Court Opinion

ID: 4579994
Source: CourtListenerOpinion
Date Created: 2020-10-23 13:01:21.78749+00
Date Added: 2024-06-11T13:40:48.836313
License: Public Domain

In the United States Court of Federal Claims
                                 OFFICE OF SPECIAL MASTERS
                                     Filed: September 10, 2020
                                           For Publication

*************************
KRISTIE ROBY                                *      No. 15-125V
                                            *
                      Petitioner,           *      Special Master Sanders
                                            *
              v.                            *
                                            *
SECRETARY OF HEALTH AND                     *
HUMAN SERVICES,                             *      Hepatitis B Vaccine;
                                            *      Connective tissue disease;
                      Respondent.           *      Scleroderma
                                            *
*************************
Richard Gage, Richard Gage, PC, Cheyenne, WY, for Petitioner.
Lynn Schlie, United States Department of Justice, Washington, D.C., for Respondent.

                                               DECISION 1

        On February 9, 2015, Kristie Roby (“Petitioner”) filed a petition for compensation,
pursuant to the National Vaccine Injury Compensation Program (“Program” or “Act”). Pet. at 1,
ECF No. 1; 42 U.S.C. § 300aa-10 to -34 (2012). Petitioner alleged that she received a combined
vaccination for hepatitis A and hepatitis B on June 27, 2013 that caused her to suffer pain, fatigue,
and weakness. Pet. at 1. Petitioner filed an amended petition on April 22, 2016, alleging that the
vaccination “triggered scleroderma with accompanying symptoms of pain, fatigue, and weakness.”
Am. Pet. at 2, ECF No. 42. Petitioner revised her claim again in her post-hearing memorandum,
alleging that she developed undifferentiated connective tissue disease and sine scleroderma 2 as a
result of the hepatitis B component of the vaccine. Pet’r’s Post-Hr’g Br. at 1–2, ECF No. 87.
1
  This Decision shall be posted on the United States Court of Federal Claims’ website, in accordance with
the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of
Electronic Government Services). This means the Decision will be available to anyone with access to
the Internet. In accordance with Vaccine Rule 18(b), a party has 14 days to identify and move to delete
medical or other information that satisfies the criteria in § 300aa-12(d)(4)(B). Further, consistent with the
rule requirement, a motion for redaction must include a proposed redacted Decision. If, upon review, I
find that the identified material fits within the requirements of that provision, such material will be
deleted from public access.
2
  Scleroderma in general is the “chronic hardening and thickening of the skin.” Scleroderma, Dorland’s
Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=45002&searchterm=scleroderma (last visited
Aug. 17, 2020). Sine scleroderma occurs in a small number of patients who experience “the presence of
visceral involvement occurring in the absence of skin manifestations.” See Pet’r’s Ex. 34 at 2: E.
Kucharz, M. Kopeć-Mędrek, Systemic sclerosis sine scleroderma, ADV. CLIN. EXP. MED. (2017)
        After carefully analyzing and weighing all the evidence and testimony presented in this
case in accordance with the applicable legal standards, I find that Petitioner has not met her legal
burden. Petitioner has failed to provide preponderant evidence that the hepatitis vaccination she
received on June 27, 2013 caused her to develop scleroderma. Accordingly, Petitioner is not
entitled to compensation.

   I.      Procedural History

        Petitioner filed her claim on February 9, 2015. She initially alleged she suffered pain,
fatigue, and weakness as the result of receiving a combination hepatitis A and B vaccination on
June 27, 2013. Pet. at 1. The case was assigned to Special Master Lisa Hamilton-Fieldman and,
over the next six months, Petitioner filed exhibits in support of her claim. ECF Nos. 9, 10, 17, 20,
23.

        On September 30, 2015, Respondent contested entitlement in his Rule 4(c) report, noting
that Petitioner had not alleged a specific injury. ECF No. 27. At a status conference on October
14, 2015, Petitioner indicated that the alleged injury would likely be scleroderma. ECF No. 30.
She filed additional medical records on March 4, 2016, and an amended petition on April 22, 2016,
claiming the vaccination “triggered” her scleroderma. ECF Nos. 38, 42.

       Petitioner submitted an expert report from Dr. Vera Byers on August 31, 2016, who opined
that the vaccination caused or substantially contributed to Petitioner’s development of an
autoimmune disorder. ECF No. 46-1. On November 28, 2016, Respondent filed an expert report
from Dr. Chester Oddis who disagreed that Petitioner even had an autoimmune disorder. ECF No.
50-1.

        On December 15, 2016, Special Master Hamilton-Fieldman held a status conference to
address the uncertainty of Petitioner’s diagnosis and resulting failure of the experts’ ability to reach
the issue of causation. ECF No. 51. Special Master Hamilton-Fieldman ordered Petitioner to file
updated records and a supplemental responsive expert report from Dr. Byers. Id.

       The case was reassigned to me on January 11, 2017. ECF No. 53. Over the following
months, Petitioner submitted updated medical records and a supplemental expert report. ECF Nos.
55, 61. Respondent also submitted a supplemental responsive expert report. ECF No. 63. On
August 3, 2017, the parties contacted me to request an entitlement hearing, which was then set for
March 14, 2019. ECF No. 66.

        In preparation for the entitlement hearing, the parties each filed a pre-hearing memorandum
and supplemental exhibits including records, medical literature, and reports. ECF Nos. 68, 71–75,
77–79, 81. I held an entitlement hearing on March 14, 2019, and heard testimony from Petitioner,
Dr. Byers, and Dr. Oddis. Petitioner filed a post-hearing brief in which she further refined her
allegations, claiming she developed undifferentiated connective tissue disease and scleroderma
sine scleroderma, specifically from the hepatitis B component of the combined vaccination. ECF
No. 87. Respondent filed a post-hearing memorandum with demonstrative charts from the hearing.
ECF Nos. 90, 93. This matter is now ripe for adjudication.

26(5):875-880.

                                                   2
    II. Factual Background

        A.      Medical Records

         Petitioner was 40 years old and working as a nurse in a jail when she received a combined
vaccine for hepatitis A and B 3 on June 27, 2013. Pet’r’s Ex. 10. In the three months prior to
vaccination, she saw her primary care physician (“PCP”), Rolf Lyon, M.D., twice: first for
moodiness on April 5, 2013, then for pain in her left calf on June 3, 2013. Pet’r’s Ex. 1 at 1–5. Dr.
Lyon’s records are sparse but indicate Petitioner complained of crying and excessive anger in
April. Id. In response, Dr. Lyon checked her hormones, increased her Effexor, 4 and assessed her
with vasomotor instability 5 and Raynaud’s. 6 Id. Then, in June, in response to her complaints of
left calf pain, he noted the Raynaud’s again, and included post-traumatic stress disorder (“PTSD”)
and anxiety in his assessment. Dr. Lyon recommended over-the-counter niacin and a psychiatric
referral. Id. In addition to the Effexor, Petitioner’s medication list at this time included Procardia, 7
Alprazolam, 8 and Topamax. 9 Id. Before seeing Dr. Lyon, Petitioner was treated by Elaine Wood,

3
  Twinrix vaccine – “a combination preparation of hepatitis A vaccine inactivated and hepatitis B vaccine
(recombinant).” Twinrix, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=51545&searchterm=Twinrix (last visited Aug. 17,
2020).
4
  Effexor is “used as an antidepressant and antianxiety agent.” Venlafaxine hydrochloride, Dorland’s
Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=52779 (last visited
Aug. 17, 2020); Effexor, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=15636&searchterm=Effexor (Aug. 17, 2020)
(“trademark for preparations of venlafaxine hydrochloride”).
5
  Vasomotor instability is not a readily definable term.
6
  Raynaud’s phenomenon is “intermittent bilateral ischemia of the fingers, toes, and sometimes ears and
nose, with severe pallor and often paresthesia and pain, usually brought on by cold or emotional stimuli
and relieved by heat; it is usually due to an underlying disease or anatomic abnormality.” Raynaud
Phenomenon, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=97633&searchterm=Raynaud+phenomenon (last
visited Aug. 17, 2020).
7
  Procardia is a “a calcium channel blocking agent used as a coronary vasodilator in the treatment of
coronary insufficiency and stable angina pectoris, and as an antihypertensive.” Nifedipine, Dorland’s
Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=34003 (last visited
Aug. 17, 2020); Procardia, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=41007&searchterm=Procardia (Aug. 17, 2020)
(“trademark for preparations of nifedipine”).
8
  Alprazolam is “a short-acting benzodiazepine used as an antianxiety agent in the treatment of anxiety
disorders and panic disorders and for short-term relief of anxiety symptoms.” Alprazolam, Dorland’s
Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=1937&searchterm=alprazolam (last visited Aug.
17, 2020).
9
  Topamax is “a substituted monosaccharide used as an anticonvulsant in the treatment of partial
seizures.” Topiramate, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=50310 (last visited Aug. 17, 2020); Topamax,
Dorland’s Medical Dictionary Online, Topiramate, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=50298&searchterm=Topamax (Aug. 17, 2020)
(“trademark for a preparation of topiramate.”).

                                                   3
D.O., who provided refills of Petitioner’s Xanax and Effexor prescriptions from 2010 through
2012. See generally Pet’r’s Ex. 18.

        On July 1, 2013, four days after vaccination, Petitioner presented to John Popp, M.D.,
complaining of painful joints, fatigue, and sores in her mouth. Pet’r’s Ex. 8 at 1. Dr. Popp’s nurse
noted Petitioner had a “one-week history of being very fatigued and all of her joints hurting.” Id.
Petitioner rated the pain as moderate to severe and worse in the morning. Id. Petitioner described
sores in her mouth, stating that she gets them “fairly regularly.” Id. None were noted to be present
at the visit. Id. The physical exam was normal, and Dr. Popp diagnosed Petitioner with fatigue
and polyarthritis. Pet’r’s Ex. 8 at 3. He ordered lab work and x-rays of her hands then prescribed
a course of Prednisone. 10 Id. The lab work was within normal limits, and the x-rays were negative
for chronic arthritis. Pet’r’s Ex. 3 at 1–4, Ex. 2 at 5.

        Petitioner returned to Dr. Lyon on July 4, 2013 complaining of “trouble breathing, chest
pain, chills, and joint aching.” Pet’r’s Ex. 1 at 6. Dr. Lyon assessed her with Reiter’s syndrome, 11
administered a Rocephin injection, 12 and ordered further tests, including an echocardiogram. Id.
at 8–10. The results of all tests were normal. Id.

        Petitioner next sought treatment on July 17, 2013 from rheumatologist, M. Sami Mughni,
M.D., at the Florida Arthritis and Osteoporosis Center. Pet’r’s Ex. 3 at 9–12. Dr. Mughni noted
that Petitioner had a longstanding history of PTSD and three weeks of “increasing pain and
stiffness involving multiple joints and muscle groups.” Id. He indicated that her condition did not
respond to high-dose steroids and that Petitioner had received a “hepatitis vaccination [four] days
before acute exacerbation of symptoms.” Id. Dr. Mughni wrote the following in the review of
systems: “Constipation. Acid reflux. Shortness of breath. Headaches. Dizzy spells. Low-grade
fever. Some sensitivity. Sinus infections. Raynaud’s.” Id. The examination was normal with no
synovitis, 13 negative serologies or x-rays, and Dr. Mughni concluded that Petitioner had

10
   Prednisone is “a synthetic glucocorticoid derived from cortisone, administered orally as an anti-
inflammatory and immunosuppressant in a wide variety of disorders.” Prednisone, Dorland’s Medical
Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=40742&searchterm=prednisone (last visited Aug.
17, 2020).
11
   Reiter’s syndrome is “the triad of acute aseptic arthritis, nongonococcal urethritis, and conjunctivitis;
there may also be mucocutaneous manifestations such as keratoderma blennorrhagicum, circinate
balanitis, and stomatitis.” Reiter syndrome, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=111277 (last visited Aug. 17, 2020).
12
   Rocephin is “a semisynthetic, β-lactamase–resistant, broad-spectrum, third-generation cephalosporin
effective against a wide range of gram-positive and gram-negative bacteria.” Ceftriaxone sodium,
Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=8471 (last
visited Aug. 17, 2020); Rocephin, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=44026&searchterm=Rocephin (Aug. 17, 2020)
(“trademark for a preparation of ceftriaxone.”).
13
   Synovitis is the “inflammation of a synovial membrane; it is usually painful, particularly on motion,
and is characterized by a fluctuating swelling due to effusion within a synovial sac. Some types are named
for accompanying tissue changes, such as fibrinous, hyperplastic, or lipomatous synovitis; others are
named for accompanying disease processes or complications, such as gonorrheal, metritic, puerperal,
rheumatic, scarlatinal, syphilitic, or tuberculous synovitis.” Synovitis, Dorland’s Medical Dictionary

                                                     4
fibromyalgia and chronic fatigue syndrome. Id. He noted, however, that these diagnoses did not
explain the “acute exacerbation recently associated with joint swelling.” Id. He recommended
she continue Seroquel for PTSD, add niacin for Raynaud’s, and follow-up in two months. Id. at
11. Petitioner returned to Dr. Mughni one week later still complaining of pain and stiffness. Pet’r’s
Ex. 3 at 12–13. He confirmed the previous diagnoses and added Effexor plus hydrocodone for
pain control. Id.

        Dr. Mughni referred Petitioner to neurologist, Qahtan Adbul Fattah, M.D., at The
Headache and Neurology Clinic for an examination on August 1, 2013. Pet’r’s Ex. 2 at 8–10. Dr.
Fattah indicated Petitioner was “worried about having [multiple sclerosis].” Id. He wrote:

                [Petitioner] received vaccine for hepatitis A and B at work as she is an RN.
                [Four] days later she started having muscle pain and swollen joints. Steroids
                and antibiotics did not help. She has been falling and feeling weak all over.
                She is tired and [has] no energy. Her hands are also weak[,] and she finds it
                hard to hold on things. Her chronic finger numbness has also gotten worse.
Id. He performed a neurological exam which was normal and commented that “her symptoms are
likely a reaction to vaccination.” Id. Dr. Fattah prescribed Gabapentin 14 and ordered labs and a
spinal MRI. Id. Petitioner returned on September 9, 2013, still reporting problems with walking
and muscle pain. Id. at 14. Dr. Fattah diagnosed her with “hyper-reflexia with mute toes” 15 and
myalgia and further recommended an MRI of the head. The MRI occurred on December 13, 2013
and revealed she might have a pituitary microadenoma, 16 but was otherwise normal. Id. at 15–16.

       Petitioner followed up with Dr. Mughni on October 3, 2013, who described Petitioner as
having fibromyalgia with poor response to intervention. Pet’r’s Ex. 3 at 19. Her serologies were

Online, https://www.dorlandsonline.com/dorland/definition?id=48576&searchterm=synovitis (last visited
Aug. 19, 2020).
14
   Gabapentin is “an anticonvulsant that is a structural analogue of γ-aminobutyric acid (GABA), used as
adjunctive therapy in the treatment of partial seizures and the management of postherpetic neuralgia.”
Gabapentin, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=19523&searchterm=gabapentin (last visited Aug.
17, 2020).
15
   Hyperreflexia is “dysreflexia characterized by exaggeration of reflexes.” Hyperreflexia, Dorland’s
Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=23992&searchterm=hyperreflexia (last visited
Aug. 17, 2020). A definition for mute toes is not readily available.
16
   Microadenoma is “specifically, a pituitary adenoma less than 10 mm in diameter and not visible by
usual radiographic techniques; most endocrine-active adenomas are this size and are detected because of
their hormone activities.” Microadenoma, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=31164&searchterm=microadenoma (last visited
Aug. 19, 2020).

                                                   5
normal with negative ANA, 17 negative rheumatoid factor, 18 and normal ESR. 19 Id. He confirmed
he did not see clinical evidence of SLE 20 or rheumatoid arthritis and he thought her symptoms
were consistent with fibromyalgia and osteoarthritis. Id. He continued the hydrocodone as needed,
plus Effexor, Seroquel, and Xanax for depression and anxiety. Id.

        During the first half of 2014, Petitioner visited numerous specialists for clarification of her
diagnosis and treatment of her symptoms. First, she went to neurosurgeon, Steven Bailey, M.D.,
on January 31, 2014, who evaluated her for neck pain and upper extremity numbness. Pet’r’s Ex.
4 at 1–3. He ruled out Petitioner’s need for neck surgery but recommended EMG and nerve
conduction studies. Id. The upper extremity EMG performed on February 6, 2014 revealed
bilateral carpal tunnel syndrome and diffuse sensory delays in both hands, with an underlying mild
sensory neuropathy of an unknown origin. Id. at 9. The EMG of the lower extremities was normal.
Id. at 11. On March 14, 2014, Dr. Bailey referred Petitioner for a carpal tunnel release and
suggested she follow-up with a rheumatologist and an endocrinologist. Id. at 16–18.

       Neurosurgeon, Steven Reid, M.D., evaluated Petitioner for bilateral hand weakness on
March 26, 2014, and noted that Petitioner thought she had a condition called macrophagic
myofasciitis. 21 Pet’r’s Ex. 7 at 1. Petitioner wanted a deltoid muscle biopsy to confirm this

17
   ANA is an abbreviation for antinuclear antibodies—which are “antibodies directed against nuclear
antigens; ones against a variety of different antigens are almost invariably found in systemic lupus
erythematosus and are frequently found in rheumatoid arthritis, scleroderma (systemic sclerosis), Sjögren
syndrome, and mixed connective tissue disease.” Antinuclear antibodies, Dorland’s Medical Dictionary
Online, https://www.dorlandsonline.com/dorland/definition?id=56804 (last visited Aug. 17, 2020).
18
   Rheumatoid factor is “antibodies directed against antigenic determinants, i.e., Gm, in the Fc region of
the IgG class of immunoglobulins; these are found in the serum of about 80 percent of persons with
classical or definite rheumatoid arthritis but only about 20 percent of those with juvenile rheumatoid
arthritis.” Rheumatoid factor, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=74591&searchterm=rheumatoid+factor (last
visited Aug. 17, 2020).
19
   ESR (erythrocyte sedimentation rate) is “the rate at which erythrocytes precipitate out from a well-
mixed specimen of venous blood, measured by the distance the top of the column of erythrocytes falls in
a given time interval under specified conditions; an increase in rate is usually due to elevated levels of
plasma proteins, especially fibrinogen and immunoglobulins, which decrease the zeta potential on
erythrocytes by dielectric shielding and thus promote rouleau formation. It is increased in monoclonal
gammopathy, hypergammaglobulinemia due to inflammatory disease, hyperfibrinogenemia, active
inflammatory disease, and anemia.” Erythrocyte sedimentation rate, Dorland’s Medical Dictionary
Online,
https://www.dorlandsonline.com/dorland/definition?id=102146&searchterm=erythrocyte+sedimentation+
rate (last visited Aug. 17, 2020).
20
   SLE is an abbreviation for systemic lupus erythematosus, “a chronic, inflammatory, often febrile
multisystemic disorder of connective tissue that proceeds through remissions and relapses; it may be
either acute or insidious in onset and is characterized principally by involvement of the skin (cutaneous l.
erythematosus), joints, kidneys, and serosal membranes.” Systemic lupus erythematosus, Dorland’s
Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=87476 (last visited
Aug. 17, 2020).
21
   Macrophagic myofasciitis is detected in patients with diffuse arthromyalgias and fatigue. It is
characterized by muscle infiltration by granular periodic acid-Schiff’s reagent-positive macrophages and
lymphocytes. See D'Angiolini v. Sec'y of Health & Human Servs., No. 99-578V, 2014 WL 1678145 (Fed.

                                                     6
diagnosis. Id. Dr. Reid performed bilateral deltoid muscle biopsies and a right median nerve
neuroplasty 22 on June 12, 2014. Id. at 14–15. The neuroplasty was successful in relieving some
right-hand symptoms, but the muscle biopsies did not confirm pathology. Id. at 16.

        Petitioner saw endocrinologist, Sreevidya Subbarayan, M.D., to follow up on the potential
pituitary microadenoma revealed by the MRI performed by Dr. Fattah. Pet’r’s Ex. 5 at 3, 8–12.
Petitioner indicated she received the combined hepatitis A and B vaccination and developed
painful swelling in her joints three days later. Id. Dr. Subbarayan wrote that “patient states that
[she] researched into her issue and found that there is a rare syndrome caused by aluminum in the
vaccine.” Id. at 8. Dr. Subbarayan advised Petitioner that she might have a pituitary
microadenoma, but it was unlikely to be the cause of her various symptoms since her hormonal
profile was completely normal. Id.

       Petitioner consulted with a second rheumatologist, Miguel Rodriguez, M.D., at the
Southeastern Arthritis Center, in March and April of 2014. Pet’r’s Ex. 6 at 7–8. Dr. Rodriguez
sent Petitioner for a series of joint x-rays, lab work, and a CT of the chest. Id. at 2–11. Dr.
Rodriguez noted a positive SCL-70 23 (which would suggest scleroderma), a negative ANA, and
an abnormal CT of the chest, but he advised her that the diagnosis was unclear. Id. at 14–15. He
recommended she go to a specialty center such as Cleveland Clinic or Johns Hopkins for further
evaluation and treatment. Id. at 15.

        The day after, Dr. Rodriguez advised Petitioner of the abnormal serology findings.
Petitioner returned to her first rheumatologist, Dr. Mughni, on April 10, 2014. Pet’r’s Ex. 3 at 29.
He wrote that she had a positive SCL-70 and Raynaud’s phenomenon but no objective evidence
of inflammation or other skin changes suggestive of scleroderma. Id. at 30. Dr. Mughni suspected
most of Petitioner’s symptoms were due to fibromyalgia and chronic fatigue syndrome. He
explained to Petitioner that the physical examination did not support the diagnosis of scleroderma,
although she may progress to it in the future. Id. at 30–31. He recommended evaluation by another
rheumatologist, because he was unable to control her symptoms. Id.

Cl. Mar. 27, 2014), aff'd, 122 Fed. Cl. 86 (2015), aff'd, 645 F. App'x 1002 (Fed. Cir. 2016) (citing R.K.
Gherardi et al., Macrophagic myofasciitis lesions assess long-term persistence of vaccine-derived
[aluminum] hydroxide in muscle, 124 BRAIN 1821, 1826 (2001)). Macrophages are “any of the many
forms of mononuclear phagocytes found in tissues. They arise from hematopoietic stem cells in the bone
marrow, which develop according to the stages of the monocytic series until they are monocytes; these
then enter the blood, circulate for about 40 hours, and subsequently enter tissues, where they increase in
size, phagocytic activity, and lysosomal enzyme content to become macrophages.” Macrophage,
Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=29296&searchterm=macrophage (last visited
Aug. 18, 2020).
22
   Neuroplasty is “plastic surgery of a nerve.” Neuroplasty, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=33823&searchterm=neuroplasty (last visited Aug.
17, 2020).
23
   According to Mayo Clinical Laboratories, testing for SCL-70 antibodies is useful for “[e]valuating
patients with signs and symptoms of scleroderma and other connective tissue diseases in whom the test
for antinuclear antibodies is positive.” Test ID: SCL-70, MAYO CLINIC LABORATORIES,
https://www.mayocliniclabs.com/test-catalog/Overview/80178 (last visited Aug. 17, 2020).

                                                    7
        On May 14, 2014, Petitioner saw rheumatologist, John Donohue, M.D., of the Cleveland
Clinic for a consultation. Pet’r’s Ex. 16 at 1–7. He examined Petitioner and described her as
having diffuse musculoskeletal pain without frank synovitis. Id. at 5. Although she had an
elevated SCL-70 antibody, he noted she had no skin manifestations of scleroderma other than mild
Raynaud’s phenomenon. Id. He advised Petitioner that it was possible she had early scleroderma,
but there was no specific therapy given her lack of findings. Id. He determined her
musculoskeletal discomfort was likely myofascial pain and wrote that “there [was] no objective
muscle weakness and her muscle enzymes and inflammatory markers [were] normal.” Id. He
suggested formal neuropsychiatric testing to determine whether her memory issues had organic
versus functional origin. Id. A pulmonologist at the clinic also reviewed the abnormal chest CT;
he determined there was no evidence of scleroderma lung and suggested the CT be repeated in six
months. Id. at 8–11.

         Other than a pain management appointment in July, Petitioner did not seek treatment for
the rest of 2014. Pet’r’s Ex. 9 at 1. Petitioner resumed treatment in 2015, starting with a behavioral
health consult on January 20, 2015. Pet’r’s Ex. 15 at 1–4. She was diagnosed with PTSD, chronic
and “major depressive disorder, recurrent, severe, without psychotic features[,]” and her
psychiatric medications were adjusted. Id. at 3–4.

        Rheumatologist, Yih Lin, M.D., treated Petitioner during 2015 and 2016. Pet’r’s Ex. 14 at
1–4, Ex. 22 at 17–19, Ex. 19 at 3–5, ECF Nos. 45, 47. Dr. Lin noted on March 10, 2015 that
Petitioner described her symptoms starting after a hepatitis vaccination in June of 2013. Pet’r’s
Ex. 14 at 1–4. Dr. Lin referenced Petitioner’s positive SCL-70 and Raynaud’s and concluded she
likely had undifferentiated connective tissue disease 24 with possible systemic sclerosis 25 (although
Dr. Lin indicated she did not satisfy the criteria at the time). Id. Dr. Lin suggested a trial of

24
   Undifferentiated connective tissue disease (“UCTD”) is a concept “used to typify individuals who
present with clinical and serologic features suggestive of a connective tissue disease (“CTD”), but who do
not meet criteria for a definable CTD like systemic lupus, Sjögren’s, scleroderma, or mixed connective
tissue disease (“MCTD”), but yet may be at risk for developing significant disease over time.” L.A.M. v.
Sec'y of Health & Human Servs., No. 11-852V, 2017 WL 897430 (Fed. Cl. Jan. 31, 2017). Mixed
connective tissue disease is “a disorder combining features of scleroderma, myositis, systemic lupus
erythematosus, and rheumatoid arthritis, and marked serologically by the presence of antibody against
extractable nuclear antigen.” Mixed connective tissue disease, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=70607 (last visited Aug. 19, 2020).
25
   Systemic sclerosis (also known as systemic scleroderma) is “a systemic disorder of the connective
tissue characterized by fibrosis with hardening and thickening of the skin, as well as abnormalities of both
microvasculature (telangiectasias) and larger vessels (Raynaud phenomenon); there are also fibrotic
degenerative changes in body organs such as the heart, lungs, kidneys, and gastrointestinal tract. It may be
confined to the face and hands for long periods or may progress, spread diffusely, and become
generalized. Called also diffuse s. and systemic sclerosis.” Systemic scleroderma, Dorland’s Medical
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=105101 (last visited Aug. 17,
2020).

                                                     8
hydroxychloroquine 26 and a referral to a swallowing center for dysphagia. 27 Id. On January 8,
2016, Dr. Lin noted that Petitioner’s disease had not improved; she had continuing dysphagia, joint
pain and swelling, and shortness of breath. Pet’r’s Ex. 22 at 17–19. Dr. Lin switched Petitioner
from hydroxychloroquine to methotrexate 28 and recommended symptomatic care for the
Raynaud’s. Id. Petitioner followed up with Dr. Lin again on May 9, 2016, and he noted
Petitioner’s disease was stable, and her joint pains were better since starting methotrexate. Pet’r’s
Ex. 19 at 3–5.

        In addition to Dr. Lin, Petitioner saw other specialists throughout 2015 and 2016 for
evaluation of her varied symptoms. She saw a neurologist who assessed her with diffuse muscle
weakness, pseudodementia, 29 and sensory polyneuropathy. Pet’r’s Ex. 17 at 1-–5, Ex. 22 at 8–12.
An ophthalmologist diagnosed her with dry eyes and prescribed eye drops. Pet’r’s Ex. 14 at 9–16.
A gastroenterologist assessed her with acid reflux, dysphagia, and altered bowel function and
ordered further tests. Pet’r’s Ex. 14 at 5–7. A high-resolution esophageal motility study showed
frequent failed peristalsis, possibly indicating early scleroderma esophagus. Pet’r’s Ex. 12 at 2.
Next, Petitioner was referred to Joel Richter, M.D., a swallowing specialist, and she underwent a
gastric emptying study with abnormal results. Pet’r’s Ex. 22 at 1–7, 20–22. Dr. Richter assessed
her with “scleroderma with diffuse GI involvement, including bad esophageal reflux with
aperistalsis, gastroparesis, and colonic inertia with bad constipation.” Pet’r’s Ex. 22 at 21. Dr.
Richter referred her to a surgeon who determined she was not a good candidate for operative
intervention. Id. at 30–31.

        Pulmonologist, Kimberly Cao, M.D., evaluated Petitioner on May 18, 2015, for complaints
of shortness of breath and hoarseness, and referred her for a vocal cord evaluation. Pet’r’s Ex. 17

26
   Hydroxychloroquine is “a 4-aminoquinoline compound with antiprotozoal and anti-inflammatory
properties, used for suppression and treatment of malaria, for suppression of lupus erythematosus, and as
an anti-inflammatory disease-modifying antirheumatic drug in treatment of rheumatoid arthritis.”
Hydroxychloroquine sulfate, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=23495&searchterm=hydroxychloroquine+sulfate
(last visited Aug. 17, 2020).
27
   Dysphagia is “difficulty in swallowing.” Dysphagia, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=15265&searchterm=dysphagia (last visited Aug.
18, 2020).
28
   Methotrexate is “a folic acid antagonist that acts by inhibiting synthesis of DNA, RNA, thymidylate,
and protein; used as an antineoplastic in treatment of a wide variety of malignancies, including acute
lymphocytic, meningeal, and acute myelocytic leukemia; gestational choriocarcinoma; chorioadenoma
destruens; hydatidiform mole; carcinoma of the breast, lung, and head and neck; non-Hodgkin
lymphomas; mycosis fungoides; and osteosarcoma; administered orally. It is also used as an antipsoriatic
and antiarthritic in the treatment of severe, recalcitrant, disabling psoriasis and severe rheumatoid and
psoriatic arthritis.” Methotrexate, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=30930&searchterm=methotrexate (last visited
Aug. 18, 2020).
29
   Pseudodementia is “a disorder resembling dementia but that is not due to organic brain disease and is
potentially reversible by treatment; usually due to depression or other psychiatric disorder.”
Pseudodementia, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=41668&searchterm=pseudodementia (last visited
Aug. 18, 2020).

                                                    9
at 45–49. Although Petitioner was asymptomatic during assessment, her “complaints were
determined to be consistent with a component of vocal cord dysfunction.” Id. at 64. Repeated
chest CTs showed Petitioner’s lung nodules to be stable. Pet’r’s Ex. 19 at 6. A right heart
catheterization on June 26, 2015 was normal with no evidence of pulmonary hypertension. Id. at
16.

        Throughout 2015 and 2016, Petitioner continued to experience body pain and she attended
pain management appointments once or twice per month. See generally Pet’r’s Ex 23. She was
prescribed Percocet for pain and tizanidine, a muscle relaxer. Several referrals for physical therapy
are noted in the record, but it is unclear if she went. Pet’r’s Ex. 23 at 79, 120.

        Petitioner relocated to Illinois in 2017 and began treatment with Eric Graham, M.D. See
generally Pet’r’s Ex. 26. Dr. Graham saw Petitioner for the first time on January 24, 2017 and
wrote “[s]he is a 43 [year old] white female with a history of systemic scleroderma. [Petitioner]
has multiple other issues that give her problems sometimes, including Raynaud’s, DJD, PTSD,
and GI problems including gastroparesis and constipation.” Pet’r’s Ex. 26 at 67–69. Over the next
two years, Petitioner met with Dr. Graham once or twice per month for her symptoms.
Occasionally, her visits related to scleroderma, but were frequently due to other complaints, such
as respiratory infections or accidental injuries. See e.g. Pet’r’s Ex. 26 at 55–57, 49, 31–34, 16–19.

        Dr. Graham referred Petitioner to Monique Hinchcliff, M.D., of the Northwestern
Scleroderma Clinic. Dr. Hinchcliff saw Petitioner for the first time on March 20, 2017. Pet’r’s
Ex. 26 at 155. Dr. Hinchcliff examined Petitioner, noting 2008 as the year of Raynaud’s onset and
2015 as the year of onset of her joint pain (the first non-Raynaud’s symptom). Id. at 156. Although
Dr. Hinchcliff did not assess whether Petitioner met the 2013 ACR/EULAR 30 criteria for
scleroderma, she wrote her impression as “undifferentiated CTD versus SSC sine scleroderma.” 31
Id. at 155–160. Petitioner saw Dr. Hinchcliff again on April 14, 2017. Pet’r’s Ex. 24 at 1–5. Dr.
Hinchcliff wrote that Petitioner had a hepatitis vaccine in 2013 then developed flu-like symptoms,
such as joint swelling and pain. Id. Petitioner complained of weakness, muscle and joint pain, dry
eyes, and shortness of breath. Id. Dr. Hinchcliff again noted her impression as “undifferentiated
CTD versus SSC sine scleroderma,” with “GI involvement with gastroparesis, constipation[,] and
difficulty swallowing.” Id. Dr. Hinchcliff made recommendations regarding laxatives and exercise
and referred Petitioner to a gastrointestinal specialist and a dietician. Id.

30
   ACR/EULAR criteria—established by the American College of Rheumatology (ACR) and the
European League Against Rheumatism (EULAR)—are the classification criteria for systemic sclerosis
(SSc). In developing the criteria, the “objective was to develop a set of criteria that would enable
identification of individuals with SSc for inclusion in clinical studies, being more sensitive and specific
than previous criteria.” Frank van den Hoogen et al., 2013 Classification Criteria for Systemic Sclerosis,
65:11 Arthritis & Rheumatism 2737, 2737–39 (November 2013) (“This criteria has been approved by the
[ACR] Board of Directors and the [EULAR] Executive Committee.”).
31
   Dr. Hinchcliff indicated her impression of Petitioner’s condition as “undifferentiated CTD versus SSC
sine scleroderma.” I attribute Dr. Hinchcliff’s use of the word “versus” to account for the overlap in
Petitioner’s symptoms and to show that she suffers from one or both of these conditions simultaneously.
Therefore, throughout the Decision, I refer to Petitioner’s diagnosis interchangeably between
“undifferentiated CTD versus SSC sine scleroderma” and “undifferentiated CTD and SSC sine
scleroderma.”

                                                    10
        Petitioner returned to the Northwestern Scleroderma Clinic on January 18, 2019, for an
evaluation by Chase Correia, M.D. Pet’r’s Ex. 27 at 2–10. Dr. Correia wrote that Petitioner has
joint pains and Raynaud’s, mostly in her feet. Id. at 2. Dr. Correia ordered laboratory tests and
made a series of recommendations including following up with a specialist for her gastrointestinal
symptoms. Id. at 9. The lab tests revealed a positive SCL-70 and Petitioner’s first positive ANA,
speckled. Pet’r’s Ex. 31 at 9. Darren Brenner, M.D., evaluated Petitioner on February 6, 2019
and suggested further GI tests in order to determine future recommendations. Pet’r’s Ex. 33 at 4.

   B. Fact Testimony

        Petitioner testified at the entitlement hearing that she spent most of her life in Florida and
became a licensed practical nurse in 2005. Tr. 10:7–21. She worked as a nurse within a jail and,
due to the risks of working within the facility, received a hepatitis vaccination on June 27, 2013.
Tr. 11:8–21. She recalled receiving at least three hepatitis B vaccinations previously, but this
vaccine included hepatitis A, which she had not received before. Tr. 12:25–13:9.

        Although Petitioner stated she felt fine on the day of the vaccination, she described feeling
achy and unwell on the following Saturday. Tr. 12:14–15, 13:25. By Sunday morning, she noticed
her hands and feet were puffy, and she hurt all over like she had the flu. Tr. 14:1–3, 15:1–3. Her
husband took her to the Allen Ridge walk-in clinic, because she could not drive herself. Tr. 16:4–
6. Dr. Popp told her he thought she had acute rheumatoid arthritis. Tr. 16:14–25. She testified
that Dr. Popp knew she was in bad shape, because the swelling was visible, and he told her to see
her primary care doctor. Tr. 17:7–16.

       As an aside, Petitioner mentioned that prior to vaccination (she did not remember the date),
Dr. Lyon (her PCP) told her she had Raynaud’s. Tr. 18:1–11. She recounted that he noticed her
feet were gray, and she agreed that “they turn gray sometimes and they are cold.” Tr. 18:5–11.

        Petitioner testified that Dr. Popp’s records incorrectly state that she had been having
symptoms for a week, and she had a strong family history of rheumatoid arthritis. Tr. 19:8–19.
Petitioner clarified that only her grandmother on her mother’s side had rheumatoid arthritis, and
she would not have gone to work or received the vaccine if she had been symptomatic for a week.
Tr. 19:15–20:8. She was unsure who made the incorrect notes at Dr. Popp’s office. Tr. 19:20–
20:4.

         Next, Petitioner recounted an appointment with Dr. Lyon and stated that he thought she
had an STD or Reiter’s syndrome. Tr. 21:6–11. Dr. Lyon referred her to Dr. Mughni, a
rheumatologist, who thought she had fibromyalgia and chronic fatigue syndrome. Tr. 21:14–
22:21. As a nurse, she heard doctors talk about fibromyalgia. Tr. 22:22–23. Petitioner understood
that it is a “bucket disease” that is diagnosed when doctors do not know what is wrong with you.
Tr. 22:22–24. She thought Dr. Mughni would treat her symptoms even though he did not know
what was wrong with her, and she hoped it would give her some relief. Tr. 22:24–23:2.

        By August 1, 2013, Petitioner had tried steroids, which took the swelling down some and
antibiotics, that did nothing. Tr. 28:2–15. She was still in pain and looking for an answer. Tr.
28:13–15. Her symptoms interfered with her job, but she had helpful coworkers. Tr. 29:1–25.

                                                 11
She ultimately had to quit her job when she had to use two hands to give a shot, which is not safe.
Tr. 29:10–18. Her husband had to quit college and help at home. Tr. 29:5–9.

        Petitioner questioned the language in her medical records from October of 2013, including
the characterization of her illness as “chronic”, when she had only been sick for a month. Tr.
26:12–14. Petitioner also questioned the description of a “long standing history of fibromyalgia.”
Tr. 30:17–25. In her history, Petitioner described some neck pain prior to the vaccination, because
she was in a car accident when she was much younger and had ectopic pregnancies at ages 19 and
20. Tr. 31:9–25.

        Petitioner testified that she had surgery on her right hand in early 2014 to address carpal
tunnel syndrome. Tr. 33:8–12. She believes the surgeon, Dr. Reid, was the first doctor to mention
an autoimmune disorder. Tr. 34:6–24. The surgery helped with the palm of her hand but did not
help the swelling on her knuckles or her joints. Tr. 36:2–14.

       Petitioner testified that about eight months post-vaccination, she underwent pain
management that helped some, but the other symptoms persisted. Tr. 37:15–20. Dr. Rodriguez
ran a panel of tests and told her the blood test was “highly positive for scleroderma.” Tr. 37:9–
38:3. She took the test again with the same result. Tr. 38:4–6. She had not previously heard of
scleroderma. Tr. 38:18–21.

         Petitioner was still working three days a week about a year after the vaccination with the
assistance of her coworkers. Tr. 40:11–15. She was unable to tend to her hair and spent a lot of
time going to doctors to find out what was wrong with her. Tr. 40:16–23. She stopped playing
softball and gave up her hobbies. Tr. 41:5–6. She was on hydrocodone at that point and a pain
management physician put her on Percocet and muscle relaxers. Tr. 41:15–19. Next, Petitioner
tried a fentanyl patch, but it caused blurry vision. Tr. 41:20–24. Petitioner went back down to
Percocet and has “pretty much stayed” on that, because she cannot handle stronger pain
medication. Tr. 42:1–3.

        Petitioner testified that a gastroenterologist, Dr. Richter, sent her for tests as part of a
workup for scleroderma, because she was starting to choke when she ate. Tr. 42:13–43:22. Among
other things, they shoved a tube down her nose and gave her water to drink while she was hooked
up to machines. Tr. 43:15–25. Her test results indicated gastroparesis, and that her stomach was
not churning to push the food out. Tr. 46:1–10. She temporarily stopped her pain medications
several days before the test so they would not interfere with the results. Tr. 46:13–47:12.

       Petitioner said she moved to Illinois to see Dr. Hinchcliff at the scleroderma clinic in
Chicago, even though she loved living in Florida with her friends and family. Tr. 48:7–50:5. Dr.
Hinchcliff and the Scleroderma Clinic improved her life by giving her the right treatments and the
right medicines. Tr. 50:11–51:6. Petitioner is down to two Percocets and can walk without a
walker. Tr. 51:7–8. She follows a recommended diet and uses a pool to improve function. Tr.
51:3–13.

       Petitioner testified that her eyes feel very dry, describing the sensation as like “a cat’s
tongue licking across [her] eyes.” Tr. 52:5–12. Her doctors have explained that it is part of the

                                                12
scleroderma and she has prescription eye drops now. Tr. 52:6–14. She continues to have arthralgia
pain, and she takes Percocet, Prednisone, and sometimes a Medrol dose pack. Tr. 53:2–9. Her
gastric system “is basically a mess.” Tr. 53:14. She has to carefully chew her food, or she will
choke when she swallows. Tr. 53:14–17. Once she gets it down, the food just sits in her stomach
and makes her miserable. Tr. 53:17–20. She also struggles with constipation. Tr. 54:4–15. Dr.
Hinchcliff has told her the disease is progressive but not to be scared, because they have
“modalities” and will do the best they can to care for her. Tr. 54:16–25.

       Upon my questioning, Petitioner stated that the notations in her medical records of the
fibromyalgia diagnosis and family history of rheumatoid arthritis were carried forward by her
doctors unbeknownst to her. Tr. 58:2–5. She testified that she was not asked about it or asked to
confirm it. Tr. 58:6–15. Petitioner also indicated that none of her doctors talked about being
concerned about side effects of the drugs she was taking. Tr. 58:16–21.

   III.      Experts

          A. Expert backgrounds

             1. Petitioner’s Expert, Vera Byers, M.D., Ph.D.

        Dr. Byers submitted two expert reports and testified at the entitlement hearing. Pet’r’s Exs.
20, 25; Tr. 61–142, 224–228. Dr. Byers received her Ph.D. in immunology from the University
of California at Los Angeles in 1969 and her medical degree from the University of California at
San Francisco in 1981. Pet’r’s Ex. 21 at 1. She completed her residency at the University of
California at San Francisco in 1984 and became board-certified in internal medicine the same
year. Id.

         Over the course of her career, Dr. Byers has held numerous academic and research
positions, including serving as an adjunct professor of immunodermatology at the University of
California at San Francisco from 1976–2008. See id. at 1–5. She currently serves as the President
of Immunology, Inc., where her responsibilities include “[d]esign[ing] Phase I, II, [and] III clinical
trials in autoimmune disease[s] and cancer[s],” and “present[ing] data at national and international
scientific meetings and grand rounds.” Pet’r’s Ex. 21 at 1–2. Dr. Byers also has “[o]ver [three
hundred] articles and abstracts published in peer[-]reviewed medical journals . . . .” Id. at 1. She
currently “serves on the editorial board[s] of two leading cancer journals (Cancer Immunology and
Immunotherapy), and [on National Institute of Health] review panels in tumor immunology.” Id.

        At the hearing, Petitioner offered Dr. Byers as an expert in clinical immunology with no
objection from Respondent. Tr. 73:11–74:4. Petitioner also offered Dr. Byers as an expert in
rheumatology, but Respondent objected. Tr. 77:21–22. Dr. Byers testified that her only expertise
in the diagnosis of scleroderma was acquired during her residency for internal medicine and three-
year fellowship where she saw rheumatologic conditions. Tr. 75:8–24. She noted no specialized
rheumatology training. Tr. 75:19–24. Petitioner stated that Dr. Byers was qualified to read and
interpret what treating doctors have done and confirmed that she would not make any separate
rheumatological diagnoses as part of her testimony. Tr. 78:1–7.

                                                 13
            2. Respondent’s Expert, Chester Oddis, M.D.

        Dr. Oddis submitted three expert reports and testified at the entitlement hearing. Resp’t’s
Ex. A, C, E; Tr. 143–221. Dr. Oddis received his medical degree from Pennsylvania State
University in 1980 where he subsequently performed his internship and residency in internal
medicine. Resp’t’s Ex. B at 2. He is board-certified in both internal medicine and rheumatology.
Resp’t’s Ex. A at 1. He is currently serving as the Director of the Myositis Center, where he sees
patients three days a week and performs clinical research in rheumatology. Id.; Tr. 144. His
primary clinical and research interests for the past 30 years include all features of the idiopathic
inflammatory myopathies. Resp’t’s Ex. A at 2. Dr. Oddis has seen and consulted on hundreds of
scleroderma patients during his career. Id. at 1. He has over 100 peer-reviewed publications and
over 50 invited articles or book chapters. Id. at 1–2.

       Respondent offered Dr. Oddis as an expert in clinical immunology, rheumatology, and the
treatment and diagnosis of scleroderma. Tr. 146:15–18. Petitioner did not object. Tr. 146:19–21.

        B. Expert Reports and Testimony

            1. Dr. Byers

        It is Dr. Byers’s opinion, to a reasonable degree of medical certainty, that the vaccination
“caused or substantially contributed to the onset of [Petitioner’s] autoimmune disorder.” Pet’r’s
Ex. 20 at 7. Although her overall opinion never wavered, Dr. Byers’s supporting rationale evolved
throughout the course of this case. In her first report, dated August 24, 2016, Dr. Byers described
Petitioner as “a complicated case, which is not unusual in autoimmune diseases like MCTD or
scleroderma.” Id. at 5. Dr. Byers stated that it was clear that Petitioner had an autoimmune disease
based on poor esophageal motility, SCL-70 antibody, polyarthralgias, and fatigue. Id. However,
Dr. Byers felt the safest diagnosis to make at the time was MCTD rather than scleroderma. Id.
Dr. Byers described a puzzling lack of skin involvement and noted that no rheumatologist had
diagnosed Petitioner with scleroderma although there was some mention of the diagnosis in the
medical records. Id. at 5–6. She noted that Petitioner had Raynaud’s but mentioned that carpal
tunnel syndrome can also cause that condition. Id.

        Dr. Byers stated that she arrived at this opinion because Petitioner had a genetic propensity
to autoimmune disorders (based on family history), combined with a “temporal association” of
symptoms of autoimmune disease appearing three days after vaccination. Pet’r’s Ex. 20 at 6-7.
She further wrote that the “association between Hepatitis B vaccination and connective tissue
disease is supported by the literature[,]” 32 and that there are “18 reports in the VAERS 33 data base

32
   Michael A. Mancano, ISMP Adverse Drug Reactions 49(3) Hospital Pharmacy 227-231 (2014);
Vincenzo Bruzzese et al., Connective Tissue Disease Following Hepatitis B Vaccination 19(5) J.
CLINICAL RHEUMATOL. 280-81 (2013).
33
   VAERS, the Vaccine Adverse Event Reporting System, is “a national early warning system to detect
possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease
Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). . . . VAERS is a
passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC
and FDA. VAERS is not designed to determine if a vaccine caused a health problem but is especially

                                                    14
associating Hepatitis B vaccination with mixed connective tissue disease.” Id. at 7. Dr. Byers
explained that, in her opinion, the “mechanism of action [is] probably due to activation of T cells
and/or antibodies present from her earlier vaccination which release[d] cytokines that are capable
of activating autoreactive T cells.” 34 Id.

        Dr. Byers submitted a second report almost a year later in response to concerns raised in
Dr. Oddis’s first report. Pet’r’s Ex. 25. First, Dr. Byers noted Dr. Hinchcliff’s diagnosis of
connective tissue disease versus sine scleroderma (the latter which does not usually involve skin
manifestations). Pet’r’s Ex. 25 at 1–2. Second, Dr. Byers stated that although Petitioner had
Raynaud’s syndrome and was thus at risk of developing an autoimmune disorder, “many people
with Raynaud’s, perhaps a majority, never develop any form of autoimmune disorder.” Pet’r’s
Ex. 25 at 2. Dr. Byers agreed with Dr. Oddis that three weeks between vaccination and the
abnormal esophageal motility test is too short to develop diffuse scarring associated with
scleroderma. Id. However, Dr. Byers asserted that “scarring is preceded by inflammation which
causes the same symptoms, and the time period is correct for development of inflammation
associated with the onset of [Petitioner’s] autoimmune disease process after vaccination.” Id. Dr.
Byers also agreed that a positive ANA is characteristic of connective tissue disease, but not all
cases have it. Id. Finally, Dr. Byers concluded that although Petitioner’s condition “does not fall
into the precise ‘pigeon hole’ that most rheumatologists, including Dr. Oddis, would prefer,”
Petitioner “has an autoimmune disease [similar to] connective tissue disease/sine scleroderma, and
it was caused or contributed to by the vaccinations she received [in] June 2013.” Id. at 2.

        At the entitlement hearing, Dr. Byers began by defining general concepts. She explained
that “[m]ixed connective tissue disease is one of the four categories of rheumatologic diseases that
falls under the umbrella of overlap syndromes.” Tr. 78:16–18. She then identified four additional
diseases that fall under that umbrella: “systemic lupus erythematosus, polymyositis, scleroderma,
and rheumatoid arthritis.” Tr. 78:18–20. These four diseases are called “overlap syndromes”,
because they do “not declare themselves … for a long time.” 35 Tr. 78:20–22. She went on,
“[m]ixed connective tissue disease is arthralgias, arthritis” and “can have a strong component of
esophageal dysmotility.” Tr. 79:3–5. MCTD can look very similar to other autoimmune diseases
and is associated with “anti-RNP 36 antibodies and also with ANA antinuclear antibodies with a
speckled pattern.” Tr. 79:7–13. An autoimmune disorder is when the body’s immune system
“react[s] against self-proteins and causes damage.” Tr. 79:17–22.             She continued, “[i]n
scleroderma the fibroblasts secrete collagen and the collagen kind of holds us all together. And
it’s thought or at least was thought recently that there [are] cytotoxic T cells that are directed

useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a
possible safety problem with a vaccine.” About VAERS, VAERS, https://vaers.hhs.gov/index.html (last
visited Aug. 18, 2020).
34
   Agmon-Levin, N. et al., Vaccines and Autoimmunity, NAT. REV. RHEUMATOL. (2009) 5:648-652.
35
   Upon my questioning later in the hearing, Dr. Byers attempted to clarify these categories and primarily
confirmed that autoimmune conditions are difficult to diagnose due to overlapping symptoms. Tr. 131-
133.
36
   RNP is an abbreviation for ribonucleoprotein and is “a complex of protein and ribonucleic acid.”
Ribonucleoprotein, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=43852 (last visited Aug. 18, 2020).

                                                    15
against the fibroblasts. And they release the collagen and then the collagen causes scarring in both
the skin and the internal organs.” Tr. 80:6–12.

        Dr. Byers described two types of scleroderma: systemic (which involves internal organs
but primarily presents as lesions on the skin) and sine (which involves internal organs but not the
skin). Tr. 81:3–11. Connective tissue disease and scleroderma are both autoimmune disorders,
and Dr. Byers noted that quite a few autoimmune diseases closely follow infections. Tr. 82:19–
23. Dr. Byers testified that the vaccine community usually considers that if an autoimmune disease
“is triggered by an infectious agent, it [is] also triggered by the vaccine for that infectious agent.”
Tr. 82:23–83:2. She further testified that, in her opinion, hepatitis B vaccine can trigger
autoimmune disease process. Tr. 83:3–5. She explained that the hepatitis B vaccination “can
trigger demyelinating diseases by a mechanism called molecular mimicry.” Tr. 83:6–14. She said
she knew of no “cross-reactivity between hepatitis B and either mixed connective tissue disease or
scleroderma, but it is accepted by the vaccine community that, in fact, it can do the same thing by
something called bystander activation.” Tr. 83:7–14. All vaccines release cytokines and
“[b]ystander activation is primarily a cytokine dysfunction in which the vaccination triggers
autoreactive T cells on the basis of the cytokine release.” Tr. 83:15–21. If people have had
previous vaccines of the same type, there are “memory cells” or autoreactive T cells that can react
much faster if vaccinated again. Tr. 83:18–84:8. If someone has had a hepatitis B vaccine before,
Dr. Byers testified that a subsequent vaccine can cause a reaction in about four to seven days. Tr.
84:9–17.

        In Petitioner’s case, Dr. Byers indicated she did not see any triggers that might cause an
immunological response other than the hepatitis B vaccine. Tr. 84:18–24. Dr. Byers thought
Petitioner experienced the side effects commonly seen in the days immediately following the
vaccination she received on June 27, 2013. Tr. 85:3–16. By July 1, 2013, Petitioner presented
with swelling of the hands and feet and was later described by Dr. Fattah as having muscle pain,
swollen joints, [and] numbness of the fingers. Tr. 85:10–86:6. Dr. Byers testified that these
symptoms presented four days post-vaccination and are within the time window for the vaccination
to be the trigger in her case. Tr. 86:7–11. She was uncertain of what the “current rheumatologic
community” thinks the mechanism of action is for initiation of scleroderma. Tr. 86:12–22.

        Next, Dr. Byers explained that Raynaud’s syndrome is a vascular instability associated
with autoimmune diseases, particularly rheumatologic ones, that causes hands or feet to get very
cold and change color. Tr. 87:2–17. It can be a harbinger of an autoimmune disease, but at least
50 percent of people who have Raynaud’s never develop an autoimmune disease. Tr. 87:12–17.
Dr. Byers was not convinced that Petitioner has Raynaud’s, because Petitioner denied the color
change, and maintained that this diagnosis incorrectly “followed her through the medical records”
without confirmation. Tr. 87:21–88:4. Dr. Byers discounted Petitioner’s strong family history of
rheumatoid arthritis after Petitioner clarified that only a maternal grandmother had the condition.
Tr. 88:11–25.

        Dr. Byers testified that SCL-70 and ANA tests are both important diagnostics in
scleroderma cases. Tr. 89:1–22. SCL-70 is a small, fragile protein, and if it is elevated, it can
indicate scleroderma. Tr. 89:6–17. It can also indicate that the serum was damaged through
improper handling resulting in a false positive. Tr. 89:11–17. Petitioner, however, has had several

                                                  16
positive SCL-70 tests, which suggests it is not a false positive. Tr. 90:3–10. Dr. Byers noted that
Petitioner’s several negative ANA tests do not mean she did not have scleroderma. Tr. 90:18–
93:10. Dr. Byers testified that by January 18, 2019, Petitioner “developed a positive ANA speckled
pattern.” Tr. 95:23–96:1.

        Dr. Byers asserted that when Petitioner described swollen hands and feet with aches and
pain occurring on the Sunday after vaccination, Petitioner was describing arthralgia, which is the
early phase of “some kind of rheumatologic autoimmune disease.” Tr. 96:2–15. The pain
progressed and continued because autoreactive T cells were activated against “various components
of the rheumatologic system.” Tr. 97:7–13. The symptoms improved with methotrexate, which
has been quite successful in several autoimmune diseases. Tr. 97:18–25. This suggests, Dr. Byers
contended, that Petitioner’s disease is similar. Tr. 97:23–98:1.

       Dr. Byers pointed out that Petitioner underwent several gastroenterology tests, which
caused the specialist to conclude she had scleroderma with diffuse GI disease, rather than gastric
esophageal reflux disease. Tr. 99:3–100:18.

        Dr. Byers testified that she agrees with Dr. Hinchcliff’s diagnosis of sine scleroderma
versus undifferentiated connective tissue disease. Tr. 106:8–17. Dr. Byers thinks Petitioner has
either (or both) of these diagnoses and they overlap. Dr. Byers also thinks it is possible that they
will overlap for the rest of Petitioner’s life without declaring itself. Tr. 106:13–21.

        On cross examination, Dr. Byers explained that her opinion that the vaccination caused a
reaction within four to seven days assumes that Petitioner had received previous hepatitis vaccines.
Tr. 113:17–19. Although Dr. Byers did not have Petitioner’s vaccination record, she conceded
that the reaction would take longer if it was the first vaccination. Tr. 114:1–9. Assuming Petitioner
received previous hepatitis vaccines, Dr. Byers explained that the immune system would activate
the cytokines (which cause inflammation) within hours of receiving the vaccination and be
symptomatic by “about the fourth day.” Tr. 115:1–11. Dr. Byers agreed that one would expect to
see some type of damage as a result of inflammation. Tr. 116:1–4.

        Dr. Byers testified that inflammation “can morph into the cytotoxic T cells and antibodies”
and “[t]he T helper cells will turn on the antibody-forming cells, which then can produce damage
by attacking the self-proteins.” Tr. 117:11–17. Then she continued, “the cytotoxic cells will cause
damage by directly going against the organ and chewing it up.” Tr. 117:15–17. She was unsure
of how long to expect an inflammatory process to show damage to the tissue it is affecting. Tr.
117:18–20.

         ESR, Dr. Byers noted, is used to detect the presence of inflammation caused by infections,
tumors, or autoimmune diseases, but Dr. Byers was unsure whether it also measures the degree of
inflammation in the body. Tr. 117:21–118:9. She also mentioned the C-reactive protein (“CRP”)
test as another test used to see whether there is “active and ongoing inflammation.” Tr. 118:10–
16. Although she agreed that one would expect Petitioner to have markers of inflammation over
the last five years, Dr. Byers asserted that sometimes the ESR and CRP tests pick up inflammation,
and sometimes they do not. Tr. 118:13–119:6.

                                                 17
        Dr. Byers explained that arthralgia and arthritis were used to describe Petitioner’s
condition. Tr. 119:7–20. It was beyond her expertise to explain whether one could have an
arthralgia that is not an arthritis. Tr. 119:21–25. According to Dr. Byers, the first manifestation
of Petitioner’s autoimmune disease was the swelling in her hands and legs, but the first
manifestation of scleroderma was “when she started complaining of difficulty swallowing.” Tr.
120:1–14.

         Dr. Byers testified that “[r]heumatologic autoimmune diseases in general can be associated
with infections or vaccinations,” but she was vague on whether there are known causes of
scleroderma. Tr. 120:15–23. She agreed there is no medical literature linking vaccinations to
scleroderma. Tr. 120:24–121:2. She did not know if the mechanism of injury in rheumatoid
arthritis is the same as the mechanism of injury in scleroderma. Tr. 121:5–7. She testified that
she reviewed medical literature and databases that showed there is a proximal association between
the receipt of the hepatitis B vaccination and mixed connective tissue disease but no determination
that the hepatitis B vaccine causes mixed connective tissue disease. Tr. 122:3–12.

        When asked about the 18 VAERS reports that she referenced in her first report, Dr. Byers
agreed that it is a passive reporting system that does not attribute causality in any case. Tr. 126:11–
13. Rather, it just reports a suspicion and one would need to do a randomized clinical trial to prove
causation. Tr. 126:11–19. Dr. Byers explained that the VAERS system is intended to serve as a
warning system to pharmaceutical companies and regulatory agencies that there may be a problem
that should be further researched. Tr. 127:1–4.

        Dr. Byers clarified that her indication in her first report that Petitioner had a “clear genetic
propensity to an autoimmune disease[,]” was based on medical records that she has since realized
were incorrect after interviewing Petitioner. Tr. 129:6–21. She also addressed the issue of whether
Petitioner has Raynaud’s saying that instead “[s]he just had swelling. And, it’s possible that the
swelling caused a decrease in the vascularity of the swollen limbs, which could have appeared
gray.” Tr. 136:11–137:9. Dr. Byers was unable to explain the difference between primary
Raynaud’s and secondary Raynaud’s. Tr. 124:5–7.

        Dr. Byers testified that when a vaccine is given, there is an immunological response within
hours. Tr. 140:11–19. This response is the innate immune system producing a variety of cytokines.
Tr. 140:20–23. She testified that everyone gets some reactions to vaccines, but cytokines are going
to be activating the adaptive immune system. Tr. 141:8–18. The resulting symptoms can be either
the activation of the adaptive immune system or the innate immune system. Tr. 141:15–18.
Petitioner was complaining of significant hand and foot pain on Sunday following the vaccination.
Tr. 141:2–25. Dr. Byers testified that it could be either the adaptive or innate immune system, but
it would be the vaccine that caused it. Tr. 141:19–142:6.

           2. Dr. Oddis

        Dr. Oddis submitted a report dated November 17, 2016. Resp’t’s Ex. A. He disagreed that
Petitioner met the criteria for scleroderma, or for any autoimmune disorder, and he opined that her
chronic pain is likely related to her established diagnosis of PTSD. Id. at 7. He pointed out that
Petitioner had a history of Raynaud’s phenomenon, musculoskeletal pain, and PTSD before the

                                                  18
vaccination. He noted that her gastrointestinal symptoms, later considered by her doctors to be
scleroderma-related, began only three weeks after the vaccination. Id. at 4–5. Dr. Oddis further
noted that Petitioner never developed skin changes associated with scleroderma, she has no
pulmonary involvement, and there is no documented inflammation of her joints. Id. at 4.
Additionally, Petitioner’s gastrointestinal symptoms can all be explained by her pre-existing
GERD or her chronic narcotic use. Id. Finally, regarding Petitioner’s lab reports, Dr. Oddis
emphasized that “[i]t is essentially impossible for the ANA to be negative in the setting of a
positive anti-SCL-70 autoantibody!” Id. at 4. Therefore, he concluded that Petitioner’s positive
SCL-70 test was a false positive. Id. at 5.

         On July 28, 2017, Dr. Oddis reviewed Petitioner’s updated medical records and authored
a supplemental report. Resp’t’s Ex. C. He noted that Dr. Hinchcliff reviewed the signs and
symptoms of scleroderma and found that, of the listed symptoms, Petitioner only had Raynaud’s.
Id. at 2. Dr. Oddis wrote that Petitioner’s “primary rheumatic disease manifestations, Raynaud’s
phenomenon and GERD, predated the hepatitis vaccine.” Id. He continued that “the gastroparesis
noted to be secondary to scleroderma was likely related to chronic narcotic administration, which
[Petitioner] continues to take.” Id. He concluded that Petitioner meets no criteria for an
autoimmune disease and in his opinion, the hepatitis vaccination she received in no way
contributed to any of her subsequent medical problems. Id. at 3.

         Dr. Oddis considered Petitioner’s diagnosis again in 2019 and provided a third report.
Resp’t’s Ex. E. Even though Petitioner received a laboratory finding that showed a positive ANA
test, his opinion that Petitioner does not have scleroderma remained unchanged. Id. at 1. In
support of his opinion, he noted that the SCL-70 test is “primarily associated with diffuse
scleroderma, which [Petitioner] clearly does not have[,]” and she continues to “manifest no overt
features of systemic sclerosis (i.e. scleroderma).” Id. He stated that it was still his opinion that
“the medical evidence in this case fails to show [Petitioner] suffered a vaccine-induced
autoimmune disorder” for several reasons. Id. at 1–2. First, the initial manifestation of an
autoimmune condition was Raynaud’s phenomenon, and it preceded the vaccination by at least
five years. Id. at 2. Next, Petitioner never developed any additional objective manifestations of
scleroderma including joint inflammation (all tests of inflammation markers have been normal),
scleroderma lung, cardiac, or renal features. Id. Petitioner’s symptoms of joint and
musculoskeletal pain also predated the vaccination and are not features of scleroderma. Id. Lastly
her esophageal symptoms are non-specific and could be attributable to other causes. Id.

        At the entitlement hearing, Dr. Oddis provided an overview of autoimmunity by comparing
it to a church with pews marked “rheumatoid arthritis,” “scleroderma,” “polymyositis,” or
“multiple sclerosis.” Tr. 147:18–148:3. Patients sitting in these different pews have laboratory
tests that show where they should sit in the “church of autoimmunity.” Tr. 148:1–7. Patients with
overlap syndrome cannot find the appropriate pew because they have features of more than one
autoimmune disease. Tr. 148:8–12. Dr. Oddis continued explaining that there is another distinct
pew in the church labeled, MCTD. Tr. 148:13-17. There are four diseases that are part of MCTD:
polymyositis, rheumatoid arthritis, systemic lupus, and scleroderma. Tr. 148:20–25. Patients with
MCTD may have more symptoms of one disease than another[,] but what they all have is a positive
ANA that is “high titer speckled pattern[,]” because that is how MCTD is classified. Tr. at 149:1–
6. Dr. Oddis does not think that Petitioner meets the criteria for MCTD. Tr. 150:3–16. The most

                                                19
recent ANA test in 2019 was positive, but it was not a high titer in a speckled pattern. Tr. 150:9–
16.

        Dr. Oddis testified that the combination of a positive SCL-70 and a negative ANA does
not exist and is a red flag in diagnosing scleroderma. Tr. 151:15–152:11. However, he then stated
that 96 percent to 99 percent of patients have positive results for both tests. Tr. 151:15–152:11.
Dr. Oddis defined sine scleroderma as scleroderma without skin manifestations such as
sclerodactyly, which is thickening of the fingers, hands, and toes. Tr. 154:11–20. He then
questioned Petitioner’s diagnosis of sine scleroderma by explaining internal manifestations that
Petitioner does not have, including fibrosis of the lung, renal crisis, or inflammatory joint pain.
Tr. 156:17–157:10. He reviewed Petitioner’s gastrointestinal condition noting that symptoms were
reported within three weeks of the vaccination but appeared to have started prior to the vaccination.
Furthermore, these symptoms never advanced to pseudo-obstruction or gastric antral vascular
ectasia, two scleroderma related GI conditions. Tr. 157:11–158:12.

         Dr. Oddis testified that although Petitioner claimed her hands and feet were swollen, he
reviewed all her records and did not see any clinical notes that described objective evidence of
swollen joints. Tr. 159:1–160:3. Dr. Oddis described rheumatoid arthritis as “the prototypical
arthritis in autoimmunity.” Tr. 160:12–18. He explained that arthritis is an inflammatory
condition and a patient with rheumatoid arthritis over time would have joint destruction if left
untreated. Tr. 160:12–18. He stated that the erythrocyte sedimentation rate and the C-reactive
protein are common tests to identify inflammation, and Petitioner’s tests from 2013 to 2019 did
not show either to be elevated. Tr. 160:22–161:12.

        Dr. Oddis next turned to Dr. Byers’s opinion that the vaccination injured Petitioner through
the process of bystander activation. Dr. Oddis agreed that “T cells are part of the immune system
and whenever they are activated, they release cytokines.”           Tr. 163:1–6. Cytokines are
inflammatory mediators and are capable of bringing in other types of inflammatory cells creating
a “cascade of inflammation that occurs whenever an inflammatory process is initiated and
perpetuated.” Tr. 163:1–24. If such a process happened in Petitioner, Dr. Oddis testified he would
expect to see objective evidence in the medical records of elevated inflammatory markers in the
blood or confirmation by a physician’s examination that there was swelling, thus indicating
inflammation in the joints. Tr. 164:10–23. He did not see laboratory tests or physical examinations
that showed such a process. Tr. 164:10–23.

         Dr. Oddis disagreed with Dr. Byers’s conclusion that Petitioner’s “clinical course went
significantly downhill after receipt of her June 27, 2013 vaccination.” Tr. 166:13–23. Dr. Oddis
testified that he would expect to see not just skin changes, but also other organ manifestations such
as lung, kidney, and heart, and he did not see a progressive accumulation of symptoms in the
medical record. Tr. 168:2–9. He discussed Petitioner’s GI complaints in more detail. When
Petitioner saw Dr. Mughni, he noted Petitioner’s complaints of constipation and acid reflux
approximately three weeks after the vaccination. Tr. 169:9–170:6. Dr. Oddis stated that if these
symptoms of bowel and esophageal involvement are early signs of scleroderma, there is no way
to relate them to the vaccination because scleroderma scarring could not occur so quickly. Tr.
170:7–24. It would also be unlikely that a scleroderma patient would experience inflammation in

                                                 20
just the esophagus without objective evidence of inflammation in other tissues such as the skin or
the joints. Tr. 172:19–173:16.

        Dr. Oddis testified that it is possible that fibromyalgia could have caused the joint pain
Petitioner was complaining of during the period after the vaccination. Tr. 173:17–174:12.
Petitioner was diagnosed with fibromyalgia, and Dr. Beyley confirmed she had 18 tender points.
Tr. 174:21–176:10. Dr. Oddis testified he knows of no evidence showing the hepatitis vaccine
causes fibromyalgia. Tr. 177:11–13. Petitioner also complained of muscle weakness but
subsequent EMGs and a muscle biopsy were all normal. Tr. 177:14–178:11.

       During cross examination, Dr. Oddis agreed that autoimmune diseases can be triggered but
did not know of any evidence that they could be triggered by vaccination. Tr. 190:15–23. Dr.
Oddis defined a trigger as an immune response activator that cascades into the disease. Tr. 191:18–
25. He could not say the length of time between the trigger and the manifestation of an
autoimmune disease, because it varies depending on the patient. Tr. 192:1–25. He testified that
the medical community still does not know what the trigger is for lupus, rheumatoid arthritis,
scleroderma, or myositis. Tr. 193:5–17. Dr. Oddis stated that, without more data, he did not have
an opinion on the immunologic concept of bystander activation. Tr. 206:1–9. He did not discount
the possibility that a vaccine could trigger a disease that had already started, but he would need to
see objective evidence of inflammation. Tr. 207:15–208:18.

        Later, upon further questioning from Respondent’s counsel, Dr. Oddis reviewed the July
1, 2013 note written by the first doctor to examine Petitioner after the vaccination. Tr. 211:21–
212:9. The note was made four days after vaccination, and Dr. Oddis testified that the doctor
indicated normal range of motion, normal strength, and no swelling. Tr. 212:3–21. Dr. Oddis
explained that a doctor can detect swelling, because it feels “mushy.” Tr. 212:12–213:6. This is
called synovitis or inflammation. Tr. 213:1–6. Finally, Dr. Oddis explained that fibromyalgia
complicates the treatment of even well-documented autoimmune diseases, since a patient can have
both. Tr. 219:4–221:21.

   IV.       Applicable Legal Standard

        To receive compensation under the Vaccine Act, Petitioner must demonstrate either that:
(1) she suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table –
corresponding to the vaccine in question within the time frame prescribed by the Vaccine Injury
Table set forth at § 14, as amended by 42 C.F.R. § 100.3; or (2) that her illness is an “off-Table
Injury,” one not listed on the Table, that resulted from her receipt of a covered vaccine. See §
11(c)(1)(C); Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010);
Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1319–20 (Fed. Cir. 2006).
Petitioner does not assert a Table claim. Thus, she must prove that her vaccine was the cause-in-
fact of her injury.

        To establish causation-in-fact, Petitioner must demonstrate by a preponderance of the
evidence that the vaccines were the cause of her injury. § 13(a)(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

                                                 21
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). Petitioner must demonstrate that the vaccine
was “‘not only [the] but-for cause of the injury but also a substantial factor in bringing about the
injury.’” Moberly, 592 F.3d at 1321–22 (quoting Shyface v. Sec’y of Health & Human Servs., 165
F.3d 1344, 1352–53 (Fed. Cir. 1999)). The vaccine received, however, need not be the
predominant cause of the injury. Shyface, 165 F.3d at 1351.

         A petitioner may not receive a Vaccine Program award based solely on her assertions;
rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1). In Althen v. Sec’y of Health & Human Servs., the Federal Circuit set
forth a three-pronged test used to determine whether a petitioner has established a causal link
between a vaccine and the claimed injury. See 418 F.3d 1274, 1278 (Fed. Cir. 2005). The Althen
test requires a petitioner to set forth: “(1) a medical theory causally connecting the vaccination and
the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason
for the injury; and (3) a showing of a proximate temporal relationship between vaccination and
injury.” Id. To establish entitlement to compensation under the Program, a petitioner is required
to establish each of the three prongs of Althen by a preponderance of the evidence. See id. (internal
citations omitted).

        Specifically, under the first prong of Althen, a petitioner must offer a scientific or medical
theory that answers in the affirmative the question “can [the] vaccine(s) at issue cause the type of
injury alleged?” See Pafford v. Sec’y of Health & Human Servs., No. 01-0165V, 2004 WL
1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004), aff’d, 64 Fed. Cl. 19 (2005), aff’d, 451 F.3d
1352 (Fed. Cir. 2006). This may be accomplished in a number of ways. “Reliability and
plausibility of . . . pathogenesis can be bolstered by providing evidence that at least a sufficient
minority in the medical community has accepted the theory, so as to render it credible.” Id.
Additionally, “epidemiological studies and an expert’s experience, while not dispositive, lend
significant credence to the claim of plausibility.” Id. Medical literature published in respected
medical journals is also persuasive. Id. “However, publication ‘does not necessarily correlate
with reliability,’ because ‘in some instances well-grounded but innovative theories will not have
been published.’” Id. (quoting Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 593–94 (1993)
(emphasis in original)). Furthermore, a petitioner is not required to present medical literature or
epidemiological studies to prove her burden. Grant v. Sec’y of Health and Human Servs., 956
F.2d 1144, 1149 (Fed. Cir. 1992); Andreu v. Sec’y Health & Human Servs., 569 F.3d 1367, 1380
(Fed. Cir. 2009). However, to the extent medical literature and epidemiological studies are
provided, these are subject to critique by Respondent’s experts, and the special master will
consider them when deciding whether the petitioner has met her burden of proof. Special masters,
despite their expertise, are not empowered by statute to conclusively resolve what are essentially
thorny scientific and medical questions, and thus scientific evidence offered to establish Althen
prong one is viewed “not through the lens of the laboratorian, but instead from the vantage point
of the Vaccine Act’s preponderant evidence standard.” Id. at 1380. But this does not negate or
reduce a petitioner’s ultimate burden to establish his overall entitlement to damages by
preponderant evidence. W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir.
2013) (citations omitted).

                                                 22
        In addition to showing that the vaccine at issue can cause a particular injury, a petitioner
must also, under Althen’s second prong, prove that the vaccine actually did cause the alleged injury
in her particular case. See Pafford, 2004 WL 1717359, at *4; Althen, 418 F.3d at 1278. A
petitioner does not meet this obligation by showing only a temporal association between the
vaccination and the injury; the petitioner “must explain how and why the injury occurred.” Pafford,
2004 WL 1717359, at *4 (emphasis in original) (internal citations omitted). Ruling out other
potential causes is an important element but does not itself establish causation. Id. Additionally,
conjecture or speculation does not meet the preponderance standard. Id.

        Although a temporal association alone is insufficient to establish causation, under the third
prong of Althen, a petitioner must show that the timing of the injury fits with the causal theory.
See Althen, 418 F.3d at 1278. The special master cannot infer causation from temporal proximity
alone. See Thibaudeau v. Sec’y of Health & Human Servs., 24 Cl. Ct. 400, 403–04 (Fed. Cl. Oct.
23, 1991); see also Grant, 956 F.2d at 1148 (“‘[T]he inoculation is not the cause of every event
that occurs within the ten[-]day period. . . . Without more, this proximate temporal relationship
will not support a finding of causation.’” (quoting Hasler v. United States, 718 F.2d 202, 205 (6th
Cir. 1983))). 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.” de 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).

        Petitioners who demonstrate by a preponderance of the evidence that they suffered an
injury caused by vaccination are entitled to compensation, unless Respondent can demonstrate by
a preponderance of the evidence that the injury was caused by factors unrelated to the vaccination.
See Althen, 418 F.3d at 1278; Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373, 1386
(Fed. Cir. 2015) (citing de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed.
Cir. 2008) (holding that it is not a petitioner’s burden “to rule out possible alternative causes”
(internal citations omitted))); Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 547 (Fed.
Cir. 1994).

        Respondent frequently offers experts to rebut a petitioner’s case. Where both sides offer
expert testimony, a special master’s decision may be “based on the credibility of the experts and
the relative persuasiveness of their competing theories.” Broekelschen v. Sec’y of Health & Human
Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (internal citations omitted). Weighing the relative
persuasiveness of competing expert testimony, based on a particular expert’s credibility, is part of
the overall reliability analysis to which special masters must subject expert testimony in Vaccine
Program cases. Moberly, 592 F.3d at 1325–26 (“[a]ssessments as to the reliability of expert
testimony often turn on credibility determinations”); see also Porter v. Sec’y of Health & Human
Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously explained that special

                                                 23
masters are expected to consider the credibility of expert witnesses in evaluating petitions for
compensation under the Vaccine Act”).

       Both parties filed medical and scientific literature in this case, but not every filed item was
probative to 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.
Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record
evidence even though he does not explicitly reference such evidence in his decision”) (citation
omitted); see also 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”).

     V.      Discussion

          A. Petitioner’s Diagnosis

         Petitioner initially filed her petition with no diagnosed injury, claiming only that the
hepatitis vaccine caused her to suffer pain, fatigue, and weakness. She now claims that the
hepatitis B component of the vaccine caused her to develop undifferentiated connective tissue
disease and sine scleroderma. Respondent, on the other hand, contends Petitioner does not have
scleroderma or any other autoimmune disease. Since I cannot determine whether the vaccination
caused the Petitioner’s injury without first establishing what her injury is, the first step in this case
is to determine what injury is best supported by the evidence in the record. Broekelschen v. Health
& Human Serv., 618 F.3d at 1346. After a careful review of the record, I find the evidence
supports, by a preponderant standard, that Petitioner currently suffers from a condition described
by Dr. Hinchcliff as “undifferentiated connective tissue disease versus sine scleroderma.”

        Dr. Byers accurately noted in her first report that Petitioner presents a complicated case,
which is not unusual with autoimmune diseases. Pet’r’s Ex. 20 at 5. Generally, when doctors
diagnose a disease, the doctor evaluates the patient’s signs and symptoms and compares them to
the diagnostic criteria. Because the treating doctors have direct experience with the patient whom
they are diagnosing, their views about the appropriate diagnosis are often persuasive. See
McCulloch v. Sec’y of Health & Human Servs., No. 09-293V, 2015 WL 3640610, at *20 (Fed. Cl.
Spec. Mstr. May 22, 2015). Unfortunately, in this case, a series of treating doctors, including at
least five rheumatologists (who typically diagnose and treat autoimmune diseases), assessed
Petitioner with little agreement among them. Similarly, the experts retained in this matter have
also come to different conclusions.

        In the months and years since vaccination, Petitioner has presented to rheumatologists with
complaints of pain and stiffness in her joints and muscles, as well as an assortment of
gastrointestinal symptoms, shortness of breath, and dry eyes. Petitioner’s first rheumatologist, Dr.
Mughni, noted on July 17, 2013, that she had a history of Raynaud’s 37 but also that her serologies
37
   As previously noted, Raynaud’s phenomenon is considered a harbinger of autoimmune disease, and it is
a symptom of scleroderma. Petitioner’s history prior to the vaccination is notable for a diagnosis of

                                                   24
were normal. Pet’r’s Ex. 3 at 9–12. As a result, he concluded she suffered from fibromyalgia and
chronic fatigue syndrome. Id. Dr. Rodriguez was the second rheumatologist to consider
Petitioner’s symptoms. He was the first to record a positive SCL-70, which suggested she had
scleroderma, and a negative ANA, which suggested she did not. Pet’r’s Ex. 6 at 14–15. He
recommended she be evaluated at a specialty center since her diagnosis was unclear. Id. Dr.
Donohue of the Cleveland Clinic was the third rheumatologist to evaluate Petitioner. He advised
her it was possible she had early scleroderma, but ultimately determined that Petitioner’s
musculoskeletal discomfort was likely myofascial pain. Pet’r’s Ex. 16 at 1–7. Dr. Lin was
Petitioner’s fourth rheumatologist. Pet’r’s Ex. 14 at 1–4. He diagnosed systemic scleroderma
and treated her with hydroxychloroquine and methotrexate. See generally Pet’r’s Exs. 19, 22. Dr.
Hinchcliff of the Northwestern Scleroderma Clinic is Petitioner’s current rheumatologist, and she
diagnosed Petitioner with undifferentiated connective tissue disease versus sine scleroderma. In
support of Dr. Hinchcliff’s diagnosis, Petitioner had laboratory testing performed in January of
2019 that resulted in another finding of positive SCL-70 (again suggesting scleroderma) plus a
positive ANA in a speckled pattern (suggesting connective tissue disease).

         At the entitlement hearing, both experts discussed the challenges of diagnosing
autoimmune diseases. It is often the case that these patients have symptoms of more than one
disease, resulting in overlapping conditions and diagnostic uncertainty. When Dr. Byers prepared
her first report in connection with this case, she felt Petitioner had an autoimmune disease, but she
did not feel comfortable diagnosing Petitioner with scleroderma due to the lack of skin
involvement. Pet’r’s Ex. 20 at 5. At the hearing, Dr. Byers testified that she agreed with Dr.
Hinchcliff that Petitioner had connective tissue disease or sine scleroderma, and furthermore, they
overlap and will probably overlap for the rest of Petitioner’s life without a clear diagnosis. Tr.
106:10–21.

        Dr. Oddis, on the other hand, believes very strongly that Petitioner does not have any form
of autoimmune disease, because she never developed skin changes associated with scleroderma,
has no pulmonary involvement, and there is no documented inflammation of her joints anywhere
in the records. Resp’t’s Ex. A at 4.

         After a thorough review of the medical records, I find it compelling that Dr. Hinchcliff, a
treating rheumatologist practicing at the Northwestern Scleroderma Clinic, addressed the overlap
in Petitioner’s symptoms and diagnosed her with undifferentiated connective tissue disease versus
sine scleroderma. Dr. Hinchcliff had the opportunity to examine Petitioner in person on more than
one occasion. After a review of Petitioner’s history of Raynaud’s, lab results, and reports from
other specialists, Dr. Hinchcliff concluded that Petitioner has some form of connective tissue
disease overlapping with scleroderma. Dr. Lin, the rheumatologist who treated Petitioner
immediately prior to Dr. Hinchcliff, also considered Petitioner to suffer from undifferentiated
connective tissue disease with possible systemic sclerosis and treated her accordingly. The

Raynaud’s, and the diagnosis appears throughout her medical records until at least 2019. Most of the
rheumatologists she saw after the vaccination and both experts considered it significant in evaluating her
for an appropriate diagnosis, although Dr. Byers now maintains that Petitioner does not have Raynaud’s.

                                                    25
diagnosis appears to be confirmed by the most recent laboratory results showing positive SCL-70
and positive ANA.

        Although this is a close call, petitioners are accorded the benefit of close calls in the
Vaccine Program. Knudsen v. Health & Human Serv, 35 F.3d at 549. Therefore, I find that
Petitioner has provided preponderant evidence that she suffers from undifferentiated connective
tissue disease versus sine scleroderma.

          B. Althen Prong One

         Petitioner’s general theory, as explained by Dr. Byers, is that the hepatitis vaccine, like all
vaccines, can trigger autoimmune diseases through a process called bystander activation.
Undifferentiated connective tissue disease and sine scleroderma are both autoimmune diseases,
therefore, it is Dr. Byers’s opinion that the hepatitis vaccine can trigger them. Dr. Byers provides
little detail of the mechanism by which the hepatitis vaccine could trigger bystander activation to
cause either connective tissue disease or scleroderma. She testified that all vaccines release
cytokines, and bystander activation is a cytokine dysfunction where the vaccination triggers
autoreactive T cells through cytokine release. Tr. 83:15–84:8. Dr. Byers described this same
process in her first report and referenced an article 38 from 2009 that asserts that vaccines can trigger
an immune response that might eventually lead to an autoimmune disorder. Pet’r’s Ex. 20, 28.
Although the article mentions an association between the hepatitis B vaccine, multiple sclerosis,
and acute central nervous system inflammatory demyelination, there is no mention of connective
tissue disease or scleroderma.

        At the entitlement hearing, Dr. Byers first testified that the hepatitis B vaccination can
trigger demyelinating diseases by a mechanism called molecular mimicry. Tr. 83:3–14. However,
she could not describe what would lead to cross-reactivity between hepatitis B and either mixed
connective tissue disease or scleroderma. Tr. 83:3–14. Consequently, Dr. Byers moved on to the
bystander activation theory, because “it is accepted by the vaccine community that, in fact, it can
do the same thing[].” Tr. 83:3–14.

       Dr. Byers asserted at the hearing that rheumatologic autoimmune diseases in general can
be associated with infections or vaccinations. Tr. 120:15–19. However, she conceded that she
was uncertain of the mechanism of injury in scleroderma and unaware of any specific known
causes of scleroderma other than some drugs that she could not name. Tr. 120:20–23. Dr. Byers
was unable to find any medical literature linking the hepatitis vaccine, or any vaccines, to
scleroderma. Tr. 120:24–121:4. When she referred instead to literature linking vaccinations to
rheumatoid arthritis, she was unable to explain whether the mechanism of injury was the same
with scleroderma as with rheumatoid arthritis, and if so, how. Tr. 121:2–7.

         Dr. Byers testified that a proximal relationship between the hepatitis B vaccine and mixed
connective tissue disease had been reported but she could not recall the details without reviewing
the literature. She referenced two case studies 39 in her first report to show connective tissue disease
following the hepatitis B vaccination. Pet’r’s Exs. 29, 30. However, upon closer look, they appear
38
     Agmon-Levin, supra note 34.
39
     See e.g., supra note 32.

                                                   26
to be two accounts of the same 43-year-old woman with no history of autoimmune disease who
developed symptoms of undifferentiated connective tissue disease after receiving the vaccination.
Neither report determined that the hepatitis B vaccine was the cause of the disease or explained
the mechanism by which the vaccination led to the development of the disease. Dr. Byers also
mentioned 18 reports in the VAERS database associating hepatitis B vaccine and mixed connective
tissue disease but agreed at the hearing that VAERS is a passive reporting system and does not
attribute causality in any of the cases. Pet’r’s Ex. 20 at 7, Tr. 126:3–21.

        While Dr. Oddis thoroughly explained his opinion that Petitioner does not have
scleroderma, he did not have much to add regarding whether the hepatitis vaccination can cause
autoimmune disease. He testified that when T cells are activated, they release cytokines as part of
the adaptive immune system and the cytokines bring in other types of inflammatory cells, leading
to a cascade of inflammation. Tr. 162:8–163:24. However, he clarified that immunologic
activation is the result of a trigger, such as infection, and not the cause of it. He then questioned
whether a specific trigger can be identified in the development of autoimmune diseases. Tr.
190:24–193:17. He also questioned whether there is enough data to confirm the bystander
hypothesis, but he did not rule out the possibility that a vaccine can trigger illness. Tr. 206:1–17.

        Although both parties were vague in their efforts to address prong one in this case, the
burden is on Petitioner to make a case. Bystander activation is a not a novel theory of
autoimmunity. See e.g., Bender v. Sec'y of Health & Human Servs., No. 11-693V, 2018 WL
3679637 (Fed. Cl. July 2, 2018), review den’d, 141 Fed. Cl. 262 (2019); see also Bucci v. Sec'y of
Health & Human Servs., No. 11-513V, 2019 WL 1891809 (Fed. Cl. Mar. 27, 2019). However, the
ability of vaccines generally to stimulate the immune system does not establish a pathogenic effect.
Furthermore, simply because other vaccines can cause autoimmune disease is not enough to prove
that a hepatitis vaccine can cause either sine scleroderma or connective tissue disease.
Accordingly, I have concluded that the evidence of bystander activation is too speculative to
establish a theory of vaccine causation in this case. Therefore, Petitioner has not carried her burden
to establish by a preponderance of the evidence that bystander activation is a theory under which
the hepatitis vaccine can cause undifferentiated connective tissue disease or sine scleroderma.

        C. Althen Prong Two

        Petitioner relies primarily on the timing of symptom onset and the lack of other triggers to
show that the hepatitis vaccine caused her illness. 40 She claims that she was healthy and very
active prior to the vaccination and then developed symptoms of a connective tissue disease by the
fourth day post vaccination. Petitioner asserts in her post hearing brief that her records provide a
straight line between the vaccination on June 27, 2013, and her current diagnoses of
undifferentiated connective tissue disease and sine scleroderma. This claim, however, ignores the
medical records immediately prior to the vaccination (specifically the references to Raynaud’s),
which tend to suggest that Petitioner’s symptoms began before she was vaccinated. Pet’r’s Ex. 1
at 1–5.

40
  Dr. Byers also cited to Petitioner’s “clear genetic propensity to autoimmune disease” in her first report
as a basis for her opinion that the vaccination contributed to the onset of the autoimmune disorder but
changed her mind at the hearing after speaking with Petitioner about her family medical history. Pet’r’s
Ex. 20, Tr. 128.

                                                    27
        Petitioner testified that Dr. Lyon initially diagnosed her with Raynaud’s phenomenon after
he observed her feet were gray, and she told him they change color and feel cold at times. Tr.
18:1–11. Presumably, this is the visit in April of 2013, when he assessed her with Raynaud’s and
vasomotor instability. Pet’r’s Ex. 1 at 1–5. Dr. Byers testified that Raynaud’s is often a harbinger
of autoimmune disease and that 90 percent of scleroderma patients have it. Each of Petitioner’s
rheumatologists noted her Raynaud’s diagnosis, including Dr. Hinchcliff who wrote that
Petitioner’s Raynaud’s began in 2008. This strongly suggests that Petitioner’s disease process was
already underway when she was vaccinated in 2013.

        Dr. Byers mentioned Petitioner’s pre-existing Raynaud’s in her first report but questioned
whether she had been tested for it. Pet’r’s Ex. 20 at 5. Dr. Byers also noted that Petitioner’s carpel
tunnel syndrome can cause Raynaud’s. Id. In her second report and at the entitlement hearing,
Dr. Byers asserted that many people with Raynaud’s never go on to develop scleroderma or other
autoimmune diseases. This assertion belies the facts in this case where Petitioner did develop
scleroderma. Dr. Byers went further at the entitlement hearing insisting that, despite the agreement
of the rheumatologists who examined and treated Petitioner, Petitioner did not have Raynaud’s.
This opinion was based on a conversation Dr. Byers had with Petitioner the night before the
hearing. Dr. Byers theorized that Petitioner could have had swelling in her lower extremities that
caused her skin to appear gray to Dr. Lyon. Tr. 136:11–137:9.

        Although Dr. Byers deferred to and agreed with Dr. Hinchcliff in the diagnosis of
Petitioners undifferentiated connective tissue disease and sine scleroderma, Dr. Byers disregarded
Dr. Hinchcliff’s diagnosis of Raynaud’s. However, as Dr. Byers noted, Dr. Hinchcliff is a board-
certified rheumatologist and the associate clinical director for the Northwestern Scleroderma
Clinic. Whereas, Dr. Byers has no specialized rheumatological training other than her residency
for internal medicine and a three-year fellowship many years ago. Tr. 75:8–18. As previously
mentioned, Petitioner agreed at the entitlement hearing that while Dr. Byers was qualified to read
and interpret what treating doctors have done, she is not qualified to make any separate
rheumatological diagnoses as part of her testimony. Tr. 78:1–7. The treating providers
unanimously concluded that Petitioner has Raynaud’s, and it appears to have manifested prior to
the vaccination at issue in this case. The straight line seems to be between the appearance of
Raynaud’s in April of 2013, and the current diagnoses of undifferentiated connective tissue disease
and sine scleroderma. See Locane v. Sec'y of Health & Human Servs., 99 Fed. Cl. 715, 729 (2011),
aff'd, 685 F.3d 1375 (Fed. Cir. 2012) (holding “[n]owhere in the statutory scheme of Federal
Circuit precedent emerges a requirement that the special master conduct a causation analysis once
the special master has determined that a preponderance of the evidence shows that the onset of the
illness predates the vaccination”).

       Notwithstanding Petitioner’s pre-existing Raynaud’s, Petitioner’s timeline is not
compelling. Dr. Byers based her opinion that the hepatitis vaccine triggered Petitioner’s
autoimmune disease on Petitioner’s complaint of swelling in her hands and feet four days post
vaccination. Tr. 109:7–110:24. If Dr. Byers is correct that Petitioner had swelling in her feet rather
than Raynaud’s prior to the vaccination, then it seems her autoimmune symptoms started before
the vaccination and were not triggered by it. Furthermore, the medical records from the month
immediately after the vaccination are significant for complaints of joint pain with no objective
documentation of joint swelling.

                                                 28
         Dr. Oddis suggested in his testimony that Petitioner’s complaints of joint pain during the
post-vaccination period are better explained by fibromyalgia, for which Petitioner was diagnosed
and treated by her first rheumatologist. Tr. 173:17–174:12, Pet’r’s Ex. 3 at 9–12. The first
objective indication that Petitioner might have an autoimmune disease rather than fibromyalgia
was not until March of 2014 when she tested positive for SCL-70 antibodies. Her diagnosis
remained uncertain for years after that due, in part, to her consistently negative ANA. It is possible
that Petitioner had ongoing fibromyalgia that accounted for her joint pain in 2013 and, as Dr. Oddis
testified, fibromyalgia complicates the treatment of even well-documented autoimmune diseases,
since a patient can have both. Tr. 219:4–221:21.

        Although I determined that Petitioner provided preponderant evidence that she now has
undifferentiated connective tissue disease versus sine scleroderma, the record is unclear when she
developed the disease and unclear what triggered it. Respondent argued that Dr. Byers’ theory of
vaccine causation depends on the existence of an inflammatory process upon receipt of a
vaccination, but there is no evidence of such a process. Resp’t’s Post-Hr’g Br. at 15. Indeed,
there are no objective indicators that Petitioner experienced inflammation in the period
immediately following the vaccination that would suggest an inflammatory process was taking
place. Dr. Byers testified that scleroderma is an inflammatory disease and, based on the bystander
activation mechanism of injury, she would have expected to see markers of inflammation in
Petitioner. She conceded that there were none. Tr. 117:1–119:6. It is undisputed that there were
no markers of autoimmune disease in temporal connection to Petitioner’s vaccination, thus casting
doubt on bystander activation as the cause of Petitioner’s disease.

       Dr. Byers failed to articulate “a logical sequence of cause and effect showing that the
vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. Accordingly, based on the
forgoing, I find that Petitioner has failed to show by preponderant evidence that the hepatitis
vaccine was the cause of her claimed condition.

       D. Althen Prong Three

        Dr. Byers proposed a timeline for disease onset of four to seven days post-vaccination
since, according to Petitioner’s testimony, she had previously been exposed to the hepatitis B
vaccine. Tr. 84:9–17, 113:17–115:17. Dr. Byers agreed that the timeline would be longer if this
was Petitioner’s first hepatitis B vaccine. Tr. 113:17–115:17. As with the first and second prongs,
Dr. Byers supports her opinion regarding onset with general assertions about vaccines causing
autoimmune diseases by way of bystander activation. She provides no basis for her opinion that a
hepatitis B vaccine causes onset of either connective tissue disease or scleroderma in four to seven
days post-vaccination. Dr. Byers also disregards Petitioner’s account of symptoms during the first
few days after vaccination as general malaise from “normal side effects from a vaccination.” Tr.
85:6–16. Dr. Byers was uncertain whether it was the adaptive or innate immune system causing
Petitioner’s hand and foot symptoms during the initial week, concluding simply and vaguely that
it was the vaccine that caused them. Tr. 140:11–142:6. Petitioner has not provided preponderant
evidence that four to seven days is an appropriate temporal relationship for hepatitis B vaccine
induced undifferentiated connective tissue disease verses sine scleroderma.

                                                 29
     VI.     Conclusion

        After a review of the record, including Petitioner’s medical records, expert reports,
accompanying literature, and testimony, Petitioner has not proven it is more likely than not that
she suffered from a vaccine-caused injury.

       Accordingly, I have no choice but to DENY Petitioner’s claim and DISMISS this
petition. 41

           IT IS SO ORDERED.

                                                s/Herbrina D. Sanders
                                                Herbrina D. Sanders
                                                Special Master

41
  Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of a notice
renouncing the right to seek review.

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