Roby v. Secretary of Health and Human Services

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

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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

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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

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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

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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).

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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

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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.

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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.

30