memorandum Opinion and Order was originally filed under seal on March 17, 2020. ECF No. 53. The parties were given an opportunity to advise the Court of their views with respect to what information, if any, should be redacted from the Memorandum Opinion and Order. On April 27, 2020, petitioner filed a joint status report on behalf of the parties stating that the parties had no redactions to the Memorandum Opinion and Order. ECF No. 56. And so, the Court is reissuing its Memorandum Opinion and Order, dated March 17, 2020, as the public opinion. 1 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 2 of 22 (“Tdap”) vaccine, caused her to develop acute disseminated encephalomyelitis (“ADEM”). For the reasons set forth below, the Court DENIES petitioner’s motion for review and SUSTAINS the decision of the special master. II. FACTUAL AND PROCEDURAL BACKGROUND1 A. Factual Background In this Vaccine Act matter, petitioner alleges that the influenza vaccine that she received on October 23, 2014, and/or the Tdap vaccine that she received on November 18, 2015, caused her to develop ADEM. See generally Pet’r Pet. On October 31, 2019, the special master denied petitioner’s claim for compensation under the Vaccine Act. See generally October 31, 2019, Decision. 1. Petitioner’s Medical History Petitioner’s medical history is discussed in detail in the special master’s October 31, 2019, Decision and is briefly summarized here. October 31, 2019, Decision at 3-8. Petitioner received the influenza vaccine on October 23, 2014, at approximately 7:00 a.m. Pet’r Ex. 1(c) at 00036. Later that day, petitioner was treated at the emergency room for visual disturbances in both eyes that had presented after receiving the influenza vaccine. Id. At the time, petitioner stated her belief that she was suffering from an allergic reaction to the vaccination. Id. But, petitioner’s treating physician assistant disagreed and directed petitioner to follow up with her primary care physician. Id. at 000036-37. On December 5, 2014, petitioner presented to her primary care physician, Charles Burger, M.D., to discuss her post-traumatic distress disorder and related symptoms that she believed had been triggered by an allergic reaction to the influenza vaccine. Pet’r Ex. 1(f) at 000003. During this visit, Dr. Burger referred petitioner to a psychiatrist, David Breer, M.D., without prescribing any medication. Id. 1 The facts recounted in this Memorandum Opinion and Order are taken from the petitioner’s petition (“Pet’r Pet.”); petitioner’s motion for review (“Pet’r Mot. for Rev.”) and memorandum in support thereof (“Pet’r Mem.”); petitioner’s exhibits (“Pet’r Ex.”); the Secretary’s exhibits (“Resp’t Ex.”); and the Special Master’s October 31, 2019, Decision (“October 31, 2019, Decision”). Except where otherwise noted, the facts recited herein are undisputed. 2 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 3 of 22 On January 22, 2015, petitioner presented to Dr. Breer, describing “significant recent physical symptoms which have contributed to feelings of anxiety and being overwhelmed with stress.” Pet’r Ex. 7 at 1. During this appointment, petitioner stated a concern that her “ocular respiratory” symptoms were related to the influenza vaccine. Id. at 2. On November 18, 2015, petitioner received the Tdap vaccine during a visit with a new primary care physician, David Preston, M.D. Pet’r Ex. 1(a) at 000073. During this visit, petitioner mentioned having a hemifacial spasm since birth and she was referred to physical therapy for “longstanding neck discomfort and limitation of range of motion.” Id. at 000070. Petitioner did not raise concerns about any neurological symptoms, or state that she previously experienced an adverse reaction to the influenza vaccine during the visit. Id. at 000070-73. On December 10, 2015, petitioner began physical therapy and stated to her physical therapist that her neck pain began five years prior without associated trauma. Pet’r Ex. 1(b) at 000039. After the completion of petitioner’s physical therapy, petitioner presented to Dr. Preston, reporting that her neck pain had been alleviated, but also reporting “a new problem, in that she gets intermittent tingling and numbness of the toes of both feet.” Pet’r Ex. 1(a) at 000067. Dr. Preston concluded that petitioner’s symptoms were “consistent with an early sensory peripheral neuropathy” and “most consistent with the carpal tunnel syndrome.” Id. at 000068. And so, Dr. Preston directed petitioner to wear wrist splints at night to control the symptoms. Id. On March 2, 2016, petitioner reported to Dr. Preston for a follow-up visit and she reported that the tingling in her hands and, especially her feet, had worsened. Id. at 000064. At this time, petitioner raised a concern that these symptoms were an autoimmune response to her receipt of the Tdap vaccine on November 18, 2015. Id. Dr. Preston concluded that the “fluctuating nature” of petitioner’s symptoms and the simultaneous experience in the hands and feet “would possibly argue against a peripheral neuropathy and more towards an anxiety reaction.” Id. at 000065. And so, he referred petitioner to Robert Stein, M.D. for a neurology consultation. Id. On April 20, 2016, petitioner presented to Dr. Stein and she reported that “[o]ne and a half hours after the flu shot [in October 2014] she developed shortness of breath and blurring of her eye site.” Pet’r Ex. 5 at 1. Petitioner also reported that her symptoms alleviated within two 3 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 4 of 22 and one-half hours of their onset. Id. After receiving the influenza vaccine in 2014, and again after receiving the Tdap vaccine in 2015, petitioner reported tingling in her “feet and hands and arms and legs” that developed over the following several days. Id. at 1-2. Dr. Stein assessed petitioner with paresthesias likely as the result of a peripheral neuropathic dysfunction stemming from a dependent small fiber polyneuropathy, migraine-like event, and a right hemifacial spasm. Id. at 4. And so, Dr. Stein concluded that the cause of petitioner’s symptoms was unlikely to be multiple sclerosis (“MS”). Id. On July 14, 2016, petitioner presented to Dr. Alexandra Degenhardt for a neurological consultation. Pet’r Ex. 1(b) at 000057-60. After reviewing petitioner’s medical history, Dr. Degenhardt took notice of the temporal proximity between petitioner receiving the influenza and Tdap vaccines and the onset of her symptoms. Id. at 000057. After reviewing a MRI and conducting a physical examination, Dr. Degenhardt diagnosed petitioner with non-infectious ADEM. Id. at 000060. In reaching this diagnosis, Dr. Degenhardt noted “mild cognitive and visual changes” that suggested some degree of a central nervous system (“CNS”) syndrome, “[a]lthough there is very little on brain MRI to diagnose ADEM.” Id. In this regard, Dr. Degenhardt found that petitioner’s symptoms suggest some degree of peripheral nervous syndrome. Id. And so, Dr. Degenhardt diagnosed the presentation of the peripheral nervous syndrome symptoms such as Guillain-Barre Syndrome-like (“GBS”) and linked its presentation to the Tdap and influenza vaccines. Id. On August 5, 2016, petitioner followed up with Dr. Preston, who disagreed with Dr. Degenhardt’s diagnosis. Pet’r Ex. 1(a) at 000059-62. Dr. Preston attributed petitioner’s symptoms to an anxiety and panic disorder. Id. at 000061. Thereafter, petitioner underwent a MRI of her cervical spine on September 9, 2016, which found “no intrinsic cord abnormality,” and she underwent an electromyography (“EMG”) on that same date resulting in “an essentially normal study.” Id. at 000036; Pet’r Ex. 1(c) at 000042-46. On September 12, 2016, petitioner followed up with Dr. Degenhardt, who noted that petitioner identified new cranial pressure, in addition to pre-existing recurring headaches, which could produce cognitive issues. Pet’r Ex. 1(a) at 000027. Dr. Degenhardt also noted that with ADEM, it is “[v]ery atypical to have prolonged associated symptoms, however, [petitioner] has 4 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 5 of 22 a mildly elevated protein which is abnormal and can indicate[] inflammation.” Id. at 000029. And so, Dr. Degenhardt ordered testing for autoimmune antibody mediated encephalopathies, which returned negative and without informative antibodies. Id. at 00004, 000029. During a follow-up appointment with Dr. Degenhardt, on December 5, 2016, petitioner was again assessed with a “[p]ossible ADEM-like reaction to vaccination,” following neuropsychology testing that detected a CNS issue and a lumber puncture that revealed elevated proteins. Pet. Ex. 1(a) at 000021-22. Dr. Degenhardt found the timing of the onset of petitioner’s symptoms to be of particular relevance to the diagnosis. Id. at 000021. Given this, Dr. Degenhardt concluded that petitioner was experiencing a “rare and an atypical presentation.” Id. On January 12, 2017, petitioner received a second opinion from Dr. Haatem Reda regarding the ADEM diagnosis. Pet’r Ex. 1(b) at 000046. Dr. Reda observed that petitioner’s “brain imaging findings . . . have been stable for at least 8 years and probably longer.” Id. at 000044. And so, Dr. Reda concluded that “if [petitioner] does have CNS demyelinating disease, it predates the vaccination in 2014 and the symptoms she developed at the time.” Id. Dr. Reda also concluded that the “differential diagnosis still includes prior [ADEM], though [MS] would be more likely on neuroimaging grounds.” Id. During a follow-up appointment with Dr. Degenhardt on February 16, 2017, Dr. Degenhardt disagreed with the conclusion of Dr. Reda that MS was more likely. Pet’r Ex. 1(a) at 000010. On June 5, 2018, Dr. Degenhardt reaffirmed her ADEM diagnosis, citing ongoing tingling in petitioner’s palms and left leg as well as occasional skin reactions around the Tdap injection site. Pet’r Ex. 3 at 000006. 2. Proceedings Before The Special Master On July 13, 2017, petitioner filed a petition under the Vaccine Act alleging that the influenza vaccine and/or the Tdap vaccine, caused her to develop ADEM. See generally Pet’r Pet. The Secretary submitted his Rule 4(c) report on April 23, 2018. See generally Resp’t Report. 5 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 6 of 22 i. Petitioner’s Submissions On July 16, 2018, petitioner submitted seven pages of medical records from Dr. Degenhardt. See generally Pet’r Ex. 3. On August 21, 2018, the special master ordered petitioner to file an expert report with supporting medical literature, because the initial report by Dr. Degenhardt did not “adequately address the issue of causation.” Order, dated Aug. 21, 2018 at 1. In the order, the special master directed that this report include, among other things: (1) the expert’s qualifications; (2) the materials reviewed in informing the expert’s opinion; (3) a summary of the pertinent medical facts; (4) an explanation of the relevant disease; (5) the expert’s theory of how the vaccination can cause the disease; (6) an analysis of relevant temporal considerations; (7) an explanation of the logical sequence of cause and effect; and (8) whether a non-vaccine factor could or did contribute to petitioner’s condition. Id. at 2-4. On October 2, 2018, petitioner notified the special master of the fact that Dr. Degenhardt would serve as her expert in the proceedings before the special master. Pet’r Notice, dated Oct. 2, 2018. On October 2, 2018, petitioner also submitted a one-page document from Dr. Degenhardt stating that petitioner’s ADEM diagnosis was based upon the presentation of petitioner as detailed in cited-to office notes. Pet’r Ex. 4. Dr. Degenhardt also stated that she did “not know if it is a[n] adjuvant in the vaccine that [petitioner] is reacting to, as it occur[r]ed after both a flu shot 10/2014 and a tetanus shot 11/2015, or if it is the actual superantigen.” Id. But, Dr. Degenhardt found that the “clear temporal relationship” between the vaccines and petitioner’s symptoms established ADEM as the most “consistent” diagnosis. Id. On October 15, 2018, the special master ordered petitioner to submit an expert report that complied with the special master’s August 21, 2018, Order. See generally Order, dated Oct. 15, 2018. On October 17, 2018, petitioner filed a final status report stating that she did not intend to submit any reports from non-treating experts. Pet’r Status Report, dated Oct. 17, 2018 at 2. On December 12, 2018, petitioner filed a motion for a ruling on the record and she submitted five exhibits, consisting of medical records, medical literature, and an affidavit in support of that motion. See generally Pet’r Mot. for Ruling on the Record; Pet’r Exs. 5-10. In her motion, petitioner argued that her two submitted medical articles—The spectrum of post- vaccination inflammatory CNS demyelinating syndromes, by Dimitrios Karussis and Panayiota 6 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 7 of 22 Petrou and Acute Disseminated Encephalomyelitis following Vaccination against Hepatitis B in a Child: A Case Report and Literature Review, by Jun-liang Yuan, et al.—establish a “valid medical theory as to how vaccinations can cause an immunological inflammatory response.” Pet’r Mot. for Ruling on the Record at 9; see also Pet’r Exs. 6, 9. Petitioner also submitted a letter from Dr. Degenhardt, which states that vaccinations can cause ADEM and that petitioner’s history of symptoms are “most consistent with recurrent symptoms of ADEM.” Pet’r Ex. 8. Dr. Degenhardt’s letter also states that “I have diagnosed [petitioner] with ADEM, as a reaction to her vaccinations.”2 Id. ii. The Secretary’s Expert Report On March 27, 2019, the Secretary submitted an expert report by Dr. Subramaniam Sriram, a Professor of Neurology and Microbiology Immunity at Vanderbilt Medical Center and the head of the Multiple Sclerosis Clinic, and one piece of medical literature.3 See generally Resp’t Exs. A, C. In his expert report, Dr. Sriram opined that “the neurological symptoms suffered by [petitioner] were not related to the receipt of her flu or Tdap . . . vaccines.” Resp’t Ex. A at 7. Dr. Sriram’s expert report also questioned petitioner’s ADEM diagnosis, because Dr. Sriram found that petitioner did not meet the criteria for ADEM. Id. at 5-6. In this regard, Dr. Sriram observed that the “only objective finding [with regards to petitioner’s symptoms] is a mild left sided weakness of uncertain etiology.” Id. at 5. Dr. Sriram also questioned the alleged connection between the vaccines and petitioner’s symptoms. Id. In this regard, Dr. Sriram observed the mild left side weakness was first noted by Dr. Degenhardt in July 2016, and that the weakness was also present when Dr. Reda saw petitioner on January 19, 2017. Id. And so, Dr. Sriram opined that the weakness experienced by petitioner must have occurred after April 2016, which was 16 months after petitioner received the influenza vaccination and six months after she received the tetanus vaccination. Id. 2 On April 24, 2019, petitioner filed a reply along with an additional affidavit and two additional exhibits in support of her motion. See generally Pet’r Reply to Mot. for Ruling on the Record; Pet’r 2nd Aff.; Pet’r Exs. 11, 12. 3 Dr. Sriram holds board certifications in internal medicine and neurology. Resp’t Ex. B at 1. 7 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 8 of 22 Dr. Sriram also opined that petitioner was not suffering from ADEM, because the MRI images of petitioner’s brain, both prior to and subsequent to the vaccinations, were: [N]ot consistent with the diagnosis of CNS demyelinating disease, either acute (ADEM) or subacute chronic (MS). The MRI images are more likely patterns seen in patients with chronic migraine, which the patient suffered from. Id.4 In addition, Dr. Sriram opined that petitioner’s other stated symptoms were inconsistent with ADEM. Id. Notably, Dr. Sriram observed that petitioner’s “transient loss of vision in both eyes which lasted a few hours” following the influenza vaccination, “is inconsistent with the time line necessary for the development of an autoimmune response.” Id. at 5-6. And so, Dr. Sriram concluded that petitioner’s lack of noted change in the level of consciousness, encephalopathy, behavioral changes, or other fulfilment of other key criteria listed in the “[c]onsensus definition for ADEM” were determinate in concluding petitioner did not suffer from ADEM related to the vaccines at issue. Id. at 5-7. 3. The Special Master’s Decision On October 31, 2019, the special master issued a decision denying petitioner’s motion for a ruling on the record. See generally October 31, 2019, Decision. In the decision, the special master found that petitioner failed to meet her burden of proof under Prongs 1, 2 and 3 of Althen. Id. at 15-19. And so, the special master dismissed petitioner’s Vaccine Act claim for insufficient proof. Id. at 19. With regards to Althen Prong 1, the special master determined that petitioner failed to demonstrate that either the influenza or the Tdap vaccines could cause her ADEM, because petitioner did not present a medical theory causally connecting either of the vaccines at issue to her injury. Id. at 15. Specifically, the special master identified two deficiencies in Dr. Degenhardt’s opinion: First, the special master found that Dr. Degenhardt’s assertion of a causal link between the vaccines and ADEM was “superficial,” due to the lack of clarity of Dr. Degenhardt’s statements regarding whether one or both of the vaccines at issue caused petitioner’s ADEM. Id. at 16. In this regard, the special master found that Dr. Degenhardt 4 Dr. Sriram’s expert report states that “ADEM is an acute monophasaic disease, which is often fulminant in nature, occurring usually under the age of 10.” Resp’t Ex. A at 5. 8 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 9 of 22 failed to: (1) identify a discrete mechanism for how the vaccination(s) caused ADEM; (2) discuss relevant temporal considerations; and (3) cite to supporting medical literature. Id. Second, the special master found that Dr. Degenhardt’s qualifications as an expert were not adequately demonstrated during the proceedings before the special master. Id. Specifically, the special master noted the absence of a curriculum vitae, resume, or other form of documentation detailing Dr. Degenhardt’s educational and professional background. Id. And so, the special master concluded that Dr. Degenhardt’s “opinions and reports are not persuasive evidence to meet Petitioner’s burden under Althen prong one.” Id. With regards to the medical literature submitted by petitioner, the special master also found that the two articles petitioner submitted to support her claim were insufficient to show causation. Id. Specifically, the special master observed that the Karussis and Petrou article relied upon by petitioner did not examine the viability of the hypotheses regarding how vaccines can cause ADEM. Id. In this regard, the special master noted that the article explicitly states that, “‘despite a close temporal relation[ship] to vaccinations, there is no concrete evidence of a clear pathogenic correlation’ between vaccinations and ADEM.” Id. at 16-17 (citing Pet’r Ex. 6 at 3). With regards to the Yuan article, which details vaccination-induced ADEM after receipt of the Hepatitis B vaccination, the special master found that this article was not instructive because petitioner failed to explain how the Hepatitis B vaccine was similar to either the influenza or Tdap vaccines, or how petitioner was similarly situated to the child involved in the case study addressed in that article. October 31, 2019, Decision at 17; see also Pet’r Ex. 9. The special master similarly found that the existence of a temporal link between the timing of petitioner’s vaccinations and the onset of her symptoms alone was insufficient to support a finding under Althen Prong 1, absent separate evidence addressing causation. October 31, 2019, Decision at 17. In this regard, the special master observed that the immediate onset of petitioner’s symptoms following administration of the vaccinations was inconsistent with the Karussis and Petrou article, which states that symptoms “appear [a] few days following the immunization (mean: 14.2 days) but there are cases where the clinical presentation was delayed (more than 3 weeks or even up to 5 months post-vaccination) . . . .” Id.; Pet’r Ex. 6 at 1. And so, the special master concluded that the record evidence was insufficient to meet petitioner’s 9 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 10 of 22 burden to show a medical theory causally connecting the vaccines at issue in this case to her injury. October 31, 2019, Decision at 17. With regards to Althen Prong 2, the special master similarly determined that petitioner did not meet her burden to demonstrate a logical sequence of cause and effect showing that the vaccines at issue were the reason for her injury. Id. In making this determination, the special master rejected petitioner’s argument that the evidence showing the proximity between the timing of her vaccinations and the onset of her symptoms is sufficient to satisfy Althen Prong 2. Id. Notably, the special master found that “Dr. Degenhardt’s filings do not adequately explain why she believed Petitioner suffered from ADEM nor what criteria she used to diagnose Petitioner with ADEM.” Id. The special master also observed that Dr. Degenhardt’s report did not directly respond to the contrary opinions of petitioner’s other physicians, Dr. Reda and Dr. Preston, or respond to Dr. Sriram’s finding that petitioner did not meet the criteria for ADEM. Id. at 18. Lastly, with regards to Althen Prong 3, the special master determined that petitioner did not demonstrate “an appropriate temporal relationship between [her] vaccines and her alleged injury.” Id. Specifically, the special master determined that Dr. Degenhardt failed to “define[] the applicable onset window,” or to address the two week time period for the onset of symptoms addressed in the Karussis and Petrou article, in light of the facts in this case regarding the immediate onset of petitioner’s symptoms. Id.5 And so, the special master concluded that petitioner also had not shown a proximate temporal relationship between the vaccinations at issue and her injury. Id. at 18-19. Because the special master concluded that petitioner had not met her burden to show that either of the vaccines at issue caused her injury, the special master dismissed petitioner’s claim for insufficient proof. Id. at 19. Petitioner, alleging error, seeks review of the special master’s decision. See generally Pet’r Mot. for Rev.; Pet’r Mem. 5 The special master also noted that Dr. Sriram opined that “vaccine-induced ADEM would require at least seven-to-ten days” before the onset of symptoms. October 31, 2019, Decision at 18 (citing Resp’t Ex. A at 6). 10 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 11 of 22 B. Procedural History On November 20, 2019, petitioner filed a motion for review of the special master’s October 31, 2019, Decision, and a memorandum in support thereof. See generally Pet’r Mot. for Rev.; Pet’r Mem. The Secretary responded to the motion for review on December 19, 2019. See generally, Resp’t Resp. Petitioner filed a reply in support of her motion on January 6, 2020. See generally Pet’r Reply. The petitioner’s motion for review having been fully briefed, the Court resolves the pending motion. III. STANDARDS FOR DECISION A. Vaccine Act Claims The United States Court of Federal Claims has jurisdiction to review the record of the proceedings before a special master and, upon such review, may: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision, (B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or (C) remand the petition to the special master for further action in accordance with the court’s direction . . . . 42 U.S.C. § 300aa–12(e)(2). The special master’s determinations of law are reviewed de novo. Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1373 (Fed. Cir. 2009). The special master’s findings of fact are reviewed for clear error. Id. (citation omitted); see also Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010) (“We uphold the special master’s findings of fact unless they are arbitrary or capricious.”). The special master’s discretionary rulings are reviewed for abuse of discretion. Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). In addition, a special master’s findings as to the probative value of the evidence and the credibility of witnesses will not be disturbed so long as they are “supported by substantial 11 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 12 of 22 evidence.” Doe v. Sec’y of Health & Human Servs., 601 F.3d 1349, 1355 (Fed. Cir. 2010); see also Burns v. Sec’y of Dep’t of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that the decision of whether to accord greater weight to contemporaneous medical records or later given testimony is “uniquely within the purview of the special master”). This “level of deference is especially apt in a case in which the medical evidence of causation is in dispute.” Hodges v. Sec’y of Dep’t of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993). In evaluating the reliability of evidence, a special master may “determine whether the testimony has a reliable basis in the knowledge and experience of the relevant discipline.” Terran ex rel. Terran v. Sec’y of Health & Human Srvs., 195 F.3d 1302, 1316 (Fed. Cir. 1999) (citations omitted) (internal edits omitted). And so, the Court will not substitute its judgment for that of the special master, “if the special master has considered all relevant factors, and has made no clear error of judgment.” Lonergan v. Sec’y of Dep’t of Health & Human Servs., 27 Fed. Cl. 579, 580 (1993). Under the Vaccine Act, the Court must award compensation if a petitioner proves, by a preponderance of the evidence, all of the elements set forth in 42 U.S.C. § 300aa–11(c)(1), unless there is a preponderance of evidence that the illness is due to factors unrelated to the administration of the vaccine. 42 U.S.C. § 300aa–13(a)(1). A petitioner can recover either by proving an injury listed on the Vaccine Injury Table (the “Table”), or by proving causation-in- fact. See 42 U.S.C. § 300aa–11(c)(1)(C); Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). And so, to receive compensation under the National Vaccine Injury Compensation Program, a petitioner must prove either that: (1) the petitioner suffered a “Table Injury” that corresponds to one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) the petitioner’s illnesses were actually caused by a vaccine. See 42 U.S.C. §§ 300aa–11(c)(1)(C)(i)-(ii), 300aa–13(a)(1)(A), 300aa–14(a); see also Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1319-20 (Fed. Cir. 2006). In Table and non-Table cases, a petitioner bears a “preponderance of the evidence” burden of proof. 42 U.S.C. § 300aa–13(a)(1)(A); Althen, 418 F.3d at 1278 (citing Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)). And so, a petitioner must offer evidence that leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the 12 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 13 of 22 burden to persuade the [judge] of the fact’s existence.” Moberly, 592 F.3d at 1322 n.2 (brackets existing) (internal quotation omitted) (citation omitted); see also Snowbank Enter., Inc. v. United States, 6 Cl. Ct. 476, 486 (1984) (holding that mere conjecture or speculation is insufficient under a preponderance standard). To establish a prima facie case when proceeding on a causation-in-fact or a significant aggravation theory, a petitioner must “prove, by a preponderance of the evidence, that the vaccine was not only a but-for cause of the injury but also a substantial factor in bringing about the injury.” Shyface, 165 F.3d at 1352. In addition, petitioner must prove by a preponderance of the evidence: (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 the vaccination and the injury. Althen, 418 F.3d at 1278. But, medical or scientific certainty is not required. Knudsen by Knudsen v. Sec’y of Dep’t of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). In Althen, the Federal Circuit addressed the three elements to prove causation-in-fact. Althen, 418 F.3d at 1278. The Federal Circuit has also held that all three elements “must cumulatively show that the vaccination was a ‘but-for’ cause of the harm, rather than just an insubstantial contributor in, or one among several possible causes of, the harm.” Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). In addition, if a petitioner establishes a prima facie case, the burden shifts to the Secretary to show, by a preponderance of the evidence, that the injury was caused by a factor unrelated to the vaccine. See 42 U.S.C. § 300aa–13(a)(1)(B); Shalala v. Whitecotton, 514 U.S. 268, 270-71 (1995). But, regardless of whether the burden of proof ever shifts to the Secretary, the special master may consider the evidence presented by the Secretary in determining whether the petitioner has established a prima facie case. See Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373, 1379 (Fed. Cir. 2012) (“[E]vidence of other possible sources of injury can be relevant not only to the ‘factors unrelated’ defense, but also to whether a prima facie showing has been made that the vaccine was a substantial factor in causing the injury in question.”); de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1353 (Fed. Cir. 2008) (“The government, like any defendant, is permitted to offer evidence to demonstrate the inadequacy of the petitioner’s evidence on a requisite element of the petitioner’s case[-]in-chief.”). 13 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 14 of 22 B. Vaccine Rule 8 Vaccine Rule 8(d) of the Rules of the United States Court of Federal Claims (“RCFC”) provides that: The special master may decide a case on the basis of written submissions without conducting an evidentiary hearing. Submissions may include a motion for summary judgment, in which event the procedures set forth in RCFC 56 will apply. RCFC App. B, Rule 8(d). And so, special masters may rule on the record without conducting an evidentiary hearing in a Vaccine Act case. See Simanski v. Sec’y of Health & Human Servs., 671 F.3d 1368, 1371 (Fed. Cir. 2012) (noting that “the Vaccine Rules provide that the special masters can decide cases on written submissions, including, in appropriate cases, by summary judgment”); Kreizenbeck v. Sec'y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (affirming no due process problem when the special master ruled on the record, without the consent of a party, after determining the record was comprehensive and fully developed). IV. LEGAL ANALYSIS In her motion for review, petitioner objects to the special master’s conclusion that she did not meet her burden of proof in this Vaccine Act case due to the lack of an expert opinion. Pet’r Mem. at 2. Specifically, petitioner argues that the special master erred by refusing to consider the testimony and opinions of her treating physician, Dr. Degenhardt, and by ordering petitioner to hire an expert. Id. at 11-19. In addition, petitioner contends that the special master erred by not holding an evidentiary hearing in this case. Id. at 2. And so, petitioner requests that the Court set aside the special master’s October 31, 2019, Decision, or remand this matter to the special master for further proceedings. Id. at 19-20. The Secretary counters that the special master’s decision to dismiss petitioner’s claim for insufficient proof is supported by the record evidence and that the special master reasonably determined that petitioner failed to meet her burden of proof under Prongs 1, 2 and 3 of Althen. Resp’t Resp. at 13-20. And so, the Secretary requests that the Court deny petitioner’s motion for review and sustain the decision of the special master. Id. at 20. For the reasons discussed below, the evidentiary record in this matter shows that the special master appropriately considered and reasonably weighed the opinions of Dr. Degenhardt 14 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 15 of 22 and applied the correct burden of proof in analyzing petitioner’s claims under Althen. The record evidence also shows that the special master did not abuse her discretion in declining to conduct an evidentiary hearing in this matter. And so, the Court: (1) DENIES petitioner’s motion for review and (2) SUSTAINS the decision of the special master. A. The Special Master’s Decision To Dismiss Petitioner’s Claim For Insufficient Proof Was Reasonable And Supported By The Substantial Record Evidence Petitioner’s primary objection in this matter is that the special master erred in finding that petitioner had not meet her burden of proof under Althen, due to the lack of an expert opinion. Pet’r Mem. at 2. Specifically, petitioner argues that the special master refused to consider the opinions and reports of Dr. Degenhardt and erred by ordering petitioner to hire an expert. Id. at 11-12. The evidentiary record shows, however, that the special master appropriately considered and weighed the evidence in this case and reasonably determined that petitioner had not met her burden of proof under Althen. And so, the Court will not disturb the findings of the special master. 1. The Special Master Reasonably Determined That Petitioner Did Not Satisfy Althen Prong 1 As an initial matter, the record evidence shows that the special master adequately considered and appropriately weighed the opinions of Dr. Degenhardt regarding the alleged connection between the vaccines at issue and petitioner’s ADEM diagnosis. The Court will not disturb the special master’s findings regarding the probative value of Dr. Degenhardt’s opinions and reports, so long as those findings are “supported by substantial evidence.” Doe v. Sec’y of Health & Human Servs., 601 F.3d 1349, 1355 (Fed. Cir. 2010); see also Burns v. Sec’y of Dep’t of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that the decision of whether to accord greater weight to contemporaneous medical records or later given testimony is “uniquely within the purview of the special master”). In the October 31, 2019, Decision, the special master found the two opinions provided by Dr. Degenhardt to be of limited probative value, because Dr. Degenhardt’s assertion of a causal link between the vaccines at issue and ADEM was “superficial.” October 31, 2019, Decision at 15-16. Specifically, the special master found that Dr. Degenhardt failed to: (1) establish whether either the influenza or Tdap vaccine, or both, caused petitioner’s ADEM; (2) 15 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 16 of 22 identify a causal mechanism for how either vaccine, or both vaccines, cause ADEM; (3) discuss relevant temporal considerations; (4) cite to supporting medical literature; and (5) provide her qualifications to opine on the issue of causation as an expert witness. Id. at 16. The special master also found that Dr. Degenhardt’s qualifications as an expert were not adequately demonstrated during the proceedings before the special master, due to the absence of a curriculum vitae, resume, or other form of documentation detailing Dr. Degenhardt’s educational and professional background. Id. And so, the special master concluded that Dr. Degenhardt’s “opinions and reports are not persuasive evidence to meet Petitioner’s burden under Althen prong one.” Id. The special master’s decision to afford limited weight to Dr. Degenhardt’s opinions is supported by the substantial record evidence. A careful review of Dr. Degenhardt’s two opinions shows that Dr. Degenhardt did not explain whether she believed that the influenza or Tdap vaccine—or both vaccines—caused petitioner’s ADEM. See Pet’r Exs. 4, 8. As the special master correctly observed in the October 31, 2019, Decision, Dr. Degenhardt’s two opinions also do not address a mechanism for how either vaccine—or a combination thereof— could cause ADEM. October 31, 2019, Decision at 16. In fact, Dr. Degenhardt acknowledges in her first opinion that: I do not know if it is a[n] adjuvant in the vaccine that [petitioner] is reacting to, as it occur[r]ed after a flu shot 10/2014 and tetanus shot 11/2015, or if it is the actual superantigen. However, there is a clear temporal relationship between the vaccinations and her symptoms, and so the most consistent diagnosis is ADEM. Pet’r Ex. 4. Dr. Degenhardt’s second opinion is similarly lacking with regards to establishing a medical theory of causation, because this opinion simply states “[a]s is commonly known in medicine and public health, vaccinations can cause [ADEM].” Pet’r Ex. 8. The record evidence also supports the special master’s determination that Dr. Degenhardt failed to discuss relevant temporal considerations with regards to petitioner’s medical theory of causation. As the special master observed in the October 31, 2019 Decision, Dr. Degenhardt “did not discuss what an appropriate temporal relationship would be for the flu or Tdap vaccines to be linked to the development of ADEM” in either of her opinions. October 31, 2019, Decision at 16; see also Pet’r Exs. 4, 8. The special master also correctly observed 16 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 17 of 22 that Dr. Degenhardt failed to cite to any supporting medical literature to substantiate the view that the vaccines at issue caused petitioner’s ADEM. Id.6 Given this, the substantial evidence in the record supports the special master’s determination that Dr. Degenhardt’s opinions and reports were not persuasive evidence to meet petitioner’s burden under Althen Prong 1.7 October 31, 2019, Decision at 16. The special master also reasonably concluded that the medical literature submitted by petitioner did not advance a reliable medical theory of causation in this case. See October 31, 2019, Decision at 16-17. In the October 31, 2019, Decision, the special master correctly observed that the Karussis and Petrou article upon which petitioner relies does not establish causation, because this article fails to examine the viability of the hypotheses of how the vaccines at issue can cause ADEM. Id.; Pet’r Ex. 6 at 2-3. The special master also correctly observed that the Yuan article, upon which petitioner also relies, was unhelpful, because neither petitioner nor the article explain how the Hepatitis B vaccine is like the influenza and/or Tdap vaccines, or how petitioner, who is an adult, is similarly situated to the child addressed in that article. October 31, 2019, Decision at 16-17; see also Pet’r Ex. 9.8 6 Petitioner’s reliance upon Capizzano v. Sec'y of Health & Human Servs., to establish a medical theory of causation is also misplaced. Pet’r Mem. at 9-10, 12. Capizzano addresses the weight afforded to the opinion of a treating physician in satisfying Althen Prong 2. Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). 7 The Court is also not persuaded by petitioner’s argument that the special master failed to properly consider and weigh the temporal evidence in this case. Pet’r Mem. at 15-17. In the October 31, 2019, Decision, the special master found that the evidence that petitioner offered to show that her symptoms occurred immediately after receiving the influenza and Tdap vaccines was not alone sufficient to establish causation. October 31, 2019, Decision at 17. The Federal Circuit has long held that “a proximate temporal association alone does not suffice to show a causal link between the vaccination and the injury.” Grant v. Sec'y of Dep't of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). And so, the special master appropriately concluded that petitioner had not established a causal link between the influenza and Tdap vaccines and her injury. 8 Petitioner’s reliance upon Mondello v. Sec'y of Dep't of Health & Human Servs., to argue that the special master erred by affording limited weight to Dr. Degenhardt’s opinions, is also misplaced. Pet’r Mem. at 18-19; Mondello v. Sec'y of Dep't of Health & Human Servs., 132 Fed. Cl. 316 (2017). In Mondello, the Court reversed the special master’s decision to deny a vaccine injury claim because, “[b]y emphasizing the fact that petitioner did not submit an outside expert opinion and by not taking account of the relevant medical and scientific literature, the Special Master impermissibly raised petitioner's burden of providing a medical theory beyond that of biological plausibility . . . .” Mondello, 132 Fed. Cl. at 321. But, in this case, there is no evidence that the special master relied upon the fact that petitioner did not have an outside expert, or that the special master ignored the relevant medical and 17 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 18 of 22 Because the evidentiary record makes clear that the special master appropriately considered and weighed the opinions and reports of Dr. Degenhardt—and the other evidence submitted by the parties in this case—in analyzing petitioner’s Vaccine Act claim, petitioner has not shown that the special master erred by concluding that petitioner failed to meet her burden of proof under Althen Prong 1. 2. The Special Master Reasonably Determined That Petitioner Failed To Satisfy Althen Prong 2 The record evidence similarly shows that the special master reasonably concluded that petitioner failed to prove a logical sequence of cause and effect showing that the influenza and/or Tdap vaccines were the reason for her injury. Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005) (stating that, to satisfy Althen Prong 2, petitioner must prove by preponderant evidence “a logical sequence of cause and effect showing that the vaccination was the reason for the injury”). In the October 31, 2019, Decision, the special master rejected petitioner’s argument that evidence showing a proximate temporal relationship between her receipt of the influenza and Tdap vaccines and the onset of symptoms was sufficient to satisfy Althen Prong 2. October 31, 2019, Decision at 17-18. The special master also found that the totality of the evidence in this case did not establish that petitioner suffers from ADEM, because “Dr. Degenhardt’s filings do not adequately explain why she believed Petitioner suffered from ADEM nor what criteria she used to diagnose Petitioner with ADEM.” Id. at 17. In this regard, the special master observed that Dr. Degenhardt’s opinions and reports do not directly respond to the contrary opinions of petitioner’s other treating physicians, Dr. Reda and Dr. Preston, and the expert opinion of Dr. Sriram, regarding petitioner’s ADEM diagnosis. Id. at 18. And so, the special master concluded that petitioner failed to meet her burden under Althen Prong 2. Id. The special master’s conclusion is supported by the evidentiary record. As discussed above, the special master correctly concluded that the evidence showing a proximate temporal relationship between petitioner’s receipt of the influenza and Tdap vaccines and the onset of her scientific literature, in reaching her decision to dismiss petitioner’s claim for insufficient proof. See generally October 31, 2019, Decision. 18 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 19 of 22 symptoms was insufficient to meet her burden of proof in this case. See Grant v. Sec'y of Dep't of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992) (holding that “a proximate temporal association alone does not suffice to show a causal link between the vaccination and the injury”). The special master also reasonably concluded that Dr. Degenhardt’s ADEM diagnosis lacks support, when considered in light of the totality of the evidentiary record in this case. October 31, 2019, Decision at 18. In this regard, a careful review of Dr. Degenhardt’s two opinions reveals that Dr. Degenhardt failed to state the diagnostic criteria that she employed in diagnosing petitioner with ADEM, or to explain how this diagnosis was made without a prior finding that petitioner had developed an encephalopathy—a requirement for an ADEM diagnosis. Pet’r Exs. 4, 8. It is also noteworthy that petitioner’s other treating physicians, Dr. Preston and Dr. Reda, both disagree with Dr. Degenhardt’s ADEM diagnosis. Pet’r Ex. 1(a) at 000065 (finding that petitioner’s symptoms were related to her anxiety problems); Pet’r Ex. 1(b) at 000044 (finding that petitioner was more likely to have MS). During the proceedings before the special master, Dr. Sriram also opined that petitioner’s symptoms and neuroimaging results are inconsistent with an ADEM diagnosis. Resp’t Ex. A at 5. Given the substantial evidence calling into question petitioner’s ADEM diagnosis, the special master reasonably concluded that petitioner had not met her burden under Althen Prong 2. 3. The Special Master Reasonably Determined That Petitioner Failed To Satisfy Althen Prong 3 Lastly, the record evidence also makes clear that the special master reasonably concluded that petitioner failed to prove an appropriate, proximate temporal relationship between the two vaccines at issue and her injury. Althen, 418 F.3d at 1278 (stating that, under Althen Prong 3, petitioner must prove by preponderant evidence “a showing of a proximate temporal relationship between the vaccination and the injury”). In the October 31, 2019, Decision, the special master determined that petitioner did not demonstrate “an appropriate temporal relationship between [her] vaccines and her alleged injury,” because Dr. Degenhardt did not “define[] the applicable onset window,” or address how to reconcile the two-week onset time period discussed in the Karussis and Petrou article with evidence regarding the immediate onset of petitioner’s symptoms in this case. October 31, 2019, Decision at 18; see also Pet’r Ex. 6 at 2 (stating that “[u]sually the symptoms . . . appear [a] few days following the immunization 19 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 20 of 22 (mean: 14.2 days[]) but there are cases in which the clinical presentation was delayed (more than 3 weeks or even up to 5 months post-vaccination)”). As discussed above, Dr. Sriram also opined in his expert report that vaccine-induced ADEM would require at least seven-to-ten days before the onset of symptoms—such an onset window would be several days after the timing of the onset of symptoms alleged by petitioner in this case. Resp’t Ex. A at 6. And so, the special master concluded that petitioner had not shown a proximate temporal relationship between the vaccinations at issue and her injury. The record evidence supports the findings of the special master. A review of Dr. Degenhardt’s two opinions shows that Dr. Degenhardt failed to identify either a specific time period for the onset of petitioner’s symptoms or to show a link between the vaccines and petitioner’s ADEM. See generally Pet’r Exs. 4, 8. Petitioner also has not addressed or reconciled the difference between the two-week onset window identified in the Karussis and Petrou article and the immediate onset of symptoms following the vaccinations in this case. See Pet’r Mem. at 8-19 (showing that petitioner does not address this difference).9 Nor has petitioner addressed or challenged Dr. Sriram’s expert opinion, that the onset of petitioner’s symptoms should have occurred within 7-10 days after receiving the vaccines. Id. Given this, the special master reasonably concluded that petitioner failed to satisfy her burden under Althen Prong 3. B. The Special Master Did Not Err By Declining To Conduct A Hearing As a final matter, petitioner’s objection to the special master’s decision not to hold an evidentiary hearing in this matter is unpersuasive. Pursuant to Vaccine Rule 8(d), “the special master may decide a case on the basis of written submissions without conducting an evidentiary hearing.” RCFC App. B, Rule 8(d); see also Simanski v. Sec’y of Health & Human Servs., 671 F.3d 1368, 1371 (Fed. Cir. 2012) (noting that “the Vaccine Rules provide that the special masters can decide cases on written submissions, including, in appropriate cases, by summary judgment”); Kreizenbeck v. Sec'y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (affirming no due process problem when the special master ruled on the record, without 9 The Karussis and Petrou article does not identify any instance of influenza vaccine-induced symptoms that occur earlier than four days after receipt of the vaccine, nor any instance of tetanus vaccine-induced symptoms that occur earlier than 15 days after receipt of the vaccine. Pet’r Ex. 6 at 4-5 (Table 2). 20 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 21 of 22 the consent of a party, after determining the record was comprehensive and fully developed). The Court reviews the special master’s decision regarding whether to conduct an evidentiary hearing in this case for abuse of discretion. Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). The evidentiary record in this case makes clear that the special master did not abuse her discretion in declining to hold an evidentiary hearing. It is undisputed that petitioner filed a motion for a ruling on the record, based upon the medical records, medical literature, opinions of Dr. Degenhardt and an affidavit that petitioner submitted to support her claim. See generally Pet’r Mot. for Ruling on the Record; Pet’r Aff.; see also Pet’r Exs. 5-10. While petitioner may have preferred that the special master had conducted an evidentiary hearing before resolving this case, she acknowledges that the special was under no obligation to do so in this case. Pet’r Mot. for Ruling on the Record at 1. The special master’s decision not to conduct an evidentiary hearing was reasonable. As discussed above, the record evidence in this case also shows that the special master carefully and appropriately considered all of the evidence submitted by the parties before ruling on petitioner’s motion for a ruling on the record. In fact, the special master allowed petitioner to submit an additional affidavit and medical records in support of her claim, after petitioner filed her motion for a ruling on the record. See generally Pet’r 2nd Aff.; see also Pet’r Exs. 11, 12. The record evidence also shows that petitioner did not provide sufficient evidentiary support for her claim that the influenza and/or Tdap vaccines caused her alleged ADEM. Given this, the Court declines to disturb the decisions of the special master. Because the evidentiary record in this matter shows that the special master appropriately weighed the evidence, reasonably concluded that petitioner failed to meet her burden of proof under Prongs 1, 2 and 3 of Althen and provided a rational basis for dismissing this matter for insufficient proof, the Court will not set aside the sound determination of the special master. V. CONCLUSION In sum, petitioner has not shown that the special master erred in considering and weighing the opinions of Dr. Degenhardt, or that the special master applied an incorrect burden of proof in analyzing petitioner’s claims under Althen. Petitioner has also not shown that the 21 Case 1:17-vv-00936-LKG Document 58 Filed 04/27/20 Page 22 of 22 special master abused her discretion in declining to conduct an evidentiary hearing in this matter. And so, for these reasons, the Court: 1. DENIES petitioner’s motion for review of the special master’s October 31, 2019, Decision; and 2. SUSTAINS the decision of the special master. The Clerk is directed to enter judgment accordingly. Some of the information contained in this Memorandum Opinion and Order may be considered privileged, confidential or sensitive personally-identifiable information that should be protected from disclosure. And so, this Memorandum Opinion and Order shall be FILED UNDER SEAL. The parties shall review the Memorandum Opinion and Order to determine whether, in their view, any information should be redacted prior to publication. The parties shall also FILE, by April 20, 2020, a joint status report identifying the information, if any, that they contend should be redacted, together with an explanation of the basis for each proposed redaction. IT IS SO ORDERED. s/Lydia Kay Griggsby LYDIA KAY GRIGGSBY Judge 22