VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-00752 Package ID: USCOURTS-cofc-1_15-vv-00752 Petitioner: Peter C. Harrington Filed: 2015-07-17 Decided: 2018-09-20 Vaccine: influenza Vaccination date: 2014-10-24 Condition: Guillain-Barré syndrome (GBS) Outcome: denied Award amount USD: AI-assisted case summary: On July 17, 2015, Peter C. Harrington filed a petition seeking compensation under the National Vaccine Injury Compensation Program, alleging that the influenza vaccine he received on October 24, 2014, caused him to develop Guillain-Barré syndrome (GBS). Mr. Harrington, age 40, had a history of hypertension, allergies, abdominal pain, and obesity, and had been treated for a sore throat, nasal congestion, body aches, and headaches the week prior to vaccination. Thirteen days after the vaccination, on November 6, 2014, he presented to the emergency room with complaints of heaviness, shortness of breath, and muscle weakness. He was diagnosed with anxiety, dysrhythmia, dehydration, anemia, and an electrolyte imbalance. He was admitted to the hospital on November 10, 2014, with persistent muscle weakness, discoordination, and dysphagia, and was evaluated by neurologist Dr. Marcus Schmitz, who considered the possibility of acute inflammatory polyneuropathy related to the vaccine but expressed skepticism about a GBS diagnosis. Diagnostic tests, including a lumbar puncture showing slightly elevated protein and normal white blood cell count, and MRIs of the brain and spinal cord, did not confirm GBS. He was treated with steroids and discharged on November 14, 2014, with a likely diagnosis of post-viral syndrome. He experienced a second hospital visit on November 18, 2014, for malaise and weakness, but no concerning problems were noted. He was seen by neurologist Dr. Henry Porter on November 19, 2014, who noted normal MRIs and stated that Petitioner's physical examinations were not consistent with GBS, though he included GBS as a possible diagnosis. Petitioner continued to experience symptoms and was diagnosed with anemia and vitamin B12 deficiency by Dr. Porter. By December 2014, a third neurologist, Dr. David Bear, found all nerve conduction studies to be within normal limits and no evidence of diffuse peripheral polyneuropathy. None of Mr. Harrington's treating physicians concluded he had GBS. On January 14, 2015, Dr. Porter noted Petitioner's symptoms had "completely resolved" and attributed them to weakness dating back to October 2014, with low B12 levels being treated. Subsequent records in 2015 and 2016 continued to note B12 deficiency, hypertension, fatigue, and paresthesia, but no GBS diagnosis or connection to the flu vaccine. Petitioner stated that his neurologists did not treat him for GBS because his symptoms were not typical and test results were not definitive, and he felt they were trying to avoid reporting it. He continued to experience fatigue, jaw weakness, tingling, body aches, difficulty concentrating, and mood changes, with normal test results. Petitioner's expert, Dr. William Shackelford, opined in two reports that Petitioner had a "typical Guillain-Barré reaction" caused by the flu vaccine, stating that treaters could find "no other cause" for his symptoms. Dr. Shackelford's reports were found to be conclusory and unsupported by scientific literature. Respondent's expert, Dr. Jeffrey Cohen, a neurologist, concluded that Petitioner's symptoms were inconsistent with GBS based on established diagnostic criteria, noting that Petitioner never displayed bilateral flaccid paralysis, had normal strength on examination, lacked decreased or absent reflexes, and experienced fluctuating symptoms inconsistent with the GBS nadir. Dr. Cohen suggested Petitioner's symptoms could be attributed to anxiety with hyperventilation. Special Master Brian H. Corcoran denied entitlement, finding that Petitioner failed to establish he had GBS or that the vaccine caused his symptoms. The Special Master found Dr. Shackelford's opinion unpersuasive and conclusory, and Dr. Cohen's opinion credible. The Special Master noted that while GBS was added to the Vaccine Injury Table for the flu vaccine after the petition was filed, Petitioner had not established he actually had GBS. The Special Master also found Petitioner failed to satisfy the three prongs of the Althen test for non-Table injuries, as Dr. Shackelford's causation theory was unreliable and unsupported, and there was no logical sequence of cause and effect demonstrated. Petitioner appealed the Special Master's decision. Senior Judge Mary Ellen Coster Williams of the Court of Federal Claims affirmed the Special Master's decision, finding that Petitioner failed to establish he had GBS for a Table claim and failed to establish causation in fact for a non-Table claim. The Court found the Special Master's assessment of the expert testimony, particularly the unpersuasiveness of Dr. Shackelford and the credibility of Dr. Cohen, was not arbitrary or capricious. The Court also noted that the absence of an alternate explanation does not establish causation. Petitioner's claim was denied. Theory of causation field: Petitioner Peter C. Harrington, age 40, received an influenza vaccine on October 24, 2014. He alleged that this vaccine caused Guillain-Barré syndrome (GBS). The public decision does not describe the specific mechanism by which the vaccine allegedly caused GBS. Petitioner's expert, Dr. William Shackelford, opined that the flu vaccine caused Petitioner's symptoms, which he characterized as a "typical Guillain-Barré reaction," stating that treaters could find "no other cause" for the symptoms. Respondent's expert, Dr. Jeffrey Cohen, a neurologist, concluded that Petitioner's symptoms were inconsistent with GBS based on established diagnostic criteria and could be attributed to anxiety with hyperventilation. The Special Master, Brian H. Corcoran, denied entitlement, finding that Petitioner failed to establish he had GBS and that Dr. Shackelford's opinion was unpersuasive and conclusory, while Dr. Cohen's opinion was credible. The Court of Federal Claims affirmed, agreeing that Petitioner failed to prove a Table injury (GBS) or causation in fact for a non-Table injury, and that the expert testimony was unpersuasive. Petitioner's claim was denied. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_15-vv-00752-0 Date issued/filed: 2018-03-01 Pages: 17 Docket text: PUBLIC DECISION (Originally filed: 1/19/2018) Regarding 26 DECISION of Special Master (Signed by Special Master Brian H. Corcoran). (cr) Service on parties made. -------------------------------------------------------------------------------- Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 1 of 17 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 15-752V (not to be published) * * * * * * * * * * * * * * * * * * * * * * * * * Special Master Corcoran * PETER C. HARRINGTON, * * Filed: January 19, 2018 Petitioner, * v. * Entitlement; Ruling on Record; * Influenza (“flu”) Vaccine; SECRETARY OF HEALTH * Guillain-Barré Syndrome (“GBS”). AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Jeffrey C. Adams, Largo, FL, for Petitioner. Amy Kokot, U.S. Dep’t of Justice, Washington, DC, for Respondent. DECISION DENYING ENTITLEMENT1 On July 17, 2015, Peter Harrington filed a petition seeking compensation under the National Vaccine Injury Compensation Program (“Vaccine Program”).2 In it, Mr. Harrington alleged that the influenza (“flu”) vaccine he received on October 24, 2014, caused him to develop Guillain- Barré syndrome (“GBS”). Petition (ECF No. 1) at 1. Respondent’s Rule 4(c) Report (filed June 10, 2016 (ECF No. 15)) proposed that in fact Petitioner had not experienced GBS. See Section 11(c)(1)(D). The parties subsequently filed dueling expert reports, and after my review of them, I determined that this case was best resolved on the papers rather than by hearing. To that end, Petitioner filed a brief in support of his claim, dated July 20, 2017 (ECF No. 24) (“Mem.”), and Respondent thereafter opposed Petitioner’s 1 Although this Decision has been formally designated “not to be published,” it will nevertheless be posted on the Court of Federal Claims’s website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012)). This means that the Decision will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa- 12(d)(4)(B), however, the parties may object to the Decision’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen 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). Otherwise, the whole Decision will be available to the public. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended, 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the Act”]. Individual section references hereafter will be to § 300aa of the Act. Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 2 of 17 entitlement to a damages award by brief dated August 31, 2017 (ECF No. 25) (“Opp.”). Having completed my review of the evidentiary record and the parties’ filings, I hereby DENY Petitioner’s request for compensation, for the reasons stated below. I. Factual Background A. Medical Records On October 24, 2014, Mr. Harrington received the flu vaccine at Graf Clinic in Pensacola, Florida. Ex. 3 at 20. At the time of the vaccination, Petitioner had a history of hypertension, allergies, abdominal pain and obesity. Ex. 2 at 8, 11-17. Earlier records also indicate treatment for a swollen toe, an ear infection, lightheadedness, body aches, congestion, eye twitching, dizziness, and a rash. Ex. 2 at 8-10, 16. In addition, the immediate week before (on October 17, 2014), Petitioner had been treated for a sore throat, nasal congestion, arthralgias, myalgias, and headaches. Id. at 18. He was ultimately diagnosed with an upper respiratory infection (“URI”) and proscribed antibiotics. Id. As of the October 17th visit, Petitioner’s medications also included Lisinopril, Bentyl, Claritin, and a multivitamin. Id. at 18. Two weeks after the vaccination, on November 6, 2014, Petitioner presented to the emergency room at West Florida Regional Medical Center with complaints of heaviness, shortness of breath, and muscle weakness in his arms and legs, although his physical exam indicated that he had no respiratory distress and his breathing appeared normal. Ex. 4 at 23-24, 26. A neurological examination was conducted, including a tomography of the brain, which revealed no evidence of acute intracranial abnormalities. Id. at 24, 27, 33. A chest x-ray was also conducted, displaying no radiographic evidence of an acute disease. Id. at 27, 34. Petitioner declined admission to the hospital, but was examined and ultimately diagnosed with anxiety, dysrhythmia, dehydration, anemia, and an electrolyte imbalance. Id. at 28. Petitioner returned to West Florida Hospital on November 10, 2014, now complaining of persistent muscle weakness, discoordination of the hands, and dysphagia, and was admitted. Ex. 5 at 36, 38-40; Ex. 7 at 95-96. Intake notes suggest that Mr. Harrington’s primary care physician requested that he be evaluated for GBS. Id. at 41. During this hospital stay, Petitioner was evaluated by Dr. Marcus Schmitz, a neurologist. Ex. 5 at 56. It was during this visit that Petitioner informed Dr. Schmitz that following the flu vaccine he began experiencing adverse symptoms, including paresthesia and numbness in his fingers, legs, and toes which eventually progressed to his chest and arms, and developed a sensation of breathing difficulty. Id. at 56. Petitioner also informed Dr. Schmitz that he believed he might have been exposed to a tick. Id. After an initial evaluation, Dr. Schmitz allowed for the possibility that Mr. Harrington’s symptoms were consistent with possible acute inflammatory polyneuropathy, or acute autoimmune neuropathy, and that these symptoms could be related to the flu vaccine, but expressed skepticism that Petitioner actually had GBS. Id. at 56-57. A physical exam conducted earlier that day also indicated that Mr. Harrington’s reflexes were “brisk and symmetric” and his coordination was normal. Id. at 54. 2 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 3 of 17 While at West Florida Hospital, Mr. Harrington underwent several diagnostic tests. A lumbar puncture was performed which showed slightly elevated protein levels in his cerebral spinal fluid (“CSF”), but otherwise displayed normal functions and a normal white blood cell count. Ex. 5 at 39, 59. The lumbar puncture did indicate gram-positive cocci3 in his CSF, but the treating physician attributed this to contamination of the equipment used to perform the procedure rather than to an underlying bacterial infection. Id. at 60. An MRI of Petitioner’s spinal cord was also conducted that revealed “questionable stenosis,” but otherwise normal imaging, and the treating neurologist did not propose a neurological problem as the source of Petitioner’s symptoms. Id. at 39, 59, 77. Petitioner also received an MRI of his brain, which similarly resulted in normal imaging, and contained no evidence of demyelination. Id. at 76. Petitioner was treated with steroids and discharged on November 14, 2014. The discharging physician, Dr. Tanner Eiden, opined that Mr. Harrington likely had a post-viral syndrome, possibly related to a viral URI or the flu vaccine he had received. Ex. 5 at 39. Petitioner’s primary care physician, Dr. Roger Henson, also examined Petitioner during this hospital stay. Ex. 7 at 95-96. After reviewing the admitting physician’s emergency room notes, Dr. Henson’s assessment included muscle weakness, dyspnea, tachycardia, and diarrhea. Id. at 96. Petitioner initially felt better after leaving the hospital, but then returned for a second hospital visit on November 18, 2014, with complaints of malaise, fever, weakness, and fatigue. Ex. 6 at 87. During this visit, Petitioner was seen by Jeffrey Chandler, a nurse practitioner, who reviewed the records and testing completed during Mr. Harrington’s hospital visit the week before, and also examined him. Id. at 92. Nurse Chandler did not find any concerning problems, and proposed that Petitioner should follow up with his primary care physician and treating neurologist. Id. Supervising physician Dr. Mark Brodeur reviewed Mr. Chandler’s findings and also noted no concerning problems. Id. The next day, on November 19, 2014, Mr. Harrington was seen by another neurologist, Dr. Henry Porter, for a post-hospitalization evaluation. Ex. 8 at 112. Dr. Porter noted that Petitioner reported experiencing weakness and difficulty moving his arms and legs, and difficulty breathing as well. Id. Dr. Porter reviewed all relevant testing conducted during Petitioner’s hospital stay, including the brain and spinal MRIs, both of which he noted indicated normal imaging. Id. Although Dr. Porter’s assessment included GBS as a possible diagnosis, his notes reiterated that “[Petitioner’s] physical examinations [were] not consistent with Guillain-Barre.” Id. at 114. Petitioner returned to see Dr. Henson on November 21, 2014, complaining of worsening episodes of weakness, tingling in in his lower legs, fatigue, chills, palpitations, and trouble swallowing. Ex. 7 at 97. Dr. Henson diagnosed Petitioner with muscle weakness, dyspnea, shortness of breath, and 3 Gram-positive cocci is a term used to indicate the presence of bacterial cells in the CSF. Dorland’s Illustrated Medical Dictionary 387-79, 801 (32nd ed. 2012). The presence of bacteria in a lumbar puncture can indicate a serious bacterial infection, such as meningitis or encephalitis. Lumbar Puncture (Spinal Tap): Why It’s Done, Mayo Clinic, https://www.mayoclinic.org/tests-procedures/lumbar-puncture/basics/why-its-done/prc-20012679 (last visited Jan. 14, 2018). 3 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 4 of 17 tachycardia. Id. at 98. Thereafter, Petitioner again presented to Dr. Porter, who diagnosed him with anemia and a vitamin B12 deficiency. Ex. 8 at 116. Dr. Porter recommended that Petitioner began receiving B12 injections to treat these conditions. Id. Not long thereafter, on December 12, 2014, Mr. Harrington saw a third neurologist, Dr. David Bear, with complaints of diffuse weakness, heaviness, difficulty breathing and loss of dexterity in the hands. Ex. 8 at 118. After examining Petitioner, Dr. Bear noted that all of Petitioner’s nerve conduction studies produced results within normal limits, and that all examined muscles showed no evidence of electrical instability. Id. Dr. Bear reiterated to Petitioner that his tests suggested no evidence of any lumbosacral radiculopathy, plexopathy, myopathy, or diffuse peripheral polyneuropathy. Id. Dr. Bear’s office notes do not mention a diagnosis. Thus, less than two months after receiving the flu vaccine, none of Mr. Harrington’s treaters had concluded that he was experiencing GBS. Even if some had initially proposed it might explain his symptoms, the testing he had received, coupled with medical examinations, had not corroborated that diagnosis. On January 14, 2015, Petitioner returned to Dr. Porter for a follow-up appointment for his complaints associated with muscle weakness. Ex. 8 at 122. After examination, Dr. Porter determined that Petitioner’s symptoms had “completely resolved,” and noted that Petitioner seemed to be doing well. Laboratory results obtained during the visit indicated low B12 levels, for which Petitioner was being treated with injections. Id. at 122. Dr. Porter’s ultimate assessment concluded that Petitioner was recovering from “weakness” dating back to October 2014. Id. The next record filed in this case is dated March 5, 2015, and primarily reflects Petitioner’s follow-up appointment with Dr. Henson for ongoing anemia, continued B12 deficiency, hypertension and a rash. Ex. 7 at 101. Laboratory tests completed during this visit indicated Petitioner’s continued low levels of B12. Id. Approximately six months later, on September 9, 2015, Petitioner had a follow-up appointment with Dr. Henson. Id. at 103. During this visit, Petitioner complained of severe fatigue, paresthesia, and tingling in in his extremities. Id. Dr. Henson’s impressions included hypertension, B12 deficiency, fatigue, malaise, paresthesia, and numbness. Id. at 104. None of these records state that Petitioner ever experienced or had been diagnosed with GBS, or that the flu vaccine he received the previous October was connected with any of his symptoms. Petitioner has also filed records in this action from 2016 visits to Drs. Henson and Porter. See generally Ex. 10 at 132-33; 138-41, 152. At these visits, Mr. Harrington again expressed concerns about a variety of symptoms similar to what he complained of after his October 2014 vaccination, but no treaters proposed either that the symptoms were reflective of GBS or that the flu vaccine had any connection to them. B. Petitioner’s Statement Concerning Treatment History 4 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 5 of 17 In addition to the medical records discussed above, Petitioner offered a statement, dated October 14, 2015, detailing the course of his treatment and health history following his receipt of the flu vaccine. See Ex. 1 at 1-7. Mr. Harrington therein asserts that his neurologists did not treat him for GBS because his symptoms were not consistent with a typical GBS patient, and his test results were not definitive. Id. at 2. Petitioner maintains that during his treatment, “[he] felt like no one wanted to label [him] with GBS, as if they were trying to avoid having to report it to the CDC.” Id. He also states that he continues to experience symptoms, including fatigue, jaw weakness, tingling in his legs, body aches, difficulty in concentration, and mood changes. Id. at 3. Although Petitioner routinely experiences these symptoms, he maintains in his health statement that his tests continue to yield normal results. Id. II. Expert Reports A. Petitioner’s Expert—Dr. William Shackelford Dr. Shackelford submitted two written reports in this case. See Expert Report, dated November 26, 2016, filed as Ex. 11 (ECF No. 17-1) (“Shackelford First Rep.”); Expert Report, dated April 10, 2016, filed as Ex. 13 (ECF No. 23) (“Shackelford Second Rep.”). According to Dr. Shackelford, Petitioner experienced GBS following receipt of the flu vaccine. Dr. Shackleford graduated from the University of Illinois Medical School in 1955, and entered practice in 1956 in Cerro Cordo, Illinois. Shackelford First Rep. at 1544; Shackelford Second Rep. at 162. His report indicated that he has remained in that practice until the present time. Shackelford First Rep. at 154. Dr. Shackelford stated that he has administered several thousand flu vaccinations during his years of practice, and has treated “many” patients with GBS. Id. He considers himself an expert on flu vaccine reactions based on his own experience. Id.; Shackelford Second Rep. at 163. Dr. Shackelford’s report did not provide any other details with regard to his qualifications, however, and Petitioner never submitted a CV setting forth Dr. Shackelford’s academic or professional background. Dr. Shackelford began his analysis by recounting Mr. Harrington’s medical history relating to the flu vaccination and alleged GBS diagnosis. Shackleford First Rep. at 155-57. Although no treating physician ever formally diagnosed Petitioner with GBS, Dr. Shackelford maintained that Petitioner did in fact have a “typical Guillain-Barré reaction.” Id. at 158. Dr. Shackelford noted that Petitioner had remained generally healthy prior to receiving the flu vaccine (apart from his past diagnoses of hypertension, allergic rhinitis, and ear infections), but began exhibiting symptoms “a few days later.” Id. Furthermore, Dr. Shackelford contended, all of Petitioner’s symptoms were consistent with GBS. Id. Overall, Dr. Shackelford’s first report concluded that Petitioner’s GBS injury was caused by the flu vaccine, a determination bulwarked by the fact that treaters could find 4Petitioner filed exhibits along with his expert report from Dr. Shackelford (including multiple medical records and his personal health log), totaling 161 pages. See Exhibit Expert and Medical Opinion, dated Nov. 29, 2017 (ECF No. 17-1). Although the total page count is 161 pages, Dr. Shackelford’s report (filed separately as Ex. 11) spans only pages 153- 159. 5 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 6 of 17 “no other cause” for the complained of symptoms. Id. at 159. Dr. Shackelford submitted no medical evidence or scientific literature in support of the statements contained in this first report. The report was also very difficult to follow, as it amounted to a compilation of exhibits from the filed medical record, along with photocopies of handwritten pages on Dr. Shackelford’s stationary setting forth his opinion. See e.g., Ex. 11 at 158. Dr. Shackelford’s supplemental expert report provided no additional analysis or scientific evidence, but simply repeated the assertions made in his initial report. See generally Shackelford Second Rep. In particular, the second report mirrored the first in recounting Petitioner’s medical history and the facts relied on by Dr. Shackelford in opining that the flu vaccine caused Petitioner’s symptoms. Id. at 165-67. Overall, Dr. Shackelford maintained again that the flu vaccine caused Petitioner to suffer GBS symptoms “within days” following receipt of the vaccine, and treaters could find no other cause for Petitioner’s symptoms. Id. at 168. Again, Dr. Shackelford provided no medical or scientific evidence in support of his assertions, and the second report was characterized by the same handwritten, conclusory statements found in the first. Rather, his final, unsupported analysis summarily concluded that “it is logical to assume the cause and effect between [Petitioner’s] injury and the vaccine.” Id. B. Respondent’s Expert—Dr. Jeffrey Cohen Respondent’s expert filed one written report in this case. See Expert Report, dated February 28, 2017, filed as Ex. A (ECF No. 20-1) (“Cohen Rep.”). According to Dr. Cohen, Mr. Harrington’s symptoms were not consistent with GBS, and no treater otherwise definitively diagnosed him with GBS. Dr. Cohen received his medical degree from the University of Oklahoma College of Medicine, and he completed two fellowships during his postdoctoral training: one in clinical neurology at Massachusetts General Hospital, and one in peripheral nerve diseases at the Mayo Clinic. Cohen CV at 1; Cohen Rep. at 1. He is currently a professor of neurology at Dartmouth Hitchcock Medical Center and the Geisel School of Medicine. Cohen Rep. at 1. He is board certified in neurology, with added qualifications in clinic neurophysiology and neuromuscular disease. Id. Dr. Cohen’s primary area of practice involves neuromuscular diseases, including GBS and Chronic Inflammatory Demyelinating Polyradiculoneuropathy. Id. He also trains and supervises neurology residents and fellows. Id. According to Dr. Cohen, Petitioner’s symptoms following his receipt of the flu vaccine were inconsistent with GBS. Dr. Cohen based his assertion on a review of the established criteria for a GBS diagnosis. Cohen Rep. at 2; see also C. Fokke, et al., Diagnosis of Guillain-Barré Syndrome and Validation of Brighton Criteria, 137 Brain 33, 33-43 (2014), filed as Ex. C (ECF No. 20-3) (“Fokke”). Fokke was a cohort study examining electrophysiological and laboratory features of adult GBS patients and developed a new set of criteria for a GBS diagnosis, establishing levels of diagnostic certainty based on ranges from one to four, one being the highest and four being the 6 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 7 of 17 lowest. Fokke at 34. Criteria for a GBS diagnosis include: bilateral flaccid weakness in the limbs; decreased or absent deep tendon reflexes in the weak limbs; monophasic downward course of symptoms occurring between twelve hours and twenty-eight days post-onset; low CSF protein levels; nerve conduction studies consistent with GBS subtypes; and absence of an alternative diagnosis for the weakness. Id. at 38; Cohen Rep. at 2. Relying on the Fokke criteria, Dr. Cohen opined that Petitioner’s clinical course, medical evaluations, and testing results did not suggest that he suffered from GBS. Cohen Rep. at 3 (Petitioner’s “clinical course, normal neurological examinations, spontaneous improvements despite no therapy, his CSF picture, and normal NCV’s make [a GBS] diagnosis untenable”). Mr. Harrington never displayed bilateral flaccid paralysis in his limbs, but only complained of weakness, and numerous evaluations documented his normal strength. Cohen Rep. at 2. In addition, Petitioner’s treating neurologists never noted any decreased or absent tendon reflexes in the weakened limbs. Id. Finally, Petitioner’s symptoms tended to get better over time and then worsen, rather than spiral downward in the progressive, acute manner consistent with the expected GBS nadir. Id. Petitioner’s symptoms could just as credibly be attributed to his documented anxiety with hyperventilation, evidenced by symptoms including a racing heart, difficulty breathing, jaw symptoms, and twitching, all of which were symptom’s Petitioner experienced. Id.; see also J. Stone, et al., The Symptom of Functional Weakness: A Controlled Study of 107 Patients, 133 Brain 1537, 1537-38, 1540-41, 1549 (2010), filed as Ex. E (ECF No. 20-5). Dr. Cohen also discussed some of the specific test results that initial treaters seemed to have taken into account in first including GBS in the differential diagnosis. He opined that Petitioner’s elevated CSF protein levels were most likely due to a grossly, bloody spinal tap. Cohen Rep. at 2. According to Dr. Cohen, a traumatic spinal tap could lead to elevated protein levels. Id.; see also D. Seehusen et al., Cerebrospinal Fluid Analysis, 68 Am. Family Physician 1103, 1106 (2003), filed as Ex. D (ECF No. 20-4). By contrast, Petitioner’s nerve conduction studies yielded normal results in his lower extremities. Id. at 3. Besides rejecting the GBS diagnosis given the medical record, Dr. Cohen dismissed Dr. Shackelford’s assertions as conclusory, noting that his notes only suggested a GBS reaction, with no theory or evidence to support the assertions. Id. at 3. Dr. Cohen maintained that Dr. Shackelford’s opinions were “not based on any clear reasoning” and ultimately gave no explanation of Petitioner’s symptoms beyond his statement that Petitioner suffered from a “typical GBS reaction.” Id. III. Procedural History Petitioner initiated this case on July 17, 2015. Pet. at 1. After obtaining and filing medical records from July 2015 to February 2016, Respondent filed a Rule 4(c) Report on June 10, 2016, setting forth the view that Petitioner was not entitled to compensation because he had failed to establish a GBS diagnosis. ECF No. 15. Petitioner then filed his first expert report from Dr. Shackelford on November 29, 2016, after receiving two extensions of time to act. ECF No. 17. Thereafter, Respondent filed his expert report from Dr. Cohen on February 28, 2017. ECF No. 20. 7 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 8 of 17 After the filing of the initial expert reports, I held a status conference on March 7, 2017, to discuss what I perceived as weaknesses in Petitioner’s claim. In particular, I expressed my concerns that (as pointed out by Dr. Cohen’s report) Petitioner’s medical records did not support a GBS diagnosis. See Order, dated Mar. 7, 2017 (ECF No. 21). In addition, I informed Petitioner that Dr. Shackelford’s report was unpersuasive and deficient, although I nevertheless provided Petitioner the opportunity to supplement it. Id. at 1. In response, Petitioner submitted another expert report from Dr. Shackelford, which (as noted above) largely mirrored the first report filed, addressing none of my concerns. ECF No. 23. I subsequently held another status conference, at which time I proposed ruling on the record in this matter in lieu of a hearing. The parties did not object to my proposal. Petitioner filed a brief in support of his claim on July 20, 2017, and Respondent filed her brief in opposition on August 31, 2017. The matter is ripe for adjudication. IV. Parties’ Respective Arguments Petitioner’s submission attempts to remedy his lack of supporting medical record and scientific evidence bulwarking the assertion that he suffered from GBS as a result of the flu vaccine. In support of his Table claim5, Petitioner maintains that a formal GBS diagnosis is not required, as long as he can establish “a timely connection with the inoculation and direct harm to the patient . . . .” Mem. at 8 (citing 42 C.F.R. § 100.3(a)). Petitioner acknowledges that his medical records do not support a GBS diagnosis, but maintains that they did demonstrate a timely connection and a direct harm. Id. Regarding his non-table claim, Petitioner analyzes the prongs of the test set forth by the Federal Circuit in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005), arguing that he satisfies all three. Mem. at 8-9. More specifically, Petitioner argues that Dr. Shackelford’s causation opinion that there is no alternate explanation for Petitioner’s symptoms is enough to satisfy Althen Prongs One and Two. Id. And a three-day symptom onset (also unsupported) is a medically appropriate timeframe to warrant entitlement to compensation under the third prong. Id. Respondent’s opposition brief stresses that the medical records do not support Petitioner’s assertion that he suffered from GBS. Opp. at 10. Petitioner was never conclusively diagnosed with GBS, and in fact some treaters explicitly stated that his symptoms were inconsistent with such a diagnosis. Id. Respondent also dismisses Dr. Shackelford’s opinion as unreliable, noting that he submitted no scientific evidence in support of his opinions. Id. at 11. Thus, Petitioner has not satisfied any of the Althen prongs, because Petitioner’s expert sets forth no reliable, supported 5 Although the Petition in this case was filed in July 2015 – and hence before the Vaccine Table was amended as of February 2017 to include GBS as a flu vaccine-caused injury – and although it does for formally state a Table claim, Petitioner has argued as if his claim nevertheless could meet the standards for such a claim. See, e.g., Mem. at 6 (ECF No. 24). For purposes of allowing Petitioner every opportunity to make his case, I have analyzed his arguments about the sufficiency of his Table claim as if the claim itself had been filed after the amendment. 8 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 9 of 17 causation theory and no medically supported onset timeframe. Id. at 12. Petitioner has therefore failed to support his alleged vaccine injury and is not entitled to compensation. Id. at 13. V. Relevant Legal Standards A. Claimant’s Burden in Vaccine Program Cases To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table – corresponding to one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; § 11(c)(1)(C)(ii)(I); 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, 1320 (Fed. Cir. 2006). For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. Section 13(1)(a). That is, 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 burden to persuade the judge of the fact’s existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard). Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions; rather, the petition must be supported by either medical records or by the opinion of a competent physician. Section 13(a)(1). In attempting to establish entitlement to a Vaccine Program award of compensation for a Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit in Althen: “(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.” Althen, 418 F.3d at 1278. Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this prong, the petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.” 9 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 10 of 17 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 549. Petitioners may satisfy the first Althen prong without resort to medical literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing Capizzano, 440 F.3d at 1325-26). 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.” Id. at 1380. Accordingly, special masters must take care not to increase the burden placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of Health & Human Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility . . . in many cases may be enough to satisfy Althen prong one” (emphasis in original)). 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). 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; Andreu, 569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored in vaccine cases, as 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’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly trustworthy evidence, since they are created contemporaneously with the treatment of the patient. Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). However, medical records and/or statements of a treating physician’s views do not per se bind the special master to adopt the conclusions of such an individual, even if they must be considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions or bases. The views of treating physicians should also be weighed against other, contrary evidence also present in the record – including conflicting opinions 10 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 11 of 17 among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians’ conclusions against each other), aff'd, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Health & Human Servs., 100 Fed. Cl. 119, 136 (2011), aff'd, 463 F. App’x 932 (Fed. Cir. 2012); Veryzer v. Sec’y of Health & Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed. Cir. 2012). The third Althen prong requires establishing a “proximate temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof that the onset of symptoms occurred within a timeframe which, given the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation.” Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den’d (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014). B. Law Governing Factual Determinations The process for making determinations in Vaccine Program cases regarding factual issues begins with consideration of the medical records. Section 11(c)(2). The special master is required to consider “all [] relevant medical and scientific evidence contained in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury, condition, or death,” as well as “the results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then required to weigh the evidence presented, including contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to afford greater weight to contemporaneous medical records than to other evidence, such as oral testimony surrounding the events in question that was given at a later date, provided that such a determination is evidenced by a rational determination). Medical records that are created contemporaneously with the events they describe are presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his 11 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 12 of 17 contemporaneous medical records, the special master’s decision to rely on petitioner’s medical records was rational and consistent with applicable law”), aff’d, Rickett v. Sec’y of Health & Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people honestly report their health problems to those professionals; and (iii) medical professionals record what they are told or observe when examining their patients in as accurate a manner as possible, so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F.2d 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to accurately report the onset of their daughter’s symptoms. It is equally unlikely that pediatric neurologists, who are trained in taking medical histories concerning the onset of neurologically significant symptoms, would consistently but erroneously report the onset of seizures a week after they in fact occurred”). Accordingly, if the medical records are clear, consistent, and complete, then they should be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records are generally found to be deserving of greater evidentiary weight than oral testimony – especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd, 968 F.2d 1226 (Fed. Cir.), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)). However, there are situations in which compelling oral testimony may be more persuasive than written records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent”) (quoting Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed. Cir. 1992)). Ultimately, a determination regarding a witness’s credibility is needed when determining the weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). When witness testimony is offered to overcome the presumption of accuracy afforded to contemporaneous medical records, such testimony must be “consistent, clear, cogent, and compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Human 12 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 13 of 17 Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the accuracy and completeness of medical records, the Court of Federal Claims has listed four possible explanations for inconsistencies between contemporaneously created medical records and later testimony: (1) a person’s failure to recount to the medical professional everything that happened during the relevant time period; (2) the medical professional’s failure to document everything reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. La Londe v. Sec’y Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making a determination regarding whether to afford greater weight to contemporaneous medical records over contrary testimony, there must be evidence that this decision was the result of a rational determination. Burns, 3 F.3d at 417. C. Analysis of Expert Testimony Establishing a sound and reliable medical theory often requires a petitioner to present expert testimony in support of his claim. Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999)). “The Daubert factors for analyzing the reliability of testimony are: (1) whether a theory or technique can be (and has been) tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) whether there is a known or potential rate of error and whether there are standards for controlling the error; and (4) whether the theory or technique enjoys general acceptance within a relevant scientific community.” Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-95). The Daubert factors play a slightly different role in Vaccine Program cases than they do when applied in other federal judicial fora (such as the district courts). Daubert factors are usually employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health & Human Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88 Fed. Cl. at 742-45. In this matter (as in numerous other Vaccine Program cases), Daubert has not been employed at the threshold, to determine what evidence should be admitted, but instead to determine whether expert testimony offered is reliable and/or persuasive. Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s 13 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 14 of 17 case. Where both sides offer expert testimony, a special master’s decision may be “based on the credibility of the experts and the relative persuasiveness of their competing theories.” Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion “connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec’y of Health & Human Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for review den’d, 108 Fed. Cl. 743 (2013), aff’d, 540 Fed. App’x 999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). D. Consideration of Medical Literature Respondent’s expert filed some medical and scientific literature in this case, including articles offered in support of their causation theories. See generally Exs. 21 and 24–30. I have reviewed all of the medical literature submitted in this case, although my decision does not discuss each filed article in detail. Moriarty v. Sec'y of Health & Human Servs., No. 2015–5072, 2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record evidence even though he does not explicitly reference such evidence in his decision”) (citation omitted). This is due to the fact (as expanded upon below) that the theories for which they are offered have been addressed at length in prior decisions—but in no cases have petitioners previously succeeded in meeting their burden of proof with respect to such theories. E. Resolution of Case Via Ruling on Record After a status conference held on June 19, 2017, I proposed determining entitlement based on written submissions and evidentiary filings, including both side’s expert reports, rather than by holding a hearing, and the parties acceded to my proposal. The Vaccine Act and Rules not only contemplate but encourage special masters to decide petitions on the papers where (in the exercise of their discretion) they conclude that doing so will properly and fairly resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been affirmed on appeal. See Hooker v. Sec’y of Health & Human Servs., No. 02-472V, 2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided on the papers in lieu of hearing and that decision was upheld). I am simply not required to hold a hearing in every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health & Human Servs., 38 Fed. Cl. 397, 402-03 (1997) (special master acted within his discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health & Human Servs., No. 90-882V, 1991 WL 71500, at *2 (Ct. Cl. Spec. Mstr. Apr. 19, 1991). 14 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 15 of 17 ANALYSIS After careful review of the expert reports, medical records, and the arguments of both sides, and taking into account my own experience resolving similar claims (as well as parallel decisions from other Vaccine Act cases), I conclude that Petitioner has not established preponderant evidence in favor of his claim. I. Petitioner Has Not Established GBS as His Injury The record evidence does not support Petitioner’s principal allegation: that he suffered from GBS after his October 2014 vaccination. Vaccine claimants must establish evidence of an injury in order to prevail. See Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1346 (Fed. Cir. 2010) (a petitioner “must specify his vaccine-related injury and shoulder[s] the burden of proof of causation”). Here, there is no evidence in the record that any treater diagnosed vaccine-induced GBS at or around the time of the vaccination, or later for that matter. At best, the record suggests that certain treaters initially considered GBS as a possible explanation for Petitioner’s symptoms, but later abandoned it after test results came in that did not corroborate the diagnosis. While contemporaneous records do indicate that Petitioner was experiencing adverse symptoms in the time after his vaccination, no treaters definitely related those symptoms to GBS. Dr. Cohen’s report also persuasively explained why Petitioner’s symptoms and test results did not satisfy the current clinical criteria for a GBS diagnosis. Petitioner cites to medical records (in particular Ex. 7 at 56-59, 76-77, 118; Ex. 8 at 112- 114) in which treaters referred to possible GBS or symptoms of unknown origin, or instances where treaters proposed a possible link between the flu vaccine to Petitioner’s symptoms. But this evidence has far less probative value than Petitioner assumes. The fact that treaters reasonably allowed for the possibility of a GBS diagnosis based on initial, limited information must be considered against the entire record. And, as that record reveals, most of Petitioner’s treaters later stated either that they had no explanation for Petitioner’s symptoms, or that they did not believe his symptoms were related to GBS after taking into account additional relevant testing (for example, reflex tests or nerve conduction studies). Thus, looking at the entirety of the record rather than just portions of it, preponderant evidence does not support the conclusion that Mr. Harrington “more likely than not” experienced GBS. This leaves only Petitioner’s own statements that he suffered from vaccine- induced GBS, which are by themselves insufficient evidence to base factual determination supportive of a finding of entitlement. See Section 13(a)(1); see, e.g., Lozano v. Sec’y of Health & Human Servs., No. 15-369V, 2017 WL 3811124, at *7 (Fed. Cl. Spec. Mstr. Aug. 4, 2017). II. Petitioner’s Table Claim is Not Supported by Preponderant Evidence Petitioner’s Table injury claim is based on the allegation that he experienced GBS after receiving the flu vaccine. Pet. at 1. However, the evidence offered by Petitioner establishing his post-vaccination symptoms does not satisfy the Table definition for GBS as set forth in the Vaccine 15 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 16 of 17 Table. The Vaccine Injury Table requires a petitioner alleging this kind of claim to establish onset of GBS within three to forty-two days post-vaccination (42 C.F.R. § 100.3(a)(XIV)(D)), and that in fact he suffered from GBS. In the present case, however, Petitioner was never affirmatively diagnosed with GBS, regardless of when his symptoms began. Furthermore, Petitioner’s treating physicians indicated that his symptoms were not related to GBS, despite some initial suspicions. Overall, Petitioner did not offer any compelling testimony or other evidence to refute the contemporaneous medical records. Thus, Petitioner has not shown it to be more likely than not that he was in fact suffering from GBS, and that his medical records were somehow incorrect. III. Petitioner has not satisfied the Three Althen Prongs Apart from the fact that Petitioner has not shown that he was in fact diagnosed with GBS, Petitioner has failed to offer a reliable, persuasive medical or scientific theory supporting a causal connection between the vaccine and his alleged injury. Dr. Shackelford’s opinion was unpersuasive, conclusory, and disjointed, and was also unsupported by any corroborative literature that might have made up for its facial deficiencies.6 Dr. Cohen, by contrast, credibly rebutted Petitioner’s allegations, noting that Petitioner had not satisfied the GBS diagnostic criteria. Thus, Petitioner cannot satisfy Althen prong one. I acknowledge that, given the large number of Program cases in which the flu vaccine has been found to be causal of GBS, had Petitioner’s injury been properly characterized as GBS, my resolution of this component of his case would be different, in spite of the deficiencies in Dr. Shackelford’s opinion. As it is, however, Mr. Harrington has not successfully demonstrated that the symptoms he experienced post-vaccination, whatever they were, could have been caused by the flu vaccine. Petitioner’s obligation under the second Althen prong was to demonstrate a logical sequence of cause and effect connecting the particular facts of her case to a medical theory. See, e.g., Sturdivant v. Sec’y of Health & Human Servs., No. 07-788V, 2016 WL 552529, at *18 (Fed. Cl. Spec. Mstr. Jan. 21, 2016) (prong two requires a fact-based inquiry into whether the vaccine in question did cause the particular injury). But again, Petitioner’s expert offered no persuasive, reliable explanation for how the facts contained in the medical record establish that the flu vaccine caused Mr. Harrington’s injuries, and he failed to provide a cogent, understandable opinion setting forth a logical sequence of cause and effect. Instead, Dr. Shackelford simply assumed a causal relation based on a purported lack of alternate explanation for Petitioner’s symptoms7, and offered 6 As previously noted, Vaccine Act claimants are not required to offer medical or scientific literature to prevail. Andreu, 569 F.3d at 1378-79. But where a claimant’s expert report is facially thin or conclusory – as is the case here – and where medical or scientific literature could help bulwark the report’s facial deficiencies, it is reasonable to take into account the absence of such supportive evidence when evaluating the sufficiency of the claimant’s first prong showing under Althen. 7 In fact, there are multiple alternative diagnoses noted in Petitioner’s medical records, any of which could be the cause of his symptoms. For example, the records indicate that Petitioner was diagnosed with a URI a week prior to receiving the flu vaccine. Ex. 2 at 18. Earlier records indicate treatment for hypertension, body aches, dizziness, and abdominal pain. Id. at 8-10, 16. Records post-vaccination also show that Petitioner was diagnosed with anxiety, dysthymia, anemia, muscle weakness, tachycardia, and a B12 deficiency. Ex. 4 at 28; Ex. 5 at 96; Ex. 8 at 16. 16 Case 1:15-vv-00752-MCW Document 31 Filed 03/01/18 Page 17 of 17 no explanatory support for his opinion. The third Althen prong would have evidentiary support if Petitioner had been able to demonstrate that he suffered from GBS, given that his symptoms began within two to three weeks of the flu vaccine’s administration – a timeframe well within what is considered medically acceptable for the onset of GBS after receipt of the flu vaccine. See Barone v. Sec’y of Health & Human Servs., No. 11-707V, 2014 WL 6834557, at *13 (Fed. Cl. Spec. Mstr. Nov. 12, 2014) (asserting that eight weeks is the longest reasonable timeframe for a flu/GBS claim). But because Dr. Shackelford did not persuasively establish that a non-GBS injury consistent with what Petitioner experienced could be vaccine-caused, he has also failed to demonstrate that the timing of onset of those same symptoms was medically acceptable. CONCLUSION The record does not support Mr. Harrington’s contention that the flu vaccine caused him to develop GBS, and the expert support offered for his claim was deficient. Petitioner has therefore not established entitlement to a damages award, and I must DISMISS his claim. In the absence of a timely-filed motion for review (see Appendix B to the Rules of the Court), the Clerk shall enter judgment in accordance with this decision.8 IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Special Master 8 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their right to seek review. 17 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_15-vv-00752-2 Date issued/filed: 2018-09-20 Pages: 7 Docket text: JUDGE VACCINE REPORTED OPINION re: 33 Order on Motion for Review. Signed by Senior Judge Mary Ellen Coster Williams. (tjk) Service on parties made. Docketed for Administrative Purposes..(tjk). -------------------------------------------------------------------------------- Case 1:15-vv-00752-MCW Document 39 Filed 09/20/18 Page 1 of 7 In the United States Court of Federal Claims No. 15-752V (Filed: September 20, 2018) 1 * * * * * * * * * * * * * * * * * * * * * * * * * PETER C. HARRINGTON, * * Vaccine Act, 42 U.S.C. §§ 300aa-1 et Petitioner, * seq.; Influenza Vaccine; Table * Injury; Althen Test; Causation in v. * Fact; Guillain-Barre Syndrome. * SECRETARY OF HEALTH AND * HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * Jeffrey C. Adams, 8491 121 Avenue North, Largo, FL, 33773, for Petitioner. Chad A. Readler, C. Salvatore D’Alessio, Catherine E. Reeves, Gabrielle M. Fielding, and Amy P. Kokot, United States Department of Justice, Civil Division, Torts Branch, P.O. Box 146, Benjamin Franklin Station, Washington, D.C., 20044, for Respondent. _________________________________________________________ OPINION AND ORDER _________________________________________________________ WILLIAMS, Judge. This matter comes before the Court on Petitioner’s motion for review of the Special Master’s decision denying his claim that the influenza (“flu”) vaccine caused him to develop Guillain-Barre Syndrome (“GBS”) or symptoms similar to those experienced by individuals with GBS, including muscle weakness, tachycardia, speech difficulties, dizziness, and extreme fatigue. Petitioner lodges two challenges to the Special Master’s decision denying his claim. First, Petitioner claims that the Special Master erred in finding that Petitioner was required to establish he had GBS to support a Table Vaccine claim. Second, Petitioner claims the Special Master erred in finding that Petitioner failed to establish causation in fact. For the reasons stated below, the Special Master’s decision denying compensation is sustained. 1 Pursuant to Vaccine Rule 18 of the Rules of the United States Court of Federal Claims, the Court issued its Opinion under seal to provide the parties an opportunity to submit redactions. The parties did not propose any redactions. Accordingly, the Court publishes this Opinion. Case 1:15-vv-00752-MCW Document 39 Filed 09/20/18 Page 2 of 7 Factual Background2 On October 24, 2014, Mr. Harrington, a 40-year old male, received the flu vaccine at Graf Clinic in Pensacola, Florida. Pet’r’s Ex. 3 at 20. Thirteen days after receiving this vaccine, on November 6, 2014, Petitioner went to the emergency room at West Florida Regional Medical Center complaining of “heaviness,” shortness of breath, and muscle weakness in his arms and legs.” Harrington v. Sec’y of Health & Human Servs., No. 15-752V, 2018 WL 1125831, at *1 (Fed. Cl. Spec. Mstr. Jan. 19, 2018). A neurological examination and a chest x-ray were conducted, but neither revealed evidence of a physiological problem, and Petitioner was diagnosed with anxiety, dysrhythmia, dehydration, anemia, and an electrolyte imbalance. Id. A few days later, on November 10, 2014, Petitioner returned to the hospital, and then returned again on November 18, 2014. Id. at *2. Petitioner saw three different doctors and was subject to a battery of tests while in the hospital, including an evaluation for GBS, but none of these physicians diagnosed Petitioner as having GBS. Id. An MRI of Petitioner’s brain evidenced no abnormalities, and an MRI of his spinal cord revealed “questionable stenosis,” but was otherwise normal. Id. Later in November 2014, Petitioner saw a second neurologist, who also determined that “[Petitioner’s] physical examinations [were] not consistent with Guillain-Barre.” Id. In December 2014, Petitioner saw a third neurologist, and in 2015, saw his primary care physician and one of the neurologists who had examined him in 2014. None of his treating physicians ever diagnosed Petitioner with GBS, or determined that the flu vaccine he received in October 2014, was connected with any of his symptoms. Id. at *3. While some of Petitioner’s physicians had initially explored whether GBS might explain his symptoms, ensuing medical examinations and testing did not corroborate that diagnosis. Petitioner states that he continues to experience symptoms, including fatigue, jaw weakness, tingling in his legs, body aches, difficulty in concentration, and mood changes, but medical tests continue to yield normal results. Pet’r’s Ex. 1 at 3. Petitioner’s Expert Reports Petitioner submitted two expert reports to the Special Master, both prepared by Dr. William Shackelford, a physician.3 Harrington, 2018 WL 1125831, at *4. Dr. Shackelford opined that Petitioner suffered GBS symptoms following receipt of the flu vaccine. Id. Dr. Shackelford maintained that Petitioner experienced a “typical Guillain-Barré reaction” and noted that Petitioner was generally healthy prior to receiving the flu vaccine (apart from his past diagnoses of 2 The factual background is derived from the Special Master’s Decision and medical records filed by Petitioner. Harrington v. Sec’y of Health & Human Servs., No. 15-752V, 2018 WL 1125831 (Fed. Cl. Spec. Mstr. Jan. 19, 2018). 3 Petitioner did not submit a curriculum vitae for Dr. Shackelford to the Special Master. The only reference to Dr. Shackelford’s credentials in the record are statements in Dr. Shackelford’s report that he graduated from the University of Illinois Medical School in 1955, entered practice in 1956, in Cerro Cordo, Illinois, was still in that practice as of the date of his report, and had administered several thousand flu vaccinations and treated “many” patients with GBS. Dec. 5. 2 Case 1:15-vv-00752-MCW Document 39 Filed 09/20/18 Page 3 of 7 hypertension, allergic rhinitis, and ear infections). Id. Dr. Shackelford opined that all of Petitioner’s symptoms were consistent with GBS and concluded that the flu vaccine caused Petitioner to suffer GBS symptoms “within days” following receipt of the vaccine, primarily because physicians could find “no other cause” for his symptoms. Id. Petitioner submitted no scientific literature in support of Dr. Shackelford’s opinions. Respondent’s Expert Report Respondent’s expert, Dr. Jeffrey Cohen, a professor of neurology at Dartmouth Hitchcock Medical Center and the Geisel School of Medicine, is board certified in neurology with added qualifications in clinical neurophysiology and neuromuscular disease, and his primary area of practice involves neuromuscular diseases, including GBS and Chronic Inflammatory Demyelinating Polyradiculoneuropathy. Id. at *5. Dr. Cohen concluded that Petitioner’s symptoms following his flu vaccine were inconsistent with GBS based on his review of the established criteria for a GBS diagnosis in the accepted medical literature. Id. Dr. Cohen opined that Petitioner’s clinical course, medical evaluations, and test results did not suggest that he suffered from GBS for the following reasons:  Petitioner never displayed bilateral flaccid paralysis in his limbs;  even though Petitioner complained of weakness, numerous evaluations documented Petitioner’s normal strength;  Petitioner’s treating neurologists never noted any decreased or absent tendon reflexes in the weakened limbs; and  Petitioner’s symptoms tended to get better over time and then worsen, rather than to spiral downward in the progressive, acute manner consistent with the expected GBS nadir. Id. Dr. Cohen opined that Petitioner’s symptoms—“a racing heart, difficulty breathing, jaw symptoms, and twitching”—could credibly be attributed to “anxiety with hyperventilation.” Id. Discussion Jurisdiction and Standard of Review In Vaccine Act cases, the Court of Federal Claims has “jurisdiction to undertake a review of the record of the proceedings” and may: (1) uphold the findings of fact and conclusions of law and sustain the special master’s decision; (2) set aside any of the findings of fact or conclusions of law “found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law” or (3) “remand the petition to the special master for further action in accordance with the court’s direction.” 42 U.S.C. § 300aa- 12(e)(2)(A)-(C) (2012); Doe 93 v. Sec’y of Health & Human Servs., 98 Fed. Cl. 553, 564-65 (2011). “Findings of fact of the special master are reviewed under the arbitrary and capricious standard, conclusions of law are reviewed under the not in accordance with law standard, and discretionary rulings are reviewed under the abuse of discretion standard.” Broekelschen v. Sec’y 3 Case 1:15-vv-00752-MCW Document 39 Filed 09/20/18 Page 4 of 7 of Health & Human Servs., 89 Fed. Cl. 336, 343 (2009), aff’d, 618 F.3d 1339 (Fed. Cir. 2010) (internal citation and quotation marks omitted). The Court’s role is not to “reweigh the factual evidence,” “assess whether the special master correctly evaluated the evidence,” or “examine the probative value of the evidence or the credibility of the witnesses.” Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000) (internal citation and quotation marks omitted). However, the Court has “a duty to ensure that the special master has properly applied Vaccine Act evidentiary standards, ‘considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for [his] decision.’” Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373, 1380 (Fed. Cir. 2015) (quoting Hines ex rel. Sevier v. Sec’y of Dep’t of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)) (alteration in original). Burden of Proof Under the Vaccine Act To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he suffered a “Table Injury” corresponding to one of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that his illness was actually caused by a vaccine (a “Non-Table Injury”). See Moberly ex rel. 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, 1320 (Fed. Cir. 2006). For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof, requiring a petitioner to offer evidence that leads the trier of fact to believe that the existence of a fact is more probable than not. Moberly, 592 F.3d at 1322 n.2. Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). A petitioner must demonstrate that the vaccine was “not only [the] 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)). Petitioner Failed to Establish That the Special Master Erred Petitioner contends that the Special Master erred in finding that Petitioner did not establish either a Table Vaccine Case or causation in fact for a non-Table injury. Petitioner’s Table Case Petitioner argues that the Special Master applied the wrong legal standard by mandating that Petitioner demonstrate a clear diagnosis of a specific disease in order to prevail in a Table Vaccine case. Pet’r’s Mot. 6. Petitioner asserts that he submitted sufficient evidence demonstrating he experienced GBS-like symptoms and that he satisfied his burden of proof through the testimony of Dr. Shackelford, who stated that regardless of whether Petitioner has GBS, “[a]ll symptoms can be blamed on the vaccine.” Id. at 8-9.4 4 The Special Master correctly found that the Vaccine Table did not include GBS as a listed injury for the flu vaccine until March 21, 2017. National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table; Delay of Effective Date, 82 Fed. Reg. 11,321 (Feb. 22, 2017). Because Petitioner filed his petition in 2015, and the amended Table does not apply retroactively, Petitioner could not establish a Table Vaccine injury. Nonetheless, the Special 4 Case 1:15-vv-00752-MCW Document 39 Filed 09/20/18 Page 5 of 7 The Special Master correctly ruled that to establish entitlement in a Table Vaccine case, Petitioner was required to establish by a preponderance of the evidence that he actually experienced the illness, disability, injury, or condition listed in the vaccine injury table. 42 C.F.R. 100.3(a). The Federal Circuit explained that for “Table injuries,” “causation is presumed when a designated condition follows the administration of a designated vaccine within a designated period of time.” Moberly, 592 F.3d at 1321 (citing 42 U.S.C. §§ 300aa–11(c), 300aa–14) (emphasis added). The Special Master correctly concluded that Petitioner failed to establish that he in fact had GBS, the “designated condition” he claimed, as Petitioner has never been diagnosed with GBS. Merely claiming symptoms of GBS did not establish that Petitioner suffered from that table injury. See Pet’r’s Mot. 8; Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 960 (Fed. Cir. 1993) (“Although the symptoms of her death are among the statutory indicia of HHC listed in § 300aa- 14(b)(1), these symptoms do not independently establish an HHC that is a table injury.”). The Special Master explained: [t]he Vaccine Injury Table requires a petitioner alleging this kind of claim to establish onset of GBS within three to forty-two days post-vaccination (42 C.F.R. § 100.3(a)(XIV)(D)), and that in fact he suffered from GBS. In the present case, however, Petitioner was never affirmatively diagnosed with GBS, regardless of when his symptoms began. Furthermore, Petitioner’s treating physicians indicated that his symptoms were not related to GBS, despite some initial suspicions. Harrington, 2018 WL 1125831, at *12. Petitioner’s Non-Table Case Petitioner argues that he established causation in fact because he “had no significant physical problems prior to the vaccination and very significant problems after the vaccine” and his medical records “clearly show that no other factors have been found that could have caused petitioner’s medical problems.” Pet’r’s Mot. 5. Petitioner contends that the Special Master erred in concluding that Petitioner did not satisfy the three-part test set forth in Althen v. Secretary of Health & Human Services, 418 F.3d 1274, 1278 (Fed. Cir. 2005). Under Althen, a petitioner must: show by preponderant evidence that the vaccination brought about her injury by providing: (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. Althen, 418 F.3d at 1278. Petitioner argues that the Special Master arbitrarily disregarded Petitioner’s evidence of “a medical theory causally connecting the vaccination and injury” because “the injuries have persisted since the time of the vaccination” and Petitioner’s expert, Dr. Shackelford, stated in his Master considered Petitioner’s claim “as if the claim itself had been filed after the amendment.” Harrington, 2018 WL 1125831, at *6 n.5. 5 Case 1:15-vv-00752-MCW Document 39 Filed 09/20/18 Page 6 of 7 report that “[a]ll symptoms can be blamed on the vaccine” and “[n]o M.D. would give a diagnosis other than a vaccine reaction.” Pet.’r’s Mot. 8-9. Contrary to Petitioner’s argument, the Special Master did consider Dr. Shackelford’s opinions. The Special Master found that Dr. Shackelford’s opinion was “unpersuasive, conclusory, and disjointed,” and was “unsupported by any corroborative literature.” Harrington, 2018 WL 1125831, at *12. As such, the Special Master concluded that Petitioner failed to demonstrate that the symptoms he experienced post-vaccination could have been caused by the flu vaccine. Id. Conversely, the Special Master determined that Dr. Cohen “persuasively explained why Petitioner’s symptoms and test results did not satisfy the current clinical criteria for a GBS diagnosis” and that Dr. Cohen “credibly rebutted Petitioner’s allegations.” Id. at *11, *12. Special masters “are entitled—indeed, expected—to make determinations as to the reliability of the evidence presented to them and, if appropriate, as to the credibility of the persons presenting that evidence.” Moberly, 592 F.3d at 1326. Such findings “‘are virtually unchallengeable on appeal.’” Broekelschen, 618 F.3d at 1345 (quoting Lampe, 219 F.3d at 1362); see also Paluck v. Sec’y of Health & Human Servs., 104 Fed. Cl. 457, 467 (2012) (“This court does not reweigh the factual evidence, assess whether the special master correctly evaluated the evidence, or examine the probative value of the evidence or the credibility of the witnesses—these are all matters within the purview of the fact finder.”) (internal citations and quotation marks omitted). There is no basis for this Court to disturb the Special Master’s assessment of the expert testimony or of Dr. Cohen’s credibility and the reliability of his opinion. Second, Petitioner argues that he established “a logical sequence of cause and effect showing that the vaccination was the reason for the injury” because “there have been no other medical theories submitted” and Respondent “failed to establish any other explanation.” Pet’r’s Mot. 8-9. It is well established that the lack of an alternate explanation for a petitioner’s injury does not establish that the injury was caused by a vaccine. See Lampe, 219 F.3d at 1367-68; Moberly, 592 F.3d at 1323 (“temporal association between a vaccination” and injury, “together with the absence of any other identified cause” for the injury does not on its own compel a finding of causation); Althen, 418 F.3d at 1278 (“neither a mere showing of a proximate temporal relationship between vaccination and injury, nor a simplistic elimination of other potential causes of the injury suffices, without more, to meet the burden of showing actual causation”).5 Conclusion Petitioner’s motion for review is DENIED. The Special Master’s decision denying compensation is SUSTAINED. 5 Petitioner also argues that “the proximate temporal relationship between the vaccine and the injury” is clear given that Petitioner “developed his first symptoms and went to the doctor and made multiple calls to his physician” three days after receiving the vaccine. Pet’r’s Mot. 9. The Special Master acknowledged that there was a temporal connection between Petitioner’s claimed injuries and the vaccine. Harrington, 2018 WL 1125831, at *13. This circumstance does not undermine the Special Master’s conclusion that Petitioner failed to establish that he had GBS or that his symptoms were caused by the flu vaccine. 6 Case 1:15-vv-00752-MCW Document 39 Filed 09/20/18 Page 7 of 7 The Clerk shall not disclose this decision publicly for 14 days. s/Mary Ellen Coster Williams MARY ELLEN COSTER WILLIAMS Judge 7