No. 07-465V | Fed. Cl. | Oct 26, 2009
OPINION AND ORDER
Petitioner, Frances Campbell, seeks review of a decision by a special master dated July 7, 2009, denying her compensation under the National Childhood Vaccine Injury Act of 1986, Pub.L. No. 99-660, § 311, 100 Stat. 3743, 3755 (1986) (codified, as amended, at 42 U.S.C. §§ 300aa-l to -34) (“Vaccine Act”). Ms. Campbell alleges that her injection with a trivalent influenza vaccine in 2003 caused the onset of her rheumatoid arthritis. See Campbell v. Secretary of Health & Human Servs., No. 07-465, 2009 WL 2252550, at *1 (Fed.Cl. July 7, 2009) (“Entitlement Decision”).
This is a so-called off-Table vaccine injury case in which the claimant must establish causation in fact.
FACTS
Frances Campbell was born in August of 1957. Entitlement Decision at *1. At the time she received the influenza vaccine on December 4, 2003, Ms. Campbell had several pre-existing medical conditions. Orthopedi-eally, Ms. Campbell had (i) clinical and radio-graphic osteoarthritis in her cervical and lumbar spine,
On December 4, 2003, Ms. Campbell saw her primary care doctor, Dr. Thad Jackson. Entitlement Decision at *1. Ms. Campbell reported pain in both of her shoulders, hip, and upper and lower back, and severely restricted use of her left shoulder. Id.; R. Ex. 1 at 100024-25. Dr. Jackson noted that Ms. Campbell appeared depressed because her pain and loss of mobility prevented her from participating in activities she once enjoyed, such as hunting and fishing. Entitlement Decision at *1; R. Ex. 1 at 100024-25. Dr. Jackson recommended psychological counseling, which Ms. Campbell did not pursue, and water therapy. Entitlement Decision at *1. Ms. Campbell received the trivalent influenza and pneumonococcal vaccines during this visit. Id
On December 8, 2003, Ms. Campbell returned to Dr. Jackson’s office. Entitlement Decision at *2. Ms. Campbell reported that “she was in her usual state of health until Sunday,” December 7, 2003, when she was bumped by three teenagers while leaving church. Entitlement Decision at *2; R. Ex. 2 at 200100; Tr. at 117:5-8 (Brawer), 240:1-9 (Lightfoot). Dr. Jackson made a note in Ms. Campbell’s medical records that this incident “was quite painful for her as she has had a history of chronic left upper shoulder pain.” R. Ex. 2 at 200100. Ms. Campbell reported
While admitted to Mercy, Ms. Campbell underwent orthopedic testing and evaluation. See Entitlement Decision at *2. Ms. Campbell had an MRI scan of her brain, which was normal, and one of her cervical spine, which showed some disc bulging at the C4-5 and C5-6 disc spaces. Id. X-rays of her lumbar spine showed some narrowing of disc space. Id. An orthopedist, Dr. Darius Divina, examined Ms. Campbell on December 9, 2003, and noted that her “left and right shoulders seem[ed] somewhat swollen and slightly warm to touch.” R. Ex. 2 at 200110. Dr. Divina was unable to determine the cause of Ms. Campbell’s pain, see Entitlement Decision at *2; however, Dr. Divina noted two conditions to “rule out,” (i) “acute inflammatory response to vaccine” and (ii) “septic bursitis.” R. Ex. 2 at 200109.
Also during her stay at Mercy, Ms. Campbell underwent ANA and rheumatoid factor testing, the results of which were a positive ANA test and a rheumatoid factor of 20. Entitlement Decision at *2; R. Ex. 2 at 200092-94.
According to Ms. Campbell, she continued to experience pain and swelling in her upper extremities after having been discharged from the hospital, and on December 12, 2003, Ms. Campbell visited the emergency room at Mercy, reporting pain in her extremities, including her left foot. Entitlement Decision at *2. The emergency room doctor who examined Ms. Campbell had the impression that her pain was due to inflammatory arthritis. Id. Neither the doctor’s report nor his examination notes mention whether Ms. Campbell had swelling in her joints at the time of her emergency room visit. Id. The emergency room doctor prescribed Dilaudid for Ms. Campbell’s pain and arranged a wheelchair for her. Id.; R. Ex. 2 at 200152. Ms. Campbell was not admitted to the hospital on December 12, 2003. Entitlement Decision at *2.
Ms. Campbell returned to Dr. Jackson, her primary care doctor, about one week later, on December 19, 2003. Entitlement Decision at *2; R. Ex. 1 at 100023. Ms. Campbell “reported that she had developed weakness in her legs such that she could stand for only ten seconds [at a time] and could not walk.” Entitlement Decision at *2. With regard to her upper extremities, Ms. Campbell reported that her “joint symptoms, particularly [in] the upper extremities, [were] 100% better.” Id. Dr. Jackson noted that Ms. Campbell had “some joint tenderness,” but did not note any joint swelling. Id. Dr. Jackson’s impressions from his examination of Ms. Campbell on December 19, 2003, as quoted in the Entitlement Decision, were as follows:
1. [A] constellation of symptoms involving polyarticular- arthralgias, myalgias, and new onset of lower extremity weakness in which she is able to stand in the office for only about [ten] seconds be*375 fore her legs get weak to the point that she has to sit down.
2. Positive RA and ANA profiles, which may represent new rheumatologic[al] disease versus possible reactivity due to her previous influenza vaccine.
Id. at *3.
During her stay at Munson, Ms. Campbell underwent neurological and rheumatological testing. Entitlement Decision at *3. Neuro-muscular testing revealed no polyneuropathy, myopathy, or any other major defect or neu-romuscular junction disorder. See R. Ex. 8 at 8-15.
1. Post vaccination reactive arthritis, question myalgias weakness in a woman with positive seriologies, ANA, [and] rheumatoid factor ...13
a. I think the differential diagnosis includes in descending order of probability immunization related autoimmune phenomenon which will probably be transient, possibility of long-lasting symptomatology is there and while it is not well reported in literature I have seen several eases of onset of lupus more often than onset of rheumatoid arthritis after immunization.
Entitlement Decision at *3 (quoting R. Ex. 3 at 300026). Dr. Gilhooly recommended “watchful waiting,” which included, among other things, repeat testing of Ms. Campbell’s rheumatic serologies. Id.
Ms. Campbell was also evaluated by Dr. Richard D. Ball during her hospital admission on December 19, 2003. Entitlement Decision at *3.
On December 24, 2003, Ms. Campbell returned to Dr. Jackson’s office, at which time he reviewed some of the laboratory work from her hospitalization on December 19, 2003 and examined her extremities. Entitlement Decision at *4. Dr. Jackson’s examination revealed “[n]o active tenosynovitis [(sy-novitus involving a tendon)] [or] edema [(‘presence of abnormally large amounts of fluid in the intercellular tissue spaces of the body’)].” Id.; Borland’s at 600, 1905. Dr. Jackson’s impression at that time was that Ms. Campbell had “inflammatory arthritis, etiology indeterminate.” Entitlement Decision at * 4.
On January 13, 2004, Ms. Campbell had a further appointment with Dr. Gilhooly, the purpose of which was described by Dr. Gil-hooly as “follow-up regarding question post-vaccination immune phenomenon versus triggering of primary autoimmune phenomenon such as lupus, Sjogren’s [syndrome], or rheumatoid.” Entitlement Decision at *4; R. Ex. 3 at 300048. Ms. Campbell reported she had “[n]o swelling, [but] some warmth [and] stiffness in the morning [for] a half hour.” Id. Dr. Gilhooly noted that the physical examination showed “passive range of motion about the joints, slight tenderness at the extremes of right wist extension [and] left elbow extension.” Id. Dr. Gilhooly did not note any swelling. Id. Dr. Gilhooly’s impressions at this time were “[q]uestion autoimmune disease, undifferentiated ... Keep in mind Sjogren’s, lupus versus immune phenomenon simply triggered by the immunization that will gradually resolve.” Id.
Ms. Campbell saw Dr. Gilhooly again in February 2004. Entitlement Decision at *4. Ms. Campbell reported that she continued to have bilateral pain and stiffness at her meta-carpophalangeal, metatarsophalangeal, and proximal interphalangeal joints and “[v]aria-ble morning stiffness” that worsens as the day goes on. Id. These joints are located in the hands, feet, and fingers and toes, respectively. Id. at *4 n. 1 (citation omitted). Ms. Campbell reported that her symptoms became “[w]orse with weight bearing and gripping activities.” Id. at *4. Again, Ms. Campbell did not report any swelling. Id. Dr. Gilhooly’s physical examination of Ms. Campbell showed “[t]enderness to palpation of the [metacarpophalangeal, metatarsophalangeal, and proximal interphalangeal joints] as well as to squeeze but no active synovitus.” Id. Dr. Gilhooly’s impression of Ms. Campbell’s condition as of the date of this visit was “[q]uestion inflammatory arthritis; question forme fruste of lupus triggered by immunization.” Id.
Ms. Campbell was examined by Dr. Jackson on March 11, 2004. Entitlement Decision at *4. The physical examination showed “[n]o edema.” Id. At that time, Dr. Jackson noted that Ms. Campbell “had difficulty with an inflammatory arthritis after she received a flu vaccine.” R. Ex. 1 at 100020. His impressions were “[generalized arthralgias and myalgias with working diagnosis of post-inflammatory arthritis status post flu injection.” Entitlement Decision at *4. Dr. Jackson also included an adverse reaction to the influenza vaccine in Ms. Campbell’s allergy list. R. Ex. 1 at 100015.
Ms. Campbell was seen by Dr. Gilhooly on April 23, 2004. Entitlement Decision at *4. Dr. Gilhooly’s typed office notes from this visit state that the purpose of the visit was to “follow up for undifferentiated connective tissue disease, ANA positive, rheumatoid factor negative, and hypergammaglobulinemia.” Id.
Ms. Campbell’s next appointment with Dr. Gilhooly was on September 21, 2004 for a follow up for “PA” (psoriatic arthritis) and “FM” (fibromyalgia). Entitlement Decision at *5; see also id. (citing Neil M. Davis, Medical Abbreviations 148 (12th ed.2005)).
After Dr. Gilhooly’s death, Ms. Campbell began to visit the Harbor Arthritis Center for treatment. Entitlement Decision at *5. Ms. Campbell saw Jane Denay, a Certified Family Nurse Practitioner, on January 13, 2005. Id.; see id. at n. 2. Ms. Denay reported “no evidence of an inflammatory arthropa-thy[,] ... [and] suggested that Ms. Campbell might have fibromyalgia.” Id. (internal quotation marks omitted).
Ms. Campbell moved to Reno, Nevada, at which time she began to see Dr. Teresa Bachman, a rheumatologist referred to her by Ms. Denay. See R. Ex. 4 at 400005-07. Ms. Campbell was eventually diagnosed with rheumatoid arthritis, a diagnosis the accuracy of which neither party disputes. Entitlement Decision at * 1.
Ms. Campbell filed a petition for vaccine injury compensation on June 28, 2007 and an amended petition on August 31, 2007. Entitlement Decision at *5. By agreement of the parties, hearings were held on October 21, 2008, in New York, New York and on January 15, 2009, in Washington, D.C., “limited to determining whether Ms. Campbell suffered an adverse reaction to the flu vaccine.” Id. at *6. During the hearing, Ms. Campbell’s expert, Dr. Brawer, offered six separate theories that could explain how receipt of influenza vaccine could cause onset of rheumatoid arthritis. Tr. 17:17 to 30:25, 38:7 to 55:23 (Brawer). Nonetheless, Dr. Brawer focused on the “primary theory,” Tr. 26:19 (Brawer), that “antigens of infectious agents can cross-react with self-antigens present on immunocompetent cells, thereby triggering inflammatory systemic connective tissue diseases such as Rheumatoid Arthritis.” R. Ex. 11 at 11-1. Dr. Brawer drew support for this theory from case reports of patients developing rheumatoid arthritis after receiving a vaccination. See Entitlement Decision at *10 (citing R. Exs. 23, 24, 25, 27, 32, 33).
The special master rejected Dr. Brawer’s medical explanation, finding that Dr. Brawer did not explain very well his theories “for how the influenza vaccine could cause rheumatoid arthritis” or “plae[e] them into the context of Ms. Campbell’s case.” Entitlement Decision at *9. The special master opined that the “medical theory[, even if established as reliable,] must focus on the specific vaccine and the specific injury at issue.” Id. Applying this principle, the special master concluded that Dr. Brawer’s failure to “show[ ] some similarity in molecular structure between a portion of the vaccine and a portion of a relevant body part ... lessens the reliability of his opinion that molecular mimicry explains the connection between the influenza vaccine and rheumatoid arthritis.” Id. at *10. The special master also gave little or no consideration to the ease reports submitted by Ms. Campbell of patients who developed rheumatoid arthritis after having received a vaccination. See id. at **10-11. Based on the testimony of respondent’s expert, Dr. Lightfoot, that purely by chance “184 people [per] day ... are getting rheumatoid arthritis and [influenza] vaccines,” Tr. 426:19-21 (Lightfoot), the special master concluded that “[the case reports] presented] a chronological picture only.” Entitlement Decision at *11.
The special master also discounted Dr. Brawer’s opinion that Ms. Campbell’s rheumatoid arthritis began within two to fourteen days of receiving the influenza vaccine. Entitlement Decision at * 11. Specifically, the special master found that “Ms. Campbell was not experiencing swelling in her joints — the hallmark of rheumatoid arthritis — within [two to fourteen days]” of receiving the vaccination. Id. at *13. “One simple reason” that the special master gave in support of his finding was “that Dr. Lightfoot did not agree with Dr. Brawer” and “Dr. Lightfoot’s opinion [was] more persuasive.” Id. at *11. Notwithstanding Dr. Jackson’s diagnosis on December 10, 2003 of “[a]eute bilateral upper extremity inflammatory arthritis,” the special master afforded it only “some consideration.” Id. at *12. In the special master’s view, a series of factors “raise[d] questions about the accuracy of Dr. Jackson’s December 10, 2003 diagnosis,” viz., (i) “Dr. Jackson anticipated that a consultation with a rheumatologist might be necessary to provide a more complete diagnosis;” (ii) “Dr. Jackson did not provide a basis for his conclusion that Ms. Campbell suffered from inflammatory arthritis;” (iii) “the report suggests that Ms. Campbell had swelling throughout her upper arms, not just in [her] joints” and “[t]his type of swelling is not consistent with the usual presentation of rheumatoid arthritis;” and (iv) “Dr. Jackson may have also considered that Ms. Campbell’s test for ANA was positive ... [and] a positive ANA [test] is not diagnostic for rheumatoid arthritis.” Id.
Overall, the special master rejected “the statements of Ms. Campbell’s treating physicians” as proof of causation because they were “not clear statements that the flu vaccine caused [her] to develop rheumatoid arthritis.” Entitlement Decision at *14 (emphasis added). The special master found that “[Dr. Gilhooly’s] records [were] ambiguous in that they mention the flu vaccine and the pneumonococcal vaccine” with respect to a possible adverse reaction, and “the statements of Ms. Campbell’s treating doctors ... sometimes did not say that the vaccination ‘caused’ a problem,” but instead they merely “presented a chronology.” Id. The special master recognized that Dr. Jackson’s report of November 12, 2004, which stated that Ms. Campbell was “positive for severe adverse reaction to influenza vaccine last year requiring hospitalization,” “more clearly supported] a finding of entitlement,” but the
STANDARDS FOR REVIEW
Under the Vaccine Act, when reviewing a decision of a special master on a motion for review, the court has jurisdiction to “undertake a review of the record of the proceedings” and may take any of the following actions:
(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 conclusions 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); see also RCFC, App. B, Rule 27.
In adopting the Vaccine Act, Congress sought to “establish a[f]ederal ‘no-fault’ compensation program under which awards can be made to vaccine-injured persons quickly, easily, and with certainty and generosity.” H.R.Rep. No. 99-908, at 3 (2d Sess.1986), reprinted in 1986 U.S.C.C.A.N. 6334, 6334. To pursue its goals of a generous remedial program, Congress established a Vaccine Injury Table.
However, if a petitioner is unable to bring a claim that falls within the scope of the Table,
In Althen, the Federal Circuit clarified that to prove causation in fact, a petitioner must show, by preponderant evidence, the following:
(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 1274" court="Fed. Cir." date_filed="2005-07-29" href="https://app.midpage.ai/document/althen-v-secretary-of-health-and-human-services-211771?utm_source=webapp" opinion_id="211771">418 F.3d at 1278.
The preponderance of the evidence standard does not require “scientific certainty.” Bunting v. Secretary of Health & Human Servs., 931 F.2d 867" court="Fed. Cir." date_filed="1991-06-20" href="https://app.midpage.ai/document/gary-g-bunting-as-father-and-next-friend-of-bradley-bunting-a-minor-v-secretary-of-the-department-of-health-and-human-services-560003?utm_source=webapp" opinion_id="560003">931 F.2d 867, 873 (Fed.Cir.1991). “[D]etermination 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 ex rel. Knudsen v. Secretary of Health & Human Servs., 35 F.3d 543" court="Fed. Cir." date_filed="1994-09-09" href="https://app.midpage.ai/document/debra-ann-knudsen-by-her-parents-and-legal-guardians-doris-p-knudsen-and-dale-knudsen-v-secretary-of-the-department-of-health-and-human-services-677925?utm_source=webapp" opinion_id="677925">35 F.3d 543, 548-49 (Fed.Cir.1994) (citations omitted). “[A]scertaining precisely how and why ... vaccines sometimes destroy the health and lives of certain [individuals] while safely immunizing most others ... is for scientists, engineers, and doctors working in hospitals, laboratories, medical institutes, pharmaceutical companies, and government agencies.” Id. at 549. The absence of “a link between a vaccine and a particular injury,” or “that the state of medical knowledge regarding a causal link ... can be characterized as ‘controversial,’ ” “will not bar recovery, because ‘the purpose of the Vaccine Act’s preponderance standard is to allow the finding of causation in a field bereft of complete and direct proof of how vaccines affect the human body.” Rotoli, 89 Fed.Cl. at 79-80 (quoting Althen, 418 F.3d 1274" court="Fed. Cir." date_filed="2005-07-29" href="https://app.midpage.ai/document/althen-v-secretary-of-health-and-human-services-211771?utm_source=webapp" opinion_id="211771">418 F.3d at 1280); id. at 80 n. 7. Thus, a finding of causation in fact in vaccine cases can be “based on epidemiologi
“[Pursuant to 42 U.S.C. § 300aa-13(a)(1), a finding of preponderant evidence of causation[ ] in[ ] fact must be substantiated by medical records or by medical opinion.” Rotoli, 89 Fed.Cl. at 79-80 (citing Althen, 418 F.3d 1274" court="Fed. Cir." date_filed="2005-07-29" href="https://app.midpage.ai/document/althen-v-secretary-of-health-and-human-services-211771?utm_source=webapp" opinion_id="211771">418 F.3d at 1279). A finding of preponderant evidence of causation in fact “may be based on a reliable medical opinion alone,” id. (citing Althen, 418 F.3d 1274" court="Fed. Cir." date_filed="2005-07-29" href="https://app.midpage.ai/document/althen-v-secretary-of-health-and-human-services-211771?utm_source=webapp" opinion_id="211771">418 F.3d at 1280), but where medical literature or epidemiological 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.’ ” Id. at 80 n. 9 (quoting Andreu, 569 F.3d 1367" court="Fed. Cir." date_filed="2009-06-18" href="https://app.midpage.ai/document/andreu-ex-rel-andreu-v-secretary-of-health-and-human-services-208532?utm_source=webapp" opinion_id="208532">569 F.3d at 1379-80, and citing Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579" court="SCOTUS" date_filed="1993-06-28" href="https://app.midpage.ai/document/daubert-v-merrell-dow-pharmaceuticals-inc-112903?utm_source=webapp" opinion_id="112903">509 U.S. 579, 593-97, 113 S. Ct. 2786" court="SCOTUS" date_filed="1993-06-28" href="https://app.midpage.ai/document/daubert-v-merrell-dow-pharmaceuticals-inc-112903?utm_source=webapp" opinion_id="112903">113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) for the proposition that “one factor for assessing the reliability of expert testimony is whether the theory espoused enjoys general acceptance within a relevant scientific community”).
ANALYSIS
One of the confounding aspects of this case is that it involves a diagnosis of rheumatoid arthritis, which frequently is classified as an autoimmune disease, whereas other forms of arthritis are not considered autoimmune diseases. See supra, at 373 n. 4.
A Rheumatoid Arthritis
In very broad terms, rheumatoid arthritis is “a chronic systemic disease primarily of the joints, usually polyarticular [ (‘affecting many joints’) ], marked by inflammatory changes in the synovial membranes and articular structures and by muscle atrophy and rarefaction [ (‘diminution in density and weight’)] of the bones. In late stages deformity and ankylosis [ (‘immobility and consolidation of a joint’) ] develop. The cause is unknown, but autoimmune mechanisms and virus infection have been postulated.” Dorland’s at 94, 152, 159, 1509, 1617. The parties’ experts appeared to be in general agreement with the following seven criteria for the classification of rheumatoid arthritis as developed by the American College of Rheuma-tology (formerly the American Rheumatology Association): (1) “[m]orning stiffness in and around the joints, lasting at least [one] hour before maximal improvement;” (2) “[a]t least [three] joint areas simultaneously have had soft tissue swelling or fluid;” (3) at least one of the swollen joint areas is in a wrist or hand; (4) symmetry of the arthritis; (5) “rheumatoid nodules;”
Arthritis literally means joint inflammation, Dorland’s at 152, and encompasses over 100 different recognized conditions, many of which, such as osteoarthritis and gout, do not implicate an autoimmune cause. See, e.g., supra, at 3 n. 4. Of relevance to this case, acute arthritis is “marked by pain, heat, redness, and swelling, due to inflammation, infection, or trauma,” Dorland’s at 152, and reactive arthritis is “arthritis after an infection.” Id. Both of these conditions may well be transient. See, e.g., supra, at 6 (quoting Dr. Gilhooly’s initial impressions of Ms. Campbell’s condition).
The parties’ experts agreed that Ms. Campbell had rheumatoid arthritis at the time of the hearing and that the medical records submitted to the special master as exhibits accurately described her condition. Entitlement Decision at * 1. The parties’ experts disagreed, however, as to what caused the onset of Ms. Campbell’s rheumatoid arthritis and when it occurred. Id. Petitioner’s expert, Dr. Brawer, stated that “the vaccine directly initiated the onset of [Ms. Campbell’s] rheumatoid arthritis,” Tr. at 57:9-10 (Brawer), which Dr. Brawer believed “began on December 6, 2003.” Tr. at 118:2 (Brawer). Respondent’s expert, Dr. Light-foot, disagreed, opining that “only live or attenuated live vaccines[, which the influenza vaccine is not,] are capable of causing chronic arthritis,” Tr. 367:10-19 (Lightfoot), and that it is impossible to determine when the onset of Ms. Campbell’s rheumatoid arthritis occurred. Tr. 242:1-4 (Lightfoot).
B. The Special Master’s Credibility Determination
Both Dr. Brawer and Dr. Lightfoot were experienced rheumatolologists who endeavored to help the special master analyze the various diagnoses provided by Ms. Campbell’s treating physicians and to explain the different forms of arthritis. Dr. Brawer graduated from Boston University’s School of Medicine. After completing an internship and a residency, Dr. Brawer spent two years completing an arthritis fellowship at Boston University Medical Center. He went into private practice in 1976 and has seen approximately 15,000 new patients in that capacity and through a free arthritis clinic of which Dr. Brawer is the director. Tr. 9:3-24,14:16 to 15:8 (Brawer). Dr. Brawer has been board certified in internal medicine and rheumatology since 1975 and 1976, respectively. Tr. 9:25 to 10:6 (Brawer). Dr. Brawer’s academic and other professional appointments include the following: (1) Associate Clinical Professor of Medicine at Hahnemann University Hospital, Drexel University; (2) Assisting Clinical Professor of Medicine at Robert Wood Johnson Medical School; (3) Director of Rheumatology at Monmouth Medical Center; (4) Former Vice President and Former President of the New Jersey Rheumatology Association; and (5) fellow of the American College of Rheumatology. Tr. 10:10 to 11:3 (Brawer). Dr. Brawer has also authored and co-authored some 16 publications and one book on various topics related to rheumatology. Tr. 11:6-17 (Brawer). Correspondingly, Dr. Lightfoot graduated from Vanderbilt’s Medical School. After completing an internship, Dr. Lightfoot also spent two years completing rheumatology training, at Columbia Presbyterian Medical Center. Tr. 220:13-22 (Lightfoot). He then served two years in the military, returning to take an academic position first on the faculty at Columbia University and subsequently on the faculty at Cornell University Medical Center. Tr. 220:21 to 221:2 (Lightfoot). Thereafter, he shifted to the University of Wisconsin’s Medical College in Milwaukee and then to the University of Kentucky. Tr. 221:3-9 (Lightfoot). Dr. Lightfoot has authored chapters in textbooks on immunopa-
In this case, the special master based his decision to deny Ms. Campbell compensation in substantial part on his finding that Dr. Lightfoot was more credible than Dr. Brawer. See Entitlement Decision at *7. Because there was no genuine issue with regard to Dr. Brawer’s candor or truthfulness, the special master ran afoul of the Federal Circuit’s standards regarding the use of credibility determinations. In Andreu, the Federal Circuit held that “[w]hile considerable deference must be accorded to the credibility determinations of special masters, this does not mean that a special master can cloak the application of an erroneous legal standard in the guise of a credibility determination, and thereby shield it from appellate review.” Andreu, 569 F.3d 1367" court="Fed. Cir." date_filed="2009-06-18" href="https://app.midpage.ai/document/andreu-ex-rel-andreu-v-secretary-of-health-and-human-services-208532?utm_source=webapp" opinion_id="208532">569 F.3d at 1379 (citation omitted). The Federal Circuit clarified that “[a] trial court makes a credibility determination in order to assess the candor of a fact witness, not to evaluate whether an expert witness’ medical theory is supported by the weight of the epidemiological evidence.” Id. As in Andreu and Rotoli, the special master in this ease “cloak[ed]” his rejection of Ms. Campbell’s theory of causation in a credibility determination regarding Ms. Campbell’s expert witness, Dr. Brawer. See Rotoli, 89 Fed.Cl. at 80-81 (citing Andreu, 569 F.3d 1367" court="Fed. Cir." date_filed="2009-06-18" href="https://app.midpage.ai/document/andreu-ex-rel-andreu-v-secretary-of-health-and-human-services-208532?utm_source=webapp" opinion_id="208532">569 F.3d at 1379). Just as in Rotoli, petitioner’s expert in this case, Dr. Brawer, was “a highly qualified expert witness whose extensive credentials [were] not in dispute.” Id.
“[W]here a highly qualified expert such as [Dr. Brawer] presents a biologically plausible theory of causation in a vaccine case, the issue is not one of credibility.” Rotoli, 89 Fed.Cl. at 80-81 (citing Andreu, 569 F.3d 1367" court="Fed. Cir." date_filed="2009-06-18" href="https://app.midpage.ai/document/andreu-ex-rel-andreu-v-secretary-of-health-and-human-services-208532?utm_source=webapp" opinion_id="208532">569 F.3d at 1379). Yet, the special master’s evaluation of Dr. Brawer’s credibility permeated his analysis of Ms. Campbell’s claim for compensation. Prior to analyzing whether Ms. Campbell established causation in fact, the special master provided a “general evaluation of the experts.” Entitlement Decision at *7-8; see also Rotoli, 89 Fed. Cl. 71" court="Fed. Cl." date_filed="2009-09-02" href="https://app.midpage.ai/document/rotoli-v-secretary-of-health--human-services-6659520?utm_source=webapp" opinion_id="6659520">89 Fed.Cl. at 81-82 (criticizing this same approach). The special master concluded that Dr. Lightfoot was more “persuasive” than Dr. Brawer based on the following factors: (i) Dr. Light-foot had “more experience in rheumatology” than Dr. Brawer as well as a “sterling” reputation; (ii) Dr. Lightfoot’s demeanor conveyed that he was receptive to the court’s inquires and “want[ed] to impart knowledge,” whereas Dr. Brawer’s demeanor was more like that of an “advocate;” (iii) Dr. Lightfoot, as compared to Dr. Brawer, has “participated in litigation[ ] relatively rarely” and “does not derive a significant portion of his income from working as an expert witness;” and (iv) Dr. Brawer’s expert opinions have not withstood Daubert challenges on at least two occasions. Entitlement Decision at *7-8. At the conclusion of this evaluation, the special master stated that “[the factors that contributed] to the finding that Dr. Lightfoot was more persuasive than Dr. Brawer ... underlie the analysis of the three factors from Althen [that follows].” Id. at *8.
Thereafter, the special master’s “evaluation of the experts” informed his analysis of whether Ms. Campbell met her burden of proof under Althen. Specifically, the special master cited Dr. Brawer’s credibility as a primary reason to find Ms. Campbell had not established “a proximate temporal relationship between vaccination and injury” under the third prong of Althen. Entitlement Decision at *11 (internal quotation marks omitted). And, by couching his rejection of Ms. Campbell’s claim in terms of credibility, the special master expected his analysis of whether Ms. Campbell had established causation in fact to be “virtually not reviewable on appeal.” Id. at *7 (“A decision about the persuasiveness of a witness is virtually not reviewable on appeal”) (citing Bradley v. Sec
Despite the special master’s attempt to insulate his decision from review by the incantation of magic words, the court finds that he erroneously relied on an assessment of Dr. Brawer’s credibility as a basis for rejecting Dr. Brawer’s testimony and concluding that Ms. Campbell had not met her burden to establish causation in fact. As stated supra, an evaluation of the credibility of an expert witness should be reserved for “assess[ing] the candor of a fact witness” and Dr. Brawer’s candor is not in dispute. Andrew, 569 F.3d 1367" court="Fed. Cir." date_filed="2009-06-18" href="https://app.midpage.ai/document/andreu-ex-rel-andreu-v-secretary-of-health-and-human-services-208532?utm_source=webapp" opinion_id="208532">569 F.3d at 1379. Further, the special master’s error has tainted his entire analysis of whether Ms. Campbell established causation in fact. Not only did the special master expressly base his finding that Ms. Campbell did not establish a proximate temporal relationship primarily on his evaluation of Dr. Brawer’s credibility, see Entitlement Decision at *11, but, by the special master’s own averment, his evaluation of the experts pervaded his analysis of the remaining factors under Althen. See id. at *8. In accord with Andreu and 42 U.S.C. § 300aa-12(e)(2)(B), the court finds that the special master improperly framed his rejection of Ms. Campbell’s claim “under the rubric of a ‘credibility’ determination,” and thereby sets aside the special master’s findings as legal error. An-dreu, 569 F.3d 1367" court="Fed. Cir." date_filed="2009-06-18" href="https://app.midpage.ai/document/andreu-ex-rel-andreu-v-secretary-of-health-and-human-services-208532?utm_source=webapp" opinion_id="208532">569 F.3d at 1379 (citation omitted); Rotoli, 89 Fed. Cl. 71" court="Fed. Cl." date_filed="2009-09-02" href="https://app.midpage.ai/document/rotoli-v-secretary-of-health--human-services-6659520?utm_source=webapp" opinion_id="6659520">89 Fed.Cl. at 81-82.
C. Petitioner’s Medical Theory
Dr. Brawer’s primary theory — that the molecular structure of a part or parts of the trivalent influenza vaccine resembled the structure of Ms. Campbell’s synovial tissue or fluid because of her genomic makeup and engendered an autoimmune response
However, the special master also criticized Dr. Brawer for not connecting the medical theory more specifically with the administration of the vaccine and the injury. See Entitlement Decision at *9. Dr. Brawer acknowledged that the theory as applied to Ms. Campbell’s circumstances had not been proven or disproven. Id. at *19. After having provided a detailed explanation of the theory, see Tr. 135:8 to 137:1 (Brawer), Dr. Brawer suggested that “the crux of it probably lies with your genetic makeup.” Tr. 137:5-6 (Brawer).
Now in reactive arthritis in certain situations you can find sequences of bacteria like e.coli in the joint itself, okay. In other words, you can find evidence of the exact infection in an intestinal tract now deposited in the joint[s] themselves. In occasional cases that’s been described.
And in the rheumatoid synovium to make things even more complicated, it’s been shown that the B cells, the antibody-producing cells in that, that rheumatoid panus, that sponge there, actually if you look for certain antibodies, you can actually find some that are directed toward viruses.
But the general — I think that those studies are unrewarding because the protein would usually not exist in the form it was administered in. The body would dismember it and present only certain pieces to the immune system.
So it probably would not survive in its entirety to be found in the joint. And I don’t think the amino acid sequences would be long enough to draw any conclusions.
Tr. 195:10 to 196:2 (Brawer).
The special master reduced this explanation to the postulate that “this lack of testability” “shows a weakness and lack of reliability of [Dr. Brawer’s] theory.” Entitlement Decision at * 10. This supporting conclusion by the special master was erroneous. As the Federal Circuit had explained in Knudsen, “to require identification and proof of specific biological mechanisms would be inconsistent with the purpose and nature of the vaccine compensation program.” 35 F.3d 543" court="Fed. Cir." date_filed="1994-09-09" href="https://app.midpage.ai/document/debra-ann-knudsen-by-her-parents-and-legal-guardians-doris-p-knudsen-and-dale-knudsen-v-secretary-of-the-department-of-health-and-human-services-677925?utm_source=webapp" opinion_id="677925">35 F.3d at 549. Instead, “causation can be found in vaccine eases based on epidemiological evidence and the clinical picture regarding the particular [vaccinated person] without detailed medical and scientific exposition on the biological mechanisms.” Id.
In fact, both epidemiological evidence and the clinical records of the treating physicians were presented on Ms. Campbell’s behalf in this case.
The special master noted that the medical articles presented by Ms. Campbell were generally case reports, “primarily asserting] that a patient developed rheumatoid arthritis after receiving a vaccination.” Entitlement Decision at *10. These case reports were discounted by the special master because they “presented] a chronological picture only” and they “cannot exclude the possibility that the disease developed coincidentally after the vaccination.” Id. at *11. These observations by the special master about the case reports have some validity but they do not indicate that the ease reports are deprived of evidentiary value in support of Ms. Campbell’s medical theory as expounded by Dr. Brawer.
At the entitlement hearings, Dr. Lightfoot viewed the case reports along the lines later adopted by the special master, see, e.g., Tr. 264:19-24, 376:15 to 378:25 (Lightfoot); see also 277:12-16 (Lightfoot) (“[Although a temporal relationship between several vaccines and the occurrence of autoimmune disease has been suggested in many case reports, there is so far no conclusive evidence for a causal link.”) (paraphrasing the conclusion of an article included in the record as R. Ex. C: Thierry Vial & Jacques Descotes, Autoimmune Diseases and Vaccinations, 14 Eur. J. Dermatol. 86 (2004)).
Respecting conclusive evidence or proof to a scientific standard, the gold standard would be a double-blind control, placebo-controlled study of drug verses placebo. See Tr. 355:10-14 (Lightfoot). That was not the standard Dr. Lightfoot employed however,
However, any suggestion of a requirement for a study meeting scientific standards of proof was rejected by courts addressing the Vaccine Act some time ago. As the Federal Circuit said in Bunting, 931 F.2d 867" court="Fed. Cir." date_filed="1991-06-20" href="https://app.midpage.ai/document/gary-g-bunting-as-father-and-next-friend-of-bradley-bunting-a-minor-v-secretary-of-the-department-of-health-and-human-services-560003?utm_source=webapp" opinion_id="560003">931 F.2d at 873, “[t]he standard of proof required by the Act is simple preponderance of evidence; not scientific certainty.” See also Andreu, 569 F.3d 1367" court="Fed. Cir." date_filed="2009-06-18" href="https://app.midpage.ai/document/andreu-ex-rel-andreu-v-secretary-of-health-and-human-services-208532?utm_source=webapp" opinion_id="208532">569 F.3d 1367, 1379-80 (Fed.Cir.2009) (‘Althen makes clear that a claimant’s theory of causation must be supported by a ‘reputable medical or scientific explanation’” (quoting Althen, 418 F.3d 1274" court="Fed. Cir." date_filed="2005-07-29" href="https://app.midpage.ai/document/althen-v-secretary-of-health-and-human-services-211771?utm_source=webapp" opinion_id="211771">418 F.3d at 1278); “[mjedical literature and epidemiological evidence must be viewed, however, not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.”).
Accordingly, to the extent that the special master reached beyond his credibility findings to draw conclusions about the validity of the principal medical theory propounded on behalf of Ms. Campbell, he proceeded on erroneous grounds. Testing and proof of specific biological mechanisms are not required in a case of this type, nor do epidemiological studies need to satisfy the requirements for scientific certainty as to causation.
D. The Treating Physicians’ Diagnoses
As addressed previously, the clinical records of Ms. Campbell’s treating physicians were presented in aid of her efforts to establish entitlement to compensation under the Vaccine Program. The special master concluded that those records failed to establish that the influenza vaccination Ms. Campbell received on December 4, 2003 caused the onset of her rheumatoid arthritis. See Entitlement Decision at * 11-15. The special master discounted the diagnoses of Ms. Campbell’s treating physicians as ambiguous and drew every inference against petitioner.
In addressing the third prong of the Althen test, i.e., whether Ms. Campbell established “a proximate temporal relationship between vaccination and injury,” the special master afforded only “some consideration” to Dr. Jackson’s diagnosis rendered on December 10,2003, within a week of Ms. Campbell’s vaccination, of “[a]cute bilateral upper extremity inflammatory arthritis.” Id. at *12 (internal quotation marks and citations omitted); see supra, at 10. Applicable precedents indicate, however, that statements made by treating physicians in vaccine cases should be afforded more than “some consideration.” Moreover, here the special master used that phrase as a prelude to rejecting Dr. Jackson’s diagnosis and those of all of the other treating physicians.
The special master discounted Dr. Jackson’s diagnosis of December 10, 2003 for reasons that included the fact that “Dr. Jackson did not prescribe any medications usually given to treat inflammatory arthritis.” Entitlement Decision at * 12. The special master also pointed to the fact that persons suffering from rheumatoid arthritis exhibit “chronic inflammation in their peripheral joints.” Entitlement Decision at *12. The special master found that “Ms. Campbell presented little persuasive evidence that she was suffering from inflammation in her joints within two weeks after vaccination.” Id. Additionally, in the special master’s view, “Dr. Jackson did not provide a basis for his conclusion that Ms. Campbell suffered from inflammatory arthritis,” id., although acknowledging that “he [i.e., Dr. Jackson] may have considered that her upper extremities were swollen and filled with fluid” and “Ms. Campbell’s test for ANA was positive.” Id. The special master opined that “a positive ANA is not diagnostic for rheumatoid arthritis.” Id. The special master also considered that “as a practical matter, favoring the reports of all treating physicians may be impossible” in this instance because Dr. Jackson had used the term “inflammatory arthritis” to describe Ms. Campbell’s condition and the rheumatologist, Dr. Gilhooly, who subsequently treated Ms. Campbell, used the term “reactive arthritis.” Id. at *12 n. 8. The special master considered that this divergence showed “different conclusions,” and thus “the persuasiveness of each report must be evaluated.”
Still further, the special master drew what he termed “[a] reasonable inference” from Dr. Gilhooly’s records “that because there was no synovitis at the time of Dr. Gilhooly’s examination of Ms. Campbell [on December 19, 2003, two weeks after Ms. Campbell’s vaccination], Dr. Gilhooly did not diagnose rheumatoid arthritis.” Entitlement Decision at *13. The special master’s inference was neither “reasonable” nor appropriate; both parties’ experts agreed that it would have been impossible to diagnose Ms. Campbell with rheumatoid arthritis until at least six or eight weeks had elapsed since the vaccination. See supra, at 381-82 & n. 28.
CONCLUSION
For the stated reasons, petitioner’s motion for review is GRANTED, the decision of the special master dated July 7, 2009, denying compensation is VACATED, and the case is REMANDED to the special master for further proceedings. Specifically, the court sets aside the findings of the special master although it makes no affirmative findings of its own.
It is so ORDERED.
. In accord with the Rules of the Court of Federal Claims ("RCFC"), App. B, Rule 18(b), this opinion and order is initially being filed under seal. By rule, the parties are afforded fourteen days in which to propose redactions.
. Trivalent influenza vaccine appears on the Vaccine Injury Table maintained by the Secretary of Health and Human Services pursuant to statute, see 42 C.F.R. § 100.3 (2008), as adopted and revised pursuant to the authority of 42 U.S.C. § 300aa-14(c). Provision XIII of the Table lists "[a]ny new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children, after publication by the Secretary of a notice of coverage.” 42 C.F. R. § 100.3(a) Table, Provision XIII. By a notice published on April 12, 2005, "the Secretary announce[dJ that trivalent influenza vaccines are covered vaccines under the National Vaccine Injury Compensation Program.” National Vaccine Injury Compensation Program: Application of Trivalent Influenza Vaccines to the Vaccine Injury Table, 70 Fed.Reg. 19092 (Apr. 12, 2005). As the Secretary explained:
[Tjwo types of influenza vaccines are routinely given to millions of individuals in the United States each year. One is an activated (killed) virus vaccine administered using a syringe, while the other is a live, attenuated product administered in a nasal spray. Both vaccine types are trivalent, meaning that they contain three vaccine virus strains which are thought most likely to cause disease outbreaks during the influenza season.
Id.
However, no Table injuries are specified for this vaccine. See 42 C.F.R. § 100.3(a) Table, Provision XIII. For most listed vaccines, "[tjhe Table lists symptoms and injuries associated with each listed vaccine and a timeframe for each symptom or injury.” de Bazan v. Secretary of Health & Human Serv's., 539 F.3d 1347" court="Fed. Cir." date_filed="2008-08-28" href="https://app.midpage.ai/document/de-bazan-v-secretary-of-health-and-human-services-209667?utm_source=webapp" opinion_id="209667">539 F.3d 1347, 1351 (Fed.Cir.2008). If a listed symptom occurs after vaccination within the specified timeframe, causation is presumed. Id. Injuries not listed in the Table or injuries that occur outside the specified timeframe following vaccination are deemed "off-Table” injuries, and causation is not presumed in such cases. Id. In this instance, however, because no injuries are specified for trivalent influenza vaccine, all claims related to that vaccine are off-Table injuries.
. In this recitation of the facts, the transcript of the entitlement hearing before the special master will be cited as "Tr. -" and references to documentary materials made part of the record will be to “R. Ex. at • — .”
. Osteoarthritis is "a noninflammatory degenerative joint disease seen mainly in older persons ... [that is] accompanied by pain, usually after prolonged activity, and stiffness, particularly in the morning or with inactivity.” Dorland's Illustrated Medical Dictionary, 1365 (31st ed.2007). Unlike rheumatoid arthritis, osteoarthritis is not considered an autoimmune disease. See Tr. 191:8 to 193:2 (Test, of Dr. Arthur E. Brawer who provided expert testimony for petitioner) (describing the differences between rheumatoid arthritis and osteoarthritis). The “cervical spine” is that portion of the spine "pertaining to the neck.” Dorland's at 339. The "lumbar spine” is that portion of the spine "pertaining to the loins, the parts of the sides of the back between the thorax and the pelvis.” Id. at 1092. "Clinical” is defined as "founded on actual observation and treatment of patients [at the bedside].” Id. at 378. "Radiographic” is defined as "pertaining to or produced by radiography [or X-rayl" Id. at 1596.
. Non-alcoholic steatohepatitis is an inflammatory disease of the liver that occurs in people who drink little or no alcohol. See Dorland’s at 1794.
. Antinuclear antibodies are "substances produced by the immune system that attack the body’s own tissues.” U.S. National Library of Medicine and National Institutes of Health, Med-linePlus, Antinuclear Antibody Panel, http://www. nlm.nih.gov/medlineplus/ency/article/003535.htm (updated Feb. 3, 2009).
. Neither party in this case has alleged that the pneumococcal vaccine Ms. Campbell received on December 4, 2003 caused the onset of her rheumatoid arthritis. See Entitlement Decision at *6. Ms. Campbell received the adult version of the pneumococcal vaccine, called Pneumovax 23, which is not listed on the Vaccine Injury Table. Id. at *1 (citing 42 C.F.R. § 100.3(a)(Table, Provision XIII); 66 Fed.Reg. 28166 (May 22, 2001)).
. Septic bursitis is "inflammation of a bursa that [is] caused by infection, usually the result of bacterial inoculation due to trauma.” Dorland’s at 269. A bursa is "a sac or saclike cavity filled with a viscid fluid and situated at places in the tissues at which friction would otherwise develop.” Id. at 266.
. According to Dr. Robert Lightfoot, an expert who testified on behalf of the government, a rheumatoid factor of 20 is normal or “negative” and a rheumatoid factor of 50 or 80 or higher is abnormal or "positive.” Tr. 413:21-25 (Light-foot).
. Arthralgia is "pain in a joint,” Dorland's at 152, while myalgia is "pain in a muscle or muscles.” Dorland’s at 1233.
. Polyneuropathy is "a functional disturbance or pathological change in ['several peripheral nerves simultaneously’].” Dorland's at 1287, 1513. Myopathy is "any disease of a muscle.” Dorland's at 1243.
. Serologies indicate "the presence of antibodies against a microorganism.” U.S. National Library of Medicine and National Institutes of Health, MedlinePlus, Serology, http://www.nlm. nih.gov/medlineplus/ency/article/003511.htm (updated Oct. 15, 2007).
. At the hearing, Dr. Lightfoot opined that Dr. Gilhooly, who dictated this note, intended the word "question" to be a question mark immediately following "post vaccination reactive arthritis,” rather than a verb preceding "myalgias [and] weakness.” See Tr. 415:23 to 416:25 (Lightfoot).
. Although the Entitlement Decision states that Dr. Ball’s specialty "is not apparent,” Entitlement Decision at *3, Dr. Ball's medical determinations regarding Ms. Campbell's condition suggest that Dr. Ball practices as a neurologist. See id. (“Dr. Ball determined that Ms. Campbell did not have a polyneuropathy of any type.").
. Hypergammaglobulinemia is "an excess of gamma globulins in the blood, seen frequently in chronic infectious diseases.” Borland's at 901.
. Psoriasis is "any of a group of common chronic, squamous dermatoses with variable symptoms and courses; some are inherited." Dorland’s at 1570. "Plaque psoriasis” is "the most common type of psoriasis, in which lesions are in round plaques with distinct borders." Id. at 1571.
. Psoriatic arthritis is "a syndrome of psoriasis in association with arthritis; rheumatoid factor is usually not present in the serum of affected individuals." Dorland’s at 152.
. Fibromyalgia is "pain and stiffness in the muscles and joints that either is diffuse or has multiple trigger points." Dorland’s at 711. At the hearing, Dr. Brawer opined that fibromyalgia was a “gross oversimplification” of Ms. Campbell's diagnosis because in his experience, patients can simultaneously fulfill the criteria for fibromyalgia and rheumatoid arthritis. Tr. 75:4-12 (Brawer).
. Arthropathy is "any joint disease.” Dorland’s at 160.
. Prior to 1989, the judges on this court had the option of either "adopting] the findings of the special master as [their] own judgment, or mak[ing] a de novo determination of any matter and issuing] [their] judgment accordingly.” Randall B. Keiser, Deja Vu All Over Again? The National Childhood Vaccine Injury Compensation Act of ¡986, 47 Food & Drug L.J. 15, 23 (1992). The statute was amended in 1989 to eliminate the ability of the judges on this court to review any portion of the special master's decision de novo. See Omnibus Budget Reconciliation Act of 1989, Pub.L. No. 101-239, § 6601(h), 103 Stat. 2106, 2289 (codified at 42 U.S.C. § 300aa-12(e)).
. The initial Vaccine Injury Table was published at 42 U.S.C. § 300aa-14(a). The Table can be, and has been, revised by the Secretary of Health and Human Services acting pursuant to notice- and-comment rulemaking under the authority of 42 U.S.C. § 300aa-14(c). The current version of the Vaccine Injury Table, as amended, is set out at 42 C.F.R. § 100.3. See supra, at 2 n. 2.
. As noted, the inclusion of trivalent influenza vaccine on the Table is not accompanied by any listing of Table injuries or any time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration. See supra, at 2 n. 2. Thus, no claims related to administration of trivalent influenza vaccine can be said to fall within the Table, and all such claims necessarily must be for off-Table injuries.
. With regard to this test, the Federal Circuit also stated in Althen that ‘‘[a] persuasive medical theory is demonstrated by proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury, the logical sequence being supported by reputable medical or scientific explanation, i.e., evidence in the form of scientific studies or expert medical testimony.” Althen, 418 F.3d 1274" court="Fed. Cir." date_filed="2005-07-29" href="https://app.midpage.ai/document/althen-v-secretary-of-health-and-human-services-211771?utm_source=webapp" opinion_id="211771">418 F.3d at 1278 (internal quotation marks omitted) (citation omitted); see also Capizzano v. Secretary of Health & Human Servs., 440 F.3d 1317" court="Fed. Cir." date_filed="2006-03-09" href="https://app.midpage.ai/document/rose-capizzano-v-secretary-of-health-and-human-services-793652?utm_source=webapp" opinion_id="793652">440 F.3d 1317, 1324-27 (Fed.Cir.2006) (applying the Althen test).
"The 'proximate temporal relationship’ standard requires 'preponderant proof that the onset of symptoms occurred within the timeframe for which, given the medical understanding of the disorder's etiology, it is medically acceptable to infer causation-in-fact.” Rotoli v. Secretary of Health & Human Servs., 89 Fed. Cl. 71" court="Fed. Cl." date_filed="2009-09-02" href="https://app.midpage.ai/document/rotoli-v-secretary-of-health--human-services-6659520?utm_source=webapp" opinion_id="6659520">89 Fed.Cl. 71, 79 n. 5 (2009) (quoting de Bazan, 539 F.3d 1347" court="Fed. Cir." date_filed="2008-08-28" href="https://app.midpage.ai/document/de-bazan-v-secretary-of-health-and-human-services-209667?utm_source=webapp" opinion_id="209667">539 F.3d at 1352).
. Other somewhat related autoimmune diseases or conditions include lupus, scleroderma, and Sjogren's syndrome. See Entitlement Decision at *4 (listing autoimmune conditions cited by Dr. Gilhooly in her notes after a visit by Ms. Campbell on January 13, 2004) (quoted supra, at 8); Dorlancl's at 1093, 1705, 1871.
. Dr. Lightfoot described “rheumatoid nodules” as "small inflammatory nodules that can occur over pressure points, typically [in] the elbow.” Tr. 272:4-6 (Lightfoot).
. "A rheumatoid factor test measures the amount of ... autoantibodies — proteins produced by [the] immune system that can attack healthy tissue in [the] body” — in the blood. Mayo Clinic, Rheumatoid Factor Definition, http://www.mayoclinic.com/health/rheumatoid factor/MY00241.
. According to Dr. Lightfoot, joint erosions are the result of “inflammatory tissue in the joint burrow[ing] in[to] [the joint] like a tumor and causLing] little caves in the joint structure.” Tr. 272:7-10 (Lightfoot).
. The following annotation appears beneath the list of criteria for the classification of rheumatoid arthritis published by the American College of
. The same special master made the same assertion in the Rotoli cases. See Rotoli, 89 Fed. Cl. 71" court="Fed. Cl." date_filed="2009-09-02" href="https://app.midpage.ai/document/rotoli-v-secretary-of-health--human-services-6659520?utm_source=webapp" opinion_id="6659520">89 Fed.Cl. at 81-82.
. This theory has on occasion been cryptically described by the somewhat vernacular term "molecular mimicry.” See e.g., Entitlement Decision at *9.
. The same statistical argument was made and rejected in Capizzano, relating to an association of the hepatitis B vaccine with rheumatoid arthritis. See Capizzano, 440 F.3d 1317" court="Fed. Cir." date_filed="2006-03-09" href="https://app.midpage.ai/document/rose-capizzano-v-secretary-of-health-and-human-services-793652?utm_source=webapp" opinion_id="793652">440 F.3d at 1326-27 (recognizing the fact that "statistically” there are "instances where individuals suffer an initial onset of rheumatoid arthritis shortly after receiving the vaccine, but not as the result of the vaccine;” however, that possibility "does not prevent a finding that it is more likely than not that the vaccine caused the [rheumatoid arthritis]"). The statistical-coincidence argument is no more persuasive here than it was in Capizzano.
.Dr. Brawer indicated that
if certain amino acid sequences of the protein of the arms of those Class 2 molecules [HLA Class 2 molecules present only on immuno-competent cells] bears some striking resemblance to the foreign protein that you're mounting the response against, then you may not shut the process off. It may continue unabated and you hence go from eradication of infection to persistence of inflamation.
Tr. 137:6-12 (Brawer).
. Dr. Lightfoot considered the testability possibility in a different but not inconsistent framework, commenting that ‘'[f)or decades rheuma-tologists have been looking for clues to the viral etiology of rheumatoid arthritis.” Tr. 393:3-5 (Lightfoot). In that connection, he related the results of research efforts that tended to show merely that rheumatoid arthritis patients "have higher general antibody levels, gamma [globulin] levels, than the normal population.” Tr. 393:22-23 (Lightfoot).
. As Dr. Lightfoot testified:
I think as Dr. Brawer has indicated, it may take time to prove someone has rheumatoid arthritis. Very often, mild rheumatoid disease, you don’t really know that’s what it is until several months or maybe a year have gone by and all the other possibilities have fallen by the wayside, in retrospect you make the diagnosis.
Tr. 230:19-24 (Lightfoot); see also Tr.319:6-18 (Lightfoot).
In this respect, Dr. Gilhooly’s initial diagnosis, made on December 19, 2003, two weeks after Ms. Campbell's vaccination, seems reasonably prescient. As she then said:
I think the differential diagnosis includes in descending order of probability immunization related autoimmune phenomenon which will probably be transient, possibility of long-lasting symptomatology is there and while it is not well reported in literature I have seen several cases of onset of lupus more often than onset of rheumatoid arthritis after immunization.
R. Ex. 3 at 300026.
. None of Ms. Campbell's treating physicians testified at the entitlement hearings. Only one of the two principal treating physicians, Dr. Jackson, could have been called to testify because Dr. Gilhooly had tragically been killed in an automobile accident. This lack of direct testimony is not of evidentiary significance. As the Federal Circuit has observed:
In most instances, however, it is both inadvisable and unnecessary to subpoena the testimony of treating physicians. It would not be in the public interest for the specter of a subpoena to provide physicians with a disincentive to treat a vaccine-injured patient or to cause them to be less than forthright in creating medical records assessing the relationship between a vaccine and a patient's injury. The submitted documentaiy evidence can, under most circumstances, provide adequate insight into the medical opinions of treating physicians, and there is little need to subject them to cross-examination in federal court.
Andreu, 569 F.3d 1367" court="Fed. Cir." date_filed="2009-06-18" href="https://app.midpage.ai/document/andreu-ex-rel-andreu-v-secretary-of-health-and-human-services-208532?utm_source=webapp" opinion_id="208532">569 F.3d at 1383 (citing Cucuras v. Secretary of Health & Human Servs., 993 F.2d 1525" court="Fed. Cir." date_filed="1993-05-14" href="https://app.midpage.ai/document/john-cucuras-and-maria-cucuras-parents-and-next-friends-of-nicole-cucuras-v-secretary-of-the-department-of-health-and-human-services-607196?utm_source=webapp" opinion_id="607196">993 F.2d 1525, 1528 (Fed.Cir.1993)).
.Dr. Lightfoot testified that there are
occasional cases where rheumatoid arthritis comes on explosively, and every joint in the body is swollen, and the patient is unable to get out of bed. And they even run a fever, and a very profound onset.
But it’s characteristically not easy to date the onset.
Tr. 269:17-22 (Lightfoot). Manifestly, Ms. Campbell's onset of rheumatoid arthritis was not of the "explosive” type but rather of the more characteristic type.