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Full Opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 22-1384V
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*
MARK RADKE, * Chief Special Master Corcoran
*
Petitioner, * Filed: October 6, 2025
*
v. *
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
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Amber Diane Wilson, Wilson Science Law, Washington, DC, for Petitioner.
Tyler King, U.S. Department of Justice, Washington, DC, for Respondent.
ENTITLEMENT DECISION 1
On September 27, 2022, Mark Radke filed a petition seeking compensation under the
National Vaccine Injury Compensation Program (the âVaccine Programâ). 2 Petitioner alleges that
he suffered polymyalgia rheumatica (âPMRâ) after receipt of a pneumococcal conjugate vaccine
on September 30, 2019. Petition (ECF No. 1) at 1.
The Vaccine Program has routinely dismissed claims alleging PMR as a vaccine injuryâ
regardless of the vaccine involved. Because of my reasoned skepticism that this claim had any
more legal basis than matters previously decided, I directed the parties to brief the claim, and they
have done so. See Petitionerâs Brief in Support of Entitlement, dated Jan. 10, 2025 (ECF No. 36)
(âBr.â); Respondentâs Opposition, dated Mar. 21, 2025 (ECF No. 39) (âOpp.â); Petitionerâs
1
"Under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction âof 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.â Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public
in its present 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. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (âVaccine Actâ or âthe Actâ).
Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).
Rebuttal Brief, dated Apr. 18, 2025 (ECF No. 41) (âReplyâ). For the reasons set forth in more
detail below, I hereby deny entitlement.
I. Factual Background
Pre-Vaccination Medical History
Petitioner had a number of treatment events in the years before the vaccination at issue that
bear on his alleged injury. For example, in mid-2014, injuries to his right knee were deemed by
treaters significant enough to make him a good candidate for a knee replacement procedure. Ex.
11 at 19â20. It was observed as early as 2015 that Petitioner had a history of lower limb
neuropathy, featuring paresthesias and reduced reflexes, that impacted his ambulation. Ex. 19 at
268â70, 306â07. These neurologic issues lead in February 2015 to a diagnosis of peripheral
neuropathy. Id. at 270. An EMG 3 performed that spring confirmed the presence of early axonal
sensorimotor neuropathy. Id. at 266. These kinds of symptoms continued to plague Petitioner in
2015, although treaters did not propose any neuropathic-specific medications or comparable
interventions. Id. at 216â17.
In 2017, Petitioner sought treatment for a worsening rash, as well as reported muscle
weakness and fatigue. Ex. 19 at 271, 273. He underwent a brain MRI that August, although the
findings shed no light on possible explanations for some of his complaints. Ex. 18 at 58. He was
again treated for neuropathic symptoms, and now reported mild progression to his upper
extremities. Ex. 20 at 3, 7. Petitioner informed some neurologists that the symptoms had existed
for several years. Ex. 14 at 1, 4. Testing did not, however, aid in identifying an etiologic
explanation for these symptoms. Id. at 6â10. In the fall of 2017, Petitioner also saw an
endocrinologist, who proposed that alcohol use might explain Petitionerâs condition. Ex. 15 at 33.
Petitioner continued in 2018 to explore his conditions with a variety of treaters. He sought
help in January 2018 for head pain and strange sensations, although testing identified no
explanation for the symptoms. Ex. 14 at 25, 29â31. He reported more neuropathic concerns that
summer, coupled with weakness and fatigue, but a repeat MRI revealed nothing of concern. Id. at
39, 43â45. He reported tinnitus and hearing loss in October 2018. Ex. 13 at 45, 47. And in July
2019 (two months before vaccination), he again sought treatment for tinnitus and polyneuropathy
concerns, although his symptoms were then deemed to be stable. Ex. 14 at 58.
Vaccination and Purported Adverse Impact
Mr. Radke was sixty-seven years old when he received a pneumococcal vaccine on
September 30, 2019. Ex. 2 at 21. There is no medical record evidence of any immediate reaction
3
âElectromyographyâ is defined as âan electrodiagnostic technique for recording the extracellular activity (action
potentials and evoked potentials) of skeletal muscles at rest, during voluntary contradictions, and during electrical
stimulation; performed using any of a variety of surface electrodes, needle electrodes, and devices for amplifying,
transmitting, and recording the signals.â Electromyography, Dorlandâs Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=15854&searchterm=electromyography (last visited Oct. 6,
2025).
2
to the vaccination. Two days later (October 2, 2019), Petitioner went to see his neurologist, Dr.
Terry Wimpey, for follow-up evaluation of his preexisting neuropathy symptoms. Ex. 3 at 2.
Petitioner now stated that he had been feeling increasing right leg neuropathy for the past week
(which would mean prior to the vaccination), and that he was feeling âpain behind his calf
associated with the neuropathy and muscle tightnessâ which was causing him to limp. Id.
Examination revealed nothing inconsistent from prior treatment encounters, however, and
Petitioner was referred to physical therapy (âPTâ) for treatment of his symptoms. Id. at 6.
A month later (November 1, 2019), Petitioner went to orthopedist John Manfredi for
treatment of his prior, ongoing right knee pain. Ex. 11 at 16. He now stated, however, that it had
worsened over the past month, and maintained that he had experienced pain and swelling the day
after vaccination. Id. X-rays of Petitionerâs right knee, however, revealed only evidence of
preexisting knee concerns (severe degenerative changes in the knee and calcifications throughout
the medial femoral condyle). Id. at 17. Petitioner was provided a lidocaine injection at this visit to
treat his knee. Id.
That same November, Petitioner saw a different orthopedist for shoulder pain that he
related to falling out of bed the prior month. Ex. 4 at 2. He fell a second time in November, resulting
in an emergency room visit. Ex. 2 at 94. He claimed at this time that he had been experiencing
chronic muscle aches, weakness, and headaches following his receipt of a pneumococcal vaccine.
Id. His examination was normal, additional testing did not reveal any concerns, and he was
eventually discharged home. Id. at 95. A post-ER visit to Dr. Wimpey resulted in the same kind of
normal exam, but blood work revealed a somewhat-elevated CRP 4 and sedimentation rateâboth
of which are biomarkers for inflammation. Ex. 9 at 138â39. Later in November, Petitioner began
PT for right shoulder and knee issues (and was later discharged from PT the following winter after
reporting improvement). Ex. 16b at 1, 106.
On December 6, 2019, Mr. Radke saw rheumatologist Sana Makhdumi, M.D., with
complaints of weight loss, fever, and night sweats, which he deemed to have begun two days after
his receipt of the pneumococcal vaccine. Ex. 5 at 95. But the sole abnormality identified after
examination was âsome painâ upon rotation of Petitionerâs hips. Id. at 96. Dr. Makhdumi was
unable to propose an explanation for Petitionerâs complaints, although she did express concern
that he was experiencing some form of inflammatory arthritisâPMR or rheumatoid arthritisâthat
could have an infectious or neoplastic cause. Id. Dr. Makhdumi prescribed a steroid taper, and also
tested for two viral infections (Epstein-Barr (âEBVâ) and cytomegalovirus (âCMVâ)). Id.
Petitioner tested positive for a prior/resolved EBV infection, and also again displayed an elevated
4
âC-reactive Proteinâ is defined as âa globulin that forms a precipitate with the somatic C-polysaccharide of the
pneumococcus in vitro; it is the most predominant of the acute-phase proteins.â C-reactive Protein, Dorlandâs Medical
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=100489 (last visited Oct. 6, 2025).
3
sedimentation rate (although it was deemed within a normal limit after repeat testing from the
following month). Ex. 9 at 127, 130â31.
2020 Treatment
On January 7, 2020, Petitioner returned to Dr. Makhdumi for follow up of his symptoms.
Ex. 5 at 93. He felt the prednisone was not working, and he was experiencing side temporal
headaches. Id. Examination revealed some limitations with movement of Petitionerâs spine, knees,
and hips. Id. at 94. Dr. Makhdumiâs differential diagnosis now included giant cell arteritis versus
PMR versus reactive arthritis, and she altered his steroid dose while referring him for a temporal
artery biopsy and eye exam. Id. The eye exam yielded normal results, however, and Petitioner later
decided to cancel the biopsy. Ex. 5 at 91; Ex. 12 at 10â14. Petitioner also saw Dr. Wimpey in
January, and reported a cessation of headaches and improvement in how his shoulder felt. Ex. 14
at 89.
In February, Dr. Makhdumi reduced Petitionerâs prednisone dose, while maintaining a
differential comparable to what she had previously proposed (and keeping PMR in it). Ex. 5 at 88â
89. Petitioner again visited the ER that month, complaining of left upper extremity numbness,
heart flutters, mild left sided chest tightness, disequilibrium, and two days of mild urinary
frequency. Ex. 2 at 170. But his exam was normal and he was again discharged. Id. at 173. He had
a second ER visit later that month, reporting right calf pain and swelling. Id. at 223â24. An
ultrasound showed fluid collection consistent with a ruptured Bakerâs cyst, and it was treated. Id.
at 227.
On March 19, 2020, Petitioner saw rheumatologist Stephen Elmore, M.D., for a second
opinion regarding his symptoms, which he felt were not being ameliorated by prednisone. Ex. 5 at
80. Examination revealed some soreness to Petitionerâs shoulders with range of movement,
slightly decreased strength, and tenderness to Petitionerâs right wrist. Id. at 82. Dr. Elmore
expressed concern for PMR versus seronegative rheumatoid arthritis, and proposed more blood
tests plus different medications. Id. at 83. Petitioner continued to see Dr. Elmore in the coming
months. Ex. 5 at 74 (June visit), 75, 78 (May 2020 visit). Dr. Elmore again noted difficulty in
assessing the nature of Petitionerâs illness (while maintaining PMR in the differential), but also
observed that there was no evidence of inflammatory biomarkers, and that treatments were
presuming that some kind of rheumatic condition existed. By July, however, Petitioner informed
Dr. Elmore that he felt better overall, and Dr. Elmore directed a tapering of Petitionerâs prednisone
treatments. Id. at 65. A similar assessment was provided by Dr. Elmore in September. Id. at 24â
25, 60, 63.
4
Treatment Beyond 2021
Petitioner has produced a large number of medical records reflecting treatment he received
from 2021 to the fall of 2022, but they shed little to no light on the issue of vaccine causation.
Petitioner continued at times to deem some of his non-orthopedic symptoms to reflect PMR, and/or
to identify them as beginning close-in-time to vaccination. And while PMR remained a fair
explanation for these symptoms, no treaters appear to have themselves proposed a vaccination-
related etiology for it. See, e.g., Ex. 5 at 5 (September 2022 visit with Dr. Elmore).
II. Expert Opinions
A. Petitionerâs Expert - Petros Efthimiou, M.D., FACR
Dr. Efthimiou, a rheumatologist, offered three written reports on behalf of Petitioner. See
Report, dated Aug. 15, 2023 (ECF No. 25-1) (âFirst Efthimiou Rep.â); Report, dated Apr. 19, 2024
(ECF No. 30-2) (âSecond Efthimiou Rep.â); Report, dated Sept. 13, 2024 (ECF No. 35-1)
(âEfthimiou Third Rep.â). Dr. Efthimiou opined that Petitionerâs receipt of the pneumococcal
vaccine âmore likely than not was a substantial factor contributing to the onset of clinical
polymyalgia rheumaticaâ herein. First Efthimiou Rep. at 1.
Dr. Efthimiou received his medical degree from the University of Ioannina Medical School
in Ioannina, Greece. Curriculum Vitae, filed as Ex. 26 (ECF No. 25-2) (âEfthimiou CVâ). He then
completed an internship in Internal Medicine at the University of Iowa Hospital and Clinics,
followed by his residency in Internal Medicine at Brown University and a fellowship in
Rheumatology at the Hospital for Special Surgery and New York Presbyterian and Memorial Sloan
Kettering Cancer Center Hospital. Id. at 1â2. Dr. Efthimiou currently serves as an Associate
Professor of Medicine at St. Georgeâs University School of Medicine and Ross University Medical
School. Id. at 2. He is board-certified by the American Board of Internal Medicine in
Rheumatology and has an active clinical practice. Efthimiou CV at 3; First Efthimiou Rep. at 1.
Throughout his clinical career, Dr. Efthimiou frequently evaluates and treats individuals with
PMR, and he has spent the last twenty-one years researching inflammatory rheumatic conditions,
such as PMR and other associated inflammatory disorders. First Efthimiou Rep. at 1â2.
First Report
Dr. Efthimiou maintained at the outset of his first report that â[t]he current understanding
of the pathogenesis of PMR is a consensus model of immune-mediated disease that includes the
interaction of multiple factors, both genetic and environmental.â First Efthimiou Rep. at 15; D.
Camellino et al., Pathogenesis, Diagnosis and Management of Polymyalgia Rheumatica, 36 Drugs
& Aging 1015 (2019), filed as Ex. 28 (ECF No. 25-4). Given the understood likely pathogenesis
for it, Dr. Efthimiou deemed it reasonable to propose that multiple vaccine types could be
associated with triggering the clinical onset of the diseaseânoting that PMR can be clinically
expressed in predisposed individuals by an environmental stimulus, such as an infection or
5
vaccination. There is generally a broad spectrum for inflammatory rheumatic diseases, and that
spectrum includes autoinflammatory and autoimmune diseases. First Efthimiou Rep. at 17; E.
Hysa et al., Immune System Activation in Polymyalgia Rheumatica: Which Balance between
Autoinflammation and Autoimmunity? A Systemic Review, 21 Autoimmunity Reviews 1, 7 (2022),
filed as Ex. 30 (ECF No. 25-6) (âHysaâ) (suggesting that âthe balance of [PMR] between
autoinflammation and autoimmunity seems to lie halfway ⌠by considering both ends of the
pathophysiological spectrum of immune-mediated rheumatic disease, PMR might be regarded as
an inflammatory immune-mediated disease with mixed mechanismsâ). As a result, Dr. Efthimiou
opined, it did not matter where PMR fit on that spectrum, since âthe vaccines administered can
reliably explain clinical onset of either subtype of immune mediated response.â First Efthimiou
Rep. at 17.
Dr. Efthimiou maintained that PMR likely clinically presents due to an environmental
trigger, such as infection or vaccination, which then dysregulates an individualâs T-cell response.
First Efthimiou Rep. at 17. In support, he referenced government publications about how vaccine-
caused adverse events can occur. Committee to Review Adverse Effects of Vaccines: Evidence and
Causality 59â60 (K. Stratton et al., eds., 2012), filed as Ex. 33 (ECF No. 25-9) (the âIOM Rep.â)
(listing T-cells as an immune-medicated mechanism that likely contributes to the development of
adverse events after vaccination). T-cells , he contended, contribute to an individualâs maintenance
of the immune system and self-tolerance. First Efthimiou Rep. at 18. But PMR is understood to
mechanistically arise as a result of the disruption of oneâs self-tolerance by certain T-cells and
their inability to prevent autoreactivity. Id.
Components in a particular vaccine could initiate autoreactive T-cells that in turn attack
the body by providing immune signals leading to dysregulation and clinical disease onset. First
Efthimiou Rep. at 18. Here, Petitioner may have already possessed these autoreactive cells due to
previous vaccine exposure or some different environmental exposure. Id. Because a vaccine has
the potential to trigger âalready presentâ immune cellsâ in an individual, Dr. Efthimiou argued, the
vaccine âcould beâ triggering a non-specific immune signal which adversely activates another
immune signal and leads to disease onset. Id. at 18â19; IOM Rep. at 82 (explaining that both
epidemiological and mechanistic research has recognized that individuals experiencing an adverse
reaction to vaccine administration have a predisposition that can exists for several reasons,
including genetics, intervening illness, or prior immunological and environmental exposures).
Medical literature has recognized an association between the seasonal flu vaccine and the
Tdap vaccine, on the one hand, and PMR, and in Dr. Efthimiouâs view such evidence bore on Mr.
Radkeâs circumstances (although the vaccine involved in this case is different). First Efthimiou
Rep. at 19. The pneumococcal vaccine covered by the Program and at issue herein contains an
adjuvant, and pneumococcal proteins are conjugated to the carrier protein, Diphtheria CRM 197â
thus, making any reported associations with the Tdap vaccine (which includes the same diphtheria
proteins) relevant when analyzing Petitionerâs case, in Dr. Efthimiouâs opinion Id. at 20. He further
explained that because these vaccines share the diphtheria toxoid component, they can both elicit
6
B-cell responses in a T-cell dependent manner, making it reasonable to conclude that Petitionerâs
immune response post-vaccination became more susceptible to triggering cross-reactive immune
memory cells, and hence causing PMR. Id.
Second Report
Dr. Efthimiouâs second report responded to comments made by Respondentâs expert, Dr.
Chester Oddis. He first addressed Dr. Oddisâs opinion that Petitionerâs more likely diagnosis was
an âexaggerated pain response,â evidenced by interactions with his surgeon following his knee
replacement surgery. Second Efthimiou Rep. at 1. Dr. Efthimiou maintained in reaction that studies
have reported that âperipheral arthritis has been described in up to 50% of patients with PMR with
knee involvement present in the majority.â Id. (citing M. Cimmino et al., High Frequency of
Capsular Knee Involvement in Polymyalgia Rheumatica/Giant Cell Arthritis Patients Studied by
Positron Emission Tomography, 52 Rheumatology 1865 (2013), filed as Ex. 40 (ECF No. 30-3)).
Moreover, recent research on the pathophysiology of PMR has confirmed the frequency of knee
involvement. See K. Kobayashi et al., Ultrasound of Shoulder and Knee Improves the Accuracy of
the 2012 EULAR/ACR Provisional Classification Criteria for Polymyalgia Rheumatica, 61
Rheumatology 1185, 1180 (2022), filed as Ex. 41 (ECF No. 30-4) (finding that the data revealed
not only the shoulder but also the knee [as] the joint where [ultrasound] abnormalities are
frequently detected ⌠95% of patients with definite PMR had some [ultrasound] abnormalities in
the knee, whereas 77% and 10% had tenderness and swelling, respectively.â).
Here, between October and November 2019 (and hence after the September vaccination),
Mr. Radke reported that his chronic right knee pain had worsened, and he noticed an acute change
in pain over the past month. Second Efthimiou Rep. at 1; Ex. 24 and 139. Petitioner consistently
reported a difference in his knee pain to his primary care physician, Dr. Young, and also pain that
occurred suddenly. Because, Dr. Efthimiou argued, âPMR arthritis is an inflammatory arthritis that
is known to occur suddenly, and joint âwarmthâ is a hallmark of inflammatory arthritisââboth of
which were reported and documented in Petitionerâs medical recordsâthe onset of these problems
was consistent with a PMR diagnosis. Second Efthimiou Rep. at 3.
Dr. Efthimiou then described atypical PMR, and how it relates to Petitionerâs clinical
presentation. Second Efthimiou Rep. at 3. While patients with âclassicâ PMR present more
commonly with bilateral shoulder abnormalities (such as bursitis or bicep tenosynovitis), patients
with an âatypicalâ clinical presentation commonly report a history of pain and swelling in the knee,
symptoms of carpal tunnel syndrome, or pain localized to both knees with radiation. Id. at 4; M.
Fitzcharles & J. Esadile, Atypical Presentation of Polymyalgia Rheumatica, 33 Arthritis & Rheum
403, 406 (1990), filed as Ex. 42 (ECF No. 30-5) (describing six patients that did not present with
any symptoms referable to the limb girdles, and where five out of the six patients developed a
more typical presentation of PMR over the course of two to twelve months). Dr. Efthimiou noted,
however, that âthe differential diagnosis of PMR can have overlapping symptomsâ and that â[t]he
most challenging mimicking disorderâ is seronegative RA. Second Efthimiou Rep. at 4.
7
Concurring with Dr. Oddis, Dr. Efthimiou maintained that seronegative RA, along with other
mimicking PMR disease, had properly been ruled out by Petitionerâs treating physicians. Id.
Regarding Petitionerâs inflammatory markers throughout his treatment course, Dr.
Efthimiou noted that Mr. Radke had two documented increasesâon May 5, 2020, and February
21, 2022. Id. Although Dr. Oddis argued that Petitionerâs inflammatory markers were not
consistently concordant, Dr. Efthimiou responded that â[s]ymptoms and ESR/CRP levels 5 are
often not concordantââstating that â[p]atients with PMR can present with normal ESR values and
in patients with relapse, ESR levels have been observed in 68% of cases and CRP levels normal
in 62% of cases.â Id. at 5 (referencing M. Florescu et al., Polymyalgia Rheumatica: An Update
(Review), 26 Experimental & Therapeutic Medicine 1, 4 (2023), filed as Ex. 44 (ECF No. 30-7).
Despite the medical records demonstrating multiple instances of normal labs over the course of
Petitionerâs treatment course, Dr. Efthimiou opined that Petitioner exhibited a ârelapsing course
[of PMR] that requires longer treatment.â Second Efthimiou Rep. at 5 (emphasizing Dr. Oddisâ
citation to literature discussing slower response times to treatment with low-dose glucocorticoids).
Dr. Efthimiou concluded his second report reiterating his opinion in the matterâthat
Petitionerâs development of PMR was likely triggered by his receipt of the pneumococcal vaccine,
and that his clinical presentation and course is most representative of a probable post-vaccination
cause. Id. at 6.
Third Report
In his final report, Dr. Efthimiou addressed the assertion of Respondentâs other expert, Dr.
Stephen Jameson, that it is essential to consider whether there is a likely link between a given
vaccine and a given autoinflammatory disease in the medical literature. Third Efthimiou Rep. at 2.
In response, Dr. Efthimiou instead maintained that his own analysis âfocused on reliably
explaining why the vaccines administered and [Petitionerâs] sequence of immunological events is
supported by both the clinical evidence and a biologically plausible mechanistic explanation âŚâ
Id. Moreover, Dr. Efthimiou reiterated that his proposed medical theory for causally linking
Petitionerâs receipt of the vaccine and his development of PMR was based on reliable medical and
scientific information available within the field of PMR. Id.
Dr. Efthimiou briefly acknowledged his disagreement with Dr. Jamesonâs understanding
of the level of support needed in the medical literature to confirm a medical theory causally
connecting the pneumococcal vaccination and PMR. Third Efthimiou Rep. at 3. He explained that
5
ESR stands for âerythrocyte sedimentation rate,â and is defined as âthe rate at which erythrocytes precipitate out
from a well-mixed specimen of venous blood, measured by the distance the top of the column of erythrocytes falls in
a given time interval under specified conditions; an increase in rate is usually due to elevated levels of plasma proteins,
especially fibrinogen and immunoglobulins, which decrease the zeta potential on erythrocytes by dielectric shielding
and thus promote rouleau formation. It is increased in monoclonal gammopathy, hypergammaglobulinemia due to
inflammatory disease, hyperfibrinogenemia, active inflammatory disease, and anemia.â Erythrocyte Sedimentation
Rate, Dorlandâs Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=102146 (last
visited Oct. 6, 2025).
8
both, âscientificâ and âmedicalâ literature are necessary when evaluating Petitionerâs overall
clinical sequenceâand here, Dr. Efthimiou argued, the literature supports a finding that
Petitionerâs vaccination and subsequent development of PMR represents a vaccine-associated
cause. Id. at 3â4. In his own analysis, Dr. Efthimiou stated that he examined âthe totality of th[e]
clinical information that supports how a biologically plausible mechanistic link connects the
pneumococcal vaccination to being capable of initiating the understood adverse pathology of PMR
illness.â Id. at 4.
Dr. Efthimiou then addressed criticisms that he had generalized outcomes of other case
studies involving different vaccines with triggering the onset of PMR in certain individuals. He
noted, however, that such studies are ânot intended, especially in isolation, to provide general
conclusion,â yet âif epidemiological studies observed an increased risk of PMR illness in
association with receiving pneumococcal vaccines, administration of the vaccine would not be
recommended.â Third Efthimiou Rep. at 5 (citing T. Shimabukuro et al., Safety Monitoring in the
Vaccine Adverse Event Reporting System (VAERS), 33 Vaccine 4398 (2015), filed as Ex. 47) (ECF
No. 35-2). Similarly, such clinical associations with different types of vaccine antigens, does not,
according to Dr. Efthimiou, âequate to different adverse biological mechanisms explaining how a
patientâs PMR illness can reliably be pathologically caused within a few days.â Third Efthimiou
Rep. at 7.
Thus, relying on the timing of Petitionerâs vaccination and his overall clinical presentation,
plus indirect evidence such as the various cited case reports, and the VAERS data directly
associating the pneumococcal vaccine with PMR, Dr. Efthimiou maintained Petitionerâs PMR had
likely been vaccine-caused.
B. Respondentâs Experts
1. Chester V. Oddis, M.D.
Dr. Oddis, a rheumatologist, offered one written report on behalf of Respondent. See
Report, dated Dec. 26, 2023 (ECF No. 29-1) (âOddis Rep.â). Based on his years of experience in
the practice clinical inpatient and outpatient rheumatology, Dr. Oddis opined that Petitioner did
not have PMR, and that he also did not suffer from vaccine-induced PMR. Oddis Rep. at 12.
Dr. Oddis received his undergraduate degree from the University of Pittsburgh, and his
medical degree from Pennsylvania State University College of Medicine. He is board-certified in
both Internal Medicine and Rheumatology. Oddis Rep. at 1. Dr. Oddis is currently Professor of
Medicine in the Division of Rheumatology and Clinical Immunology and the Director of the
Myositis Center in the School of Medicine at the University of Pittsburgh. Id. His primary area of
research and clinical care is in the clinical, epidemiologic, serologic and treatment aspects of
myositis and autoimmune interstitial lung disease. Id. Dr. Oddis has also published numerous
journal articles on these subjects. Id. at 2. Over the course of his clinical career, Dr. Oddis has
9
diagnosed, treated, and managed the care of many individuals with PMR and other
rheumatological disease. Id.
Dr. Oddis summarized the pertinent medical facts before discussing PMR in general. See
generally Oddis Rep. at 2â8. PMR is understood as a common inflammatory rheumatic condition,
oftentimes characterized by prominent morning stiffness of the shoulder, hip girdle, and neck. Id.
at 8; C. Salvarani & F. Muratore, Clinical Manifestations and Diagnosis of Polymyalgia
Rheumatica, UpToDate (Oct. 2023), filed as Ex. A Tab 1 (ECF No. 29-2) (âSalvaraniâ) at 1. PMR
is found in individuals almost exclusively over the age of 50, and with a peak incidence occurring
between the ages of 70 and 80. Oddis Rep. at 8; Salvarani at 2. Dr. Oddis further explained that
the clinical manifestations of PMR include an abrupt onset of symmetrical aching and stiffness of
the shoulders, hip girdle, neck and torso, with pain being the worst in the morning. Oddis Rep. at
8; Salvarani at 4. Approximately 70â95% of patients with PMR will exhibit bilateral shoulder pain
as the presenting clinical manifestation, with about 50% exhibiting lower extremity symptoms.
Salvarani at 4. Patients with PMR, however, can also present with non-specific signs or symptoms,
such as malaise, fatigue, depression, weight-loss or low-grade fever. Id. at 5; Oddis Rep. at 8.
Dr. Oddis then discussed the common laboratory findings in PMRâemphasizing the
significance of the diagnostic value of ESR and CRP. Oddis Rep. at 9. ESR, the âtraditional
laboratory finding in PRM,â typically ranges from mildly to markedly increased, whereas CRP is
ânearly always elevated.â Salvarani at 5 (stating that âin two reports, an elevated ESR (greater than
30 mm/hour) was noted in 92 to 94 percent of patients at the time of diagnosis of PMR, while 99
percent of such patients had an increased serum CRP level (greater than 5mg/L).â). Here,
Petitionerâs inflammatory markers, specifically ESR and CRP, were not âconsistently concordant
with either an improvement or an exacerbation of PMR symptoms.â Oddis Rep. at 10. Similarly,
during a follow-up with Dr. Young on June 15, 2021, Petitioner reported âconstant morning
stiffnessâ but his inflammatory markers at that time were noted as within the normal range. Ex. 5
at 46, 49. Dr. Oddis stated that this instance, among others noted in the medical records, indicates
an inconsistency between Petitionerâs symptoms and lab results and proposed diagnosis. Oddis
Rep. at 10.
The initial treatment course for PMR typically involves the use of low-dose glucocorticoids
(i.e., Prednisone) and the therapeutic response is understood to be brisk and complete. Oddis Rep.
at 9. Patients oftentimes start with a suggested dose of 15mg/day; however, lower dosages may be
more appropriate for certain individuals. Id. On the other hand, chronic management of PMR
involves the gradually tapering of the Prednisone dosage, of which the duration of treatment can
vary among individuals (i.e., some patents can wean off treatment in 1 to 2 years, while others
require longer). Id. Dr. Oddis emphasized not only how unusual it was that Petitionerâs Prednisone
dosage fluctuated greatly throughout his treatment course, but that the dosage often exceeded
20mg/dayâa level that generally aids in alleviating symptoms of PMR quickly and completely.
Id. at 11; C. Salvarani & F. Muratore, Treatment of Polymyalgia Rheumatica, UpToDate (Oct.
2023), filed as Ex. A Tab 2 (ECF No. 29-3) at 1â2.
10
Based on the medical records and literature, Dr. Oddis opined that Petitioner more than
likely did not have PMR. Oddis Rep. at 11. Petitionerâs symptoms did not feature the classical
presentation of bilateral shoulder pain and hip stiffness that improves throughout the day and
responds well steroid treatment. Id. at 10. Moreover, Petitionerâs treating physicians were not
confident that his overall signs and symptoms were consistent for a diagnosis of PMRâand Dr.
Oddis referenced a note from an April 2, 2020, visit with Dr. Young that stated â[w]e discussed
that [Petitionerâs] presentation has not been classic for PMR ⌠the doses of prednisone which
have relieved [Petitionerâs] symptoms are higher than which would normally be used in PMR.â
Id. at 11 (citing Ex. 24 at 186). In addition, Petitionerâs treating physicians ruled out other
inflammatory and non-inflammatory diseases that can sometimes mimic PMR, such as elderly
onset Rheumatoid Arthritis, late-onset Spondyloarthropathy, Inflammatory Myopathy, Lupus,
various forms of Vasculitis, Calcium pyrophosphate Deposition Disease, or infection. Oddis Rep.
at 9.
2. Stephen C. Jameson, Ph.D.
Dr. Jameson, an immunologist, offered one written report on behalf of Respondent. See
Report, dated June 25, 2024 (ECF No. 34-1) (âJameson Rep.â). Dr. Jameson opined that it is more
likely than not Petitionerâs receipt of the pneumococcal vaccine on September 20, 2019, did not
cause his development of PMR. Jameson Rep. at 5.
Dr. Jameson attended the University of Bristol, England for his undergraduate degree in
Cellular Pathology, and the University of Cambridge, England for his Ph.D. in Physiology and
Genetics Research. Curriculum Vitae, filed as Ex. C (ECF No. 34-4) (âJameson CVâ) at 1. He then
completed a post-doctoral fellowship in Immunology at the Scripps Research Institute, La Jolla,
California, and the University of Washington, Seattle, before establishing his own laboratory at
the University of Minnesota in 1995. Id.; Jameson Rep. at 1. Dr. Jameson is currently a Professor
in the Center for Immunology, Masonic Cancer Center and Department of Laboratory Medicine
and Pathology, at the University of Minnesota Medical School. Jameson Rep. at 1â2. He has
published over 130 primary research papers, as well as over 50 review articlesânearly all focusing
on various topics in immunology and on the immune response to pathogens. Id. at 2. Dr. Jamesonâs
primary research focus is the study of cellular immune response against pathogens and vaccines
via animal models, and the impact the studied immune responses have on protective immunity,
immunopathology, and autoimmunity. Id.
Dr. Jameson primarily focused his brief report on responding to Dr. Efthimiouâs
proposition that Petitionerâs immune response to his receipt of the pneumococcal vaccine
subsequently led to his development of PMR. The innate immune response, explained Dr.
Jameson, can be considered as âthe acute response to infection, vaccination or tissue damageâ that
typically leads to the subsequent induction of inflammatory responses. Jameson Rep. at 3. This
response involves several different cell typesâpredominantly myeloid cells, such as macrophages.
Id. When an individual has an immune response to a trigger such as an infection or vaccination,
11
however, it is the secondary, adaptive immune response (involving primarily T- and B-cells) that
takes over. Id. This is because macrophages are usually insufficient in containing an individualâs
immune response to infection or vaccination. Id. Specifically, T-helper cells promote the activation
of B-cells which then lead to the production of âpotent high-affinity antibodies, capable of
neutralizing the pathogen or its toxins.â Id. And when a cooperative response exists between T-
cells and B-cells, their populations of cells can persist long-term, thus, creating immunological
memory. Id. Therefore, any future exposure to the same or related pathogens will essentially
trigger faster and more effective control via the adaptive immune response, Dr. Jameson opined.
Jameson Rep. at 3. However, because vaccines (like the pneumococcal vaccine) are attenuated,
âeffective immune memory is typically generated without excessive or prolonged inflammation.â
Id.
Dr. Jameson briefly responded to Dr. Efthimiouâs assertion that aspects of the innate and
adaptive immune response have been observed in immunopathological responses, such as
autoimmunity and autoinflammatory diseasesârelied upon by Dr. Efthimiou for his contention
that PMR may involves both autoimmunity and autoinflammatory characteristics. Jameson Rep.
at 3. Dr. Jameson, however, argued that simply because the same types of pathways are involved
in protective immune responses and those that lead to autoimmune and/or autoinflammatory
disease, does not on its own, lead to the conclusion that one type of pathway will likely lead to
illness. Id. If this were true, every infection or vaccination would lead to âdamaging
autoinflammatory diseases and multiorgan autoimmunityâ, even though that is not the case. Id.
Instead, Dr. Jameson maintained that the similarity between the types of pathways involved in
protective and damaging inflammatory/immune responses can exist without being causally related.
Id.
When considering whether a causal link exists between a given infection or vaccination
and a specific autoimmune/autoinflammatory disease, Dr. Jameson maintained, the scientific
community looks for reliable evidence such as epidemiological and mechanistic studies (although
he admitted that establishing sound bases for concluding causality under such circumstances was
difficult). Jameson Rep. at 3, 4. But here, there was very little in the way of medical literature
suggesting the existence of a causal link between infections and/or vaccination and PMR. Id. at 4.
At most, Dr. Efthimiou had offered articles that discuss a possible connection between PMR and
the flu or Tdap vaccinesâ neither of which were relevant to Mr. Radkeâs case. Indeed, one such
article ultimately concluded that âa causal association between [influenza vaccination] and GCA
or PMR is not supported by adequate evidence.â Id.; E. Liozon et al., Giant Cell Arteritis or
Polymyalgia Rheumatica after Influenza Vaccination: A Study of 12 Patients and a Literature
Review, 20 Autoimmunity Rev. 1 (2021), filed as Ex. 32 (ECF No. 25-8) (âLiozonâ) at 5.
Dr. Efthimiou also proposed âa somewhat tortuous linkâ for a causal association, Dr.
Jameson argued. Jameson Rep. at 5. Dr. Efthimiou had attempted to demonstrate an association
between pneumococcal vaccine and PMR based upon the fact that the Tdap and pneumococcal
vaccines share the same conjugate CRM197 component, and therefore, the pneumococcal vaccine
12
could also provoke the onset of PMR. Id.; see also P. Falsetti et al., Polymyalgia Rheumatica
following Infective Triggers or Vaccinations: A Different Subset of Disease?, 58 Rheumatologia
76 (2020), filed as Ex. 29 (ECF No. 25-5) (âFalsettiâ) at 3 (finding that two out of six patients
received a Tdap vaccination prior to the onset of PMR). Dr. Jameson, however, took issue with
Dr. Efthimiouâs reliance on Falsettiâarguing that âall [one] can glean from [the] report is that
those patients received tetanus toxoid vaccinesâand since tetanus toxoid is not a component of
the Prevnar 13 pneumococcal conjugate vaccine received by [Petitioner], this undercuts Dr.
Efthimiouâs argument that the presence of diphtheria toxin in Prevnar 13 provides a mechanistic
basis by which it could induce PMR, based on the literature.â Jameson Rep. at 5.
Dr. Jameson maintained that Dr. Efthimiouâs generalization that the âelements of the
immune system that are involved in the response to vaccines are also involved in autoimmune
responseâ is ânot pertinentâ when analyzing whether Petitionerâs receipt of the pneumococcal
vaccine on September 13, 2019, most likely led to his development of PMR. Jameson Rep. at 5.
He opined instead that based on Petitionerâs clinical presentation and course, as well as the medical
literature, it is more likely than not that Petitionerâs receipt of the vaccine at issue did not cause
his alleged injury. Id.
III. Procedural History
As noted above, this matter was initiated in September 2022. Respondent filed a status
report on April 12, 2023, indicating his intent to defend the matter, but acknowledging the lack of
filed medical records at that time. See Status Report, dated Apr. 12, 2023 (ECF No. 19). Petitioner
completed the filing of all pertinent medical records on August 15, 2023. Thereafter, the process
of obtaining expert reports began, with the final report from Dr. Efthimiou filed in September
2024. I issued a scheduling order on October 2, 2024, setting forth a briefing scheduling for a
ruling on the record. The parties subsequently filed their briefs, and the matter is now ripe for
resolution.
IV. Partiesâ Arguments
Petitioner
Petitioner maintains that the evidentiary record preponderantly establishes that PMR is his
proper diagnosis. Br. at 1â2. As support, Petitioner emphasizes that following the receipt of the
vaccine he reported symptoms of chills, muscle aches, and joint aches, and that he continued to
report such clinical symptoms of PMR in the weeks after. Id. at 2, 3. In addition, several of
Petitionerâs treating physicians involved in his care âopined that [Petitioner] diagnostically
suffered from a clinical picture that included the diagnosis of PMR, even though his clinical picture
represents a refractory subtype of PMR illness. Id. at 2 (referencing Ex. 5 at 93â95; Ex. 2 at 53;
Ex. 5 at 36). Moreover, Petitionerâs current treating rheumatologist opined in a filed stated that he
would âlean more towards a diagnosis of PMRâ and that Petitionerâs âlargest areas of symptom
13
involvement included his shoulders with some lower extremity and hand involvement. Id. at 6
(citing Dr. Elmore Treater Letter, dated July 22, 2024 (ECF No. 35-3) at 1, 2). And through highly
relevant and recently published items of literature, Petitioner argues that Dr. Efthimiou provided
âreputable support for his opinion that PMR patients are known to have a similar clinical of
medical facts as [Petitioner].â Br. at 8.
Petitioner next asserts that he has provided a logical sequence of cause and effect showing
that the pneumococcal vaccine is the reason for his PMR injury. Br. at 15. Based on the objective
medical records and the cited medical literature, Dr. Efthimiou preponderantly explained how
Petitionerâs clinical presentation of pain, the morning stiffness, the generalized aches and pains,
the weight loss, and symptoms of fatigue were all indicative, according to Dr. Efthimiou, that
Petitioner was more likely than not suffering from an inflammatory condition consistent with the
diagnosis of PMR. Id. at 16. Because Petitionerâs symptoms started âabruptlyâ within several days
post-vaccination, and there being no record evidence to suggest Petitioner suffered similar
symptoms prior to receipt of the vaccine, a logical sequence of cause and effect has been shown.
Id. at 17. Furthermore, Dr. Efthimiou found no other cause factors present in Petitionerâs medical
history, clinical presentation, or alleged by Respondentâs experts, that would provide a better
causal explanation for Petitionerâs development of PMR. Id.
Petitioner also maintains that he has established a medically and scientifically reliable
theory causally connecting vaccination and the alleged injury. Br. at 21. Relying on clinical
evidence and mechanistic data, Dr. Efthimiou preponderantly explained how associations
examined in the various cited clinical studies support a causal link that is biologically credible. Id.
at 22. Petitioner notes that Dr. Efthimiou provided several items of literature demonstrating that
more than one vaccine, including pneumococcal, is associated with triggering an onset of PMR.
Id. at 23. Specifically, Petitioner finds significant that the âmost studied and associatedâ vaccine
and an onset of PMR is the flu vaccineâwhich, Petitioner emphasizes that he âfactually received
just four weeks prior to [his] receipt of [the] Prevnar 13 vaccine.â 6 Id. Moreover, because of the
identified innate immune mechanism responses common to both the flu and pneumococcal
vaccines, Dr. Efthimiou has preponderantly established âhow an innate immune response from the
Prevnar 13 vaccination can cause the dysregulation of immune cells already present [an]
individual.â Id. at 26. Thus, Petitioner argues that, via multiple types of evidence, Dr. Efthimiou
has provided a sound a reliable medical theory.
Lastly, Petitioner briefly maintains that he has established a preponderant showing of a
proximate temporal relationship between vaccination and the alleged injury. Br. at 34. Dr.
6
In his opposition, Respondent âcontends that [P]etitioner has not plead this in his petition, nor in the [Motion for
Ruling on Record], that the flu vaccine caused in any way his PMR.â Opp. at 32. Moreover, Respondent argues that
in this regard, Petitioner has failed to demonstrate how the two vaccines working in conjunction could cause PMR.
Id. at 33. I find that this stray reference is not Petitionerâs actual proposed theory in this case (and in any event it would
not render the claim more successful, since PMR claims uniformly failâregardless of the vaccine at issue).
14
Efthimiou provided items of medical literatureâinvolving the flu vaccine and a subsequent
develop of PMRâthat adequately supports his assertion that such clinical symptoms can occur
within a day of vaccination via the innate immune response. Id. at 35. When considering the totality
of the evidence (i.e., Petitionerâs medical records and the medical and scientific literature),
Petitioner maintains that Dr. Efthimiou preponderantly established a medically acceptable
timeframe that involves the vaccine initiating a fast and non-specific immune response resulting
in the development of PMR. Br. at 35.
Respondent
Respondent maintains that Petitioner has the burden of showing a defined and recognized
injury by preponderant evidenceâand thus must establish PMR was the likely diagnostic
explanation for his injury. Opp. at 23. But Petitionerâs initial presenting symptoms were not
considered the more âclassicalâ onset of proximal shoulder and hip stiffness. Id. at 24. Instead, his
first symptomatic complaints included weight loss, fatigue, and night sweats, with any report of
shoulder pain not occurring until approximately one-month post-vaccination. Id. Similarly,
Petitionerâs inflammatory markers, specifically his ESR/CRP levels, were not consistently
associated with either his improvement and/or exacerbation of his alleged symptoms. Id. at 25.
Moreover, his multiple reports of crippling pain and his lack of a complete response to prednisone
treatment, is again, unusual with a diagnosis of PMR. Id. Accordingly, Respondent contends that
Petitioner has failed to prove, by a preponderance of the evidence, that he more than likely suffered
from PMR. Id.
Respondent further argues that Petitioner has failed to submit preponderant evidence
establishing a reliable and persuasive medical theory. Opp. at 27. Respondent first notes that
âexisting case law overwhelmingly favors a finding that PMR is not caused by vaccines,â and that
the case adds nothing new to Dr. Efthimiouâs previously relied-upon theories of causation in
similarly situated vaccine injury claims. Id. at 2, 729; Munoz v. Secây of Health & Hum. Servs.,
No. 21-11369V, 2024 WL 4113486 (Fed. Cl. Spec. Mstr. Aug. 12, 2024), mot. for review denâd,
174 Fed. Cl. 276 (2024), appeal docketed, No. 2025-1409 (Fed. Cir. Feb. 4, 2025). In addition,
Dr. Efthimiouâs theory is relatively âunclear.â Opp. at 29. The cited medical literature is not only
âscant,â but even Dr. Efthimiouâs reliance on several items of literature regarding the flu vaccine
and PMR explicitly state the inadequacy of finding a causal association. Id. at 31 (referencing
Liozon at 5). And while Dr. Efthimiou did present a study that supported the contention that some
overlap exists between the pneumococcal and flu vaccines (i.e., specific gene profiles), he failed
to identify which of the overlapping genes, if any, is relevant in how vaccines activate the immune
response. Id. at 33.
Next, Respondent contends that Petitioner has failed to submit preponderant evidence of a
logical sequence of cause and effect showing that the vaccination was the reason for his alleged
15
injury. Opp. at 34. A majority of Petitionerâs alleged symptoms either pre-dated the vaccine at
issue, were not commonly recognized symptoms of PMR, or were caused by other injuries
altogether. Id. at 35. For example, his hip pain was consistently attributed to his osteoarthritis by
treating physicians and his initial complained of symptoms including fatigue, muscle weakness,
and loss of stamina. Id. (citing Ex. 5 at 41; Ex. 6 at 2). Moreover, Respondent argues that Petitioner
reportedly developed symptoms of PMR approximately twenty-four hours post-vaccination, and
relying on Petitionerâs own cited medical literature, such a timeframe is far too quick for such a
disease onset. Opp. at 35.
Respondent concludes his argument by stating that Petitioner did not present any reliable
evidence, that is consistent with his proposed theory, and in range with a medically acceptable
timeframe to infer causation. Id. at 36.
V. Applicable Law
A. Petitionerâs Overall Burden in Vaccine Program Cases
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a âTable Injuryââi.e., an injury falling within the Vaccine Injury Tableâ
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 âNon-Table
Injuryâ). 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, 592 F.3d at 1321; Capizzano v. Secây of Health & Hum. Servs.,
440 F.3d 1317, 1320 (Fed. Cir. 2006). 7 There is no Table claim for PMR as an injury associated
with any covered vaccine, so Petitioner can only advance a causation-in-fact claim.
For both Table and Non-Table claims, Vaccine Program petitioners bear a âpreponderance
of the evidenceâ burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the âtrier 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 factâs
existence.â 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. Secây of Health & Hum. Servs., 931 F.2d 867,
873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was ânot only
[the] but-for cause of the injury but also a substantial factor in bringing about the injury.â Moberly,
592 F.3d at 1321 (quoting Shyface v. Sec'y, Health & Hum. Servs., 165 F.3d 1344, 1352â53 (Fed.
7
Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority.
Hanlon v. Secây of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning
legal issues are binding on special masters. Guillory v. Secây of Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003),
affâd 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Secây of Health & Hum. Servs., No. 13-159V, 2014 WL
504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
16
Cir. 1999)); Pafford v. Secây of Health & Hum. 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 v. Sec'y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): â(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.â
Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a âreputable medical theory,â demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355â56 (citations omitted). To satisfy this prong, a
petitionerâs theory must be based on a âsound and reliable medical or scientific explanation.â
Knudsen v. Secây of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must
only be âlegally probable, not medically or scientifically certain.â 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, 569 F.3d at 1378â79 (citing Capizzano, 440 F.3d at 1325â26). 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 ânot through the lens of the laboratorian, but instead from the vantage point
of the Vaccine Actâs preponderant evidence standard.â 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.
In discussing the evidentiary standard applicable to the first Althen prong, the Federal
Circuit has consistently rejected the contention that it can be satisfied merely by establishing the
proposed causal theoryâs scientific or medical plausibility. See Cerrone v. Secây of Health & Hum.
Servs., No. 17-1158V, 2023 WL 3816718 (Fed. Cl. Spec. Mstr. June 1, 2023), mot. for rev. denied,
168 Fed. Cl. 745 (2023), affâd, 146 F.4th 1113 (Fed. Cir. 2025); Kalajdzic v. Secây of Health &
Hum. Servs., No. 2023-1321, 2024 WL 3064398, at *2 (Fed. Cir. June 20, 2024) (arguments âfor
a less than preponderance standardâ deemed âplainly inconsistent with our precedentâ (citing
Moberly, 592 F.3d at 1322)); Boatmon v. Secây of Health & Hum. Servs., 941 F.3d 1351, 1359
(Fed. Cir. 2019); see also Howard v. Sec'y of Health & Hum. Servs., 2023 WL 4117370, at *4
(Fed. Cl. May 18, 2023) (â[t]he standard has been preponderance for nearly four decadesâ), affâd,
2024 WL 2873301 (Fed. Cir. June 7, 2024) (unpublished). And petitioners always have the
17
ultimate burden of establishing their overall Vaccine Act claim with preponderant evidence. W.C.
v. Secây of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell
v. United States, 133 Fed. Cl. 782, 793 (2017) (noting that Moberly âaddresses the petitionerâs
overall burden of proving causation-in-fact under the Vaccine Actâ by a preponderance standard).
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitionerâs medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375â77; Capizzano, 440 F.3d at 1326; Grant v. Secây of Health & Hum. Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine âdid causeâ injury, the opinions
and views of the injured partyâs treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (âmedical 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
âlogical sequence of cause and effect show[s] that the vaccination was the reason for the injuryââ)
(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. Secây of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
Medical records and statements of a treating physician, however, 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 â[a]ny such diagnosis, conclusion, judgment,
test result, report, or summary shall not be binding on the special master or courtâ); Snyder v. Secây
of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (âthere is nothing . . . that mandates
that the testimony of a treating physician is sacrosanctâthat it must be accepted in its entirety and
cannot be rebuttedâ). 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 recordâincluding conflicting opinions among such individuals.
Hibbard v. Secây of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious
for special master to weigh competing treating physiciansâ conclusions against each other), affâd,
698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Secây of Dept. of Health & Hum. Servs., No. 06-522V,
2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review denâd, 100 Fed.
Cl. 344, 356 (2011), affâd without opinion, 475 F. Appx. 765 (Fed. Cir. 2012).
The third Althen prong requires establishing a âproximate temporal relationshipâ between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase âmedically-acceptable temporal relationship.â Id. A petitioner must offer âpreponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorderâs etiology, it is medically acceptable to infer causation.â de Bazan v.
Secây of Health & Hum. 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
18
an injury (Althen prong oneâs requirement). Id. at 1352; Shapiro v. Secây of Health & Hum. Servs.,
101 Fed. Cl. 532, 542 (2011), recons. denâd after remand, 105 Fed. Cl. 353 (2012), affâd mem.,
503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Secây of Health & Hum. Servs., No. 11-355V, 2013
WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. denâd (Fed. Cl. Dec. 3, 2013),
affâd, 773 F.3d 1239 (Fed. Cir. 2014).
B. Legal Standards Governing Factual Determinations
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 âall [ ] relevant medical and scientific evidence contained in the record,â including
âany 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,â as well as the âresults of any diagnostic or evaluative test which are
contained in the record and the summaries and conclusions.â 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 & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir.
1993) (determining that 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).
As noted by the Federal Circuit, â[m]edical records, in general, warrant consideration as
trustworthy evidence.â Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95
Fed. Cl. 598, 608 (2010) (â[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 lawâ), aff'd, Rickett v. Sec'y of Health & Hum.
Servs., 468 F. Appâx 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked
propositions explains why such records deserve some weight: (i) sick people visit medical
professionals; (ii) sick people attempt to 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 & Hum. Servs., No. 11â685V,
2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum.
Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (â[i]t strains reason to
conclude that petitioners would fail to accurately report the onset of their daughter's symptomsâ).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03â1585V, 2005 WL
6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records
19
are often found to be deserving of greater evidentiary weight than oral testimonyâespecially
where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also
Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d
1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (â[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.â)).
However, the Federal Circuit has also noted that there is no formal âpresumptionâ that
records are accurate or superior on their face to other forms of evidence. Kirby v. Secây of Health
& Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which
compelling oral or written testimony (provided in the form of an affidavit or declaration) may be
more persuasive than written records, such as where records are deemed to be incomplete or
inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (âlike 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 lackingâ); Lowrie, 2005 WL
6117475, at *19 (â[w]ritten records which are, themselves, inconsistent, should be accorded less
deference than those which are internally consistentâ) (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 & Hum. 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 âconsistent, clear, cogent, and
compelling.â Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs.,
No. 90â2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person's failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional's failure to document everything
reported to her or him; (3) a person's faulty recollection of the events when presenting testimony;
or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203â04 (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.
20
C. 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. Secây of Health & Hum. Servs., 219 F.3d 1357,
1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the
factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 594â96 (1993). See Cedillo v. Secây of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed.
Cir. 2010) (citing Terran v. Secây of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999).
Under Daubert, the 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 592â95).
In the Vaccine Program the Daubert factors play a slightly different role than they do when
applied in other federal judicial settings, like the district courts. Typically, Daubert factors are
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are
used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health &
Hum. Servs., 94 Fed. Cl. 53, 66â67 (2010) (âuniquely in this Circuit, the Daubert factors have been
employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of expert
testimony already admittedâ). 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 742â45. 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 in order to rebut a petitionerâs case.
Where both sides offer expert testimony, a special master's decision may be âbased on the
credibility of the experts and the relative persuasiveness of their competing theories.â Broekelschen
v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d
at 1362). However, nothing requires the acceptance of an expert's conclusion âconnected to
existing data only by the ipse dixit of the expert,â especially if âthere is simply too great an
analytical gap between the data and the opinion proffered.â Snyder, 88 Fed. Cl. at 743 (quoting
Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec'y of Health & Hum. Servs.,
No. 08â601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for review
21
den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. Appâx. 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 1325â26
(â[a]ssessments as to the reliability of expert testimony often turn on credibility determinationsâ);
see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (âthis court
has unambiguously explained that special masters are expected to consider the credibility of expert
witnesses in evaluating petitions for compensation under the Vaccine Actâ).
D. Consideration of Medical Literature
Both parties filed numerous items of medical and scientific literature in this case, but not
all such items factor into the outcome of this decision. While I have reviewed all the medical
literature submitted in this case, I discuss only those articles that are most relevant to my
determination and/or are central to Petitionerâs caseâjust as I have not exhaustively discussed
every individual medical record filed. Moriarty v. Secây of Health & Hum. Servs., No. 2015â5072,
2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (â[w]e generally presume that a special master
considered the relevant record evidence even though he does not explicitly reference such evidence
in his decisionâ) (citation omitted); see also Paterek v. Secây of Health & Hum. Servs., 527 F.
Appâx 875, 884 (Fed. Cir. 2013) (â[f]inding certain information not relevant does not lead toâand
likely underminesâthe conclusion that it was not consideredâ).
E. Disposition of Case Without Hearing
I am resolving Petitionerâs claim on the filed record, as per the partiesâ request. 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. Kreizenbeck v. Secây of Health & Hum. Servs., 945
F.3d 1362, 1366 (Fed. Cir. 2020); see also Hooker v. Secây of Health & Hum. Servs., No. 02-472V,
2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where
special masters decided case 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. Secây of Health & Hum. Servs., 38 Fed. Cl. 397, 402â03 (1997) (determining that special
master acted within his discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy
v. Secây of Health & Hum. Servs., No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr.
19, 1991).
22
ANALYSIS
I. Program Treatment of PMR as Vaccine Injury
PMR has not generally been deemed in the Program to be a likely vaccine-caused injury.
See generally Munoz, 2024 WL 4113486; Sciortino v. Secây of Health & Hum. Servs., No. 22-
99V, 2024 WL 4579389 (Fed. Cl. Spec. Mstr. July 24, 2024); Thompson v. Secây of Health &
Hum. Servs., No. 18-1217V, 2023 WL 9053982 (Fed. Cl. Spec. Mstr. Dec. 5, 2023) (SM Oler)
(pneumococcal vaccine not found causal of claimantâs PMR); Van Dycke v. Secây of Health &
Hum. Servs., No. 18-106V, 2023 WL 4310701 (Fed. Cl. Spec. Mstr. June 7, 2023) (SM Dorsey)
(Tdap vaccine not found causal of claimantâs PMR); Giesbrecht v. Secây of Health & Hum.
Servs., No. 16-1338V, 2023 WL 2721578 (Fed. Cl. Spec. Mstr. March 30, 2023) (SM Moran)
(flu vaccine not found causal of claimantâs PMR); Kelly v. Secây of Health & Hum. Servs., No.
17-1475V, 2022 WL 1781957 (Fed. Cl. Spec. Mstr. Oct. 12, 2022) (SM Horner) (flu vaccine not
found causal of claimantâs PMR); Suliman v. Secây of Health & Hum. Servs., No. 13-993V, 2018
WL 6803697 (Fed. Cl. Spec. Mstr. Nov. 27, 2023) (SM Roth) (Tdap vaccine not found causal of
claimantâs PMR). All of these decisions provide persuasive, useful guidance for resolving this
matter.
The most on-point determination is Thompson, since it also involves the pneumococcal
vaccine. There was no dispute as to the accuracy of the PMR diagnosis in that case. Thompson,
2023 WL 9053982, at *2. The petitionerâs causal theory was that the vaccine promoted (as part
of the innate immune response) upregulation of cytokines, leading to immune dysregulation
followed by an autoimmune condition. Id. at *13. The special master found, however, that theory
proposed over-relied of aberrant cytokine upregulation (an oft-rejected concept) and literature
involving different vaccines. Id. at *14â16. She also emphasized how many times other special
masters had rejected theories of vaccine causation of PMR. Id. at *16 (citing five prior decisions,
including Suliman, Kelly, Giesbrecht, and Van Dyke).
I also note that I am familiar with the causation theory offered by Dr. Efthimiou in this
case, since he has previously proposed essentially the same theory. In Munoz (which was decided
after hearingânot on the papers, as here), Dr. Efthimiou offered a medical theory in which a
claimantâs receipt of a Tdap vaccine initiated a heightened immune response which resulted in a
loss of immunologic tolerance and led to his symptoms onset of PMR. Munoz, 2024 WL
4113486, at *2â3. Not only were several items of literature relied upon in Munoz also cited herein
(and for the same proposition), but Dr. Efthimiou also appears to have essentially copied and
pasted several sections of his of previously-filed experts reports to his reports addressing the case
at hand. 8
8
See Munoz, 2024 WL 4113486, at *4 (discussing the Falsetti, Salvarani , and Soriano articles).
23
These cases do not control the outcome of this matter. But they all provide reasoned
grounds to be highly skeptical of claims that any covered vaccines can cause PMR.
II. Petitioner Has Not Carried His Burden of Proof
As is well understood in the Program, the failure to establish even one of the three Althen
prongs in the context of a causation-in-fact claim is sufficient basis for a claimâs dismissal.
Dobrydnev v. Secây of Health & Hum. Servs., 566 Fed. Appx. 976, 980 (Fed. Cir. 2014). This case
wholly turns on the first, âcan causeâ prongâand because I find it has not been preponderantly
established, no discussion of Petitionerâs success with respect to the other prongs is necessary. For
even if Petitioner had experienced PMR, as alleged, 9 he has not preponderantly established that
the pneumococcal vaccine could be causal of it.
Dr. Efthimiouâs causation opinion largely repeats the kinds of arguments that other special
mastersâincluding meâhave routinely rejected as unpersuasive. See generally Munoz, 2024 WL
4113486, at *13. Indeed, the report offered in this case is exceedingly similar to what I reviewed
in Munoz, even if the vaccines are not the same. Further, and like experts in past cases, he fails to
identify a specific antigen associated with the development of PMR, or demonstrate that Petitioner
himself possessed any genetic susceptibility. Petitioner has not otherwise offered any more recent
scientific or medical studies or articles that would suggest a PMR-vaccine association is now
thought to be more likely. And he did not persuasively show that the pneumococcal vaccine can
be for present purposes deemed interchangeable with the Tdap vaccineâthe former does not
include the tetanus toxoid component, and pneumococcal conjugate is not wholly equivalent to the
diphtheria component of Tdap. By contrast, Respondentâs experts effectively and persuasively
rebutted Petitionerâs causation contentionsâDr. Jameson in particular, who succinctly
demonstrated the clear failings in Petitionerâs causation theory.
This is, in the end, another matter in which a claimant wants to treat the intended effect of
vaccination, and/or a vaccineâs understood capacity to provoke some immune response, into
something pathogenic, but without sufficient probative evidence to connect all the dots. Palattao
v. Sec'y of Health & Hum. Servs., No. 13-591V, 2019 WL 989380, at *36 (Fed. Cl. Spec. Mstr.
Feb. 4, 2019) (âclaimants cannot transmute scientific evidence exploring how vaccines normally
function in the immune system into a reliable and persuasive causation theory that any vaccine can
be pathogenic without a more specific showing that applies to the circumstances at handâ). And to
reverse-engineer a causation theory, Petitioner assumes different autoimmune susceptibilities that
9
Respondent vigorously disputes the PMR diagnosisâand his arguments raise reasonable questions about the nature
of the injury. As a result, even if Petitioner were to prevail in appealing this decision, I would still need to resolve the
diagnosis issue. In addition, Petitionerâs many preexisting related conditions somewhat undermine the conclusion that
the pneumococcal vaccine did cause his PMRâand his onset either predated vaccination or occurred too close in time
to have been medically acceptable. Thus, the remaining two Althen prongs are also unlikely to have been satisfiedâ
but I need not reach these matters, given Petitionerâs prong one failure.
24
are not bulwarked with enough evidence to show that vaccination likely poses risks in these
contexts.
My analysis herein is admittedly truncated. I could certainly write 50 or more pages
spelling out in detail all the ways in which the proposed causal theory is preponderantly deficient.
But special masters should not be compelled to do so when they are familiar with a theory that they
understand has almost never succeededâas is the case here. The Vaccine Program has too many
cases before it to engage in lengthy analysis in each and every case, picking through each item of
literature filed and addressing every argument made by an expert, no matter how many times that
expert has said the same thing. Special masters must streamline their review of matters so that
Program resources can be devoted to reasonably disputed issues and/or novel causation theories.
Admittedly, as scientific knowledge progresses, new discoveries could call into question
the reasoning that has so often led special masters to reject theories that vaccines cause PMR. But
I have provided Petitioner the opportunity, through the filing of expert reports and briefs, to
substantiate what about the pneumococcal vaccine and PMR is now known that is different from
the pastâand that challenge was not met. Nothing filed in this case suggests to me that this vaccine,
or any other, is more likely to be causal of PMR than before.
CONCLUSION
Preponderant evidence does not support Petitionerâs causation theory. He is therefore not
entitled to compensation.
In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the
Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision. 10
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
10
Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices
renouncing their right to seek review.
25
Case Information
- Court
- Fed. Cl.
- Decision Date
- November 5, 2025
- Status
- Precedential