VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_13-vv-00439
Package ID: USCOURTS-cofc-1_13-vv-00439
Petitioner: Carolynne Olson
Filed: 2013-07-01
Decided: 2017-07-14
Vaccine: HPV
Vaccination date: 2010-07-01
Condition: rheumatoid arthritis
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Carolynne Olson, a 52-year-old woman, received the HPV Gardasil vaccine on July 1, 2010, for the treatment of warts, an off-label use. She alleged that the vaccine caused her to develop rheumatoid arthritis (RA). Her medical history at the time of vaccination was significant for hypothyroidism, vitamin D deficiency, asthma, and chronic sinusitis. Olson claimed to experience burning in her hands within two weeks of vaccination, with knuckle enlargement and pain developing about three months later. She was diagnosed with probable seronegative rheumatoid arthritis by Dr. Gregory Middleton in September 2013, who attributed it to an immune system overreaction from the vaccine. Olson's theory of causation posited that alum, an adjuvant in the vaccine, could trigger RA in individuals with pre-existing inflammatory lung conditions by activating inflammasomes and subsequently cytokines. She presented expert testimony from Dr. Middleton and Dr. Lawrence Mayer. Respondent argued that Olson could not establish causation. The Special Master denied entitlement, finding that Olson failed to prove by a preponderance of the evidence that the HPV vaccine caused her RA. The Special Master concluded that her theory lacked reliable scientific support, particularly regarding the role of alum and cytokine upregulation as a trigger for RA, and that the evidence did not establish a logical sequence of cause and effect. The Court of Federal Claims affirmed the Special Master's decision, finding it was not arbitrary, capricious, or contrary to law. The case was denied compensation.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_13-vv-00439-0
Date issued/filed: 2017-08-23
Pages: 33
Docket text: PUBLIC DECISION (Originally filed: 07/14/2017) Regarding 67 DECISION of Special Master (Signed by Special Master Brian H Corcoran). (cr) Copy to parties.
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Case 1:13-vv-00439-EJD Document 75 Filed 08/23/17 Page 1 of 33
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 13-439V
(to be published)
* * * * * * * * * * * * * * * * * * * * * * * * *
*
CAROLYNNE OLSON, *
* Filed: July 14, 2017
Petitioner, *
*
v. * Decision; Dismissal of Claim;
* Human Papillomavirus (“HPV”)
SECRETARY OF HEALTH AND * Vaccine; Rheumatoid Arthritis
HUMAN SERVICES, * (“RA”); Causation Theory;
* Alum Adjuvant; Cytokine
Respondent. * Upregulation.
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Mitchel J. Olson, Law Office of Mitchel J. Olson, JD, MD, Carlsbad, CA, for Petitioner.
Jennifer L. Reynaud, U.S. Dep’t of Justice, Washington, DC, for Respondent.
DECISION DENYING ENTITLEMENT1
On July 1, 2013, Carolynne Olson filed this action seeking compensation under the
National Vaccine Injury Compensation Program (the “Vaccine Program”2). Petition (“Pet.”) (ECF
No. 1). Petitioner alleges that she developed rheumatoid arthritis (“RA”) as a result of the human
papillomavirus (“HPV”) vaccine she received on July 1, 2010. Pet. at 1. An entitlement hearing
was held in Washington, DC, on March 27-28, 2017.
1 This decision will be posted on the United States Court of Federal Claims’ website, and in accordance with the E-
Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the ruling will be available to anyone with access
to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the published
ruling’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has
fourteen (14) days within which to request redaction “of any information furnished by that party: (1) that is a trade
secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or
similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b).
Otherwise, the entire decision will be available in its current form. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3755 (codified as amended at 42 U.S.C. § 300aa-10 through 34 (2012)) (hereinafter “Vaccine Act” or “the
Act”). All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. §
300aa.

Case 1:13-vv-00439-EJD Document 75 Filed 08/23/17 Page 2 of 33
Many facts relevant to Petitioner’s claim are undisputed or unrebutted: she has been
diagnosed with RA, and her obvious clinical symptoms manifested not long after she received the
HPV vaccine. The primary issue to be resolved is whether Petitioner’s causation theory is reliable
and persuasive. After considering the record as a whole, and for the reasons explained below, I
find that Petitioner has failed to carry her burden in establishing causation, and therefore her
request for entitlement is DENIED. Petitioner’s causation theory is wholly dependent on the
vaccine’s adjuvant causing her RA, but reliable science does not corroborate its alleged potential
to initiate a pathogenic sequence. Moreover, Petitioner’s medical history does not demonstrate her
theory in action.
I. Factual Background
Petitioner received a Gardasil vaccination from her gynecologist, Angelica Zaid, M.D., on
July 1, 2010. Ex. 1 at 11. At the time of vaccination, she was 52 years old, and therefore (as
discussed further below) not within the target age group to receive the vaccine. However, as the
administration note stated, she asked to receive it nonetheless after learning from her daughter’s
dermatologist that the vaccine could be effective in treating warts. Id.; Tr. at 4.
Mrs. Olson’s medical history as of the date of her vaccination was significant for
hypothyroidism, vitamin D deficiency, osteochondroma,3 an Achilles tendon rupture, and anemia.
Ex. 2 at 1. She had additionally seen her otolaryngologist (“ENT”) specialist, Cynthia Davis, M.D.,
from 2007 to 2009 for sinus-related symptoms, and she was diagnosed with chronic sinusitis in
September 2008. Ex. 4-1 at 13. Petitioner also testified that she suffered generally from asthma
since childhood. Tr. at 9. Petitioner’s chronic respiratory problems are highly relevant to her
causation theory.
Immediate Post-Vaccination Health
The medical records from the months immediately following Mrs. Olson’s receipt of the
HPV vaccine do not set forth any occasions when she complained of RA-like symptoms. Thus,
nearly three months after receiving the Gardasil vaccine, on September 24, 2010, Petitioner saw
Dr. Davis with complaints of sinus pressure, facial pain, and lung congestion over the previous
month. Petitioner at this time appears to have been diagnosed with acute sinusitis and reactive
airway disease (“RAD”), and she was prescribed several medications, including prednisone and
antibiotics. Ex. 4-1 at 35.
Nearly three more months passed before Mrs. Olson again visited a doctor. On December
13, 2010, Petitioner returned to Dr. Zaid for a hormone replacement therapy consult. The records
3 Osteochondroma is a benign tumor consisting of projecting adult bone capped by cartilage projecting from the lateral
contours of endochondral bones. Dorland’s Medical Dictionary 1345 (32nd ed. 2012) (hereinafter Dorland’s).
2

Case 1:13-vv-00439-EJD Document 75 Filed 08/23/17 Page 3 of 33
from this visit contain the first reference to any symptoms that could be associated with Petitioner’s
RA, noting that she reported to Dr. Zaid that she had developed “knuckle enlargement w[ith] pain
(first R[ight] and then L[eft]) and persistent,” after receiving the HPV vaccine. Ex. 1 at 12.
Petitioner was assessed as having a vitamin D deficiency and hormone imbalance. Id. Dr. Zaid
started Petitioner on estrogen replacement therapy, but also referred her to a rheumatologist,
Alexander Shikhman, M.D., for evaluation of her knuckle enlargement and pain. Id.
2011-12 Treatment of Respiratory and Arthritic Symptoms
Petitioner returned to Dr. Zaid on January 13, 2011, complaining of pelvic pain, and she
was diagnosed with bacterial vaginosis. Ex. 1 at 14-15. Dr. Zaid did not evaluate Petitioner for her
joint symptoms, but instead reiterated her prior recommendation that she “see Dr. Shikhman” in
January. Id. at 15. That appointment with Dr. Shikhman did not occur, however, until February
22, 2011. Ex. 2 at 33.
At her first visit to Dr. Shikhman, Mrs. Olson reported that she had received the HPV
vaccine as therapy treatment for warts six months before and “soon after” began to experience
symptoms (pain, knuckle enlargement, fatigue, etc.). Ex. 2 at 33. Such symptoms had become
progressively worse, although she had noticed improvement after taking prednisone for a recent
asthma attack. Id. Examination revealed confluent erythema of the hands, dermatitis herpetiformis-
like lesions over her elbows, low grade synovitis of her proximal interphalangeal joints (“PIPs”)
and metatarsophalangeal joints (“MTPs”), and tenderness of her elbows, wrists, knees, and ankles.
Id. at 34. A musculoskeletal ultrasound showed small effusion with synovial hypertrophy of both
knees, low grade synovitis of the left wrist extensor tendon sheaths, a small right wrist effusion
with active synovitis of the extensor tendon sheaths, and active bicipital tenosynovitis of both
shoulders with periarticular calcific deposits. Id.
Dr. Shikhman’s records from his initial visit with Mrs. Olson noted that her “clinical
presentation [wa]s highly suspicious for reactive arthritis.” Ex. 2 at 34. He proposed the existence
of an evolving inflammatory arthropathy or a crystal-induced arthropathy.4 Id. Other possible
etiologies included in the differential diagnoses were knee enthesopathy,5 carpal tunnel syndrome,
and rotator cuff syndrome. Id. Dr. Shikhman noted a history of Raynaud’s disease6 for Mrs. Olson,
4 Arthropathy includes any joint disease. Dorland’s at 158. Crystal-induced arthropathy is arthritis due to the
deposition of inorganic crystalline material within the joints. Id. at 150.
5 Enthesopathy is a disorder of the muscular or tendinous attachment to the bone. Dorland’s at 627.
6 Raynaud’s disease is a primary or idiopathic vascular disorder characterized by areas of the body (such as fingers or
toes) feeling numb in response to cold temperatures or stress due to limited blood circulation to affected areas.
Dorland’s at 542; Diseases and Conditions: Raynaud’s Disease, The Mayo Clinic,
http://wwwmayoclinic.org/diseases-conditions/raynauds-disease/basics/definition/CON-20022916 (last visited Jul.
5, 2017). It affects females more often than males. Dorland’s at 542.
3

Case 1:13-vv-00439-EJD Document 75 Filed 08/23/17 Page 4 of 33
and he was of the opinion that gluten intolerance and connective tissue disease should be ruled
out. Id.
During the February 2011 visit to Dr. Shikhman, Petitioner had extensive laboratory testing
performed. Ex. 2 at 101-02, 104, 106-09, 111. Results showed a mildly elevated sedimentation
rate, as well as a positive Mycoplasma IgG antibody level – indicative of a prior resolved infection.
Id. at 101, 109, 111. Other test results were normal, including C-reactive protein levels, rheumatoid
factor, autoimmune panel, celiac disease, and Chlamydia pneumonia. Id. at 101-02, 104, 106-09.
Importantly, this initial testing did not reveal the presence of anti-citrullinated protein antibodies
(“ACPA”) – a biomarker strongly associated with RA and relevant to Petitioner’s claim, as
discussed in greater detail below.
Mrs. Olson had a follow-up visit to Dr. Shikhman the next month, on March 29, 2011. At
this time, additional testing was performed, and the lab results now showed low IgG levels,
elevated sedimentation rate, and mild anemia, along with low thyroid hormone levels. Ex. 2 at 31.
Petitioner’s physical exam was otherwise consistent with her February exam, but Dr. Shikhman
added hypothyroidism to his previous diagnoses. Id. at 32.
While being treated for her arthritis symptoms in 2011, Mrs. Olson continued to experience
the lung and respiratory conditions that predated her vaccination. Thus, on April 12, 2011,
Petitioner returned to her ENT specialist, Dr. Davis, complaining of increased facial swelling,
nasal discharge, and lung congestion. A nasal endoscopy performed at this time revealed results
consistent with allergic rhinitis, but a CT scan of her chest performed the following week was
negative for any acute disease. Ex. 4-1 at 47, 51, 53. Dr. Davis subsequently increased Mrs.
Olson’s prednisone dosage as her symptoms had not improved. Id. at 56. Two days later, on April
14, 2011, Petitioner consulted with a pulmonologist, W. Wayne Hooper, M.D., about a cough and
a concern for lung infection. Ex. 8 at 26.
Petitioner saw Dr. Shikhman again on May 10, 2011. At this time, she informed him of the
problems she had been having with bronchitis, but the record makes no mention of new complaints
concerning her joints or previously-documented arthritic symptoms. Ex. 2 at 29-31. Repeat tests
for mycoplasma showed a negative IgG and IgM. Ex. 2 at 100. Dr. Shikhman’s notes and diagnoses
remained unchanged from the March 29th visit. Id. However, Petitioner represented to other
treaters that the cause of her arthritis-related symptoms was better understood than what Dr.
Shikhman’s records actually suggest. Thus, at a visit to Dr. Hooper on August 9, 2011, Mrs. Olson
reported that she suffered from “joint disease involving her knuckles of both hands,” which she
described as attributable to “post inoculation [sic] arthritis from a wart infection on her body.” Ex.
8 at 16.
4

Case 1:13-vv-00439-EJD Document 75 Filed 08/23/17 Page 5 of 33
Petitioner saw Dr. Shikhman on several occasions from September 2011 to December 2011
for her joint pain and concurrent symptoms, as well as shortness of breath, pain in her lungs, and
fatigue. Ex. 2 at 19-23, 26. After a September visit, Dr. Shikhman listed several possible diagnoses:
a clinical presentation highly suspicious for reactive arthritis; evolving inflammatory arthropathy
versus crystal-induced arthropathy; chronic bronchitis; knee enthesopathy; carpal tunnel
syndrome; rotator cuff syndrome; hypothyroidism; Raynaud’s disease; and connective tissue
disease. Id. at 28.
2012 Treatment
In 2012, Mrs. Olson continued to obtain treatment for both her respiratory and arthritis-
related symptoms. With respect to the former, she went back to see Dr. Davis in January 2012,
complaining of a headache, chest pain, and eye pain. Ex. 4-2 at 99. She had a productive cough
and sinus drainage for which she received IVIG infusions for gamma globulin deficiency. Id. Dr.
Davis noted diagnoses of asthma, allergic rhinitis, and chronic ethmoid sinusitis. Id. at 101.
Petitioner followed up with Dr. Davis in June, but now reported that her symptoms had improved
and that she was able to exercise regularly as well. Id. at 93, 101. Dr. Davis observed no joint
swelling, and her differential diagnosis was consistent with prior diagnoses. Id. at 93, 95.
For treatment of her joint pain and swelling, Petitioner continued to see Dr. Shikhman. She
returned to him in May 2012, complaining of worsening fatigue, hand stiffness, hand and calf
weakness, and morning stiffness. Ex. 2 at 17. An examination confirmed the existence of
“worsening of ulnar deviation” in Petitioner’s right and left knuckles, with low grade synovitis of
her hands and feet. Id. at 18. By the following month, however, Mrs. Olson reported to Dr.
Shikhman that she felt much better. Id. at 13. Dr. Shikhman added “hypogammaglobulinemia vs.
CVID [common variable immunodeficiency]” to his list of diagnoses. Id. at 13-14. At a final 2012
visit on December 28th, Dr. Shikhman recorded Petitioner’s complaints of generalized hand pain.
Ex. 2 at 5. Dr. Shikhman’s diagnoses were unchanged from previous visits, however. Id. at 6-7.
Treatment by Dr. Middleton and RA Diagnosis
Mrs. Olson continued to experience in 2013 the same kinds of arthritis-related symptoms
she claims to have first suffered around the time of her 2010 HPV vaccination, and to seek
evaluation of these symptoms, although she was able to cope with them while leading an active
life. See, e.g., Ex. 8 at 6 (February 12, 2013, visit with Dr. Hooper); Tr. at 23, 25. During a June
11, 2013, visit to Dr. Shikhman, Petitioner was in fact noted to be doing well overall, reporting
only “minor joint pain” which was controlled with a combination of herbs and supplements. Ex. 2
at 1.
5

Case 1:13-vv-00439-EJD Document 75 Filed 08/23/17 Page 6 of 33
By the late summer and early fall, however, Petitioner was finding coping with her pain
more challenging – and treaters began to make more definitive diagnoses for her ongoing
condition. Thus, on August 8, 2013, Petitioner saw Dr. Hooper for a routine examination. He now
observed that her “hands [were] more arthritic” and that the “patient thinks it is related to a
vaccination for warts.” Ex. 8 at 1. By this point, the Petition had already been filed.
The next month, on September 10, 2013, Petitioner saw Gregory Middleton, M.D., a
rheumatologist, for evaluation of “hand deformity.” Ex. 5 at 171. At this first visit (now three years
post-vaccination), Mrs. Olson informed Dr. Middleton that she had developed swelling of her
knuckles in both hands about three months after receiving a Gardasil vaccination and that she had
never noticed significant pain from it, but that she had a high pain tolerance that helped her to
endure it. Id. She also observed that her pain was more manageable during the times she was taking
prednisone for her respiratory symptoms, but that her arthritis symptoms became “a lot worse with
both pain and swelling” when she was tapered off steroidal treatment. Id.
Dr. Middleton noted that although Petitioner had been seeing Dr. Shikhman throughout the
entire period, she had never received formal treatment for arthritis. Ex. 5 at 1. Dr. Middleton’s
examination revealed mild Raynaud’s changes in Petitioner’s feet and reducible ulnar deviations
of her knuckle joints, but no evidence of synovitis in the hands, wrists, elbows, knees, ankles or
toes. Id. He diagnosed her with probable “seronegative” rheumatoid arthritis (meaning that testing
did not reveal the presence of autoantibodies highly associated with RA, such as ACPAs or
rheumatoid factor) attributable to “immune system over-reaction” from her 2010 HPV vaccine,
although this record provided no explanation as to the basis for this conclusion. Id. at 2.
On September 16, 2013, Mrs. Olson saw Dr. Middleton again. Ex. 5 at 4. He noted that x-
rays of her hand taken the previous week showed no evidence of bone erosions. Id. He felt that she
had chronic inflammatory synovitis of her MTP joints “after Gardasil vaccination,” which led to
ulnar deviation without bone destruction, and he deemed her overall presentation in light of the
exam to be “consistent with seronegative rheumatoid arthritis.” He prescribed medication while
also adding hypothyroidism and IgG deficiency/bronchiectasis to the differential diagnoses. Id. at
4-5.
Petitioner followed-up with Dr. Middleton on October 22, 2013, stating that her joint pain
and function of her hands and feet had improved since she had begun taking medicines targeted
for her RA. Ex. 5 at 6. Upon examination, she displayed mild active synovitis of the right MTP
joint not present on her prior visits. Id. Dr. Middleton diagnosed mild but deforming seronegative
inflammatory arthritis compatible with rheumatoid arthritis. Id.
Since then, Petitioner has continued to obtain treatment from Dr. Middleton. Tr. at 32. She
has also repeated to other treaters her allegation in this action that her arthritic symptoms began
6

Case 1:13-vv-00439-EJD Document 75 Filed 08/23/17 Page 7 of 33
not long after she received the HPV vaccine, as well as her belief that the vaccine caused those
symptoms. See, e.g., Ex. 6-1 at 18 (onset/duration stated “6/2010 [sic] after Gardasil vaccine,”
with further notes that Petitioner “got a Gardasil vaccine to get rid of warts and then a month later
got pain in hands and then 6 months later she got lots of problems”).
II. RA and its Pathophysiology
Before reviewing the testimony offered at hearing regarding Petitioner’s claimed injury
and the role the HPV vaccine is alleged to have played, it would be useful to summarize the
features of RA as well as its understood pathophysiology.
RA is a long-term autoimmune condition mainly affecting the joints. See, e.g., M. van de
Sande et al., Different Stages of Rheumatoid Arthritis: Features of the Synovium in the Preclinical
Phase, 70 Ann. Rheum. Dis. 772-77 (2011) (filed as Article 3) (“van de Sande”). Its causes are
thought to be a mix of immune, genetic, and environmental factors, but in essence it involves an
autoimmune attack on the synovial membranes of the joints, causing inflammation and later
erosion and destruction of joint surfaces, along with deformity of affected joints, fingers, or toes.
Id. at 772. It can also cause complications in the lungs, kidneys, and other organs. See, e.g., A.
Ytterberg et al., Shared Immunological Targets in the Lungs and Joints of Patients with
Rheumatoid Arthritis: Identification and Validation, 74 Ann. Rheum. Dis. 1772-77 (2015) (filed
as Article 13) (“Ytterberg”); T. Skare et al., Pulmonary Changes on High-Resolution Computed
Tomography of Patients with Rheumatoid Arthritis and their Association with Clinical,
Demographic, Serological and Therapeutic Variables, 51 Rev. Bras. Reumatol. 4:325-37 (2011)
(filed as Article 28).
RA initiates from some kind of nonspecific inflammatory event, the trigger for which can
be a variety of things. G. Firestein, Etiology and Pathogenesis of Rheumatoid Arthritis, Textbook
of Rheum. 1059-60 (10th ed. 2012) (filed as Article 1) (“Firestein”). But it is the subsequent stages
of the condition where its pathologic amplification occurs – and where the autoimmune character
of the condition manifests. See, e.g., V. M. Holers, Insights from Populations At-Risk for the
Future Development of Classified Rheumatoid Arthritis, 40 Rheum. Dis. Clin. North Am. 4:605-
20 (2014) (filed as Article 21). Medical and scientific research has helped pinpoint one explanation
for RA. Although not fully understood, it is now believed that some individuals, through a post-
translational (or enzymatic) modification of certain amino acids found in the body, undergo
“citrullination” – the conversion of the amino acid arginine into citrulline (not one of “the standard
20 amino acids encoded by DNA in the genetic code”). See N. Sofat et al., Interaction Between
Extracellular Matrix Molecules and Microbial Pathogens: Evidence for the Missing Link in
Autoimmunity with Rheumatoid Arthritis as a Disease Model, 5 Frontiers in Microbiology 1-6
7

Case 1:13-vv-00439-EJD Document 75 Filed 08/23/17 Page 8 of 33
(2015) (filed as Article 117) (“Sofat”); Ytterberg at 1772. The adaptive immune system in such
individuals will then create autoantibodies that attack the citrullinated proteins as if they were
foreign antigens, and in the process encourage the autoimmune process and chronic inflammation
that characterizes RA. Sofat at 1-2. This in turn leads to the progressive tissue damage that later
causes the appearance of the more overt clinical signs of RA. Id.
There are a number of risk factors associated with the development of RA – some, but not
all of which, are present in this case. Smoking is the most widely-recognized non-genetic risk
factor, but it is inapplicable here as Mrs. Olson has not been established to be a smoker. See
Ytterberg at 1; Sofat at 1-2; Tr. at 149-50. Gender, however, is another well-recognized risk factor,
as more women than men develop the disorder. See, e.g., V. Holers, Autoimmunity to Citrullinated
Proteins and the Initiation of Rheumatoid Arthritis, 25 Curr. Opin. Immunol. 728:728 (2013) (filed
as Article 22) (“Holers II”). Genetic factors are also associated with RA, but they have not been
demonstrated to be applicable herein. Firestein at 1059; Holers II at 728. It is also undisputed in
this case that Mrs. Olson has never been shown to possess two of the autoantibody biomarkers
strongly associated with RA – rheumatoid factor or ACPAs – and this absence of evidence has
some bearing on the persuasive strength of Petitioner’s case, as discussed below.
III. Hearing Testimony
A. Petitioner’s Witnesses
1. Carolynne Olson – Petitioner was the first witness to testify in the case. Her
educational background includes a nursing degree, and she later practiced nursing. Tr. at 4.
Petitioner confirmed her receipt of the HPV vaccine in July 2010, as well as the purpose of
receiving it: to treat warts on her feet (since her daughter’s dermatologist had informed her that
the vaccine had this side effect). Id.
Importantly, Mrs. Olson maintained that she began to experience relevant symptoms
(“burning in both hands”) within one to two weeks of receipt of the vaccine (Tr. at 6), with “knobs”
(or evidence of swelling) beginning to appear on her right hand knuckles about two to three months
after July 1st. Id. at 6-7. She did not, however, seek treatment immediately, but waited for nearly
six months – and in fact first informed her gynecologist, Dr. Zaid, about her condition rather than
a rheumatologist. Tr. at 7-8.8 She explained the delay as the product of her initial assumption that
7 Petitioner’s appendix of medical literature indicates this article as “Article 12” in the Volume 1 table of contents.
However, the actual article within the appendix was marked as “Article 11.”
8 Mrs. Olson was asked about some medical records (particularly from her first visit to Dr. Middleton) suggesting that
her symptoms actually began three months after the vaccination rather than two weeks. Tr. at 25. However, she
maintained that her pain had been progressive in its severity, and therefore she had distinguished the degree of pain
she felt shortly after receipt of the vaccine from what she experienced later on – consistent with her overall decision
to delay medical treatment. Id.
8

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her pain might resolve on its own (Id. at 8), noting as well that she was used to working through
pain and discomfort due to her lifelong asthma (Id. at 9). Id. at 23.
2. Dr. Gregory Middleton – Dr. Middleton, one of Mrs. Olson’s treaters,
provided an opinion for the theoretical causative role the HPV vaccine could play in Petitioner’s
RA. In addition to testifying at hearing, Dr. Middleton provided three expert reports (presented in
the form of witness affidavits) during the course of this matter. See Affidavit, dated December 1,
2014 (ECF No. 32) (“First Middleton Rep.”); Supplemental Affidavit, dated December 1, 2015
(ECF No. 41) (“Second Middleton Rep.”); and Second Supplemental Affidavit, dated January 14,
2017 (ECF No. 49-1) (“Third Middleton Rep.”).
As reflected in his affidavit and trial testimony, Dr. Middleton is a clinical rheumatologist
whose expertise primarily arises from his training and subsequent treatment of hundreds of
patients. Tr. at 29-31. Dr. Middleton received his M.D. from Boston University in 1989, and he
thereafter completed a residency in internal medicine in 1992 and a fellowship in rheumatology in
1994 at the University of Texas Southwestern. First Middleton Rep. at 1. He is board certified in
rheumatology, and he serves as a clinical professor at the University of California San Diego
Medical School in the rheumatology and orthopedics departments. Id. By his own admission, Dr.
Middleton lacks deep or focused expertise in vaccines, nor is immunology his specialty (Tr. at 100
(“I am testifying here as a clinical immunologist, not as a vaccine expert”)) – although in this case
he repeatedly opined on matters in this case having far more to do with the immunologic process
(or the literature offered to explain it)9 than RA itself.
Dr. Middleton’s first report sets forth a somewhat conclusory overview of Mrs. Olson’s
causation theory. After a brief recounting of Petitioner’s medical history, Dr. Middleton opines
that the HPV vaccine was likely causative of Petitioner’s RA, deeming it an “auto-immune
response triggered by the vaccination itself.” First Middleton Rep. at 4. He placed heavy emphasis
on the temporal relationship between receipt of the vaccine in 2010 and Petitioner’s first symptoms
approximately two weeks later, based upon reports contained in the records that Mrs. Olson made
to treaters prior to the time that he began treating her. Id. at 2-3. He also relied on the vaccine’s
9 Petitioner’s counsel led Dr. Middleton through a redirect examination in which the witness was largely asked to
confirm or accept what various pieces of Petitioner’s filed medical literature said on a specific issue, rather than to
explain how the literature informed his opinion, based upon his demonstrated expertise in treating patients with RA.
See, e.g., Tr. at 88 (“going over to the second column of page 1065, the last sentence, ‘Although the role of the
inflammasome in RA has not been fully defined, its ability to induce cytokine production by exposure to bacterial
products and other danger signals suggests that it is – that it participates in IL-1 and IL-18 regulation.’ Do you agree
with that statement?”). Petitioners may of course file medical and scientific literature supporting their claim
independent of whether their expert selected it, or even specifically relies on it for his opinion (and special masters
must review and consider that literature in ruling on entitlement). But factual statements contained in that literature
do not become more probative simply because a witness confirms orally what the item already says – especially when
that witness lacks sufficient particularized expertise in the subject matter of the underlying article to comment
intelligently on the topic.
9

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package inserts (which identified “arthralgia” as a known side-effect), as well as 43 instances of
reports to the Vaccine Adverse Events Reporting System (“VAERS”).10 Id. at 5-6.
Dr. Middleton’s second expert report endeavored to provide a more detailed scientific and
medical explanation for potential causes of RA generally, as well as Petitioner’s theory for how
the HPV vaccine might have been involved in causing her RA specifically. He began with a
discussion of Petitioner’s current condition, acknowledging that she lacked the autoantibody
biomarkers closely associated with RA – in particular the rheumatoid factor or the ACPAs – but
that her diagnosis was still clinically correct due to the number of affected joints as well as the
duration of her condition. Second Middleton Rep. at 2. Dr. Middleton otherwise downplayed the
absence of these biomarkers, noting that 30 percent of RA patients lack them (Second Middleton
Rep. at 3) – but in so doing implicitly acknowledged that the majority do possess them. He also
stated that known genetic risk factors were more applicable to individuals positive for these
antibodies, although some studies11 established that even RA patients negative for ACPAs had
enough genetic risk factors to develop the condition. Id. at 4.
Despite Mrs. Olson not possessing the more well-understood biomarkers or genetic factors
that could explain her RA, Dr. Middleton opined that she did possess an important risk factor –
her recurrent respiratory problems – that made her predisposed to develop RA under the right
circumstances. Second Middleton Rep. at 5. Dr. Middleton noted that Petitioner was a lifelong
asthma sufferer, and she had also been diagnosed with bronchiectasis, an “abnormal and permanent
distortion of a bronchus or other airway . . . typically caused by a lung infection.” Second
Middleton Rep. at 7.12 Citing several items of literature, he opined that current scientific and
10 VAERS is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and
Prevention and the Food and Drug Administration, and allows individuals who believe they may have experienced a
vaccine reaction to make a report of the incident. See https://vaershhs.gov/index (last visited July 6, 2017). Because
it is a passive reporting system, VAERS database findings that a number of individuals have complained of a supposed
adverse effect from a particular vaccine do not imply causation, although such evidence may suggest potential signals
of causation. For this reason, special masters do not typically afford great weight to VAERS data in determining
causation. See Analla v. Sec’y of Health & Human Servs., 70 Fed. Cl. 552, 558 (2006) (“the Court [of Federal Claims]
uniformly has upheld the Chief Special Master's concerns about the reliability of VAERS data”) (citations omitted).
11 For this proposition, Dr. Middleton cited an unfiled item of literature – T. Frisell et al., Familial Risks and
Heritability of Rheumatoid Arthritis: The Role of Rheumatoid Factor/Anti-Citrullinated Protein Antibody Status,
Number and Type of Affected Relatives, Sex, and Age, 65 Arthritis Rheum. 2773:2773-82 (2013). This was a consistent
deficiency in Petitioner’s case, as both of her experts referenced many items of literature that were never filed for
review and consideration as evidence in this action.
12 See Dorland’s at 252. Dr. Middleton has represented in both his expert report and trial testimony that Mrs. Olson
was diagnosed with bronchiectasis, but the medical records supporting this assertion are fairly thin, as they do not
clearly establish when this initial diagnosis was made, nor by whom. However, there are a few references to a
bronchiectasis diagnosis being made in the past (Ex. 7 at 1, 26; Ex. 9 at 1). This, coupled with the other documented
asthma issues, constitutes sufficient support for concluding as a general matter that Petitioner has chronic respiratory
problems. Therefore, whether she actually had bronchiectasis need not be conclusively decided in order to evaluate
Petitioner’s general contention that her respiratory problems set the stage for a susceptibility to RA.
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medical thinking links persistent lung conditions with the initiation of RA. Id. at 5-6; see also
Sofat. In particular, certain protein complexes common to the joints and synovial spaces (forming
the extracellular matrix or “ECM”) were also expressed in the lung, and have been closely
associated with the tissue and cartilage destruction characteristic of RA. Id. at 6-7. Lung
inflammation has also been associated with the generation of ACPAs – even though, as noted
above, Mrs. Olson has repeatedly tested negative for this autoantibody.
Sofat was referenced several times during the entitlement hearing and provides some
general guidance about elements of Petitioner’s causation theory. See, e.g., Tr. at 41, 43, 72, 76.
Sofat is a review article summarizing the findings of other studies linking citrullination in the lung
to the autoimmune processes resulting in RA. In particular, Sofat discusses a number of ECM
proteins, like fibronectin and fibrinogen, that are found both in the lung and joints, and which
either participate in the processes leading to RA or have been found in citrullinated form in RA
synovial tissue. Sofat at 2. Sofat’s authors proposed that “it is possible that primary citrullination
occurs outside the synovium” and could in fact begin in the lung, which is “susceptible to
inflammatory responses triggered by infection and autoimmunity.” Id. at 3. Thus, an individual
with preexisting lung and respiratory conditions could later develop RA – if the right impetus to
start the process occurred.
Based upon the above, Dr. Middleton proposed several possible mechanisms by which the
HPV vaccine might trigger the autoimmune process leading to RA. He noted that individuals with
RA often were in possession of some of the antibodies believed implicated in the process (but
which he had previously admitted Mrs. Olson lacked)13 for years before they displayed outward
clinical symptoms. Second Middleton Rep. at 9-10. Introduction of a variety of environmental
factors – including vaccination – could then trigger the autoimmune and inflammatory processes.
Id. at 10-11, citing V. Molina and Y. Shoenfeld, Infection, Vaccines and Other Environmental
Triggers of Autoimmunity, 38 Autoimmunity 235-45 (2005) (filed as Article 4) (“Molina”).
Here, Dr. Middleton maintained that a single specific component of the HPV vaccine was
the trigger: alum, an adjuvant included in the HPV vaccine due to its ability to elicit an immune
response. Id. at 11-12.14 In support, he referenced several pieces of literature exploring the precise
13 Dr. Middleton did propose that a bacterial infection in one of Mrs. Olson’s thumb joints treated by surgical
intervention in 2004 – six years before the vaccination at issue – might have produced some unidentified antibodies
that, via the biologic mechanism of “bystander activation,” could have themselves contributed to the overall
autoimmune process alleged to have occurred in this case. Second Middleton Rep. at 7-9. He did not, however, revisit
this point in his hearing testimony – and taking into account Dr. Middleton’s lack of particularized expertise on the
topic of immunology, I find it speculative, and therefore not appreciably helpful in establishing Petitioner’s claim.
14 Dr. Middleton’s second report also proposed broadly that protein components of the HPV vaccine might, via the
process of molecular mimicry, have had sufficient homology with self-proteins to encourage the production of
autoantibodies involved in the pathogenesis of RA. Second Middleton Rep. at 13-14. The literature cited for this
proposition, however, mostly involved individuals possessing the ACPAs that Mrs. Olson indisputably lacks. Id. at
14 n.31. Moreover, Dr. Middleton expressly acknowledged under cross-examination that the causation theory he was
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means by which alum accomplishes its immune system-stimulating function. Middleton Rep. at
12; see also R. Goldbach-Mansky, Immunology in Clinic Review Series; Focus on
Autoinflammatory Diseases: Update on Monogeneic Autoinflammatory Diseases: the Role of
Interleukin (IL)-1 and an Emerging Role for Cytokines Beyond IL-1, 167 Clinical and
Experimental Immunology 391-404 (2011) (filed as Article 5) (“Goldbach-Mansky”); H. Li,
Cutting Edge: Inflammasome Activation by Alum and Alum’s Adjuvant Effect are Mediated by
NLRP3, 181 J. Immunol. 1-12 (2008) (filed as Article 6) (“Li”); L. Franchi and G. Nunez, The
NLRP3 Inflammasome is Critical for Alum-Mediated IL-1β Secretion but Dispensable for
Adjuvant Activity, 38 Eur. J. Immunol. 1-7 (2008) (filed as Article 7) (“Franchi”).
Underlying the contention that alum could trigger autoimmunity was scientific literature
exploring the innate immune response (as opposed to the adaptive response, whereby the human
immunologic system learns to manufacture antibodies to foreign pathogens that a given vaccine
presents in a non-pathologic form based upon the vaccine’s protein-based components) and alum’s
role in provoking it. Dr. Middleton proposed that certain protein complexes – NLRP3
inflammasomes – were key to igniting the autoimmune process relevant to RA’s pathogenesis.
Petitioner’s filed literature defines an inflammasome to be “a high molecular weight complex that
activates inflammatory caspsases and the cytokine IL-1β.” F. Martinon et al., The Inflammasomes:
Guardians of the Body, 27 Annu. Rev. Immunol., 229-65 (2009) (filed as Article 10) (“Martinon”)
at 237. Once such inflammasomes were activated by alum contained in a vaccine, an inflammatory
process that Dr. Middleton alleged was central to RA began, because the inflammasomes
themselves mediated the release of other proinflammatory cytokines that fueled the process.
Middleton Rep. at 12-13. He thus posited that because alum has been demonstrated to stimulate
these kinds of inflammasomes known to be factors in RA, there is a causal relationship between
the vaccine and the pathogenesis of RA.
The literature specifically referenced to support the contention that alum was a plausible
triggering factor in the cause of RA actually said far less on the topic than Dr. Middleton or
Petitioner assumed, however. Goldbach-Mansky primarily focused on monogenic
autoinflammatory diseases – a group of rare hereditary disorders distinguishable from RA.
Monogenic autoinflammatory disorders are characterized by clinical and biological inflammatory
syndromes in which there is little or no evidence of autoimmunity (for example, the presence of
autoantibodies as measured by testing). Goldbach-Mansky at 392. Such conditions (which have
an identified genetic underlying cause) are greatly influenced by stimuli (including an alum
adjuvant) capable of activating the NLRP3 inflammasome, and an individual suffering from that
condition lacks the capacity to neutralize or balance the process initiated by the stimulated
propounding did not rely on identification of any components of the HPV vaccine other than the alum adjuvant as
implicated in causing RA. Tr. at 64 (“I don’t think there is good scientific information that [other components of the
HPV vaccine] are related”). I accordingly deem this element of his second report to have been abandoned, speculative,
and/or too far outside of Dr. Middleton’s primary expertise to constitute a reliable proposition for Petitioner’s
causation theory.
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inflammasome (due to the same “intrinsic activating mutations” that cause the condition in the
first place). Id. at 392, 394. But this is not comparable to RA, which not only has identifiable
autoimmune biomarkers but also is not similarly monogenic (even if genetic risk factors can play
some role in the condition’s development). Indeed, treatments proposed in Goldbach-Mansky as
effective in blocking cytokines promoted by the inflammasome (Id. at 400) have not yet been
shown to be applicable to a disparate condition like RA. And Goldbach-Mansky does not address
RA or state that its findings bear on that condition.
Other literature that Petitioner and Dr. Middleton offered on this point focused more on the
general role that alum plays as an adjuvant than its supposed pathogenic potentiality. Li, for
example, begins by characterizing alum’s “adjuvanticity” as “poorly understood,” but goes on to
explore via an animal study how it might actually work. Li at 1-2. Although Li concludes that
alum’s activation of certain cytokines is mediated by the NLRP3 inflammasome, it says nothing
about whether this process could be pathogenic with respect to any disease, let alone RA. Franchi,
via another animal study, similarly observed that alum triggered activation of the NLRP3
inflammasome, but also noted that the adjuvant’s role in promoting the production of certain
antibodies could be accomplished without the inflammasome’s involvement. Franchi at 1-2.
Franchi thus did not address whether alum could stimulate production of proinflammatory
cytokines in a sustained enough manner to be pathogenic.
Finally, Dr. Middleton’s second report addressed the timing of onset of Petitioner’s
symptoms in light of the timeframe in which RA would be expected to occur under her theory of
causation. Second Middleton Rep. at 17-18. He contrasted the fact that Petitioner had no symptoms
before she received the HPV vaccine in July 2010, but then (based on her own statements as well
as statements contained in medical records beginning five to six months after) began to experience
pain and swelling a week or two after vaccination. Id. at 18. Dr. Middleton proposed that this
timeframe was medically acceptable, analogizing the onset of Petitioner’s RA to macrophagic
myofasciitis (“MMF”), an immune-mediated condition in which the alum adjuvant has also been
implicated and in which onset has been proposed to be possible as long as years after vaccination.
Id., citing E. Israeli et al., Macrophagic Myofasciitis: A Vaccine (alum) Autoimmune-Related
Disease, 41 Clinic. Rev. Allerg. Immunol. 163-68 (2011) (filed as Article 8) (“Israeli”). Israeli,
however (similar to Goldbach-Mansky), involved a different disease, characterized by a “local-
stereotyped and immunologically active lesion in the site of inoculation (deltoid muscle),” and
also found specific evidence of the alum remaining at the vaccine administration site based on
muscle biopsy. Israeli at 163, 166-67.
Dr. Middleton’s third and final report was filed in January 2017. It mainly offers some
additional explanation bulwarked by new literature in support of the component of his theory
pertaining to the NLRP3 inflammasome and its posited role in RA’s development. Third
Middleton Rep. at 1-2. He alleges that the inflammasome is “centrally involved in allergic lung
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inflammation” of the kind Petitioner suffers from, via its activation of proinflammatory cytokines
as well as other T-cells, and thus the putative activation of the inflammasome by the alum
contained in the HPV vaccine would trigger this process. Id. at 2, citing A.-G. Besnard et al.,
NLRP3 Inflammasome is Required in Murine Asthma in the Absence of Aluminum Adjuvant, 66
Allergy 1047-57 (2011) (filed as Article 14) (“Besnard”). Lung inflammation would also in theory
encourage production of ECM proteins that are involved in the destruction of cartilage and joint
tissue central to RA. Third Middleton Rep. at 2. But, as with other literature offered in this case,
Besnard does less for Petitioner’s theory than Dr. Middleton proposes. Besnard is an animal study
that confirmed the importance of the NLRP3 inflammasome in the pathogenesis of asthma by
excluding alum from its experiment “to avoid any overlapping effect of this strong NLRP3
activator,” so that the study could identify the inflammasome’s specific role. Besnard at 1053,
1055. Besnard does not stand for the proposition that alum is itself a sufficient trigger of the
inflammasome to be pathogenic.
At hearing, Dr. Middleton largely summarized the contents of his reports, confirming his
history of treating Mrs. Olson since 2013 until the present and reiterating his views as to the role
the HPV vaccine played in her RA. See generally Tr. at 30-109. He referenced one point more
forcefully addressed later by Dr. Mayer, but only briefly touched upon in his written reports (see,
e.g., First Middleton Rep. at 6-7): that existing epidemiologic evidence suggesting no relationship
between the HPV vaccine and RA is unreliable.15 Dr. Middleton stressed the fact that even though
he was aware of such studies, Petitioner did not fit into the younger age cohort of individuals
studied, reducing the applicability of findings from such studies to this case. Tr. at 79.
Dr. Middleton’s testimony also acknowledged many of the limitations of Petitioner’s
theory. He claimed that there existed studies focused on the causal role of alum in the pathogenesis
of RA, but admitted he was unaware of any that had been filed in the case. Tr. at 62-63. And he
accepted that some of the literature that Petitioner offered mainly spoke to the intended role that
alum played as an adjuvant in stimulating the innate immune system in a biologically proper
manner, rather than to its alleged capacity to instigate a pathogenic process (see, e.g., Tr. at 69
(“[s]o the reason that [the inflammasome]’s there is to provide a response. It helps to make the
vaccine more effective”) – although he maintained that individuals susceptible to RA would
potentially experience an “exaggerated response” to the adjuvant regardless. Tr. at 69. He further
agreed that it was speculative to propose that Petitioner had some underlying genetic predisposition
to developing RA. Tr. at 64.
Dr. Middleton was pressed on the extent to which aspects of Petitioner’s theory even
applied to Petitioner. Thus, he acknowledged that his “trigger” theory about the impact of the alum
15 Because Dr. Mayer was far more qualified to opine on such matters, and because (as discussed below) Respondent
has not offered epidemiologic evidence possibly rebutting some of Petitioner’s contentions in this case, I do not
address in detail Dr. Middleton’s arguments herein regarding alleged deficiencies of such studies.
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adjuvant was more relevant to “people who develop antibodies to citrullinated proteins” – a group
not including Petitioner. Tr. at 75-76. He nevertheless maintained that Mrs. Olson was susceptible
to RA, although he could not predict that, absent the HPV vaccine, she would have developed the
disease in any event. Tr. at 81 (“[i]t’s possible that something else in the future may have triggered
it, but it’s also more likely that nothing ever would have.”)
Finally, Dr. Middleton admitted that he largely relied on the temporal relationship between
receipt of the HPV vaccine and Petitioner’s subsequent development of RA to corroborate his
theory. Tr. at 78. When specifically asked to identify evidence from the medical record establishing
that “the theory you’ve proposed actually happened [to] Ms. Olson,” he responded that “I think
what you’re asking me is something that’s impossible in anyone,” maintaining that it was contrary
to “the way medical science works” to ask him “to prove in an individual patient that these things
happened.” Tr. at 80.
3. Dr. Lawrence Mayer – Petitioner also offered a single written report from
Dr. Mayer that was intended to address certain epidemiologic evidence relevant to her causation
theory (although – importantly – never offered in this case, or relied upon by Respondent). See
Mayer Report, dated September 25, 2015 (ECF No. 39) (“Mayer Rep.”).
As Dr. Mayer’s report indicates, he has been a medical doctor since 1970; he obtained his
B.S. in psychology and pre-med, M.S. in mathematics, and Ph.D. in mathematics, statistics, and
biostatistics from The Ohio State University. Mayer Rep. at 1. He finished and obtained his M.D.
in England and subsequently worked for the British Health Service studying psychiatry and
epidemiology. Tr. at 117. He is currently employed as a professor at Johns Hopkins University
Bloomberg School of Public Health and School of Medicine, a professor of epidemiology at the
College of Public Health, University of Arizona, and a professor of biostatistics, economics, and
biomedical informatics at Arizona State University. Id. Dr. Mayer has a focused expertise in
epidemiology, and he was in fact retained to offer such an opinion in this case. Mayer Rep. at 2.
Thus, although Dr. Mayer reviewed Mrs. Olson’s medical records in formulating his opinion, such
review largely did not inform the core of his opinion (with one exception addressed below).
Dr. Mayer opined that in fact the HPV vaccine did cause Mrs. Olson’s RA, but his
conclusion was indirectly derived, rather than the product (as with Dr. Middleton’s opinion) of a
causation theory explaining how the vaccine might result in the disease. As he observed, not only
had Mrs. Olson received the vaccine for an “off-label” purpose (the treatment of warts), but also
the vaccine itself was indicated for prevention of certain diseases, not treatment of them – facts
that he deemed meaningful in assessing the vaccine’s capacity to injure. Mayer Rep. at 3-5.
Dr. Mayer was, however, more specific about the putative risks of the vaccine in addressing
Petitioner’s circumstances. He began by noting that “Gardasil has not been shown to be safe and
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effective for women over 26 who are exposed to HPV,” and in fact is indicated mainly for young
and adolescent women who have not yet been exposed to the virus. Mayer Rep. at 5. Thus, the
vaccine has yet to be tested for women outside the targeted age group, like Petitioner. Id. at 7-9.
From this, Dr. Mayer concluded that the vaccine was in fact not safe for Petitioner, based on
“scientific and statistical principles.” Id. at 9. In addition, the vaccine’s safety is uncertain for
“immunocompromised individuals” – a category Dr. Mayer assumed included Mrs. Olson due to
her use of steroidal medications to treat her chronic lung/respiratory problems, since “[s]teroids
work by suppressing the immune system.” Id. at 8.
Dr. Mayer next discussed several epidemiologic studies relevant to HPV’s safety. First, he
offered a study from Denmark and Sweden that he purported demonstrated (in a population of girls
10-17 years old) a higher incidence of RA among those vaccinated than not, although he
acknowledged that the differential between the relevant incidence rates was not statistically
significant enough to constitute strong evidence about the vaccine’s risks. Mayer Rep. at 10, citing
L. Arnheim-Dahlstrom et al., Autoimmune, Neurological, and Venous Thromboembolic Adverse
Events after Immunisation of Adolescent Girls with Quadrivalent Human Papillomavirus Vaccine
in Denmark and Sweden: Cohort Study, 347 BMJ 5906 (2013).16 Dr. Mayer also referenced
passive reporting system evidence alleging adverse events after receipt of the HPV vaccine (much
like the VAERS data Dr. Middleton’s reports evaluated), although he acknowledged that from an
epidemiologic standpoint, such evidence was of relatively low probative value. Mayer Rep. at 14.
Dr. Mayer’s report discusses at length what he termed the “Merck study” – C. Chao et al.,
Surveillance of Autoimmune Conditions Following Routine Use of Quadrivalent Human
Papillomavirus Vaccine, 271 J. Intern. Med. 193-203 (2012) (filed as Article 29) (“Chao”). Chao
(funded but not authored by Gardasil’s manufacturer, Merck & Co.) was a peer-reviewed
observational study17 analyzing a database comprised of the medical histories of approximately
189,000 women (members of two of Kaiser Permanente’s managed care health organizations in
the State of California) to determine whether the studied population had developed a variety of
autoimmune conditions18 after receiving the Gardasil vaccine. Chao at 194. The researchers
16 Dr. Mayer’s expert report was not accompanied by the filing of any of the items of literature referenced therein, and
Petitioner later filed only one of the epidemiologic studies he referenced – making it very difficult for me to assess if
he has properly attributed their findings. Because, however, I ultimately did not find Dr. Mayer’s opinion to be useful
in resolving this case, the absence of support for the opinions he proposes is a moot point.
17 In an observational epidemiologic study, researchers analyze groups of individuals who were exposed to a test agent,
comparing them with groups not so exposed. Michael D. Green et al., “Reference Guide on Epidemiology,” in
Reference Manual on Scientific Evidence 549, 555-56 (3d ed. 2011). Chao’s investigators drew inferences about the
side effects of Gardasil based on historic data, where the assignment of subjects into a treatment group (women who
received the Gardasil vaccine) versus a control group (women who did not) was outside of the investigators’ control.
See Chao at 194.
18 The diseases monitored in Chao included rheumatologic/autoimmune disorders, including immune
thrombocytopenia, autoimmune hemolytic anemia, systemic lupus erythematosus, RA, and JRA. Chao at 194.
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compared the results of the studied vaccinated population with unvaccinated, similarly-situated
individuals also enrolled with Kaiser Permanente in Southern California, in order to compare
incident rate ratios for the identified autoimmune conditions. Id. at 194-95. Chao did not observe
an increased risk of developing RA (or other autoimmune conditions) following receipt of the
Gardasil vaccine (Id. at 196, 201), but Dr. Mayer nevertheless opined that the studied population
was not comparable to Petitioner’s circumstances, for reasons similar to what Dr. Middleton had
argued. Mayer Rep. at 12-13.19
Dr. Mayer testified at the entitlement hearing, albeit only briefly. He reiterated his overall
point that he discounted the existing epidemiologic evidence suggesting no link between RA and
the HPV vaccine for the reasons mentioned, and that he therefore questioned the use of such
evidence to vouch for the vaccine’s safety. Tr. at 122-23. He emphasized again that in Mrs. Olson’s
case, the vaccine had been used for a non-indicated purpose (Id. at 125), and that the epidemiologic
studies that existed, such as Chao, simply were not applicable since the determinations they
proposed were based on population samples that excluded people like Petitioner. Id. at 126, 129-
30.
B. Respondent’s Witness: Dr. Robert Lightfoot
Dr. Lightfoot acted as Respondent’s sole witness and expert in this action, filing two
reports as well as testifying at the entitlement hearing. See Report, dated May 15, 2015 (ECF No.
35-1), filed as Exhibit A (“Lightfoot Rep.”); Second Report, dated March 31, 2016 (ECF No. 48-
1), filed as Exhibit E (“Second Lightfoot Rep.”). As his CV indicates, Dr. Lightfoot graduated
from Vanderbilt University with a Bachelor of Arts degree in 1958, and then attended Vanderbilt’s
School of Medicine, graduating in 1961. ECF No. 35-2 (filed as Exhibit B) (“Lightfoot CV”) at 1.
Dr. Lightfoot then interned at the Columbia Presbyterian Medical Center from July 1, 1961 to June
30, 1962, completing a residency there before returning to Vanderbilt in 1964 for a subsequent
residency. Id. He then held a fellowship in rheumatology (his present specialty) at Columbia
University from July 1, 1964, to June 30, 1966. Id. He subsequently served as Chief of the
Rheumatology Division at the Medical College of Wisconsin from 1976 to 1986, where he also
taught. Id. at 2. Dr. Lightfoot thereafter served as Division Director of the Allergy, Immunology,
and Rheumatology Division at the University of Kentucky at Lexington, and as a professor of
Medicine and a professor of Medicine Emeritus at the University of Kentucky, College of
Medicine. Id.
19 Dr. Mayer’s report raised other questions about the reliability of Chao based on its methodology, but because I
accept Petitioner’s point about its reduced probative value in this case (and given that Respondent has not offered it
to rebut Petitioner’s claim), I need not address such additional challenges to the weight this evidence should be given.
In prior cases, however, I have found that Chao is reliable science relevant to claims that the HPV vaccine injured a
young woman who would be included in the age group the study considered. See, e.g., Sullivan v. Sec’y of Health &
Human Servs., No. 10-398V, 2015 WL 1404957, at *19-20 (Fed. Cl. Spec. Mstr. Feb. 13, 2015).
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Dr. Lightfoot is board certified by the American Board of Internal Medicine and the
American Board of Internal Medicine in rheumatology, and he is a licensed physician in Kentucky.
Lightfoot CV at 1. He is a member of the American College of Rheumatology and has co-authored
41 peer-reviewed articles, which are listed on his CV. Id. at 3, 14–18. Dr. Lightfoot has extensive
experience treating individuals with RA (Tr. at 140), but he is not an immunologist. Tr. at 227.
Dr. Lightfoot’s primary written report is based on a review of the medical records plus Dr.
Middleton’s first report. As confirmed at hearing, he opines that Petitioner’s RA was idiopathic in
origin, and he disputes that the evidence shows any relationship to her receipt of the HPV vaccine.
Tr. at 224-25. Dr. Lightfoot generally termed Petitioner’s RA as relatively mild, based on his
examination of her medical records (which he felt did not display a severe case of the condition,
given the low inflammation levels her testing revealed) as well as her demonstrated ability to
remain active despite the pain. Lightfoot Rep. at 5. Petitioner’s underlying respiratory problems,
and the steroidal treatments she received for them, might in fact have (in his view) blunted her
overall symptoms as well as her specific initial onset. Id.
Much of Dr. Lightfoot’s primary written report was aimed at rebutting Dr. Middleton’s
proposed causation theory. Thus, he attacked the concept that Mrs. Olson’s early onset after
vaccination was proof of a causal link to the HPV vaccine as post hoc ergo propter hoc reasoning,
and he questioned overall whether Petitioner’s theory was supported by reliable evidence (for
example, in the form of an identified antigen in the vaccine that might have initiated an
autoimmune reaction). Lightfoot Rep. at 5-6. He attacked the statistical significance of vaccine
risks identified on the vaccine package insert and also questioned whether VAERS data was useful
in establishing causation. Id. at 6. And he attempted to defend the statistical evidence like Chao –
although neither Drs. Lightfoot nor Middleton, as RA specialists, were particularly qualified to
opine on the reliability of a large scale epidemiologic study. Id. at 7.
Dr. Lightfoot’s second report was a point-by-point review of certain aspects of Dr.
Middleton’s second report. See generally Second Lightfoot Rep. Dr. Lightfoot began with an
overall explanation of RA, noting that it is a very common disorder in which no etiologic cause
has been defined. Second Lightfoot Rep. at 2. Dr. Lightfoot then addressed Dr. Middleton’s several
references to Petitioner’s supposed genetic predisposition to RA. Id. While Dr. Lightfoot
acknowledged that genetic factors in families can create a predisposition to RA, he noted that fact
is irrelevant to this case. Id. at 2-3. There is no evidence that Petitioner’s relatives had ever been
tested or found positive for genetic factors, and Petitioner herself did not possess RA-associated
antibodies. Id. at 3. Due to the lack of any evidence in the medical records revealing a family
history of arthritis, he disputed the accuracy of such assumptions. Id.
Dr. Lightfoot next addressed Dr. Middleton’s supposition that Petitioner’s medical records
revealed no other possible environmental trigger than the HPV vaccination, and thus it must have
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been the cause. Second Lightfoot Rep. at 3. However, Dr. Lightfoot maintained that no RA patients
have a proven causative environmental trigger, and while it might be convenient to select the
“nearest suspect in time,” it is not possible to know the exact trigger. Id. He also reiterated that a
causal relationship cannot be proven simply because Petitioner’s onset of arthritis symptoms was
close in time to the vaccination. Id. at 4. Dr. Lightfoot went on to also explain that while he agreed
with Dr. Middleton that there is a connection between pulmonary inflammation and RA, it occurs
in unvaccinated individuals as well, and that respiratory problems do not necessarily predispose
an individual to developing RA. Id. He also disagreed with Dr. Middleton’s focus on the antibodies
to citrullinated proteins in RA individuals, asserting that there was no evidence that elevated levels
of the CCPA autoantibodies are specific to a certain virus or other infectious agent. Id. at 5. Finally,
Dr. Lightfoot suggested that, in fact, Petitioner’s clinical presentation better fit the features of
spondyloarthopathy syndrome. Id. at 5-6. This syndrome’s treatment is similar to RA, and the
causation discussion would be the same as RA, as it follows no recognizable antecedent event. Id.
At trial, Dr. Lightfoot’s brief oral testimony on direct examination tracked his report, re-
emphasizing that the cause of Petitioner’s RA was unknown. Tr. at 148. He seemed to allow for
the possibility that her preexisting lung and respiratory problems could be connected to her
subsequent RA, but he questioned whether generalized lung inflammation had been adequately
linked to joint damage to relate them causally. Id. at 147. In response, Petitioner’s counsel devoted
the majority of cross-examination to attempting to obtain Dr. Lightfoot’s concession as to the
reasonableness of numerous statements and factual or scientific points set forth in a variety of
Petitioner’s items of literature relating to the immunologic aspects of her theory. See, e.g., Tr. at
150-69.
Petitioner largely succeeded in this task. Dr. Lightfoot was hard-pressed to deny the
reasonableness or accuracy of many of the statements contained in Petitioner’s literature when put
before him. See, e.g., Tr. at 168-69 (Dr. Lightfoot, shown a portion of Besnard, confirmed that he
had no basis upon which to disagree with the statement that “the alum adjuvant is a strong NLRP3
activator”). Yet this approach to impeaching Dr. Lightfoot was of limited effectiveness – for the
same expertise limitations that reduced the evidentiary value of Dr. Lightfoot’s statements about
the causal role of the HPV vaccine herein also limited the weight that can be given to his
admissions about the contents of articles dealing with immunology. And in any event (and as
discussed in greater detail below), the fact that components of Petitioner’s theory were facially
sound or reliable (and that Respondent’s expert on the injury at issue conceded certain points
relevant to the science behind Petitioner’s causation theory) does not lead to the conclusion that
the theory as a whole is reliable or persuasive.
IV. Procedural Background
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After initiating this action in July 2013, Mrs. Olson began filing medical records in support
of her claim, completing the process approximately one year later. Respondent’s Rule 4(c) Report
was then filed on September 15, 2014 (ECF No. 30). Petitioner was ordered to file an expert report
by December 31, 2014, and she did so with the filing of Dr. Middleton’s Declaration in January
2015. ECF Nos. 32 and 33. I thereafter ordered Respondent to file an expert report, which he did
on May 15, 2015. ECF No. 35.
I subsequently instructed Petitioner to file a supplemental expert report aiming to bulwark
her causation theory as well as to better explain how onset of her RA related to the course of the
condition. See Order, dated May 21, 2015 (ECF No. 36). After some extensions of time were
requested and granted, Petitioner filed Dr. Mayer’s report on September 28, 2015 (ECF No. 39).
But, after review of the new report, I held another status conference in which I reiterated my
previously-expressed concerns about gaps in Petitioner’s theory and invited her to supplement her
expert report again. See Order, dated October 5, 2015 (ECF No. 40). Petitioner then filed a second
expert report from Dr. Middleton on December 1, 2015 (ECF No. 41).
In 2016, Respondent opted to file a second report from Dr. Lightfoot on April 1, 2016 (ECF
No. 48). By this point, the parties also had discussed potential hearing dates, and an entitlement
hearing was set for March 27-28, 2017. Order, dated March 31, 2016 (ECF No. 47). Petitioner also
filed a third expert report from Dr. Middleton on January 14, 2017. ECF No. 49-1. The hearing
went forward as scheduled, and the parties agreed that no post-hearing briefing was necessary.
This matter is now ripe for a decision.
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 v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).20
In this case, Petitioner does not assert a Table claim.
20 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings
concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121,
124 (2003), aff’d 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-
159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
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For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d
867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not
only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344,
1352-53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions;
rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen v. Sec’y of Health & Human 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.” Althen, 418 F.3d at 1278.
Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory
must only be “legally probable, not medically or scientifically certain.” Id. at 549.
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325-26). Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of
Health & Human Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility . . . in many cases may be
enough to satisfy Althen prong one” (emphasis in original)), vacated on other grounds, 844 F.3d
21

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1363 (Fed. Cir. 2017). But this does not negate or reduce a petitioner’s ultimate burden to establish
his overall entitlement to damages by preponderant evidence. W.C. v. Sec’y of Health & Human
Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted).21
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is
nothing . . . that mandates that the testimony of a treating physician is sacrosanct – that it must be
accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a
theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the
reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence also present in the record – including conflicting opinions
among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742, 749 (2011)
(not arbitrary or capricious for special master to weigh competing treating physicians’ conclusions
against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Dept. of Health &
Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot.
for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed.
Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
21 Although decisions like Contreras suggest that the burden of proof required to satisfy the first Althen prong is less
stringent than the other two, there is ample contrary authority for the more straightforward proposition that when
considering the first prong, the same preponderance standard used overall is also applied when evaluating if a reliable
and plausible causal theory has been established. Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339,
1350 (Fed. Cir. 2010).
22

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proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for
what is a medically acceptable timeframe must also coincide with the theory of how the relevant
vaccine can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of
Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl.
353 (2012), aff’d mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human
Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review
den’d (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Law Governing Analysis of Fact Evidence
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [] relevant medical and scientific evidence contained in the record,” including “any
diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the
record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury,
condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained
in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then
required to weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is
within the special master’s discretion to determine whether to afford greater weight to
contemporaneous medical records than to other evidence, such as oral testimony surrounding the
events in question that was given at a later date, provided that such determination is evidenced by
a rational determination).
Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s
health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed.
Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his
contemporaneous medical records, the special master’s decision to rely on petitioner’s medical
records was rational and consistent with applicable law”), aff’d, Rickett v. Sec’y of Health &
Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is
based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people
honestly report their health problems to those professionals; and (iii) medical professionals record
what they are told or observe when examining their patients in as accurate a manner as possible,
so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez
v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr.
Apr. 10, 2013); Cucuras v. Sec’y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993
23

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F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to
accurately report the onset of their daughter’s symptoms.”).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical
records are generally found to be deserving of greater evidentiary weight than oral testimony –
especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;
see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam,
968 F.2d 1226 (Fed. Cir. 1992), cert. 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, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon
common sense and experience, this rule should not be treated as an absolute and must yield where
the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19
(“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than
those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a
determination regarding a witness’s credibility is needed when determining the weight that such
testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Human
Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Human
Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In
determining the accuracy and completeness of medical records, the Court of Federal Claims has
listed four possible explanations for 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 & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir.
2014). In making a determination regarding whether to afford greater weight to contemporaneous
medical records or other evidence, such as testimony at hearing, there must be evidence that this
decision was the result of a rational determination. Burns, 3 F.3d at 417.
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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 & Human Servs., 219 F.3d
1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to
the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1339
(Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir.
1999). “The Daubert factors for analyzing the reliability of testimony are: (1) whether a theory or
technique can be (and has been) tested; (2) whether the theory or technique has been subjected to
peer review and publication; (3) whether there is a known or potential rate of error and whether
there are standards for controlling the error; and (4) whether the theory or technique enjoys general
acceptance within a relevant scientific community.” Terran, 195 F.3d at 1316 n.2 (citing Daubert,
509 U.S. at 592-95).
The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial for a (such as the district courts). Daubert factors are usually
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors
are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health
& Human Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742-45. In this matter (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.
Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Human 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 91997)); see also Isaac v. Sec’y of Health &
Human Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot.
for review den’d, 108 Fed. Cl. 743 (2013), aff’d, 540 Fed. 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
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masters must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325-26
(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);
see also Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this
court has unambiguously explained that special masters are expected to consider the credibility of
expert witnesses in evaluating petitions for compensation under the Vaccine Act”).
D. Consideration of Medical Literature
Both parties filed medical and scientific literature in this case, but not every filed item
factors into the outcome of this decision. While I have reviewed all of the medical literature
submitted in this case, I discuss only those articles that are most relevant to my determination
and/or are central to Petitioner’s case – just as I have not exhaustively discussed every individual
medical record filed. Moriarty v. Sec’y of Health & Human Servs., 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 & Human Servs., 527 F. App'x
875, 884 (Fed. Cir. 2013) (“[f]inding certain information not relevant does not lead to – and likely
undermines – the conclusion that it was not considered”).
At the same time, and as previously noted, there were many items of literature that
Petitioner’s experts referenced in the action that were not filed as part of the record in this case.
See, e.g., Tr. at 62-63. While in a few such instances, I have considered an unfiled or late-filed
item22 because of its apparent significance to Petitioner’s claim, I have not attempted to locate and
then review every single unfiled item cited in this case —and am not otherwise obligated to do so,
consistent with the fact that Program claimants are not required to produce medical literature to
establish causation. See Capizzano, 440 F.3d at 1324; Althen, 418 F.3d at 1280. Petitioners are
responsible for raising with the special master those items that they deem important enough to
constitute favorable relevant evidence, and ensuring that they are included in the evidentiary
record, if they want them considered. See, e.g., Cedillo, 617 F.3d at 1347 (special master did not
err in disregarding articles where no experts gave any testimony as to the “validity or import” of
such article).
ANALYSIS
22 To give the most notable example, from the time of the filing of Dr. Middleton’s first expert report in December
2014, Petitioner and her experts repeatedly referenced Chao, in an effort to undermine its probative weight as an
epidemiologic study casting doubt on any relationship between the HPV vaccine and autoimmune conditions such as
RA – and yet she did not file it until after the hearing this year. See ECF No. 62 (Medical Articles Appendix, filed
March 31, 2017).
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Although Petitioner credibly established that onset of her RA most likely began within one
or two weeks of her receipt of the HPV vaccine, this finding alone is not a sufficient basis upon
which to prevail. Rather, she needed to show that (a) the HPV vaccine could cause RA, and (b)
that it did so in her case. She was unable to meet either of these Althen test prongs.
A. Althen Prong One
My discussion of Petitioner’s causation theory begins with what she acknowledges is
missing from that theory. She explicitly does not claim that any protein component specific to the
HPV vaccine is implicated in her theory. See, e.g., Tr. at 52-53, 64. Petitioner has also offered no
evidence that the HPV vaccine has ever been associated with RA (although, as discussed below,
she has offered expert testimony intended to rebut the opposite conclusion). Of course, Program
petitioners are not required to offer direct proof supporting their theory, or even any specific type
of evidence, but instead may rely on circumstantial evidence. See, e.g., Althen, 418 F.3d at 1280.
Regardless of what kind of evidence is relied upon, however, claimants must still establish
preponderant proof. And in addressing the first Althen prong, that proof must go toward
establishing a reliable scientific or medical theory – and if it comes in the form of a scientific or
medical article, it must be reliable. Knudsen, 35 F.3d at 548.
There are several interlocking components of Petitioner’s theory. First, she maintains that
certain individuals with preexisting conditions – here, persistent lung infections or asthma – are
more likely to develop RA. The lung, she maintains, can be the situs of the development of a
process (as evidenced by the presence of ACPAs or some other, not-yet-identified antibodies) that
greatly contributes to the chronic, autoimmune inflammatory state that allows the cellular
destruction directly responsible for the pain and visible clinical symptoms associated with RA.
The fact that there are similarities between the ECMs in the lung and those found in synovial
locations further supports the contention that a pathologic process beginning in the lungs could
impact the joints under Petitioner’s theory.
Second, Petitioner asserts that vaccines can function as the trigger that sets off the
autoimmune process resulting in RA – particularly due to the inclusion of alum as an adjuvant.
Scientific research associates alum with the increased production of certain cytokines that are
involved in the inflammatory process leading to RA. Key to this process are the proinflammatory
cytokines like IL-1 that Petitioner posits play an integral role in allowing the chronic inflammatory
conditions in which a person susceptible to RA will then experience it. The production of those
cytokines is mediated by the NLRP3 inflammasome – which is stimulated by alum. Thus, she
theorizes, the HPV vaccine’s capacity to stimulate the innate immune system in an individual like
herself is the causative factor that would produce RA.
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A few overarching aspects of this theory are medically or scientifically sound. Petitioner
has offered persuasive evidence in support of her contention that persistent lung inflammation is
often associated with RA. In addition, her explanation for the role ACPAs play (as primarily set
forth in the filed literature) in causing RA, and the likelihood that the citrullination that precedes
ACPA production occurs in the lung, is logical and scientifically reliable. She also offers
trustworthy articles exploring the not-fully-understood processes by which adjuvants like alum
help stimulate the innate immune system, thereby increasing the efficacy of vaccines. She has
established that cytokines play some role in the process of encouraging the unchecked
inflammation that is so integral to RA’s development. And inflammasomes have been shown
herein to play a mediating role in the overall immune reaction process. Martinon at 242.
Where Petitioner’s theory falters, however, is in its specifics, for many of its most
important elements are inadequately supported. First, Petitioner has failed to demonstrate that
cytokine upregulation allegedly resulting from vaccine administration is itself a trigger for RA,
rather than either a byproduct or subsequent component of the disease. Instead, Petitioner has
established a general point – that many different environmental factors could initiate the process
that would cause a susceptible individual to develop RA, and that it is not unreasonable to consider
a vaccine (like a wild virus infection) as one of those factors. But it remains a speculative issue as
to whether cytokine production instigated by a single vaccine containing alum would be robust
enough, and occur for long enough, to be pathogenic generally, let alone to cause RA.
Reliable scientific support is also lacking for Petitioner’s argument that the alum included
as an adjuvant in a wide variety of vaccines is the pathogenic key herein. As noted above, and by
the admission of Petitioner’s experts, this is the sole HPV component implicated in their causation
theory (or at least the only one they were able to identify as possibly causative). It was therefore
critically important that Petitioner marshal reliable scientific or medical evidence suggesting that
alum could precipitate RA or some other comparable autoimmune disease. But the literature
Petitioner offered – the most scientifically-reliable items of which were studies aimed at
understanding how alum performs as a stimulatory actor in the immune process – does not do this.
See, e.g., Li; Franchi; Martinon. Rather, such studies explore in detail a known fact: that alum is
an effective adjuvant in its stimulation of the immune system, and hence such research helps
science understand why it is included in vaccines in the first place. They do not permit the broader
conclusion that Petitioner urges: that alum can be pathogenic – and indeed none of Petitioner’s
offered literature so proposes.23
23 Israeli – the article about MFF – is the closest Petitioner and her experts come to establishing some possible
pathogenic role for alum. But that article involves an entirely different disease, and one in which the muscle biopsies
have established that alum remained at the injection site – a showing that has not been made here, or (at least based
on Petitioner’s literature) in any RA cases. Israeli’s findings are thus too narrowly focused upon a different disease to
be applicable.
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The articles referencing the general capacity of alum to stimulate inflammasomes, or the
possibly pathogenic role of over-stimulation of inflammasomes, do not fill this gap. They do not
establish that such stimulation by alum alone, in levels found in a vaccine, is pathogenic in
connection with a disease like RA (as opposed to distinguishable diseases such as those discussed
in Goldbach-Mansky). Literature that shows that inflammasomes are important to the tissue/ECM
destruction or general inflammation that characterize RA does not explain why alum in a vaccine
would likely initiate or increase that process. At best, there is some support for the concept that
different environmental factors might trigger RA. But there is nothing specific enough regarding
any of the possible triggers (which include things that the population is broadly subjected to, like
UV rays in sunlight) to define how the triggering process would theoretically work, and/or whether
all triggers would impact the process in the same way. The fact that many vaccines also contain
alum but have not been implicated in RA or other autoimmune conditions as alleged herein also
merits some weight. See, e.g., Johnson v. Sec’y of Health & Human Servs., No. 10-578V, 2016
WL 4917548, at *8-9 (Fed. Cl. Spec. Mstr. Aug. 18, 2016) (noting the unreliability of the theory
that if an adjuvant can cause an autoimmune disease, it could cause any autoimmune disease). If
alum can cause RA, there should be more robust evidence that it is associated with other
autoimmune conditions in different vaccines.
An additional problem with Petitioner’s theory is the degree to which it relies on science
that is ultimately inapposite to the present context. For example, many articles Petitioner offered
discuss or address the ACPAs that are the result of citrullination, a process widely understood to
be an explanation for RA in numerous cases (and which allows a link to be drawn between chronic
lung infections akin to what Mrs. Olson experienced and her RA). But Petitioner has never tested
positive for those autoantibodies, and therefore she cannot credibly propose a theory involving a
process that she cannot also establish occurred to her. See Ex. 2 at 65, 101-02, 104, 106-09, 111.
This also impacts Petitioner’s argument that an individual with chronic lung infections, due to
asthma or other respiratory ailments, is susceptible to a vaccine trigger, since the literature
discussing the lung as an initiatory situs for RA largely depends on citrullination occurring there
first. See, e.g., Sofat at 3; Ytterberg at 13 (“[t]he data give further support to the hypothesis that
immunity to citrullinated proteins may be initiated in the lungs and potentially contribute to
inflammation in the joints.”).
Similarly, at hearing Petitioner made a point of stressing Goldbach-Mansky (and related
articles involving discussions of proinflammatory cytokines) as particularly trustworthy support
for her theory, given the authors’ employment at the National Institutes of Health (Tr. at 53, 161
(“[s]o you’re aware that [Goldbach-Mansky]’s actually an employee of a division of the
Respondent”)). Yet, as noted above, Goldbach-Mansky involved monogeneic autoinflammatory
diseases that far more closely fit the “powder keg” scenario envisioned by Petitioner than does
RA, because only in those rare instances has it been more definitely established that an
environmental factor like alum might actually initiate a pathogenic process. Certainly Petitioner
29

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offered nothing reliable or persuasive – whether in the form of Dr. Middleton’s testimony or from
the literature filed herein – that suggests that alum plays any role in abetting the citrullination
process (a process that Petitioner and her experts acknowledged might begin years before
introduction of a vaccine). See, e.g., Tr. at 41, 48, 75-76.
Petitioner’s experts could not ameliorate these deficiencies via their reports or live
testimony. Dr. Middleton, though qualified to testify about RA generally and its possible etiology,
lacked the specialized immunologic grounding necessary to explain and defend in a persuasive
manner the theory articulated in this case, given that theory’s dependency on complex immune
system processes. The fact that he was a treater, or that his medical training allowed him to
comprehend sections of Petitioner’s selected items of literature, did not counterbalance his lack of
specific expertise relevant to the theory at issue. Program case law makes clear that a treater’s
opinion is not sacrosanct, but rather subject to the same reliability and weighing considerations
that underlie application of the Daubert standards to any medical or scientific testimony. Snyder,
88 Fed. Cl. at 746 n. 67. I also take note of the fact that Dr. Middleton did not even begin to see
Mrs. Olson until three years from date of her July 2010 vaccination. See, e.g., Tr. at 31; Ex. 5 at 1.
His opinions are thus not the product of real-time observations of her immediate post-vaccination
condition – further reducing the deference to be afforded his treater status. Nuttall v. Sec’y of
Health & Human Servs., 122 Fed. Cl. 821, 832 (2015) (“[t]he reasoning underlying the finding
that opinions of treating physicians should be given particular weight does not apply when . . . the
treating physician only saw the patient after the injury and based his opinion on the same evidence
as relied upon by the retained experts”).
Dr. Mayer for his part raised a few reasonable questions about the relevance of some
epidemiologic evidence bearing on the causal relationship between Gardasil and autoimmune
conditions like RA. In other cases involving the HPV vaccine, I have found such evidence
(particularly Chao) probative and reliable. Sullivan, 2015 WL 1404957, at *19-20. Here, however,
Petitioner’s point about the inapplicability of such studies to an older individual was persuasive.
But that was a narrow success, since Respondent does not rely on Chao to defend against
Petitioner’s claim.
Otherwise, Dr. Mayer’s testimony did not appreciably assist Petitioner in establishing a
causal relationship between the vaccine and RA, as he lacked the qualifications to reliably opine
on such matters. And some of his other arguments (e.g., that the HPV vaccine, since it has not been
shown to be conclusively safe, might carry risk nonetheless, or that a non-indicated use of a vaccine
as occurred here could be dangerous) were not germane to the standard of proof governing a non-
Table claim, which focuses only on whether the vaccine caused injury. See Section
(b)(1)(C)(ii)(I).24
24 Under the Act, evidence of a physician’s mistaken administration of the wrong vaccine – the flu vaccine in place of
a DTaP vaccine, for example – would not help establish a cause of action if the petitioner could not also establish that
30

Case 1:13-vv-00439-EJD Document 75 Filed 08/23/17 Page 31 of 33
B. Althen Prong Two
Pursuant to Petitioner’s causation theory, receipt of the HPV vaccine was enough of a
trigger, given her underlying circumstances, to initiate a process that ultimately led to a diagnosis
of RA. But her medical history does not provide the corroboration necessary to conclude that
Petitioner’s theory worked out as predicted – and leaves open the possibility that other factors were
more likely to have precipitated her RA than the vaccine.
Most significantly, the record does not reflect the existence of an ongoing inflammatory
process that would establish the persistent, pathogenic cytokine upregulation that Petitioner’s
theory envisions after administration of an alum-adjuvanted vaccine. Overall, as Dr. Lightfoot
observed in his report, Mrs. Olson’s case of RA was on the mild end of the spectrum – reflected
in its lengthy course, her ability to tolerate the associated pain while conducting her life, and the
lack of evidence demonstrating a more progressively severe trajectory. Petitioner has also pointed
to no testing results or other laboratory proof (primarily in the first six months to a year after
vaccination) that would establish that her causation theory was occurring as expected, such as
results evidencing the presence of ongoing inflammation.25
Also missing are other pieces of proof that, under Petitioner’s causation theory, should
have been reflected in the medical records. In particular, Petitioner has consistently tested negative
for ACPAs – even though citrullination, and its connection to persistent inflammatory conditions
in the lung, was repeatedly referenced in both Petitioner’s literature and Dr. Middleton’s testimony
as significant in establishing an individual’s susceptibility to RA given longstanding respiratory
problems. See, e.g., Sofat at 1; Tr. at 45-46. The literature cited about the connection between the
lung and RA repeatedly talks of citrullination as occurring specifically in the lung – but here, it
cannot be determined that this even occurred in Mrs. Olson’s case, absent a finding of the
autoantibodies’ presence. It is not enough to speculatively propose, as Dr. Middleton did, that there
must be some other, “unidentified,” antibodies at work in the process. Tr. at 76, 78.26
the mistakenly-administered vaccine injured him, despite the literal “non-indicated” use of a vaccine. In contrast, the
administration of the correct vaccine in a mechanically-improper way that causes injury does establish a specific kind
of claim (a shoulder injury resulting from vaccine administration, or “SIRVA” claim), even if the vaccine otherwise
performs as intended from an immunologic standpoint.
25 Of course, the absence of testing that would not otherwise have been considered so early on given Petitioner’s initial,
somewhat mild symptoms is not something that deserves excess weight, but it also does not demonstrate the existence
of an active immune-mediated disease course.
26 Petitioner attempted to argue at hearing, through Dr. Middleton, that not all antibodies possibly associated with RA
may have been identified to date, thereby minimizing the significance of the absence of ACPAs herein. Tr. at 91-92;
105-107. But even if this is true from a broad scientific standpoint, for purposes of this claim it constitutes speculation
that cannot be the basis for the finding that Petitioner has established preponderant evidence sufficient to meet her
burden of proof. See, e.g., Snowbank Enter., 6 Cl. Ct. at 486 (speculation is insufficient under the preponderant
evidence standard). A theory that depends in part on a finding of the presence of one kind of specific autoantibody
31

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All in all, Petitioner could not establish that the course of her RA is consistent with her
causation theory (beyond the fact that her RA began post-vaccination). As a treater, Dr. Middleton
was qualified to offer a reading of the medical record consistent with Petitioner’s theory, by
highlighting aspects of it that showed Petitioner’s causation theory occurring in real time. Instead,
he expressly disavowed the ability to do so at all, confirming his view at trial that the most
significant evidence he could identify as supporting the theory was the temporal relationship
between vaccination and injury. Tr. at 105 (“On the ‘did cause’ part of the case that I have to
decide, we have to rely upon the timing predominantly, right? A: Um-hum. Q: Yes? A. Correct”).
It is a long-settled matter in the Program that this is an insufficient basis for an entitlement award.
Grant, 956 F.2d at 1148. I cannot find on the basis of this medical record that the HPV vaccine
more likely than not was the cause of Petitioner’s RA – and indeed, cannot even pinpoint evidence
supporting what its most likely cause was, given the total absence of any of the
biomarkers/antibodies most associated with the disorder.
C. Althen Prong Three
As briefly noted above, Mrs. Olson persuasively testified that onset of her obvious RA-
related symptoms began manifesting within one to two weeks of her receipt of the HPV vaccine
in July 2010. But this temporal relationship is not enough for me to conclude that the third Althen
prong has been satisfied.
First, because of the close relationship between the first and third Althen prongs, petitioners
are obligated to establish that the timing of onset of symptoms is “medically appropriate” under
their proposed causation theory. See, e.g., de Bazan, 539 F.3d at 1352 (the explanation for what is
a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine
can cause an injury (Althen prong one’s requirement)); Shapiro v. Sec’y of Health & Human Servs.,
101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d mem.,
503 Fed. Appx. 952 (Fed. Cir. 2013). But I have not found that Petitioner met her first Althen
prong burden, because I do not find her theory – that alum in the HPV vaccine is alone sufficient
to trigger RA in a person susceptible to the condition, and pursuant to the mechanism proposed in
this case – to be scientifically or medically reliable. Accordingly, it does not matter that onset of
the first obvious symptoms of Mrs. Olson’s RA was temporally consistent with a theory that itself
is not scientifically or medically reliable. Caves v. Sec’y of Health & Human Servs., No. 07-443V,
2010 WL 5557542, at *22 (Fed. Cl. Spec. Mstr. Nov. 29, 2010) (a finding of an appropriate
temporal relationship is insufficient to show causation-in-fact, as the other two prongs must also
be met).
cannot evade the absence of such proof by proposing that some other autoantibody not yet identified by medical
science is also likely to be present instead.
32

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Second, that aspect of Petitioner’s theory relying on an association between RA and
individuals with chronic lung infections or like conditions, like Mrs. Olson, actually allowed for
the possibility that her RA might have preceded vaccination – that it might already have been
triggered independent of the HPV vaccine. Petitioner’s theory that a vaccine could possibly act as
an environmental trigger in a person susceptible to RA relied heavily on science involving the
citrullination process initiating in the lung. See, e.g., Sofat at 3; Ytterberg at 13. Such science
establishes that an individual can possess the citrullinated antibodies that lead to the ECM protein
destruction reflected in RA’s primary symptoms long before clinical evidence of those symptoms
manifests. Sofat at 2; van de Sande at 1. Indeed, Petitioner made a point of discussing the existence
of a synovial subclinical period in which ACPAs (or some still-unidentified autoantibodies) would
begin to perform their damaging, cross-reactive functions, even though outward clinical proof of
RA (joint pain, visual swelling in joints) is lacking. Tr. at 49-51. And Dr. Middleton forthrightly
admitted that he could not rule out all of the above starting before the HPV vaccine was
administered. Tr. at 108.
CONCLUSION
Petitioner has unquestionably suffered from her RA, and I conclude from observing her at
hearing that she is a truthful individual seeking a logical explanation for what caused her condition.
Given the facts, I do not find it surprising that she and her experts deemed significant the fact that
onset of her RA symptoms came after she received the HPV vaccine. The Vaccine Act, however,
places far less stock in a mere temporal association. It permits me to award compensation only if
a petitioner alleging a “non-Table Injury” can show by medical records or competent medical
opinion that the injury was more likely than not vaccine-caused. Here, the weight of the evidence
does not support Petitioner’s causation theory, and there is insufficient evidence in the record that
could be cited to show her theory working out as expected in real time, leaving me no choice but
to hereby DISMISS this claim.
In the absence of a timely-filed motion for review (see Appendix B to the Rules of the
Court), the Clerk shall enter judgment in accord with this decision.27
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Special Master
27 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their
right to seek review.
33

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_13-vv-00439-1
Date issued/filed: 2018-01-05
Pages: 18
Docket text: JUDGE VACCINE REPORTED OPINION re: 77 Order on Motion for Review. Signed by Senior Judge Edward J. Damich. (lp1) Service on parties made.
--------------------------------------------------------------------------------
Case 1:13-vv-00439-EJD Document 80 Filed 01/05/18 Page 1 of 18
In the United States Court of Federal Claims
No. 13-439V
(Filed Under Seal: December 14, 2017)1
Released for Publication: January 5, 2018
************************************
*
CAROLYNNE OLSON, *
* Vaccine Act, 42 U.S.C. §§ 300aa-1 et seq.;
Petitioner, * Review of Special Master’s Decision;
* Off-Table Injury; Rheumatoid Arthritis
v. * (“RA”) ; Human Papillomavirus
* (“HPV”); Gardasil Vaccine.
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
*************************************
Mitchel J. Olson, Law Office of Mitchel J. Olson, JD, MD, Carlsbad, CA, for Petitioner.
Jennifer L. Reynaud, United States Department of Justice, Washington, DC, for Respondent.
OPINION AND ORDER
DAMICH, Senior Judge:
On July 1, 2013, Petitioner filed a petition for compensation under the National
Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (2012) (“Vaccine Act”),
claiming that the HPV Gardasil vaccine she received on July 1, 2010 caused her to develop
rheumatoid arthritis (“RA”). On September 15, 2014, Respondent filed its Rule 4(c) Report
asserting that Petitioner was not entitled to compensation because she could not carry the burden
of proof under Althen v. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). After the Rule
4(c) Report was filed, the experts for each party submitted their reports. An entitlement hearing
was held on March 27-28, 2017, and the parties agreed that no post-hearing briefing was needed.
On July 14, 2017, Special Master Brian H. Corcoran denied compensation on the grounds that
Petitioner did not establish by preponderant evidence that the vaccine caused her RA. Olson v.
1 Vaccine Rule 18(b), contained in Appendix B of the Rules of the United States Court of
Federal Claims, affords each party fourteen days in which to object to the disclosure of (1) trade
secrets or commercial or financial information that is privileged or confidential of (2) medical
information that would constitute “a clearly unwarranted invasion of privacy.”
1

Case 1:13-vv-00439-EJD Document 80 Filed 01/05/18 Page 2 of 18
Sec'y of HHS, No. 13-439V, 2017 U.S. Claims LEXIS 1032, at 1 (Fed. Cl. Spec. Mstr. July 14,
2017) (hereinafter “Olson”). There was no motion for reconsideration, and this petition for
review of the Special Master’s decision followed on August 14, 2017.
In her motion for review, Petitioner requests this Court to enter judgment in her favor. In
support, Petitioner argues that the Special Master’s decision was arbitrary, capricious, contrary
or otherwise not in accordance with law in that he: (1) misconstrued her theory, (2) raised her
burden of proof, (3) erred in his conclusions, and (4) improperly weighed the evidence.
For the reasons set forth below, the Court holds that the Petitioner’s arguments are
without merit and that the Special Master’s decision was not arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law. Petitioner’s motion for review is, therefore,
DENIED.
I. BACKGROUND
A. Medical History2
On July 1, 2010, Petitioner received an HPV Gardasil vaccine from her gynecologist,
Angelica Zaid, M.D. At the time of the vaccination Petitioner was 52 years old, and was not
within the medically targeted age group to receive the vaccine. Despite this, Petitioner asked to
receive the vaccine in order to treat warts after learning from her daughter’s dermatologist that it
could be effective.
At the time of the vaccination, Petitioner’s medical history was significant. She was
being treated for hypothyroidism,3 vitamin D deficiency, osteochondroma,4 an Achilles tendon
rupture, anemia, lifelong asthma, sinus pressure, facial pain, lung congestion, and chronic
sinusitis.
Petitioner claims that within two weeks after the receipt of the vaccine she began to feel a
burning sensation in both hands. However, the first medical record of these symptoms was made
by Dr. Zaid on December 13, 2010, more than five months after the vaccination. During this
visit, Petitioner reported to Dr. Zaid that she had developed “knuckle enlargement w[ith] pain”
that was persistent after receiving the vaccine. Olson, at 4. For further treatment, Dr. Zaid
referred Petitioner to rheumatologist Alexander Shikhman, M.D.
Petitioner saw Dr. Shikhman for the first time on February 22, 2011, and he noted that
2 The court derives Petitioner’s medical history from the Special Master’s decision.
3 Hypothyroidism is defined as a “deficiency of thyroid activity.” Dorland's Medical
Dictionary for Health Consumers, The Free Dictionary, https://medical-
dictionary.thefreedictionary.com/hypothyroidism, (last visited Dec. 7, 2017).
4 Osteochondroma is defined as “a benign bone tumor consisting of projecting adult bone
capped by cartilage projecting from the lateral contours of endochondral bones.” Dorland's
Medical Dictionary for Health Consumers, The Free Dictionary, https://medical-
dictionary.thefreedictionary.com/osteochondroma, (last visited Dec. 7, 2017).
2

Case 1:13-vv-00439-EJD Document 80 Filed 01/05/18 Page 3 of 18
Petitioner’s “clinical presentation [wa]s highly suspicious for reactive arthritis.”5 Olson, at 5
(emphasis added). Dr. Shikhman then ordered extensive laboratory testing. The results showed
a mildly elevated sedimentation rate, as well as a positive Mycoplasma IgG antibody level –
indicative of a prior resolved infection consistent with reactive arthritis. Petitioner’s test results
for rheumatoid factor and anti-citrullinated peptide antibodies (“ACPA”) were negative.
Rheumatoid factor and ACPA are two antibody markers that are strongly associated with RA.
Olson, at 6.
Petitioner continued to see Dr. Shikhman until late in 2013. During this period, she
continued to experience arthritis-like symptoms, although on occasion she felt better and had
only minor joint pain. Experiencing worsening symptoms, Petitioner began treatment with
Gregory Middleton, M.D., a rheumatologist, on September 10, 2013. Dr. Middleton diagnosed
the Petitioner with “seronegative rheumatoid arthritis.” Olson, at 11. “Seronegative” RA is a
diagnosis of RA despite the absence in the blood of the two antibody markers (mentioned above)
that are strongly associated with RA. Dr. Middleton also attributed the RA to her “immune
system over-reaction from her 2010 HPV vaccine.” Id. To date, Dr. Middleton continues to
treat Petitioner for “mild but deforming seronegative inflammatory arthritis compatible with
rheumatoid arthritis.” Olson, at 12.
B. Petitioner’s Theory
According to Petitioner’s Motion for Review, her medical theory has the following
components:
(1) While people with RA may have pre-existing risk factors or genetic predispositions to
develop the condition, an additional environmental “trigger” or “second hit” is necessary to
precipitate the autoimmune condition.
(2) Vaccines can be an environmental trigger for RA.
(3) Inflammatory lung conditions (as Petitioner had) create a significant risk of RA.
(4) Alum (an adjuvant in the HPV vaccine)6 can act as an environmental trigger by
activating inflammatory pathways in the lungs of people with inflammatory lung conditions.
Petr.’s Mot. at 4.
5 “Reactive arthritis” is not rheumatoid arthritis. Reactive arthritis is “joint pain and
swelling triggered by an infection in another part of the body. MayoClinic.org, “Reactive
Arthritis,” https://www.mayoclinic.org/diseases-conditions/reactive-arthritis/symptoms-
causes/syc-20354838, (last visited Dec. 7, 2017).
6 An “adjuvant” is “a substance that aids another, such as an auxiliary remedy.”
Dorland’s Medical Dictionary for Health Consumers, The Free Dictionary, https://medical-
dictionary.thefreedictionary.com/adjuvant, (last visited Dec. 7, 2017). In this case, the adjuvant
boosts the immune system to make more antibodies with the result that the vaccine is more
effective and long-lasting.
3

Case 1:13-vv-00439-EJD Document 80 Filed 01/05/18 Page 4 of 18
Petitioner called two expert witnesses, Dr. Gregory Middleton, a clinical rheumatologist,
and Dr. Lawrence Mayer, a professor of epidemiology. Dr. Middleton prepared three expert
reports and testified at the hearing; Dr. Mayer prepared one expert report and also testified at the
hearing. Petitioner also submitted supportive medical literature.
According to the Special Master’s summation of the expert reports and testimony, Dr.
Middleton elaborated on Petitioner’s medical theory attempting to link RA to the HPV vaccine.
Essentially, Dr. Middleton’s theory was that alum triggered certain protein complexes, called
inflammasomes7, which are
“key to igniting the autoimmune process relevant to RA’s pathogenesis. . . . Once
such inflammasomes were activated by alum contained in a vaccine, an
inflammatory process . . . central to RA began, because the inflammasomes
themselves mediated the release of other proinflammatory cytokines8 that fueled
the process. Middleton Rep. at 12-13. [Dr. Middleton] thus posited that because
alum has been demonstrated to stimulate these kinds of inflammasomes known to
be factors in RA, there is a causal relationship between the vaccine and the
pathogenesis of RA.” Id. at 12.
Furthermore, Dr. Middleton linked the inflammasomes that contributed to RA as the same as
those found in patents with inflammatory lung conditions. Id. at 13-14. According to the
Special Master, “many articles Petitioner offered discuss or address the ACPAs9 that are the
result of citrullination,10 a process widely understood to be an explanation for RA in numerous
cases (and which allows a link to be drawn between chronic lung infections akin to what Mrs.
Olson experienced and her RA).” Olson, at 63.
C. The Special Master’s Decision
According to Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir. 2005), to establish a legal
cause in a Non-Table Injury case, Petitioner must establish each of the three Althen prongs by
7 An inflammasome is “[a] multiprotein cytoplasmic complex which activates one or
more caspases (proteins), leading to the processing and secretion of pro-inflammatory cytokines.
Sergen’s Medical Dictionary, The Free Dictionary, https://medical-
dictionary.thefreedictionary.com/inflammasome, (last visited Dec. 7, 2017).
8 A proinflammatory cytokine is “any of the circulating substances in the blood that
deplete lean body mass in critical illness.” Medical Dictionary, The Free Dictionary,
https://medical-dictionary.thefreedictionary.com/proinflammatory+cytokines, (last visited Dec.
7, 2017).
9 Anti-citrullinated protein antibodies (“ACPAs”) are biomarkers strongly associated with
RA. Olson, at 12.
10 Citrullination is “the conversion of the amino acid arginine into citrulline (not one of
‘the standard 20 amino acids encoded by DNA in the genetic code’)”. Olson, at 15 citing N.
Sofat et al., Interaction Between Extracellular Matrix Molecules and Microbial Pathogens:
Evidence for the Missing Link in Autoimmunity with Rheumatoid Arthritis as a Disease Model, 5
Frontiers in Microbiology 1-6 (2015) (“Sofat Article”).
4

Case 1:13-vv-00439-EJD Document 80 Filed 01/05/18 Page 5 of 18
preponderant evidence: (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 proximate temporal relationship between vaccination and injury. Althen, 418
F.3d at 1278. This is a non-table injury.11
The Special Master concluded: (1) that petitioner failed to present reliable, persuasive
evidence of a medical theory causally connecting the HPV vaccination and RA under the facts
and circumstances of this case (prong 1), (2) that petitioner failed to show a logical sequence of
cause and effect between the HPV vaccine and petitioner’s RA (prong 2), and (3) that petitioner
failed to show that the timing between vaccination and the onset of petitioner’s RA was
medically appropriate for the HPV vaccine to be causative (prong 3).
Regarding prong 1, the Special Master noted that it is reliably established that “adjuvants
like alum help stimulate the innate immune system, thereby increasing the efficacy of vaccines.”
Olson, at 59. But the Special Master concluded that it is speculative whether this innate immune
system stimulation “instigated by a single vaccine containing alum would be robust enough, and
occur for long enough, to be pathogenic generally, let alone to cause RA.” Olson, at 60. The
Special Master noted that, although alum is used as an adjuvant in many vaccines, Petitioner
offered no literature that concluded that alum was pathogenic: “If alum can cause RA, there
should be more robust evidence that it is associated with other autoimmune conditions in
different vaccines.” Olson, at 62.
Regarding prong 2, the Special Master found that “her medical history does not provide
the corroboration necessary to conclude that Petitioner’s theory worked out as predicted.”
Olson, at 67.
Regarding prong 3, the Special Master concluded that, although Petitioner’s RA-like
symptoms occurred within one to two weeks of the vaccine, she failed to show that the timing of
the onset of symptoms was “medically appropriate” under the proposed causation theory.
Furthermore, the Special Master added that, since he had rejected Petitioner’s theory in the
context of the prong 1 analysis, “it does not matter that onset of the first obvious symptoms of
Mrs. Olson’s RA was temporally consistent with a theory that itself is not scientifically or
medically reliable.” Olson, at 70 (emphasis in original).
The Special Master came to these conclusions after reviewing the testimony of Petitioner
and of the Petitioner’s experts and their reports and after reviewing supportive medical literature,
including some medical literature that was not filed by Petitioner. Of course, the Special Master
also reviewed the testimony and reports of Respondent’s expert, Dr. Robert Lightfoot, a
rheumatologist.
11 A Table Injury is “an injury falling within the Vaccine Injury Table - corresponding to
one of the vaccinations in question within a statutorily prescribed period of time . . .” Olson, at
44.
5

Case 1:13-vv-00439-EJD Document 80 Filed 01/05/18 Page 6 of 18
II. STANDARD OF REVIEW
Under the Vaccine Act, the Court may set aside a Special Master’s findings of fact or
conclusions of law only if they are found to be “arbitrary, capricious, an abuse of discretion, or
otherwise not in accordance with law.” 42 U.S.C. § 300aa-12I(2)(B). With respect to findings
of fact, the Special Master has broad discretion to weigh expert evidence and make factual
determinations. See Bradley v. Sec’y of HHS, 991 F.2d 1570, 1575 (Fed. Cir. 1993). The
Federal Circuit has clearly indicated its longstanding standard of review when the Court of
Federal Claims hears petitions on review from the Special Masters:
Congress assigned to a group of specialists, the Special Masters within the Court
of Federal Claims, the unenviable job of sorting through these painful cases and,
based upon their accumulated expertise in the field, judging the merits of the
individual claims. The statute makes clear that, on review, the Court of Federal
Claims is not to second guess the Special Masters [sic] fact intensive conclusions;
the standard of review is uniquely deferential for what is essentially a judicial
process. Our cases make clear that, on our review . . . we remain equally deferential.
That level of deference is especially apt in a case in which the medical evidence of
causation is in dispute.
Hodges v. Sec’y of HHS, 9 F.3d 958, 961 (Fed. Cir. 1993) (internal citations omitted); see also
Snyder v. Sec’y of HHS, 2014 U.S. App. LEXIS 1674, at 10-11 (Jan. 28, 2014) (quoting
Hodges).
In Hines v. Sec’y of HHS, it was stated that “[i]f the special master has considered the
relevant evidence of the record, drawn plausible inferences and articulated a rational basis for the
decision, reversible error will be extremely difficult to demonstrate.” 940 F.2d 1518, 1528 (Fed.
Cir. 1991). This Court ought not to second-guess the Special Master’s fact-intensive
conclusions, particularly in cases “in which the medical evidence of causation is in dispute.”
Hodges, 9 F.3d at 961. In such cases, which often involve expert testimony, the Federal Circuit
has “unambiguously explained that special masters are expected to consider the credibility of
expert witnesses in evaluating petitions for compensation under the Vaccine Act.” Porter v.
Sec’y of HHS, 663 F.3d 1242, 1250 (Fed. Cir. 2011). “Such credibility determinations are
‘virtually unreviewable’” on appeal. Id. at 1251. With respect to questions of law, legal rulings
are reviewed de novo under the “not in accordance with law” standard. See, e.g., Moberly, 592
F.3d at 1321; Munn v. Sec’y of HHS, 970 F.2d 863, 870 n.10 (Fed. Cir. 1992).
III. DISCUSSION
When evaluating a motion for review, it is the Court’s task to determine whether the
Special Master properly considered the relevant evidence in the record, came to a factual
conclusion based on plausible inferences, and provided a reasoned explanation in his or her
decision. Hines, 940 F.2d at 1528. It is not the Court’s task to second-guess the Special Master,
especially in cases “in which the medical evidence of causation is in dispute.” Hodges, 9 F.3d at
961. Thus, on review, the Court accords deference to the Special Master’s factual findings and
fact-based conclusions.
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Petitioner raises 31 objections with respect to prongs one and two of the three prong
Althen test. Petitioner did not raise any objections to the Special Master’s decision with respect
to prong three. In her motion for review, Petitioner argues that the Special Master (1)
misconstrued her theory, (2) raised her burden of proof, (3) erred in his conclusions, and (4)
improperly weighed the evidence. As discussed in depth below, these arguments are without
merit.12
A. Althen Prong 1 and Petitioner’s Objections
Under the first prong of the Althen test, the Petitioner must establish by a preponderance
of the evidence “a medical theory causally connecting the vaccination and the injury.” Althen,
418 F.3d at 1278. This means that Petitioner must demonstrate that the vaccine can cause the
injury that she has alleged by providing a “reputable medical theory.” Pafford v. Sec'y of HHS,
451 F.3d 1352, 1355-56 (Fed. Cir. 2006) (citations omitted). Thus, it is not enough to establish a
mere possibility that the vaccine caused the injury.
Petitioner alleges 18 total objections to the Special Master’s decision with respect to
prong 1. These objections can be grouped into three categories: whether the Special Master
misapprehended Petitioner’s theory (Objections 1, 3, 9, 16, and 17), increased Petitioner’s
burden of proof by requiring particular evidence (Objections 2, 6, 8, 10, 11, 12, 14, and 15), and
erred in making his conclusions (Objections 4, 5, 7, 13, and 18).
Respondent argues that the Special Master properly weighed the evidence and declined to
recognize Petitioner’s theory as persuasive thus failing to meet her burden. Resp. at 8.
Respondent maintains that Petitioner only suggested a theory of causation, whereas Althen and
Moberly held that a petitioner must provide a persuasive medical explanation that is specific to
the case and supported by reliable evidence. Moberly, 592 F.3d at 1322. According to
Respondent, Petitioner did not meet this burden.
1. The Special Master Did Not Misapprehend Petitioner’s Theory.
Petitioner claims that the Special Master “misapprehended petitioner’s medical theory”
on five separate occasions with regard to Althen prong 1. Under Federal Circuit precedent, if a
Special Master misapprehends a petitioner’s theory, the Special Master’s decision must be set
aside. Paluck v. Sec’y of HHS, 786 F.3d 1373, 1380 (Fed. Cir. 2015). The Court holds that the
Special Master did not misapprehend the Petitioner’s theory.
a. Objection 1
According to the Motion for Review, “Petitioner introduced evidence that alum triggers
‘inflammasomes,’ which are immune cellular complexes that recognize ‘danger signals,’
12 The Court observes that after examining each of the 31 objections in detail, it is left
with the general impression that Petitioner has cherry-picked sentences from the Special
Master’s opinion without close regard to their context.
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including alum. Inflammasomes, in turn, activate particular cytokines that are centrally involved
in asthma, bronchiectasis, and RA.” Petr.’s Mot. at 5. Petitioner alleges that the Special Master
“required evidence that cytokine upregulation [was] itself [a] trigger for RA.” Obj. 1. In other
words, the activation of particular cytokines was a trigger for RA. Petitioner notes that, in his
opinion, the Special Master stated that:
Petitioner has failed to demonstrate that cytokine upregulation allegedly resulting
from vaccine administration is itself a trigger for RA. . .
Olson, at 60. Petitioner claims that it is not an element of her theory that cytokine
upregulation is itself a trigger for RA but rather that something in the chemical environment can
trigger inflammasomes. Petitioner’s theory is a “chain reaction,” that is, the alum in the HPV
vaccine triggered inflammasomes which, in turn, activated particular cytokines centrally
involved in RA.
The Court is puzzled that in her Motion for Review, the Petitioner, on the one hand,
states that she did not argue that cytokine activation is a trigger for RA, when, on the other hand,
(on the same page) she states that “[I]nflammasomes, in turn, activate particular cytokines that
are centrally involved in asthma, bronchiectasis, and RA.” Petr.’s Mot. at 5. It seems that the
disagreement is between the Special Master’s use of the word, “trigger,” and her use of the word,
“centrally involved.”
In any event, there is a connection alleged by Petitioner’s theory between RA and
cytokine activation. In order for Petitioner’s medical theory to be “reputable,” it would seem
that the connection between cytokine activation (mediated by inflammasomes) and RA must be
plausibly one of cause and effect. The Special Master used the word “trigger” to represent this
connection. It is not enough, it would seem, for the Petitioner to propose that cytokine activation
is only “centrally involved.” In other words, the Special Master understood the Petitioner’s
chain reaction theory but felt that the link between cytokine activation and RA was not
sufficiently established to causally connect cytokine activation and RA.
Putting aside this cavil, on page 58 of the Special Master’s opinion, the Special Master
summarized Petitioner’s theory clearly:
Petitioner asserts that vaccines can function as the trigger that sets off the
autoimmune process resulting in RA — particularly due to the inclusion of alum
as an adjuvant.
Olson, at 58. He understood that she alleges that alum was the trigger that started the “chain
reaction.” The Special Master noted that Petitioner’s theory
established a general point — that many different environmental factors could
initiate the process that would cause a susceptible individual to develop RA, and
that it is not unreasonable to consider a vaccine . . . as one of those factors. But it
remains a speculative issue as to whether cytokine production instigated by a
single vaccine containing alum would be robust enough, and occur for long
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enough, to be pathogenic generally, let alone to cause RA.
Olson, at 60 (emphasis added).
b. Objection 3
Petitioner also claims that the Special Master misconstrued her theory when he required
evidence “that alum directly precipitates RA.” Obj. 3. Similar to Objection 1, Petitioner asserts
that she never claimed that alum precipitated RA. Instead, her theory was based on how the
alum in the HPV vaccine was the environmental trigger.
In reviewing his decision, the Court notes that the Special Master found that Petitioner
lacked “reliable scientific support,” that alum “could precipitate RA.” The Special Master did
not require evidence that alum directly precipitates RA; he found that it could precipitate RA.
The Special Master’s use of the word “could” left open the possibility that alum could have
caused the RA, but remained unconvinced, as he was unable to determine if her RA was caused
by any other environmental factor. As such, he understood Petitioner’s medical theory and did
not require proof that alum directly precipitates RA, but concluded that Petitioner had not
converted the possibility that alum precipitated RA into a reputable medical theory that explains
how it could.
c. Objection 9
Petitioner also argues that the Special Master misunderstood her theory when he found
that Petitioner “failed to prove that alum alone causes RA.” Obj. 9. Petitioner argues that she
never claimed “alum alone” causes RA but may only trigger RA in people with pre-existing lung
conditions.
The Special Master, again, understood Petitioner’s theory and held that the studies
submitted do “not explain why alum in a vaccine would likely initiate or increase,” the
development of RA and there was, “nothing specific enough regarding any of the possible
triggers . . . to define how the triggering process would theoretically work.” Olson, at 62
(emphasis in original). In other words, the Special Master did not conclude that Petitioner failed
to show that “alum alone” caused RA, but rather found that Petitioner’s theory did not establish
how alum caused her to develop RA.
d. Objection 16
Petitioner also maintains that the Special Master misunderstood her theory as “dependent
on citrullination.” Obj. 16. Citrullination is important in explaining the link between RA and
lung inflammation in general, and the link between Petitioner’s lung inflammation and RA is
part of her theory. (See p. 3 of this opinion.) It is discussed in the Sofat article, which was part
of the medical literature submitted by Petitioner. (See footnote 10 above.)
The Special Master considered that the link between lung inflammation and RA was
scientifically established, but he noted that the explanation in the submissions for this link
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depended on citrullination. Citrullination is the process by which the amino acid arginine (found
naturally in DNA) is converted into citrulline. Olson, at 15 citing Sofat article. As citrulline is
not one of the amino acids found in DNA, the autoantibodies of the immune system may attack
the citrulline, causing inflammation. Sofat Article at 1-2. This inflammation can occur in the
lung and is also characteristic of RA. Id. These autoantibodies are called anti-citrullinated
protein antibodies (ACPAs), and they are a scientifically accepted marker for RA. Olson, at 63.
According to the Sofat article, relied upon by Dr. Middleton, Petitioner’s expert, citrullination
may first occur in the lungs before it occurs in the joints. But an indicator of citrullination is the
existence of ACPAs, and Petitioner has never tested positive for ACPAs. Olson, at 63. (See p. 3
above.) Thus, the Special Master found that the evidence proposed by Petitioner was “ultimately
inapposite to the present context.” Olson, at 62.
Petitioner protests that “because the antibodies responsible for petitioner’s RA . . . is not
known, she is obviously unable to introduce evidence about how that autoantibody functions.”
Petr.’s Mot. at 15. But, unless Petitioner can propose a theory that does not rely upon
citrullination to establish a link between lung inflammation and RA, we are left to imagine how
lung inflammation is linked to RA. Furthermore, we are left to imagine how alum triggered the
chain reaction that produced Petitioner’s RA in the context of the link between lung
inflammation and RA.
In sum, it appears that Petitioner did introduce a theory linking lung inflammation with
RA that was dependent on citrullination. But this theory could not be linked to Petitioner’s RA
because she did not test positive for ACPAs, which are an effect of citrullination. Therefore, the
Petitioner was thrown back to asserting that there are other explanations to explain the link—
although Petitioner did not provide a plausible theory. It is not enough to satisfy Althen prong 1
to say that because the autoantibodies that may have caused Petitioner’s RA were unknown,
Petitioner is relieved from the obligation to provide a plausible scientific explanation for the
element of her theory that involves a link between lung inflammation and RA.
The Special Master understood Petitioner’s theory.
e. Objection 17
Petitioner also proffers that the Special Master misconstrued her theory by stating:
Certainly Petitioner offered nothing reliable or persuasive . . . that suggests that alum
plays any role in abetting the citrullination process.
Olson, at 64; Obj. 17.
In doing so, Petitioner claims that the citrullination process is not part of her theory, but
rather that the alum activates particular pathways that are responsible for lung inflammation and
these pathways have nothing to do with citrullination.
As noted above, citrullination was an explanation that an expert of Petitioner’s used to
explain the link between lung inflammation and RA, that link being an element of Petitioner’s
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theory. Insofar as citrullination provides this link, the Special Master noted that there was no
reliable or persuasive evidence that alum would abet the citrullination process. Thus, the Special
Master merely alludes to the fact that the Petitioner’s evidence did not prove that alum abets the
citrullination process. This statement is not equivalent to what Petitioner claims, that the
Petitioner’s theory rested upon the determination that alum abets the citrullination process. As
such, he did not misapprehend Petitioner’s theory.
2. The Special Master Did Not Increase Petitioner’s Burden of Proof.
Petitioner’s second group of objections is that the Special Master increased her burden of
proof by requiring proof of specific biologic mechanisms, experimental evidence, other medical
literature, required testimony of an immunologist, and cloaked the legal standard in a
“credibility” determination. Specifically, Petitioner claims that the Special Master required
evidence of a specific biologic mechanism for two components of her theory: linking alum to RA
and demonstrating how environmental factors trigger RA.
Respondent argues that the Special Master recognized that a biological mechanism is not
a required component of the Petitioner’s medical theory, but because Petitioner offered a specific
biological mechanism, the Special Master was then required to consider it. Resp. at 11.
Respondent also argues that the Special Master did not require an immunologist; he simply took
into consideration that Dr. Middleton was not an immunologist in finding Dr. Middleton’s theory
unpersuasive. Resp. at 11. Finally, Respondent reminds the Court that a Special Master is
allowed to make credibility determinations and that such determinations should ordinarily be
upheld on review, but its Response does not directly address Petitioner’s “cloaking” argument.
Resp. at 7.
a. Objections 2, 10, 11, 12, 14, and 15
As the Federal Circuit held in Moberly, the Special Master is endowed with the authority
to weigh the evidence of a biological mechanism presented to him, and “[a]lthough a Vaccine
Act claimant is not required to present proof of causation to the level of scientific certainty, the
special master is entitled to require some indicia of reliability to support the assertion of the
expert witness.” Moberly ex rel. Moberly v. Sec'y of HHS, 592 F.3d 1315, 1324 (Fed. Cir. 2010)
(citing Terran v. Sec'y of HHS, 195 F.3d 1302, 1316 (Fed. Cir. 1999)). Thus, the Special Master
is authorized to weigh the evidence of the Petitioner’s biologic mechanism.
The Special Master did not require proof of a specific biologic mechanism,
epidemiological evidence, or other medical literature. In fact, the Special Master specifically
noted that, “Program petitioners are not required to offer direct proof supporting their theory, or
even any specific type of evidence, but instead may rely on circumstantial evidence.” Olson, at
57. However, as Petitioner offered evidence of a specific biologic mechanism, the Special
Master was then required to consider it and evaluate its persuasiveness.
After reviewing this evidence, the Special Master concluded that it was not persuasive, or
in the case of the submitted medical literature, even applicable. For example, with regard to the
specific biologic mechanism, because Petitioner identified only that component (the alum
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adjuvant) of the HPV vaccine as potentially having caused RA, the Special Master concluded it
was “critically important that Petitioner marshal reliable scientific or medical evidence
suggesting that alum could precipitate RA.” Olson, at 61. Thus, in addressing this issue, the
Special Master was not requiring the Petitioner to show that alum was the sole trigger of the
theory, but rather was pointing out that Petitioner had not shown it to be a trigger by
preponderant evidence. The Special Master also discussed the kinds of evidence that, if present,
would have assisted Petitioner in proving her theory, but did not require Petitioner to produce
that evidence. See Olson, at 62 (“If alum can cause RA, there should be more robust evidence
that it is associated with other autoimmune conditions in different vaccines.”).
Moreover, after reviewing the medical literature, the Special Master noted that many of
the articles offered relied on very different factual circumstances from those in this case and,
therefore, gave them little weight. For instance, the Besnard article13 was an animal study that
explicitly excluded alum as part of the study. Ultimately, the Special Master found that these
differences weakened the relevance and applicability of the articles. Thus, the Special Master
properly considered the relevant evidence in the record, came to a factual conclusion based upon
plausible inferences, and provided a reasoned explanation in his decision.
b. Objections 6 and 814
Petitioner also alleges that the Special Master required her to provide the testimony of an
immunologist, implying that only immunologists have the expertise to testify about complex
immune processes. However, this argument is without merit. In his decision, the Special Master
wrote:
Dr. Middleton, though qualified to testify about RA generally and its possible
etiology, lacked the specialized immunologic grounding necessary to explain and
defend in a persuasive manner the theory articulated in this case, given that
theory's dependency on complex immune system processes.
Olson, at 64 (emphasis added). Thus, it is clear to the Court that the Special Master did not
require an immunologist, but rather articulated the reasons as to why Dr. Middleton was not
persuasive—he could neither articulate nor could he defend in a persuasive manner his theory
without more specialized knowledge of the immune system. Considering the complex factors
involved, the Special Master properly weighed and considered the relevant evidence and
provided a reasoned explanation in his decision.
13 A.-G. Besnard et al., NLRP3 Inflammasome is Required in Murine Asthma in the
Absence of Aluminum Adjuvant, 66 Allergy 1047-57 (2011) (“Besnard”); see Olson, at 28.
14 Objection 8 is entitled, “The decision cloaked an erroneous legal standard with a
‘credibility determination.’” Petr’s. Mot. at 10. But in the one-paragraph explanation of this
objection, Petitioner merely asserts: “In this proceeding, the erroneous legal standard was that
only immunologists have the expertise to testify about the complex immune processes involved
in RA.” Petr’s Mot. at 11. She does not explain how this erroneous standard was
“cloaked…with a credibility determination.”
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3. The Special Master Did Not Err In Making Factual Conclusions.
The remaining objections under Althen prong one is that the Special Master applied the
wrong evidentiary standard which led to findings contrary to the factual record. However, the
Special Master incorporated Petitioner’s evidence and weighed the persuasiveness of her
experts’ theory and testimony. The Special Master repeatedly noted that, while Petitioner’s
theory has merit, it simply was not persuasive in this case.
The Special Master noted that the Petitioner offered persuasive evidence that, “persistent
lung inflammation is often associated with RA,” and that it is likely citrullination precedes
ACPA production in the lungs. Olson, at 59.
However, the Special Master concluded that this was not enough to satisfy the burden
under Althen prong 1 showing a medically plausible theory linking the vaccine to RA. The
Special Master stated that even though some of the, “components of Petitioner's theory were
facially sound or reliable (and that Respondent's expert on the injury at issue conceded certain
points relevant to the science behind Petitioner's causation theory) [it] does not lead to the
conclusion that the theory as a whole is reliable or persuasive.” Olson, at 42 (emphasis in
original).
As discussed above, the Special Master understood Petitioner’s theory and was not
persuaded by the medical theory of causation. He thus concluded that she failed to prove this by
preponderant evidence. As the decision of the Special Master properly weighed and understood
the evidence, his decision was not arbitrary, capricious, contrary or otherwise not in accordance
with law and this Court will not second guess his fact intensive conclusions.
B. Althen Prong 2 Objections
With respect to prong two of the Althen test, Petitioner alleges 13 total objections to the
Special Master’s decision. These objections can be grouped into four categories: whether the
Special Master again misapprehended Petitioner’s theory (Objection 28), increased Petitioner’s
burden of proof (Objections 19, 21, 22, 23, 25, 31), erred in making different evidentiary and
legal conclusions (Objections 20, 27, 29, 30), and failed to give proper weight to Petitioner’s
expert testimony (Objections 24, 26).
Respondent highlights that in order to satisfy prong two of Althen, Petitioner must
establish by a preponderance of the evidence that “a logical sequence of cause and effect
showing that the vaccination was the reason for the injury,” and that this is usually supported by
Petitioner’s medical records. Althen, 418 F.3d at 1278. Then applying this standard to the facts
of the case the Respondent concludes that, “[m]ost devastating to petitioner’s case is that
repeated testing confirmed that she did not have the requisite antibodies that would be present if
the citrullination process described by Dr. Middleton had actually occurred in her body.” Resp.
at 13. In other words, because the Petitioner lacked the antibodies associated with this process
she failed to establish the “logical sequence of cause and effect.” Althen, 418 F.3d at 1278.
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1. The Special Master Did Not Misapprehend Petitioner’s Theory Under Althen
Prong 2.
Petitioner claims that the Special Master “misapprehended the theory of alum as a trigger
of RA.” Petr.’s Mot. at 22. Petitioner argues that “no part of petitioner’s medical theory posits
‘persistent pathogenic cytokine upregulation’ after alum administration. Rather . . . petitioner’s
medical theory is that alum can be an environmental “trigger” for RA in a person with a chronic
inflammatory lung condition.” Petr.’s Mot. at 23 (emphasis in original). In other words,
“Petitioner’s medical theory is that alum can be an environmental trigger for RA by heightening
the inflammation in a person with a pre-existing inflammatory lung condition[;] th[is] does not
require that there be a “persistent” elevation in inflammation “primarily in the first six months to
a year after vaccination.” Petr.’s Mot. at 23.
In support of this argument, the Petitioner relies on the following excerpt from the
Special Master’s decision:
Most significantly, the record does not reflect the existence of an ongoing
inflammatory process that would establish the persistent, pathogenic cytokine
upregulation that Petitioner's theory envisions after administration of an alum-
adjuvanted vaccine.
Olson, at 67. However, after reviewing the evidence provided, the Special Master found that:
[Petitioner’s] medical history does not provide the corroboration necessary to
conclude that Petitioner's theory worked out as predicted — and leaves open the
possibility that other factors were more likely to have precipitated her RA than the
vaccine.
Olson, at 67. Therefore, the Special Master was discussing how and why he was unable to
determine which “factor” caused Petitioner’s RA, namely, because Petitioner’s medical history
did not corroborate with her own theory of causation. The Special Master explained:
[Petitioner was] missing are other pieces of proof that, under Petitioner's
causation theory, should have been reflected in the medical records. In particular,
Petitioner has consistently tested negative for ACPAs — even though
citrullination, and its connection to persistent inflammatory conditions in the lung,
was repeatedly referenced in both Petitioner's literature and Dr. Middleton's
testimony as significant in establishing an individual's susceptibility to RA given
longstanding respiratory problems.
Olson, at 68. Thus, after reviewing the evidence, he did not misconstrue Petitioner’s theory, but
held it to be inconsistent with her causation theory. Therefore, as the Special Master understood
Petitioner’s theory and properly reviewed the relevant evidence, his conclusion was not arbitrary,
capricious, contrary or otherwise not in accordance with law.
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2. The Special Master Did Not Increase Petitioner’s Burden of Proof.
Petitioner’s second category of arguments under prong 2 of Althen maintains that the
Special Master impermissibly raised the burden of proof by requiring: (1) “her to negate
possibilities and alternatives that might have occurred,” (2) “evidence of causation relating to
other vaccines,” (3) “evidence of other autoimmune conditions,” (4) epidemiological evidence,
(5) “evidence of pathological markers,” and (6) “test results consistent with the medical theory.”
See Petr.’s Mot at Objs. 19, 21, 22, 23, 25, and 31.
Petitioner argues that the Special Master required her to negate any alternatives and this
raised her burden of proof. However, he wrote that Petitioner’s theory, “leaves open the
possibility that other factors were more likely to have precipitated,” the RA. Olson, at 67
(emphasis added). This statement does not require Petitioner to negate anything, but rather
highlighted weaknesses in the medical theory proffered by her. Thus, the Special Master did not
raise Petitioner’s burden.
With regard to Petitioner’s argument that the Special Master raised her burden of proof
by requiring her to provide “evidence of causation relating to other vaccines,” and “evidence of
other autoimmune conditions,” these arguments lack merit. In his decision, the Special Master
was not persuaded by her theory that alum in the vaccine caused her RA. As the Special Master
explained,
The fact that many vaccines also contain alum but have not been implicated in RA
or other autoimmune conditions as alleged herein also merits some weight. See,
e.g., Johnson v. Sec'y of HHS, No. 10-578V, 2016 U.S. Claims LEXIS 1284, *8-9
(Fed. Cl. Spec. Mstr. Aug. 18, 2016) (noting the unreliability of the theory that if
an adjuvant can cause an autoimmune disease, it could cause any autoimmune
disease). If alum can cause RA, there should be more robust evidence that it is
associated with other autoimmune conditions in different vaccines.
Olson, at 62 (emphasis added). This statement only indicates that if Petitioner’s theory that alum
in Gardasil caused RA could be proven, other evidence would exist indicating that alum in other
vaccines caused for instance RA, or other autoimmune conditions. As such, the Special Master
was not persuaded and this Court will not second guess his decision.
Further, Petitioner’s attempt to equate the lack of “more robust evidence,” to requiring
epidemiological evidence, along with the allegation that the Special Master required evidence of
pathological markers and “test results consistent with the medical theory,” is misleading. As
explained above, the “more robust evidence” was made regarding the persuasiveness of the
theory, and not the type of evidence provided. Therefore, the Special Master did not require
epidemiological evidence.
Also, as discussed above, the Special Master took into consideration all the evidence
provided and ultimately concluded that he could not find what the “most likely cause was, given
the total absence of any of the biomarkers/antibodies most associated with the disorder.” To the
Special Master, this was the most persuasive evidence. Olson, at 69. And because, “Petitioner
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has never tested positive for those autoantibodies . . . she cannot credibly propose a theory
involving a process that she cannot also establish occurred to her.” Olson, at 63.
The Special Master did not require any of the evidence described above to establish a
logical sequence of cause and effect, but properly considered the relevant evidence in the record,
came to a factual conclusion based on plausible inferences, and provided a reasoned explanation
in the decision.
3. The Special Master Did Not Err In Making Factual Conclusions.
The Petitioner alleges that the Special Master erred in making findings contrary to the
factual record. Particularly, Petitioner alleges that the Special Master erred when he: “based
findings on evidence not in the record,” found that she “did not have an active immune-mediated
disease course,” lacked “tests that supported her theory,” and failed to recognize that Petitioner
established a plausible medical theory. See Petr.’s Objs. 20, 27, 29, and 30. Upon review, these
allegations are without merit.
a. Objection 20
Petitioner claims that the Special Master based findings of fact on evidence not in the
record by taking into account the lack of evidence that alum causes RA. In support, Petitioner
points to this statement by the Special Master, “The fact that many vaccines also contain alum
but have not been implicated in RA or other autoimmune conditions as alleged herein also merits
some weight.” Olson, at 62.
However, this statement recognizes the weakness of Petitioner’s overall theory, that alum
has not been shown to trigger RA in any vaccine, and does not support the conclusion that he
considered evidence not in the record.
b. Objection 27
Petitioner also argues that, in general, the Special Master erred when he failed to find that
Petitioner established a logical sequence of cause and effect between the receipt of the vaccine
and injury. Petitioner maintains that her biologically plausible theory, “combined with a close
temporal proximity of vaccine administration and the onset of RA, is a valid basis for a medical
opinion that there is a logical sequence of cause and effect between vaccine and injury.” Petr’s
Mot. at 22.
However, as discussed supra, the Special Master did not find her medical theory to be
plausible, thus failing the first element. Moreover, Petitioner’s evidence on this prong rests
solely upon the temporal relationship; this is not enough to establish a link. See Grant v. Sec'y of
HHS, 956 F.2d 1144, 1147-48 (Fed. Cir. 1992) (“the petition must affirmatively demonstrate that
the injury or aggravation was caused by the vaccine. Simple similarity to conditions or time
periods listed in the Table is not sufficient evidence of causation.”).
According to the Special Master, Petitioner failed to show by preponderant evidence that
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affirmatively demonstrated that the injury was caused by the vaccine, the Special Master
concluded that she failed to meet her burden under Althen. This conclusion is not arbitrary,
capricious, contrary or otherwise not in accordance with law.
c. Objections 29 and 30
Petitioner maintains that the Special Master’s finding that Petitioner “didn’t have tests
that supported her theory was a factual inference wholly unsupported by the record,” and was
arbitrary.15 Petr.’s Mot. at 24. Petitioner derives this argument from the following statement by
the Special Master:
Petitioner has also pointed to no testing results or other laboratory proof
(primarily in the first six months to a year after vaccination) that would establish
that her causation theory was occurring as expected, such as results evidencing
the presence of ongoing inflammation.
Olson, at 67 (bold in original). However, this is not an arbitrary finding by the Special Master.
The Special Master found that:
The record does not reflect the existence of an ongoing inflammatory process that
would establish the persistent, pathogenic cytokine upregulation that Petitioner's
theory envisions after administration of an alum-adjuvanted vaccine. Overall, as
Dr. Lightfoot observed in his report, Mrs. Olson's case of RA was on the mild end
of the spectrum — reflected in its lengthy course, her ability to tolerate the
associated pain while conducting her life, and the lack of evidence demonstrating
a more progressively severe trajectory.
Olson, at 67 (emphasis added).
Thus, as the Special Master makes clear, Petitioner failed to meet her burden based upon
the record as it was in front of him. As such, the Special Master was not arbitrary, capricious,
contrary or otherwise not in accordance with law.
4. The Special Master Properly Weighed the Evidence
The remaining objections relate to the Special Master’s weight to particular testimony.
The first objection relates to the Special Master’s alleged failure to accord weight to Petitioner’s
epidemiologist expert, Dr. Mayer. The second relates to the Special Master’s alleged failure to
not consider the opinion of the treating physician, Dr. Middleton.
As discussed, the Special Master took into consideration the testimony of Petitioner’s
15 Petitioner also argues that the Special Master’s finding that she both had RA and
“failed to demonstrate the existence of an active immune-mediated disease course,” are
inconsistent and an abuse of discretion. Olson, at 68. However, the Special Master did not
accord this “absence of testing” any “excess weight.” Olson, at 68 n.25.
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epidemiologist expert, Dr. Mayer; he was just not persuaded by him.
As to the testimony of the physician, Dr. Middleton, “a treating physician’s opinion on
vaccine causation is only as strong as the underlying basis for the opinion.” See Perreira v.
Sec’y of HHS, 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994). As discussed at length above, the
Special Master was not persuaded by Dr. Middleton’s “underlying basis” for his theory of
causation. As such, the Special Master properly weighed Dr. Middleton’s testimony.
IV. CONCLUSION
For the reasons stated above, the Court DENIES Petitioner’s motion for review and
SUSTAINS the decision of the Special Master. The clerk is directed to enter the judgment
accordingly.
IT IS SO ORDERED.
s/ Edward J Damich___
EDWARD J. DAMICH
Senior Judge
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