VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_11-vv-00631 Package ID: USCOURTS-cofc-1_11-vv-00631 Petitioner: Roy Greene Filed: 2011-09-29 Decided: 2020-02-12 Vaccine: Td Vaccination date: 2009-07-22 Condition: brachial neuritis Outcome: denied Award amount USD: AI-assisted case summary: Roy Greene filed a petition on September 29, 2011, alleging that a tetanus-diphtheria (Td) vaccination he received on July 22, 2009 caused him to develop brachial neuritis (also known as Parsonage-Turner Syndrome or neuralgic amyotrophy). Petitioner had received the Td vaccine in his right arm following a construction-related hand injury at his workplace. After a fact hearing in March 2015, Special Master Corcoran found that petitioner's symptoms began no earlier than September 1, 2009—forty-one days after the vaccination—and dismissed petitioner's Table claim because the onset fell outside the twenty-eight-day brachial neuritis Table window. Petitioner's remaining non-Table causation claim required him to establish that a forty-one-day onset was medically acceptable for Td-induced brachial neuritis. Petitioner submitted expert reports from Dr. Thomas W. Wright (orthopedist) and Dr. Marcel Kinsbourne (neurologist). The special master issued an initial Decision Denying Entitlement on May 26, 2017, finding that petitioner's experts had relied on conclusory ipse dixit reasoning and improperly attempted to leverage the Vaccine Injury Table's twenty-eight-day timeframe for the non-Table claim. The special master subsequently granted reconsideration, and in a September 26, 2017 Decision on Reconsideration again denied entitlement. The United States Court of Federal Claims (Judge Sweeney) vacated the reconsideration decision on February 27, 2018, finding that the special master had applied the interest-of-justice standard rather than the merits standard and had improperly discounted petitioner's evidence based on its dilatory submission. On remand, the parties participated in an entitlement hearing on May 9, 2019, at which both sides presented expert testimony. Special Master Corcoran again denied entitlement on August 2, 2019, concluding that petitioner had not met his burden of establishing by a preponderance that a forty-one-day timeframe for onset of brachial neuritis after receipt of the Td vaccine was medically reasonable. The special master found petitioner's expert evidence insufficiently specific to brachial neuritis or the Td vaccine, that respondent's expert credibly opined that four weeks was the outer limit for medically acceptable latency, and that petitioner's contemporaneous workplace hand trauma constituted an unrebutted alternative cause. The Court of Federal Claims (Chief Judge Sweeney) denied petitioner's motion for review on January 28, 2020 and sustained the special master's decision. Theory of causation field: Td July 22, 2009 → brachial neuritis. Onset 41 days post-vaccination (fact hearing March 2015); Table claim dismissed (28-day window). Non-Table claim: DENIED. Multiple proceedings: SM denial May 2017; reconsideration denial Sept 2017 (vacated by CFC Feb 2018, wrong standard); remand hearing May 2019; SM denial Aug 2019; CFC affirmed Jan 28, 2020. Insufficient proof 41-day onset medically acceptable for Td brachial neuritis; hand trauma alternative cause. All DB fields correct. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_11-vv-00631-0 Date issued/filed: 2015-12-16 Pages: 22 Docket text: PUBLIC ORDER/RULING (Originally filed: 07/31/2015) Regarding 56 Findings of Fact & Conclusions of Law (Signed by Special Master Brian H. Corcoran). (ay) Copy to parties. -------------------------------------------------------------------------------- Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 1 of 22 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 11-631V (Not to be Published) * * * * * * * * * * * * * * * * * * * * * * * * * * Filed: July 31, 2015 ROY GREENE, * * Petitioner, * Finding of Fact; Tetanus-Diphtheria * (“Td”) Vaccination; Brachial Neuritis; v. * Timing of Onset of Symptoms; * Contemporaneous Medical Records SECRETARY OF HEALTH AND * Versus Testimony; Dismissal of HUMAN SERVICES, * Table Claim * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * F. John Caldwell, Jr., Maglio Christopher & Toale, PC, Washington, D.C., for Petitioner. Ann Martin, U.S. Dep’t of Justice, Washington, D.C., for Respondent. RULING REGARDING FINDINGS OF FACT1 On September 29, 2011, Roy Greene filed a petition for compensation in the National Vaccine Injury Compensation Program (the “Vaccine Program”),2 alleging that he developed brachial plexopathy as a result of his July 22, 2009, receipt of the tetanus-diphtheria (“Td”) vaccine. Pet. (ECF No. 1). Mr. Greene has alleged both a Table Injury and a “Non-Table” claim (id. at 2), but success on the Table claim will require Petitioner to establish onset of his symptoms within two to twenty-eight days of vaccination (42 C.F.R. § 100.3(a)(I)(B)). 1 Because this ruling contains a reasoned explanation for my actions in this case, I will post it on the United States Court of Federal Claims website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (Dec. 17, 2002) (current version at 44 U.S.C. § 3501 (2014)). As provided by 42 U.S.C. § 300aa- 12(d)(4)(B), however, the parties may object to the published ruling’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 ruling 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 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 2 of 22 At the parties’ request, a fact hearing was held in the matter on March 26, 2015. My fact ruling, based on the record as a whole, is set forth herein, and I conclude that Mr. Greene’s symptoms began no earlier than September 1, 2009. As a result, Petitioner’s Table Injury claim shall be dismissed. I. Factual Background A. Documentary Treatment History On July 22, 2009, Mr. Greene (who worked in the construction industry) presented to the emergency room at Clear Lake Regional Medical Center in Webster, Texas with a puncture wound in his right hand caused by a drill accident at a construction site. Pet’r’s Ex. 10 at 10-15, 19-27. Petitioner received the Td vaccination in his right arm as a result of this injury. Id. Petitioner was discharged from the hospital that same day with a prescription for a narcotic medication for pain management. Id. at 15. Petitioner saw no other healthcare providers in connection with his injury until September 7, 2009 (Labor Day of that year). He presented to Houston Northwest Medical Center in Houston, Texas on that date reporting that he had been experiencing sharp pain in his right upper arm for the past four days, as well as chest pain earlier that day. Pet’r’s Ex. 12 at 15, 19-20. At the time of the visit, Petitioner indicated that he had pain on the right side of his body that was radiating from his neck down his arm which was not alleviated by changing his position or any other self- treatment. Id. at 15. Petitioner underwent a physical, neurological, and psychological examination. Id. at 18-20. Results of a chest and shoulder x-ray conducted during this visit were largely unremarkable, however, and Mr. Greene was diagnosed as suffering from a muscle spasm. Id. at 21-22. He was discharged from the hospital that same day with medication for his pain (Darvocet and Skelaxin3), and a referral for an outpatient doctor’s visit regarding his symptoms. Id. at 16-18. Petitioner visited his chiropractor, Todd Hatch, DC, the next day (September 8, 2009) regarding his symptoms and was referred for magnetic resonance imaging (“MRI”) of his cervical spine. Pet’r’s Ex. 3 at 100. The MRI was performed on September 9, 2009, by Jeffery L. Watts, MD, a board certified radiologist, at Woodlands Open MRI and Imaging Center in The Woodlands, Texas. Id. at 34-35. At the time of the MRI, the treatment record reflects that Petitioner reported 3 Darvocet is the trademark for a combination preparation of propoxyphene napsylate (an opioid analgesic) and acetaminophen (which has analgesic and antipyretic effects similar to aspirin’s). Dorland’s Illustrated Medical Dictionary (32d ed. 2012) at 12, 472, and 1527 [hereinafter Dorland’s]. Skelaxin is the trademark for a preparation of metaxalone, “a centrally acting skeletal muscle relaxant used in the treatment of painful musculoskeletal conditions. Id. at 1145, 1723. 2 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 3 of 22 to Dr. Watts that he had been experiencing “[s]evere pain, burning, and numbness in the right arm,” but he did not specify when these symptoms began. Id. at 36. Later that month, on September 24, 2009, Petitioner was seen by neurologist Benny Wang, MD, at Sadler Clinic in The Woodlands, Texas regarding his symptoms. Pet’r’s Ex. 6 at 2. During that visit, Petitioner reported that in “early 9/09 he started with last two fingers of his hand numb and burning up to elbow and some soreness of the armpit area and the chest.” Id. Petitioner reported that his skin was very sensitive, he was experiencing pain that was at least moderate in severity, and he was experiencing “some stiffness at times,” although his strength was “ok when there is no pain.” Id. According to Dr. Wang’s assessment, Mr. Greene was suffering from right ulnar neuritis.4 Id. at 3. Dr. Wang recommended treatment with Medrol5 and a Lyrica6 titrate, and proposed that Petitioner undergo electromyography (“EMG”)7 testing if the prescribed medications were unhelpful. Id. at 3. Mr. Greene subsequently had an initial appointment with Muni A. Shah, MD, at Woodlands Sports Medicine Centre in The Woodlands, Texas on September 30, 2009. Pet’r’s Ex. 1 at 6-7. In the “Accident/Injury Information” form that Petitioner filled out for that visit, Mr. Greene states that his symptoms began on “Labor Day” (September 7, 2009). Id. at 23. Dr. Shah recorded the known facts relating to Mr. Greene’s injury in his notes from the visit, stating that Mr. Greene had “sustained a penetrating trauma to his right hand on July 27, 2009,” after which he “experienced immediate digital pain and swelling” for which he was evaluated at the emergency room that same day. Id. at 6-7. At the emergency room, Petitioner was administered a Td vaccination and “told to follow up with an orthopedic surgeon, but ‘decided not to go’ because he felt ‘pretty good.’” Id. Since his hand accident, however, Petitioner “has had persistent ‘burning, tingling, and shooting’ discomfort,” in his right hand and certain fingers, which is “exacerbated by ‘applying pressure’ to the hand.” Id. Although it was noted that Dr. Wang had previously diagnosed Petitioner with a “nerve injury,” Dr. Shah explained to Petitioner that “[i]in order to better quantitate this injury, [] an EMG would be prudent,” and he therefore arranged a right upper extremity nerve test for Petitioner Id. at 7. Upon completion of such testing, Petitioner was to return so that they could “review the results together and decide on further treatment.” Id. 4 Neuritis is defined as “inflammation of a nerve, with pain and tenderness, anesthesia and paresthesia, paralysis, wasting, and disappearance of reflexes.” Dorland’s at 1263. 5 Medrol is the trademark for preparations of methylprednisolone, which is used as an anti-inflammatory and immunosuppressant. Dorland’s at 1120, 1154. 6 Lyrica is the trademark for a preparation of pregabalin, which is indicated for used in the treatment of neuropathic pain in diabetic neuropathy and post-herpetic neuralgia. Dorland’s at 1088, 1509. 7 EMG is “an electrodiagnostic technique for recording the extracellular activity (action potentials and evoked potentials) of skeletal muscles at rest, during voluntary contractions, and during electrical stimulations.” Dorland’s at 602. 3 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 4 of 22 On October 5, 2009, Petitioner presented to Allen Chu, MD, PhD, an EMG and neuromuscular disease specialist in Houston, Texas, complaining of pain and numbness in his right upper extremity. Pet’r’s Ex. 3 at 15. Dr. Chu’s notes from this visit indicate that “[t]he numbness [which Petitioner described as ‘burning; hot; loss of feeling’] sometimes radiates, from the armpit down to the hand.” Id. Upon physical examination, Dr. Chu found some abnormalities, including issues with muscle strength (in the right ulnar), deep tendon reflexes, and decreased pinprick sensation (in some of the dermatomes of the upper extremities). Id. at 16. Dr. Chu listed cervical radiculopathy, brachial plexopathy,8 carpal tunnel syndrome, and focal neuropathy as components of the overall differential diagnosis. Id. In order to pinpoint the cause of Mr. Greene’s pain and numbness, as well as to evaluate the nature and extent of the denervation, Dr. Chu performed an EMG of Petitioner’s upper extremities (as originally recommended by Dr. Shah). Pet’r’s Ex. 3 at 16. The EMG revealed a “pattern of neurophysiologic abnormalities [] consistent with a moderate right brachial plexopathy involving the lower plexus, primarily the lower trunk;” “[m]ild ulnar neuropathy across the elbow (cubital tunnel) on the right;” and “[m]ild to moderate median neuropathy at the wrist (carpal tunnel syndrome) on the right.” Id. at 18-21. Based on these results, Dr. Chu identified Parsonage- Turner syndrome9 as the source of Mr. Greene’s symptoms in his right arm and right shoulder. However, although he speculated that Petitioner’s shoulder symptoms could be related to his “work-related injury,” he felt that Mr. Greene’s hand numbness was less related, given the following supporting evidence: “1) the involvement of Abd. Dig. Mini (ADM) cannot be caused by puncture injury in the palm; 2) the mild extent of ulnar neuropathy at the elbow cannot explain the significant denervation changes distally; 3) the denervation changes involve[] median and radial innervated C8-T1 myotomes; 4) clinically, patient has sensory loss in the C8-T1 dermatomes which are beyond the scope of ulnar innervated areas.” Id. Records generated during Mr. Greene’s visit to Dr. Chu are a primary source of factual conflict in this matter. In a “Questionnaire for Arm Numbness” filled out by Petitioner during this appointment but prior to his actual visit with Dr. Chu, Mr. Greene wrote down that the numbness (which he reported to be constant and radiating from his armpit down to his right hand) had begun thirty days before (presumably meaning the first week of September). Pet’r’s Ex. 4 at 87-89. When 8 Brachial plexopathy is defined as a neuropathy (nerve disorder) of the brachial plexus. Dorland’s at 1462. “The brachial plexus is the network of nerves ‘situated partly in the neck and partly in the axilla’ and ‘originating from the ventral branches of the last four cervical spinal nerves and most of the ventral branch of the first thoracic spinal nerves.’” Velchek v. Sec'y of Health & Human Servs., No. 02-1479V, 2005 WL 2847451, at *3 (Fed. Cl. Spec. Mstr. Oct. 28, 2005) (quoting Dorland's Illustrated Medical Dictionary (30th ed. 2003) at 1453). 9 Parsonage-Turner syndrome (also known as neuralgic amyotrophy) is characterized by “pain across the shoulder and upper arm, with atrophy and paralysis of the muscles of the shoulder girdle.” Dorland’s at 70, 1391. In Vaccine Program cases, brachial neuritis is an alternative medical term often used interchangeably with Parsonage-Turner syndrome, as well as brachial plexopathy, to describe the same set of symptoms. Devonshire v. Sec’y of Health & Human Servs., No. 99-31V, 2006 WL 2970418, at *1 (Fed. Cl. Spec. Mstr. Sept. 28, 2006). 4 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 5 of 22 asked elsewhere on the questionnaire to identify by checking one of two boxes when the numbness started (“immediately” or “gradually”), Petitioner hand-wrote on the form (and also appears to have checked), an additional box indicating that its development was “delayed.” Id. at 87. On that same questionnaire, Petitioner wrote the following more specific description of the nature and start of his symptoms: Rt [right] hand was drilled by coworker – 7-22. No symptoms at time – no work missed – Labor Day weekend hard work triggered neuro explosion assumed from Neck – MRI done + traction therapy on personal insurance and cost. Visit neurologist Wang said it was triggered from hand injury. Id. at 89. In a “Clinical Information Form” from Dr. Chu’s office, presumably filled out on that same day, Mr. Greene similarly reported that his symptoms had started on Labor Day weekend. Pet’r’s Ex. 4 at 90. However, typewritten notes from this same visit (which are signed by Dr. Chu) indicate that the onset of “[t]he numbness started about after work-related injury on [July 22, 2009].” Pet’r’s Ex. 3 at 15 (emphasis added). These notes further indicate that the precipitating factor was an accident, and that the numbness “started gradually” after that July accident (rather than “delayed” as Mr. Greene appears to have written on the aforementioned questionnaire). Id. On October 14, 2009, Petitioner returned to Dr. Shah for a follow-up evaluation of his right hand. Pet’r’s Ex. 1 at 4-5. At this time, Mr. Greene stated that his right hand was “improving” and a physical examination performed during this visit led Dr. Shah to concur that Petitioner was “recovering from what appears to be a brachial plexopathy” and “may now engage in activities without restriction.” Id. Thereafter, on December 8, 2009, Petitioner had a new patient evaluation with Jeffrey E. Buddoff, MD, an orthopedic surgeon in Houston, Texas. Pet’r’s Ex. 2 at 4. At that time, Mr. Greene reported that he had “[n]o previous history of right hand problems until 4-1/2 months ago [mid- July of that year] when he got drilled through the hand.” Id. Petitioner indicated that “[h]e did fairly well after that,” experiencing “[n]o infection or problem,” but “[t]hen 2 months ago [October], he had a hard day of work, and that night he could not sleep” because “[h]e had [severe] pain shooting down from his axilla down to the hand.” Id. Petitioner went on to indicate that he was subsequently “diagnosed with Parsonage-Turner syndrome,” which “seems to be improving, except the numbness to the ulnar 1-1/2 digits persists.” Id. Dr. Budoff noted that “[n]erve study shows a plexus injury, especially at the lower trunk, with mild carpal and cubital tunnel syndrome and denervation of multiple muscles consistent with Parsonage-Turner syndrome.” Id. at 5-6. 5 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 6 of 22 Petitioner returned to see Dr. Budoff on February 9, 2010, for a workers’ compensation follow-up examination. Pet’r’s Ex. 2 at 2. At that time, Petitioner’s hand wound was doing well, and his Parsonage-Turner syndrome appeared to be improving. Id. However, Dr. Budoff noted that he was “a little concerned the cubital tunnel/ulnar innervated area [was] worsening” and discussed the possibility of observing the change versus undergoing surgery with Petitioner. Id. at 3. Petitioner indicated that he would prefer observation, so Dr. Budoff recommended that Petitioner return in one month for a follow-up assessment.10 Id. B. Factual Matters The following are facts as set forth by witness testimony or in documents that were created directly or provided by Petitioner or his wife. 1. Petitioner’s VAERS Report and Supplemental Documentation Related to that Report On March 6, 2010, Petitioner filled out a VAERS report identifying (for the first time in the chronology established by any records filed in this action)11 that onset of his purportedly vaccine-related symptoms began August 8, 2009, at 10:00 PM. 12 Pet’r’s Ex. 4 at 33, 51; Tr. at 72. At the same time, Petitioner detailed his understanding regarding the onset of his alleged vaccine- related injury in a report titled, “Tetanus Vaccine Injury Timeline and Condition” [hereinafter “Timeline”]. Pet’r’s Ex. 4 at 27-28. In the VAERS report, Mr. Greene recounted the construction work site injury to his hand that led to his receipt of a Td vaccine on July 22, 2009. Pet’r’s Ex. 4 at 27, 51. Although at first the puncture wound appeared to have healed normally, seventeen days later (or on August 8th) his “shoulder blade area began to hurt.” Id. at 27. At first, Petitioner discounted these symptoms since he “live[d] with soreness all the time and ha[d] creams and a tens [transcutaneous electrical nerve stimulation (“TENS”)] unit13 to help with evening pains,” and thus rather than seeking medical 10 A follow-up appointment was scheduled for March 9, 2010 (Pet’r’s Ex. 2 at 7). Records from that visit were not filed, however (and I did not request that such records be filed as they were not germane to my decision in this case). There are also no subsequent records describing Petitioner’s condition after this point, although at hearing Mr. Greene testified that he continues to experience symptoms related to his alleged injury. 11 The VAERS report was included among the materials in Dr. Chu’s possession (Pet’r’s Ex. 4 at 33), but Dr. Chu testified that he did not have any hand in the creation of this document, had never seen it prior to the hearing, and believed that it was likely provided to his office by Mr. Greene’s attorney after its creation. Tr. at 30. 12 Mr. Greene specifically testified at hearing that in his recollection, the “Tetanus Vaccine Timeline and Condition” (which is dated March 6, 2010) was likely submitted through the VAERS reporting system at the same time as the VAERS report. Tr. at 74. 13 TENS units “are predominately used for nerve related pain conditions,” and “work[] by sending stimulating pulses across the surface of the skin and along the nerve strands.” The Original TENSUnit, http://www.tensunits.com/ (last accessed July 10, 2015); see also Tr. at 83-84 (Petitioner’s description of the device). 6 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 7 of 22 attention at this time he “just asked [his] wife to rub the stuff on the shoulder blade and kept on living and working.” Id. The report goes on to say that by August 15, 2009 (twenty-four days post-vaccination), Mr. Greene’s “shoulder still was tender [and] the next symptom to appear was soreness in the back side of right arm in upper area,” and he was also “waking up several times a night with one or both hands tingling.” Pet’r’s Ex. 4 at 27. Thereafter, on September 1, 2009, Mr. Greene’s right arm was cramping down from the forearm to his hand. Id. Petitioner continued to believe that such symptoms were not related to his hand injury or post-hand injury vaccination, however, and believed self-treatment would be sufficient. Id. The Timeline identifies September 7, 2009, as the date Mr. Greene opted to seek emergency medical attention given the severity of pain. Pet’r’s Ex. 4 at 27. Two weeks later, because the pain was making it impossible for him to sleep, he went to Dr. Wang to obtain some kind of prescription pharmaceutical relief. Id. at 28. It was at that point, Petitioner asserted, that he was first led to believe (after speaking with Dr. Wang) that the hand numbness that he was experiencing was likely related to his July hand injury. 14 Id. During his subsequent visit to Dr. Chu, however, Petitioner learned that his condition “was severe and widespread affecting fiber nerves of just [his] right arm and hand,” and also that “it was auto immune and based in the brachial area and not the hand” (id.), although as the Timeline reflects, Dr. Chu himself did not indicate – at that time or any other – that it was his professional conclusion that the Td vaccine had any relationship to Mr. Greene’s symptoms. Id. at 28. 2. Witness Testimony During the fact hearing on March 26, 2015, Petitioner and his wife testified, as well as one of his treating physicians, Dr. Chu. In addition, pre-hearing affidavits were submitted from both of the Greenes (see Pet’r’s Exs. 15 and 16). Although I do not credit the truth of every statement made by each witness (primarily due to inconsistencies, or the existence of contradictory but more persuasive documentary evidence), the witnesses sincerely attempted to recall the relevant facts to which they were asked to testify. 14 The medical record, while inconsistent on this point, also suggests that Mr. Greene did not learn of a possible relationship between the Td vaccine and his symptoms until later in the fall of 2009. See, e.g., Pet’r’s Ex. 3 at 55-56 (handwritten note on a treatment form from a visit to a chiropractor on October 23, 2009, where Petitioner indicated, “I think too many tetanus shots hurt people 2, 3 yrs”); Pet’r’s Ex. 1 at 48-49, 53 (note from Petitioner’s chiropractor dated November 10, 2009, indicated that Petitioner was continuing to see a specialist regarding tetanus toxicity). Mr. Greene himself testified that he was not sure when exactly he became aware of the possibility of making a VAERS report, but indicated that he had located the form to do so through personal research on the internet some time after he saw Dr. Chu. Tr. at 72-73. Petitioner acknowledged that he had consulted with an attorney regarding bringing a Vaccine Program claim before signing the form on March 6, 2010. Id. at 73. 7 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 8 of 22 a. Roy Greene – Mr. Greene’s pre-hearing affidavit, notarized on November 6, 2014, is generally consistent with the assertions in his VAERS report and supporting Timeline. Thus, he avers that within a week of the July 22nd vaccination, he “began to have a gradual onset of numbness in [his] right hand,”15 which “seemed to radiate from [his] armpit down to [his] hand.” Aff. of Roy Greene (Pet’r’s Ex. 15) [hereinafter “Greene Aff.”] ¶¶ 1-3. Accordingly, Petitioner asserts that onset of his symptoms began sometime between late July and early August of 2009. Id. ¶ 6. He also confirms his allegation that he misinterpreted the early symptoms as caused directly by the puncture wound he had suffered, and that he did not begin to suspect that any of his subsequent symptoms were related to the Td vaccine until he saw Dr. Chu, well after his Labor Day emergency room visit. Id. ¶¶ 3, 5. Mr. Greene’s testimony provided additional details surrounding the accident that ultimately led to his receipt of the Td vaccination. After providing some background into his employment history in the construction industry, 16 he described the incident in which a co-worker accidently drilled through his right hand, leading to his receipt of the vaccination at issue in this case. Tr. at 43-44. Petitioner indicated that based on his years of working in the construction industry he was used to working in pain, and there were some kinds of pain that he would simply ignore because he assumed that they were work related. Id. at 82-83. Petitioner indicated that if he was experiencing pain, he would normally take a hot bath or use his TENS unit. Id. at 83-84. Accordingly, Petitioner asserted he did not readily seek medical treatment even though he had been experiencing pain and discomfort in the weeks immediately following vaccination. Id. at 57- 58, 82-84. Petitioner in particular attempted to bulwark the Timeline’s specification of August 8, 2009, as the onset of his vaccine-related symptoms. He testified that to the best of his recollection, this was the first day his shoulder blade area began to hurt “based on the work that we had in progress and how it correlated to my pain levels and the wife’s having to attend to me and help me with the shoulder region,” although he acknowledged that the actual onset could have been within a few days of that date. Tr. at 75-76. He also tried to explain why he did not link his August symptoms to the Td vaccine. Thus, Petitioner testified that when he first began experiencing pain he thought it might be emanating from his chest, leading him at that time to be concerned that the pain might be a symptom of lung cancer. Id. at 46. However, he now believes that this pain was actually his brachial plexus first getting sore. Id. Mr. Greene described this pain as a gradual, progressive type of pain – indicating that it did not at first affect his movement, but over time it 15 At hearing, however, Petitioner indicated that this was a misuse of the term “numbness” (as described in greater detail below). 16 Petitioner indicated that he first started working in construction when he was in high school (around 1974), and that he had been working in the commercial construction industry since receiving a degree from Texas A & M in 2001. Tr. at 82. Petitioner indicated that although he was a superintendent and, as such, he does not get paid to do physical labor, he does physical labor at a construction site when needed. Id. at 82-83. 8 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 9 of 22 radiated and increased in intensity. Id. He continued to attempt to self-treat his pain until, by September 7, 2009, the chest pain and hand numbness he was experiencing led him to believe that he might be having a heart attack. Id. at 47. As noted above, the first medical records setting forth the injuries complained of in this action are from Petitioner’s 2009 Labor Day emergency room visit, and contain statements identifying that time period as the onset of Mr. Greene’s symptoms. Accordingly, Mr. Greene attempted at hearing to explain why those records do not reflect the correct onset date. See generally Tr. at 45-49, 51-89. Petitioner admitted that the medical records from his emergency room visit pinpointed his symptoms as having begun no earlier than four or so days prior (Pet’r’s Ex. 12 at 12-20), but attributed the inconsistency to miscommunication, adding that he felt confident that he had told his treaters that the symptoms and pain that he was experiencing had begun at an earlier point in time. Tr. at 61-64. Petitioner otherwise stated that some of the emergency room-related contemporaneous records (see, e.g., Pet’r’s Ex. 3 at 34) accurately captured his symptoms at that time. Tr. at 65-66.17 Petitioner also attributed inconsistencies about the onset date in the treatment record as arising from the ambiguous nature of the term “numbness.” Tr. at 45-48, 51-54, 56-57. As context for his understanding of this term, Mr. Greene indicated that he had previously broken his back, and as a result of that injury he had become generally familiar with “neurological verbiage.” Id. at 45. Based on this experience, Petitioner understood the word “numbness” to refer to something very specific – meaning that one could “stick a pin in and it not hurt,” not merely a tingling sensation – and something that could become permanent if not addressed. Id. at 45-48. Accordingly, although the severity of his Labor Day symptoms impelled him to seek immediate treatment, he did not inform his treaters about his earlier, less severe symptoms that had begun in the first half of August (even though he now associates them with his later symptoms). Id. at 45- 46, 51. Despite the fact that Mr. Greene was told during his Labor Day emergency room visit that he was suffering from a pulled muscle or muscle spasm, he pursued treatment on his own due to his concerns about the numbness he had experienced, but continued not to inform treaters about his August symptoms for the reasons discussed above. Tr. at 48. Thus, in his initial visit with Dr. Shah,18 Petitioner filled out the date of the injury as being July 22, 2009, but reported his symptoms 17 Petitioner also attempted to explain a discrepancy regarding chest pain complaints as set forth on his Timeline and relevant medical records. Although the Timeline reported that Mr. Greene had experienced chest pain as early as August 18, 2009 (Pet’r’s Ex. 4 at 27), in his oral testimony he distinguished these symptoms from the chest pain that led him to visit the emergency room over Labor Day 2009, because the prior chest pain was not accompanied with numbness. Tr. at 77-78. 18 This record is presumed to be from September 30, 2009, even though it is not dated (see Pet’r’s Ex. 1 at 6). Tr. at 69. 9 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 10 of 22 as beginning on Labor Day (Pet’r’s Ex. 1 at 23), discounting the earlier pain he had been experiencing (Tr. at 68-69, 70-71). Similarly, when Petitioner visited Dr. Wang on September 24th, he still did not connect his symptoms with the Td vaccine or hand injury that led him to receive the vaccination. Id. at 48-49.19 By the time Mr. Greene filled out the questionnaire during his initial visit to Dr. Chu, he continued to rely on his mistaken belief that his August symptoms were not preliminary to the numbness that he later experienced in September, as contemporaneously reported to treaters. Tr. at 47-48, 51. Accordingly, in writing down on Dr. Chu’s intake/questionnaire form that his right hand numbness was “delayed,” he was trying to convey the fact that the sensations he had experienced between August and September 2009 had evolved from soreness to burning and then finally numbness. Id. at 48. He also reiterated that even as late as October 2009, he still did not understand that there could be any relationship between his hand injury (and/or the vaccination that he received as a result of it) and his subsequent symptoms. Id. at 67-68. Overall, Petitioner’s testimony at hearing emphasized his belief that the factual allegations in his affidavit and Timeline most accurately recounted the progression of his symptoms (and should therefore be relied upon, rather than the contemporaneous medical records, when there was a discrepancy). Tr. at 46, 54-55.20 He noted that the Timeline had been prepared before his affidavit, and less than a year after his accident, and also stressed that his recollection of other events that were taking place during that time (including work occurrences in his construction career) had aided his memory in identifying this earlier onset. Id. at 54-55. Petitioner also stated that the Timeline’s reliability was supported by the fact that it had initially been created in connection with his effort to make a successful Texas workers’ compensation claim; in the process of so doing he had been reminded of when certain events had transpired. Id. at 54-56, 74, 79, 102. He was thus able to recall his physical status on certain dates by connecting it to employment- related “landmark” events. Id. at 76. b. Cheryl Greene – Mrs. Greene, Petitioner’s wife, provided an affidavit regarding the onset of Petitioner’s alleged injury and testified at the hearing. The affidavit, dated March 2, 2015, states that a few weeks after Petitioner’s July 22, 2009, receipt of the Td vaccine, Mrs. Greene observed that her “husband was having pain and numbness in his right arm and hand.” Aff. of Cheryl Greene (Pet’r’s Ex. 16) (ECF No. 49) [hereinafter “Mrs. Greene Aff.”] ¶¶ 1-2. 19 Petitioner corroborated this assertion by pointing out that he paid for this doctor’s visit through his personal insurance, rather than his workers’ compensation insurance, as he would have done if he had viewed the medical treatment to be connected with a work-related injury. Tr. at 48-49. 20 Petitioner explained some of the inconsistencies between the affidavit that he submitted prior to trial and other evidence in this case (specifically the filed Timeline and his testimony at trial) as the product of having passed drafts of the affidavit back and forth with his lawyer, which he believed may have resulted in certain terms (in particular, “numbness”) not being carefully chosen. Tr. at 54. 10 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 11 of 22 During this time the pain left him unable to sleep, and she “would hear him up at night sitting in a chair in the living room.” Id. at ¶ 2. She initially attributed these symptoms “to the drill puncture injury that led to the vaccine and expected it would fade.” Id. However, rather than fade away, the symptoms increased in severity until Mr. Greene finally sought treatment over Labor Day of 2009. Id. ¶ 3. Only later, in the course of seeing doctors regarding the symptoms, did the Greenes begin to identify the true nature of the injury. Id. At hearing, Mrs. Greene testified regarding her recollection of Petitioner’s symptoms before, and then leading to, his emergency room visit in September 2009. Prior to the emergency room visit she had heard her husband up at night on several occasions moaning as a result of the pain that he was experiencing. Tr. at 92-94.21 Mrs. Greene testified that she specifically remembered four or five nights when her husband was up as it was very unusual for him to be up at night, and he had awakened her with his moans. Id. at 97-98. Mrs. Greene clarified the statement in her affidavit that his pain and symptoms began “a few weeks” after his accident (Mrs. Greene Aff. ¶ 2), indicating that this nighttime suffering likely occurred two or three weeks after the initial injury and associated vaccination. Tr. at 94-95. In an effort to substantiate her recollections of the August onset of Mr. Greene’s symptoms, Mrs. Greene testified that she attempted to help him self-treat his symptoms through the application of homeopathic remedies, including therapeutic oils that she purchased online or at a health food store. Tr. at 95, 101. Mrs. Greene specifically recalled massaging such oils on Petitioner’s arm in an attempt to help make him feel better. Id. at 93, 95. She also recalled (but was unable to corroborate) conversations with Petitioner’s mother or members of the Greenes’s church22 about his condition. Id. at 100. But because the Greenes were accustomed to not sharing openly with others the status of Petitioner’s physical health, due to concerns that the disclosure of such information might result in his loss of a construction-related job, she indicated that it was not likely that she or her husband would have discussed his condition with third parties. Id. Mrs. Greene further testified that when her husband finally visited the emergency room in September of 2009 to address the pain that he was experiencing, she accompanied him but she did not specifically recall any conversations that he had with healthcare providers. Tr. at 95-96. She did, however, indicate that had she heard her husband tell a doctor or nurse during this visit that 21 Mrs. Greene specifically testified that she believed that Mr. Greene also was experiencing pain during the day but was forcing himself to go to work in spite of it. Tr. at 98. She added that Petitioner’s occupation required him frequently to work through, or in spite of, physical pain (id. at 101). 22 Mrs. Greene specifically recalled that her husband’s pre-emergency room visit pain was so great that the Greenes had gone to their church and requested that church members pray over Petitioner. Tr. at 96. No statements or testimony from any such individuals has been provided in this case, however. Mrs. Greene also testified that she had emailed Petitioner’s mother, informing her about the pain that he was experiencing and requesting that she pray for him as well. Id. However, that email was not provided because Petitioner no longer had access to it, as his mother’s computer had crashed. Id. at 100. 11 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 12 of 22 his pain had begun only four days prior, she would have thought the statement was incorrect. Id. at 96. c. Testimony of Dr. Chu – In order to address some of the inconsistencies arising from certain medical records, at my direction Petitioner summoned Dr. Chu by subpoena to testify in this case as a fact witness, and he did so. See Order for Issuance of a Trial Subpoena, dated Jan. 29, 2015 (ECF No. 45). After basic inquiries into his medical background,23 Dr. Chu was questioned about Mr. Greene’s October 2009 office visit. See generally Tr. at 6-42. He testified that although he remembered Mr. Greene personally, he did not remember the specifics regarding any of his visits and so had to refresh his memory through a pre-hearing review of Petitioner’s medical chart. Id. at 32-34. Based on that review, Dr. Chu testified that Petitioner had informed him that early September of 2009 was the time Mr. Greene’s symptoms began. Tr. at 24. The arm numbness questionnaire that Mr. Greene filled out during his initial visit, for example, indicated that Petitioner’s symptoms had started only thirty days prior to the October 5th visit. Id. The questionnaire also included a section intended to provide patients with an opportunity to provide any additional explanation related to their condition, which Mr. Greene completed and which again identified Labor Day weekend as the start of his symptoms. Pet’r’s Ex. 4 at 89; Tr. at 25-27. In addition, when Mr. Greene filled out the new patient form (Pet’r’s Ex. 4 at 90) he again identified the same period as the onset of his symptoms. Tr. at 26-27. With respect to the section of the patient questionnaire where Mr. Greene wrote in by hand a third box in order to describe the development of his numbness as “delayed” (Pet’r’s Ex. 4 at 87), Dr. Chu testified that he interpreted that to mean that Petitioner’s numbness did not occur immediately after his hand injury, but instead had happened at a later, albeit unspecified, point in time. Tr. at 25. He contrasted this with the “gradually” box, stating that he considered that kind of symptom development to mean that the numbness began after the event but had increased in intensity and severity over time. Id. Dr. Chu acknowledged that the typewritten notes recording Petitioner’s visit and reported symptom history could be understood as consistent with Petitioner’s testimony that his symptoms had begun well before his Labor Day emergency room visit. Tr. at 29, 32-35. In an attempt to explore this discrepancy, the parties asked Dr. Chu a number of questions about his patient information-compiling practices during the time Mr. Greene was his patient. Id. at 8, 19-23, 33- 23 After graduating from medical school in Taiwan in 1987, Dr. Chu did his residency at Duke University and then went on to complete a fellowship at Harvard University before moving to Houston, Texas to practice medicine. Tr. at 7. Dr. Chu has been working as a neurologist in Houston, Texas since 2000. Id. Dr. Chu testified that his primary expertise involves performing EMG testing, and as part of his private practice he sees approximately 1,500 to 2,000 patients per year for such testing. Id. at 17. In preparation for his testimony at hearing, Dr. Chu spoke with his attorney and reviewed Mr. Greene’s chart, including clinical notes and an EMG report. Id. at 8. 12 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 13 of 22 39. Dr. Chu explained this process, stating that patients generally first filled out information a standard questionnaire and form before examination, although Dr. Chu would also ask additional questions during the examination, amending the questionnaire accordingly if necessary. Id. at 19- 23, 34. However, Dr. Chu testified that he did not have any additional handwritten notes regarding Mr. Greene’s medical history (and that he did not in this case believe that he had amended the questionnaire or form that Petitioner filled out). Id. at 22-23. Dr. Chu next explained how, in his medical practice, the typewritten history section of the “office visit” document would have been created. Although in some instances he would dictate the contents of that document,24 in Mr. Greene’s case he thought it most likely that this section (Pet’r’s Ex. 4 at 87) was transcribed by his administrative assistant from the standard documents that a patient completes during an initial office visit. Tr. at 22-23, 37. It was thus Dr. Chu’s belief that whoever had transcribed the information from the handwritten documents into the electronic medical records had inaccurately transcribed some of the information. Id. at 39. Dr. Chu testified to his personal view that the records containing Petitioner’s handwritten statements were the most accurate representation of Mr. Greene’s medical history (as he reported it during his initial visit). Tr. at 22-23, 27, 29, 35-36. As a result, Dr. Chu gave more credence to Mr. Greene’s handwritten assertions about onset occurring around Labor Day than to the later- created typewritten history that could be read to place onset as closer to the date of the hand injury itself (and associated vaccination). Id. at 32. Indeed, Petitioner’s handwritten insert that his numbness was “delayed,” (when given the opportunity to check “gradually”) made that more likely to be true, in Dr. Chu’s estimation, than the typewritten note stating that the numbness began gradually. Id. at 24-25, 28, and 35.25 3. Post-Hearing Documentary Materials After the hearing, I directed the Petitioner to file certain documents that the witnesses had referenced and that might assist the fact-finding process. Non-PDF Order Regarding Hr’g, dated Mar. 26, 2015. The requested records were filed on April 9, 2015. Pet’r’s Exs. 17-19 (ECF No. 50). After these documents were filed, Petitioner also filed affidavits (from himself and his wife) 24 Dr. Chu would only personally dictate the notes when there was additional information not included in the standard documents that he wrote down when meeting with the patient. Tr. at 38. In this case, however, Dr. Chu testified to his belief that there was no such dictation after Mr. Greene’s initial visit; the first four lines of the typewritten note were “standard template” in his office for an EMG visit, so those records would have been transcribed in a summarized fashion from the documents that Petitioner filled out during his visit. Id. at 27, 36-37. 25 Dr. Chu also testified, however, that for him, determining the onset of a patient’s injury was not of primary importance to his treatment of a patient, such as Petitioner, even though his preference would be to treat an injury as soon as possible. Tr. at 40. Moreover, he could not opine as to the onset of Petitioner’s symptoms based on the degree of severity of those symptoms when he examined and tested Mr. Greene. Id. at 41-42. 13 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 14 of 22 attesting to the fact that the submitted documents were what they purport to be, and specifying the dates upon which the documents were created, as well as the method of creation. Pet’r’s Exs. 20- 21 (ECF No. 51). Descriptions of these items appear below. Although I have considered all of them in my factual determination, I do not give them equal weight, for the reasons discussed herein. a. Petitioner’s Calendar – Petitioner filed a calendar (Pet’r’s Ex. 17), which, as noted above, was created in connection with his efforts to substantiate his Texas workers’ compensation claim (Pet’r’s Ex. 21). The calendar contains information regarding the onset of his alleged injury (including information that he later used when putting together the VAERS report and associated Timeline, as well as his affidavit regarding the onset of his alleged injury). 26 Tr. at 55-56, 59, 74, 79-80. In an affidavit submitted in conjunction with the calendar, Petitioner described its origin, and indicated that the information contained in the calendar was as accurate as he could recall. Pet’r’s Ex. 21 at 2. The submitted calendar spans a period of eight months, from July of 2009 through February of 2010.27 Pet’r’s Ex. 17. It pinpoints August 8th as the date Petitioner’s right shoulder blade began to ache. Id. at 2. Information from the calendar further states that this aching continued a week later (on August 15th), when Petitioner also began to experience other symptoms (including aching radiating to his back and upper right arm, as well as hand tingling) and that he was at that point also experiencing sleep difficulties as a result of his symptoms. Id. By August 18th, Petitioner was experiencing pain in his chest, which felt like it was in the lung area, and coughing became painful. Id. By September 1st, the calendar indicates that Petitioner was experiencing severe right arm cramping, and by September 4th his symptoms had intensified and included tingling and numbness on his right side. Id. at 3. I do not give significant weight to the calendar as evidence establishing the onset of Petitioner’s symptoms. Although there is nothing in the record to suggest that the calendar was created for the purpose of this litigation, it remains uncertain precisely when the document was 26 Petitioner indicated that this calendar “probably originated in the cusp between 2009 and ’10.” Tr. at 56. However, it is unclear whether the filed copy of the calendar is the same calendar that he referenced during his testimony at the hearing. For instance, during the hearing Petitioner indicated that there was information that he would need to redact from the calendar before filing it, because it included certain names and addresses. Id. at 80-81. The filed version, however, does not appear to include redactions or such referenced information. Petitioner also indicated that the actual construction projects themselves that he had worked on, and that helped him recall dates, were not added to the calendar (Pet’r’s Ex. 21 at 2), yet the submitted calendar appears to reference specific projects ((see, e.g., Pet’r’s Ex. 17 at 2)). 27 During this period of time, a number of events are recorded including doctors’ visits, symptoms Petitioner was experiencing, and workers’ compensation claim information. See generally Pet’r’s’ Ex. 17. For purposes of this decision I have focused only on entries relating to the onset of Petitioner’s alleged vaccine-related injury. 14 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 15 of 22 created – and in particular, how close to the time of Mr. Greene’s injury and the onset of his symptoms.28 It may well have been created during the time of, or even in conjunction with, the preparation of Mr. Greene’s VAERS report in March 2010. By that date, he clearly understood his injury might be vaccine-related, and was therefore reasonably trying to relate prior facts to this theory. The calendar therefore has less evidentiary value than the contemporaneous medical records or Mr. Greene’s own sworn oral and written testimony. b. Mrs. Greene’s Diary Entry – As noted above, Mrs. Greene testified that she thought she might possess written diary entries contemporaneous with Petitioner’s purported August 2009 onset. Tr. at 96, 98-100, 103. After the hearing, Petitioner filed a copy of a single entry, as well as an affidavit from Mrs. Greene describing its origin. Pet’r’s Exs. 18 and 20. The filed document is a one-page, handwritten diary entry dated September 15, 2009,29 which indicated that Mr. Greene had “been in excruciating pain for over 1 week,” and noted that Mrs. Greene was praying for a breakthrough in his healing. Pet’r’s Ex. 18. I find this diary entry to be accurate and a true copy of what it purports to be. However, by its own date and temporal reference to a single week in September, it does not corroborate either Mr. or Mrs. Greene’s testimony that Petitioner’s symptoms began in August of 2009. c. Additional Documentation – Petitioner also submitted documentation establishing his wife’s purchase of homeopathic oils akin to those Mrs. Greene testified that she had used to treat Mr. Greene’s initial symptoms. Mr. Greene submitted a receipt dated August 19, 2009, for the purchase of Hydrastis Canadensis at American Health Foods in Houston, Texas, as well as a National Center for Homeopathy membership receipt dated August 29, 2009. Pet’r’s Ex. 19. Along with (and in support of) this documentation, Petitioner submitted information from a book or pamphlet regarding homeopathic solutions for puncture wounds, indicating that “hypericum and ledum are generally the first choice, and work amazingly well for reducing swelling, pain and potential infection.” Id. Petitioner additionally submitted an affidavit from his wife, which indicated that the Hydrastis Canadensis that was purchased on August 19th was specifically intended to help manage pain in Mr. Greene’s shoulder/arm area. Pet’r’s Ex. 20. 28 In his affidavit regarding the calendar’s creation, Petitioner indicated that “[i]n the version with red text [presumably referring to the filed calendar, as only one calendar was submitted and that calendar contained text in two colors – red and black] I have back filled my five year old memories of the construction process and how my health affected and what work we did.” Pet’r’s Ex. 21 at 3. 29 Notably, the submitted entry was dated (see Pet’r’s Ex. 18) even though Mrs. Greene testified at hearing that Petitioner had opted not to submit Mrs. Greene’s diary entries prior to the hearing because the entries relevant to his claim were not individually dated with the day or month of the entry, just the relevant year. Tr. at 99. 15 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 16 of 22 I find these additional materials establish the purchase of the homeopathic products in August of 2009 and corroborate in part Mrs. Greene’s testimony that she at least possessed such items during the time she purports to have assisted her husband with his initial symptoms. II. Procedural History As noted above, Mr. Greene filed his petition in September of 2011, alleging that he experienced a brachial plexopathy30 after receiving the Td vaccine in July of 2009. Pet. at 1. In support of his petition, Mr. Greene filed medical records from a number of healthcare providers (Pet’r’s Exs. 1-12) followed by the filing of a statement of completion on March 9, 2012 (ECF No. 12). Respondent reviewed the record and then filed her Rule 4(c) report on April 23, 2012. Resp’t’s Rule 4(c) Report (ECF No. 14). In it, Respondent asserted that although brachial neuritis is listed on the Vaccine Injury Table in association with vaccines containing tetanus toxoid like the Td vaccine, Petitioner was not entitled to a presumption of vaccine causation because he could not demonstrate by preponderant evidence that his first symptom or manifestation of his alleged injury had occurred within twenty-eight days of vaccination, as set forth in the Table. Id. at 10-11. In support of this argument, Respondent noted that the first time that Petitioner sought medical care was forty-seven days after administration of the Td vaccine, on September 7, 2009, when he presented to the emergency department at Houston Northwest Medical Center in Houston, Texas complaining of right upper arm pain that he reported had begun four days earlier. Id. at 11-12. Respondent further contended that subsequent medical histories set forth in Petitioner’s medical records support the timing of onset from this emergency room visit. Id. at 12. Thereafter, Petitioner filed additional medical records (see Pet’r’s Exs. 13-14), as well as his own affidavit regarding onset of his symptoms (Pet’r’s Ex. 15 (ECF No. 41)). As a general matter, Mr. Greene maintained that (although he was not aware of it at the time) he experienced a gradual onset of symptoms of brachial neuritis after his Td vaccination in July of 2009. Id. Respondent subsequently filed a report indicating that “Petitioner’s affidavit d[id] not change [R]espondent’s position on the onset of the symptoms or the merits of the case as set forth in her Rule 4(c) [r]eport.” Resp’t’s Resp. to Pet’r’s Filing of Nov. 6, 2014, dated Dec. 8, 2014 (ECF No. 42). The parties requested that a fact hearing be conducted for the purpose of determining the timing of the onset of Mr. Greene’s alleged injury. See Order, dated Dec. 18, 2014 (ECF No. 43). 30 Although Mr. Greene formally refers to his injury in the petition as a brachial plexopathy, it appears that the term is to some extent interchangeable with the term “brachial neuritis” as used in the Vaccine Table, and there is ample support in the Program for treating it in this manner, given the congruence of symptoms and clinical indicia. See, e.g., Devonshire, 2006 WL 2970418, at *1. 16 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 17 of 22 Prior to the hearing, Petitioner filed an additional affidavit regarding the onset of his symptoms (this time from his wife, Mrs. Greene). ECF No. 47. A fact hearing was held on March 26, 2015, in Houston, Texas, with the above-described witnesses testifying. The parties opted not to file post-hearing briefs (although Petitioner did, at my request, file the additional evidence discussed above regarding onset of his alleged injury (see Pet’r’s Exs. 17-21)). This matter is now ready for resolution. III. Legal Standard Governing Fact-Finding To receive compensation under 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).31 Mr. Greene alleges both kinds of claims in the alternative, although (as discussed in greater detail below) his Table Injury claim is of greater interest herein, since its resolution is dependent directly on the fact findings of this ruling. Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof. See 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). A petitioner may not receive a Vaccine Program award for a Table Injury, such as the injury alleged in this case, based solely on his claims alone; the petition must be supported by either medical records or by the opinion of a competent physician. Section 13(a)(1). The process for making determinations in Vaccine Program cases regarding factual issues, such as the timing of onset of a petitioner’s alleged injury, 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, 31 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit decisions are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121, 124 (2003), aff’d, 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014). 17 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 18 of 22 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 v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993); 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 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 an accurate manner, 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. 03-1585, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneously 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.”)). In making contemporaneous reports, the declarant’s motivation for accurate explication of symptoms is more immediate, as opposed to testimony offered after the events in question, which is considered inherently less reliable. Reusser v. Sec’y of Health & Human Servs., 28 Fed. Cl. 516, 523 (1993). 18 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 19 of 22 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 v. Sec'y of Health & Human Servs., No. 03-1585V, 2005 WL 6117475, at *19 (Fed. Cl. Spec. Mstr. Dec. 12, 2005) (“[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 v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). When witness testimony is used 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 Servs., No. 90-2808, 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, 2014 WL 1258137 (Fed. Cir. Mar. 28, 2014). In making a determination regarding whether to afford greater weight to contemporaneous medical records or other evidence, such as testimony at hearing, there must be evidence that this decision was the result of a rational determination. Burns, 3 F.3d at 417. Despite the weight afforded medical records, special masters are not bound rigidly by those records in determining onset of a petitioner’s symptoms. Vallenzuela v. Sec'y of Health & Human Servs., No. 90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30, 1991); see also Eng v. Sec'y of Health & Human Servs., No. 90-1754V, 1994 WL 67704, at *3 (Fed. Cl. Spec. Mstr. Feb. 18, 1994) (Section 13(b)(2) “must be construed so as to give effect also to § 13(b)(1) which directs the special master or court to consider the medical records (reports, diagnosis, conclusions, medical judgment, test reports, etc.), but does not require the special master or court to be bound by them”). 19 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 20 of 22 III. Analysis Petitioner’s Table Injury claim is based on the factual allegation that he experienced brachial neuritis after receiving the Td vaccine, which is a vaccine containing tetanus toxoid. Pet. at 2. The evidence offered by Mr. Greene establishing his post-vaccination symptoms would appear to satisfy the definition of a brachial neuritis as set forth in the Qualification and Aids to Interpretation (QAI) that accompany the Vaccine Act. 42 C.F.R. § 100.3(6).32 However, the Vaccine Table also requires a petitioner alleging this kind of claim to establish that his injury occurred within two to twenty-eight days of vaccination (42 C.F.R. § 100.3(a)(I)(B)) – here, sometime between July 24, 2009, and August 19, 2009. It is undisputed that Mr. Greene was not seen by a healthcare provider in August 2009, at the time that he now alleges that his symptoms began, and there are no contemporaneous records for that time period documenting his alleged symptoms. The first records from his treatment history relevant to onset are those from both the start and end of September of 2009 – all of which offer strong support for the conclusion that Mr. Greene’s symptoms began no sooner than the start of that month, in the days before his emergency room visit. Indeed – the very fact that Mr. Greene went to the emergency room at this time, while not dispositive, lends support to the conclusion that onset occurred around that time period, as a sick person would presumably not wait to treat severe pain, and would also attempt to explain to his treaters the nature of his symptoms and their duration as accurately as possible. The subsequent records from early October, when Petitioner visited Dr. Chu, are also consistent with onset having occurred around the time of Petitioner’s Labor Day emergency room visit. When given the chance to write down his symptoms and reason for seeking treatment from Dr. Chu, Mr. Greene specified early September as the onset of his pain. Pet’r’s Ex. 4 at 87-90. He also characterized the start of his post-accident numbness not as “gradual” (which would be more consistent with his testimony that his symptoms were increasing in severity over time) but instead 32 The QAI defines brachial neuritis as “dysfunction limited to the upper extremity nerve plexus (i.e., its trunks, divisions, or cords) without involvement of other peripheral (e.g., nerve roots or a single peripheral nerve) or central (e.g., spinal cord) nervous system structures. A deep, steady, often severe aching pain in the shoulder and upper arm usually heralds onset of the condition. The pain is followed in days or weeks by weakness and atrophy in upper extremity muscle groups. Sensory loss may accompany the motor deficits, but is generally a less notable clinical feature. The neuritis, or plexopathy, may be present on the same side as or the opposite side of the injection; it is sometimes bilateral, affecting both upper extremities.” Moreover, “[w]eakness is required before the diagnosis can be made. Motor, sensory, and reflex findings on physical examination and the results of nerve conduction and electromyographic studies must be consistent in confirming that dysfunction is attributable to the brachial plexus. The condition should thereby be distinguishable from conditions that may give rise to dysfunction of nerve roots (i.e., radiculopathies) and peripheral nerves (i.e., including multiple mononeuropathies), as well as other peripheral and central nervous system structures (e.g., cranial neuropathies and myelopathies).” 42 C.F.R. § 100.3(6). 20 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 21 of 22 to create a new check-in box, “delayed,” which is more reasonably construed to mean beginning later, rather than sooner but growing in magnitude over time.33 See Id. 4 at 87. The typewritten page from Dr. Chu’s records contains two entries that could be interpreted as placing onset prior to Labor Day, or at least suggesting that the development of Petitioner’s symptoms was gradual. Pet’r’s Ex. 3 at 15. But Dr. Chu persuasively explained why a patient’s handwritten questionnaire entries would be more trustworthy than a subsequently-transcribed version, and also why the characterization of Mr. Greene’s numbness in those typewritten records as “gradual” was less likely to be correct than what Mr. Greene himself had written down (“delayed”). See generally Tr. at 6-42. The records from the latter period of Mr. Greene’s initial treatment (in the late fall of 2009) similarly support onset as around Labor Day rather than weeks before. See, e.g., Pet’r’s Ex. 2 at 4. It was only by the time that Petitioner completed the VAERS report and Timeline – in March of 2010 – that he began to identify August 2009 as the beginning of his symptoms. The fact that these documents were prepared months after the symptoms that Petitioner was reporting had occurred (and seven months from his receipt of the Td vaccine) makes them less reliable than the contemporaneous records from the time of his initial treatment in September 2009 and thereafter. The same goes for Mr. Greene’s calendar; while it may reflect his sincere attempt to record the dates of occurrences relevant herein, I cannot be sure when it was created, and I do not find that it more accurately identifies the date of onset, since it primarily reflects Petitioner’s own recollection. In the face of the above evidence, Petitioner offered his own contrary testimony plus that of his wife. But the Greenes’s testimony was not sufficiently “clear, cogent, convincing, [or] compelling” to rebut the treatment record, which was not itself incomplete or demonstrably inconsistent. See, e.g., Cucuras, 993 F.2d at 1528 (discussing the presumption of accuracy afforded to contemporaneous medical records). Mr. Greene persuasively explained why a person in his position might not have immediately realized that the symptoms he was experiencing were vaccine-related. But he was not persuasive in differentiating between the milder August symptoms he alleged and the more severe pain and numbness that resulted in his Labor Day emergency room visit. In addition, Petitioner’s explanation for his personal understanding of numbness, and why he distinguished it from his purported earlier symptoms, did not make sense. And he did not persuasively explain why he would have told so many of his treaters that onset of his symptoms occurred later than he now proposes. Mrs. Greene for her part established that at some point, the Greenes attempted to self-treat Petitioner’s symptoms with natural remedies, and that she had purchased some of these items in August 2009. But her testimony did not establish that these home treatments occurred in August. 33 Something is delayed if it is “postpone[]d until a later time.” Webster’s Second, New College Dictionary (Houghton Mifflin Co. 1995) at 298. 21 Case 1:11-vv-00631-MMS Document 61 Filed 12/16/15 Page 22 of 22 Indeed, the diary entry she offered to establish Mr. Greene’s August onset was dated in September – after Mr. Greene’s emergency room visit – and thus not only did not support the alleged August onset, but could be understood to suggest that her husband’s nocturnal suffering actually began after his emergency room visit rather than before (which is consistent with the treatment record). Overall, Petitioner did not offer enough sufficiently compelling testimony or other evidence to refute the contemporaneous medical records, which firmly support an onset period a few weeks later than that alleged by Mr. Greene. It is understandable that an individual might have trouble recalling, several years later, whether a symptom began earlier or later within a five-week period (measured here between the start of August and the first week of September). But in this case, Petitioner has not shown it to be more likely than not that his recollection is correct, and the medical records wrong. Conclusion Based on consideration of the record as a whole, I find that the onset of Mr. Greene’s brachial neuritis more likely than not began no earlier than September 1, 2009 (or 41 days post- vaccination). Based on this determination, Petitioner cannot succeed on his Table Injury claim, and accordingly it is DISMISSED. Petitioner may nevertheless proceed with his Non-Table claim. The parties are ordered to provide this ruling to any expert whom they retain for the purpose of litigating that claim. I am unlikely to find persuasive expert opinion that is inconsistent with these findings of fact. See Burns, 3 F.3d at 417 (special master did not abuse his discretion in refraining from conducting a hearing when the petitioner’s expert “based his opinion on facts not substantiated by the record”). The parties shall also immediately contact my chambers and schedule a telephonic status conference in this case to discuss next steps. IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Special Master 22 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_11-vv-00631-2 Date issued/filed: 2017-11-14 Pages: 9 Docket text: PUBLIC DECISION (Originally filed: 9/26/2017) Regarding 102 DECISION of Special Master (Signed by Special Master Brian H. Corcoran). (cr) Copy to parties. -------------------------------------------------------------------------------- Case 1:11-vv-00631-MMS Document 105 Filed 11/14/17 Page 1 of 9 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 11-631V (to be published) * * * * * * * * * * * * * * * * * * * * * * * * * ROY GREENE, * * Petitioner, * Filed: September 26, 2017 * v. * * Entitlement; Reconsideration; SECRETARY OF HEALTH * Tetanus-Diphtheria (“Td”) AND HUMAN SERVICES, * Vaccine; Evidentiary Support * for Onset Timeframe; Expert Respondent. * Opinions * * * * * * * * * * * * * * * * * * * * * * * * * * Richard Gage, Law Offices of Richard Gage, Cheyenne, WY, for Petitioner. Ann Martin, U.S. Dep’t of Justice, Washington, DC, for Respondent. DECISION ON RECONSIDERATION DENYING ENTITLEMENT1 On May 26, 2017, I issued a decision denying Petitioner’s request for compensation in this case and dismissing his claim. ECF No. 93. Petitioner then filed a motion for reconsideration of my decision on June 16, 2017, along with a supplemental (albeit unauthorized) expert report and several items of previously-unfiled medical literature. ECF Nos. 94-97. I withdrew my decision in order to evaluate the merits of the reconsideration request. Now, having had the chance to do so, I hereby again DENY entitlement after reconsideration. Petitioner has not established why the arguments he raises on reconsideration 1 This decision has been designated “to be published,” and will therefore be posted on the United States Court of Federal Claims website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (Dec. 17, 2002) (current version at 44 U.S.C. § 3501 (2014)). As provided by 42 U.S.C. § 300aa- 12(d)(4)(B), however, the parties may object to the published ruling’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 in its present form will be available to the public. Id. Case 1:11-vv-00631-MMS Document 105 Filed 11/14/17 Page 2 of 9 pertaining to the third Althen prong could not have been asserted earlier, and I also find that those arguments are not otherwise persuasive. Factual and Procedural History The facts relevant to the present decision, as well as the general procedural history in this matter, are set forth in my earlier onset fact ruling and withdrawn initial decision denying entitlement, and are incorporated by reference. See Ruling Regarding Findings of Fact, dated July 31, 2015 (ECF No. 56) (“Fact Ruling”); Decision Denying Entitlement, dated May 23, 2017 (ECF No. 93) (“Decision”), withdrawn by Order dated June 19, 2017 (ECF No. 98). In short, on September 29, 2011, Roy Greene filed a petition for compensation in the National Vaccine Injury Compensation Program (the “Vaccine Program”),2 alleging that he developed brachial neuritis as a result of his July 22, 2009, receipt of the tetanus-diphtheria (“Td”) vaccine. Pet. (ECF No. 1). Mr. Greene originally alleged both a Table injury claim and a “non- Table” causation-in-fact claim (id. at 2), but I dismissed the Table claim after a March 2015 fact hearing, at which time I determined that his symptoms arose 41 days after the vaccination, and thus occurred outside the 28-day limit for the Table claim. 42 C.F.R. § 100.3(a)(I)(B)). Over the next two years, the parties engaged in ultimately-fruitless settlement discussions, including a mediation. By the end of 2016, original counsel had withdrawn and present counsel (Richard Gage, Esq.) had appeared. But the parties’ inability to settle the case was made known to me earlier in the fall of 2016 – as well as the fact that Respondent had questioned the adequacy of Petitioner’s showing as to the third prong under Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005), which evaluates whether the timing of a claimant’s alleged post- vaccine injury is medically acceptable. See Order, dated September 29, 2016 (ECF No. 72). Since my 2015 Fact Decision, it has been well understood that the propriety of the 41-day onset timeframe was pivotal to the claim’s resolution. Fact Ruling at 22. Yet Petitioner’s initial expert (Dr. Thomas Wright, an orthopedist) inadequately addressed this matter, despite two opportunities to do so in written reports, relying instead on the conclusory argument that the onset date I had determined was still “close” enough to the 28-day period for a Table claim to be medically acceptable. Decision at 2-4. After I inquired as to why the parties had not resolved the claim, and learned that Respondent rejected the adequacy of Petitioner’s showing on this prong, I ordered Petitioner to obtain a supplemental expert opinion. See Order, dated September 29, 2016 (ECF No. 72). In early 2017, Petitioner offered a report from a second expert, Dr. Marcel Kinsbourne, but it similarly relied on conclusory reasoning in arguing that the 41-day onset for Mr. Greene’s brachial neuritis was medically appropriate. Decision at 5. I thereafter invited a motion to dismiss 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. 2 Case 1:11-vv-00631-MMS Document 105 Filed 11/14/17 Page 3 of 9 from Respondent, ruling in his favor. Id. at 16. In so doing, I noted that Petitioner could not as a matter of law rely on a timeframe set for a Table claim to justify the timeframe for a comparable non-Table claim. Id. at 12-13. But that was the sole offered explanation for the reasonableness of the timeframe at issue, as neither of Petitioner’s experts offered any other substantiation for why 41 days was medically acceptable. Id. at 13-14. Instead, they merely set forth an opinion on timeframe based on their ipse dixit. Id. at 14. Request for Reconsideration On June 16, 2017, Mr. Greene filed the pending motion for reconsideration. See Motion for Reconsideration, dated June 16, 2017 (ECF No. 97) (“Reconsid. Mot.”). The reconsideration request makes two general sets of arguments – one based on evidentiary standard grounds, the other on substantive grounds. With respect to the former, Mr. Greene posits that Dr. Wright’s opinion was never rebutted by any responsive expert opinion, and therefore should have been deemed sufficient to constitute preponderant evidence establishing the third prong. Reconsid. Mot. at 2. He also maintained that I unreasonably required that opinion to be supported by medical literature, contrary to controlling Federal Circuit case law. Id. at 2, citing Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1321 (Fed. Cir. 2006). And he maintained that the 42-day period for onset of a wide variety of autoimmune conditions found ample support in other Program decisions (although the reconsideration request does not explain why no reference was made to these decisions when opposing Respondent’s motion). Id. at 4. Throughout the reconsideration request, Petitioner also repeats his view (rejected by my initial decision dismissing the claim) that reliance on the Table timeframe applicable to brachial neuritis or similar neuropathic injuries is reasonable. See, e.g., id. at 2 (“not a huge analytical gap” to go from the Table’s 28-day timeframe to the 41 day period relevant to the non-Table claim), 4 (noting that Table claim for guillain-barré syndrome (“GBS”) allows latency after vaccine of up to 42 days).3 Regarding the second argument (and despite Petitioner’s assertion that requiring him to make a more substantiated showing as to the third prong amounted to holding him to a “higher standard” than required by the Vaccine Act (Reconsid. Mot. at 5)), Petitioner maintained that reliable medical and scientific evidence supports 41 days as a medically appropriate timeframe for onset of brachial neuritis after receiving the Td vaccine. Id. at 5-6. To that end, Mr. Greene has filed a supplemental expert report from Dr. Kinsbourne, dated June 13, 2017, filed as Ex. 45 (ECF 3 Petitioner’s motion for reconsideration otherwise avoids explaining why he failed to address squarely Respondent’s challenge to the adequacy of his third Athen prong showing, beyond asserting that (perhaps relying on his belief that the showing he had made, such as it was, satisfied his evidentiary burden) he and his experts “were unaware” that they needed to do more than invoke the Table’s timeframe and present conclusory expert opinions. Reconsid. Mot. at 4-5. 3 Case 1:11-vv-00631-MMS Document 105 Filed 11/14/17 Page 4 of 9 No. 94-1) (“Kinsbourne Supp. Rep.”)),4 along with 19 pieces of additional medical or scientific literature. See ECF Nos. 94-96 (Exs. 46-66). Despite the volume of additionally-filed materials, there is less contained in these filings, substantively speaking, than meets the eye. None of these pieces of literature were published after my initial May decision denying entitlement, and therefore do not constitute “new” evidence that could only have been discovered in the past several months. Moreover, of the 19 new items filed, only seven directly involve brachial neuritis or an arguably parallel condition. Some are inapposite case studies in which the affected individual experienced a possible vaccine-related reaction far sooner than relevant herein. See, e.g., G. Martin et al., Brachial Neuritis and Seventh Nerve Palsy – A Rare Hazard of DPT Vaccination, 12 Clin. Ped. 506, 506-07 (1973), filed as Ex. 61 (ECF No. 95-8) (five-month old developed symptoms of brachial neuritis within two days of vaccination). Dr. Kinsbourne nevertheless argues that the risk interval incorporated into the Table’s brachial neuritis claim would have been longer if the relevant studies when the Table claim was created had not over-relied on such limited instances (or excluded longer timeframe occurrences outright). Kinsbourne Supp. Rep. at 2. Of course, in making that argument, Petitioner was once again attempting to leverage the adequacy of the Table timeframe in his favor – a posture I have already rejected in my initial entitlement decision. Dr. Kinsbourne also attempts to analogize brachial neuritis to other autoimmune diseases such as GBS, given the fact the both involve peripheral nerve damage, and possibly the same autoimmune target and/or antibodies. See, e.g., Kinsbourne Supp. Rep. at 3 (“Brachial Neuritis and GBS are Related Disorders”), and Exs. 50-52, 54. But to do so, he invoked scientific or medical literature that upon close inspection was not reliable for the purpose cited. Thus, Dr. Kinsbourne cites R. Verma et al., Neuralgic Amyotrophy Associated with Dengue Fever: Case Series of Three Patients, 57 J. Postgrad. Med. 329, 329-31 (2011), filed as Ex. 52 (ECF No. 94-8) (“Verma”) as helping establish the association between GBS and brachial neuritis mechanistically (and therefore in turn allowing for the conclusion that timeframes associated with one could be applied to the other). Kinsbourne Supp. Re. at 3. Verma, however, not only involved a three-person case study 4 Accompanying Dr. Kinsbourne’s supplemental report is a fifth expert report (from Dr. Vera Byers) not otherwise disclosed or identified as such (although referenced in Dr. Kinsbourne’s own report), and not solicited or approved by me in advance of filing. See Ex. 46 (filed as ECF No. 94-2) (“Byers Rep.”). The report (which was accompanied by five items of literature) has also been mistakenly filed twice. See Ex. 59. This unauthorized additional expert report does not substantially aid Petitioner’s case, however. Dr. Kinsbourne’s newest report references the concept that variations in “host factors” can impact the timing of an autoimmune response, citing to Dr. Byers’s opinion (presented in a two-page letter) for support. Kinsbourne Supp. Rep. at 1. Dr. Byers in turn expands on this concept, discussing variation in cytokine ranges in experiments involving diabetic mice as suggesting that humans might also experience variability in the length of an autoimmune response based on inherent genetic differences between individuals. Byers Rep. at 1-2. But Mr. Greene has not been identified as possessing any notable factors that would suggest his immune response would take longer than what usually might be expected for an autoimmune reaction resulting in brachial neuritis (or any possibly comparable peripheral neuropathy for that matter). And Dr. Byers offers no opinion directly relevant to Mr. Greene’s circumstances either (i.e., she does not opine that the 41-day post-vaccination onset of his brachial neuritis was attributable to the variations she discusses, nor does she maintain that the progression or onset of brachial neuritis has been specifically found to be subject to such difference). I therefore give this additional, unauthorized expert opinion little weight. 4 Case 1:11-vv-00631-MMS Document 105 Filed 11/14/17 Page 5 of 9 (a type of evidence that Program case law generally gives less weight)5, but addressed brachial neuritis arising after an active dengue fever infection rather than post-vaccination. Verma at 329. And each case study evaluated in Verma involved post-infectious onset occurring in a far more acute manner than herein. Id. at 329-330 (onset of first symptoms of arm or shoulder pain occurring approximately two weeks, 17 days, and one week, respectively, after initial dengue fever symptoms). In seeking to establish a longer timeframe for Td-induced brachial neuritis, Petitioner offered some reliable items of literature discussing the timeframes accepted in the medical community for autoimmune illnesses. See, e.g., Rowhani–Rahbar et al., Biologically Plausible and Evidence–Based Risk Intervals in Immunization Safety Research, 31 Vaccine 271, 271–77 (2012), filed as Ex. 48 (ECF No. 94-4) (“Rowhani-Rahbar”). Rowhani-Rahbar proposed risk interval estimates for two adverse events following vaccine administration – febrile seizures and acute disseminated encephalomyelitis (“ADEM”). Id. at 273. For ADEM (the closest analog to Petitioner’s brachial neuritis, given its neurologic nature), Rowhani-Rahbar concluded that the likely time period from vaccination to onset “best substantiated by available biological and epidemiologic data” was five to 28 days. Id. at 274. A secondary, longer interval of two to 42 days was also deemed “biologically plausible,” and therefore worthy of consideration in order to fully assess a potential safety problem, but was more uncertain, since “there might be reason to suspect that most of the excess risk, if any, is concentrated in a much shorter period of time.” Id. at 275. This secondary interval has nevertheless been found persuasive by other special masters despite its admitted foundational limitations. See, e.g., Day v. Sec’y of Health & Human Servs., No. 12- 630V, 2015 WL 8028393, at *22 (Fed. Cl. Nov. 13, 2015) (applying Rowhani–Rahbar secondary risk interval to case alleging that petitioner’s multiple sclerosis was vaccine-caused). Objections to Reconsideration After Petitioner’s motion for reconsideration was filed, I urged the parties to make a final, good-faith effort to settle the case. See Order, dated June 28, 2017 (ECF No. 99). Their efforts were unsuccessful, however, and so Respondent filed an objection to the reconsideration request in August. Response to Motion for Reconsideration, dated August 23, 2017 (ECF No. 101) (“Opp.”). In it, Respondent (after reviewing the relevant legal standards) stressed that Petitioner had received a “full and fair” opportunity to substantiate his timeframe argument, and therefore had established no grounds to continue to seek to litigate the point. Opp. at 3-6. Respondent also addressed some of the specific arguments embodied in Dr. Kinsbourne’s new report and associated medical and scientific literature. Respondent observed that some of the studies offered to establish that 42 days was a medically acceptable timeframe actually undercut the conclusion that the tetanus vaccine posed any risk at all of brachial neuritis. Opp. at 6-7, citing 5 See Holt v. Sec'y of Dep't of Health & Human Servs., No. 05-0136V, 2015 WL 4381588, at *28 (Fed. Cl. Spec. Mstr. June 24, 2015) (discussing evidentiary limitations of case study evidence in establishing vaccine causation). 5 Case 1:11-vv-00631-MMS Document 105 Filed 11/14/17 Page 6 of 9 Tseng et al., Safety of the Tetanus-Diphtheria-Acellular Pertussis Vaccine When Used Off-Label in an Elderly Population, 56 CID 315, 315-21 (2013). Respondent further pointed out the legal limitations of analogizing brachial neuritis to GBS in attempting to make an Althen three showing, noting the long-recognized principle in the Vaccine Program that the timeframes relevant to different vaccines and their injuries are not “interchangeable.” Id. at 8, citing Grant v. Sec’y of Health & Human Servs., 956 F. 2d 1144, 1147-48 (Fed. Cir. 1992). More specific to the injury in question, Respondent noted that the best existing evidence of a link between vaccines containing tetanus toxoid and brachial neuritis -- the Institute of Medicine’s (“IOM”) 1994 report -- had also set forth a proposed latency timeframe that did not exceed four weeks. Opp. at 8-9 citing Stratton et al, Adverse Effects of Vaccines: Evidence and Causality 54-55, 90-94 (Nat’l Acad, Press 2011), filed as Ex. A (“IOM Rep.”). Dr. Kinsbourne sought to establish that the reasonableness of a longer timeframe simply had not been investigated since the IOM’s findings over twenty years ago, which were now somewhat stale. Kinsbourne Supp. Rep. at 4. However, to make that argument was to seek to discredit the same evidence that Petitioner relied upon to establish a causal relationship in the first place. Opp. at 11. The reconsideration request is now fully briefed and ripe for resolution. Analysis Vaccine Rule 10(e) governs motions for reconsideration of a special master’s decision. As it provides, “[e]ither party may file a motion for reconsideration of the special master’s decision within 21 days after the issuance of the decision . . . .” Vaccine Rule 10(e)(1). Special masters have the discretion to grant a motion for reconsideration if to do so would be in the “interest of justice.” Vaccine Rule 10(e)(3). Although I voluntarily withdrew my earlier decision, I shall still apply and consider the standards for reconsideration, since the underlying merits of Petitioner’s request have not yet been resolved. As noted by another special master, “there is a dearth of law interpreting Vaccine Rule 10(e)(3),” beyond the conclusion that (as the rule itself makes clear) it is within the special master’s discretion to decide what the “interest of justice” is in a given case. R.K. v. Sec’y of Health & Human Servs., No. 03-632V, 2010 WL 5572074, at *3 (Fed. Cl. Spec. Mstr. Jan. 10, 2011) (granting reconsideration of decision dismissing case for failure to prosecute). Many decisions assume that the standard for reconsideration is congruent with the “manifest injustice” standard utilized under Rule 59(a) of the Rules of the Court of Federal Claims, which has been defined to be unfairness that is “clearly apparent or obvious.” Amnex, Inc. v. United States, 52 Fed. Cl. 555, 557 (2002); see also R.K., 2010 WL 5572074, at *3-5 (citations omitted). At bottom, the question is whether reconsideration would provide a Vaccine Act petitioner a full opportunity to prove her case. R.K., 2010 WL 5572074, at *5. 6 Case 1:11-vv-00631-MMS Document 105 Filed 11/14/17 Page 7 of 9 I have denied reconsideration requests where no truly novel evidence is offered, but rather where the movant mainly disagrees with my initial decision and seeks to reargue an earlier-stated position. See, e.g., D’Tiole v. Sec’y of Health & Human Servs., No. 15-085V, 2016 WL 8136296 (Fed. Cl. Spec. Mstr. Dec. 21, 2016), mot. for review den’d, 132 Fed. Cl. 421 (2017), appeal docketed (Fed. Cir. May 4, 2017); Kerrigan v. Sec’y of Health & Human Servs., No. 16-270V, 2016 WL 7575240 (Fed. Cl. Spec. Mstr. Nov. 22, 2016). Having reviewed the materials offered by Petitioner relevant to onset, I do not find that he has established persuasive grounds for reversing my earlier entitlement decision, and therefore I will reinstitute my initial decision denying compensation. My determination flows from the same two considerations – one procedural, the other substantive – that Petitioner’s reconsideration request revolves around. Although the former consideration bears somewhat less on my determination, it is still important. As the procedural history of this case starkly reveals, Petitioner was unreasonably dilatory in substantiating the long-identified deficiencies in his Althen three showing. Since the summer of 2015, Petitioner has been aware that the success of his non-Table claim depended on establishing the validity of a 41-day post-vaccination onset. He had more than enough time to obtain a competent expert to so opine – and to adjust that opinion in reaction to Respondent’s objections. He also had ample time to marshal whatever medical or scientific literature he thought would bulwark the theory. Yet he did nothing, relying instead on conclusory opinions that in turn depended on the mistaken belief that the Table timeframe could be applied to this claim. By the time Dr. Kinsbourne’s report was filed in January 2017, Petitioner clearly was aware of Respondent’s objections about the timing of onset – yet that report as well was largely conclusory on this critical component of his claim. Given the above, it is difficult to justify Petitioner’s present, all-out effort to make a case he should have made months ago. Petitioner has not offered a single persuasive explanation for his prior failure to address this matter at the appropriate time.6 He has also not endeavored to establish any of the specific grounds for reconsideration (nor could he, as the evidence offered is far from new). Petitioner might respond that it is more generally in the “interests of justice” that I permit him the fullest opportunity possible to make his case – but if so, it is hard to envision any circumstance in which a claimant, having failed to satisfy some element of his claim, would not be entitled to continue to argue the merits of a point despite the passage of deadlines to act, since allowing a claimant to do so would inherently provide him a more “full and fair” opportunity to establish entitlement (regardless of how much of an opportunity he had already received). Although relevant case law counsels leniency in affording Vaccine Program claimants every 6 The change in counsel in November 2016 is certainly no justification for reconsideration. Petitioner has been represented by two individuals well versed in the Vaccine Program’s practices and applicable law, and was in fact represented by prior counsel for nearly five years. Present counsel had a reasonable opportunity to review the record, take note that the third Althen prong was the primary point of contention, and prepare an expert report addressing the matter. 7 Case 1:11-vv-00631-MMS Document 105 Filed 11/14/17 Page 8 of 9 chance to make their case, this procedural record establishes that Petitioner already received such an opportunity. Nevertheless – I am loathe to reject Petitioner’s reconsideration request solely on the unjustifiably dilatory nature of his Althen prong three showing. I therefore have reviewed and considered the 20-plus pieces of literature, plus supplemental report, filed after my Decision, to evaluate if they fill the evidentiary hole in Mr. Greene’s overall showing. I find they do not. Petitioner has offered little evidence directly relevant to the injury at issue – a failing not completely fatal to his claim, but still a factor to be taken into account in determining how much weight to give the evidence offered overall. He has offered case studies which largely underscore the reliability of the Table’s timeframe, but do not bulwark his claims that a longer period is acceptable. He has also made an inadequately specific showing with respect to either the illness in question or the Td vaccine. And he has done all the above utilizing an expert, Dr. Kinsbourne, who has not been demonstrated to have specific, applicable experience with peripheral neuropathies of any kind, or brachial neuritis itself, sufficient to render his interpretation of the facts of this case or background science persuasive in the absence of other direct convincing proof. By contrast, there is applicable law relating to what is medically reasonable for onset of post-vaccination brachial neuritis – but it is not favorable to Petitioner. For example, in Garner v. Sec’y of Health & Human Servs., No. 15-063V, 2017 WL 1713184 (Fed. Cl. Mar. 24, 2017), mot. for review den’d, 2017 WL 3483352 (Fed. Cl. July 31, 2017), I considered a claim that the Hepatitis A and B vaccines caused Parsonage-Turner Syndrome (a parallel descriptor for brachial neuritis). The earliest onset possible in Garner was 45 days after vaccination, based on the first record documentation of any complaints by petitioner about arm or shoulder pain. Garner, 2017 WL 1713184, at *1. Respondent’s expert, however, argued that the condition was far more acute in nature (and in terms of the causative mechanism), making in his opinion four weeks the outer limit for latency. Id. at *8. I found this point to be dispositive, even though the claimant’s Althen prong one showing was persuasive. Id. at 16. Nothing Petitioner has argued in this case is any more persuasive than what I have previously rejected in like circumstances. I acknowledge that Petitioner has offered some reliable evidence supporting the medical acceptability of a 41-day onset for other autoimmune conditions. Rowhani-Rabhar, for example, supports the assertion that an autoimmune process could begin in the same timeframe that Mr. Greene experienced. But the fact that this article does not involve brachial neuritis, or any comparable peripheral neuropathic injury, does somewhat limit its applicability. More generally, it is too sweeping to maintain that there is a single temporal yardstick applicable to any autoimmune illness. To so argue is to ignore the different ways in which specific kinds of injuries unfold. Garner, 2017 WL 1713184, at *16 (rejecting attempt to apply timeframes relevant to different autoimmune demyelinating illness to brachial neuritis). Petitioner’s showing is thus too nonspecific to the injury at issue, even if it is based in reliable science. 8 Case 1:11-vv-00631-MMS Document 105 Filed 11/14/17 Page 9 of 9 Although I have attempted to avoid resolving this reconsideration request solely on the basis of Petitioner’s untimely acts, my weighing of the late-filed substantive evidence is nevertheless reasonably informed by the temporal circumstances of its filing. If Petitioner had been able to marshal more straightforward and/or compelling evidence supporting the conclusion that the timing of onset of his brachial neuritis was medically acceptable – either due to directly on- point literature or by citing prior decisions involving the same injury – the strength of that showing would not be as diminished by its dilatory character. Here, however, the evidence is mixed at best, and requires too much reliance on timeframes relevant to distinguishable autoimmune illnesses. Such evidence is thus insufficiently novel or persuasively striking enough on its own to ignore its unjustifiably late assertion. Petitioner’s other arguments on reconsideration are meritless. The fact that Respondent offered no expert to attack the assertions of Drs. Wright and Kinsbourne does not mean I am required to accept their opinions wholesale. See Barone v. Sec’y of Health & Human Servs., No. 11-707, 2014 WL 6834556, at *12 (Fed. Cl. Spec. Mstr. Nov. 12, 2014) (evaluating reasonableness and reliability/persuasiveness of Petitioner’s expert showing, even where Respondent offered no rebuttal expert of his own). Nor, as previously noted in my withdrawn Decision, need I accept an expert’s unsubstantiated ipse dixit. Decision at 14. And Petitioner’s repeating (whether openly or implicitly) of his prior argument that the timeframe in question herein is only a bit longer than the Table’s timeframe, and therefore should gain credence from that fact, makes the argument no more credible or persuasive than it was the first time I rejected it, and is certainly not an independent basis for reconsideration. Id. at 12-13. CONCLUSION The record does not support Petitioner’s allegation that his Td vaccine more likely than not caused his brachial neuritis 41 days following the vaccination. Petitioner has not established entitlement to compensation, and therefore I must DISMISS the 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.7 IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Special Master 7 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their right to seek review. 9 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_11-vv-00631-3 Date issued/filed: 2018-03-14 Pages: 12 Docket text: JUDGE VACCINE REPORTED OPINION reissuing 112 Judge Vaccine Reported Opinion. Signed by Judge Margaret M. Sweeney. (kb1) -------------------------------------------------------------------------------- Case 1:11-vv-00631-MMS Document 114 Filed 03/14/18 Page 1 of 12 In the United States Court of Federal Claims No. 11-631V (Filed Under Seal: February 27, 2018) (Reissued for Publication: March 14, 2018)1 ************************************* ROY GREENE, * * Petitioner, * Vaccine Act; Motion for Review; Tetanus- * Diphtheria Vaccine; Brachial Neuritis; v. * Causation-in-Fact; Althen Prong Three; * Motion for Reconsideration Under Vaccine SECRETARY OF HEALTH AND * Rule 10(e) HUMAN SERVICES, * * Respondent. * ************************************* Richard Gage, Cheyenne, WY, for petitioner. Robert P. Coleman III, United States Department of Justice, Washington, DC, for respondent. OPINION AND ORDER SWEENEY, Judge Petitioner Roy Greene seeks compensation under the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”), 42 U.S.C. §§ 300aa-1 to -34 (2012), for an alleged vaccine-caused injury. Before the court is petitioner’s motion for review of the special master’s decision denying compensation. Because the special master applied the incorrect legal standard when evaluating the evidence offered by petitioner, the court grants petitioner’s motion and vacates the special master’s decision. I. BACKGROUND Petitioner filed a petition for compensation under the Vaccine Act on September 29, 2011, alleging that he developed brachial neuritis as a result of a July 22, 2009 tetanus-diphtheria 1 Vaccine Rule 18(b), contained in Appendix B of the Rules of the United States Court of Federal Claims, affords each party fourteen days in which to object to the disclosure of (1) trade secrets or commercial or financial information that is privileged or confidential or (2) medical information that would constitute “a clearly unwarranted invasion of privacy.” Neither party objected to the public disclosure of any information contained in this opinion. Case 1:11-vv-00631-MMS Document 114 Filed 03/14/18 Page 2 of 12 (“Td”) vaccination.2 He asserted two theories of recovery: first, that he was entitled to compensation pursuant to the Vaccine Injury Table, which provides that brachial neuritis that develops between two and twenty-eight days after receiving a vaccine containing tetanus toxoid is a compensable injury; and second, that he was entitled to compensation because the Td vaccine actually caused his brachial neuritis. The special master held a fact hearing in March 2015 to determine the onset date of petitioner’s brachial neuritis. In a July 31, 2015 decision, the special master found that petitioner’s symptoms began no earlier than September 1, 2009–forty-one days after the Td vaccination. Because petitioner’s symptoms arose after the time period prescribed in the Vaccine Injury Table, the special master dismissed petitioner’s Table claim. Over the next two years, in an effort to resolve petitioner’s remaining claim of actual causation, petitioner filed two expert reports from Thomas W. Wright, M.D., and the parties engaged in settlement discussions. In September 2016, the special master learned that the settlement discussions had not been successful because respondent rejected as inadequate petitioner’s showing that forty-one days was a medically acceptable time frame for the Td vaccine to cause brachial neuritis. Thus, the special master directed petitioner to file a supplemental expert report. In early 2017, petitioner filed an expert report from Marcel Kinsbourne, M.D. In March 2017, respondent filed a motion for a ruling on the record, to which petitioner responded the following month. In a May 26, 2017 decision, the special master found that the record did not support petitioner’s claim that the Td vaccine caused his brachial neuritis because petitioner could not establish, more probably than not, that a forty-one-day period between the vaccination and the first symptoms of the injury was medically acceptable. On June 16, 2017, petitioner filed a motion for reconsideration pursuant to Vaccine Rule 10(e), as well as a supplemental expert report from Dr. Kinsbourne and supporting documentation (including eighteen medical and scientific articles and a letter/report from Vera S. Byers, M.D., Ph.D.). In his motion, petitioner argued that he had provided sufficient evidence to establish that a forty-one-day onset period was medically acceptable, but that if the special master continued to deem the existing evidence insufficient, Dr. Kinsbourne’s supplemental expert report and supporting documentation would establish the medical acceptability of the onset period. Vaccine Rule 10(e)(3) provides that a “special master has the discretion to grant or deny” a motion for reconsideration “in the interest of justice.” If a special master grants a motion for reconsideration, Vaccine Rule 10(e)(3)(A) provides that “the special master must file an order 2 The court derives much of the background from the special master’s September 26, 2017 decision. See generally Greene v. Sec’y of HHS, No. 11-631V, 2017 WL 5382856 (Fed. Cl. Spec. Mstr. Sept. 26, 2017). The remaining background is taken from the docket of the case. -2- Case 1:11-vv-00631-MMS Document 114 Filed 03/14/18 Page 3 of 12 withdrawing the challenged decision” and that the withdrawn decision “becomes void for all purposes and the special master must subsequently enter a superseding decision.” Pursuant to Vaccine Rule 10(e)(3)(A)(ii), “[t]he special master may not . . . issue a superseding decision reaching a different result from the original decision without affording the nonmoving party an opportunity to respond to the moving party’s arguments.” The special master granted petitioner’s motion for reconsideration in a June 19, 2017 order, which provided: ORDER GRANTING PETITIONER’S MOTION FOR RECONSIDERATION On May 26, 2017, I issued a decision denying Petitioner’s request for compensation and dismissing his claim. ECF No. 93. Petitioner then filed a motion for reconsideration of my decision on June 16, 2017, along with a supplemental (albeit unauthorized) expert report and several items of previously-unfiled medical literature. ECF Nos. 94-97. I hereby grant the motion for reconsideration. Accordingly, the clerk of the Court is hereby instructed to withdraw the original decision issued on May 26, 2017. I will discuss the next steps for resolving this claim with the parties during the status conference currently set for June 28, 2017. In accordance with this order, the docket entry for the May 26, 2017 decision was amended to reflect that the decision had been withdrawn. Specifically, the following language was added at the beginning of the docket entry: “**VACATED PURSUANT TO ORDER . . . OF 6/19/2017.**” The special master conducted a status conference with the parties on June 28, 2017, and issued an order later that day memorializing the proceedings: The status conference was held to discuss Petitioner’s recent motion for reconsideration and supporting materials filed on June 16, 2017. . . . . . . [After I granted Respondent’s motion for a ruling on the record], Petitioner filed a fourth supplemental expert report and numerous additional pieces of literature aimed at bulwarking the onset/timing issue. Although these materials were filed late, I have determined that in fairness to Petitioner I must at least consider them (although I will weigh their persuasiveness against the fact of their dilatory submission), and therefore I am reconsidering my dismissal decision. -3- Case 1:11-vv-00631-MMS Document 114 Filed 03/14/18 Page 4 of 12 Prior to deciding reconsideration, however, I informed the parties that I would give them one final opportunity to engage in litigative risk settlement negotiations. . . . If petitioner cannot compromise on the amount of requested damages, he risks a determination on reconsideration that the new evidence is simply too dilatory to change my previous decision. . . . If the parties fail to reach an agreement, Respondent will have the opportunity to submit an opposition to Petitioner’s motion for reconsideration. (first and third emphasis added). The parties were unable to reach a settlement, and thus respondent filed a response to petitioner’s motion for reconsideration on August 23, 2017. On September 26, 2017, the special master issued a “Decision on Reconsideration Denying Entitlement.” At the outset of the decision, he stated that he had withdrawn his earlier entitlement decision “to evaluate the merits of the reconsideration request.” Greene, 2017 WL 5382856, at *1. Then, in a section containing the case’s factual and procedural history, the special master indicated that he was “incorporat[ing] by reference” the facts and procedural history set forth in his withdrawn decision. Id. He also succinctly described the conclusion he reached in the withdrawn decision, indicating that he had cautioned petitioner that he could not “rely on a timeframe set for a Table claim to justify the timeframe for a comparable non-Table claim,” that petitioner’s experts nevertheless relied solely on the Vaccine Injury Table’s twenty- eight-day time frame to support the reasonableness of a forty-one-day time frame, that “neither of Petitioner’s experts offered any substantiation for why 41 days was medically acceptable,” and that petitioner’s experts “merely set forth an opinion on timeframe based on their ipse dixit.” Id. at *2. The special master then described the arguments advanced by petitioner in his motion for reconsideration and the new evidence submitted by petitioner in conjunction with his motion. With respect to the latter, the special master remarked: [O]f the 19 [documents] filed [in support of Dr. Kinsbourne’s supplemental expert report], only seven directly involve brachial neuritis or an arguably parallel condition. Some are inapposite case studies in which the affected individual experienced a possible vaccine-related reaction far sooner than relevant herein. Dr. Kinsbourne nevertheless argues that the risk interval incorporated into the Table’s brachial neuritis claim would have been longer if the relevant studies when the Table claim was created had not over-relied on such limited instances (or excluded longer timeframe occurrences outright). Of course, in making that argument, Petitioner was once again attempting to leverage the adequacy of the Table timeframe in his favor–a posture I have already rejected in my initial entitlement decision. -4- Case 1:11-vv-00631-MMS Document 114 Filed 03/14/18 Page 5 of 12 Dr. Kinsbourne also attempts to analogize brachial neuritis to other autoimmune diseases such as [Guillain-Barré syndrome (“GBS”)], given the fact the both involve peripheral nerve damage, and possibly the same autoimmune target and/or antibodies. But to do so, he invoked scientific or medical literature that upon close inspection was not reliable for the purpose cited. Thus, Dr. Kinsbourne cites [an article by R. Verma] (“Verma”) as helping establish the association between GBS and brachial neuritis mechanistically (and therefore in turn allowing for the conclusion that timeframes associated with one could be applied to the other). Verma, however, not only involved a three-person case study (a type of evidence that [Vaccine] Program case law generally gives less weight), but addressed brachial neuritis arising after an active dengue fever infection rather than post-vaccination. And each case study evaluated in Verma involved post-infectious onset occurring in a far more acute manner than herein. In seeking to establish a longer timeframe for Td-induced brachial neuritis, Petitioner offered some reliable items of literature discussing the timeframes accepted in the medical community for autoimmune illnesses. [An article by A. Rowhani-Rahbar (“Rowhani-Rahbar”)] proposed risk interval estimates for two adverse events following vaccine administration–febrile seizures and acute disseminated encephalomyelitis (“ADEM”). For ADEM (the closest analog to Petitioner’s brachial neuritis, given its neurologic nature), Rowhani-Rahbar concluded that the likely time period from vaccination to onset “best substantiated by available biological and epidemiologic data” was five to 28 days. A secondary, longer interval of two to 42 days was also deemed “biologically plausible,” and therefore worthy of consideration in order to fully assess a potential safety problem, but was more uncertain, since “there might be reason to suspect that most of the excess risk, if any, is concentrated in a much shorter period of time.” This secondary interval has nevertheless been found persuasive by other special masters despite its admitted foundational limitations. Id. at *3 (citations and footnote omitted). After describing the parties’ arguments on reconsideration, the special master set forth his analysis. He began by noting that he would be applying the standard set forth in Vaccine Rule 10(e)(3) for ruling on a motion for reconsideration (the “interest-of-justice standard”), explaining: “Although I voluntarily withdrew my earlier decision, I shall still apply and consider the standards for reconsideration, since the underlying merits of Petitioner’s request have not yet been resolved.” Id. at *4. Then, after setting forth the standard, he stated: “Having reviewed the materials offered by Petitioner relevant to onset, I do not find that he has established persuasive grounds for reversing my earlier entitlement decision, and therefore I will reinstitute my initial decision denying compensation.” Id. -5- Case 1:11-vv-00631-MMS Document 114 Filed 03/14/18 Page 6 of 12 The special master proceeded to explain his decision in more detail. Initially, he found that “Petitioner was unreasonably dilatory in substantiating the long-identified deficiencies” in his showing that forty-one days was a medically acceptable time period between a Td vaccination and the onset of brachial neuritis. Id. at *5. Then, noting that he was “loathe to reject Petitioner’s reconsideration request solely on the unjustifiably dilatory nature of [that] showing,” the special master “reviewed and considered the 20-plus pieces of literature, plus supplemental report, filed after [his withdrawn] Decision, to evaluate if they fill[ed] the evidentiary hole in [Petitioner’s] overall showing.” Id. at *6. He found that they did not: Petitioner has offered little evidence directly relevant to the injury at issue–a failing not completely fatal to his claim, but still a factor to be taken into account in determining how much weight to give the evidence offered overall. He has offered case studies which largely underscore the reliability of the Table’s timeframe, but do not bulwark his claims that a longer period is acceptable. He has also made an inadequately specific showing with respect to either the illness in question or the Td vaccine. And he has done all the above utilizing an expert, Dr. Kinsbourne, who has not been demonstrated to have specific, applicable experience with peripheral neuropathies of any kind, or brachial neuritis itself, sufficient to render his interpretation of the facts of this case or background science persuasive in the absence of other direct convincing proof. By contrast, there is applicable law relating to what is medically reasonable for onset of post-vaccination brachial neuritis–but it is not favorable to Petitioner. For example, in Garner . . . , I considered a claim that the Hepatitis A and B vaccines caused Parsonage-Turner Syndrome (a parallel descriptor for brachial neuritis). The earliest onset possible in Garner was 45 days after vaccination . . . . Respondent’s expert, however, argued that the condition was far more acute in nature (and in terms of the causative mechanism), making in his opinion four weeks the outer limit for latency. I found this point to be dispositive . . . . Nothing Petitioner has argued in this case is any more persuasive than what I have previously rejected in like circumstances. I acknowledge that Petitioner has offered some reliable evidence supporting the medical acceptability of a 41-day onset for other autoimmune conditions. Rowhani-[Rahbar], for example, supports the assertion that an autoimmune process could begin in the same timeframe that [Petitioner] experienced. But the fact that this article does not involve brachial neuritis, or any comparable peripheral neuropathic injury, does somewhat limit its applicability. More generally, it is too sweeping to maintain that there is a single temporal yardstick applicable to any autoimmune illness. To so argue is to ignore the different ways in which specific kinds of injuries unfold. . . . Petitioner’s showing is thus too nonspecific to the injury at issue, even if it is based in reliable science. -6- Case 1:11-vv-00631-MMS Document 114 Filed 03/14/18 Page 7 of 12 Id. (citations omitted). Considering his procedural and substantive objections together, the special master stated: Although I have attempted to avoid resolving this reconsideration request solely on the basis of Petitioner’s untimely acts, my weighing of the late-filed substantive evidence is nevertheless reasonably informed by the temporal circumstances of its filing. If Petitioner had been able to marshal more straightforward and/or compelling evidence supporting the conclusion that the timing of onset of his brachial neuritis was medically acceptable–either due to directly on-point literature or by citing prior decisions involving the same injury–the strength of that showing would not be as diminished by its dilatory character. Here, however, the evidence is mixed at best, and requires too much reliance on timeframes relevant to distinguishable autoimmune illnesses. Such evidence is thus insufficiently novel or persuasively striking enough on its own to ignore its unjustifiably late assertion. Id. (emphasis added). Thus, at the end of his decision, the special master concluded: The record does not support Petitioner’s allegation that his Td vaccine more likely than not caused his brachial neuritis 41 days following the vaccination. Petitioner has not established entitlement to compensation, and therefore I must DISMISS the claim. In the absence of a timely-filed motion for review . . . , the Clerk shall enter judgment in accordance with this decision. Id. at *7. Notably, the special master did not direct the clerk to reinstate or refile his withdrawn decision (or to remove the text from the docket entry for the May 26, 2017 decision indicating that the decision had been withdrawn3). Nor does the withdrawn decision appear on the website of the United States Court of Federal Claims (“Court of Federal Claims”) or in the online databases maintained by Westlaw and LexisNexis. Petitioner timely filed a motion for review of the special master’s September 26, 2017 decision on reconsideration, which respondent opposes. Upon reviewing the record that was before the special master and hearing argument on February 13, 2018, the court is prepared to rule. 3 Instead, a note was added to the docket entry for the May 26, 2017 decision to indicate that the entry was modified on September 26, 2017 “to correct docket text and to remove restriction on [the] attachment.” -7- Case 1:11-vv-00631-MMS Document 114 Filed 03/14/18 Page 8 of 12 II. DISCUSSION A. Standard of Review The Court of Federal Claims has jurisdiction to review the record of the proceedings before a special master, and upon such review, may: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision, (B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or (C) remand the petition to the special master for further action in accordance with the court’s direction. 42 U.S.C. § 300aa-12(e)(2). The standards set forth in section 12(e)(2)(B) “vary in application as well as degree of deference. . . . Fact findings are reviewed . . . under the arbitrary and capricious standard; legal questions under the ‘not in accordance with law’ standard; and discretionary rulings under the abuse of discretion standard.” Munn v. Sec’y of HHS, 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). In the instant case, petitioner enumerates, pursuant to Vaccine Rule 24, two objections to the special master’s September 26, 2017 decision. First, petitioner contends that “[t]he special master erred as a matter of law in applying the standard for considering a motion for reconsideration under Vaccine Rule 10(e) to his actual consideration of the case on the merits after granting a Vaccine Rule 10(e) motion.” Mot. 1. Second, petitioner asserts that “[t]he special master erred as a matter of law by increasing the burden of proof on Petitioner to supply direct evidence instead of circumstantial evidence of a medically appropriate time frame for onset . . . .” Id. Petitioner accordingly requests that the “Court rule that Petitioner has made a legally adequate showing of causation and remand this case [to the special master] for a determination of damages.” Id. at 20. Petitioner further requests that the “Court order that this case be reassigned to a new special master.” Id. B. The Special Master’s Application of the Interest-of-Justice Standard Was Legal Error Petitioner first argues that the special master, in his September 26, 2017 decision, should not have applied the interest-of-justice standard because the special master had already ruled on petitioner’s motion for reconsideration on June 19, 2017. Respondent disagrees, asserting that the special master explained in his June 28, 2017 order that he considered the merits of petitioner’s motion for reconsideration to be unresolved, and that the special master’s application of the interest-of-justice standard in his September 26, 2017 decision did not prejudice -8- Case 1:11-vv-00631-MMS Document 114 Filed 03/14/18 Page 9 of 12 petitioner.4 As explained below, the court concludes that the special master erred by applying the interest-of-justice standard in his September 26, 2017 decision, and that in doing so, he prejudiced petitioner. Pursuant to Vaccine Rule 10(e)(3), special masters have “the discretion to grant or deny” a motion for reconsideration “in the interest of justice.” As the special master noted in his September 26, 2017 decision, there is a paucity of case law construing the interest-of-justice standard. The prevailing assumption is that the standard “is congruent with the ‘manifest injustice’ standard utilized under Rule 59(a) of the Rules of the Court of Federal Claims, which has been defined to be unfairness that is ‘clearly apparent or obvious.’” Greene, 2017 WL 5382856, at *4 (quoting Amnex, Inc. v. United States, 52 Fed. Cl. 555, 557 (2002)). But see Krakow v. Sec’y of HHS, No. 03-632V, 2010 WL 5572074, at *5 (Fed. Cl. Spec. Mstr. Nov. 12, 2010) (“[T]he ‘interest of justice’ standard is likely less onerous than ‘manifest injustice.’”). According to the special master, “[a]t bottom, the question is whether reconsideration would provide a Vaccine Act petitioner a full opportunity to prove her case.” Greene, 2017 WL 5382856, at *4. As such, the interest-of-justice standard is separate and distinct from the standard for resolving the merits of the underlying claim for compensation.5 4 Although respondent observes that petitioner did not object to the special master’s characterization of the motion for reconsideration as unresolved, he does not advance a waiver argument. Accordingly, the court need not consider whether petitioner waived his objection. 5 Petitioner seeks compensation under a theory of actual causation. To prove causation under the Vaccine Act, a petitioner must show by preponderant evidence that the vaccination brought about [his] 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 v. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). Establishing the third element of the Althen test “requires preponderant proof that the onset of symptoms occurred within a timeframe for which, given the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation-in-fact.” de Bazan v. Sec’y of HHS, 539 F.3d 1347, 1352 (Fed. Cir. 2008). “The determination of causation in fact under the Vaccine Act involves ascertaining whether a sequence of cause and effect is ‘logical’ and legally probable, not medically or scientifically certain.” Knudsen v. Sec’y of HHS, 35 F.3d 543, 548-49 (Fed. Cir. 1994). Thus, causation can be established with circumstantial evidence–in other words, with medical records or medical opinion. Althen, 418 F.3d at 1279-80 (citing 42 U.S.C. § 300aa-13(a)(1)). A petitioner “need not produce medical literature or epidemiological evidence to establish -9- Case 1:11-vv-00631-MMS Document 114 Filed 03/14/18 Page 10 of 12 In his June 19, 2017 order, the special master unambiguously and unconditionally granted petitioner’s motion for reconsideration. Although the special master subsequently stated, in his June 28, 2017 order, that he had not yet “decid[ed] reconsideration,” the June 19, 2017 order granting reconsideration did not explicitly or implicitly indicate that the motion had not been fully resolved.6 In other words, the special master’s June 28, 2017 statements regarding the status of petitioner’s motion for reconsideration did not alter the legal effect of the June 19, 2017 order granting reconsideration.7 Thus, the special master should not have applied the interest-of- justice standard in his September 26, 2017 decision.8 causation,” but “where such evidence is submitted, the special master can consider it in reaching an informed judgment as to whether a particular vaccination likely caused a particular injury.” Andreu v. Sec’y of HHS, 569 F.3d 1367, 1379 (Fed. Cir. 2009); see also id. at 1380 (remarking that a special master may assess “the relevant scientific data” when determining whether a petitioner has offered a reputable and reliable explanation supporting his theory of causation); Capizzano v. Sec’y of HHS, 440 F.3d 1317, 1325 (Fed. Cir. 2006) (“[R]equiring either epidemiologic studies, rechallenge, the presence of pathological markers or genetic disposition, or general acceptance in the scientific or medical communities to establish a logical sequence of cause and effect is contrary to what we said in Althen[, and] impermissibly raises a claimant’s burden under the Vaccine Act . . . .”). But see LaLonde v. Sec’y of HHS, 746 F.3d 1334, 1341 (Fed. Cir. 2014) (“In Vaccine Act cases, petitioners must proffer trustworthy testimony from experts who can find support for their theories in medical literature in order to show causation under the preponderance of the evidence standard. The level of specificity of such support may vary from circumstance to circumstance.”). 6 Other special masters have stated such an intent in orders addressing motions for reconsideration. See, e.g., Order Granting Recons., July 28, 2015, Cozart v. Sec’y of HHS, No. 00-590V (“Petitioner’s motion is GRANTED to the extent that the June 30, 2015 decision is WITHDRAWN. Whether petitioners will be entitled to the substantive relief that they request will be determined after further analysis. Respondent shall file a response to petitioner’s Motion for Reconsideration . . . .”); Order Granting Recons., Mar. 4, 2014, Lerwick v. Sec’y of HHS, No. 06-847V (“The Secretary’s motion is GRANTED to the extent that the February 7, 2014 decision is WITHDRAWN. Whether the Secretary will be entitled to the substantive relief that she requests will be determined after further analysis. Ms. Lerwick shall file a response to the Secretary’s Motion for Reconsideration . . . .”). 7 The special master did not amend or reissue his June 19, 2017 order granting reconsideration to accurately reflect his purported intent. 8 The court also has a housekeeping concern not raised by petitioner in his motion for review: it is not convinced that the special master’s September 26, 2017 decision constitutes the “superseding decision” required by Vaccine Rule 10(e)(3)(A). That rule provides: “If the special master grants the motion for reconsideration, the special master must file an order withdrawing the challenged decision. The decision, once withdrawn, becomes void for all purposes and the -10- Case 1:11-vv-00631-MMS Document 114 Filed 03/14/18 Page 11 of 12 Furthermore, the special master’s application of the interest-of-justice standard prejudiced petitioner. The special master explicitly stated in his decision, when assessing the probative value of petitioner’s newly submitted evidence, that his “weighing of the late-filed substantive evidence [was] . . . reasonably informed by the temporal circumstances of its filing,” and that had petitioner “been able to marshal more straightforward and/or compelling evidence supporting the conclusion that the timing of onset of his brachial neuritis was medically acceptable . . . the strength of that showing would not [have been] as diminished by its dilatory character.” Id. at *6. While special masters have the discretion to determine the probative value of evidence, Munn, 970 F.2d at 871, the timing of the submission of an expert report and medical and scientific literature should not affect their probative value. Because the special master did not weigh all of the evidence offered by petitioner based solely on its quality, his assessment of the evidence as a whole is compromised, prejudicing petitioner. III. CONCLUSION Because the special master’s application of the interest-of-justice standard tainted his entire entitlement decision, the court need not address petitioner’s second objection–that the special master improperly increased petitioner’s burden of proving a medically acceptable time frame for onset by requiring him to produce direct, rather than just circumstantial, evidence.9 special master must subsequently enter a superseding decision.” Vaccine Rule 10(e)(3)(A). When the special master granted petitioner’s motion for reconsideration, he withdrew his initial entitlement decision, rendering that decision “void for all purposes” and triggering the requirement to issue a “superseding decision.” By definition, a “superseding decision” is a decision that replaces the withdrawn, void decision. See The American Heritage College Dictionary 1386 (4th ed. 2004) (defining “supersede” as “[t]o take the place of; replace”). The special master obviously intended his September 26, 2017 decision–in which he “incorporated by reference” the facts and procedural history included in his initial entitlement decision and then purported to “reinstitute” the initial entitlement decision–to be a replacement decision. However, the special master’s initial entitlement decision remains “vacated” on the case’s docket and is unavailable on the court’s website or in online databases–circumstances that may be attributable to the fact that the special master did not specifically direct the clerk, in the summation section of his September 26, 2017 decision, to reinstate or reissue his initial entitlement decision. See, e.g., Cozart v. Sec’y of HHS, No. 00-590V, 2015 WL 6746499, at *10 (Fed. Cl. Spec. Mstr. Oct. 15, 2015) (“For the aforementioned reasons, the undersigned hereby DENIES petitioners’ Motion for Reconsideration. The Original Decision will be reinstated and considered filed as of today’s date, October 15, 2015.”). Consequently, because the September 26, 2017 decision does not contain both the special master’s original findings and conclusions (in their entirety) and the special master’s new findings and conclusions, it appears not to constitute a replacement decision as contemplated by Vaccine Rule 10(e)(3)(A). 9 It bears noting, however, that although the special master never explicitly stated that petitioner was required to submit direct evidence of a medically acceptable onset period for post- -11- Case 1:11-vv-00631-MMS Document 114 Filed 03/14/18 Page 12 of 12 Thus, for the reasons stated above, the court GRANTS petitioner’s motion for review, VACATES the special master’s September 26, 2017 decision, and REMANDS the case to the special master to issue a new entitlement decision.10 In the new entitlement decision, the special master shall address all of the evidence offered by petitioner in support of his position that a forty-one-day onset period is medically acceptable, and not just the evidence submitted by petitioner with his motion for reconsideration. See Vaccine Rule 10(e)(3)(A); supra note 8. Further, the special master shall evaluate that evidence under the proper legal standard. See supra note 5. Finally, the special master shall issue his new entitlement decision within ninety days of the date of this decision. See 42 U.S.C. § 300aa-12(e)(2); Vaccine Rule 28(b). IT IS SO ORDERED. s/ Margaret M. Sweeney MARGARET M. SWEENEY Judge Td vaccination brachial neuritis, and did acknowledge that petitioner’s “offer[ing of] little evidence directly relevant to the injury at issue [was] a failing not completely fatal to his claim,” Greene, 2017 WL 5382856, at *6, he strongly suggested that direct evidence from medical or scientific literature was necessary, see, e.g., id. at *3 (“[O]f the 19 new items filed, only seven directly involve brachial neuritis or an arguably parallel condition.” (emphasis added)), *6 (“[Petitioner] has . . . made an inadequately specific showing with respect to either the illness in question or the Td vaccine. . . . [He has] utiliz[ed] an expert, Dr. Kinsbourne, who [lacks the] specific, applicable experience . . . sufficient to render [his opinion] persuasive in the absence of other direct convincing proof. . . . Rowhani-Rahbar . . . does not involve brachial neuritis, or any comparable peripheral neuropathic injury . . . . Petitioner’s showing is thus too nonspecific to the injury at issue, even if it is based in reliable science. . . . If Petitioner had been able to marshal more straightforward and/or compelling evidence supporting the conclusion that the timing of onset of his brachial neuritis was medically acceptable–either due to directly on-point literature or by citing prior decisions involving the same injury–the strength of that showing would not be as diminished by its dilatory character.” (emphasis added)). Such a requirement would be an improper heightening of petitioner’s burden of proof. 10 The court denies petitioner’s request for an order directing that the case be reassigned to another special master. -12- ================================================================================ DOCUMENT 4: USCOURTS-cofc-1_11-vv-00631-4 Date issued/filed: 2018-07-03 Pages: 16 Docket text: PUBLIC RULING (Originally filed: 5/7/2018) regarding 116 Findings of Fact & Conclusions of Law (Signed by Special Master Brian H. Corcoran). (cr) Service on parties made. -------------------------------------------------------------------------------- Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 1 of 16 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 11-631V (to be published) * * * * * * * * * * * * * * * * * * * * * * * * * ROY GREENE, * * Petitioner, * Filed: May 7, 2018 * v. * * SECRETARY OF HEALTH * Tetanus-Diphtheria (“Td”) AND HUMAN SERVICES, * Vaccine; Evidentiary Support * for Onset Timeframe; Expert Respondent. * Opinions; Remand Decision; * * * * * * * * * * * * * * * * * * * * * * * * * * Richard Gage, Law Offices of Richard Gage, Cheyenne, WY, for Petitioner. Ann Martin, U.S. Dep’t of Justice, Washington, DC, for Respondent. RULING ON REMAND DENYING RESPONDENT’S MOTION FOR RULING ON RECORD1 On September 29, 2011, Roy Greene filed a petition for compensation in the National Vaccine Injury Compensation Program (the “Vaccine Program”),2 alleging that he developed brachial neuritis as a result of his receipt of the tetanus-diphtheria (“Td”) vaccine on July 22, 2009. Pet. (ECF No. 1). Mr. Greene originally alleged both a Table injury claim and a “non-Table” causation-in-fact claim (id. at 2), but I dismissed the Table claim after a March 2015 fact hearing, 1 This Ruling has been designated “to be published,” and will therefore be posted on the United States Court of Federal Claims website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (Dec. 17, 2002) (current version at 44 U.S.C. § 3501 (2014)). As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the published Ruling’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 Ruling in its present form 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 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 2 of 16 at which time I determined that Petitioner’s symptoms arose 41 days after the vaccination, and thus occurred outside the 28-day limit for the Table claim. 42 C.F.R. § 100.3(a)(I)(B)). After the parties were unsuccessful in settling the matter, in 2017 Respondent moved for a ruling on the record dismissing the claim due to Petitioner’s purported inability (under the third prong of the Federal Circuit’s test for entitlement established in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005)) to offer preponderant support for his contention that a 41-day timeframe for onset of brachial neuritis was medically acceptable. See Motion to Dismiss, dated March 31, 2017 (ECF No. 90) (“Mot.”) On May 26, 2017, I issued a decision denying Petitioner’s request for compensation in this case and dismissing his claim.3 Petitioner then filed a motion for reconsideration of that decision on June 16, 2017, along with two supplemental expert reports as well as several items of previously-unfiled medical literature. ECF Nos. 94-97. I withdrew my Decision in order to evaluate the merits of the reconsideration request. See Order, dated June 19, 2017 (ECF No. 98) (“Reconsideration Order”). I subsequently denied entitlement a second time (see Greene v. Sec’y of Health & Human Servs., No. 11-631, 2017 WL 5382856 (Fed. Cl. Spec. Mstr. Sept. 26, 2017)(“Second Dismissal Decision”) – although in doing so I erroneously conflated the standards applied to evaluating a reconsideration request with the legal standards applied to entitlement claims generally. Petitioner sought review of the Second Dismissal Decision, and the Court of Federal Claims granted his motion on February 27, 2018, remanding this matter back to me for a new disposition of Respondent’s original motion, based on all evidence Petitioner has submitted to date and applying the proper legal standards. Greene v. Sec’y of Health & Human Servs., No. 11-631, 2018 WL 1514440 (Fed. Cl. Feb. 27, 2018) (“Review Order”). For the reasons stated below, I hereby DENY Respondent’s Motion, because Petitioner has now offered sufficient evidence to support his claim on the timing prong of the Althen test. However, I do not find that Petitioner is at this time entitled to an award of damages, because the record remains incomplete - Respondent has requested the opportunity to offer his own expert on the third Althen prong, and fairness requires me to permit him to do so. Factual History The facts relevant to the present decision are set forth in my earlier onset fact ruling. See Greene v. Sec’y of Health & Human Servs., No. 11-631, 2015 WL 9056034, at *1-4 (Fed. Cl. Spec. Mstr. July 31, 2015 (“Fact Ruling”). They are incorporated by reference herein. That fact ruling was issued after a 2015 hearing at which several witnesses testified, including the Petitioner. 3 After I issued the order granting Petitioner’s motion for reconsideration that later resulted in the present remand, my prior entitlement decision was withdrawn from the docket, and thus can no longer be cited. 2 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 3 of 16 For present purposes, the most important findings reached at the Fact Ruling are as Follows: (a) Petitioner received the Td vaccine on July 22, 2009, in his right arm after an injury at his workplace; (b) Petitioner saw no other healthcare providers in connection with his injury until September 7, 2009 (Labor Day of that year), when he went to a hospital emergency room in Houston, Texas, complaining of sharp pain in his right upper arm that had begun a few days before (and not any time in the month of July or August); and (c) after hearing witness testimony and comparing it to the medical records filed in the case, I determined that onset of Petitioner’s subsequently-diagnosed brachial neuritis had occurred no earlier than September 1, 2009 (or 41 days post-vaccination). See generally Fact Ruling at *1-4, *17. Brief Procedural Review Summary Between the time of the Fact Ruling and the fall of 2016, the parties had no success in settling the non-Table claim despite their concerted efforts. In that period, Petitioner submitted two expert reports from an orthopedist, Thomas W. Wright, M.D. (see Report dated December 18, 2015, ECF No. 62 (Ex. 22) (“First Wright Rep.”); Report dated April 25, 2016, ECF No. 66 (Ex. 29) (“Second Wright Rep.”)). But Respondent took issue with the adequacy of the opinions expressed therein – arguing in particular that more was needed on the third Althen prong because of the conclusory nature of Dr. Wright’s opinion, which relied heavily on the fact that a 41-day onset was only about two weeks longer than what the Table contemplates as a reasonable timeframe for onset, rendering the additional time period a de minimis difference. In response to Respondent’s objections, I proposed that Petitioner obtain an additional expert report addressing the Althen prong three issue. See Status Conference Order, dated September 29, 2016 (ECF No. 72). Mr. Greene filed the supplemental report, from Dr. Marcel Kinsbourne, on January 6, 2017. See ECF No. 82-1 (Ex. 38) (“Kinsbourne Rep.”). Respondent, however, deemed this report also inadequate and conclusory. In response (and mindful that the case was now nearly six years old) I proposed that Respondent either consider the matter contested and file his own expert report, or in the alternative move for a ruling on the record as it stood. See Status Conference Order, dated January 26, 2017 (ECF No. 86). Respondent took the second option and filed a motion to dismiss in March 2017. See generally Mot. Importantly, Respondent based his request for dismissal at that time solely on Petitioner’s purported inability to carry his initial burden of proof. Thus, Respondent argued that the record itself (which included only the two Wright expert reports plus the supplemental Kinsbourne report, as well as my fact determination on onset) established “legally insufficient 3 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 4 of 16 proof” for a favorable entitlement decision and should therefore be dismissed. Mot. at 1. In particular, Respondent challenged Dr. Wright’s attempt to “piggyback” on the Table timeframes for appropriate onset. Id. at 5-6. Respondent also maintained that Dr. Kinsbourne’s report set forth a scientifically unreliable opinion, and was just as conclusory as Dr. Wright’s reports in assuming that a 41-day onset period was within what is “generally recognized” as medically reasonable for other autoimmune illnesses, without providing reliable scientific or medical substantiation for that proposition. Id. at 8-9. Petitioner opposed Respondent’s motion. See Opposition, dated April 17, 2017 (ECF No. 92). He argued that he had “done everything necessary” to establish his claim, pointing out that he had offered two experts, and three reports, in comparison to Respondent’s none, and urging me to rule in his favor based upon such evidence, which he deemed “unrebutted.” Opp. at 5. As noted above, I originally granted Respondent’s Motion in late May of 2017, finding that Petitioner’s expert reports had not offered persuasive or reliable arguments as to the Althen prongs – and in particular with respect to timing – sufficient to find he had carried his preponderant evidentiary burden. About 20 days later, however, Petitioner filed a timely motion under Vaccine Rule 10(e) requesting reconsideration of my dismissal decision. See Motion for Reconsideration, dated June 16, 2017 (ECF No. 97) (“Reconsideration Request”). In so doing, Petitioner argued that the expert reports he had previously filed did in fact meet the legal standards necessary for a decision in his favor. Reconsideration Request at 2-3. He also noted the existence of other Program decisions finding 42 days for onset of other autoimmune illnesses (although not brachial neuritis specifically) to be medically acceptable. Id. at 4. At the same time, however, Petitioner offered new evidence to support his claim: (a) a supplemental expert report from Dr. Kinsbourne; (b) an expert report from an immunologist, Dr. Vera Byers; and (c) 19 additional pieces of previously-unfiled medical literature. See Kinsbourne Supplemental Report, dated June 13, 2017, filed as Ex. 45 (ECF No. 94-1) (“Kinsbourne Supp. Rep.”)); Byers Report, dated June 15, 2017, filed as Ex. 46 (filed as ECF No. 94-2) (“Byers Rep.”);4 ECF Nos. 94-96 (Exs. 46-66). These materials did a far superior job in providing substantiation for Petitioner’s Althen prong three arguments than the previously- filed expert reports. In response, I opted to grant Petitioner’s request for reconsideration. See generally Reconsideration Order. A few days later, I held a status conference with the parties in which I elaborated on my reasoning for so doing. See Scheduling Order, dated June 28, 2017 (ECF No. 99). In particular, I stated that (although I considered the new expert reports and literature to have been filed unjustifiably late), I believed fairness required me to give them consideration. Id. at 1. I also asked Respondent (in the event the newly-filed literature and expert reports did not convince him to revisit settlement) to file a brief responding to the arguments set forth therein – but, 4 The Byers report (which was accompanied by five items of literature) was mistakenly filed twice. See Ex. 59. 4 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 5 of 16 importantly, not to file an expert report until I had addressed the substantive evidentiary value of Petitioner’s supplemental filings. Id. at 2. Specifically, I stated that “I would prefer that Respondent first attempts to oppose the motion without the need for an expert’s opinion (although Respondent may express in his opposition the desire to offer an expert report later).” Id. (emphasis added). Respondent filed the requested brief on August 23, 2017. See Response (ECF No. 101). In it, Respondent argued that the legal grounds for reconsideration under Rule 10(e) had not been met – in particular because of the grossly dilatory nature of the newly-filed evidence. Response at 1-5. He maintained as well that the additional expert reports and literature did not make persuasive points, or relied on inapposite comparisons (in arguing that a 41-day timeframe was acceptable) to other autoimmune illnesses. Id. at 6-11. In addition - in the event that I were inclined to reverse my earlier entitlement decision, based on the newly-submitted evidence, and consistent with his previously-expressed desire - Respondent asked that he be provided the chance to obtain and file an expert report of his own. Id. at 5, 11. After reconsidering my original decision, I issued a second decision dismissing Petitioner’s claim. See generally Second Dismissal Decision. Relying in part on the Rule 10(e) standard for reconsideration, I deemed the newly-filed materials as too dilatory in character to establish persuasive grounds for a different outcome, especially given the extent to which they largely were inapposite to present circumstances. I also found that Petitioner’s existing evidence did not meet his burden of proof, especially with respect to the third Althen prong, in some part because it was too circumstantial in character, and thus (under the reconsideration standard)5 not evidence that should be given much weight so late in the case’s procedural life. I did, however, note that some of the newly-filed evidence was more reliable or persuasive than what Petitioner had previously offered. See, e.g., A. Rowhani-Rahbar, et al., Biologically Plausible and Evidence–Based Risk Intervals in Immunization Safety Research, 31 Vaccine 271, 271–77 (2012), filed as Ex. 48 (ECF No. 94-4) (“Rowhani-Rahbar”). Rowhani-Rahbar proposes risk interval estimates for two adverse events following vaccine administration – febrile seizures and acute disseminated encephalomyelitis (“ADEM”). Id. at 273. For ADEM (an inexact, but not unreasonable, analog to Petitioner’s brachial neuritis, given its neurologic nature), Rowhani- Rahbar concluded that the likely time period from vaccination to onset “best substantiated by available biological and epidemiologic data” was five to 28 days. Id. at 274. A secondary, longer interval of two to 42 days was also deemed “biologically plausible,” and therefore worthy of consideration in order to fully assess a potential safety problem, but was more uncertain, since “there might be reason to suspect that most of the excess risk, if any, is concentrated in a much shorter period of time.” Id. at 275. This secondary interval has nevertheless been found persuasive 5 The standard applied to motions for reconsideration permit special masters to take into account the character of newly-filed evidence – including whether it could have been filed earlier, as well as its probative value. Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1348 (Fed. Cir. 2010) (finding that the special master “did not abuse his discretion in declining to grant reconsideration in view of evidence that was previously available”). 5 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 6 of 16 by other special masters in cases alleging autoimmune injuries (albeit not involving brachial neuritis). See, e.g., Day v. Sec’y of Health & Human Servs., No. 12-630V, 2015 WL 8028393, at *22 (Fed. Cl. Nov. 13, 2015) (applying Rowhani-Rahbar secondary risk interval to case alleging that petitioner’s multiple sclerosis was vaccine-caused). Court’s Adjudication of Motion for Review Petitioner filed a timely motion for review of my second Decision dismissing the case. Motion for Review, dated October 26, 2017 (ECF No. 103). After considering it and Respondent’s opposition, the Court granted the motion by Order dated February 27, 2018. See generally Review Order. The Court determined that I erred in misapplying the “interests of justice” standard, which is relevant only to a Rule 10(e) motion for reconsideration, to the legal merits of Petitioner’s claim itself and to the evidence offered in its support. Review Order at *7. Once I had decided to permit reconsideration at all, I could no longer take into account issues like the dilatory nature of Petitioner’s supplemental expert filings, and thus in doing so I had prejudiced Petitioner. Id. at *8. The Court therefore vacated the Second Dismissal Decision, remanding the matter to me to be re-determined in light of the proper legal standards applicable in entitlement cases. Review Order at *6 n.5, *8. The Review Order also specifies that (in accordance with Section 12(e)(2) of the Act and Vaccine Rule 28(b)) I am to “issue [the] new entitlement decision within ninety days of the date of this decision,” or by May 29, 2018. Id. at *8 (emphasis in original). Applicable 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).6 As already noted, Petitioner’s Table claim was dismissed after issuance of the Fact Ruling. 6 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121, 6 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 7 of 16 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 (which is the kind of claim asserted in this matter), 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.” 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 124 (2003), aff’d, 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13- 159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014). 7 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 8 of 16 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, 956 F.2d at 1148. 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 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 8 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 9 of 16 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. 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. The fact that a claimant offers an expert opinion does not render the opinion that expert espouses scientifically reliable or persuasive. 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 9 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 10 of 16 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). C. Standards for Deciding Entitlement on the Record The Vaccine Act and Rules permit 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). Hearings are not required 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). Deciding if a case requires a hearing can often turn on what the special master expects will be accomplished by allowing live testimony. Hearings are most helpful where witness credibility is at issue, or where posing questions to a witness in order to obtain information not contained in, or not self-evident from, the existing filings is likely to illuminate matters in dispute. See, e.g., Hooker, 2016 WL 3456435, at *21 (discussing a special master’s discretion in holding a hearing and the factors that weighed against holding a hearing in the matter); Murphy, 1991 WL 71500, at *2 (no justification for a hearing where the claim is fully developed in the written records and the special master does not need to observe the fact witnesses for the purpose of assessing credibility). It may also permit a claimant to expand upon points already set forth in paper filings, or respond to unanticipated questions raised in the matter – but again, only where necessary to reach a decision. In addition, prior decisions have recognized that a special master’s discretion in deciding whether to conduct an evidentiary hearing “is tempered by Vaccine Rule 3(b),” or the duty to “afford[] each party a full and fair opportunity to present its case.” Hovey, 38 Fed. Cl. at 400-01 (citing Rule 3(b)). But that rule also includes the obligation to create a record “sufficient to allow review of the special master’s decision.” Id. Thus, the fact that a claim is legitimately disputed, such that the special master must exercise his intellectual faculties in order to decide a matter, is not itself grounds for a trial (for if it were, trials would be required in every disputed case). 10 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 11 of 16 ANALYSIS As already noted, my now-vacated resolution(s) of Respondent’s dismissal motion turned on the adequacy of Mr. Greene’s Althen prong three showing.7 In particular, I determined that the expert opinion evidence he had submitted from Drs. Wright and Kinsbourne was conclusory and unreliable in asserting that a 41-day post-vaccination onset was medically acceptable, and that Petitioner unreasonably relied on the Table’s timeframe to argue that a timeframe 13 days longer was still acceptable. Petitioner’s more recently-filed expert reports and associated literature provide a variety of additional evidence to support his position with respect to timing. He has now offered reliable literature, like Rowhani-Rahbar, that supports his contention that a longer onset for autoimmune conditions is medically acceptable. He has also offered a more fleshed-out report from Dr. Kinsbourne, and a report from a third expert, Dr. Byers, also having some bearing on the timing question. For such reasons, it is appropriate, based upon all such evidence, to deny Respondent’s March 2017 motion for a ruling on the record. There is sufficient evidence in the record that, if unrebutted, would allow me to conclude that Petitioner has met his preponderant burden of proof. The circumstances are now considerably different from when Respondent (based solely on the two conclusory Wright reports plus Dr. Kinsbourne’s initial report) first moved to dismiss the claim. This does not mean, however, that the opposite is true – that Petitioner has carried his burden based solely upon the existing record (which includes the supplemental expert reports and literature). Instead, I must in fairness permit Respondent the opportunity to rebut Petitioner’s expert showing before I can fully rule on entitlement in this case. My determination herein is the product of both substantive and procedural considerations. Substantively, I do not find that a 41-day timeframe for onset of brachial neuritis is a settled matter in the Program, as Petitioner has argued. Indeed – I have found the opposite to be true in other cases I have decided involving precisely the same injury. For example, in Garner v. Sec’y of Health & Human Servs., No. 15-063V, 2017 WL 1713184 (Fed. Cl. Spec. Mstr. Mar. 24, 2017), mot. for review den’d, 2017 WL 3483352 (Fed. Cl. July 31, 2017), I considered a claim that the Hepatitis A and B vaccines had caused Parsonage-Turner Syndrome (a parallel descriptor for brachial 7 My two decision(s) to dismiss the case included no in-depth discussion of the remaining two Althen prongs. However, it did appear to me, and does now as well, that the first, “can cause” prong has been met, given the ample prior decisions associating vaccines with a tetanus component with brachial neuritis, as well as the showing made in this case by Petitioner’s experts. See, e.g., Devonshire v. Sec’y of Health & Human Servs., No. 99-031V, 2006 WL 2970418, at *15 (Fed. Cl. Spec. Mstr. Sept. 28, 2006) (stating that it is well known that brachial neuritis can occur following a tetanus vaccination), aff’d, 76 Fed. Cl. 452 (2007); DeGrandchamp v. Sec’y of Health & Human Servs., No. 01-413V, 2003 WL 21439670, at *7 (Fed. Cl. Spec. Mstr. May 15, 2003) (relying on Institute of Medicine publications to find that in theory, the tetanus toxoid in Td can cause brachial neuritis). The future disposition of Petitioner’s claim will not likely turn on the first Althen prong. 11 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 12 of 16 neuritis). The earliest onset possible in Garner was 45 days after vaccination, based on the first record documentation of any complaints by petitioner about arm or shoulder pain. Garner, 2017 WL 1713184, at *1. Respondent’s expert, however, persuasively argued that the condition was far more acute in nature (and in terms of the causative mechanism as well), making in his opinion four weeks, or 28 days, the outer limit for latency. Id. at *8. I found this point to be dispositive, even though the claimant’s Althen prong one showing was (as here) sufficient, and dismissed the case on the record. Id. at 16. Nothing Petitioner has argued in this case is any more persuasive facially than what I have previously rejected. Tellingly, Petitioner has cited no contrary cases involving brachial neuritis and a timeframe equivalent to that herein, and although I am not bound by the decisions of other special masters, they can be persuasive and relevant in understanding whether a claimant has met his burden. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). I thus have doubts about the sufficiency of Petitioner’s current evidentiary showing, and those doubts are best resolved by permitting Respondent the opportunity to offer his own expert views on the subject.8 I also note that I have reasonable misgivings about the weight to give the existing expert support offered on this point based on questions regarding expert credentials and competency. For example, I must evaluate whether Dr. Kinsbourne’s lack of direct expertise in studying, researching, and/or treating brachial neuritis (let alone any patients for many years) is grounds for giving his views less weight. Holmes v. Sec’y of Health & Human Servs., No. 08-185V, 2011 WL 2600612, at *2 n.9 (Fed. Cl. Spec. Mstr. April 26, 2011) (noting that Dr. Kinsbourne has not had a clinical neurology practice for 37 years), aff’d 115 Fed. Cl. 469 (2014). I also wish for Petitioner’s experts to explain why literature offered relating to other autoimmune conditions, and the timeframe in which a vaccine would cause the relevant pathogenic reaction, can be analogized to brachial neuritis. In addition, should Petitioner call Dr. Wright at hearing, I would expect to probe the degree to which the opinion he previously offered on the timing issue relied on his own experience treating individuals with brachial neuritis, as opposed to his conclusory determination that the Table time periods were not that far off the time period in question (something Program law says is not permitted). All of the above will likely require a hearing, in order to assess expert credibility and probe the extent to which their opinions deserve the weight requested. Under such circumstances, I cannot rule favorably for Petitioner on entitlement without a more complete opportunity to weigh all the evidence together – which means directing Respondent to file an expert report. Procedurally, I find that the present record remains incomplete on the timing issue. Respondent has not had the opportunity to offer his own expert to address the points raised in 8 Of course, if Respondent opted not to file an expert report in this case, but were instead simply to ask me to decide the case based on the evidence as it stands, I would likely be compelled despite my doubts to find that he had met his burden, if barely. But Respondent has indicated the desire to file an expert report. 12 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 13 of 16 Petitioner’s existing evidentiary showing. This is not something that I am raising sua sponte. Rather, the potential utility and necessity of a counter-expert was raised by Respondent in opposing the reconsideration request, in the event his motion to dismiss were denied after reconsideration. See Response at 5. Respondent wishes to offer an expert report of his own, and fairness dictates that I allow Respondent that opportunity.9 See Rule 3(b)(2). I also find that a hearing will likely be necessary before I can reach an entitlement decision in this case, given the present record (which in my estimation is incomplete for the reasons stated). As noted above, it is within a special master’s discretion to decide when a hearing is required – and that decision can turn on whether the chosen form of adjudication “affords each party a full and fair opportunity to present its case.” Hovey, 38 Fed. Cl. at 400-01 (citing Rule 3(b)). In some cases, I have decided that the matters presented could be reasonably resolved without hearing. See, e.g., D’Toile v. Sec’y of Health & Human Servs., No. 15-85V, 2016 WL 7664475, at *25-28 (Fed. Cl. Spec. Mstr. Nov. 28, 2016) (resolving claim based on expert submissions and without hearing), mot. for review den’d, 132 Fed. C. 421 (2017), aff’d, No. 2017-1982, slip op. (Fed. Cir. Apr. 12, 2018). Here, I reach the opposite conclusion – to afford Respondent a “full and fair” opportunity to articulate his defense, and also to permit Petitioner to examine Respondent’s experts, I will require an entitlement hearing mainly focused on the third Althen prong, in order to assess expert credibility and probe the bases for the opinions offered. Petitioner’s reconsideration request also suggested that Respondent’s failure to offer an expert report requires me to find that Petitioner’s evidence is unrebutted, but such arguments fly in the face of the evidentiary weighing and credibility determinations afforded to the special masters. As a general matter, I am not required to adopt the opinions of a petitioner’s experts wholesale - even where Respondent chooses not to offer a rebuttal expert. See Barone v. Sec’y of Health & Human Servs., No. 11-707, 2014 WL 6834556, at *12 (Fed. Cl. Spec. Mstr. Nov. 12, 2014) (evaluating reasonableness and reliability/persuasiveness of Petitioner’s expert showing, despite the fact that Respondent had offered no rebuttal expert of his own). Indeed, in discussing the duties of the special masters, the Court of Federal Claims has previously noted that “[n]o judge or jury can be forced to accept or reject an expert’s opinion or a party’s theory at face value,” and that to propose that special masters must do otherwise “is to neglect the Special Master’s duty to ‘vigorously and diligently investigate the factual elements’ underlying [a] petition.” Sword v. United States, 44 Fed. Cl. 183, 188 (1999), citing Mills v. Sec’y of Health & Human Servs., 27 9 In opting to seek a ruling on the record, Respondent has not waived the right to offer his own expert. Respondent’s brief reacting to the Reconsideration acknowledges that Respondent was willing to forego offering an expert at the time of the first motion to dismiss, filed in March 2017. Response at 5. But once Petitioner offered supplemental expert reports and additional literature in the context of his reconsideration request, Respondent was explicit in asking that he too be permitted to obtain an expert opinion. Id. I in fact asked that Respondent forestall that effort, since I was unsure the degree to which I would find the Petitioner’s new evidence persuasive. Scheduling Order at 2 (ECF No. 99). Now, applying the correct legal standard, I find the newly-filed evidence to be sufficient to defeat Respondent’s motion – but not enough to result in judgment for Petitioner. 13 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 14 of 16 Fed. Cl. 573, 578 (1993). I may thus weigh the evidence offered by a petitioner in determining in the first instance if he has met his burden of proof. In addition, I am empowered to permit, and to request, the filing of additional evidence in my role as special master – even at the later stages of a proceeding. Parties in Program cases are allowed many opportunities to supplement a record with expert support, and have been permitted to do so even immediately before or after a hearing’s completion, or after issuance of an entitlement decision. See, e.g., Cedillo v. Sec'y of Dep't of Health & Human Servs., No. 98–916V, 2009 WL 331968, *62 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff'd, 89 Fed. Cl. 158 (2009), aff’d, 617 F.3d 1328 (Fed. Cir. 2010) (special master permitted two expert reports to be filed only four days before the hearing in the case was to commence); Vant Erve v. Secretary of Department of Health & Human Services, 39 Fed. Cl. 607 (1997), aff'd after remand, 232 F.3d 914 (Fed. Cir. 2000) (unpublished table decision) (special master’s refusal to reopen a question of liability was an abuse of discretion even though three years had passed since decision; information offered by Respondent was highly probative, there was no showing of prejudice to Petitioners, and Respondent was not at fault for the delay). Such discretion flows from the special master’s authority to determine whether, when, and how to take and consider evidence in resolving a petitioner’s entitlement to damages. Hovey, 38 Fed. Cl at 400 (concluding that it was within the special master’s discretion to determine whether to allow in new evidence after an evidentiary hearing in the case); Section 12(d)(3)(B) (special master afforded discretion when making determinations regarding admission of evidence). Here, my misgivings about the adequacy of Petitioner’s current evidentiary showing make it impossible for me to decide the case on the existing record, and may best be addressed by permitting a counter-expert’s testimony. Allowing Respondent to file an expert report under the present circumstances would not otherwise prejudice Petitioner. I have previously in this case bemoaned the excessive amount of time it is taking to resolve the matter, so it pains me to increase delay – but Petitioner’s refusal earlier in the case to substantiate a critical element of his claim, coupled with his last-minute filing of the materials necessary to do so, remain the proximate cause of delayed resolution. Petitioner will be afforded a reasonable opportunity to respond to the additional expert report as well. A reasoned determination of the timing issue is most likely if all parties have had a full and fair opportunity to make their respective cases. Petitioner has also maintained10 that I am constrained by the Court’s Review Order to decide entitlement based solely on the record before me, and therefore cannot allow Respondent to file his own expert report at this point. See Status Report, dated March 16, 2018 (ECF No. 115). 10 After the issuance of the Court’s Review Order, I held a status conference with the parties to discuss the best means of proceeding. See non-pdf Scheduling Order, dated March 12, 2018. At the time, I informed Petitioner of my preliminary view that I should permit Respondent to file an expert report before I decided entitlement in the matter again. Petitioner objected, however, to my proposal, as indicated in his March 16th Status Report. 14 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 15 of 16 Such a reading of the Review Order is too narrow. The Order required me to resolve Respondent’s motion to dismiss by applying the proper evidentiary standard, and to so act in the 90-day period defined by the Vaccine Act and Rules upon remand. See Rule 28(b).11 I have done precisely as ordered – and am now denying a summary disposition of this case in favor of either party. The Review Order does not state that I am to determine entitlement based only on the record as it stands, or to close the record to additional proof. I have in fact found that I cannot decide the case at this time without evidentiary inputs from Respondent, consistent with my discretion and in accordance with what has occurred in many other Program cases – even after trial and even after a decision has issued. Declining to decide this case at the present, before an entitlement hearing has been held on the disputed matter, arguably constitutes stronger grounds for the obtaining of additional evidence. Fairness must be a two-way street in Vaccine Program cases, and concerns for fairness compel me, consistent with Vaccine Rule 3(b), to provide Respondent the same opportunities that Petitioner has obtained, and that Program claimants are allowed frequently. 11 I acknowledge that the Court’s Review Order specifically directs me to issue a “new entitlement decision,” and thus my present disposition, taken literally, does not accomplish this – but only if the term “decision” is given the technical meaning employed in the Vaccine Program for the reasoned determinations of special masters. In the Program, “decisions” trigger issuance of judgments by the Clerk of the Court, and must therefore involve either the denial of entitlement (in effect, a judgment awarding $0) or the awarding of a specified sum of damages. See 42 U.S.C. §300aa- 12(d)(3)(A);Vaccine Rule 10. Because I am no longer granting the relief requested by Respondent (dismissal of the claim), however, I am only “ruling” on entitlement, and thus not yet issuing a decision. At the same time, granting Petitioner’s counter-request for a favorable ruling on the record would also not constitute a “decision” until damages were resolved (a matter than in my experience can take a year or more) – and would therefore be just as much a technical abrogation of the Review Order. My disposition of this matter on remand is consistent with the spirit of the Court’s Review Order (parsing the Court’s usage herein of the word “decision” for its more broadly-understood meaning, i.e. to resolve an outcome of a disputed matter). This raises an additional concern – the fact that my disposition of Respondent’s pending motion will not result in the complete resolution of this case in the 90-day period prescribed for special masters to act upon remand under Rule 28(b). Review Order at 12. By permitting Respondent the time to obtain an expert report and setting the matter for hearing, the case is unlikely to be resolved in so short a period. But there are two countervailing considerations that suggest this too is not an abrogation of my responsibilities in carrying out the mandate of the Court’s Review Order. First, the present ruling is being issued within 90 days of the Court’s February 27, 2018 Review Order (a time period that would expire no sooner than May 29, 2018). Second, there is persuasive dicta from other Court decisions observing that “the Vaccine Act does not identify any consequences for failure to act within the ninety-day remand period,” and therefore parties to a litigation, in consultation with the relevant special master, can agree to extend the period if to do so would be in the “interests of justice” and that the Court of Federal Claims would likely support such a determination. See Hodge v. Sec’y of Health & Human Servs., No. 09-453V, slip. op. at 1-2 (Fed. Cl. Nov. 9, 2015) (emphasis added), citing Paluck v. Sec’y of Health & Human Servs., 111 Fed. Cl. 160,165-66 (2013). If Petitioner deems the 90-day time period to require total and complete resolution of his claim, and is therefore unwilling to accede to the necessity of this matter taking more time to resolve, he may so argue in another motion for review, after I have resolved entitlement (and assuming I do so against him), or in response to a motion to the Court by Respondent to extend the 90-period. 15 Case 1:11-vv-00631-MMS Document 122 Filed 07/03/18 Page 16 of 16 CONCLUSION Petitioner has now offered adequate evidentiary support for his claim that the 41-day onset period for his brachial neuritis was medically acceptable, thereby removing the former grounds upon which I dismissed his claim, and causing me to DENY Respondent’s Motion. However, I cannot otherwise rule on whether Petitioner has carried his burden of proof on the record as it stands, and therefore do not decide entitlement at this time in his favor either. The parties shall contact chambers and request a status conference, at which time a schedule for Respondent’s filing of an expert report, as well as a final response to that report from Petitioner’s expert(s) and then trial of this matter, shall be discussed. IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Special Master 16 ================================================================================ DOCUMENT 5: USCOURTS-cofc-1_11-vv-00631-5 Date issued/filed: 2019-08-29 Pages: 29 Docket text: PUBLIC DECISION (Originally filed: 8/2/2019) regarding 140 DECISION of Special Master Signed by Special Master Brian H. Corcoran. (mml) Service on parties made. -------------------------------------------------------------------------------- Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 1 of 29 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 11-631V (to be published) * * * * * * * * * * * * * * * * * * * * * * * * * ROY GREENE, * * Petitioner, * Filed: August 2, 2019 * v. * * SECRETARY OF HEALTH * Tetanus-Diphtheria (“Td”) AND HUMAN SERVICES, * Vaccine; Evidentiary Support * for Onset Timeframe; Expert Respondent. * Opinions; Vaccine Trial * Risk Intervals * * * * * * * * * * * * * * * * * * * * * * * * * Richard Gage, Law Offices of Richard Gage, Cheyenne, WY, for Petitioner. Brittany Ditto, U.S. Dep’t of Justice, Washington, DC, for Respondent. DECISION DENYING ENTITLEMENT1 On September 29, 2011, Roy Greene filed a petition for compensation in the National Vaccine Injury Compensation Program (the “Vaccine Program”),2 alleging that he developed brachial neuritis as a result of his receipt of the tetanus-diphtheria (“Td”) vaccine on July 22, 2009. Pet. (ECF No. 1). Mr. Greene originally asserted both a Table injury claim and a “non-Table” causation-in-fact claim (id. at 2), but I dismissed the Table claim after a March 2015 fact hearing, at which time I determined that Petitioner’s symptoms arose forty-one days after the vaccination, 1 This Decision has been designated “to be published,” and will therefore be posted on the United States Court of Federal Claims website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (Dec. 17, 2002) (current version at 44 U.S.C. § 3501 (2014)). As provided by 42 U.S.C. § 300aa- 12(d)(4)(B), however, the parties may object to the published 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 in its present form 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 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 2 of 29 and thus outside of the twenty-eight-day limit for a brachial neuritis Table claim. 42 C.F.R. § 100.3(a)(I)(B)). This case has had a tortuous procedural history, but at long last the parties participated in an entitlement hearing on May 9, 2019, at which time both sides offered expert testimony— primarily addressing whether Mr. Greene’s brachial neuritis began in a medically acceptable timeframe as measured from the date of vaccination. After listening to that expert testimony, and considering the expert reports and literature offered, I find that Petitioner has not met his burden of establishing by a preponderance that a six-week timeframe for onset of brachial neuritis after receipt of the tetanus vaccine is medically reasonable—or that the vaccine “more likely than not” did injure him given the undisputed facts. Factual History The facts relevant to the present decision are set forth in my earlier onset fact ruling. See Greene v. Sec’y of Health & Human Servs., No. 11-631V, 2015 WL 9056034, at *1 - 4 (Fed. Cl. Spec. Mstr. July 31, 2015) (“Fact Ruling”). They are incorporated by reference herein. The Fact Ruling was issued after a 2015 hearing at which several witnesses testified, including Petitioner. For present purposes, the most important of the Fact Ruling’s findings are as follows: (a) Petitioner received the Td vaccine on July 22, 2009, in his right arm after experiencing a significant construction-related injury to his hand at his workplace; (b) Petitioner saw no healthcare providers in connection with his injury until September 7, 2009 (Labor Day of that year), when he went to a hospital emergency room in Houston, Texas, complaining of sharp pain in his right upper arm that he stated had begun only a few days before—not any time in the month of July or August; (c) after hearing witness testimony and comparing it to the medical records filed in the case, I determined that onset of Petitioner’s subsequently-diagnosed brachial neuritis3 had occurred no earlier than September 1, 2009 (or 41 days post-vaccination); and (d) based on this fact determination, I dismissed the Table claim, since Petitioner’s onset had not been established preponderantly to have occurred within 28 days of administration of the tetanus vaccine. See generally Fact Ruling at *1–4, *17. 3 As recognized by the parties and their experts, the term “brachial neuritis” is medically synonymous with the terms “Parsonage Turner Syndrome” or neuralgic amyotrophy. See, e.g., Tr. at 10, 69. I shall use the former as an overall descriptor of Mr. Greene’s injury herein, although certain items of literature filed in this case use the other terms in discussing the condition’s nature and etiology. 2 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 3 of 29 Brief Summary of Relevant Procedural History Between the date of the Fact Ruling and the fall of 2016, the parties could not settle the non-Table claim. In that period, Petitioner submitted two expert reports from an orthopedist, Thomas W. Wright, M.D. See Report dated Dec. 18, 2015, filed as Ex. 22 (ECF No. 62); Report dated Apr. 25, 2016, filed as Ex. 29 (ECF No. 66). But Respondent took issue with the adequacy of the opinions expressed therein—arguing in particular that more was needed on the third Althen prong because of the conclusory nature of Dr. Wright’s opinion, which relied heavily on the fact that a 41-day onset was only about two weeks longer than what the Table contemplates, rendering the extra time a de minimis difference. In light of Respondent’s objections, I proposed that Petitioner obtain an additional expert report addressing the Althen prong three issue. See Status Conference Order, dated Sept. 29, 2016 (ECF No. 72). Mr. Greene thereafter filed an expert report from Dr. Marcel Kinsbourne on January 6, 2017. Respondent, however, deemed this report similarly inadequate and conclusory. In response (and mindful that the case was now nearly six years old) I proposed that Respondent either file his own expert report or move for a ruling on the record as it stood. See Status Conference Order, dated Jan. 26, 2017 (ECF No. 86). Respondent took the second option, filing a motion to dismiss in March 2017. See Motion to Dismiss, dated Mar. 31, 2017 (ECF No. 90) (“Mot.”). Respondent argued that the record itself (which at that time included only the two Wright expert reports plus the supplemental Kinsbourne report, as well as my fact determination on onset) established “legally insufficient proof” for a favorable entitlement decision and should therefore be dismissed. Id. at 1. In particular, Respondent challenged Dr. Wright’s attempt to “piggyback” on the Table timeframes for appropriate onset, despite clear Program law establishing that non-Table claims could not do so. Id. at 5–6; (citing Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1147–48 (Fed. Cir. 1992) (“[s]imple similarity to conditions or time periods listed in the Table is not sufficient evidence of causation”)). Respondent also maintained that Dr. Kinsbourne’s report set forth a scientifically unreliable opinion, and was just as conclusory as Dr. Wright’s reports in assuming that a 41-day onset period was within what is “generally recognized” as medically reasonable for other autoimmune illnesses, without providing reliable scientific or medical substantiation for that proposition. Id. at 8–9. After the Motion was fully briefed, I granted it, but Petitioner subsequently filed a motion for reconsideration on June 16, 2017, along with two new, supplemental expert reports (one from Dr. Kinsbourne and an additional report from Dr. Vera Byers4) as well as several items of previously-unfiled medical literature. ECF Nos. 94–97. I subsequently withdrew my initial dismissal decision in order to evaluate the merits of the reconsideration request, but then denied 4 The Byers report (which was accompanied by five items of literature) was mistakenly filed twice. See Ex. 59. Its contents were not referenced during the May 2019 hearing, and Dr. Byers did not testify there. 3 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 4 of 29 entitlement a second time. Greene v. Sec’y of Health & Human Servs., No. 11-631V, 2017 WL 5382856 (Fed. Cl. Spec. Mstr. Sept. 26, 2017) (“Second Dismissal Decision”). The Second Dismissal Decision arose from my determination that Petitioner’s experts were improperly relying on the Table timeframes to defend the medical sufficiency of the timeframe for onset of his brachial neuritis. Second Dismissal Decision at *6–7. In dismissing Mr. Greene’s claim, I erroneously conflated the standards applied to evaluating a reconsideration request with the legal standards applicable to entitlement claims generally. Petitioner thus sought review of the Second Dismissal Decision, and the Court of Federal Claims granted his motion on February 27, 2018, remanding this matter back to me for a new disposition of Respondent’s original motion, based on all evidence Petitioner had submitted and applying the proper legal standards. Greene v. Sec’y of Health & Human Servs., No. 11-631V, 2018 WL 1514440 (Fed. Cl. Feb. 27, 2018). I thereafter determined that, because Petitioner had now offered sufficient evidence to meet his preponderant burden of proof if unrebutted, I could not grant Respondent’s request to dismiss the case. Remand Ruling, dated May 7, 2018 (ECF No. 116) (“Remand Ruling”). However, I also found that fairness required that I permit Respondent (based on a prior request) the chance to submit his own expert report on the timeframe question, and that I would hold a hearing thereafter. Id. at 11, 16.5 Respondent subsequently filed an expert report from Dr. Eric Lancaster on June 14, 2018 (ECF No. 121-1), with Petitioner filing a report from Dr. Laurence Steinman on November 13, 2018 (ECF No. 128-1). This prompted a supplemental expert report filing from Dr. Lancaster on April 9, 2019 (ECF No. 133-1), and then a third expert report from Dr. Kinsbourne on April 29, 2019 (ECF No. 134-1). The hearing was held as scheduled on May 9, 2019, with no post-hearing briefing. The matter is now fully ripe for resolution. Summary of Expert Testimony 1. Dr. Marcel Kinsbourne Dr. Kinsbourne filed three written reports and testified at hearing. See Report, dated Jan. 6, 2017, filed as Ex. 38 (ECF No. 82-1) (“Kinsbourne Rep.”); Report, dated June 13, 2017, filed as Ex. 45 (ECF No. 94-1); Report, dated Apr. 26, 2019, filed as Ex. 73 (ECF No. 134-1); Tr. at 5– 38. Dr. Kinsbourne opined that onset of Mr. Greene’s brachial neuritis occurred in a medically acceptable timeframe, based upon his characterization of brachial neuritis as a vaccine-caused, neuropathic autoimmune injury comparable to Guillain-Barré syndrome (“GBS”). Tr. at 8. 5 Petitioner contested my determination to permit Respondent the opportunity to file his own expert report, rather than simply decide the case based on the existing record, but the Court of Federal Claims ruled that these objections had no legal merit. See Order, dated May 30, 2018 (ECF No. 119). 4 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 5 of 29 As his curriculum vitae (“CV”) indicates, Dr. Kinsbourne is a pediatric neurologist. CV, filed as Ex. 39 (ECF No. 82-2) (“Kinsbourne CV”). He received his medical degree in England, and he has been licensed to practice medicine in North Carolina since 1967. Id. at 1. From 1967 to 1974, Dr. Kinsbourne served as an associate professor in pediatrics and neurology and a senior research associate at Duke University Medical Center before holding a series of academic positions, including professorships in pediatrics, neurology, and psychology. Id. at 2. His clinical experience includes serving as a senior staff physician in Ontario from 1974–80, and as a clinical associate in neurology at Massachusetts General Hospital from 1981–91. Id. at 2–3. Dr. Kinsbourne has published several articles examining neurological diseases (though none directly addressing brachial neuritis), and he is on the editorial board of several journals, such as Brain and Cognition and Archives of Clinical Neuropsychology. Kinsbourne CV at 4, 7–40. His focus has been on teaching cognitive and behavioral neuroscience for twenty years, retiring from his teaching position at the New School a few years ago. Tr. at 28–29. Although a neurologist, and although he claims to see patients occasionally, Dr. Kinsbourne has not had a regular clinical practice for over twenty-five years, and has no specialized expertise in studying or treating peripheral neuropathies like brachial neuritis (although he asserts that he has encountered it in his patients). Id. at 6, 28, 36. Accordingly, the opinion Dr. Kinsbourne offered in this case was rooted not in his personal experience (whether from clinical or research exposure) with brachial neuritis, but arose from his own knowledge of neurology generally plus research performed specifically for the purpose of offering an expert opinion for Petitioner. Dr. Kinsbourne began with a general discussion of what brachial neuritis is, noting that it usually presents abruptly in the shoulder and upper arm, with pain that can last for days or weeks, and which can be accompanied by limb weakness and muscle atrophy. Tr. at 10. Because it is heterogeneous in nature, its etiology can include both mechanical and immunologic causes, although in either situation its symptoms follow a similar course. Id. at 11. When immunologic in origin, brachial neuritis occurs because of an attack by autoantibodies, generated in response to some external signal (i.e., infection), against either the outer myelin sheath of peripheral nerves in the arms or the nerve axons (although Dr. Kinsbourne acknowledged that attack on the axon was the main feature of brachial neuritis). Id. In so maintaining, Dr. Kinsbourne analogized brachial neuritis to a different autoimmune- in-origin peripheral neuropathy, GBS. Tr. at 12–15. He deemed GBS the most common autoimmune peripheral neuropathy, stating that it “comes in two variants,” with one primarily featuring demyelination of the nerve sheath, while the other, acute motor axonal neuropathy (AMAN)6 involves attack on the nerve axon itself. Id. at 12, 14. He noted in particular that, regardless of the variant and situs of nerve attack, medical literature supports the conclusion that 6 AMAN is a GBS subtype commonly seen in China, generally caused by the campylobacter virus. Dorland’s Illustrated Medical Dictionary 1268 (32nd ed. 2012) [hereinafter “Dorland’s”]. It features motor axonal degeneration with little inflammation or demyelination. P. Dyck & P.K. Thomas, 2 Peripheral Neuropathy 2200 (4th ed. 2005) [hereinafter “Dyck & Thomas”]. 5 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 6 of 29 the same antiganglioside autoantibodies are involved in the pathologic process leading to GBS (thus allowing the inference that these autoantibodies might also be part of the process leading to brachial neuritis). See R. Yu, et al., Ganglioside Molecular Mimicry and its Pathological Roles in GBS and Related Diseases, 74 Infection & Immunity 6517 (2006), filed as Ex. 54 (ECF No. 95-1) (AMAN and acute motor and sensory axonal neuropathy both associated with antibodies against the ganglioside component of nerve membrane). GBS variants otherwise present with the same symptoms and course, proceeding in a monophasic manner and peaking within thirty days at most from onset (although the timeframe from instigation to onset can be longer). Id. at 13.7 To support his contention that GBS was sufficiently comparable to brachial neuritis to apply the former’s timeframe for onset, Dr. Kinsbourne referenced several pieces of medical or scientific literature. E.g., R. Verma, et al., Neuralgic Amyotrophy Associated with Dengue Fever: Case Studies of Three Patients, 57 J. Postgraduate Med. 329 (2011), filed as Ex. 52 (ECF No. 94- 8) (“Verma”). Verma considered three patients who presented with brachial neuritis associated with dengue infection (as opposed to vaccination). Verma at 329; Tr. at 51. All three developed brachial neuritis in days to a week after experiencing an acute fever and/or rash brought on by the instigating infection, suggesting to Verma’s authors that immune-mediated mechanisms explained each case. Verma at 331. Dr. Kinsbourne felt Verma supported the possibility that brachial neuritis could have a similar mechanism as GBS, such as molecular mimicry. Tr. at 19–20. Other literature was offered to establish the existence of certain autoantibodies common to both GBS and brachial neuritis – thus strengthening the idea that they have a common pathogenesis. See, e.g., N. Van Alfen, The Clinical Spectrum of Neuralgic Amyotrophy in 246 Cases, 129 Brain 438, 448 (2006), filed as Ex. 51 (ECF No. 94-7) (“Van Alfen I”). Van Alfen I observed that a certain percentage of individuals with brachial neuritis tested positive for antiganglioside antibodies comparable to those associated with GBS. Tr. at 20–21; Van Alfen I at 444 (nine of thirty-four patients tested, or 26 percent). Van Alfen I itself, however, acknowledges (consistent with what is understood about brachial neuritis generally in the medical community) that “motor symptoms are said to predominate” in the condition, with sensory symptoms (which would reflect impact on sensory nerves) secondary. Van Alfen I at 447–48. To further support the contention that GBS and brachial neuritis are analogous autoimmune conditions (making it reasonable to use the same timeframes for onset in both), Dr. Kinsbourne also offered three Japanese case studies. Tr. at 22–23, 24–27, 33–34 (discussing K. Naito, et al., Intravenous Immunoglobulin (IVIg) Therapy with Methylprednisolone Pulse Therapy for Motor Impairment of Neuralgic Amyotrophy: Clinical Observation in 10 Cases, 51 Internal Med. 1493 7 Dr. Kinsbourne also endeavored to identify record evidence suggesting that Mr. Greene had experienced demyelination rather than simply an axonal attack. See, e.g., Tr. at 9–10 (citing Ex. 4 at 15 (notes from October 5, 2009 testing indicated presence of “a focal demyelinating process”)). However, Dr. Lancaster forcefully disputed that this particular evidence established the presence of demyelination, allowing at best that the interpreting physician’s comment “was an extremely indirect inference based upon very limited data,” and opining instead, based upon his own reading of the same test results, that they did not establish demyelination. Id. at 96–97. 6 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 7 of 29 (2012), filed as Ex. 74 (ECF No. 134-2) (“Naito”); R. Morishima, et al., Chronic Brachial Plexus Neuritis that Developed into Typical Neuralgic Amyotrophy and Positively Responded to Immunotherapy, 57 Internal Med. 1021, filed as Ex. 75 (ECF No. 134-3) (“Morishima”); K. Moriguchi, et al., Four Cases of Anti-Ganglioside Antibody-Positive Neuralgic Amyotrophy with Good Response to Intravenous Immunoglobulin Infusion Therapy, 238 J. Neuroimmunology 107 (2011), filed as Ex. 76 (ECF No. 135-1) (“Moriguchi”)). Naito and Morishima both examined the efficacy of immunotherapy treatments (common to the treatment of GBS) such as intravenous immunoglobulin (“IVIG”)8 for brachial neuritis. In Naito, for example, nine of ten brachial neuritis patients who received a form of IVIG treatment showed improvement in motor impairment. Naito at 1499; Tr. at 22–23. Dr. Kinsbourne felt Naito therefore supported his overall contention about GBS and brachial neuritis’s similarities— although Naito’s authors were careful to limit their conclusions to the concept that only those experiencing a severe form of brachial neuritis characterized by a prolonged autoimmune response might benefit from immunosuppressive treatments like IVIG, adding that the overall efficacy of such treatments for brachial neuritis as a whole remained unresolved—similar to the contention (central to Petitioner’s theory herein) that antiganglioside antibodies are commonly a component of brachial neuritis’s pathogenesis. Naito at 1499. Morishima is a single-patient case study involving a fifty-five-year-old man who developed brachial neuritis after a marine sports accident that caused direct injury to his arm and shoulder. Morishima at 1021. After an initial acute response, the man’s pain and related symptoms subsided for three months, but reappeared thereafter, proving resistant to treatment even a year later. Id. at 1021–22; Tr. at 24, 37. Lab tests revealed the man possessed the kind of antiganglioside antibodies discussed above (suggesting to treaters that he was experiencing an ongoing autoimmune process), leading them to employ IVIG effectively. Morishima at 1023. Morishima’s authors thus proposed that this kind of treatment might also be of use in cases of chronic brachial neuritis. Id. at 1024– 25. Dr. Kinsbourne acknowledged that the lengthy, approximately twelve-week onset for the patient’s brachial neuritis was an outlier, but maintained nonetheless that Morishima’s authors appeared to have accepted it as reasonable. Tr. at 33–34. Moriguchi considered four brachial neuritis patients, three of whom were believed to have developed it from an antecedent infection (while the fourth had a history of symptom complaints in connection with arm surgery). Moriguchi at 107; Tr. at 26. All of the studied individuals tested positive for increased levels of antiganglioside antibodies, and two of the three patients whose condition was associated with infection showed improvement after IVIG treatment—more support, Dr. Kinsbourne maintained, for the similarities between GBS and brachial neuritis as common autoimmune conditions with a similar pathogenesis. Moriguchi at 107–08; Tr. at 26–27. 8 IVIG is a blood product used to treat patients with antibody deficiencies. Caruso v. Sec’y of Health & Human Servs., No. 15-200V, 2017 WL 5381154, at *4 n.11 (Fed. Cl. Spec. Mstr. Oct. 18, 2017) (citing Clinical Uses of Intravenous Immunoglobulin, NCBI (2005), https://wwwncbi.nlm.nih.gov/pmc/articles/PMC1809480). Because it increases the effectiveness of a patient’s immune response, IVIG is commonly employed to treat autoimmune conditions. Id. 7 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 8 of 29 Significantly, however, the individuals believed to have developed brachial neuritis after infection (and hence those most analogous to a person, like Mr. Greene, whose brachial neuritis is posited to have been vaccine-caused) experienced onset between one day and two weeks after infection— not six weeks, as alleged is reasonable herein. Moriguchi at 107–08. Dr. Kinsbourne subsequently addressed in more direct form the timeframe issue central to Petitioner’s claim. Because of GBS’s “prototypical” nature as an autoimmune peripheral neuropathy, Dr. Kinsbourne reasoned that the timeframe “risk intervals” that the scientific and medical community uses for evaluating when GBS onset might properly be associated with a vaccination could also be applied to a similar neuropathy like brachial neuritis. Tr. at 15. He thus considered a number of items of literature he felt supported a longer timeframe—some, but not all, of which involved brachial neuritis. E.g., H. Tseng, et al., Safety of a Tetanus-Diphtheria-Acellular Pertussis Vaccine When Used Off-Label in an Elderly Population, 53 Clinical Infectious Diseases 315 (2012), filed as Ex. 49 (ECF No. 94-5) (“Tseng”). Tseng, for example, considered 119,573 adults over the age of sixty-five who received the tetanus-diphtheria-aceullar pertussis (“TDaP”) vaccine, following them over a four-year period to evaluate the risk of adverse events (including GBS and brachial neuritis) after vaccination, in comparison to the whole-cell form of vaccine that was previously in wide use. Tseng at 315; Tr. at 30. Tseng’s authors noted that there was reliable evidence (derived from Institute of Medicine (“IOM”) publications) supporting a possible causal relationship between TDaP and brachial neuritis, thus justifying consideration of it as a possible adverse event. Tseng at 316 (citing K.R. Stratton, et al., Adverse Events Associated with Childhood Vaccines Other Than Pertussis and Rubella, 271 J. Am. Med. Ass’n 1602 (1994), filed as Ex. A (ECF No. 91-1) (“Stratton”)). They found that brachial neuritis was no more common after Tdap vaccination than after Td. Id. at 316, 319; Tr. at 15–16, 30–31. In so doing, however, Tseng’s authors utilized a one to forty-two day risk interval to look for brachial neuritis or GBS, although they did not explain why this interval was used. Id. at 4.9 Van Alfen I included in its studied subject group individuals whose brachial neuritis was considered hereditary or idiopathic, observing that a little over half (53.2 percent) reported an antecedent event, with less than 5 percent of that subgroup reporting having been vaccinated before symptoms arose. Van Alfen I at 440, 443. Although the time between vaccine administration and onset was not reported, other onset times (after infection, exercise, or surgery) were measured as under twenty-four hours, one to seven days, one to two weeks, and over two weeks, with most 9 In prior filings in this action, Respondent has observed the incongruity of Petitioner’s reliance on the IOM determination of a causal association between tetanus-containing vaccines and brachial neuritis (see, e.g., Kinsbourne Rep. at 3) and the fact that the IOM—which Tseng also relied upon as a basis for including it as a possible adverse event—goes only to three or four weeks in proposing what a reasonable timeframe under such circumstances might be. Mot. at 5–6, 8. 8 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 9 of 29 cases seeing onset within a week (although 10 percent of post-infection cases occurred more than two weeks later). Id. at 443. Other articles offered on the risk interval period said nothing about brachial neuritis specifically. W. Yih, et al., An Assessment of the Safety of Adolescent and Adult Tetanus- Diphtheria-Acellular Pertussis (Tdap) Vaccine, Using Active Surveillance for Adverse Events in the Vaccine Safety Datalink, 27 Vaccine 4257 (2009), filed as Ex. 53 (ECF No. 94-9) “(Yih”); Tr. at 30. Yih considered five categories of potential adverse events after TDaP vaccination: encephalopathy-encephalitis-meningitis; paralytic syndromes, seizure, cranial nerve disorders, and GBS. Yih at 4258. Nearly 700,000 TDaP recipients ten to sixty-four years old were followed for 145 weeks, relying on a forty-two-day risk interval for all potential adverse outcomes save seizure. Id. at 4259, 4261. In doing so, Yih’s authors explained that, “not knowing the true window of risk and not wanting to miss late events,” they relied on the same six-week period known to be applicable to GBS, in a desire to be intentionally over-inclusive. Id. at 4259. Dr. Kinsbourne deemed Yih significant despite its failure to include brachial neuritis as an adverse event because it demonstrated the range of possible adverse outcomes involving possible autoimmune-mediated conditions. Tr. at 17. Another article discussed by Dr. Kinsbourne at hearing explored the larger question of what kind of risk intervals should be used as a general matter in vaccine safety studies. See generally A. Rowhani-Rahbar, et al., Biologically Plausible and Evidence–Based Risk Intervals in Immunization Safety Research, 31 Vaccine 271 (2012), filed as Ex. 48 (ECF No. 94-4) (“Rowhani- Rahbar”); Tr. at 17–18. Rowhani-Rahbar discussed the process for identifying and defining biologically plausible and evidence-based risk intervals (the period of time after vaccination) for adverse events following vaccination. Rowhani-Rahbar at 272. Risk intervals allow researchers to study the incidence of a potential adverse effect by following risk and control intervals, and should be determined by considering features of the adverse event, presumed or known pathologic mechanism, and the vaccine itself. Id. at 272–73. The researchers cautioned against a too-long interval, noting that the risk of adverse events is likely concentrated in a short period of time, and that applying a long interval could dilute results pointing to the actual period of highest risk (although a too-short period could also underestimate risk). Id. at 275. For these reasons, the researchers emphasized the need to identify the most biologically-plausible timeframes possible. Id. Rowhani-Rahbar specifically proposed risk intervals for only two adverse events following vaccine administration—febrile seizures and acute disseminated encephalomyelitis (“ADEM”). Rowhani-Rahbar at 273. For ADEM (which, like brachial neuritis, is neurologic in nature, but is a central nervous system disease rather than peripheral), Rowhani-Rahbar concluded that the most trustworthy time period from vaccination to onset “best substantiated by available biological and epidemiologic data” was five to twenty-eight days. Rowhani-Rahbar at 274. A secondary, longer 9 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 10 of 29 interval of two to forty-two days was also deemed “biologically plausible,”10 and therefore worthy of consideration in order to fully assess a potential safety problem, but was more uncertain, since “there might be reason to suspect that most of the excess risk, if any, is concentrated in a much shorter period of time.” Id. at 275; Tr. at 18–19. Based on the above, Dr. Kinsbourne opined that onset of Petitioner’s brachial neuritis forty- one days after vaccination was medically reasonable. He noted that he would actually support a similar six-week period for virtually any autoimmune disease with “no hesitation,” adding that although he was aware of reliable scientific support for even longer onsets in the case of other autoimmune conditions like GBS, he was not comfortable proposing a timeframe beyond forty- two days. Tr. at 31–33. He admitted, however, that even if such a six-week period was reliable, the probability of developing brachial neuritis diminished as the tail end of the temporal “curve” was reached. Id. at 38. He also acknowledged that none of the evidence offered for the timeframe question directly involved cases measuring onset from vaccination, as opposed to a different cause (although he emphasized that some evidence, like Van Alfen I, did support the more general proposition that vaccines could cause brachial neuritis). Id. at 37; Van Alfen I at 443. 2. Dr. Laurence Steinman Dr. Steinman prepared one brief written report for this case and testified at hearing. Tr. at 39–71, 135–43; Report, dated Nov. 12, 2018, filed as Ex. 68 (ECF No. 128-1). He offered an opinion that largely overlapped with what Dr. Kinsbourne presented. Dr. Steinman obtained his medical degree from Harvard Medical School, where he completed a fellowship in chemical neurobiology. Tr. at 39; see also CV at 1, filed as Ex. 77 (ECF No. 136-1) (“Steinman CV”). After medical school, Dr. Steinman went on to complete both a pediatrics and neurology residency at Stanford University. Tr. at 39; Steinman CV at 1. He then joined the faculty at Stanford in 1980, where he presently serves as the George A. Zimmerman Professor of Neurological Sciences, Neurology, Genetics and Pediatrics. Tr. at 39; Steinman CV at 1. Dr. Steinman claimed to have encountered brachial neuritis at least one hundred times in his career (although he did not specify when he most recently encountered it—or whether his encounters came via his role as professor overseeing the work of medical residents, as opposed to his own treatment of patients). Tr. at 136. Dr. Steinman has also published extensively in peer- reviewed journals on topics including neuroimmunology and GBS. Steinman CV at 5–45. He has demonstrated expertise in both a wide variety of central nervous system diseases (multiple sclerosis in particular) and immunologic issues, and claimed great familiarity in treating brachial neuritis, although he does not appear to have focused on it over other central nervous system 10 The only support for this timeframe offered in Rowhani-Rahbar is the statement that “[b]ased on prior reports of the onset of ADEM following immunization, the occurrence of such events appears to decrease substantially beyond 6 weeks.” Rowhani-Rahbar at 274. This statement is footnoted in turn by nine items of literature—all involving ADEM, however, and some of which appear to discuss passive surveillance reports of post-vaccine cases rather than to weigh actual biologic risk. 10 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 11 of 29 diseases (such as multiple sclerosis). Dr. Steinman characterized brachial neuritis as a kind of neuropathic autoimmune disease. Although his testimony on this point was mostly indistinguishable from Dr. Kinsbourne’s, he did attempt to refine some of Dr. Kinsbourne’s earlier assertions. Thus, Dr. Steinman emphasized that brachial neuritis is in his opinion likely an inflammatory autoimmune condition, similar to GBS in pathophysiology, although more focal (i.e., restricted to an arm and shoulder as opposed to having an impact bilaterally/symmetrically). Tr. at 43–44. He allowed that it has different triggers than GBS, although Dr. Steinman emphasized its immunologic character, based on his experience as well as existing literature. Tr. at 135–36 (referencing Van Alfen I in support of his contention that the most common cause for brachial neuritis is not trauma but an immunologic trigger, such as vaccination or infection), 138 (noting that based upon his experience “at grand rounds or some teaching conference,” the etiology of brachial neuritis can be identified half of the time). Consistent with Dr. Kinsbourne’s testimony, Dr. Steinman asserted that brachial neuritis involves attacks on myelin and nerve axon equally. Tr. at 56–57. He admitted, however, that brachial neuritis is not exclusively immunologic in origin, but can also be the result of some direct trauma (like the case study discussed in Morishima), although the subsequent pathogenesis in all cases would be “autoimmune or at least inflammatory,” concepts he contradictorily claimed were the same but also distinguishable. Id. at 70–71. Also consistent with Dr. Kinsbourne’s prior testimony was Dr. Steinman’s overarching presumption that GBS, and what is known about it in terms of vaccine causation, provides an analog to brachial neuritis for purposes of determining timeframe in this case. Thus, he deemed significant the fact that brachial neuritis has been shown (in case reports like Naito and Moriguchi) to respond to immune-modulating treatments like IVIG,11 and that the specific antiganglioside antibodies allegedly associated with GBS were observed to be present for the patients considered by these case studies, thereby confirming its autoimmune character and/or similarity to GBS— along with the fact that (reflecting the role the immune system writ large plays in its pathogenesis) brachial neuritis does not always occur in the same arm that receives trauma. Tr. at 57–64. He also maintained, like Dr. Kinsbourne, that “host factor” variations in how an individual reacts to an event triggering an autoimmune response would impact that individual’s course. Id. at 44–45. Based upon the foregoing, Dr. Steinman echoed Dr. Kinsbourne’s conclusion that timeframes viewed as medically reasonable for onset of GBS were equally applicable to brachial neuritis. In so maintaining, he relied on the fact that both illnesses are directed at the peripheral nerves and (in his view) likely involve similar mechanistic paths. Tr. at 45. He also invoked a seminal item of medical literature (not directly relevant to brachial neuritis) from the swine flu 11 Dr. Steinman went so far as to assert that IVIG is used at his own hospital at Stanford to treat brachial neuritis, although he did not substantiate this assertion with any independent evidence. Tr. at 138. 11 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 12 of 29 epidemic in the 1970s. L. Schonberger, et al., Guillain-Barré Syndrome Following Vaccination in the National Influenza Immunization Program, 110 Amer. J. Epidemiology 105 (1979), filed as Ex. 69 (ECF No. 128-2) (“Schonberger”). Schonberger, Dr. Steinman observed, supported up to a ten-week timeframe for onset of GBS, but suggested risk was highest in the shorter, six to seven- week interval (although Schonberger itself expressly states that GBS risk “was concentrated primarily within the 5-week period after vaccination”). Schonberger at 105; Tr. at 47, 49. Because Schonberger was “based on an enormous data set of surveillance,” he felt it was a particularly reliable epidemiologic study that had applicability herein. Id. at 47, 55.12 As a result, Dr. Steinman (like Dr. Kinsbourne) endorsed a six-week timeframe for onset of brachial neuritis after vaccination as medically reasonable. Tr. at 53. He claimed that, in his own clinical experience, he had seen a variety of onsets ranging throughout the proposed six-week period, but that onset toward the end of that period “would not worry me.” Id. at 141. In explaining this conclusion, Dr. Steinman repeated many of the same points made by Dr. Kinsbourne, commenting on the same items of literature reviewed during Dr. Kinsbourne’s testimony. He was thus asked about Verma (Tr. at 50–51), Yih (id. at 52–53), Rowhani-Rahbar (id. at 54–56), Naito (id. at 58–59), Morishima (id. at 60–61), and Moriguchi (id. at 62–63). He acknowledged, however, when asked generally about the utility of risk intervals, that they were often primarily the product of what a particular study’s authors wanted to achieve in a particular study, rather than a reflection of biological plausibility for a given potentially adverse event. See, e.g., Tr. at 52–53, 55 (“where you set the dial is in the hands of the person or teams turning the dial”). On cross examination, Dr. Steinman admitted some limitations to the bases for his conclusions regarding timeframe for onset herein. He allowed that case studies like Naito equivocated as to the efficacy of immunotherapies for brachial neuritis, although he maintained nonetheless that such evidence pointed in the direction of the utility of such treatments, even if more formal scientific corroboration was still absent. Tr. at 67–68. He agreed that such treatments were not uniformly called for either, especially since certain individuals suffering from brachial neuritis might see improvement absent IVIG treatment (although he stressed the medical importance of doing whatever possible to aid patients). Id. at 68. And he conceded that one of the articles referenced in his own expert report only supported a three-week timeframe for post- vaccination onset of brachial neuritis. Id. at 65–66 (discussing P. Tsairis, et al., Natural History of Brachial Plexus Neuropathy, 27 Arch. Neurol. 109, 111–12 (1972), filed as Ex. 58 (ECF No. 95- 5) (“Tsairis”)). 12 Dr. Steinman also noted that the tetanus vaccine package insert indicates that individuals with GBS are advised against getting a second vaccine within six weeks of the disease’s appearance as further bulwarking the reliability of the six-week timeframe. Tr. at 49–50. Petitioner did not, however, file this document—and even if he had, the fact that it applies to GBS (coupled with existing sound Vaccine Program caselaw suggesting that package inserts deserve little evidentiary weight) greatly reduces the value of this argument (especially given the existence of several more reliable items of evidence that were filed in this action and which support the timeframe argument (e.g., Rowhani- Rahbar)). 12 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 13 of 29 3. Dr. Eric Lancaster Dr. Eric Lancaster provided two expert reports in this action on Respondent’s behalf, and also testified at hearing. See Report, dated May 25, 2018, filed as Ex. B (ECF No. 121-1) (“Lancaster Rep.”); Report, dated Mar. 28, 2019, filed as Ex. D (ECF No. 133-1) (“Supp. Lancaster Rep.”). Dr. Lancaster opined that the tetanus vaccine did not likely cause Petitioner’s brachial neuritis, and that the timeframe in which Petitioner’s injury began was not a medically acceptable period for post-vaccination causation. In so proposing, he disputed the assumption of Petitioner’s experts that what is known about GBS onset and timeframe can be applied equally to brachial neuritis. Dr. Lancaster is a clinical physician at the Center for Autoimmune Neurology at the University of Pennsylvania, as well as an assistant professor of neurology at the University of Pennsylvania. Ex. C at 1 (ECF No. 121-11) (“Lancaster CV”). He completed a neurology residency at the University of Pennsylvania from 2004–07, and is board certified in neurology, with subspecialties in neuromuscular medicine and electrodiagnostic medicine. Id.; Tr. at 73–74. His research focuses on antibody-mediated neurological disorders, and he sees patients with complex autoantibody disorders on a regular basis. Lancaster CV at 1; Tr. at 75. He has considerable expertise performing the tests used to evaluate peripheral neuropathies (e.g., EMGs, nerve conduction studies)13, and devotes half his time to a clinical practice, although he estimates only to have treated ten to twenty patients with brachial neuritis over his career. Tr. at 74–75; Lancaster Rep. at 1. Dr. Lancaster’s description of brachial neuritis was mostly consistent with that provided by Petitioner’s experts, although it diverged in a few significant respects. He characterized the condition as “inflammation in a particular area of the nervous system called the brachial plexus,” located in the shoulder near the neck. Tr. at 76–77. It has a monophasic course, with a sudden onset followed by a slow recovery over weeks or months, although patients often recovery fully. Id. at 77. He was less confident than Petitioner’s experts that brachial neuritis is primarily autoimmune in nature, however, noting that although “it certainly involves inflammation,” not enough is known about its pathophysiology and the mechanisms driving it (for example, whether it is solely antibody-mediated or the result of a T-cell response) to firmly state that it is primarily an autoimmune condition. Id. at 107. But several items of literature filed by Respondent seem to accept that autoimmunity plays a role in brachial neuritis’s pathogenesis. See, e.g., N. Van Alfen, Clinical and Pathophysiological Concepts of Neuralgic Amyotrophy, 7 Nat. Rev. Neurol. 315, 320 13 An EMG, or electromyography test, is a diagnostic procedure used to assess the health of muscles and the nerve cells that control them (motor neurons). Dorland’s at 602. A nerve conduction study, or “nerve conduction velocity test,” measures the speed of conduction of an electrical impulse through a nerve, to evaluate the presence of nerve damage or destruction. Nerve Conduction Studies, Health Library, Johns Hopkins Medicine, https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/nerve-conduction-velocity-ncv (last visited July 23, 2019). 13 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 14 of 29 (2011), filed as Ex. B-1 (ECF No. 121-2) (“Van Alfen II”) (acknowledging that brachial neuritis “is thought to be autoimmune in origin”). Dr. Lancaster nevertheless stressed (in contrast to Drs. Kinsbourne and Steinman) that brachial neuritis is primarily an “axonal” injury to the nerves, readily ascertainable via an EMG study, rather than one featuring multifocal demyelination—and in fact it is this axonal characteristic that causes recovery after onset to take time. Tr. at 77, 96–97; Lancaster Rep. at 6; J. Feinberg, et al., Parsonage-Turner Syndrome, 6 Hosp. for Spec. Surg. 199, 202 (2010), filed as Ex. B-2 (ECF No. 121-3) (“Feinberg”); see also Van Alfen II at 319 (“[a]s in other [peripheral nervous system] disorders, the amount of axonal damage provides a fair prediction of the possibility for nerve recovery,” adding that subsequent reinnervation can take months or years). He indicated no awareness, based on existing literature or medical community views, that brachial neuritis should be considered primarily a demyelinating injury, noting that testing (such as nerve conduction studies) used to diagnose brachial neuritis does not usually reveal “severe conduction slowing or reversible conduction blocks”—either of which would reflect the existence of demyelination. Tr. at 79. Dr. Lancaster similarly took issue with the efforts of Petitioners’ experts to borrow GBS onset timeframes for this case, stressing the differences in the two conditions: the focal and localized nature of the inflammation present in brachial neuritis, as opposed to the multifocal, bilateral character of GBS, and the demyelination featured most often in GBS, as opposed to the “axonal process” in brachial neuritis. Tr. at 87–88, 89 (“these are very different disorders and it isn’t that hard to tell them apart”), 94–95 (referencing Van Alfen II). He also disputed the efficacy of immunosuppressive treatments for brachial neuritis, arguing that although such treatments have been medically established to be effective for GBS, there is a lack of persuasive and reliable scientific data establishing their utility for brachial neuritis, and that he had not in his experience encountered the use of such treatments for this condition (or the testing of brachial neuritis patients for the presence of autoantibodies). Id. at 88–89, 124–26. And he noted that given what is known about the two diseases and their differing courses (with brachial neuritis having a higher likelihood of a fast onset after triggering event than GBS), it made sense to him that the latency period relevant to one would be inapplicable to the other. Id. at 89–91. In fact, he felt it far more medically likely that brachial neuritis would have a shorter, post-trigger onset than GBS. Id. at 91–92. Another distinction between GBS and brachial neuritis that Dr. Lancaster deemed significant was the fact that the latter can be initiated by “different triggering events” not associated with the former. Tr. at 77. Brachial neuritis can be caused by injury from exertion or other arm trauma, infection, or vaccination—although half of the time in his experience no causal factor could be identified. Id. at 77, 104 (discussing vaccination as possible cause). Regardless, the presentation and progression of most cases of brachial neuritis was the same. Id. at 78. He also emphasized that direct injury to the nerve itself was not a requirement for triggering of brachial 14 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 15 of 29 neuritis. Id. at 78, 83–84. On the contrary, “relatively minor events” could produce brachial neuritis, from overexertion after exercise to maintaining the same body position on a lengthy airplane flight. Id. at 99–100, 111–12; Lancaster Rep. at 7. He particularly stressed that unlike GBS, brachial neuritis could have direct arm trauma as its triggering event. Tr. at 90 (“[t]his has not, to my knowledge, ever been accepted as the cause of [GBS]”). Turning to the present record, Dr. Lancaster agreed that Petitioner has brachial neuritis. He did not, however, see evidence that would suggest Mr. Greene’s immune system was undergoing an autoimmune process in the forty-one-day period between receipt of the tetanus vaccine and onset of his symptoms in September 2009. Tr. at 80. Indeed, he disputed that such a long timeframe was reasonable for onset of brachial neuritis after any inciting event. Relying on Van Alfen I as well as Tsairis, along with his personal clinical experience, Dr. Lancaster observed that half of studied cases in those items of literature began within a week of the putative trigger,14 with 90 percent occurring in two weeks. Tr. at 81, 85–87; Tsairis at 111–12; Van Alfen I at 443 (nearly 70 percent of all studied cases reporting an antecedent event involved symptom onset within a week or less). He therefore deemed an onset beyond three to four weeks of the triggering incident as “increasingly implausible.” Tr. at 81. He also disputed the validity of employing a single timeframe for all neuroimmune disorders attributable to vaccination, as Petitioner urges. Id. at 82. He did, however, acknowledge that certain items of literature, like Van Alfen I, seemed to allow for the possibility that brachial neuritis could still occur at a timeframe beyond two weeks (even though his reading of the data from that item of literature suggested that the syndrome was “very heavily concentrated” on the immediate two to three weeks after a trigger). Id. at 117–19; Van Alfen I at 443 (approximately 10 percent of forty-nine studied cases involved onset of post-infection brachial neuritis occurring more than two weeks after the infection, with the remaining 90 percent occurring two weeks or less after infection). Dr. Lancaster noted several findings in the medical record that he deemed significant to his opinion. The electrodiagnostic test results for Mr. Greene suggested to him the presence of “severe axonal injury,” with far less convincing evidence of demyelination, and nothing that would suggest the presence of GBS either. Tr. at 96–97; Lancaster Rep. at 10–11. Such results were therefore consistent with brachial neuritis. Tr. at 97. He also observed no treater support for the tetanus vaccine being causal. Id. at 98. And overall, based on his view of the totality of the record, he thought it most likely that in Mr. Greene’s specific case physical exertion close in time to onset in 14 Dr. Lancaster acknowledged that it might be difficult in cases of infection-induced brachial neuritis to pin down the date of the inciting event, but noted that incidents involving arm trauma (whether from exertion, accident, or surgery) were a different matter—and in such cases latency was often very short. Tr. at 81. 15 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 16 of 29 early September was the most likely trigger15 —otherwise the cause was idiopathic (although he did not discount the initial hand injury that Petitioner suffered, which caused him to receive the tetanus vaccine in the first place, as also possibly causative). Id. at 98–104; Ex. 12 at 19 (September 7, 2009 ER record with handwritten note referencing Petitioner’s exertion in the days prior to onset as a possible “recent injury” explanation for pain).16 Dr. Lancaster went on to review the literature and evidence offered in the case to support, or refute, a forty-one-day timeframe for onset of post-vaccination brachial neuritis. While articles like Tsairis did allow that a vaccine might be causative, they lent support for a timeframe for onset of no more than four weeks. Tr. at 82–84; Tsairis at 111. Rowhani-Rahbar also did not consider brachial neuritis in proposing the two risk intervals it discusses, and in fact its authors were in Dr. Lancaster’s view “extremely careful” to highlight that any selected interval needed “to be customized to the specific disease in question.” Tr. at 85. Schonberger similarly only involved GBS, and in Dr. Lancaster’s reading underscored the fact that brachial neuritis and GBS have distinguishable pathophysiologies. Id. at 92–93. Dr. Lancaster also directly questioned the significance of the three Japanese case studies (Naito, Morishima, and Moriguchi) filed by Petitioner and commented upon by his experts. He challenged their findings about the efficacy of immunosuppressive treatments for brachial neuritis (which, Petitioner argues, corroborates the similarity of the condition to more purely autoimmune neuropathies like GBS), allowing that even if those articles suggested IVIG might be effective in treating brachial neuritis, “the jury is still out” on the mechanism by which brachial neuritis occurs (and in particular whether it is mediated by autoantibodies at all, let alone the same ones implicated in GBS). Tr. at 94, 121–22. He also did not deem significant the fact that some evidence of autoantibodies also relevant to GBS was identified in tests performed in these case reports, noting that he could not exclude the possibility that they were merely false positive findings, reflecting the fact that many people in the population might also possess them (but not establishing that their presence meant the patient’s brachial neuritis had been mediated by the autoantibody). Id. at 108– 09. 15 See, e.g., Lancaster Rep. at 9. Because this Decision does not turn on identifying an alternative cause, but instead is the product of my determination that the proposed forty-one-day onset has not been established with sufficient preponderant evidence, I do not analyze Respondent’s success in establishing such factual contentions. 16 Mr. Greene was called at hearing to testify to rebut this point, and he maintained that he had not in fact overexerted or otherwise harmed his arm or shoulder in the days immediately prior to his ER visit in September 2009—and that he did not so inform treaters at the time, despite what the contemporaneous medical document states. Tr. at 127–29, 130–31. Respondent, however, offered a later-in-time medical record, filled out by Petitioner, in October 2009 (a month after the ER visit) in which he himself again identified “hard work” around Labor Day of that year triggering a “neuro explosion.” Id. at 132; see also Ex. 2 at 4; Ex. 12 at 19. Petitioner could not credibly explain these medical record references and their contradiction of his recollection, other than by asserting that the degree of pain he was in at the time (coupled with his lack of knowledge about what brachial neuritis was) somehow impacted his judgment or what he told treaters. Tr. at 133–34. 16 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 17 of 29 On cross examination, Dr. Lancaster granted the medical plausibility of a causation theory relying on vaccination as initiating brachial neuritis, even if the absence of evidence of the correct autoantibodies relating to the process resulting in the condition. Tr. at 110. He also acknowledged (in response to questions that seemed aimed at establishing that Dr. Lancaster’s standard for medical acceptability was far too high for purposes of a Vaccine Program case) that he personally would not accept a forty-one-day timeframe for onset of brachial neuritis without some kind of corroborative scientific or medical study specific to brachial neuritis and vaccination. Id. at 107. Applicable 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).17 As already noted, Petitioner’s Table claim was dismissed after issuance of the Fact Ruling. 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; 17 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121, 124 (2003), aff’d, 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13- 159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014). 17 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 18 of 29 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 (which is the kind of claim asserted in this matter), a petitioner must satisfy all three of the elements established by the Federal Circuit in Althen v. Secretary of Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005): “(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.” 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, 956 F.2d at 1148. 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 18 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 19 of 29 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 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 denied, 100 Fed. Cl. 344, 356 (2011), aff’d without op., 475 F. 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. denied 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 denied (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014). B. 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 19 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 20 of 29 the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharmaceuticals, 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. The fact that a claimant offers an expert opinion does not render the opinion that expert espouses scientifically reliable or persuasive. 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 denied, 108 Fed. Cl. 743 (2013), aff’d, 540 F. App’x 999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). C. Review of Medical and Scientific Literature Both parties filed medical and scientific literature in this case, but not every filed item factors into the outcome of this decision. While I have reviewed all of the medical literature submitted in this case, I discuss only those articles that are most relevant to my determination and/or are central to Petitioner’s case—just as I have not exhaustively discussed every individual medical record filed. Moriarty v. Sec’y of Health & Human Servs., 844 F.3d 1322, 1328 (Fed. Cir. 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); see also 20 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 21 of 29 Paterek v. Sec’y of Health & Human Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) (“[f]inding certain information not relevant does not lead to—and likely undermines—the conclusion that it was not considered”). ANALYSIS As I have previously noted, the first, “can cause” Althen prong has been met in this case, given the ample prior decisions associating vaccines containing a tetanus component with brachial neuritis, as well as the showing made by Petitioner’s experts. Remand Ruling at 11 n.7; Devonshire v. Sec’y of Health & Human Servs., No. 99-031V, 2006 WL 2970418, at *15 (Fed. Cl. Spec. Mstr. Sept. 28, 2006) (stating that it is well known that brachial neuritis can occur following a tetanus vaccination), aff’d, 76 Fed. Cl. 452 (2007); DeGrandchamp v. Sec’y of Health & Human Servs., No. 01-413V, 2003 WL 21439670, at *7 (Fed. Cl. Spec. Mstr. May 15, 2003) (relying on IOM publications to find that in theory, the tetanus toxoid in Td vaccine can cause brachial neuritis). Literature offered in this case also supports this determination. See, e.g., Van Alfen II at 320. This case instead turns on the remaining Althen prongs, which I address in order of their significance to my Decision. I. Petitioner Has Not Established that his Brachial Neuritis Began in a Medically-Acceptable Post-Vaccination Timeframe (Althen Prong Three) There is no dispute in this case that Mr. Greene experienced brachial neuritis, but the medical reasonableness of the timeframe in which his symptoms began, measured from date of vaccination forty-one days earlier, is very much contested. I have already determined that Petitioner cannot meet his preponderant burden of proof merely by relying on the approximately thirteen-day differential between the end date for a viable Table claim and his own onset. Grant, 956 F.2d at 1147–48.18 Petitioner was thus tasked with establishing the medical reasonableness of the timeframe herein through resort to expert testimony and whatever other evidence bears on that question. Petitioner has offered some literature addressing the amount of time medical science expects brachial neuritis will occur after an instigating trigger—but it largely does not support a 18 The reasonableness of not allowing a petitioner to rely on the Table claim timeframe for a non-Table claim is underscored by considering how this is fair to both sides. In this case, for example, Dr. Lancaster has opined that the defined Table period for a tetanus/brachial neuritis claim is based on the most persuasive medical and scientific evidence available—thus suggesting to him that anything beyond it would by definition not be medically reasonable. Tr. at 91 (mentioning that the twenty-eight-day range reflects the “consensus of experts”). If petitioners are permitted to rely on how close onset in a given case is to the defined Table period in support of a non-Table claim, then Respondent should be similarly entitled to wield the Table period offensively, as proof that science does not preponderantly support a longer timeframe. Program law instead requires petitioners (and Respondents in seeking to rebut a Vaccine Act non-Table claim) to rely on evidence to bulwark the reasonableness of the proposed period— independent of the Table timeframe (although evidence used to establish that timeframe may still be relevant). 21 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 22 of 29 six-week onset for the illness, instead suggesting more persuasively that the maximum time from trigger to onset would be no more than two or three weeks. See, e.g., Van Alfen I19, Tsairis. Indeed, and as Respondent previously argued, one of the same pieces of evidence that supports Petitioner’s Althen prong one showing—the IOM review of tetanus-caused brachial neuritis—supports at most a four-week onset risk period. Stratton at 55 (noting that latency period for brachial neuritis after vaccination “ranges from a few days to 3 or at most 4 weeks”) (emphasis added). And Dr. Lancaster convincingly explained why a shorter onset timeframe made more sense for brachial neuritis— and conversely, why a timeframe exceeding four weeks was far less medically acceptable. Accordingly, what direct proof exists on the topic does not preponderate in Petitioner’s favor. Of course, petitioners may establish their Vaccine Act claim with circumstantial evidence, so the absence of sufficient direct proof does not end the analysis. Mr. Greene sought to meet his preponderant burden through (a) invocation of risk intervals applied to other autoimmune diseases, and (b) a comparison of the timeframes that reliable scientific evidence establishes for onset of GBS. Neither argument was ultimately persuasive, however (although both were supported by some reliable scientific/medical evidence). A. Risk Intervals for Other Autoimmune Diseases Are Not Preponderant Evidence Alone of A Reasonable Timeframe Petitioner relied on some literature involving risk intervals generally, best explained in Rowhani-Rahbar. This evidence unquestionably has probative value. See generally Rowhani- Rahbar. The fact that longer risk intervals are often utilized in measuring vaccine safety is circumstantial evidence supporting the conclusion that it would be medically reasonable to expect some analogous vaccine-caused neurologic injuries to occur within a similar timeframe. It is for this reason that the longer risk interval that Petitioner’s experts propose to apply in this case has also been found persuasive by other special masters in cases alleging autoimmune injuries comparable to those evaluated in Rowhani-Rahbar. See, e.g., Day v. Sec’y of Health & Human Servs., No. 12-630V, 2015 WL 8028393, at *22 (Fed. Cl. Nov. 13, 2015) (applying Rowhani- Rahbar secondary risk interval for ADEM to case alleging that petitioner’s multiple sclerosis (“MS”) was vaccine-caused). There are, however, significant countervailing points that weigh against endorsement of a forty-one-day timeframe herein. First and foremost, not all neurologic injuries with an autoimmune component are the same, even if they have some common features. Ample Program authority has noted that, while petitioners may reasonably analogize an injury to other autoimmune conditions, they cannot prevail solely by doing so. See, e.g., R.V. v. Sec’y of Health & Human Servs., No. 08-504V, 2016 WL 3882519, at *41 (Fed. Cl. Spec. Mstr. Feb. 19, 2016) (not crediting 19 Although Van Alfen I does allow that 10 percent of studied, infectious-originating cases of brachial neuritis might have had an onset of greater than two weeks, this finding is too vague to give it significant weight – it does not allow for the conclusion that an onset of longer than four weeks is acceptable, and it does not involve vaccination directly. Van Alfen I at 443. 22 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 23 of 29 petitioner’s reliance on unsupported analogy to other illnesses in proving causation theory), mot. for review denied, 127 Fed. Cl. 136 (2016); R.K. v. Sec’y of Health & Human Servs., No. 03- 0632V, 2015 WL 10936124, at *105 (Fed. Cl. Spec. Mstr. Sept. 28, 2015) (same), mot. for review denied, 125 Fed. Cl. 57 (2016), aff’d, 671 F. App’x 792 (Fed. Cir. 2016). And as Dr. Lancaster noted, brachial neuritis is in fact not congruent with a central nervous system disease like ADEM— the latter being the basis for the forty-one-day period relied upon in Rowhani-Rahbar (and found to be analogous to the MS injury considered in Day). It is therefore unpersuasive for Petitioner to argue that timeframes involving distinguishable neurologic diseases should be applied as a consistent yardstick to all cases involving nerve-related autoimmune injuries. A secondary problem posed by Petitioner’s argument is its overreliance on a longer risk interval as a proxy for preponderant evidence establishing a medically reasonable onset timeframe. Rowhani-Rahbar addresses the application of risk intervals for epidemiologic studies evaluating overall vaccine safety. Although they are employed based on some consideration of when an adverse post-vaccination event might be expected to occur, they are also intentionally “broad nets” intended to catch as many putative adverse events as possible. Dr. Steinman himself noted that an adopted interval can mean whatever the study’s author wants it to (although he nevertheless added that a study would for the most part seek to define an interval based on when a plausible reaction or illness might occur). Tr. at 52–53, 55. Thus, a secondary interval explicitly understood to be less specific, and hence medically accurate, but included nonetheless in a study to avoid missing possible related adverse events is not particularly robust proof as to the scientific/medical consensus as to when a particular injury would most likely occur post-vaccination. The fact that a risk interval is selected for a particular study because its authors deem it to have utility therein does not mean that the same period can be deemed preponderantly established in the context of a Vaccine Act claim. Thus, while I acknowledge that Petitioner’s invocation of the risk interval concept generally had some evidentiary value, it was not by itself enough to preponderantly establish that vaccine-caused brachial neuritis could reasonably occur within six weeks of vaccination—especially since the evidence specific to brachial neuritis says otherwise. B. GBS and Brachial Neuritis Are Not Congruent for Purposes of Determining Reasonableness of Onset To bulwark adoption of a six-week timeframe, Petitioner’s experts consistently proposed that brachial neuritis is analogous to GBS—an autoimmune, peripheral nervous system-affecting neurologic condition that substantial Program caselaw (based in turn on reliable science) has determined can reasonably begin in as long as six to eight weeks after vaccination. See, e.g., Barone v. Sec’y of Health & Human Servs., No. 11-707V, 2014 WL 6834557, at *13 (Fed. Cl. Spec. Mstr. Nov. 12, 2014) (eight weeks is the longest reasonable timeframe for a non-Table 23 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 24 of 29 flu/GBS injury). But this argument was ultimately unpersuasive. Despite some of their common features, GBS is simply not sufficiently comparable to brachial neuritis to apply the same onset timeframe to both. Literature filed in this case relating to brachial neuritis, and the reports and testimony discussing it, clearly establishes that it is a neurologic injury primarily to the nerve axon—a finding confirmed by nerve electrophysiologic studies and also consistent with the motor loss associated with brachial neuritis. Feinberg at 202; see also Lancaster Rep. at 10–11.20 It also can be caused by direct trauma that would never result in GBS, further suggesting it is highly distinguishable. And while the same literature also suggests a person with brachial neuritis may have some sensory symptoms that could reflect secondary nerve demyelination, that is not the fundamental character of the condition—unlike GBS. See Auch v. Sec’y of Health & Human Servs., No. 12-673V, 2017 WL 1034396, at *9 (Fed. Cl. Spec. Mstr. Jan. 13, 2017) (Dr. Steinman opining that GBS is characterized by autoimmune attack on nerve myelin sheath, resulting in demyelination). To establish the contrary, Petitioner’s experts simply asserted that this was not the case— that brachial neuritis is as characterized by demyelination as GBS. See Tr. at 11 (Dr. Kinsbourne), 56–57 (Dr. Steinman). Alternatively, they attempted to blur the lines between the two conditions by noting the existence of AMAN, a nerve axon-oriented GBS variant. See, e.g., id. at 21–22. While this GBS variant clearly exists, Petitioner’s experts did not elaborate on the fact that AMAN is also (a) uncommon in comparison to other GBS variants, (b) largely confined to a pediatric population, and (c) mainly occurs outside of the U.S., in eastern Asian countries. Dorland’s Illustrated Medical Dictionary 1268 (32nd ed. 2012); P. Dyck & P.K. Thomas, 2 Peripheral Neuropathy 2200–01 (4th ed. 2005). It is also readily distinguishable from brachial neuritis, as Dr. Lancaster observed. Supp. Lancaster Rep. at 1. The existence of an axonal-impacting GBS variant, therefore, provides limited assistance to Petitioner’s argument that GBS and brachial neuritis are comparable for purposes of determining a medically acceptable onset timeframe. Petitioner also invoked case studies indicating that certain autoantibodies associated with GBS (antiganglioside antibodies) have been found in testing of brachial neuritis patients. The significance of the presence of these autoantibodies in individuals with brachial neuritis is far from determined, however, as more persuasive scientific literature indicates. See, e.g., Van Alfen II at 320 (“some studies have reported antiganglioside [peripheral nervous system] antibodies in patients, but this finding could well be a consequence of axonal damage rather than its cause”) (emphasis added). As Dr. Lancaster noted, none of these autoantibodies have been scientifically demonstrated to drive an autoimmune process resulting in brachial neuritis. And even if it is assumed that the pathophysiology of brachial neuritis could involve similar autoantibodies, such 20 Well-recognized authorities confirm the same. See, e.g., Dyck & Thomas at 2303 (“most of the currently available evidence from electrophysiologic studies suggest multifocal or patchy abnormalities consistent with axonal damage (loss) within the brachial plexus and isolated peripheral nerves of the upper extremities”) (emphasis added). 24 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 25 of 29 points do not establish, based on existing persuasive science and medical literature about brachial neuritis specifically, that the timeframes relevant for a different autoimmune disease can simply be applied wholesale here—that the time in which it would take for brachial neuritis (which Dr. Lancaster successfully established would usually be an acute process) to manifest would be consistent with GBS. The same goes for the Japanese case studies offered to establish that brachial neuritis has been successfully treated with the kind of immune-modulating treatments long understood to be effective for GBS. See Naito; Morishima; Moriguchi. It is routinely recognized in the Program that case reports do not merit significant weight as a class of evidence (see, e.g., Crutchfield v. Sec’y of Health & Human Servs., No. 09-39V, 2014 WL 1665227, at *19 (Fed. Cl. Spec. Mstr. Apr. 7, 2014), aff’d, 125 Fed. Cl. 251 (2014)), but here the actual reports filed are on their face even less probative than usual. Indeed, only Morishima involved a lengthy onset (admitted even by Dr. Kinsbourne to be an outlier under Petitioner’s own theory), with the other case studies observing post-infectious onset (the most analogous circumstance to vaccine-induced brachial neuritis) in a timeframe consistent with Respondent’s position of less than four weeks. Accordingly, even if I give some weight to the suggestion of these case reports that IVIG treatments have been efficacious for certain cases of brachial neuritis, these articles are greatly outweighed by other evidence establishing the many accepted differences between GBS and brachial neuritis. C. Respondent Successfully Rebutted Petitioner’s Timeframe Evidence, as well as his Expert Reports and Testimony Reliable evidence offered by Respondent and discussed by Dr. Lancaster persuasively suggests brachial neuritis is more acute in nature, and will likely begin within two or three weeks of whatever triggers it—not six weeks, as Petitioner argues here. This is consistent with what is known about the orientation of the injury (to the axon) and its acute nature, and does not rely on analogy to distinguishable autoimmune conditions. Dr. Lancaster’s opinion stemmed from a practice-derived understanding of how brachial neuritis presents and what causes it—not just from research performed for the purpose of offering an opinion herein. He has knowledge of the condition and regularly performs the EMG and nerve conduction study tests employed to evaluate its existence and course. Dr. Lancaster’s opinion is also consistent with my determinations in other cases involving similar injuries. See, e.g., Garner v. Sec’y of Health & Human Servs., No. 15-063V, 2017 WL 1713184 (Fed. Cl. Spec. Mstr. Mar. 24, 2017), mot. for review denied, 2017 WL 3483352 (Fed. Cl. July 31, 2017). In Garner, I considered a claim that the Hepatitis A and B vaccines had caused brachial neuritis. The earliest onset possible in Garner was forty-five days after vaccination, based on the first record documentation of any complaints by the petitioner about arm or shoulder pain. Id. at *1. Respondent, however, persuasively argued (also via Dr. Lancaster’s testimony) that the 25 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 26 of 29 condition was far more acute in nature (and in terms of the causative mechanism as well), making twenty-eight days the outer limit for latency. Id. at *8. I found this point to be dispositive, even though the claimant’s Althen prong one showing was (as here) sufficient, and dismissed the case on the record. Id. at *16. That decision was upheld on review. 2017 WL 3483352. Nothing about this case distinguishes it from Garner’s analysis or outcome. Petitioner’s expert testimony, by contrast, was simply less effective and persuasive.21 Both experts he relied upon are credentialed and competent to testify generally on neurologic injuries and the potential immunologic triggers for them—and they do so often in the Vaccine Program. Also, and as discussed extensively above, they offered some reliable items of evidence to support many of their contentions. And the opinion they jointly voiced -- that similarities between GBS and brachial neuritis were enough to allow application of the timeframe for onset of the former to the latter -- was reasonable, and coherently presented as well. But this does not mean that Drs. Kinsbourne and Steinman offered persuasive expert opinions that compel a favorable determination for Petitioner on the third Althen prong. Not only were their contentions effectively rebutted, but these two experts do not possess demonstrated, specific experience studying or treating brachial neuritis and its causes, even if they may have intermittently encountered it in their professional lives.22 As a result, their assertions vouching for the reasonableness of timing in this case lacked the evidentiary heft of an expert who could credibly explain how his own experience studying or treating the disease in question informed his opinion. Overall, Petitioner did not offer sufficient evidence to meet his preponderant burden on this third Althen prong. As the Federal Circuit has noted, establishing the timeframe prong is dependent upon “the medical understanding of the disorder’s etiology . . . .” Bazan, 539 F.3d at 21 Although Drs. Wright’s and Byers’s expert reports remain in evidence, Petitioner made no reference to their contentions at hearing, and I do not find that they appreciably assisted Petitioner’s case with respect to the third Althen prong. 22 Dr. Kinsbourne was particularly deficient in this regard. By his own admission, he has essentially treated almost no patients for more than twenty-five years (although he routinely seeks to offer opinions in Vaccine Program cases on an individual’s diagnosis or symptoms course). Tr. at 28; Holmes v. Sec’y of Health & Human Servs., No. 08- 185V, 2011 WL 2600612, at *2 n.9 (Fed. Cl. Spec. Mstr. April 26, 2011) (noting that Dr. Kinsbourne has not had a clinical neurology practice for thirty-seven years), aff’d, 115 Fed. Cl. 469 (2014). His neurology background cannot make up for this lack of personal understanding of the condition in question. Dr. Steinman, by contrast, appears to see patients more regularly, even if a clinical practice is not his main focus. But he does not possess specific demonstrated expertise with respect to brachial neuritis. Indeed, although he regularly testifies for Vaccine Act petitioners, by my count he has only offered an expert opinion in cases involving brachial neuritis twice before. See, e.g., Winterfeld v. Sec’y of Health & Human Servs., No. 15-933V, 2018 WL 2225178 (Fed. Cl. Spec. Mstr. Mar. 9, 2018) (awarding attorney’s fees and costs in settled case alleging brachial neuritis after receipt of influenza vaccine). And tellingly, in that case the petitioner claimed an onset of approximately two weeks after vaccination—not six. See Petition at 2, Winterfeld, 2018 WL 2225178 (ECF No. 1). 26 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 27 of 29 1352 (emphasis added). The most compelling and reliable evidence offered herein pertinent to brachial neuritis (the relevant “disorder”) establishes that it proceeds fairly acutely after a trigger, and is highly unlikely to occur more than three or four weeks after instigation. The fact that other autoimmune-mediated and somewhat comparable neurologic diseases might reasonably be understood to have a longer potential onset timeframe does not compel the conclusion that the same is true for brachial neuritis. II. Petitioner Has Not Established that his Brachial Neuritis Was Caused By the Tetanus Vaccine He Received in July 2009 Even if I had found that a forty-one-day timeframe for onset of brachial neuritis was medically acceptable, the record in this case fails to support the conclusion that the tetanus vaccine is the most likely explanation for Mr. Greene’s injury. The record provides no objective evidence whatsoever—direct, circumstantial, or otherwise—that Petitioner was experiencing an autoimmune-derived injury attributable to vaccination. Mr. Greene had no symptoms at all before he presented to the ER in early September 2009, and then only reported he had been feeling pain for a few days before—consistent with the acutely-presenting nature of brachial neuritis.23 There is nothing from the pre- or post-vaccination record suggesting that an autoimmune reaction was brewing in a subclinical form. And none of Mr. Greene’s treaters implicated the tetanus vaccine as causative of his injuries—nor did they ever propose IVIG treatment to remedy it (something that further undercuts the concept that brachial neuritis is properly deemed congruent with GBS—or that medical science is increasingly viewing immunosuppressive treatments as effective for brachial neuritis). I have similarly found in other cases involving a long, silent post-vaccination period before onset of injury that the “did cause” prong was not met. See, e.g., Bender v. Sec’y of Health & Human Servs., No. 11-693V, 2018 WL 3679637, at *34 (Fed. Cl. Spec. Mstr. July 2, 2018) (finding that petitioner’s transverse myelitis, which began forty-two days after receipt of the meningococcal and Hepatitis A vaccines, could not have been caused by the vaccines when there was no evidence of subclinical process occurring over that six-week period), mot. for review denied, 141 Fed. Cl. 262 (2019). No evidence was offered here establishing that brachial neuritis would otherwise be characterized by a subclinical period that could explain the medical record silence. And Petitioner did not fully rebut Dr. Lancaster’s point that certain medical records seem to contain statements to 23 Although at the 2015 fact hearing Petitioner attempted to establish that he had been experiencing some initial symptoms in mid-August 2009, I found that these allegations were not corroborated by the medical record, and that he did not otherwise establish why the presumption of accuracy that attaches to such records under the law should not control here as well. Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed. Cl. 598, 608 (2010) (crediting special master’s decision to rely on contemporaneous medical records over later-in-time statements from the petitioner to the contrary). 27 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 28 of 29 providers by Mr. Greene that at the time of onset, he associated his sudden pain with very recent hard work at his construction job (something Dr. Lancaster deemed as an intervening, possibly explanatory occurrence).24 Respondent also raised fair questions about whether the true cause of Petitioner’s brachial neuritis was the injury to his hand in July 2009 that prompted receipt of the tetanus vaccination in the first place. Based upon the existing record (and although I do not find the burden ever shifted to Respondent), I cannot find that an alternative cause has been established by a preponderance, any more than that the vaccine has been established to be causal. This does, however, raise a reasonable point further undercutting Petitioner’s claim. For, if the tetanus vaccine could explain Petitioner’s injury forty-one days later, on a medical record devoid of reference to any symptoms or signs in the intervening period, why would the injury that occurred immediately prior to its administration not also potentially be causal? Petitioner did not establish that brachial neuritis due to vaccine is distinguishable in course or presenting symptoms from that caused by trauma, or why the record otherwise better supports vaccination as the cause.25 CONCLUSION This claim should have been resolved far sooner. Although some delay was attributable to the parties’ good faith efforts to settle, Petitioner’s unwillingness to abandon the legally-untenable position that the Table timeframe applicable to brachial neuritis could be leveraged in a non-Table context also interfered with its timely resolution. Petitioner did eventually marshal reliable evidence to support his claim, thus justifying a hearing. But after considering the expert witnesses and evidence upon which they relied, it is my reasoned conclusion that Petitioner has failed— despite abundant opportunity—to preponderantly substantiate his contention that a forty-one-day onset period for his brachial neuritis was medically acceptable, or that the tetanus vaccine more likely than not “did cause” his subsequent injury. 24 I do not find in this case, however, that Petitioner’s brachial neuritis was “more likely than not” caused by such trauma close-in-time to the ER visit, since the record does not support that conclusion preponderantly. But this does constitute evidence undermining Petitioner’s argument that only the vaccine could be causal, and was ineffectively rebutted. 25 Of course, the causal interplay of hand injury versus vaccine does not solely cut in Respondent’s favor. If this were a case where Petitioner’s onset had occurred in a more medically-reasonable timeframe, application of the Shyface “substantial factor” could compel a finding for Petitioner under the present circumstances despite the possible role of the hand injury in producing brachial neuritis. Heinzelman v. Sec’y of Health & Human Servs., No. 07–01V, 2008 WL 5479123, at *4 (Fed. Cl. Spec. Mstr. Dec. 11, 2008) (vaccine may still be substantial factor in causing injury sufficient to justify entitlement award, even where “two forces act in concert”). But this only illuminates the significance of my finding that the timeframe of onset was too remote from either occurrence to even weigh such competing causative factors. 28 Case 1:11-vv-00631-MMS Document 141 Filed 08/29/19 Page 29 of 29 I accordingly DISMISS Petitioner’s causation claim. In the absence of a timely-filed motion for review (see Appendix B to the Rules of Court), the Clerk shall enter judgment in accord with this decision.26 IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Special Master 26 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their right to seek review. 29 ================================================================================ DOCUMENT 6: USCOURTS-cofc-1_11-vv-00631-6 Date issued/filed: 2020-02-12 Pages: 15 Docket text: JUDGE VACCINE REPORTED OPINION reissuing 155 Judge Vaccine Order/Opinion. Signed by Chief Judge Margaret M. Sweeney. (kb1) -------------------------------------------------------------------------------- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 1 of 15 In the United States Court of Federal Claims No. 11-631V (Filed Under Seal: January 28, 2020) (Reissued for Publication: February 12, 2020)1 *************************************** ROY GREENE, * * Petitioner, * * Vaccine Act; Motion for Review; Tetanus- v. * Diphtheria Vaccine; Brachial Neuritis; * Causation; Althen Prongs Two and Three; SECRETARY OF HEALTH AND HUMAN * Burden of Proof SERVICES, * * Respondent. * *************************************** Richard Gage and Kristen L. Blume, Cheyenne, WY, for petitioner. Robert P. Coleman, III and Brittany A. Ditto, United States Department of Justice, Washington, DC, for respondent. OPINION AND ORDER SWEENEY, Chief Judge Petitioner Roy Greene seeks compensation under the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”), 42 U.S.C. §§ 300aa-1 to -34 (2018), for an alleged vaccine-caused injury. Before the court is petitioner’s motion for review of the special master’s decision denying compensation.2 As discussed below, the court denies petitioner’s motion. 1 Vaccine Rule 18(b), included in Appendix B of the Rules of the United States Court of Federal Claims, affords each party fourteen days in which to object to the disclosure of (1) trade secrets or commercial or financial information that is privileged or confidential or (2) medical information that would constitute “a clearly unwarranted invasion of privacy.” Neither party objected to the public disclosure of any information contained in this opinion. 2 After issuing the decision at issue, the special master was appointed to the position of chief special master. For simplicity, the court uses the title “special master” throughout this decision. Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 2 of 15 I. BACKGROUND Petitioner filed a petition for compensation under the Vaccine Act on September 29, 2011, alleging that he developed brachial neuritis as a result of a July 22, 2009 tetanus-diphtheria (“Td”) vaccination.3 He asserted two theories of recovery: first, that he was entitled to compensation pursuant to the Vaccine Injury Table, which provides that brachial neuritis that develops between two and twenty-eight days after receiving a vaccine containing tetanus toxoid is a compensable injury; and second, that he was entitled to compensation because the Td vaccine actually caused his brachial neuritis. The special master held a fact hearing in March 2015 to determine the onset date of petitioner’s symptoms. In a July 31, 2015 decision, the special master remarked that petitioner’s symptoms satisfied the then-operative definition of brachial neuritis in the Vaccine Injury Table’s “qualifications and aids to interpretation.” Under that definition, brachial neuritis is dysfunction limited to the upper extremity nerve plexus (i.e., its trunks, divisions, or cords) without involvement of other peripheral (e.g., nerve roots or a single peripheral nerve) or central (e.g., spinal cord) nervous system structures. A deep, steady, often severe aching pain in the shoulder and upper arm usually heralds onset of the condition. The pain is followed in days or weeks by weakness and atrophy in upper extremity muscle groups. Sensory loss may accompany the motor deficits, but is generally a less notable clinical feature. The neuritis, or plexopathy, may be present on the same side as or the opposite side of the injection; it is sometimes bilateral, affecting both upper extremities. 42 C.F.R. § 100.3(b)(7)(i) (2014). The special master then found that petitioner’s symptoms began no earlier than September 1, 2009––forty-one days after the Td vaccination. Because petitioner’s symptoms arose after the time period prescribed in the Vaccine Injury Table, the special master dismissed petitioner’s Table claim. Over the next two years, in an effort to resolve petitioner’s remaining claim of actual causation, petitioner filed two expert reports from Thomas W. Wright, M.D., an orthopedist, and the parties engaged in settlement discussions. In September 2016, the special master learned that the settlement discussions had not been successful because respondent rejected as inadequate petitioner’s showing that forty-one days was a medically acceptable time frame for the Td vaccine to cause brachial neuritis. Thus, the special master directed petitioner to file a supplemental expert report. In early 2017, petitioner filed an expert report from Marcel Kinsbourne, M.D., a neurologist. 3 The court derives much of the background from its previous ruling in this case, see generally Greene v. Sec’y of HHS, 136 Fed. Cl. 445 (2018), and the special master’s August 2, 2019 decision after remand, see generally Greene v. Sec’y of HHS, No. 11-631V, 2019 WL 4072110 (Fed. Cl. Spec. Mstr. Aug. 2, 2019). The remaining information is taken from the docket of the case and the regulation setting forth the Vaccine Injury Table, 42 C.F.R. § 100.3. -2- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 3 of 15 In March 2017, respondent filed a motion for a ruling on the record, to which petitioner responded the following month. In a May 26, 2017 decision, the special master found that the record did not support petitioner’s claim that the Td vaccine caused his brachial neuritis because petitioner could not establish, more probably than not, that a forty-one-day period between the vaccination and the first symptoms of the injury was medically acceptable. On June 16, 2017, petitioner filed a motion for reconsideration pursuant to Vaccine Rule 10(e), as well as a supplemental expert report from Dr. Kinsbourne and supporting documentation (including eighteen medical and scientific articles and a letter/report from Vera S. Byers, M.D., Ph.D., an immunologist). In his motion, petitioner argued that he had provided sufficient evidence to establish that a forty-one-day onset period was medically acceptable, but that if the special master continued to deem the existing evidence insufficient, Dr. Kinsbourne’s supplemental expert report and supporting documentation would establish the medical acceptability of the onset period. The special master granted petitioner’s motion for reconsideration and then, in a September 26, 2017 “Decision on Reconsideration Denying Entitlement,” concluded that “[t]he record [did] not support Petitioner’s allegation that his Td vaccine more likely than not caused his brachial neuritis 41 days following the vaccination.” Greene v. Sec’y of HHS, No. 11-631V, 2017 WL 5382856, at *7 (Fed. Cl. Spec. Mstr. Sept. 26, 2017). He therefore dismissed petitioner’s actual causation claim. Petitioner filed a motion for review of the special master’s decision denying entitlement. Because the special master applied the incorrect legal standard when evaluating the evidence offered by petitioner, the court, in a February 27, 2018 Opinion and Order, granted petitioner’s motion, vacated the special master’s decision, and remanded the case to the special master to issue a new entitlement decision. On May 17, 2018, the special master issued a remand decision in which he denied respondent’s motion for a ruling on the record, determined that respondent should be provided the opportunity to submit an expert report, and indicated that an entitlement hearing would likely be necessary. Respondent filed an expert report from Eric Lancaster, M.D., Ph.D., a neurologist, on June 14, 2018. On November 13, 2018, petitioner filed an expert report from Lawrence Steinman, M.D., a neurologist and immunologist, and a response to Dr. Lancaster’s expert report from Dr. Kinsbourne. On April 9, 2019, respondent filed Dr. Lancaster’s response to Dr. Steinman’s and Dr. Kinsbourne’s submissions. Then, on April 29, 2019, petitioner filed a supplemental expert report from Dr. Kinsbourne. Shortly thereafter, on May 9, 2019, the special master held an entitlement hearing during which he heard testimony from Dr. Kinsbourne, Dr. Steinman, Dr. Lancaster, and petitioner. The special master issued his entitlement decision on August 2, 2019. After summarizing the case’s factual and procedural history, he provided an extensive description of the credentials, reports, and testimony of Dr. Kinsbourne, Dr. Steinman, and Dr. Lancaster, along with the medical and scientific literature relied upon by the experts. He also set forth the legal standards for his review of the experts’ opinions, for his review of the medical and scientific literature, and -3- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 4 of 15 for petitioner to establish causation. Then, the special master analyzed petitioner’s case under the test for causation set forth in Althen v. Secretary of HHS, 418 F.3d 1274 (Fed. Cir. 2005). In Althen, the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) articulated a three-part test, based on prior precedent, explaining what a petitioner must show to prove causation under the Vaccine Act: [Petitioner]’s burden is to show by preponderant evidence that the vaccination brought about [the] 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. Id. at 1278. The special master noted that he had previously concluded that petitioner had established the first prong of the test, and therefore focused his analysis on the second and third prongs. With respect to the third prong, the special master concluded that petitioner did not establish, by a preponderance of the evidence, that forty-one days was a medically acceptable length of time between petitioner’s Td vaccination and the onset of petitioner’s brachial neuritis. Specifically, he concluded that petitioner’s direct proof was insufficient and that petitioner’s arguments based on circumstantial evidence––evidence concerning risk intervals and evidence pertaining to the similarities between brachial neuritis and Guillain-Barré syndrome (“GBS”)–– were unpersuasive.4 He further noted that respondent successfully rebutted the evidence and arguments presented by petitioner, finding that respondent’s evidence was persuasive and that the opinions of petitioner’s experts were not as persuasive as Dr. Lancaster’s opinions. The 4 “GBS is an acute monophasic peripheral neuropathy that encompasses a spectrum of four clinicopathological subtypes . . . .” 42 C.F.R. § 100.3(c)(15)(i) (2017). The most common subtype in North America and Europe, comprising more than 90 percent of cases, is acute inflammatory demyelinating polyneuropathy (AIDP), which has the pathologic and electrodiagnostic features of focal demyelination of motor and sensory peripheral nerves and nerve roots. Another subtype called acute motor axonal neuropathy (AMAN) is generally seen in other parts of the world and is predominated by axonal damage that primarily affects motor nerves. AMAN lacks features of demyelination. Another less common subtype of GBS includes acute motor and sensory neuropathy (AMSAN), which is an axonal form of GBS that is similar to AMAN, but also affects the sensory nerves and roots. AIDP, AMAN, and AMSAN are typically characterized by symmetric motor flaccid weakness, sensory abnormalities, and/or autonomic dysfunction caused by autoimmune damage to peripheral nerves and nerve roots. Id. § 100.3(c)(15)(ii). -4- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 5 of 15 latter conclusion was based, in part, on petitioner’s experts’ purported lack of experience in treating patients with brachial neuritis. With respect to the second prong (which the special master was not required to address having concluded that petitioner had not satisfied the mandatory third prong), the special master determined that petitioner had not satisfied his burden of establishing that the Td vaccine did cause his brachial neuritis. This conclusion was based, in part, on his assessment that the record lacked any evidence that petitioner was experiencing an autoimmune reaction to the vaccine. In accordance with his analysis, the special master concluded that petitioner failed to establish that the Td vaccine caused his brachial neuritis and therefore dismissed petitioner’s actual causation claim. Petitioner timely filed a motion for review on September 3, 2019, and respondent filed a response on October 3, 2019. The court heard argument on January 23, 2019, and is now prepared to rule. II. DISCUSSION A. Standard of Review 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 standards set forth in section 12(e)(2)(B) “vary in application as well as degree of deference. . . . Fact findings are reviewed . . . under the arbitrary and capricious standard; legal questions under the ‘not in accordance with law’ standard; and discretionary rulings under the abuse of discretion standard.” Munn v. Sec’y of HHS, 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). Specifically, with respect to the special master’s fact findings, the 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.” Porter v. Sec’y of HHS, 663 F.3d 1242, 1249 (Fed. Cir. 2011); see also Hodges v. Sec’y of HHS, 9 F.3d 958, 961 (Fed. Cir. 1993) (“[O]n review, the Court of Federal Claims is not to second guess the Special Master[’]s fact-intensive conclusions; the standard of review is uniquely deferential for what is essentially a judicial process.”). “Rather, as long as a special master’s finding of fact is ‘based on evidence in the record that [is] not wholly implausible, [the court is] compelled to uphold that -5- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 6 of 15 finding as not being arbitrary or capricious.’” Porter, 663 F.3d at 1249 (first alteration in the original) (quoting Cedillo v. Sec’y of HHS, 617 F.3d 1328, 1338 (Fed. Cir. 2010)). In the instant case, petitioner enumerates, pursuant to Vaccine Rule 24, three objections to the special master’s August 2, 2019 decision. First, petitioner contends that the special master required petitioner to establish that a forty-one-day postvaccination onset period for his brachial neuritis was medically reasonable rather than medically acceptable, improperly increasing petitioner’s burden of proof.5 Second, petitioner contends that the special master arbitrarily and capriciously found facts related to his experts’ qualifications and theories. Third, petitioner contends that the special master required him to supply preponderant evidence that the Td vaccine was the most likely cause of his brachial neuritis rather than preponderant evidence of a logical sequence of cause and effect between the Td vaccine and his brachial neuritis, again improperly increasing his burden of proof. Petitioner accordingly requests that the court, pursuant to 42 U.S.C. § 300aa-12(e)(2)(E), set aside the special master’s findings of fact and conclusions of law, issue its own findings and conclusions, and determine that he is entitled to compensation. B. Legal Standard All of petitioner’s objections relate to the special master’s determination that petitioner had not met his burden of proving that the Td vaccine caused his brachial neuritis. As noted above, to prove causation under the Vaccine Act, a petitioner must show by preponderant evidence that the vaccination brought about [his] 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; see also Boatmon v. Sec’y of HHS, 941 F.3d 1351, 1355 (Fed. Cir. 2019) (noting that a petitioner must “prove[] all three Althen prongs by a preponderance of the evidence”). Under the first prong, a petitioner must demonstrate that the vaccine at issue can cause the injury alleged. Pafford v. Sec’y of HHS, 451 F.3d 1352, 1355-56 (Fed. Cir. 2006). To make this showing, “a petitioner must provide a reputable medical or scientific explanation that pertains specifically to the petitioner’s case, although the explanation need only be ‘legally probable, not medically or scientifically certain.’” Broekelschen v. Sec’y of HHS, 618 F.3d 1339, 1345 (Fed. Cir. 2010) (quoting Knudsen v. Sec’y of HHS, 35 F.3d 543, 548-49 (Fed. Cir. 1994)). The second prong requires a petitioner to show “that the vaccine was the ‘but for’ cause of the harm,” Pafford, 451 F.3d at 1356, or, in other words, “‘that the vaccine actually caused the alleged symptoms in [the] particular case,’” id. (quoting the decision of the special master as recited by the trial court). Establishing the third prong “requires preponderant proof that the onset of symptoms occurred within a timeframe for which, given the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation-in-fact.” de Bazan v. Sec’y 5 Petitioner does not challenge the special master’s finding that the onset of his brachial neuritis occurred forty-one days after his Td vaccination. See Mot. 4 n.3. -6- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 7 of 15 of HHS, 539 F.3d 1347, 1352 (Fed. Cir. 2008); accord Althen, 418 F.3d at 1281 (describing the requirement as “a medically-acceptable temporal relationship between the vaccination and the onset of the alleged injury”). In short, a petitioner is required “to 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 v. Sec’y of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999); see also Moberly v. Sec’y of HHS, 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (“The burden of showing something by a ‘preponderance of the evidence,’ the most common standard in the civil law, simply requires the trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the [judge] of the fact’s existence.” (quoting Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers Pension Trust for S. Cal., 508 U.S. 602, 622 (1993))). Generally, “[t]he determination of causation in fact under the Vaccine Act involves ascertaining whether a sequence of cause and effect is ‘logical’ and legally probable, not medically or scientifically certain.” Knudsen, 35 F.3d at 548-49. Thus, causation can be established with circumstantial evidence––in other words, with medical records or medical opinion. Althen, 418 F.3d at 1279-80 (citing 42 U.S.C. § 300aa-13(a)(1)); see also Knudsen, 35 F.3d at 548 (observing that the “‘logical sequence of cause and effect’ must be supported by a sound and reliable medical or scientific explanation” (citing Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993); Jay v. Sec’y of HHS, 998 F.2d 979, 984 (Fed. Cir. 1993))). A petitioner “need not produce medical literature or epidemiological evidence to establish causation,” but “where such evidence is submitted, the special master can consider it in reaching an informed judgment as to whether a particular vaccination likely caused a particular injury.” Andreu v. Sec’y of HHS, 569 F.3d 1367, 1379 (Fed. Cir. 2009). But see LaLonde v. Sec’y of HHS, 746 F.3d 1334, 1341 (Fed. Cir. 2014) (“In Vaccine Act cases, petitioners must proffer trustworthy testimony from experts who can find support for their theories in medical literature in order to show causation under the preponderance of the evidence standard. The level of specificity of such support may vary from circumstance to circumstance.”). Moreover, to say that proof in the form of epidemiological studies or well-established medical experience is not mandatory does not mean that the special masters in Vaccine Act cases are precluded from inquiring into the reliability of testimony from expert witnesses. Weighing the persuasiveness of particular evidence often requires a finder of fact to assess the reliability of testimony, including expert testimony, and . . . the special masters have that responsibility in Vaccine Act cases. Moberly, 592 F.3d at 1325. C. Petitioner’s Objections In his motion for review, petitioner challenges both the special master’s findings of fact (with respect to petitioner’s experts’ qualifications and theories) and conclusions of law (with respect to the second and third prongs of the Althen test). Because an arbitrary and capricious finding of fact can affect a legal conclusion, the court begins its analysis by addressing petitioner’s second enumerated objection to the special master’s decision. -7- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 8 of 15 1. The Challenged Findings of Fact Were Either Not Arbitrary and Capricious or Not Necessary for the Special Master’s Ultimate Conclusions In his second objection, petitioner contends that the special master omitted and misstated information regarding the qualifications and opinions of Dr. Steinman and Dr. Kinsbourne. Specifically, he asserts that the special master: • did not mention that Dr. Steinman was an immunologist in addition to a neurologist; • found that Dr. Steinman and Dr. Kinsbourne “do not possess demonstrated, specific experience studying or treating brachial neuritis and its causes,” Greene, 2019 WL 4072110, at *20, even though Dr. Kinsbourne testified that he had treated patients with brachial neuritis while he had a clinical practice (which ended in the early 1990s), Hr’g Tr. 28, May 9, 2019 (“Tr.”), and Dr. Steinman testified that he has seen “[a]t least 100” cases of brachial neuritis over the past forty years, id. at 136, recently saw a case of brachial neuritis, id. at 51, 58, 68, and is a neuroimmunologist who has focused his research on the causes and treatments of autoimmune diseases, id. at 39-40; • failed to comparably criticize Dr. Lancaster, who testified that he had diagnosed and treated “10 to 20” patients with brachial neuritis over the last ten years, that his research focus was “autoantibodies to the nervous system,” and that his research projects pertained to “autoimmune encephalitis, . . . [chronic immune demyelinating polyradiculopathy,] and autoimmune neuropathies,” id. at 74-75; • ignored the experience of Dr. Wright despite valuing clinical experience over knowledge derived from research; • distinguished brachial neuritis and GBS for the purpose of determining a medically acceptable onset period by, in part, observing that the former primarily affects the axons of neurons while the latter primarily affects the myelin sheaths of neurons, despite evidence reflecting that a subtype of GBS results from axonal damage; • disregarded petitioner’s direct proof that brachial neuritis can occur forty-one days after a triggering event in the form of (1) an article—that the special master characterized as an outlier but did not reject as incorrect—describing a man who developed brachial neuritis three months after an injury (the Morishima article), and (2) Dr. Steinman’s testimony that he had seen cases of brachial neuritis developing “four, five, six weeks” after the triggering event, id. at 141; -8- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 9 of 15 • refused to give three case reports from Japan (the Moriguchi, Morishima, and Naito articles) any weight because of his position that case reports are not entitled to much weight, which is derived from a decision of another special master who discounted case reports for a purpose other than the one for which petitioner offered the case reports in this matter; and • found that there was “nothing from the pre- or post-vaccination record suggesting that an autoimmune reaction was brewing in a subclinical form,” Greene, 2019 WL 4072110, at *21, even though no evidence was produced by the parties indicating that petitioner would have symptoms that suggested such a process. Respondent does not address most of these contentions head on. Instead, he characterizes petitioner’s contentions as a “dissatisfaction with the Special Master’s weighing of the evidence, and in particular, his decision to credit Dr. Lancaster’s opinion over his own experts.” Resp. 11. Specifically, he asserts that the special master was correct to discount the expert reports of Dr. Wright because they contained unsupported, conclusory statements,6 and to find Dr. Lancaster’s opinion, which the doctor derived from clinical experience, more reliable than the opinions of Dr. Steinman and Dr. Kinsbourne. In a single sentence at the conclusion of his discussion of petitioner’s second objection to the special master’s decision, respondent states: “Petitioner’s claim that the Special Master made arbitrary and capricious findings of fact regarding the qualifications of petitioner’s experts is impossible to reconcile with the Special Master’s discussion of their qualifications, credibility, and theories.” Id. at 17. Respondent is correct that the court is not to reweigh the evidence presented by the parties. Indeed, the law is well settled that a special master’s fact finding is entitled to deference so long as the special master’s findings are based on evidence that is “not wholly implausible . . . .” Porter, 663 F.3d at 1249 (quoting Cedillo, 617 F.3d at 1338). Thus, for petitioner’s contentions that are truly just complaints regarding how the special master valued the evidence— the discounting of Dr. Wright’s expert reports, the failure to give greater weight to the existence of a subtype of GBS (not brachial neuritis, the injury suffered by petitioner7) that is characterized 6 Respondent makes the same point regarding the letter/report from Dr. Byers even though petitioner did not address the special master’s treatment of Dr. Byers’s opinion in his motion. 7 In his decision, the special master found that “[d]espite some of their common features, GBS is simply not sufficiently comparable to brachial neuritis to apply the same onset timeframe to both.” Greene, 2019 WL 4072110, at *18. Indeed, it is axiomatic that diseases and injuries are not fungible and may have different triggers, courses, and treatments, such that it may not be appropriate to infer that a vaccine that causes one disease or injury can also cause a different, but related, disease or injury. Accord id. at *17 (“[N]ot all neurologic injuries with an autoimmune component are the same, even if they have some common features. Ample [Vaccine] Program authority has noted that, while petitioners may reasonably analogize an injury to other autoimmune conditions, they cannot prevail solely by doing so.”). -9- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 10 of 15 by axonal damage, and the failure to give greater weight to the three case studies—the court concludes that the special master’s findings of fact were not arbitrary and capricious. However, several of petitioner’s contentions implicate the accuracy of the special master’s findings of fact rather than just the weight he placed on the evidence. First, the special master found the opinions of Dr. Steinman and Dr. Kinsbourne less reliable because they “do not possess demonstrated, specific experience studying or treating brachial neuritis and its causes, even if they may have intermittently encountered it in their professional lives,” Greene, 2019 WL 4072110, at *20, but did not similarly criticize the reliability of Dr. Lancaster’s opinion even though Dr. Lancaster testified to treating only ten to twenty cases of brachial neuritis and did not profess to studying brachial neuritis and its causes in particular. In other words, although the experts—Dr. Steinman and Dr. Lancaster especially—have seen a similar number of cases of brachial neuritis (adjusted for time) and have studied autoimmune diseases in general rather than brachial neuritis in particular, the special master did not similarly critique the experts on these factors. His failure to do so was arbitrary and capricious. Moreover, the special master arbitrarily and capriciously misstated and downplayed Dr. Steinman’s credentials and experience. He remarked: Dr. Steinman claimed to have encountered brachial neuritis at least one hundred times in his career (although he did not specify when he most recently encountered it—or whether his encounters came via his role as professor overseeing the work of medical residents, as opposed to his own treatment of patients). Dr. Steinman has also published extensively in peer-reviewed journals on topics including neuroimmunology and GBS. He has demonstrated expertise in both a wide variety of central nervous system diseases (multiple sclerosis in particular) and immunologic issues, and claimed great familiarity in treating brachial neuritis, although he does not appear to have focused on it over other central nervous system diseases (such as multiple sclerosis). Id. at *8 (citations omitted). Contrary to the parenthetical in the special master’s first sentence, Dr. Steinman testified that he “saw a patient with brachial neuritis” while he “was on duty at Stanford Hospital very recently,” and that he “know[s] from [his] own practice, as recently as three weeks ago,” that brachial neuritis “has the hallmarks of an autoimmune condition.” Tr. 51; see also id. at 68 (‘[W]hen I see a patient with brachial neuritis, I like to treat them and make them feel better faster . . . . “). And, although he remarks that Dr. Steinman “has demonstrated expertise in . . . immunologic issues,” the special master fails to note that Dr. Steinman is actually an immunologist. Nevertheless, even though the special master’s findings regarding the credentials and experience of Dr. Steinman were arbitrary and capricious, they were unnecessary for his conclusion that petitioner did not establish that the Td vaccine caused his brachial neuritis. Indeed, the special master held that respondent had rebutted petitioner’s showing on the third prong of the Althen test on the merits of the evidence presented, and only noted petitioner’s experts’ purported lack of “experience studying or treating brachial neuritis and its causes” as a separate reason for discounting their opinions. -10- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 11 of 15 Second, the special master concluded that “what direct proof exists on [the amount of time brachial neuritis will occur after an instigating trigger] does not preponderate in Petitioner’s favor,” id. at *17, but did not discuss the Morishima article, which described an onset period of three months, or the testimony of Dr. Steinman, who had seen onset periods of four to six weeks. The court does not find the special master’s failure to perform a specific analysis of this evidence to be arbitrary and capricious. There is no requirement that a special master discuss every piece of evidence when making a factual finding. See, e.g., Maza v. Sec’y of HHS, 67 Fed. Cl. 36, 38 (2005) (“The Special Master need not discuss every item of evidence in the record so long as her decision makes clear that she considered the petitioners’ arguments.”); Snyder v. Sec’y of HHS, 36 Fed. Cl. 461, 466 (1996) (“The special master need not discuss every item of evidence in the record so long as the decision makes clear that the special master fully considered a party’s position and arguments on point.”), aff’d, 117 F.3d 545 (Fed. Cir. 1997); see also Hazlehurst v. Sec’y of HHS, 604 F.3d 1343, 1352 (Fed. Cir. 2010) (noting that a reviewing court presumes that the fact finder has considered all of the material in the record, regardless of whether it is mentioned in his or her decision). More fundamentally, it is clear that the special master considered the evidence identified by petitioner because he mentioned it elsewhere in his decision. See Greene, 2019 WL 4072110, at *6 (remarking that Dr. Kinsbourne recognized that the three-month onset period in the Morishima article was an outlier), *19 (same), *9 (describing Dr. Steinman’s testimony). Third, the special master observed that there was “nothing from the pre- or post- vaccination record suggesting that an autoimmune reaction was brewing in a subclinical form,” id. at *21, but did not indicate how such a reaction would be reflected in the record given that “subclinical” means “[n]ot manifesting characteristic clinical symptoms,” Subclinical, The American Heritage College Dictionary (4th ed. 2004). However, even if the court found the special master’s observation to be arbitrary and capricious, it is but one of three reasons for the special master’s conclusion that “[t]he record provides no objective evidence whatsoever— direct, circumstantial, or otherwise—that Petitioner was experiencing an autoimmune-derived injury attributable to vaccination.” Id. According to the special master: Mr. Greene had no symptoms at all before he presented to the ER in early September 2009, and then only reported he had been feeling pain for a few days before—consistent with the acutely-presenting nature of brachial neuritis. There is nothing from the pre- or post-vaccination record suggesting that an autoimmune reaction was brewing in a subclinical form. And none of Mr. Greene’s treaters implicated the tetanus vaccine as causative of his injuries—nor did they ever propose IVIG treatment to remedy it (something that further undercuts the concept that brachial neuritis is properly deemed congruent with GBS—or that medical science is increasingly viewing immunosuppressive treatments as effective for brachial neuritis). Id. Because petitioner does not challenge the other two bases of the special master’s conclusion, the fact that one basis is problematic is of no import. -11- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 12 of 15 In short, the court rejects petitioner’s second objection to the special master’s decision. Many of petitioner’s contentions relate to the weight assigned to certain evidence by the special master, which the court does not review, and the remaining contentions regard findings of fact that are not arbitrary and capricious or are not critical to the special master’s ultimate conclusions. The court therefore turns to petitioner’s contentions that the special master improperly increased his burden of proof under the second and third prongs of the Althen test. 2. The Special Master Did Not Increase Petitioner’s Burden of Proof Under the Third Prong of the Althen Test The court begins with petitioner’s Althen prong three objection: that the special master required him to establish that a forty-one-day onset period was medically reasonable, a subjective determination, rather than medically acceptable, an objective determination. He argues that the evidence in the record reflects that brachial neuritis can develop three months after a triggering event and, therefore, “medically, it must be accepted that [brachial neuritis] can arise 41 days post-triggering event.” Mot. 22. Respondent counters that petitioner’s objection is plainly inaccurate and must be rejected, as it simply ignores the Special Master’s accurate two-page recitation of case law describing petitioner’s burden of proof, the whole of the Special Master’s analysis, and the Special Master’s specific finding that “Petitioner Has Not Established that his Brachial Neuritis Began in a Medically-Acceptable Post-Vaccination Timeframe.”8 Resp. 11 (footnote added). As an initial matter, the court does not understand “medically acceptable” and “medically reasonable” to be legally distinct concepts for the purpose of analyzing the third prong of the Althen test. A scientist or doctor who finds an onset period to be medically acceptable would not find the onset period to be medically unreasonable, and a scientist or doctor who finds an onset period to be medically reasonable would not find the onset period to be medically unacceptable. Indeed, two of petitioner’s experts expressed their opinions on the postvaccination timing of the onset of petitioner’s brachial neuritis in terms of medical reasonableness. Dr. Wright concluded that petitioner’s forty-one-day onset period was “a reasonable onset window,” Pet’r’s Ex. 22 at 2; 8 The “specific finding” recited by respondent is actually a heading in the special master’s decision. The court is disinclined to treat a heading as a finding of fact or conclusion of law. Accord Target Stores, Div. of Target Corp. v. United States, 471 F. Supp. 2d 1344, 1347 (C.I.T. 2007) (“[A] section heading within a court order is not authority of any sort.”); NSK Ltd. v. United States, 462 F. Supp. 2d 1254, 1256 n.1 (C.I.T. 2006) (“[T]he headings demarcating separate sections within an opinion are dicta and not binding under the doctrine of stare decisis.”), aff’d, 510 F.3d 1375 (Fed. Cir. 2007); cf. Tutor Perini Corp. v. Banc of Am. Sec. LLC, 842 F.3d 71, 96 (1st Cir. 2016) (“For though a heading in Tutor Perini’s opening brief suggests the judge erred in dismissing the intentional-misrepresentation claim, its appellate papers never explain how this is so. And thus Tutor Perini waived any argument it might have on that claim.”). However, as set forth below, the court’s conclusion would be the same regardless of whether it considered the heading in its analysis. -12- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 13 of 15 accord Pet’r’s Ex. 29 at 2 (remarking that “41 days . . . is within a reasonable time . . . to implicate the vaccine”), and Dr. Kinsbourne concluded that “[t]he interval of 41 days falls within the 42-day timeframe that is generally recognized as being medically reasonable,” Pet’r’s Ex. 38 at 4; accord Pet’r’s Ex. 45 at 3 (“The medical literature cited above is evidence that a 42-day risk interval for brachial neuritis is medically reasonable.”).9 Thus, for present purposes, the terms “medically acceptable” and “medically reasonable” are interchangeable. Consequently, the special master could not have increased petitioner’s burden of proof by using the term “medically reasonable.” Even if the court determined that “medically acceptable” and “medically reasonable” are legally distinct concepts, it would find no error in the special master’s analysis of the third prong of the Althen test. As respondent notes, the special master accurately described petitioner’s burden to demonstrate a medically acceptable onset period and the special master’s analysis of the evidence regarding the timing issue reflects a proper understanding of that burden. Moreover, the special master clearly indicated that his holding was that petitioner had not shown, by a preponderance of evidence, that a forty-one-day onset period was medically acceptable. See Greene, 2019 WL 4072110, at *21 (“Even if I had found that a forty-one-day timeframe for onset of brachial neuritis was medically acceptable, the record in this case fails to support the conclusion that the tetanus vaccine is the most likely explanation for Mr. Greene’s injury.”), *22 (“But after considering the expert witnesses and evidence upon which they relied, it is my reasoned conclusion that Petitioner has failed—despite abundant opportunity—to preponderantly substantiate his contention that a forty-one-day onset period for his brachial neuritis was medically acceptable . . . .”). Because the court rejects petitioner’s factual and legal objections relating to the third prong of the Althen test, it does not disturb the special master’s conclusion that petitioner failed to establish the third prong by a preponderance of the evidence. The failure to prove one prong of the Althen test is fatal to petitioner’s attempt to prove that the Td vaccine caused his brachial neuritis. Accordingly, the court need not address petitioner’s contention that the special master improperly raised his burden of proving the second prong of the Althen test.10 9 Another of petitioner’s experts, Dr. Steinman, concluded that a forty-two-day risk interval is “acceptable,” “entirely appropriate,” and “standard for the timing on immunization induced brachial neuritis.” Pet’r’s Ex. 68. 10 However, the court makes two observations. First, the special master’s statement that “the record in this case fails to support the conclusion that the tetanus vaccine is the most likely explanation for Mr. Greene’s injury,” Greene, 2019 WL 4072110, at *21, is not necessarily incompatible with the applicable legal standard of demonstrating that, more likely than not, the vaccine did cause the injury. See Moberly, 592 F.3d at 1322 n.2 (“The burden of showing something by a ‘preponderance of the evidence,’ . . . simply requires the trier of fact to believe that the existence of a fact is more probable than its nonexistence . . . .” (quoting Concrete Pipe & Prods. of Cal., Inc., 508 U.S. at 622)); Pafford, 451 F.3d at 1356 (remarking that under the second prong of the Althen test, a petitioner must show “that the vaccine was the ‘but for’ cause of the harm” or, in other words, “‘that the vaccine actually caused the alleged symptoms in [the] particular case’” (quoting the decision of the special master as recited by the trial court)). Furthermore, the special master accurately described petitioner’s burden of proof and remarked -13- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 14 of 15 III. CONCLUSION Although the court likely would have reached a different conclusion on the merits of petitioner’s claim that the Td vaccine caused his brachial neuritis,11 it is constrained by binding Federal Circuit precedent dictating that it is not to reweigh the evidence when the special in his concluding paragraph that petitioner “failed . . . to preponderantly substantiate his contention . . . that the tetanus vaccine more likely than not ‘did cause’ his subsequent injury.” Greene, 2019 WL 4072110, at *22. Second, petitioner’s counsel contended during oral argument that the special master’s discussion and conclusions regarding the second prong of the Althen test were unexpected because he had previously found the existence of a “logical cause-and-effect relationship between Mr. Greene’s receipt of the vaccine and development of brachial neuritis” and that the focus of the special master and the parties leading up to the postremand fact hearing was on Althen prong three. Reliance on the special master’s prior holding is problematic for two reasons. First, the special master’s statement was dicta included in a footnote. See Greene v. Sec’y of HHS, No. 11-631V, slip p. at 12 n.5 (Fed. Cl. Spec. Mstr. May 26, 2017) (“Because I have found that Petitioner’s claim did not satisfy one of the three Althen prongs, I include no further discussion of the remaining two prongs. However, I do find that the first, “can cause” prong was met, given the ample prior decisions associating the Td vaccine with brachial neuritis, as well as the showing made in this case by Petitioner’s experts. I also note that (with respect to the second Althen prong) there is a logical cause-and-effect relationship between Mr. Greene’s receipt of the vaccine and development of brachial neuritis––although that showing is undercut by Petitioner’s inability to explain the reasonableness of the temporal interval at issue. Accordingly, this prong is not met.” (emphasis added) (citations omitted)); see also Co-Steel Raritan, Inc. v. Int’l Trade Comm’n, 357 F.3d 1294, 1307 (Fed. Cir. 2004) (explaining that dicta are “statements made by a court that are ‘unnecessary to the decision in the case, and therefore not precedential (though [they] may be considered persuasive)’” (alteration in original) (quoting Obiter dictum, Black’s Law Dictionary 1100 (7th ed. 1999))). Second, as petitioner’s counsel acknowledged, the special master withdrew the May 26, 2017 decision that included the statement at issue, rendering it void for all purposes. See Vaccine Rule 10(e)(3)(A). Furthermore, even though respondent’s counsel did not dispute petitioner’s counsel’s observation that the focus of the postremand proceedings before the special master was Althen prong three, counsel for both parties represented that there is nothing in the record indicating that petitioner would not be required to satisfy Althen prong two upon the withdrawal of the May 26, 2017 decision. Consequently, petitioner’s hearing counsel’s failure to focus on all three prongs of the Althen test cannot be attributed to any fault of the special master. 11 The court is unaware of any decision in which a special master awarded compensation to a petitioner alleging that his or her brachial neuritis was caused by a tetanus-containing vaccination administered more than twenty-eight days earlier. However, the lack of such a decision is not dispositive. See Boatmon, 941 F.3d at 1358 (holding that special masters are not bound by the decisions of other special masters and, “[b]y extension, are not required to distinguish non-binding decisions of other special masters.”). -14- Case 1:11-vv-00631-MMS Document 157 Filed 02/12/20 Page 15 of 15 master’s fact findings are based on evidence that is not “wholly implausible.” Thus, for the reasons stated above, the court DENIES petitioner’s motion for review and SUSTAINS the decision of the special master. The clerk is directed to enter judgment accordingly. In addition, pursuant to Vaccine Rule 18(b), the parties shall review this decision and submit any proposed redactions, by providing the court with redlined pages showing the redactions, by no later than Tuesday, February 11, 2020. IT IS SO ORDERED. s/ Margaret M. Sweeney MARGARET M. SWEENEY Chief Judge -15-