                      In the United States Court of Federal Claims
                                         OFFICE OF SPECIAL MASTERS
                                                 No. 16-1173V
                                              (Not to be published)

*************************
                            *                                            Special Master Corcoran
BARBARA SHEETS,             *
                            *                                            Filed: April 30, 2019
                Petitioner, *
                            *
          v.                *                                            Influenza Vaccine; Tetanus Vaccine;
                            *                                            Rippling Muscle Disease; Significant
SECRETARY OF HEALTH AND     *                                            Aggravation.
HUMAN SERVICES,             *
                            *
                Respondent. *
                            *
*************************

Leah V. Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for Petitioner.

Julia M. Collison, U.S. Dep’t of Justice, Washington, DC, for Respondent.

                                    DECISION DENYING ENTITLEMENT1

        On September 20, 2016, Barbara Sheets filed this action seeking compensation under the National
Vaccine Injury Compensation Program (the “Vaccine Program”2). Petition (“Pet.”) (ECF No. 1).
Petitioner alleges that she developed Rippling Muscle Disease (“RMD”) after receipt of the influenza
(“flu”) and tetanus vaccines on December 23, 2013, and/or that an underlying autoimmune condition was
significantly aggravated by these vaccines. Pet. at 1.




1
  Although this Decision has not formally been designated for publication, it will ultimately 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 (2012). This means
the ruling will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however,
the parties may object to the published Decision’s inclusion of certain kinds of confidential information. Specifically, under
Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information furnished by that
party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes
medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine
Rule 18(b). Otherwise, the entire Decision will be available in its current form. Id.
2
  The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat.
3755 (codified as amended at 42 U.S.C. § 300aa-10 through 34 (2012)) (hereinafter “Vaccine Act” or “the Act”). All subsequent
references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa.
        Following the filing of Petitioner’s medical records and expert reports, I informed the parties that
I intended to resolve this matter on the record. Petitioner filed a brief in support of her claim on November
9, 2018. ECF No. 30 (“Mot.”). Respondent thereafter opposed Petitioner’s entitlement to a damages award
by brief dated November 30, 2018. ECF No. 31 (“Opp.”). Petitioner filed a reply on December 28, 2018.
ECF No. 33 (“Reply”). Having completed my review of the evidentiary record and the parties’ filings, I
hereby DENY Petitioner’s request for compensation, for the reasons stated below.

I.      Factual Background

        Petitioner was born on August 30, 1964. Pet. at 1. By 2010 (three years before the vaccinations at
issue), Petitioner was believed to be suffering from an undifferentiated or mixed connective tissue
disease—an autoimmune disease characterized by the signs and symptoms of a combination of disorders
(typically lupus, scleroderma and polymyositis). Ex. 2 at 4, filed Dec. 16, 2016 (ECF No. 6); Dorland’s
Illustrated Medical Dictionary 539 (32nd ed. 2012) (hereinafter “Dorland’s”). Although Petitioner’s
symptoms abated over time, they never entirely resolved. See Ex. 5 at 1–4, filed Dec. 16, 2016 (ECF
No. 6); Ex. 36 at 6–8, filed Mar. 31, 2017 (ECF No. 11-1) (fatigue and abdominal pain noted at December
4, 2013 visit).

        In early December 2013, Petitioner was noted by gynecologist Neil Rosenshein, M.D., to be
suffering from a recurrent MRSA infection.3 Ex. 36 at 9. Later that month, on December 23, 2013,
Petitioner received the flu and tetanus-diphtheria-acellular pertussis (“Tdap”) vaccines. Ex. 3 at 25, filed
Dec. 16, 2016 (ECF No. 6). Thereafter, in early 2014, Ms. Sheets had several encounters with medical
providers (whether for a surgical procedure or visits to various specialists), but at no time did she report
any symptoms that might be considered consistent with RMD, nor did she recount experiencing any
reaction to her late-December vaccinations. See Ex. 3 at 14–15 (January 3, 2014, surgery to remove a
pelvic mass); Ex. 36 at 4–5 (January 13, 2014, post-surgical visit); Ex. 4 at 1–7, filed Dec. 16, 2016 (ECF
No. 6) (denying leg cramps to cardiologist on January 17 and 24, 2014); Ex. 5 at 1–4 (March 5, 2014 visit
with rheumatologist Enrico Villanueva, M.D.; Petitioner reporting intermittent pain/swelling of the hands,
but no record of other symptoms).

        By early spring 2014 (several months after the December 23, 2013 vaccinations), Petitioner began
reporting rippling muscle symptoms to one of her medical providers, Bruce Edwards, M.D. Ex. 6 at 1–4,
filed Dec. 16, 2016 (ECF No. 6) (April 23, 2014 visit). Ms. Sheets stated at this time that her symptoms
had actually begun just after her late December vaccinations, although there is no prior contemporaneous
medical record memorializing such a complaint. Id. Medical examination revealed Petitioner’s strength
to be normal (at 5 out of 5). Id. at 3. Dr. Edwards noted progressively worsening symptoms, and posited
that her condition could be related to either the flu vaccine or her pre-vaccination mixed connective tissue
disease. Id. at 1, 4.


3
  An MRSA [methicillin-resistant Staphylococcus aureus] infection is a staph infection that is resistant to normal antibiotic
treatment. Dorland’s at 1185, 1765.

                                                             2
        Over the next few months, Ms. Sheets’s symptoms worsened. Beginning in June 2014 (now more
than five months post-vaccination), Petitioner repeatedly saw neurologist Mehrullah Khan, M.D., who
noted that her muscular twitching affected her arms and calves as well as her thighs, and that she had
begun to experience muscle weakness and difficulty swallowing. Ex. 7 at 2, filed Dec. 16, 2016 (ECF
No. 6). Dr. Khan initially theorized that Petitioner had a motor neuron disease, but later modified his
diagnosis to polymyositis.4 Id. at 3, 4, 18, 20. After a biopsy of her left quadriceps muscle revealed a
nonspecific myopathy,5 Dr. Khan referred Ms. Sheets to a neuromuscular clinic. See id. at 8, 22; Ex. 3 at
8–9.

        On Dr. Khan’s referral, Petitioner saw Zachary Simmons, M.D., a neurologist at the Penn State
neuromuscular clinic on September 4, 2014. Ex. 3 at 31–34. At this time, Ms. Sheets reported that her
condition was affecting her ability to perform daily living tasks. Id. at 31–32. Dr. Simmons proposed a
diagnosis of RMD—the first time a treater discussed this diagnosis—and suggested that she also had
mixed connective tissue disease. Id. at 33. Because Petitioner reported her symptoms had begun shortly
after vaccination, Dr. Simmons noted that “[i]t is possible that the vaccination triggered an autoimmune
reaction that unmasked/brought an underlying neuromuscular disease to the forefront.” Id. Dr. Simmons
ordered genetic testing to determine whether Petitioner had the hereditary form of RMD, and referred her
for follow-up with rheumatology. Id. Her genetic testing, however, showed that she was negative for
mutations in the caveolin 3 gene, ruling out the hereditary form of the disease. See Ex. 22 at 435, filed
Dec. 16, 2016 (ECF No. 6).

       Petitioner next saw Shirley Albano-Aluquin, M.D., on September 15, 2014, for a rheumatology
consultation. Ex. 3 at 36–39. At this initial visit, Dr. Albano-Aluquin assessed Petitioner as likely having
a secondary form of myositis attributable to her mixed connective tissue disease. Id. at 38. Over
subsequent visits, Dr. Albano-Aluquin’s assessment evolved to include possible diagnoses of chronic
severe mixed pain, systemic lupus, and “autoimmune mediated muscle disease.” Ex. 20 at 3–4, filed Dec.
16, 2016 (ECF No. 6) (January 20, 2015 note).6 Despite various treatments, Petitioner’s symptoms
continued to worsen, eventually including blurred vision. Ex. 22 at 43.

       In May of 2015, Drs. Albano-Aluquin and Simmons referred Petitioner to a muscle disease expert,
Matthew Wicklund, M.D. Ex. 22 at 55. Ms. Sheets saw Dr. Wicklund on July 8th, at which time he
expressed the firm conclusion that she had RMD. Ex. 3 at 62–65. He theorized that her RMD was
autoimmune in nature, and suggested that she might also have lupus and neuromuscular junction disease.

4
 Polymyositis is a chronic, progressive muscle inflammation disease, often featuring symmetrical pain and weakness.
Dorland’s at 1490.
5
    A myopathy is any disease of the muscles. Dorland’s at 1224.
6
 An undated progress note included with Petitioner’s medical record states that Dr. Albano-Aluquin diagnosed Petitioner with
RMD on July 20, 2015. Ex. 25 at 10, filed Dec. 16, 2016 (ECF No. 6). It is unclear whether a primary record exists from that
July 20th visit, however.

                                                              3
Id. at 65. Ms. Sheets soon thereafter began intravenous immunoglobulin (“IVIG”) treatment, which led to
significant improvement. Id. at 66 (September 3, 2015 note); Ex. 22 at 1 (November 18, 2015 note
describing improvement lasting for two to three weeks at a time).

        By March 2016, Dr. Wicklund assessed Ms. Sheets’s RMD as significantly improved, largely due
to the IVIG treatment. Ex. 25 at 12. Petitioner characterized herself as able to function at fifty percent of
her prior capacity, and her muscles had almost entirely stopped rippling. Id. at 11. However, the most
recent medical records filed, from January 2017, reveal that Petitioner still suffers from mild to moderate
pain related to her connective tissue disease. Ex. 33 at 26, filed Mar. 6, 2017 (ECF No. 10-2).

II.    Expert Reports

       A.      Petitioner’s Expert: Dr. John Rinker

        Dr. Rinker authored three expert reports in support of Petitioner’s claim. See Ex. 37, filed Oct. 30,
2017 (ECF No. 17-1) (“First Rinker Rep.”); Ex. 54, filed Nov. 28, 2017 (ECF No. 18-1) (“Second Rinker
Rep.”); Ex. 62, filed June 17, 2018 (ECF No. 26-1) (“Third Rinker Rep”). He opined that Ms. Sheets
either developed RMD as a result of the flu and/or tetanus vaccines, or that her RMD reflected a vaccine-
induced significant aggravation of an underlying autoimmune condition. First Rinker Rep. at 8.

        As set forth in his curriculum vitae (“CV”), Dr. Rinker is an associate professor of neurology at
the University of Alabama at Birmingham. Ex. 38 at 1, filed Oct. 30, 2017 (ECF No. 17-2). He spends
part of his time as an attending neurologist at the University of Alabama at Birmingham hospital, where
he specializes in treatment of patients with multiple sclerosis and related disorders. Id. at 1, 4. He received
his B.A. from Wake Forest University and his M.D. from the Medical College of Georgia. Id. at 2. He
completed an internship and neurology residency at the Washington University School of Medicine in St.
Louis, Missouri. Id. He has published fifteen peer-reviewed articles and four book chapters, most of which
focus on multiple sclerosis. Id. at 4, 11–12. He does not, however, appear to have any notable expertise in
immunologic matters (other than what he might indirectly have obtained from his neurology practice).

        In his first report, Dr. Rinker admitted that because Ms. Sheets had previously been diagnosed
with an autoimmune disorder, distinguishing between causation-in-fact and significant aggravation in this
case would be difficult. First Rinker Rep. at 1. Based on Petitioner’s medical records and her own
descriptions of her history, however, Dr. Rinker concluded that her condition was accurately characterized
as autoimmune RMD and could be attributed to the flu and/or tetanus vaccines she received in December
2013. Id. at 4, 8.

        In discussing the correct diagnosis, Dr. Rinker acknowledged in his first report that “no formal
diagnostic criteria for RMD exist.” First Rinker Rep. at 4. He nevertheless concluded that Ms. Sheets
likely had autoimmune RMD based on “her symptoms and the signs observed by her treating physicians,”
her lack of a genetic variant that would indicate genetic RMD, the diagnosis made in September 2014 by
Dr. Simmons, and her positive response to immune modulatory treatment. Id.

                                                      4
        Dr. Rinker next considered several possible theories of vaccine causation that might apply to Ms.
Sheets’s case. First Rinker Rep. at 6–7. In particular, he discussed the theory of molecular mimicry, a
biologic mechanism for many other known autoimmune diseases (such as Guillain-Barré syndrome
(“GBS”)). Id. at 6. Under this theory as described by Dr. Rinker, a person’s immune response to an
infectious agent (or vaccine) is aberrant, resulting in a failure to discern between foreign antigens and self,
causing an inadvertent immune reaction against “self-antigens which can result in immune-mediated harm
to otherwise healthy tissues.” Id. Dr. Rinker did not offer any literature specifically relating vaccination
or wild virus infection to onset of RMD via this process, however.

        Dr. Rinker also proposed that Ms. Sheets’s pre-existing conditions impacted the molecular
mimicry process his theory relied upon. His first report discussed human leukocyte antigens (“HLA”),
polymorphic molecules that present foreign antigens (that would be contained in vaccines) to the immune
system. First Rinker Rep. at 6. He explained that an individual’s unique HLA complex “is thought to play
a role in many idiosyncratic drug and vaccine reactions.” Id. (citing J. Uetrechy & D. Naisbitt,
Idiosyncratic Adverse Drug Reactions: Current Concepts, 65 Pharmacological Rev. 779 (2013), filed as
Ex. 50, Oct. 30, 2017 (ECF No. 17-14)). At bottom, he noted that “the critical factor” in determining a
patient’s susceptibility to autoimmune conditions such as RMD was the person’s “unique immunological
background (including HLA type) and how it interacts with vaccines.” Id. at 7. Given Ms. Sheets’s history
of autoimmune disease, Dr. Rinker theorized that she was likely predisposed to autoimmunity, and
therefore the vaccines she received on December 23, 2013, would likely have triggered her subsequent
symptoms that ultimately led to an RMD diagnosis. Id.

        Finally, Dr. Rinker discussed the possible role of adjuvants included in the vaccines Petitioner
received in instigating an autoimmune reaction. Adjuvants are expressly included in vaccines to boost the
adaptive immune response (so that the body manufactures antibodies that will in the future recognize the
virus or bacterium that the vaccine is intended to address), but that literature supported the possibility that
adjuvants could also increase the production of antibodies “directed at antigens commonly associated with
systemic autoimmunity in humans.” First Rinker Rep. at 6 (citing J. Murphy-Ullrich, et al., Detection of
Autoantibodies and Glomerular Injury in Rabbits Immunized with Denatured Human Fibronectin
Monomer, 117 Anti-Fibronectin Autoantibodies 1 (1984), filed as Ex. 44, Oct. 30, 2017 (ECF No. 17-8)
(“Murphy-Ullrich”)). He admitted, however, that Murphy-Ullrich did not observe a pathogenic result from
the increased production of such autoantibodies. Id. And Dr. Rinker’s first report did not otherwise
establish, with reliable scientific literature, that any adjuvant in the Tdap vaccine (since the flu vaccine
administered in the U.S. does not contain an adjuvant)7 has been shown to be associated with RMD or a


7
  The records filed in this case do not specify precisely which seasonal flu vaccine Petitioner received. However, as noted by
the Centers for Disease Control and Prevention (the “CDC”), virtually all flu vaccines administered in the United States contain
no adjuvant. Centers for Disease Control and Prevention, Adjuvants Help Vaccines Work Better, CDC (Oct. 22, 2018),
https://www.cdc.gov/vaccinesafety/concerns/adjuvants html. Petitioner’s vaccination consent form indicates that she received
a vaccine manufactured by Sanofi Pasteur (Ex. 1 at 1–2, filed Dec. 16, 2016 (ECF No. 6)), while the single adjuvanted flu
vaccine in the United States (FLUAD) is manufactured by Seqirus. Centers for Disease Control and Prevention, Flu Vaccine
With Adjuvant, CDC (Oct. 18, 2018), https://www.cdc.gov/flu/protect/vaccine/adjuvant htm. It is thus reasonable to infer that
whatever flu vaccine Petitioner received was unadjuvanted.

                                                               5
similar condition. Indeed, he conceded that his literature search had revealed no case reports reflecting
post-vaccination RMD. Id.

       Dr. Rinker’s first report also briefly addressed the timing of Petitioner’s onset. Based on statements
Ms. Sheets made to him, Dr. Rinker opined that her RMD began approximately one day after vaccination.
First Rinker Rep. at 7. Stating that he would expect a peak immune response within a few days of
vaccination, Dr. Rinker deemed her subsequent course logically consistent with vaccine causation. Id. He
noted as well, however, that the existing medical records themselves were inconsistent with her reported
onset, since they do not record any complaints of muscle problems or weakness immediately after
vaccination. Id. at 3.

         Dr. Rinker filed his first supplemental report at my request, addressing two specific issues. See
Scheduling Order, dated Nov. 14, 2017 (non-PDF docket entry). First, he discussed in greater detail the
medical record evidence supporting Ms. Sheets’s statement that her RMD symptoms began in the days
immediately following vaccination. Second Rinker Rep. at 1. He pointed to her March 5, 2014 visit with
rheumatologist Dr. Villanueva (which occurred over two months after vaccination) as the earliest possible
evidence of Petitioner’s symptoms, as Ms. Sheets checked boxes indicating muscle aches, muscle
weakness, and joint pain at that visit. Id. (discussing Ex. 5). Dr. Rinker then turned to the related question
of the likelihood of vaccine causation if Ms. Sheets’s condition in fact began not in December, but at the
time reflected in the medical records (spring 2014). Id. at 2. He conceded that “establishing the time of
symptom onset as late as late March or early April 2014 would lessen the likelihood that Ms. Sheets’
rippling muscle disease could be ascribed to her vaccinations on 12/23/2013,” explaining that case reports
for analogous vaccine-caused autoimmune reactions typically showed onset within one to two weeks of
vaccination. Id. While he maintained his belief that Petitioner’s symptoms began in December 2013 (as
she had informed him), Dr. Rinker stated that additional accounts describing her earliest symptoms would
“help to more confidently establish the time of onset.” Id.

         In his second supplemental report, Dr. Rinker discussed the possibility that one or both of the
December 23, 2013 vaccines Ms. Sheets received had significantly aggravated her underlying
autoimmune condition. He noted that Petitioner had suffered from systemic autoimmunity more than three
years before vaccination, but had responded well to immune modulating therapy, and was “in remission”
at the time of vaccination. Third Rinker Rep. at 1. After vaccination, by contrast, her condition declined
sharply, which Dr. Rinker characterized as “a continuation of her previously diagnosed autoimmune
condition.” Id. at 2. A vaccine, he theorized, could significantly aggravate a latent, pre-existing condition
by provoking a systemic immune response shortly after vaccination. Id. He did not, however, offer
literature supporting this contention, relying instead on the absence of evidence of other explanations as
leaving the vaccine as most likely causal. Id.

       B.      Respondent’s Expert: Dr. Vinay Chaudhry

        Respondent’s expert, Vinay Chaudhry, M.D., submitted a single expert report in this case. See Ex.
A, filed Apr. 12, 2018 (ECF No. 24-1) (“Chaudhry Rep.”). Dr. Chaudhry opined that Ms. Sheets’s April

                                                      6
2014 myopathy symptoms are attributable to her pre-vaccination connective tissue disease rather than the
vaccines she received, and that she does not in fact have RMD. Id. at 9–10, 15.

        As shown in his CV, Dr. Chaudhry works as a professor of neurology at Johns Hopkins University
School of Medicine. Ex. B at 1, filed Apr. 12, 2018 (ECF No. 24-2). He also works as an attending
physician at Johns Hopkins hospital for part of the year, and he serves as co-director of the Neurology
EMG [electromyography] Laboratory there. Id. at 1, 29–30. Dr. Chaudhry received his B.S. and M.D. at
All India Institute of Medical Sciences in New Delhi, India, and many years later received his M.B.A. at
Johns Hopkins. Id. at 2. He completed his residency in neurology at the University of Alabama at
Birmingham, followed by a fellowship in neuromuscular diseases at Johns Hopkins. Id. at 2–3. He has
published dozens of peer-reviewed articles and book chapters, largely focusing on neuromuscular disease.
Id. at 3–12.

        Based on his medical expertise and review of Petitioner’s records, Dr. Chaudhry opined that
Petitioner did not in fact have RMD, but rather had experienced a resurgence of her pre-existing
connective tissue disease. Chaudhry Rep. at 11, 15. As he explained, there are two types of RMD: inherited
(corresponding to a caveolin 3 genetic variant) and immune-mediated. Id. at 10–11. Ms. Sheets
unquestionably did not have inherited RMD, as she lacks the requisite genetic variant. Id. But all acquired
cases of immune-mediated RMD noted in the literature cited by Dr. Rinker, Dr. Chaudhry observed, were
associated with myasthenia gravis8 or with abnormal electrophysiology. Id. at 11. Ms. Sheets, however,
presented with neither. Id. Additionally, Ms. Sheets experienced numerous symptoms not associated with
RMD, including severe weakness, a progressive course, myotonic discharges visible in an EMG, joint
pain, stiffness, swelling, fatigue, rash, and a lack of muscle hypertrophy. Id. at 10–11. Finally, Dr.
Chaudhry noted that the fact that Ms. Sheets responded to immune modulating therapy should not be
considered evidence of RMD, as the same treatment could be used for a range of immune and mixed
connective tissue diseases. Id. at 10.

       Dr. Chaudhry also disputed that the vaccines Petitioner received in late December 2013 could have
caused new symptoms and/or aggravated her existing connective tissue disease condition. He expressed
awareness of published literature suggesting that certain infections (such as MRSA, which Petitioner was
diagnosed with approximately three weeks before she received the Tdap vaccine) could exacerbate
connective tissue disease symptoms, but disputed that equally reliable literature existed establishing that
a vaccination could have the same effect. Chaudhry Rep. at 11 (citing T. Acvin, et al., Infections,
Connective Tissue Diseases and Vasculitis, 26 Clinical & Experimental Rheumatology S-18 (2008), filed
as Ex. F, Apr. 12, 2018 (ECF No. 24-6); Inst. of Med., Adverse Effects of Vaccines: Evidence and
Causality 335–89, 567–81 (2012), filed as Ex. C, Apr. 12, 2018 (ECF No. 24-3)).

        Dr. Chaudhry went on to review the literature relied upon by Dr. Rinker in support of a molecular
mimicry theory of causation, explaining why in his opinion each article failed to support Dr. Rinker’s
theory. Chaudhry Rep. at 12–14. In particular, he noted that Dr. Rinker cited to literature discussing

8
    Myasthenia gravis is an autoimmune condition affecting neuromuscular function. Dorland’s at 1214.

                                                              7
illnesses that Petitioner unquestionably did not have, including idiopathic thrombocytopenic purpura,
acute disseminated encephalomyelitis, GBS, autoimmune hepatitis, and idiosyncratic drug reactions. Id.
at 12–13. He noted further that the literature Dr. Rinker relied on when discussing adjuvants in fact
concluded that adjuvants had no pathogenic effect. Id. at 13. Other items of literature cited by Dr. Rinker
found no vaccine-related aggravation of conditions such as multiple sclerosis and rheumatic diseases. Id.
In sum, Dr. Chaudhry opined that Petitioner’s “immune muscle disease wasn’t caused or made worse by
the vaccination.” Id. at 16.

III.     Other Fact Evidence

        Ms. Sheets has not filed an affidavit of her own,9 but offered multiple witness and treater
statements in this case. First, Petitioner filed affidavits from family and friends. The first three—one each
from her husband, daughter and brother-in-law, all dated in 2017—discuss the onset of her symptoms. See
Ex. 55, filed Dec. 7, 2017 (ECF No. 19-1) (affidavit of husband, Raymond Sheets); Ex. 56, filed Dec. 7,
2017 (ECF No. 19-2) (affidavit of daughter, Lauren Sheets); Ex. 61, filed Dec. 8, 2017 (ECF No. 20-1)
(affidavit of brother-in-law, Ryan Clark). All purport to recall rippling muscle/myopathy symptom onset
immediately following Petitioner’s December 2013 vaccinations.

        Ms. Sheets’s husband stated that she began to notice tingling in her legs on Christmas Eve of 2013.
Ex. 55 at 1. Her daughter reiterated that Ms. Sheets experienced leg tingling on Christmas Eve, and added
that a few weeks later, while planning a birthday party for Ms. Sheets’s granddaughter in mid-January,
Ms. Sheets experienced extreme pain when her three-year-old granddaughter jumped into her lap. Ex. 56
at 1. Ms. Sheets’s brother-in-law stated that he learned about her illness “a short time before Christmas of
2013.” Ex. 61 at 1. The remaining four witness statements discuss the extent of her damages, rather than
onset. See Ex. 57, filed Dec. 7, 2017 (ECF No. 19-3) (affidavit of former coworker, Whitney Eckert);
Ex. 58, filed Dec. 7, 2017 (ECF No. 19-4) (affidavit of son Brandon Allen); Ex. 59, filed Dec. 7, 2017
(ECF No. 19-5) (affidavit of family friend, Carrie Earl); Ex. 60, filed Dec. 7, 2017 (ECF No. 19-6)
(affidavit of mother, Diane Gorby).10

       Second, Petitioner has offered treater statements on causation theory points. Two of her treaters—
a rheumatologist, Dr. Albano-Aluquin, who Petitioner first saw in September 2014 (nine months post-
vaccination), and a neuro-muscular physician, Dr. Wicklund, whom Petitioner first saw in July 2015
(seventeen months post-vaccination)—offered letters dated May and August 2016, respectively. See


9
  Petitions for compensation brought under the Vaccine Act must be accompanied by an affidavit demonstrating that the
petitioner meets basic statutory requirements (such as having received a vaccine covered by the Act, not having previously
collected an award or settlement for the claimed vaccine-related injury, etc.). Section 11(c)(1).
10
  Petitioner’s primary expert, Dr. Rinker, also has represented that she informed him during an October 3, 2017 phone call that
her symptoms began soon after her 2013 vaccination. See First Rinker Rep. at 5. Of course, such non-contemporaneous
statements (putting aside their obvious hearsay quality) have minimal probative value, especially given that they were made
after this action had been initiated.


                                                              8
Ex. 31 at 129, 241–42, filed Dec. 16, 2016 (ECF No. 6). Dr. Wicklund stated that “[a]lthough there is no
way to know for sure that vaccinations caused Ms. Sheets disease; vaccines are known to increase the
likelihood of autoimmune disorders, and Ms. Sheets rippling muscle disease is immunoresponsive.” Id. at
129 (May 14, 2016 letter). Dr. Albano-Aluquin’s initial position was more tentative, proposing that
“[w]hile her condition is immune mediated and occurred after vaccination, the mechanisms including
causes and triggers of the disease remain unclear.” Ex. 31 at 241–42 (May 23, 2016 letter). However, a
subsequent letter from Dr. Albano-Aluquin, dated August 3, 2016, stated that “[w]hile there is no direct
association or evidence that can prove causation, I believe that her mixed autoimmune disease may have
flared as a result of stress, illness, and the flu vaccination.” Ex. 29 at 1, filed Dec. 16, 2016 (ECF No. 6).11

IV.      Procedural Background

        On September 20, 2016, Ms. Sheets initiated her claim. Respondent filed his Rule 4(c) Report on
May 26, 2017, disputing Petitioner’s entitlement to damages. Respondent’s Rule 4(c) Report at 13–14
(ECF No. 15). A year later, Petitioner filed Dr. Rinker’s expert report and supporting literature. After a
status conference on November 14, 2017, Dr. Rinker filed a supplemental report clarifying his opinion
regarding the onset of Petitioner’s injury. On April 12, 2018, Respondent filed a responsive expert opinion
and medical literature from Dr. Chaudhry, prompting Petitioner to file a third report from Dr. Rinker on
June 17, 2018. I thereafter determined that the matter was best resolved on the record, and ordered the
parties to file briefs in support of their respective positions (although I also indicated that I would entertain
arguments from either side as to the propriety of a trial). The matter is now ripe for resolution.

V.       Parties’ Respective Arguments

         A. Petitioner

       Petitioner argues that she does in fact have RMD. Mot. at 10–14. In support, she points to the
diagnoses of three treaters: Dr. Simmons, who stated in September 2014 that her symptoms were
suggestive of RMD; Dr. Wicklund, who diagnosed her with RMD on July 8, 2015; and Dr. Albano-
Aluquin, who diagnosed Petitioner with RMD on July 20, 2015. Id. at 11–12 (citing Ex. 8 at 3, filed
Dec. 16, 2016 (ECF No. 6); Ex. 3 at 65; Ex. 25 at 10). Because Dr. Chaudhry does not accept this RMD
diagnosis in the face of the medical record, she contends, his entire opinion should be given little to no
weight. Reply at 2.

       Petitioner next maintains that she has made a satisfactory showing of causation-in-fact under the
Federal Circuit causation test set forth in Althen v. Secretary of Health & Human Services, 418 F.3d 1274
(Fed. Cir. 2005), or in the alternative, that she has satisfied the significant aggravation test set forth in


11
   It appears that Petitioner’s counsel not only solicited these letters, but (in the case of Dr. Albano-Aluquin) provided a draft
letter. See Ex. 31 at 37–41, 241–42, 273–74.


                                                                9
Loving v. Secretary of Health & Human Services, 86 Fed. Cl. 135, 144 (2009). As a legal matter, she
contends that she need only show that her proffered theory of causation is plausible. Mot. at 15 (citing
Tarsell v. Sec’y of Health & Human Servs., 133 Fed. Cl. 782, 792–93 (2017); Contreras v. Sec’y of Health
& Human Servs., 121 Fed. Cl. 230, 245 (2015), vacated on other grounds, 844 F.3d 1363 (Fed. Cir. 2017)).
She asserts that the theories put forth by Dr. Rinker satisfy this plausibility standard, and emphasizes that
molecular mimicry in particular has been repeatedly accepted in the Vaccine Program as a causation
mechanism. Id. at 15–16 (citing Quackenbush-Baker v. Sec’y of Health & Human Servs., No. 14-1000V,
2018 WL 1704523, at *16–17 (Fed. Cl. Spec. Mstr. Mar. 14, 2018)). Additionally, Petitioner argues that
her condition should not be viewed as a continuation of prior autoimmune disorder, as she had never
previously experienced specific symptoms relevant to the diagnosis, like rippling muscles. Reply at 5.

         Petitioner further argues that she has shown that the vaccines at issue caused her RMD. In support,
she relies on the opinions of treating doctors. Mot. at 18–19. Specifically, she notes that Dr. Simmons
believed it “possible that the vaccination triggered an autoimmune reaction that unmasked/brought an
underlying neuromuscular disease to the forefront.” Id. at 18 (citing Ex. 8 at 3). She also highlights the
letter provided by Dr. Wicklund. Id. at 18–19 (citing Ex. 28 at 1, filed Dec. 16, 2016 (ECF No. 6)). Finally,
Petitioner points to Dr. Albano-Aluquin’s letter, which states: “While there is no direct association or
evidence that can prove causation, I believe that her mixed autoimmune disease may have flared as a result
of stress, illness, and the flu vaccination.” Id. at 19 (citing Ex. 29 at 1). Additionally, Petitioner notes that
none of her treating doctors ever considered her December 2013 MRSA infection to be a likely trigger for
her condition. Reply at 6.

        Turning to the third Althen prong, Petitioner asserts that the flu and tetanus vaccines caused her
illness within a medically-acceptable timeframe. Mot. at 20–22. Relying on her own recollections of
symptom onset and the statements provided by her friends and family, Petitioner asserts that onset within
a few days after vaccination is a reasonable timeframe under Dr. Rinker’s causation theories. Id. at 20–
21. She contends that, although there is no medical record evidence corroborating her allegations of
symptoms beginning in the weeks following vaccination, her stated version of events is not specifically
contradicted by existing medical records either. Id. at 21.

        Finally (and somewhat contrary to her prior position that the vaccines did not aggravate her pre-
existing connective tissue disease), Petitioner asserts that she has also satisfied the Loving criteria and has
shown that the flu and tetanus vaccines significantly aggravated an underlying condition—specifically, a
“predisposition to autoimmunity.” Mot. at 22–25. She describes her pre-vaccination condition and how
she became markedly worse after vaccination. Id. at 23–24. She notes that treating physicians and Dr.
Rinker theorized that vaccines might have been a trigger for her progressive worsening in early 2014. Id.
at 24–25 (citing Third Rinker Rep. at 1; Ex. 29 at 1). Thus, Ms. Sheets argues that the vaccines
significantly aggravated her pre-existing predisposition to autoimmune conditions. Id. at 25.




                                                       10
        Besides making arguments as to the sufficiency of her evidentiary showing, Petitioner argues that
a hearing is necessary to resolve this matter. Mot. at 2; Reply at 4–5. In particular, she notes that a hearing
would allow for direct and cross examination of experts, and would permit her to call treating physicians
and other fact witnesses to testify about when her symptoms began. Mot. at 2; Reply at 4–5.

       B. Respondent

         In arguing against compensation, Respondent contends that Petitioner did not have RMD, and
also that her illness was not caused or significantly aggravated by vaccines. With regard to her diagnosis,
Respondent asserts that, as stated by Dr. Chaudhry, Ms. Sheets in fact suffers from a myopathy following
connective tissue disease. Opp. at 10–11 (citing Chaudhry Rep. at 10–11). Throughout her visits with
various treaters, Petitioner’s condition was frequently characterized as some form of myopathy. Id. at 10
(citing Ex. 6 at 1–4; Ex. 7 at 8; Ex. 3 at 38, 62–65; Ex. 23 at 38–44, filed Dec. 16, 2016 (ECF No. 6)).
Respondent also points out that neither Petitioner’s treaters nor Dr. Rinker ever denied the possibility that
her illness was a continuation of her prior autoimmune condition, and that several doctors, including
Petitioner’s own expert, expressly stated that it was likely so. Id. at 11 (citing Third Rinker Rep. at 2 (Dr.
Rinker stating that Petitioner’s illness “is best viewed as a continuation of her previously diagnosed
autoimmune condition, rather than a completely de novo condition”); Ex. 29 at 1 (Dr. Albano-Aluquin
describing Petitioner’s symptoms as a “flare”)).

        Respondent also asserts that Petitioner has failed to satisfy all three Althen prongs (and thus has
also failed to satisfy the Loving standard for significant aggravation). As a threshold matter, Respondent
argues that Petitioner mischaracterizes the standard for the showing she must make under Althen prong
one. Opp. at 15–16. Rather, he argues that mere plausibility or possibility is insufficient, as the Federal
Circuit has repeatedly ruled. Id. at 15 (citing LaLonde v. Sec’y of Health & Human Servs., 746 F.3d 1334,
1339 (Fed. Cir. 2014); W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013)).

         Respondent next maintains that Petitioner’s proffered theory of causation is too general and vague
to satisfy Althen prong one. Opp. at 15–16. None of the components of Petitioner’s theory are specific to
either the vaccines at issue or her claimed illness, nor does Dr. Rinker cite any literature establishing
otherwise. Id. at 16. The opinions of Petitioner’s treating physicians are similarly nonspecific. Id.
(discussing Ex. 28 at 1; Ex. 29 at 1). While Petitioner points to Quackenbush-Baker to demonstrate that
molecular mimicry has been accepted as a theory of causation in the Vaccine Program, Respondent points
out that “in that case petitioner’s expert set forth a homology sequence that was deemed to be reliable by
the special master; no homology was postulated here.” Id. at 16 n.7. Asserting that “molecular mimicry is
not a catch-all explanation for how any vaccination can cause any immune-related injury,” Respondent
argues that Petitioner’s showing on Althen prong one is insufficient. Id. at 16.

       Respondent argues further that Petitioner has not demonstrated that the vaccines at issue were the
cause-in-fact or source of significant aggravation of her illness. Opp. at 17–18. Relying on Dr. Chaudhry’s


                                                      11
expert report, Respondent states that it is more likely that Petitioner’s symptoms were a manifestation of
her pre-existing autoimmune disease, particularly as Petitioner had demonstrated some ongoing symptoms
of her autoimmune disease before vaccination. Id. at 17 (citing Ex. 36 at 6–11; Ex. 5 at 15). The view that
Petitioner’s RMD is a continuation of her pre-existing condition is supported by both Dr. Rinker and Dr.
Albano-Aluquin. Id. (citing Ex. 29 at 1; Third Rinker Rep. at 2). And to the extent that there may have
been a trigger for this flare-up of Ms. Sheets’s pre-existing condition, Respondent argues that it was more
likely her December 2013 MRSA infection. Id. Respondent notes that Dr. Chaudhry identified medical
literature linking bacterial infections to onset of other autoimmune conditions such as polymyositis and
dermatomyositis. Id. at 17–18 (citing Chaudhry Rep. at 11). Because Dr. Rinker did not address the
possibility of the MRSA infection triggering Petitioner’s flare, Respondent asserts that Petitioner failed to
demonstrate that the vaccines were more likely than not the cause-in-fact of her illness. Id. at 18.

        Finally, Respondent asserts that Petitioner’s illness did not develop within a medically reasonable
timeframe after vaccination. Opp. at 11–15. Relying on the lack of reference in Petitioner’s medical
records to RMD-like symptoms until several months after vaccinations, Respondent contends that
Petitioner’s post-vaccination symptoms likely did not begin until April 2014. Id. at 11–12. Later-in-time
records dating the start of Petitioner’s symptoms to December 2013, as well as affidavits stating the same,
are at odds with records from early 2014 showing no such symptoms, as well as records indicating that
she experienced her most severe symptoms in summer and fall of 2014. Id. at 12–14. Because Petitioner’s
own expert conceded that onset more than eight weeks after vaccination would be unreasonable under his
proffered theory, Respondent contends that Petitioner’s condition did not develop within a medically-
appropriate timeframe to satisfy Althen prong three. Id. at 14–15.

VI.      Applicable Law

         A.       Petitioner’s Overall Burden in Vaccine Program Cases

         To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that he
suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—corresponding to one
of the vaccinations in question within a statutorily prescribed period of time or, in the alternative, (2) that
his illnesses were actually caused by a vaccine (a “Non-Table Injury”). See Sections 13(a)(1)(A), 11(c)(1),
and 14(a), as amended by 42 C.F.R. § 100.3; § 11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health &
Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440
F.3d 1317, 1320 (Fed. Cir. 2006).12 In this case, Petitioner does not assert a Table claim.




12
   Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority. Hanlon
v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning legal issues
are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121, 124 (2003), aff’d 104 F. App’x
712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-159V, 2014 WL 504728, at *7 n.12 (Fed.
Cl. Spec. Mstr. Jan. 16, 2014).

                                                               12
        For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance of the
evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that leads the “trier
of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find
in favor of the party who has the burden to persuade the judge of the fact’s existence.” Moberly, 592 F.3d
at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or
speculation is insufficient under a preponderance standard). Proof of medical certainty is not required.
Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, a petitioner
must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a substantial
factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health &
Human Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human Servs.,
451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a Vaccine Program award based solely
on his assertions; rather, the petition must be supported by either medical records or by the opinion of a
competent physician. Section 13(a)(1).

        In attempting to establish entitlement to a Vaccine Program award of compensation for a Non-
Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit in Althen:
“(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause
and effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate
temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278.

        Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners must
provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type of injury
alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a petitioner’s theory must
be based on a “sound and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Human
Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or
scientifically certain.” Id. at 549.

        Petitioners may satisfy the first Althen prong without resort to medical literature, epidemiological
studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu v. Sec’y
of Health & Human Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano, 440 F.3d at 1325–
26). Special masters, despite their expertise, are not empowered by statute to conclusively resolve what
are essentially thorny scientific and medical questions, and thus scientific evidence offered to establish
Althen prong one is viewed “not through the lens of the laboratorian, but instead from the vantage point
of the Vaccine Act’s preponderant evidence standard.” Id. at 1380. Accordingly, special masters must take
care not to increase the burden placed on petitioners in offering a scientific theory linking vaccine to
injury. Contreras, 121 Fed. Cl. at 245 (“[p]lausibility . . . in many cases may be enough to satisfy Althen
prong one” (emphasis in original)). But this does not negate or reduce a petitioner’s ultimate burden to
establish his overall entitlement to damages by preponderant evidence. W.C., 704 F.3d at 1356.13

13
  Although decisions like Contreras suggest that the burden of proof required to satisfy the first Althen prong is less stringent
than the other two, there is ample contrary authority for the more straightforward proposition that when considering the first

                                                              13
        The second Althen prong requires proof of a logical sequence of cause and effect, usually supported
by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375–
77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed.
Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions and views of the injured party’s
treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326
(“medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are
likely to be in the best position to determine whether a ‘logical sequence of cause and effect show[s] that
the vaccination was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are
generally viewed as particularly trustworthy evidence, since they are created contemporaneously with the
treatment of the patient. Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir.
1993).

        However, medical records and statements of a treating physician do not per se bind the special
master to adopt the conclusions of such an individual, even if they must be considered and carefully
evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result, report,
or summary shall not be binding on the special master or court”); Snyder v. Sec’y of Health & Human
Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates that the testimony of a treating
physician is sacrosanct—that it must be accepted in its entirety and cannot be rebutted”). As with expert
testimony offered to establish a theory of causation, the opinions or diagnoses of treating physicians are
only as trustworthy as the reasonableness of their suppositions or bases. The views of treating physicians
should be weighed against other, contrary evidence also present in the record—including conflicting
opinions among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742, 749
(2011) (not arbitrary or capricious for special master to weigh competing treating physicians’ conclusions
against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Dept. of Health & Human
Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review
denied, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 F. App’x 765 (Fed. Cir. 2012).

        The third Althen prong requires establishing a “proximate temporal relationship” between the
vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the phrase
“medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof that the
onset of symptoms occurred within a timeframe which, given the medical understanding of the disorder’s
etiology, it is medically acceptable to infer causation.” 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
align with the theory of how the relevant vaccine can cause an injury (Althen prong one’s requirement).
Id. at 1352; Shapiro v. Sec’y of Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied
after remand, 105 Fed. Cl. 353 (2012), aff’d mem., 503 F. App’x 952 (Fed. Cir. 2013); Koehn v. Sec’y of



prong, the same preponderance standard used overall is also applied when evaluating if a reliable and plausible causal theory
has been established. Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1350 (Fed. Cir. 2010).

                                                             14
Health & Human Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for
review denied (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

         B.       Legal Framework for Analyzing Significant Aggravation Claims

       In this matter, Petitioner maintains that the Tdap and/or flu vaccine significantly aggravated her
predisposition to autoimmunity. Under such circumstances, the Althen test is expanded, and the petitioner
has additional evidentiary burdens to satisfy. See generally Loving, 86 Fed. Cl. at 144. In Loving, the Court
of Federal Claims combined the Althen test with the test from Whitecotton v. Secretary of Health & Human
Services, 81 F.3d 1099, 1107 (Fed. Cir. 1996), which related to on-Table significant aggravation cases.
The resultant “significant aggravation” test has six components, which are:

         (1) the person’s condition prior to administration of the vaccine, (2) the person’s current
         condition (or the condition following the vaccination if that is also pertinent), (3) whether
         the person’s current condition constitutes a ‘significant aggravation’ of the person’s
         condition prior to vaccination, (4) a medical theory causally connecting such a significantly
         worsened condition to the vaccination, (5) a logical sequence of cause and effect showing
         that the vaccination was the reason for the significant aggravation, and (6) a showing of a
         proximate temporal relationship between the vaccination and the significant aggravation.

Loving, 86 Fed. Cl. at 144; see also W.C., 704 F.3d at 1357 (holding that “the Loving case provides the
correct framework for evaluating off-table significant aggravation claims”). In effect, the last three prongs
of the Loving test correspond to the three Althen prongs.

        Subsumed within the Loving analysis is the requirement to evaluate the likely natural course of an
injured party’s pre-existing disease, in order to determine whether the vaccine made the petitioner worse
than he would have been but for the vaccination. Locane v. Sec’y of Health & Human Servs., 685 F.3d
1375, 1381–82 (Fed. Cir. 2012) (upholding special master’s determination that petitioner had failed to
carry her burden of proof in establishing that her pre-existing injury was worsened by the relevant
vaccine); Hennessey v. Sec’y of Health & Human Servs., No. 01-190V, 2009 WL 1709053, at *41–42
(Fed. Cl. Spec. Mstr. May 29, 2009), mot. for review denied, 91 Fed. Cl. 126 (2010). The critical point of
examination is thus “whether the change for the worse in [petitioner’s] clinical presentation was
aggravation or a natural progression” of the underlying condition. Hennessey, 2009 WL 1709053, at *42.14
The Federal Circuit has upheld the determinations of special masters that worsening was not demonstrated

14
  The legislative history of the Vaccine Act strongly supports interpreting “significant aggravation” as requiring a claimant to
establish that a vaccine rendered a pre-existing condition qualitatively worse than it would have been otherwise—not simply
that the affected individual experienced a post-vaccination symptom that contrasts with the individual’s comparatively better
pre-vaccination health. See H.R. Rep. No. 99-908, at 15 (1986) (“This [significant aggravation] provision does not include
compensation for conditions which might legitimately be described as pre-existing (e.g., a child with monthly seizures who,
after vaccination, has seizures every three and a half weeks), but is meant to encompass serious deterioration (e.g., a child with
monthly seizures who, after vaccination, has seizures on a daily basis” (emphasis added)).


                                                               15
by a petitioner in connection with establishing her overall preponderant burden of proof for a non-Table
causation-in-fact claim. See, e.g., Snyder/Harris v. Sec’y of Health & Human Servs., 553 F. App’x 994,
999–1000 (Fed. Cir. 2014); Locane, 685 F.3d at 1381–82.15

         Application of Loving’s “worsening” requirement has been the occasion for some disparate
holdings by special masters as well as the Court. In some cases, evidence that an injured party was literally
“worse” than she was immediately prior to the vaccination at issue has been viewed as sufficient to satisfy
this prong. See, e.g., Paluck v. Sec’y of Health & Human Servs., 113 Fed. Cl. 210, 232 (2013), aff’d, 786
F.3d 1373 (Fed. Cir. 2015). In other instances, however, the mere fact a vaccine might “trigger” a transient
negative response in an individual with an underlying condition has not been deemed proof of worsening
if that individual would be expected to experience a similar overall course regardless. Faoro v. Sec’y of
Health &Human Servs., No. 10-704V, 2016 WL 675491, at *27 (Fed. Cl. Spec. Mstr. Jan. 29, 2016), mot.
for review denied, 128 Fed. Cl. 61 (Fed. Cl. Apr. 11, 2016) (finding that “the vaccinations would not have
changed her clinical course and thus, the vaccinations did not significantly aggravate her pre-existing
condition”). Federal Circuit precedent directly addressing this standard suggests the latter understanding
is more accurate. See, e.g., Locane, 685 F. 3d at 1381 (upholding special master’s denial of significant
aggravation claim when evidence “showed that the course of [petitioner’s] condition was not inconsistent
with the disease generally”).

         C.       Law Governing Analysis of Fact Evidence

        The process for making determinations in Vaccine Program cases regarding factual issues begins
with consideration of the medical records. Section 11(c)(2). The special master is required to consider “all
[] relevant medical and scientific evidence contained in the record,” including “any diagnosis, conclusion,
medical judgment, or autopsy or coroner’s report which is contained in the record regarding the nature,
causation, and aggravation of the petitioner’s illness, disability, injury, condition, or death,” as well as the
“results of any diagnostic or evaluative test which are contained in the record and the summaries and
conclusions.” Section 13(b)(1)(A). The special master is then required to weigh the evidence presented,
including contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Human Servs.,
3 F.3d 415, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to afford
greater weight to contemporaneous medical records than to other evidence, such as oral testimony
surrounding the events in question that was given at a later date, provided that such determination is
evidenced by a rational determination).



15
    This is consistent with the fact (well recognized by controlling precedent) that evidence of “worsening” relevant to
Respondent’s alternative cause burden may reasonably by evaluated by a special master in determining the success of a
petitioner’s prima facie showing. Snyder/Harris, 553 F. App’x at 1000 (quoting Stone v. Sec’y of Health & Human Servs., 676
F.3d 1373, 1380 (Fed. Cir. 2012) (“no evidence should be embargoed from the special master’s consideration simply because
it is also relevant to another inquiry under the statute”)); see also de Bazan, 539 F.3d at 1353 (“[t]he government, like any
defendant, is permitted to offer evidence to demonstrate the inadequacy of the petitioner’s evidence on a requisite element of
the petitioner’s case-in-chief”).

                                                             16
        Medical records that are created contemporaneously with the events they describe are presumed
to be accurate and “complete” (i.e., presenting all relevant information on a patient’s health problems).
Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed. Cl. 598, 608 (2010)
(“[g]iven the inconsistencies between petitioner’s testimony and his contemporaneous medical records,
the special master’s decision to rely on petitioner’s medical records was rational and consistent with
applicable law”), aff’d sub nom. Rickett v. Sec’y of Health & Human Servs., 468 F. App’x 952 (Fed. Cir.
2011) (non-precedential opinion). This presumption is based on the linked propositions that (i) sick people
visit medical professionals; (ii) sick people honestly report their health problems to those professionals;
and (iii) medical professionals record what they are told or observe when examining their patients in as
accurate a manner as possible, so that they are aware of enough relevant facts to make appropriate
treatment decisions. Sanchez v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2
(Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec’y of Health & Human Servs., 26 Cl. Ct. 537, 543
(1992), aff’d, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail
to accurately report the onset of their daughter’s symptoms”).

        Accordingly, if the medical records are clear, consistent, and complete, then they should be
afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005 WL
6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records are
generally found to be deserving of greater evidentiary weight than oral testimony—especially where such
testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also Murphy v. Sec’y of
Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam, 968 F.2d 1226 (Fed. Cir. 1992),
cert. denied sub nom. Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v. United States
Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony which is in
conflict with contemporaneous documents is entitled to little evidentiary weight.”)).

        However, there are situations in which compelling oral testimony may be more persuasive than
written records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec’y of
Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common sense and
experience, this rule should not be treated as an absolute and must yield where the factual predicates for
its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten records which are,
themselves, inconsistent, should be accorded less deference than those which are internally consistent”)
(quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination regarding a witness’s credibility is
needed when determining the weight that such testimony should be afforded. Andreu, 569 F.3d at 1379;
Bradley v. Sec’y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

      When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and compelling.”
Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808V,
1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the accuracy and
completeness of medical records, the Court of Federal Claims has listed four possible explanations for


                                                     17
inconsistencies between contemporaneously created medical records and later testimony: (1) a person’s
failure to recount to the medical professional everything that happened during the relevant time period;
(2) the medical professional’s failure to document everything reported to her or him; (3) a person’s faulty
recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of symptoms
that did not exist. Lalonde v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203–04 (2013), aff’d,
746 F.3d 1334 (Fed. Cir. 2014). In making a determination regarding whether to afford greater weight to
contemporaneous medical records or other evidence, such as testimony at hearing, there must be evidence
that this decision was the result of a rational determination. Burns, 3 F.3d at 417.

       D.      Analysis of Expert Testimony

        Establishing a sound and reliable medical theory often requires a petitioner to present expert
testimony in support of his claim. Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1361 (Fed.
Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the factors for analyzing
scientific reliability set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 594–96
(1993). See Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing
Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999)). “The Daubert factors
for analyzing the reliability of testimony are: (1) whether a theory or technique can be (and has been)
tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) whether
there is a known or potential rate of error and whether there are standards for controlling the error; and (4)
whether the theory or technique enjoys general acceptance within a relevant scientific community.”
Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592–95).

        The Daubert factors play a slightly different role in Vaccine Program cases than they do when
applied in other federal judicial fora (such as the district courts). Daubert factors are usually employed by
judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence that is unreliable
and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors are used in the weighing
of the reliability of scientific evidence proffered. Davis v. Sec’y of Health & Human Servs., 94 Fed. Cl.
53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have been employed also as an acceptable
evidentiary-gauging tool with respect to persuasiveness of expert testimony already admitted”). The
flexible use of the Daubert factors to evaluate the persuasiveness and reliability of expert testimony has
routinely been upheld. See, e.g., Snyder, 88 Fed. Cl. at 742–45. In this matter (as in numerous other
Vaccine Program cases), Daubert has not been employed at the threshold, to determine what evidence
should be admitted, but instead to determine whether expert testimony offered is reliable and/or
persuasive.

        Respondent frequently offers one or more experts of his own in order 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, 618 F.3d at 1347
(citing Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion


                                                     18
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too great an
analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec.
Co. v. Joiner, 522 U.S. 136, 146 (1997)); see also Isaac v. Sec’y of Health & Human Servs., No. 08-601V,
2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for review denied, 108 Fed. Cl. 743
(2013), aff’d, 540 F. App’x 999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). 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 masters are expected to consider
the credibility of expert witnesses in evaluating petitions for compensation under the Vaccine Act”).

        Expert opinions based on unsupported facts may be given relatively little weight. See Dobrydnev
v. Sec’y of Health & Human Servs., 556 F. App’x 976, 992–93 (Fed. Cir. 2014) (“[a] doctor’s conclusion
is only as good as the facts upon which it is based”) (citing Brooke Group Ltd. v. Brown & Williamson
Tobacco Corp., 509 U.S. 209, 242 (1993) (“[w]hen an expert assumes facts that are not supported by a
preponderance of the evidence, a finder of fact may properly reject the expert’s opinion”)). Expert
opinions that fail to address or are at odds with contemporaneous medical records may therefore be less
persuasive than those which correspond to such records. See Gerami v. Sec’y of Health & Human Servs.,
No. 12-442V, 2013 WL 5998109, at *4 (Fed. Cl. Spec. Mstr. Oct. 11, 2013), aff’d, 127 Fed. Cl. 299
(2014).

        E.     Consideration of Medical Literature

        Both parties filed medical and scientific literature in this case, but not every filed item factors into
the outcome of this decision. While I have reviewed all of the medical literature submitted in this case, I
discuss only those articles that are most relevant to my determination and/or are central to Petitioner’s
case—just as I have not exhaustively discussed every individual medical record filed. Moriarty v. Sec’y
of Health & Human Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“[w]e generally presume that a special
master considered the relevant record evidence even though he does not explicitly reference such evidence
in his decision”) (citation omitted); see also 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”).

        F.     Resolution of Case Via Ruling on Record

        I have opted to resolve this matter on the papers, rather than by holding a hearing. The Vaccine
Act and Rules not only contemplate but encourage special masters to decide petitions on the papers where
(in the exercise of their discretion) they conclude that doing so will properly and fairly resolve the case.
Section 12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been
affirmed on appeal. See Hooker v. Sec’y of Health & Human Servs., No. 02-472V, 2016 WL 3456435, at

                                                      19
*21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided on
the papers in lieu of hearing and that decision was upheld). I am simply not required to hold a hearing in
every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health & Human Servs., 38 Fed.
Cl. 397, 402–03 (1997) (special master acted within his discretion in denying evidentiary hearing); Burns,
3 F.3d at 417; Murphy v. Sec’y of Health & Human Servs., No. 90-882V, 1991 WL 71500, at *2 (Cl. Ct.
Spec. Mstr. Apr. 19, 1991).



                                               ANALYSIS

I.     Petitioner’s Illness is Best Characterized as RMD

        A fundamental matter to be resolved before application of the Althen prongs is determining the
actual nature of Petitioner’s injury. Petitioner, supported by the diagnostic views of multiple treating
doctors and Dr. Rinker, maintains that she suffered from RMD. Mot. at 10–14. Respondent, by contrast,
urges me to adopt Dr. Chaudhry’s view that Ms. Sheets only suffers from a myopathy or myositis
attributable to her pre-existing connective tissue disease, rather than RMD. Opp. at 10–11.

         As explained in medical literature filed by both parties, RMD is a rare myopathy featuring muscle
stiffness, muscle hypertrophy, and involuntary muscle contractions that create a rippling effect. T.
Torbergsen, Rippling Muscle Disease: A Review, 11 Muscle & Nerve Supp. S103, S103 (2002), filed as
Ex. D, Apr. 12, 2018 (ECF No. 24-4) (“Torbergsen”); M. Bettini, et al., Immune-Mediated Rippling
Muscle Disease and Myasthenia Gravis, 299 J. Neuroimmunology 59, 59 (2016), filed as Ex. 40, Oct. 30,
2017 (ECF No. 17-4) (“Bettini”). It can be hereditary, resulting from variations in the caveolin-3-encoding
gene, or it can be acquired immunogenically. Bettini at 59. The parties’ respective experts concur that
Petitioner’s alleged RMD was not hereditary, as demonstrated by genetic testing. See First Rinker Rep.
at 4; Chaudhry Rep. at 10–11; Ex. 22 at 435. When acquired, RMD is generally (though not always)
associated with myasthenia gravis. Bettini at 59–60. RMD is characterized as a relatively mild disorder,
and it is non-progressive. Torbergsen at S105.

       Here, and despite reasoned points raised by Respondent’s expert about deficiencies in the
diagnosis, the medical record (when viewed in its entirety) better supports Petitioner’s proposed diagnosis.
Although Petitioner’s treating physicians regularly (and reasonably, given Petitioner’s history) included
myopathy related to pre-existing connective tissue disease among their earlier differential diagnoses, over
time they eventually coalesced around a diagnosis of RMD. See, e.g., Ex. 6 at 1–4 (Dr. Edwards
characterizing Petitioner’s symptoms in April 2014 as “possibly related to . . . mixed connective tissue
disease”); Ex. 3 at 8–9 (August 2014 biopsy of left quadriceps findings were “suggestive of myopathy”),
62–65 (Dr. Wicklund’s July 2015 differential diagnosis listing “rippling muscle disease, lupus, perhaps
neuromuscular junction disease, and perhaps muscular disease on an autoimmune basis”); Ex. 23 at 38–
44 (EMG performed July 2015 consistent with “mild, chronic myopathy with rippling muscles”). This,

                                                    20
and the fact that Petitioner’s symptoms—most notably, her well-documented rippling muscles—are
generally consistent with RMD as it is described in the filed medical literature, support Petitioner’s
argument as to the proper diagnosis.

         However, I also find that, based upon the record, it is most likely that Petitioner’s RMD was
associated with her pre-existing connective tissue disease. Certainly her treaters proposed as such. See,
e.g., Ex. 29 at 1 (Dr. Albano-Aluquin describing petitioner’s symptoms as a “flare[]” of her mixed
autoimmune disease). Dr. Rinker also acknowledged that “autoimmunity, once established, is a chronic
condition which may manifest with recurrent or even new symptoms over time,” and ultimately allowed
(in his final expert report) that “[Petitioner’s] RMD is best viewed as a continuation of her previously
diagnosed autoimmune condition, rather than a completely de novo condition.” Third Rinker Rep. at 2.
Petitioner did not otherwise successfully distinguish her pre-vaccination symptoms, other than to argue
that they merely reflected a susceptibility to autoimmunity or were milder in severity. In fact, the record
suggests that this purported susceptibility manifested in a form that was on a continuum with the symptoms
that later led treaters to identify RMD as a proper diagnosis.

II.     Petitioner Has Not Satisfied the Althen Prongs

        A.       Prong One

        Although the evidence preponderates in favor of the RMD diagnosis, I cannot also find that
Petitioner has demonstrated that the flu and/or tetanus vaccines “can cause” RMD, because the
components of the theory offered by Dr. Rinker are too piecemeal and nonspecific to constitute a reliable
scientific or medical causation theory. This is the primary deficiency in Petitioner’s overall showing.

        In his expert reports, Dr. Rinker broadly lists a variety of mechanisms by which vaccines can
purportedly cause different autoimmune conditions, but he fails to persuasively link (with reliable
scientific evidence, or on the basis of his own expertise) these theories to either the vaccines in question
or Petitioner’s own specific condition. Thus, he describes the general concept of molecular mimicry as a
mediator of other autoimmune diseases (for example, idiopathic thrombocytopenic purpura,16 or GBS),
but does not establish that the acquired form of RMD is itself also mediated via an autoimmune cross-
reaction. See First Rinker Rep. at 6. As I have previously stated, when attempting to establish a causal
mechanism, “[p]etitioners cannot simply invoke the concept of molecular mimicry and call it a day.”
Johnson v. Sec’y of Health & Human Servs., No. 14-254V, 2018 WL 2051760, at *26 (Fed. Cl. Spec.
Mstr. Mar. 23, 2018). Dr. Rinker has also offered nothing suggesting that any relevant vaccine components
could act as an antigenic stimulant sufficient to cause the production of autoantibodies associated with the
version of RMD Petitioner is believed to have had. Without more, Petitioner cannot succeed on the theory


16
  Idiopathic thrombocytopenic purpura, also known as immune thrombocytopenic purpura, is a condition characterized by a
decrease in platelet count. Johnson v. Sec’y of Health & Human Servs., No. 14-113V, 2017 WL 772534, at *1 n.3 (Fed. Cl.
Spec. Mstr. Jan. 6, 2017); Dorland’s at 1557.

                                                          21
of molecular mimicry as explanatory in this case simply because it was applicable to other kinds of
autoimmune diseases.

        The other components of Dr. Rinker’s theory are to an even greater extent too generalized and
vague to satisfy Althen prong one. Thus, Dr. Rinker discusses the role of vaccine adjuvants, explaining
correctly that they increase a vaccine’s immune response. First Rinker Rep. at 6. However, while he
maintains that adjuvants can cause “a more widespread activation of the immune response directed at
antigens other than those included in the vaccine itself,” the only medical literature he relies on for this
point is Murphy-Ullrich, a 1984 study which Dr. Rinker concedes showed no pathogenic effects. Id. (citing
Murphy-Ullrich). I have in other cases noted that petitioners cannot invoke the expected role an adjuvant
plays in aiding immunogenicity of a vaccine to also establish the same vaccine’s pathogenic capacity,
without some reliable scientific or medical evidence that demonstrates how this would occur. See, e.g.,
Johnson, 2018 WL 2051760, at *8 n.11. In addition, the flu vaccine administered in the United States does
not even contain an adjuvant, and Dr. Rinker’s reports make no showing with respect to the adjuvants
contained in the Tdap vaccine.

         Dr. Rinker’s reports also discuss HLA and T cells, but he has not coherently or persuasively
explained what role these elements could have played in Ms. Sheets’s case. In particular, he does not
identify any pertinent information regarding her specific HLA profile, nor does he explain how it would
increase the likelihood of an autoimmune reaction after vaccination.17 His discussion of HLA at best shows
that some persons might have a propensity for autoimmune disease, but does not lead to the conclusion
that this propensity means a person who receives a vaccine will likely have a specific negative autoimmune
reaction. And fundamentally, Dr. Rinker does not possess the expertise necessary to opine on the
conceptual pathogenic effects of vaccination. He has merely offered some ideas about how vaccines might
generally do harm. He has not explained how the flu or Tdap vaccine in this case could cause RMD or a
similar condition. This showing is insufficient to amount to a reliable scientific theory in satisfaction of
the first Althen prong.18

        Finally, while Petitioner encourages me to consider the opinions of her treating physicians as
evidence supporting Dr. Rinker’s causation theory, these views do little to strengthen Petitioner’s showing
on the first Althen prong. While treater opinions regarding possible vaccine causation are entitled to some
weight, they do not bind me per se. Section 13(b)(1); Snyder, 88 Fed. Cl. at 746 n.67. Here, the opinions

17
  By contrast, petitioners have in other cases succeeded in demonstrating that a particular HLA is associated with a specific
disease. McCollum v. Sec’y of Health & Human Servs., No. 14-790V, 2017 W: 5386613, at *4 .n16 (Fed. Cl. Spec. Mstr. Sept.
15, 2017), mot. for review denied, 135 Fed. Cl. 735 (2017), aff’d, 2019 WL 928499 (Fed. Cir. Feb. 25, 2019). In so doing, they
invoked persuasive and reliable medical literature specific to the illness at issue. See id. This has not been done in this case
with respect to RMD.
18
  Petitioner’s assertion that mere plausibility alone is sufficient to satisfy Althen prong one mischaracterizes her ultimate burden
satisfying each Althen prong with preponderant evidence. See Broekelschen, 618 F.3d at 1350. Given its facial weaknesses and
speculative quality, however, I would not find that Petitioner’s proffered theory meets even a lower standard of mere
plausibility.

                                                                22
offered by Drs. Albano-Aluquin, Simmons, and Wicklund were not contemporaneous with Petitioner’s
onset, as none of these medical professionals were treating her anytime before the fall of 2014—months
after both vaccination and alleged onset. Moreover, Drs. Albano-Aluquin and Wicklund offered only
equivocal opinions. See Ex. 31 at 37–41, 241–42, 273–74. And none of the treater opinions offered in this
case provided any more specificity or clarity with regards to a mechanism of causation than did the reports
provided by Dr. Rinker—that is, none explained how the flu and/or Tdap vaccine could have caused RMD.
For these reasons, I find the treater statements supporting the possibility of vaccine causation to be of little
value in the resolution of this case.

        B.       Prong Two

        Although Petitioner argues that she developed RMD almost immediately post-vaccination, it
cannot be disputed that she had a pre-existing connective tissue disease as of 2010, three years prior to
receipt of the flu and Tdap vaccines. Ex. 2 at 4. Dr. Rinker proposes that Petitioner was “in remission” as
of December 2013 (see First Rinker Rep. at 1, 5, 8), but the medical records suggest that she continued to
exhibit related symptoms around the time of vaccination (although they may have been less severe than
in the past). See, e.g., Ex. 36 at 6–11 (reports of fatigue and abdominal pain in December 2013).

         Even though Respondent did not carry the day on the diagnosis issue, on the point of connecting
Petitioner’s overall symptomology pre and post-vaccination, Respondent had the better argument. As Dr.
Chaudhry explained in his report, Ms. Sheets’s myopathy symptoms were consistent with an ongoing
autoimmune disease that flared in the spring and summer of 2014 (more than three months post-
vaccination). See Chaudhry Rep. at 11. Dr. Rinker, by contrast, did not successfully distinguish
Petitioner’s post-vaccination symptoms from her earlier autoimmune condition. Indeed, both Drs. Rinker
and Albano-Aluquin appear to agree that Ms. Sheets’s RMD is best understood to be a “continuation of
her previously diagnosed autoimmune condition” or a “flare[].” See Third Rinker Rep. at 2; Ex. 29 at 1.
If so, the flu and/or Tdap vaccine could not have been the cause-in-fact of her illness.

         Petitioner was not otherwise able to establish with preponderant evidence that the Tdap or flu
vaccine triggered any of her post-vaccination symptoms. As a threshold matter, her medical records do
not reveal that she actually experienced any vaccine reaction, and there is a large gap in the records before
Ms. Sheets sought care for new muscle-related symptoms in the spring of 2014, allowing for the inference
that no noteworthy symptoms necessitating treatment in the preceding winter had occurred. Petitioner
attempts to fill in such evidentiary “gaps” in her medical history with witness testimony purporting to
establish an onset closer in time to vaccination, and such evidence19 is worthy of some weight—especially
since it was not expressly rebutted, and is also roughly consistent with statements she made to treaters in
April 2014 about when she first experienced her symptoms. See, e.g., Ex. 6 at 1 (note from April 23, 2014



19
  I give far less weight to Dr. Rinker’s statements about onset timing, as his recount of Petitioner’s onset was based on Ms.
Sheets’s own after-the-fact statements, rather than contemporaneous observation.

                                                             23
visit describing symptom onset on December 20, 2013; noting that symptoms began after receiving flu
vaccine).

        But even if I credit as accurate such allegations, evidence of an earlier onset does not rebut my
determination that Petitioner’s overall course began prior to vaccination. Moreover, Ms. Sheets’s medical
record suggests that there was an alternative explanation for her new symptoms: her MRSA infection. See
Chaudhry Rep. at 11; Ex. 36 at 9–10 (noting probable recurrent MRSA infection at December 4, 2013
visit). Respondent established that this infection is a reasonable alternative explanation for any new
symptoms experienced by Petitioner, given that bacterial infections are known to trigger polymyositis and
dermatomyositis. See Chaudhry Rep. at 11 (citing Ex. C; Ex. F). Dr. Rinker never rebutted the relevance
of the MRSA infection, stating instead (contrary to the record) that “there is no mention in the medical
record of infectious illness” that could be the “immunological stimulus” for Petitioner’s myopathy
symptoms. Third Rinker Rep. at 2. This omission greatly undercuts the strength of Petitioner’s Althen
prong two showing, especially given that her expert’s opinion was premised on the “the absence of
alternative causes.” See Third Rinker Rep. at 2. I cannot give substantial weight to this aspect of Dr.
Rinker’s opinion about vaccine causation when it fails to address a significant aspect of Petitioner’s
medical record. See Dobrydnev, 556 F. App’x at 992–93 (citing Brooke Group Ltd., 509 U.S. at 242
(finding expert opinions based on unsupported factual allegations to be worthy of little to no weight)).20

         The weakness in Petitioner’s showing on the question of actual causation is best seen in the
evolution of her own expert’s view over the course of his three reports. Dr. Rinker began by suggesting
that the vaccines could have caused her RMD (see generally First Rinker Rep.), but ultimately opined that
the vaccines in fact significantly aggravated her ongoing “systemic autoimmunity.” Third Rinker Rep.
at 3. In effect, it appears he realized that Ms. Sheets’s pre-existing symptoms simply could not be divorced
from her later RMD diagnosis. It is well understood in the Program that a claimant cannot recover a
damages award if her symptoms predate vaccination. Shalala v. Whitecotton, 514 U.S. 268, 274–75 (1995)
(Vaccine Act claimant who demonstrates she experienced symptoms of injury after receipt of vaccination
does not succeed in her claim if the evidence fails to indicate that she had no symptoms of injury before
her vaccination); Locane v. Sec’y of Health & Human Servs., 99 Fed. Cl. 715 (2011), aff’d, 685 F.3d 1375
(Fed. Cir. 2012) (petitioner’s Crohn’s disease began prior to her vaccinations and therefore vaccine
causation could not be established). Petitioner has not demonstrated a logical sequence of cause and effect
sufficient to satisfy the second Althen prong.




20
   Based on the available medical records, Petitioner’s contention that no treater deemed her MRSA infection a likely trigger
for her RMD appears to be true. See, e.g., Ex. 33 at 3. However, this fact does little to bolster Petitioner’s showing on the
second Althen prong. Petitioner did not report her RMD symptoms to treaters until spring of 2014, at which time she appears
to have self-reported the close temporal relationship between her symptom onset and her December 23, 2013 vaccinations. See,
e.g., id. It is thus unclear whether her treaters were even aware of her December 2013 MRSA infection. Given that treaters
would likely prioritize accurate diagnosis and treatment over a determination of the etiology of Ms. Sheets’s rare condition,
this dearth of independent treater discussion regarding the cause of her RMD is unsurprising.

                                                             24
       C.      Prong Three

         Dr. Rinker concedes that an onset for Ms. Sheets’s symptoms more than a few weeks after
vaccination would greatly decrease the likelihood of vaccine causation under his proffered theory. See
Second Rinker Rep. at 2. Determining onset in this case requires comparison of the medical record to
witness statements prepared after the fact. The medical records created close in time to December 2013
unquestionably do not corroborate allegations of an immediate post-vaccination onset. In her first five
doctor’s visits following vaccination, Ms. Sheets made no mention of her symptoms to treaters. See Ex. 3
at 14–15 (January 3, 2014 surgery for pelvic mass removal); Ex. 36 at 4–5 (January 13th post-operative
visit); Ex. 4 at 1 (denying leg cramps at January 17th cardiologist visit), 4 (denying leg cramps at January
23rd cardiologist visit); Ex. 5 at 1–4 (no mention of rippling muscles at March 5th rheumatologist visit).
Given her pre-vaccination history, it is not unreasonable to expect that Ms. Sheets might have informed
some of these treaters of new symptoms different than what she had experienced prior to vaccination.

         Ms. Sheets relies heavily on witness statements and on later-in-time medical records containing
self-reported onset history to bulwark her position regarding onset. These statements—which Respondent
has not effectively rebutted—do provide evidentiary support for Petitioner’s claimed onset, as witness
statements can fill in “blanks” in a medical record that simply omits details. See Campbell, 69 Fed. Cl.
at 779. At the same time, however, contemporaneous medical records are presumed not only accurate, but
also complete, and later-in-time statements (whether made to treaters or prepared for purposes of
litigation) do not suffice to contradict such records. Cucuras, 993 F.2d at 1528; Murphy, 23 Cl. Ct. at 733.

        Ultimately, determining onset in this case presents a close question. Although Ms. Sheets’s
allegations, and the statements of her contemporaneous witnesses, are not corroborated by independent
medical records, I find she has offered just enough proof to conclude that onset likely occurred closer in
time to vaccination than Respondent allows. This success, however, is not sufficient basis upon which to
find in Petitioner’s favor overall—both because her theory of causation itself is significantly deficient,
and because (as noted above) the record suggests it more likely than not that Petitioner’s illness predated
vaccination. At most, this record allows for the conclusion that Petitioner’s pre-existing connective tissue
disease symptoms flared up in the weeks after vaccination, but were not deemed by her significant enough
to seek treatment until April. Such a fact pattern lends support to the conclusion that her later-diagnosed
RMD was associated with, rather than distinguishable from, her earlier, pre-vaccination connective tissue
disease symptoms.

III.   The Tdap and Flu Vaccines Did Not Significantly Aggravate Petitioner’s Pre-existing
       Condition

       Ms. Sheets’s medical record does suggest a recurring condition, although she defines it in
inconsistent and highly generalized terms, varyingly describing it as a “neurologic illness,” “systemic
autoimmunity,” and “predisposition to autoimmunity.” Mot. at 22, 24, 25. Even though she cannot on the


                                                    25
existing record establish that the vaccines she received caused her condition later manifesting as RMD,
she could prevail if she successfully demonstrated that the vaccines aggravated it. However, I find that
she has failed to do so.

        Setting aside Petitioner’s failure to satisfy the first two Althen prongs (both of which are subsumed
under Loving), I find that she has not shown with credible and reliable evidence that either or both of the
vaccines at issue caused her overall course to be more severe than it would have been expected to be
otherwise. Indeed, as noted above, the evidence is equivocal in support of the conclusion that she had any
immediate post-vaccination symptoms at all—and to the extent she did, her symptoms appear to have
been relatively mild for several months before flaring up in the spring and summer of 2014, causing her
to delay mention of the problem to treaters (and to fail to mention it to those treaters she did see in the
months post-vaccination). This kind of history is not consistent with the theory that vaccination resulted
in a significant change for the worse. At best, Petitioner’s post-vaccination condition featured some
symptoms that she had not previously experienced (such as rippling muscles), but this is inadequate
support for the proposition that her overall course would have been milder but for her December 23, 2013
vaccinations. Dr. Rinker otherwise did not establish how vaccination would worsen Petitioner’s condition,
nor did he persuasively describe the process by which the vaccines purportedly “did cause” the alleged
post-vaccination significant aggravation.

IV.     This Matter was Properly Resolved Without a Hearing

       In ruling on the record, I am declining to hold a hearing, as Petitioner has requested. Mot. at 2. The
choice of how best to resolve this case is a matter that lies generally within my discretion, but I will briefly
explain my reasoning here.

         A hearing provides a petitioner with the opportunity to put on live testimony, which aids the special
master most in cases where witness credibility is at issue or where there is a need to pose questions to a
witness in order to obtain information not contained in, or not self-evident from, the existing filings. See,
e.g., Hooker, 2016 WL 3456435, at *21 (discussing a special master’s discretion in holding a hearing and
the factors that weighed against holding a hearing in the matter); Murphy, 1991 WL 71500, at *2 (no
justification for a hearing where the claim is fully developed in the written records and the special master
does not need to observe the fact witnesses for the purpose of assessing credibility). It may also permit a
claimant to expand upon or illuminate points already set forth in written filings, or respond to
unanticipated questions raised in the matter—but again, only where necessary to reach a decision.

        Prior decisions have recognized that a special master’s discretion in deciding whether to conduct
an evidentiary hearing “is tempered by Vaccine Rule 3(b),” or the duty to “afford[] each party a full and
fair opportunity to present its case.” Hovey, 38 Fed. Cl. at 400–01 (citing Rule 3(b)). But that rule also
includes the obligation of creation of a record “sufficient to allow review of the special master’s decision.”
Id. Thus, the fact that a claim is legitimately disputed, such that the special master must exercise his


                                                      26
intellectual faculties in order to decide a matter, is not itself grounds for a trial (for if it were, trials would
be required in every disputed case). Special masters are expressly empowered to resolve fact disputes
without a hearing.

        In this case, live witness testimony was not required in order for me to reach a reasoned decision.
The flaws in Petitioner’s theory of causation—the most glaring weakness in her overall showing—were
self-evident from my review of the medical records and the three reports submitted by Dr. Rinker (who
ultimately did not possess the expertise necessary to establish a persuasive causation theory). Such
deficiencies did not require oral testimony to be understood for purposes of deciding the case. My
experience in resolving vaccine injury claims informs my reading of the proffered theory of causation,
and its impermissible vagueness and unreliability was apparent on its face. This case turns largely on
whether I accepted Petitioner’s causation theory, and hearing live testimony from the experts would not
have increased the likelihood of such acceptance.

        I similarly had no need to hear from Petitioner (or her several fact witnesses) directly. While there
is some ambiguity with regard to when she began to experience RMD symptoms, I have ultimately
determined that preponderant evidence (as established by declarations and witness statements) supported
her contention that her RMD symptoms began not long after vaccination. However, the outcome of this
case turned on the persuasiveness of Petitioner’s causation theory, and the degree to which she established
that her pre-existing condition was unrelated to and/or worsened by her vaccinations. These matters could
be decided without any fact testimony. Hearing testimony that Ms. Sheets experienced symptoms earlier
than her medical records indicated would, at most, serve to bulwark the temporal nexus between
vaccination and the onset of her RMD—not strengthen the overall causation theory.

        At bottom, the most significant issue in deciding whether to hold a hearing is determining if the
refusal to do so will deprive the claimant of the fair opportunity to prosecute her case. Petitioner here has
received such an opportunity. Her chances of winning would not have increased if I had opted to hold a
hearing.



                                                CONCLUSION

        The Vaccine Act permits me to award compensation to a petitioner alleging a “non-Table Injury”
only if she can show by medical records or competent medical opinion that the injury was more likely
than not vaccine-caused. Here, Petitioner’s claim depends upon my finding that she experienced post-
vaccination onset of RMD or significant aggravation of an underlying autoimmune condition, but the
weight of the evidence does not support either conclusion. Thus, there is insufficient evidence to support
an award of compensation, leaving me no choice but to hereby DENY this claim.




                                                        27
       In the absence of a timely-filed motion for review (see Appendix B to the Rules of Court), the
Clerk shall enter judgment in accord with this decision.21

IT IS SO ORDERED.

                                                                        /s/ Brian H. Corcoran
                                                                        Brian H. Corcoran
                                                                        Special Master




21
  Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their right to
seek review.

                                                              28
