Opinion

Radke v. Secretary of Health and Human Services

Court
United States Court of Federal Claims
Filed
Nov 5, 2025
Status
Unpublished
On the bench
Brian H. Corcoran
Cited by
0 cases
Authority
More cited than 36.6%

“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”

How later courts described this case

  • “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”
  • “[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”
  • “[i]t has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”
  • noting that Moberly “addresses the petitioner’s overall burden of proving causation-in-fact under the Vaccine Act” by a preponderance standard

Written by the judges who cited it.

The opinion

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 22-1384V

*************************

*

MARK RADKE, * Chief Special Master Corcoran

*

Petitioner, * Filed: October 6, 2025

*

v. *

*

SECRETARY OF HEALTH AND *

HUMAN SERVICES, *

*

Respondent. *

*

*************************

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 “Vaccine Program”). 2 Petitioner alleges that

he suffered polymyalgia rheumatica (“PMR”) 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 injury—

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 Petitioner’s Brief in Support of Entitlement, dated Jan. 10, 2025 (ECF No. 36)

(“Br.”); Respondent’s Opposition, dated Mar. 21, 2025 (ECF No. 39) (“Opp.”); Petitioner’s

1

"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 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) (“Vaccine Act” or “the Act”).

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) (“Reply”). 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 19–20. 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

268–70, 306–07. 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 216–17.

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 6–10. In the fall of 2017, Petitioner also saw an

endocrinologist, who proposed that alcohol use might explain Petitioner’s 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, 29–31. He reported more neuropathic concerns that

summer, coupled with weakness and fatigue, but a repeat MRI revealed nothing of concern. Id. at

39, 43–45. 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

“Electromyography” is defined as “an 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.” Electromyography, Dorland’s 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 “pain behind his calf

associated with the neuropathy and muscle tightness” which was causing him to limp. Id.

Examination revealed nothing inconsistent from prior treatment encounters, however, and

Petitioner was referred to physical therapy (“PT”) 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 Petitioner’s 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 rate—both

of which are biomarkers for inflammation. Ex. 9 at 138–39. 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 “some pain” upon rotation of Petitioner’s hips. Id. at 96. Dr. Makhdumi was

unable to propose an explanation for Petitioner’s complaints, although she did express concern

that he was experiencing some form of inflammatory arthritis—PMR or rheumatoid arthritis—that

could have an infectious or neoplastic cause. Id. Dr. Makhdumi prescribed a steroid taper, and also

tested for two viral infections (Epstein-Barr (“EBV”) and cytomegalovirus (“CMV”)). Id.

Petitioner tested positive for a prior/resolved EBV infection, and also again displayed an elevated

4

“C-reactive Protein” is defined as “a 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.” C-reactive Protein, Dorland’s 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, 130–31.

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 Petitioner’s spine, knees,

and hips. Id. at 94. Dr. Makhdumi’s 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 10–14. 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 Petitioner’s prednisone dose, while maintaining a

differential comparable to what she had previously proposed (and keeping PMR in it). Ex. 5 at 88–

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 223–24. An

ultrasound showed fluid collection consistent with a ruptured Baker’s 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 Petitioner’s shoulders with range of movement,

slightly decreased strength, and tenderness to Petitioner’s 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 Petitioner’s 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 Petitioner’s prednisone

treatments. Id. at 65. A similar assessment was provided by Dr. Elmore in September. Id. at 24–

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. Petitioner’s 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) (“First Efthimiou Rep.”); Report, dated Apr. 19, 2024

(ECF No. 30-2) (“Second Efthimiou Rep.”); Report, dated Sept. 13, 2024 (ECF No. 35-1)

(“Efthimiou Third Rep.”). Dr. Efthimiou opined that Petitioner’s receipt of the pneumococcal

vaccine “more likely than not was a substantial factor contributing to the onset of clinical

polymyalgia rheumatica” 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) (“Efthimiou CV”). 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 1–2. Dr. Efthimiou currently serves as an Associate

Professor of Medicine at St. George’s 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 1–2.

First Report

Dr. Efthimiou maintained at the outset of his first report that “[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.” 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 disease—noting 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) (“Hysa”) (suggesting that “the 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 mechanisms”). As a result, Dr. Efthimiou

opined, it did not matter where PMR fit on that spectrum, since “the vaccines administered can

reliably explain clinical onset of either subtype of immune mediated response.” 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 individual’s 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 59–60 (K. Stratton et al., eds., 2012), filed as Ex. 33 (ECF No. 25-9) (the “IOM Rep.”)

(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 individual’s 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 one’s 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 “already present” immune cells” in an individual, Dr. Efthimiou argued, the

vaccine “could be” triggering a non-specific immune signal which adversely activates another

immune signal and leads to disease onset. Id. at 18–19; 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. Efthimiou’s view such evidence bore on Mr.

Radke’s 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 197—

thus, making any reported associations with the Tdap vaccine (which includes the same diphtheria

proteins) relevant when analyzing Petitioner’s case, in Dr. Efthimiou’s 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 Petitioner’s

immune response post-vaccination became more susceptible to triggering cross-reactive immune

memory cells, and hence causing PMR. Id.

Second Report

Dr. Efthimiou’s second report responded to comments made by Respondent’s expert, Dr.

Chester Oddis. He first addressed Dr. Oddis’s opinion that Petitioner’s more likely diagnosis was

an “exaggerated pain response,” 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 “peripheral arthritis has been described in up to 50% of patients with PMR with

knee involvement present in the majority.” 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.”).

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, “PMR arthritis is an inflammatory arthritis that

is known to occur suddenly, and joint “warmth” is a hallmark of inflammatory arthritis”—both of

which were reported and documented in Petitioner’s medical records—the 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 Petitioner’s clinical

presentation. Second Efthimiou Rep. at 3. While patients with “classic” PMR present more

commonly with bilateral shoulder abnormalities (such as bursitis or bicep tenosynovitis), patients

with an “atypical” 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 “the differential diagnosis of PMR can have overlapping symptoms” and that “[t]he

most challenging mimicking disorder” 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 Petitioner’s treating physicians. Id.

Regarding Petitioner’s inflammatory markers throughout his treatment course, Dr.

Efthimiou noted that Mr. Radke had two documented increases—on May 5, 2020, and February

21, 2022. Id. Although Dr. Oddis argued that Petitioner’s inflammatory markers were not

consistently concordant, Dr. Efthimiou responded that “[s]ymptoms and ESR/CRP levels 5 are

often not concordant”—stating that “[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.” 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

Petitioner’s treatment course, Dr. Efthimiou opined that Petitioner exhibited a “relapsing course

[of PMR] that requires longer treatment.” Second Efthimiou Rep. at 5 (emphasizing Dr. Oddis’

citation to literature discussing slower response times to treatment with low-dose glucocorticoids).

Dr. Efthimiou concluded his second report reiterating his opinion in the matter—that

Petitioner’s 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 Respondent’s 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 “focused on reliably

explaining why the vaccines administered and [Petitioner’s] sequence of immunological events is

supported by both the clinical evidence and a biologically plausible mechanistic explanation …”

Id. Moreover, Dr. Efthimiou reiterated that his proposed medical theory for causally linking

Petitioner’s 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. Jameson’s 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 “erythrocyte sedimentation rate,” and is defined as “the rate at which erythrocytes precipitate out

from a well-mixed specimen of venous blood, measured by the distance the top of the column of erythrocytes falls in

a given time interval under specified conditions; an increase in rate is usually due to elevated levels of plasma proteins,

especially fibrinogen and immunoglobulins, which decrease the zeta potential on erythrocytes by dielectric shielding

and thus promote rouleau formation. It is increased in monoclonal gammopathy, hypergammaglobulinemia due to

inflammatory disease, hyperfibrinogenemia, active inflammatory disease, and anemia.” Erythrocyte Sedimentation

Rate, Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=102146 (last

visited Oct. 6, 2025).

8

both, “scientific” and “medical” literature are necessary when evaluating Petitioner’s overall

clinical sequence—and here, Dr. Efthimiou argued, the literature supports a finding that

Petitioner’s vaccination and subsequent development of PMR represents a vaccine-associated

cause. Id. at 3–4. In his own analysis, Dr. Efthimiou stated that he examined “the 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.” 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 “not intended, especially in isolation, to provide general

conclusion,” yet “if epidemiological studies observed an increased risk of PMR illness in

association with receiving pneumococcal vaccines, administration of the vaccine would not be

recommended.” 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, “equate to different adverse biological mechanisms explaining how a

patient’s PMR illness can reliably be pathologically caused within a few days.” Third Efthimiou

Rep. at 7.

Thus, relying on the timing of Petitioner’s 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 Petitioner’s PMR had

likely been vaccine-caused.

B. Respondent’s 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) (“Oddis Rep.”). 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 2–8. 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) (“Salvarani”) 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 70–95% 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 PMR—emphasizing the

significance of the diagnostic value of ESR and CRP. Oddis Rep. at 9. ESR, the “traditional

laboratory finding in PRM,” typically ranges from mildly to markedly increased, whereas CRP is

“nearly always elevated.” Salvarani at 5 (stating that “in 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).”). Here,

Petitioner’s inflammatory markers, specifically ESR and CRP, were not “consistently concordant

with either an improvement or an exacerbation of PMR symptoms.” Oddis Rep. at 10. Similarly,

during a follow-up with Dr. Young on June 15, 2021, Petitioner reported “constant morning

stiffness” 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 Petitioner’s 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 Petitioner’s Prednisone

dosage fluctuated greatly throughout his treatment course, but that the dosage often exceeded

20mg/day—a 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 1–2.

10

Based on the medical records and literature, Dr. Oddis opined that Petitioner more than

likely did not have PMR. Oddis Rep. at 11. Petitioner’s 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, Petitioner’s treating physicians were not

confident that his overall signs and symptoms were consistent for a diagnosis of PMR—and Dr.

Oddis referenced a note from an April 2, 2020, visit with Dr. Young that stated “[w]e discussed

that [Petitioner’s] presentation has not been classic for PMR … the doses of prednisone which

have relieved [Petitioner’s] symptoms are higher than which would normally be used in PMR.”

Id. at 11 (citing Ex. 24 at 186). In addition, Petitioner’s 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) (“Jameson Rep.”). Dr. Jameson opined that it is more

likely than not Petitioner’s 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) (“Jameson CV”) 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 1–2. He has

published over 130 primary research papers, as well as over 50 review articles—nearly all focusing

on various topics in immunology and on the immune response to pathogens. Id. at 2. Dr. Jameson’s

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. Efthimiou’s

proposition that Petitioner’s 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 “the acute response to infection, vaccination or tissue damage” that

typically leads to the subsequent induction of inflammatory responses. Jameson Rep. at 3. This

response involves several different cell types—predominantly 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 individual’s

immune response to infection or vaccination. Id. Specifically, T-helper cells promote the activation

of B-cells which then lead to the production of “potent high-affinity antibodies, capable of

neutralizing the pathogen or its toxins.” 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,

“effective immune memory is typically generated without excessive or prolonged inflammation.”

Id.

Dr. Jameson briefly responded to Dr. Efthimiou’s assertion that aspects of the innate and

adaptive immune response have been observed in immunopathological responses, such as

autoimmunity and autoinflammatory diseases—relied 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 “damaging

autoinflammatory diseases and multiorgan autoimmunity”, 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 vaccines— neither of which were relevant to Mr. Radke’s case. Indeed, one such

article ultimately concluded that “a causal association between [influenza vaccination] and GCA

or PMR is not supported by adequate evidence.” 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) (“Liozon”) at 5.

Dr. Efthimiou also proposed “a somewhat tortuous link” 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) (“Falsetti”) 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. Efthimiou’s reliance on Falsetti—arguing that “all [one] can glean from [the] report is that

those patients received tetanus toxoid vaccines—and since tetanus toxoid is not a component of

the Prevnar 13 pneumococcal conjugate vaccine received by [Petitioner], this undercuts Dr.

Efthimiou’s argument that the presence of diphtheria toxin in Prevnar 13 provides a mechanistic

basis by which it could induce PMR, based on the literature.” Jameson Rep. at 5.

Dr. Jameson maintained that Dr. Efthimiou’s generalization that the “elements of the

immune system that are involved in the response to vaccines are also involved in autoimmune

response” is “not pertinent” when analyzing whether Petitioner’s 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 Petitioner’s clinical presentation and course, as well as the medical

literature, it is more likely than not that Petitioner’s 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. Parties’ Arguments

Petitioner

Petitioner maintains that the evidentiary record preponderantly establishes that PMR is his

proper diagnosis. Br. at 1–2. 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

Petitioner’s treating physicians involved in his care “opined 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 93–95; Ex. 2 at 53;

Ex. 5 at 36). Moreover, Petitioner’s current treating rheumatologist opined in a filed stated that he

would “lean more towards a diagnosis of PMR” and that Petitioner’s “largest 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

“reputable support for his opinion that PMR patients are known to have a similar clinical of

medical facts as [Petitioner].” 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

Petitioner’s 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 Petitioner’s symptoms started “abruptly” 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 Petitioner’s medical

history, clinical presentation, or alleged by Respondent’s experts, that would provide a better

causal explanation for Petitioner’s 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 “most studied and associated” vaccine

and an onset of PMR is the flu vaccine—which, Petitioner emphasizes that he “factually received

just four weeks prior to [his] receipt of [the] Prevnar 13 vaccine.” 6 Id. Moreover, because of the

identified innate immune mechanism responses common to both the flu and pneumococcal

vaccines, Dr. Efthimiou has preponderantly established “how an innate immune response from the

Prevnar 13 vaccination can cause the dysregulation of immune cells already present [an]

individual.” 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 “contends 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.” 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 Petitioner’s actual proposed theory in this case (and in any event it would

not render the claim more successful, since PMR claims uniformly fail—regardless of the vaccine at issue).

14

Efthimiou provided items of medical literature—involving the flu vaccine and a subsequent

develop of PMR—that 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., Petitioner’s 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 evidence—and thus must establish PMR was the likely diagnostic

explanation for his injury. Opp. at 23. But Petitioner’s initial presenting symptoms were not

considered the more “classical” 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,

Petitioner’s 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

“existing case law overwhelmingly favors a finding that PMR is not caused by vaccines,” and that

the case adds nothing new to Dr. Efthimiou’s previously relied-upon theories of causation in

similarly situated vaccine injury claims. Id. at 2, 729; Munoz v. Sec’y of Health & Hum. Servs.,

No. 21-11369V, 2024 WL 4113486 (Fed. Cl. Spec. Mstr. Aug. 12, 2024), mot. for review den’d,

174 Fed. Cl. 276 (2024), appeal docketed, No. 2025-1409 (Fed. Cir. Feb. 4, 2025). In addition,

Dr. Efthimiou’s theory is relatively “unclear.” Opp. at 29. The cited medical literature is not only

“scant,” but even Dr. Efthimiou’s 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 Petitioner’s 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 Petitioner’s 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. 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, 592 F.3d at 1321; Capizzano v. Sec’y 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 “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 & Hum. 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, Health & Hum. Servs., 165 F.3d 1344, 1352–53 (Fed.

7

Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding authority.

Hanlon v. Sec’y 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. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121, 124 (2003),

aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y 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. Sec’y 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): “(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.”

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 & Hum. 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, 569 F.3d at 1378–79 (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.

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 theory’s scientific or medical plausibility. See Cerrone v. Sec’y 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), aff’d, 146 F.4th 1113 (Fed. Cir. 2025); Kalajdzic v. Sec’y of Health &

Hum. Servs., No. 2023-1321, 2024 WL 3064398, at *2 (Fed. Cir. June 20, 2024) (arguments “for

a less than preponderance standard” deemed “plainly inconsistent with our precedent” (citing

Moberly, 592 F.3d at 1322)); Boatmon v. Sec’y 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) (“[t]he standard has been preponderance for nearly four decades”), aff’d,

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. Sec’y 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 “addresses the petitioner’s

overall burden of proving causation-in-fact under the Vaccine Act” 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 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 & Hum. 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 & 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 “[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 & Hum. 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 & Hum. 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); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,

2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed.

Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 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 & 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 one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum. Servs.,

101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d mem.,

503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V, 2013

WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. den’d (Fed. Cl. Dec. 3, 2013),

aff’d, 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 “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 & 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, “[m]edical records, in general, warrant consideration as

trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. 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, Rickett v. Sec'y of Health & Hum.

Servs., 468 F. App’x 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. 11–685V,

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) (“[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 & Hum. Servs., No. 03–1585V, 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 testimony—especially

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) (“[i]t has generally been held that oral

testimony which is in conflict with contemporaneous documents is entitled to little evidentiary

weight.”)).

However, the Federal Circuit has also noted that there is no formal “presumption” that

records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y 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) (“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 & 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 “consistent, clear, cogent, and

compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. 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 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, 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.

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. Sec’y 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, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed.

Cir. 2010) (citing Terran v. Sec’y 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 592–95).

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, 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 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

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 “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. 146 (1997)); see also Isaac v. Sec'y of Health & Hum. Servs.,

No. 08–601V, 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. 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 & Hum. 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”).

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 Petitioner’s case—just as I have not exhaustively discussed

every individual medical record filed. Moriarty v. Sec’y of Health & Hum. Servs., No. 2015–5072,

2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e generally presume that a special master

considered the relevant record evidence even though he does not explicitly reference such evidence

in his decision”) (citation omitted); see also Paterek v. Sec’y of Health & Hum. 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”).

E. Disposition of Case Without Hearing

I am resolving Petitioner’s claim on the filed record, as per the parties’ 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. Sec’y of Health & Hum. Servs., 945

F.3d 1362, 1366 (Fed. Cir. 2020); see also Hooker v. Sec’y 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. Sec’y of Health & Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special

master acted within his discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy

v. Sec’y 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. Sec’y of Health & Hum. Servs., No. 22-

99V, 2024 WL 4579389 (Fed. Cl. Spec. Mstr. July 24, 2024); Thompson v. Sec’y 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 claimant’s PMR); Van Dycke v. Sec’y 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 claimant’s PMR); Giesbrecht v. Sec’y 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 claimant’s PMR); Kelly v. Sec’y 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 claimant’s PMR); Suliman v. Sec’y 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

claimant’s 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 petitioner’s 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 *14–16. 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 hearing—not on the papers, as here), Dr. Efthimiou offered a medical theory in which a

claimant’s 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 *2–3. 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 claim’s dismissal.

Dobrydnev v. Sec’y of Health & Hum. Servs., 566 Fed. Appx. 976, 980 (Fed. Cir. 2014). This case

wholly turns on the first, “can cause” prong—and because I find it has not been preponderantly

established, no discussion of Petitioner’s 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. Efthimiou’s causation opinion largely repeats the kinds of arguments that other special

masters—including me—have 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 vaccine—the former does not

include the tetanus toxoid component, and pneumococcal conjugate is not wholly equivalent to the

diphtheria component of Tdap. By contrast, Respondent’s experts effectively and persuasively

rebutted Petitioner’s causation contentions—Dr. Jameson in particular, who succinctly

demonstrated the clear failings in Petitioner’s causation theory.

This is, in the end, another matter in which a claimant wants to treat the intended effect of

vaccination, and/or a vaccine’s 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) (“claimants 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 hand”). And to

reverse-engineer a causation theory, Petitioner assumes different autoimmune susceptibilities that

9

Respondent vigorously disputes the PMR diagnosis—and 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, Petitioner’s many preexisting related conditions somewhat undermine the conclusion that

the pneumococcal vaccine did cause his PMR—and 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 satisfied—

but I need not reach these matters, given Petitioner’s 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 succeeded—as 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 past—and 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 Petitioner’s 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

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

A word about cookies

We need a few to keep you signed in and the library working. The rest help us see which pages people use and where they get stuck. They stay off unless you say yes.