Godfrey v. Secretary of Health and Human Services

IN THE UNITED STATES COURT OF FEDERAL CLAIMS
OFFICE OF SPECIAL MASTERS
No. 10-565V
Filed: October 27, 2015
For Publication
****************************
MEGAN L. GODFREY, * HPV Vaccine; Gardasil; Juvenile
* Ankylosing Spondylitis; JAS;
Petitioner, * Causation-in-Fact; Expert;
v. * Qualifications; Remand in light of
* intervening Federal Circuit Decision;
SECRETARY OF HEALTH * Effect of Prior Fact-finding in
AND HUMAN SERVICES, * Transferred Case
*
Respondent. *
****************************
Milton Clay Ragsdale, IV, Ragsdale LLC, Birmingham, AL, for petitioner.
Jennifer Reynaud, U.S. Department of Justice, Washington, DC, for respondent.
DECISION ON REMAND DENYING ENTITLEMENT1
Corcoran, Special Master:
Ms. Megan Godfrey filed a petition for compensation under the National Vaccine
Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq.2 [the “Vaccine Act” or
“Program”], on August 20, 2010, alleging, among other things, that the human
papillomavirus [“HPV”] vaccine she received on August 22, 2007 was the cause of her
subsequent development of juvenile ankylosing spondylitis [“JAS”]. After hearing
testimony and considering the record as a whole, however, former Chief Special Master
Vowell3 issued a decision denying entitlement on June 11, 2014 (ECF No. 72). Godfrey
1 Because this decision contains a reasoned explanation for my action in this case, it will be posted on the
United States Court of Federal Claims’ website, in accordance with the E-Government Act of 2002, Pub. L.
No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002) (current version at 44 U.S.C. § 3501 (2014)). As
provided by Vaccine Rule 18(b), each party has 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 to the public.
2National 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, for ease of citation, all references to Vaccine Act
sections will be to the pertinent subparagraph of 42 U.S.C. § 300aa (but will omit that statutory prefix).
3
Chief Special Master Vowell retired in September 2015.
v. Sec’y of Health & Human Servs., No. 10-565V, 2014 WL 3058353 (Fed. Cl. Spec. Mstr.
June 11, 2014) [hereinafter, “Entitlement Decision”].
Ms. Godfrey subsequently filed a motion for review, which was granted in part by
Judge Firestone of the U.S. Court of Federal Claims on July 29, 2015 (Godfrey v. Sec’y
of Health & Human Servs., 2015 WL 4972882 (Fed. Cl. Aug. 19, 2015) [hereinafter, the
“Remand Decision”]4), in order to permit reconsideration in light of the Federal Circuit’s
intervening decision in Koehn v. Sec’y of Health & Human Servs., 773 F.3d 1239 (Fed.
Cir. 2014) – and, in particular, whether its discussion of a causation theory that has some
arguable application to the present action warrants a different outcome than the
Entitlement Decision. The matter has now been transferred to me. For the reasons set
forth in more detail below, I find that Koehn does not compel a different result from that
reached in the existing Entitlement Decision, and therefore Ms. Godfrey remains
unentitled to compensation.
I. Relevant Factual and Procedural History.
A. Summary of Medical History
Ms. Godfrey’s medical history is recounted in some detail in the Decision, which I
incorporate by reference here. See Entitlement Decision at *4-*6. The essential facts are
these. Ms. Godfrey was born in August of 1989 into a family with a notable medical history
of Crohn’s disease and rheumatoid arthritis. Id. at *4; see also Pet. Exs. 7, p. 182; 8, p.
9. Save for routine childhood illnesses, however, she was generally healthy. Entitlement
Decision at *4. During high school, she was a student athlete and participated in her
school’s cheerleading team. Id.
On August 22, 2007, just after she turned 18, Ms. Godfrey received a single dose
of the HPV [“Gardasil”] vaccine from her pediatrician. Entitlement Decision at *4. Nearly
four months later, on December 19, 2007, she returned to her doctor complaining of
sharp, intermittent pain in her left hip that had been ongoing for the previous three months.
Id. at *5. An x-ray of her hip indicated no problems and she did not report any recent
injury. Pet. Ex. 3 at 1. The next week, however, an MRI revealed “[b]ilateral femoral
benign fibrous dysplasia, greater on the left side than the right, and left-sided sacroiliitis,
which the radiologist thought might have been inflammatory.” Entitlement Decision at *5;
Pet. Ex. 8 at 86.
Over the next several weeks, Ms. Godfrey underwent many tests, including a bone
scan indicating “increased activity at the left [sacroiliac] joint,” similar to what could be
seen “in osteomyelitis or in an inflammatory sacroiliitis.” Pet. Ex. 11, p. 11. In January of
4
Judge Firestone’s decision was initially issued under seal in July in an attempt to give the parties the
opportunity to request redaction. It was subsequently published in August (ECF No. 95) after Petitioner
failed to establish grounds for redaction.
2
2008, Ms. Godfrey tested positive for HLA-B27, a genetic marker that left her predisposed
to conditions such as JAS. Entitlement Decision at *5; Pet. Ex. 11, p. 7.
During a visit to a pediatric rheumatologist in April 2008, Ms. Godfrey was
diagnosed with HLA-B27 spondyloarthropathy. Pet. Ex. 7 at 180-84. Her physician, Dr.
Randy Cron, noted her familial history of Crohn’s disease and arthritis. Id. Several years
later, in August 2012, Petitioner visited another rheumatologist (Pet. Ex. 88 at 10-14),
who proposed that she had ankylosing spondylitis/axial spondyloarthropathy, and
therefore continued her course of Infliximab injections. Id. at 9. Initially prescribed the
injections by Dr. Cron in April of 2008, Petitioner has acknowledged that the “treatment
has been successful in terminating [her] symptoms” of JAS. Pet. Post-Hearing Brief (ECF
No. 69) at 2. Significantly, none of Ms. Godfrey’s treaters ever concluded that the single
Gardasil dose she had received was connected in any way with her subsequent JAS.
B. JAS and Associated Risk Factors
JAS is the pediatric form of ankylosing spondylitis [“AS”], and is in essence the
same disease. Entitlement Decision at *11. The “juvenile” modifier is applied to those who
exhibit the symptoms of AS before the age of 16. Although the experts who testified at
the hearing in this matter agreed that Ms. Godfrey was over 16 when she first began
displaying symptoms, they were satisfied with the JAS diagnosis.
There are several risk factors associated with JAS. Researchers have estimated
that “genetic risk factors contribute to 80-90% of the susceptibility to [AS].” Entitlement
Decision at *12; see also Dougados, Pet. Ex. 545 at 2128; see also Lin, Pet. Ex. 56, at
578. The primary genetic risk factor is possession of the HLA-B27 genetic marker, which
has been described as having a “direct and dominant effect.” Entitlement Decision at *12;
see also Dougados, Pet. Ex. 54, at 2129; see also Lin, Pet. Ex. 56, at 579. HLA-B27 is
present in 80-90 percent of patients with AS. Entitlement Decision at *12; see also
Dougados, Pet. Ex 54, at 2129. In patients with JAS, it is even more prevalent. Thus, in
a study of 47 patients with JAS, over 97 percent tested positive for HLA-B27. Lin, Pet. Ex.
56, at 577.6 A negative genetic test result, however, “does not preclude the presence of
spondyloarthritis.” Entitlement Decision at *12; see also Dougados, Pet. Ex. 54, at 2128.
Moreover, “only a small proportion of people in the general population who harbour HLA-
B27 (5-6% in white people) develop [AS], and HLA-B27 explains only 20-40% of the
genetic susceptibility to [AS]—suggesting the contribution of additional genes.”
Dougados, pet. Ex. 54, at 2129.
5
In referencing medical literature in this decision, I adhere to the former Chief Special Master’s practice
from the Entitlement Decision of specifying articles by the name of the primary author, cross-referenced
with the relevant exhibit number.
6 See also NELSON TEXTBOOK OF PEDIATRICS (19th ed. 2011) at Pt. XV, Ch. 150, Lab. Findings,
https://expertconsult.inkling.com/read/nelson-pediatrics-kliegman-behrman-19th/chapter-150/chapter150-
reader-4 (noting that “HLA-B27 is present in > 90% of children with JAS.”).
3
In addition to genetic factors, specific types of infection (gastrointestinal or
genitourinary infection), and physical trauma are JAS risk factors. Lin, Pet. Ex. 56, at 578;
Tr. at 195-97 (Dr. Zweiman). JAS is closely linked to gut inflammation, in association with
Crohn’s disease. Entitlement Decision at *12; see also Burgos-Vargas, Pet. Ex. 61, at
iii34. The incidence of non-specific inflammatory bowel disease in patients with JAS is
about 80 percent. Entitlement Decision at *12; see also Burgos-Vargas, Pet. Ex. 61, at iii
35. Intense physical training has also been observed in JAS patients before symptom
onset. Lin, Pet. Ex. 56, at 578.
C. Procedural History
1. Entitlement Hearing and Decision - As stated above, Ms. Godfrey
contended in this case that the HPV vaccination she received on August 22, 2007,
substantially contributed to her development of JAS. An entitlement hearing in the matter
was held on December 10, 2012, at which time Dr. Michael McCabe (Ph.D.), Dr. Carlos
Rosé (M.D.), and Dr. Burton Zweiman (M.D.) testified as expert witnesses.
At hearing, Dr. McCabe (Petitioner’s expert) opined that the single dose of Gardasil
vaccination Ms. Godfrey received triggered (and thus substantially contributed to) the
manifestation of her JAS, through the release of proinflammatory cytokines.7 Entitlement
Decision at *13; see also Tr. at 16; Pet. Ex. 52 at 7. According to Petitioner’s theory, the
increase of pro-inflammatory cytokines incited by the Gardasil vaccine “worked as an
environmental trigger causing the onset of JAS in a genetically predisposed individual.”
Pet. Brief at 6. In effect, Ms. Godfrey was “climbing a hill” toward JAS given her
susceptibility, but Gardasil pushed her to the top. Entitlement Decision at *14, citing Tr.
at 56. Dr. McCabe thus opined that the HPV vaccine was the “but for” factor triggering
her JAS.
In offering the above opinion, Dr. McCabe relied on several pieces of medical
literature discussing the effect of components of the HPV vaccine on cytokine levels in
the blood that have special relevance herein (given, as discussed below, the Federal
Circuit’s discussion in Koehn of some of these studies). See generally Pinto I, Ex. 73 and
Marks, Pet. Ex. 87. Both involved the in vitro testing of blood samples taken from
individuals who had been vaccinated with a version of the HPV vaccine containing virus-
like particles (“VLPs”).8 In the study discussed in Pinto I, cytokine levels were measurably
higher when the vaccinated blood samples were stimulated with additional HPV VLPs.
Pinto I, Pt. Ex. 73 at 3556-59. The study examined in the Marks article was actually
intended to evaluate the effects of hormones contained in combined oral contraceptives
on inflammatory response of women immunized with the HPV vaccine, but (as an incident
7
As defined in the Entitlement Decision, proinflammatory cytokines are “proteins released by one cell
population . . . on contact with a specific antigen” that can stimulate inflammation. Entitlement Decision at
*9 n.19.
8
As defined in the Entitlement Decision (and taken from the Pinto I article), VLPs are noninfectious viral
capsids that help activate the innate and adaptive immune system, increasing a vaccine’s potency.
4
to its purpose) observed the same increase in cytokines. Marks, Pet. Ex. 87 at 610.
Because the study evaluated in the Marks article involved the stimulation by HPV VLPs
of unvaccinated blood, Dr. McCabe directly invoked the Marks article as the best evidence
of which he was aware that a single dose of Gardasil would be sufficient to administer the
level of proinflammatory cytokine response to result in a spondyloarthropathy such as
JAS. Tr. at 52-53.
Respondent, by contrast, asserted there was no evidence to support a link
between Ms. Godfrey’s Gardasil vaccination and her subsequent JAS diagnosis. Dr. Rosé
opined that there were no studies linking JAS or similar conditions to Gardasil; that
Petitioner had a strong genetic predisposition toward the development of JAS as
evidenced by her HLA-B27 marker and a family history of Crohn’s disease (and that those
factors were far more likely to have caused the JAS given the known and studied
relationship between them and the disease); that Petitioner’s participation in cheerleading
could cause micro-trauma sufficient to trigger her JAS; and (most significantly for present
purposes) that Dr. McCabe’s reliance on cytokines in JAS’s etiology was incorrect, as
cytokines do not cause JAS, but at best play a role in its symptomology that can be treated
and alleviated, but without effect in treating the underlying disease. Entitlement Decision
at *16-*18. Dr. Zweiman similarly rejected Dr. McCabe’s causation theory, finding it
unsupported in medical literature and proposing that other factors more fully explained
the cause of her JAS. Id. at *18. He also expressed additional views on the role of cytokine
production in resulting in JAS, opining that Dr. McCabe’s theory would require a
prolonged increase in cytokine production to have the effect proposed by Dr. McCabe. Id.
But in fact, the relevant studies (such as the Pinto study) supported the conclusion that
Gardasil did not in fact produce sustained increases in cytokine levels of the kind
necessary for the reaction Dr. McCabe proposed. Id. at *20. Respondent’s experts for
their part did not contest the general concept that HPV VLPs would be effective in
stimulating the production of pro-inflammatory cytokines. See, e.g., Tr. at 212.
In her Entitlement Decision, the former Chief Special Master determined that
Petitioner had not met her burden on any of the prongs set forth by the Federal Circuit for
establishing causation in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278
(Fed. Cir. 2005) – but in particular with respect to the first, “can cause” prong. Entitlement
Decision at *21-*23. She found Petitioner’s theory to be unreliable because (among other
things) there was no evidence in the record suggesting that pro-inflammatory cytokines
actually play a role in the pathogenesis of JAS, although they are known to play a role in
symptomatology. Id. at *21-*22. Moreover, Ms. Godfrey had not demonstrated (by citation
to reliable medical studies or general literature) that a transient increase in cytokine levels
of the sort that would occur following the receipt of the HPV vaccination would be sufficient
to even cause the symptoms of JAS. Id. at *21. She also disputed Dr. McCabe’s
suggestion that Ms. Godfrey’s genetic susceptibility to developing JAS also made her
sensitive to increases in pro-inflammatory cytokines, noting that the position lacked
evidentiary support. Id. at *14 and *21. There was also a general lack of evidence that
Ms. Godfrey had even had an increase in cytokines after the first Gardasil dosage. Id. at
*15-*16 and *21.
5
By contrast, the former Chief Special Master found far more persuasive the
concept that other factors were more likely to cause JAS (and likely did so under the facts
of this case). Thus, her Entitlement Decision observes the uncontested fact that Ms.
Godfrey had a number of identified “substantial risk factors for developing JAS”: (a) her
HLA-B27 gene, (b) family history of Crohn’s disease, and (c) participation in an activity
known to cause micro-trauma in ankles and hips. The Chief Special Master found the
evidence presented in the testimony of Drs. Rosé and Zweiman to be more persuasive
than that offered by Dr. McCabe, concluding on that basis that “[g]enetics alone is a
sufficient ‘but for’ cause for Ms. Godfrey’s condition.” Id. at *23.
Following her discussion of Petitioner’s failure to satisfy the first Althen prong, the
Chief Special Master noted that the other two Althen prongs were similarly unsatisfied.
There was little in Petitioner’s medical history to suggest an actual link between her
Gardasil vaccination and her JAS, such as treater opinions or test results confirming that
Dr. McCabe’s theory had occurred as posited. And the Petitioner had not demonstrated
a medically acceptable temporal relationship between the onset of her symptoms and her
receipt of one dose of the Gardasil vaccine. Id. at *23.9
2. Motion for Review and Remand – After issuance of the Entitlement
Decision, Petitioner filed a timely motion for review in July 2014 (ECF No. 74). The matter
was assigned to Judge Firestone. In the course of briefing the motion, Petitioner moved
to stay the review petition given the pendency of the Koehn case, which Petitioner argued
could impact the outcome of this case, because of the similarity of causation theories
offered in both cases. The motion to stay was granted, and then (after the issuance of the
Koehn decision) the parties briefed their respective positions. Oral arguments were held
before Judge Firestone on July 14, 2015.
On July 29, 2015, Judge Firestone of the Court of Federal Claims issued an
Opinion partially remanding this case to the Office of Special Masters. In her Remand
Decision, Judge Firestone determined that the Federal Circuit’s decision in Koehn raised
issues that were best addressed by a special master in a reevaluation of the entitlement
decision in this case. Remand Decision at *6-*7. Specifically, she noted that the Federal
Circuit had suggested (albeit in dicta) in Koehn that Dr. McCabe’s theory of causation as
offered in that case (which, as discussed below, involved the autoinflammatory injury of
systemic juvenile idiopathic arthritis [“SJIA”], and also relied on the concept of the HPV
9 In so determining, the former Chief Special Master relied on the testimony of Dr. Rosé, who explained
that determining the actual onset of her JAS would be impossible given the facts. Entitlement Decision at
*23. The parties did not dispute that Ms. Godfrey’s first complained-of symptom was pain in her left hip
beginning about four weeks after her receipt of the HPV vaccine. Id. at *6. Yet imaging studies (performed
after Ms. Godfrey sought treatment in December of 2007) showed that JAS was present at that time in both
hips. Id. at *23. Dr. Rosé testified that an individual could have JAS and not experience symptoms, meaning
that the onset of Ms. Godfrey’s JAS could not be assumed to be the day she first experienced symptoms
(but could well have been much earlier). Id. This (along with Dr. McCabe’s failure to substantiate his
assertion that the timeframe for the immunological response to the HPV dose was consistent with the onset
of Ms. Godfrey’s first symptoms) was the basis for the former Chief Special Master’s Althen three
determination.
6
vaccine purportedly stimulating cytokine production) may have been legally probable, and
thus sufficient to meet the requirement of Althen’s first prong. Id. at *7. Therefore, in light
of Petitioner’s argument that Dr. McCabe’s causation theory was virtually identical to the
theory he also offered in this case and also highly apposite to Petitioner’s case, it was
advisable to have the former Chief Special Master reconsider on remand her decision to
take into account Koehn’s holding. Id. At the same time, however, Judge Firestone also
remarked that the two cases presented differences in terms of relevant disease, dosage,
and the onset of petitioners’ symptoms, the significance of which were to be addressed
on remand.
On remand, the former Chief Special Master ordered the parties to brief in
simultaneous submissions the issues raised in Judge Firestone’s Opinion. Both parties
filed their briefs on August 24, 2015. ECF Nos. 98 [“Pet. Brief”] and 97 [“Resp. Brief”]. Ms.
Godfrey argued that because her causation theory was identical to that offered in Koehn,
the Federal Circuit’s “findings regarding Koehn’s Althen theory” (i.e., that it was “legally
probable”) meant that she had satisfied her burden of proof. Pet. Brief at 2. Indeed,
Petitioner maintained that she had presented stronger evidence of a temporal relationship
between her single vaccination and JAS than the Koehn petitioner’s multiple vaccinations
and SJIA. Pet. Brief at 15. Petitioner also reargued points addressed in the original
Decision but not directly impacted by Koehn; thus, she denied that there were other
events that could have served as a trigger for the onset of her JAS, such as her high
school cheerleading, which ceased several months prior to the administration of the single
HPV vaccine dose, and maintained (in somewhat conclusory fashion) that other medical
literature offered at the hearing stood for propositions that the former Chief Special Master
contested she had established.10 Pet. Brief at 16-17.
Respondent’s brief argued that Petitioner’s reliance on Koehn was misplaced
because that opinion was neither relevant nor applicable to the issue of causation
presented herein. Resp. Brief at 1. In particular, Respondent noted that Petitioner had
“overstated the significance of the dicta contained in the Koehn decision.” Id. at 2, n.4. In
addition, Respondent argued that Dr. McCabe had not presented entirely identical
causation theories in both Koehn and Godfrey; his opinion in Koehn did not address “the
HLA-B27 gene or any known mechanical or biological stressors.” Id. at 5, n.5. Further,
the Koehn petitioner’s evidence was more compelling, as Dr. McCabe was able to offer
as support for his theory several articles discussing vaccines as a possible trigger for the
Koehn petitioner’s disease, but failed to offer any similar support in this case suggesting
10
Thus, Petitioner posits in several places in her post-remand brief that the Dougados article (Pet. Ex. 54
at 2132-33 “explains how this increase in cytokines results in pathogenesis of JAS.” Pet. Brief at 7; see also
id. at 13. This is explicitly contrary to the former Chief Special Master’s Entitlement Decision about the lack
of evidence connecting cytokines to JAS pathogenesis, however – and the Entitlement Decision accurately
observed that the Dougados article in fact supported Dr. Rosé’s theory, because it stands for the proposition
that treatment of proinflammatory cytokine inhibitors “alleviates symptoms, but does not affect the
progression of [JAS].” Entitlement Decision at *21. My own review of the Dougados article is consistent with
that of the former Chief Special Master, and I therefore find unpersuasive Petitioner’s conclusory assertions
that the article provides the very link in Dr. McCabe’s theory that the former Chief Special Master found
missing.
7
a connection between vaccines and any form of spondyloarthropathy. Id. at 6. By
contrast, Respondent asserted that her two witnesses in the instant case thoroughly
discredited Dr. McCabe’s theory of causation. Id. at 6-8. Thus, because the facts and
evidence were distinguishable from what was presented in Koehn, the case was not
relevant “for purposes of assessing the reliability of petitioner’s theory of causation.” Id.
at 8.
II. The Federal Circuit’s Decision in Koehn.
Because the purpose of the present remand is to evaluate whether the Federal
Circuit’s analysis in Koehn should alter the entitlement decision herein, discussion of the
facts of the Koehn case, as well as its holding, is warranted.
In Koehn, vaccine/petitioner Vanessia Koehn had been diagnosed with SJIA after
receiving two doses of the Gardasil vaccine. Koehn, 773 F.3d 1239 at 1241. A pediatric
rheumatologist later observed that the petitioner’s family history was notable for SJIA. Id.
Approximately two months after she received the second Gardasil injection, petitioner
developed a rash which was subsequently resolved after she was prescribed Benadryl
and prednisone.11 Id. One week later, she was hospitalized with a high fever and severe
joint pain. Id. While in the hospital, she saw a rheumatologist who prescribed her more
prednisone. When she was discharged a few days later, her presumptive diagnosis was
juvenile idiopathic arthritis. Id. Several days after her receipt of the third Gardasil dose,
petitioner developed a fever, rash, and joint pain. Id.
The Koehn petitioner thus proceeded upon the theory that her SJIA was caused
by receipt of the HPV vaccine. To establish that theory, she relied upon the expert opinion
of Dr. McCabe (the expert in the present case as well). Dr. McCabe testified therein that
the petitioner “had a predisposition for SJIA, and that Gardasil was an environmental
trigger because the vaccine caused a strong response in the same cytokines which are
dysregulated in SJIA.” Koehn, 773 F.3d at 1242. There are thus relevant factual parallels
between the theories advanced in Koehn and the present case.
One of the articles that Dr. McCabe cited in support of his theory had particular
significance to the Federal Circuit’s comments that prompted the present remand
because it was also offered in this case - Pinto I (Pet. Ex. 73). Koehn, 773 F.3d at 1242.12
This study was offered therein to support the concept that Gardasil could trigger SJIA
environmentally through the cytokine response, by providing evidence (at least from an
11
Prednisone is “a synthetic glucocorticoid derived from cortisone, administered orally as an anti-
inflammatory and immunosuppressant in a wide variety of disorders.” Dorland’s Illustrated Medical
Dictionary (32d ed. 2012) at 1509. It is sometimes prescribed for patients with SJIA. Koehn, 773 F.3d at
1241.
12
The Federal Circuit’s decision does not cite the Pinto I article explicitly, but it is cited in the special master’s
underlying decision, and it is the same article as Pinto I herein. See Koehn v. Sec’y of Health & Human
Servs., 2013 WL 3214877, at *4 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den’d, 113 Fed. Cl.
757, aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
8
in vitro study) that the HPV vaccine did in fact result in an increase in proinflammatory
ctyokines, consistent with “those dysregulated in SJIA.” Id.
Dr. Rosé, who was also retained as an expert by Respondent in the instant case,
similarly offered an opinion in Koehn for Respondent. He opined that the Koehn
petitioner’s SJIA was not caused by her Gardasil vaccinations, but more likely developed
by chance. Koehn at 1242. In so opining, he proposed that the study upon which Dr.
McCabe relied so heavily was unhelpful to petitioner’s case; the vaccinated blood
samples that were not stimulated by VLPs had consistent levels of cytokines, whereas
patients with SJIA generally have up-regulated cytokine levels, thus diminishing rather
than strengthening the relationship between the HPV vaccine and the claimed injury,
despite the study’s other findings. Id.
After conducting a hearing, the Koehn special master determined that the
petitioners had failed to offer a persuasive, reliable medical theory causally connecting
the vaccination and the injury, and thus had not satisfied the first Althen prong. In so
ruling, the special master found significant the fact that “the relevant scientific community,
pediatric rheumatologists, did not accept Dr. McCabe’s theory, primarily basing that
conclusion on Dr. Rosé’s testimony that he, as head of pediatric rheumatology at his
hospital, did not recall ever hearing of such a theory.” Koehn, 773 F.3d at 1243. But the
Koehn special master also found that the petitioners had not met their burden for the
second or third prongs of Althen, because they established neither a logical sequence of
cause and effect between the receipt of the vaccination and her subsequent SJIA
diagnosis, nor a proximate temporal relationship between the vaccination and her SJIA.
Id.
Petitioners sought review of the entitlement denial, and after the Court of Federal
Claims affirmed, C.K. v. Sec’y of Health & Human Servs., 113 Fed. Cl. 757 (2013), they
appealed to the Federal Circuit. The appeal was not successful, however. The Federal
Circuit determined that the special master’s decision presented “sufficient grounds to
deny Koehn’s petition because Koehn failed to meet her burden under the third Althen
prong.” Koehn, 773 F.3d at 1243.
Nevertheless, the Federal Circuit was critical of the special master’s application of
the first and second Althen prongs in Koehn - and it is this criticism, and the attendant
brief discussion of some of the proof and testimony offered in support of the first prong,
that lies at the heart of Koehn’s facial relevance to the present case. For the most part,
the Federal Circuit was not specific in identifying what errors had been committed in
analysis of the petitioners’ causation theory; the Koehn decision only takes issue with the
special master’s determination to give Dr. McCabe’s opinion less weight because Dr.
Rosé individually denied hearing others in the “relevant scientific community” mention or
embrace it, before moving on to the second Althen prong. Koehn, 773 F.3d at 1243-44.
But in a footnote, the Federal Circuit went on to suggest in dicta its supposition
that “[h]ad the Special Master properly evaluated the evidence, we believe [he] would
9
have likely found that Koehn met her burden under the first Althen prong.” Koehn, 773
F.3d at 1244 n.1. The sole provided basis for this suggestion was its analysis of the weight
that it proposed should have been given to the Pinto I study. The Federal Circuit took to
task the argument of Respondent’s expert (embraced by the special master) that the
study addressed in Pinto I was problematic in part because it relied on additional
stimulation of blood samples that already had been vaccinated; the only way to measure
cytokine levels was via an in vitro experiment, the Federal Circuit reasoned, and the only
way to simulate the effect of an antigen on such samples (in order to replicate what would
occur in vivo) was to stimulate the samples in the manner performed by the study. To
require petitioners to have conducted a study that might more precisely measure the in
vivo effects of the vaccine was, in the Federal Circuit’s view, to impose a higher burden
of proof than that applicable to Vaccine Program claimants. Id.
In effect, then, the Federal Circuit suggested in this footnote that the Pinto I study
was far more probative evidence supporting causation with respect to HPV and SJIA than
the Koehn special master had allowed – but that even a finding that the Koehn petitioners
had satisfied the first Althen prong would still not have been sufficient for them to prevail.
III. Legal Standards
A. Legal Standards for Off-Table Claims
Ms. Godfrey alleges an off-Table injury in this case, and in any event there is no
specified Table injury for the HPV vaccine at this time. Under such circumstances,
eligibility for compensation is established by demonstrating (by a preponderance of the
evidence13) that she received, in the United States, a vaccine set forth on the Vaccine
Injury Table and sustained an illness, disability, injury, or condition caused by the vaccine
(or experienced a significant aggravation of a preexisting condition), and that the condition
has persisted for more than six months. Section 13(a)(1)(A).
Here, Ms. Godfrey’s causation showing was a central disputed issue. To establish
legal causation in an off-Table case, petitioners must establish by 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; see also de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347,
1351-52 (Fed. Cir. 2008); Caves v. Sec’y of Health & Human Servs., 100 Fed. Cl. 119,
132 (2011), aff’d per curiam, 463 Fed. Appx. 932, 2012 WL 858402 (Fed. Cir. 2012)
13
The applicable level of proof in Vaccine Act cases is the “traditional tort standard of ‘preponderant
evidence.’” Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010) (citing de
Bazan, 539 F.3d at 1351; Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006);
Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006); Althen, 418 F.3d at
1278)). The preponderance standard “requires the trier of fact to believe that the existence of a fact is more
probable than its nonexistence.” In re Winship, 397 U.S. 358, 371 (1970) (Harlan, J., concurring) (internal
quotation and citation omitted).
10
(specifying that each Althen factor must be established by preponderant evidence);
Lalonde v. Sec’y of Health & Human Servs., 746 F.3d 1334, 1337-38 (Fed. Cir. 2014).
Failure to establish any one Althen prong constitutes a failure to establish
entitlement to compensation. A special master must evaluate a case in its entirety,
balancing all evidence offered. While scientific or medical fact evidence, whether set forth
in a record or proposed by an expert, can be persuasive, special masters are not bound
by any “diagnosis, conclusion, judgment, test result, report, or summary” contained in the
record. Section 13(b)(1).
It is important in Vaccine Act cases for special masters to take care not to elevate
the burden of proof imposed by law on a claimant. Petitioners are not required to establish
identification and proof of specific biological mechanisms, as “the purpose of the Vaccine
Act’s preponderance standard is to allow the finding of causation in a field bereft of
complete and direct proof of how vaccines affect the human body.” Althen, 418 F.3d at
1280. The petitioner similarly need not show that the vaccination was the sole cause, or
even the predominant cause, of the injury or condition; showing that the vaccination was
a “substantial factor” in causing the condition and was a “but for” cause are sufficient for
recovery. Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir.
1999); see also Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006) (petitioner must establish that a vaccination was a substantial factor and that
harm would not have occurred in the absence of vaccination). Petitioners also cannot be
required to offer into evidence “epidemiologic studies, rechallenge, the presence of
pathological markers or genetic disposition, or general acceptance in the scientific or
medical communities to establish a logical sequence of cause and effect.” Capizzano,
440 F.3d at 1325. Ultimately, causation is determined on a case by case basis, with “no
hard and fast per se scientific or medical rules.” Knudsen v. Sec’y of Health & Human
Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Close calls regarding causation must be
resolved in favor of the petitioner. Althen, 418 F.3d at 1280; but see Knudsen, 35 F.3d at
550 (when evidence is in equipoise, the party with the burden of proof fails to meet that
burden).
Congress contemplated that special masters would weigh and evaluate opposing
expert opinions in determining whether petitioners have met their burden of proof. It is
now clearly established that special masters may use the framework established by
Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), to evaluate such expert
testimony on causation. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379
(Fed. Cir. 2009) and Moberly, 592 F.3d at 1324; Terran, 195 F.3d at 1316 (concluding it
was reasonable for the special master to use Daubert to evaluate the reliability of an
expert’s testimony); Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1339
(Fed. Cir. 2010) (noting that special masters are to consider all relevant and reliable
evidence filed in a case and may use Daubert factors in their evaluation of expert
testimony); Davis v. Sec’y of Health & Human Servs., 94 Fed. Cl. 53, 67 (2010)
(describing the Daubert factors as an “acceptable evidentiary-gauging tool with respect
to persuasiveness of expert testimony already admitted . . . by special masters in vaccine
11
cases”); see also Ryman v. Sec’y of Health & Human Servs., 65 Fed. Cl. 35, 40-41 (2005)
(special masters perform gatekeeping function when determining “whether a particular
petitioner’s expert medical testimony supporting biological probability may be admitted or
credited or otherwise relied upon” and as a “trier-of-fact [a special master] may properly
consider the credibility and applicability of medical theories”).
B. Review of Fact Findings from Transferred Cases
In ruling upon the present remand, I am called upon to apply Federal Circuit
precedent to a case I did not originally hear, and in which the former Chief Special Master
made specific findings of fact. Generally, special masters may change or revisit any ruling
until judgment enters, even if the case has been transferred. See McGowan v. Sec’y of
Health & Human Servs., 31 Fed. Cl. 734, 737-38 (1994).14 In most cases, however, a
judicial officer such as a special master departs from previously decided issues only in
the event of “new evidence, supervening law, or a clearly erroneous decision.” Id. at 737;
see also Sullivan v. Sec’y of Health & Human Servs., No. 10-398V, 2015 WL 1404957,
at *20, n.36 (Fed. Cl. Spec. Mstr. Feb. 13, 2015). In fact, it is appropriate to give some
deference to prior factual determinations of the judicial officer formerly responsible for a
matter, assuming circumstances do not demand otherwise. See, e.g., Pacific Gas & Elec.
Co. v. United States, 114 Fed. Cl. 146, 149 (2013) (when a successor judge is transferred
a case in which a prior order has been rendered, the successor judge “should not overrule
the earlier judge’s order or judgment merely because the later judge might have decided
matters differently,” but should exercise his discretion in determining if circumstances
warrant reopening the previously-determined issue) (quoting United States v. O’Keefe,
128 F.3d 885, 891 (5th Cir. 1997)).
Here, although I am not compelled to defer to the former Chief Special Master’s
findings of fact, in the exercise of my discretion I do so, because I find that they are
reasonable, comprehensive, and the result of a proceeding in which both sides had ample
opportunity to present evidence. I base this determination on a careful review not only of
her Entitlement Decision, but of the case file as well. I also note that the remand was
prompted not by any change in facts or new evidence, but rather by an intervening
decision from a higher court that should reasonably be taken into account. To do so, I
need not rehear or second guess the former Chief Special Master’s factual
determinations.
IV. Analysis
I begin by observing the similarities, and then differences, between the facts of this
case forming the basis of the former Chief Special Master’s decision and the Koehn case,
and then comparing the expert theories offered in each. My analysis is based not only
14
This flows naturally from the fact that in Vaccine Act cases, decisions issued by special masters and
judges of the Court of Federal Claims constitute persuasive, not binding, authority. Hanlon v. Sec’y of Health
& Human Servs., 40 Fed. Cl. 625, 630 (1998). Only decisions issued by the Federal Circuit are binding.
12
upon review of the relevant published decisions, but my own review of the record herein
(including the expert report offered by Dr. McCabe). It also takes into account the
undeniable fact that, although I am bound to follow the conclusions of law as set forth in
the decisions of the Federal Circuit, the Koehn court did not find that the petitioners
therein established the first Althen prong (despite its non-binding suggestions that the
Koehn special master should have so determined). See Koehn, 773 F.3d at 1243-44; see
also Remand Decision at *7 (recognizing that “the circuit’s criticisms of the special
master’s decision in Koehn with regard to causation are dicta”).
A. Factual Similarities and Differences between Koehn and Godfrey Cases.
The baseline similarities between the two cases is facially apparent - both involve
the HPV vaccine, and both involve autoinflammatory diseases. In addition, the petitioners
in both cases relied on the same expert, as did the Respondent. However, the factual
differences are significant, beginning with the amount of vaccine received as well as
timing of onset of symptoms. Ms. Godfrey received only one dose of the HPV vaccine,
while Ms. Koehn received two. Compare Entitlement Decision at 6 with Koehn, 773 F.3d
at 1241. Ms. Godfrey’s symptoms of hip pain began a month after the first dose, although
she sought treatment only four months later (Entitlement Decision at *5), suggesting the
severity of her pain was not immediately significant enough to require medical
intervention; by contrast, Ms. Koehn’s first claimed symptoms were a rash (followed soon
thereafter by joint pain and a high fever) that manifested two months after the second
HPV vaccine dose. Koehn, 773 F.3d at 1241.
Underscoring such differences is the fact that the two cases involve distinct
illnesses (even if both are autoinflammatory). The petitioner in Koehn was diagnosed with
SJIA, whereas here Ms. Godfrey has been diagnosed with JAS - indisputably a condition
brought on at least in part by an identified genetic predisposition (possession of the HLA-
B27 marker) for which Ms. Godfrey tested positive. Entitlement Decision at 5 and 12.
SJIA, however, lacks such an identified biomarker and/or the same one, and so its
etiology is less traceable to such a source (and certainly Koehn does not say otherwise).
The scope of the diseases is different as well, with SJIA affecting Ms. Koehn’s entire
body, while Ms. Godfrey’s JAS was specific to her hips. Id. As a result, the two petitioners
suffered different symptoms, as noted above.
B. Factual Similarities and Differences Between Causation Theories.
While the factual differences between the two cases alone would seem to be
enough to dismiss Koehn’s application to the present case, comparison of the theories
offered in each reveals far more significant differences that help illuminate why finding
that Ms. Godfrey’s Althen one showing herein was deficient despite the suggestion in
Koehn that there it was adequate.
13
Admittedly, there are facial similarities between the theories Dr. McCabe advanced
in Koehn and the present action – for in each, he relied heavily on an increased level of
cytokines as the instigating factor for the claimed illness. Thus,
 Here, Petitioner described Dr. McCabe’s theory as: “[1.] mechanical and
biological stressors increase certain types of cytokines; [2.] these events
are considered plausible triggers in HLA-B27 individuals of the
pathogenesis of JAS; [3.] Gardasil provokes cytokines similar in quality to
the known triggers, ergo, Gardasil is also a plausible trigger.” Pet. Motion
for Review (ECF No. 74), filed July 11, 2014, at 17; whereas,
 In Koehn, Dr. McCabe’s theory was that petitioner “had a predisposition for
SJIA, and that Gardasil was an environmental trigger because the vaccine
caused a strong response in the same cytokines which are dysregulated in
SJIA.” Koehn, 773 F.3d at 1242.
But the theories were not identical, despite their parallels, given differences in their
articulation and the evidence supporting them. The identified biologic underpinnings for
JAS are one such notable distinct element. Whereas in this case, Dr. McCabe admitted
that the HLA-B27 gene was a primary causative factor underlying the development of
JAS (albeit, in his view, exacerbated after vaccine-induced cytokine production), he
offered no similar explanation in Koehn – thus increasing the likelihood in that case that
a vaccine could more probably be a “but for” causative factor. Similarly, in Koehn, Dr.
McCabe was able to cite some scientific studies linking vaccines to SJIA (Koehn, 2013
WL 3214877, at *8-9), but offered no similar evidence in this case linking Gardasil to JAS
or any spondylopathy for that matter. Entitlement Decision at *16. Although medical
and/or scientific publications are not in every case required to establish a causation
theory’s viability from a legal standpoint, a theory is unquestionably rendered more
reliable to the extent it has been tested and analyzed. See Cedillo v. Sec’y of Health &
Human Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Daubert, 509 U.S. at 593-
94); see also Andreu, 569 F.3d at 1379.
Particularly relevant to the lack of persuasive evidence supporting the theory
offered in this case is the Pinto I article that was mentioned in Koehn and also relied upon
in this case. The Federal Circuit’s decision strongly suggests that in its view (despite the
special master’s misgivings therein about the reliability of Dr. McCabe’s theory), the Pinto
I study provided legally sufficient support for the opinion that an upregulation in cytokines
would be caused by the HPV vaccine. The desire for a better experiment or study to
support the theory “would have compelled Koehn to present more than what is
scientifically possible or legally necessary.” Koehn, 773 F.3d at 1244 n.1.
In this case, by contrast, there are many more reasons to find Dr. McCabe’s theory
wanting beyond the nature of the science supporting it. Indeed, Respondent’s experts
appear to have not contested its basic premise about the relationship between cytokine
levels and the components of the HPV vaccine. But (as reflected in the Entitlement
14
Decision), numerous other “links” in the chain of Dr. McCabe’s theory were lacking, such
as: (a) an inability to offer proof that showed cytokine levels were related to the
development of JAS, as opposed to symptoms associated with it, (b) a related lack of
evidence that Gardasil’s effect in increasing proinflammatory cytokines would be more
than transient, and (c) a lack of proof that Ms. Godfrey herself actually experienced an
inflammatory incident or increase in the relevant cytokines. Entitlement Decision at *21-
*22. In fact, Dr. McCabe pointed to Marks rather than Pinto I as the “best evidence” he
could muster in support of elements of his theory, thereby diminishing the role Pinto I
played in his overall theory. It is thus evident to me from the record in this case that not
only was Pinto I not as significant to Ms. Godfrey’s causation theory, but that it can be
given less weight herein without diminishing the validity of its science (which seems to
have been the nub of the Federal Circuit’s criticism in Koehn).15
Thus, the core component for both theories – the concept that cytokine production
activated by the HPV vaccine was itself the disease trigger – was shown, through
evidence and testimony elicited at this case’s hearing, to be deficient in this particular
context. In Koehn, it was established on the record that individuals suffering from SJIA
experience some symptoms attributable to “dysfunctional production of proteins called
cytokines.” Koehn, 773 F.3d at 1240. Here, Dr. McCabe similarly testified that JAS’s
manifestation was dependent on a “sustained elevation” of cytokines (Godfrey, 2014 WL
3058353, at *14, citing Tr. at 57), yet he could not offer any reliable evidence sufficient to
make it legally probable that Gardasil would cause such an elevation (Id., citing Tr. at 75-
77). At best (as was elicited in this proceeding), the vaccine might result in a transient
increase in cytokines, no different than what would be experienced after an infection or
more mundane occurrences (such as exercise). Godfrey, 2014 WL 3058353 at *21. But
Dr. McCabe did not offer sufficient persuasive proof that such an increase would be
sustained enough (and over the time that lapsed between Ms. Godfrey’s vaccination and
development of hip pain symptoms) after a single Gardasil dose to result in JAS. Godfrey,
2014 WL 3058353, at *14, *18, and *21-22. Indeed, there have been no studies
demonstrating an association between Gardasil and arthritic conditions or JAS, while
Respondent in this case offered reliable epidemiologic evidence16 that refutes such an
15
Other special masters have reached similar conclusions about the scope of findings in the Pinto I study,
and the extent to which it supports the conclusion that excessive cytokine production attributable to the
HPV vaccine (or at least to certain of its components) is pathologic. See, e.g., McGuire v. Sec’y of Health
& Human Servs., No. 10-609V, 2015 WL 6150598, at *13 (Fed. Cl. Spec. Mstr. Sept. 18, 2015) (rejecting
theory that HPV vaccine caused chronic headaches).
16
Unquestionably, a petitioner need not offer epidemiologic proof to establish a reasonable and
scientifically-reliable theory under Althen prong one. Capizzano, 440 F.3d at 1325. However, I may properly
weigh such evidence, when offered by the Respondent, against Petitioner’s proof in evaluating whether
she has carried her overall burden as to this first Althen prong. Andreu v. Sec’y of Health & Human Servs.,
569 F.3d 1367, 1379 (Fed. Cir. 2009) (“[a]lthough Althen and Capizzano make clear that a claimant need
not produce medical literature or epidemiological evidence to establish causation under the Vaccine Act,
where such evidence is submitted, the special master can consider it in reaching an informed judgment as
to whether a particular vaccination likely caused a particular injury”).
15
association. Id. at *19 (remarking that if Gardasil could trigger JAS in HLA-B27 positive
people, “one would expect that the incidence of JAS among the over one million HLA-
B27 positive individuals who received the vaccine would be notable,” but it is not).
Thus, even if Dr. McCabe’s theory as applied to a related but distinct disease might
have been sufficient in that context to satisfy the first Althen prong, it was reasonably
determined in this case, based on the proof presented, to be insufficient when applied to
a different disease, and one with a firmly identified genetic risk factor that the Petitioner
was found to possess. No evidence in this record supports the conclusion that pro-
inflammatory cytokines play any role in the pathogenesis of JAS (though they can play a
role in the symptoms displayed).17
Equally relevant to the present analysis is the rebuttal evidence and testimony
offered by Respondent. In Koehn, the Federal Circuit expressed concern that the special
master had perhaps too readily rejected Dr. McCabe’s causation theory, based in part on
Dr. Rosé’s ipse dixit statements that the theory did not enjoy general acceptance in the
scientific community. Koehn, 773 F.3d at 1243-44. Here, by contrast, there is ample
evidence rebutting the legal sufficiency of the theory. Thus, Respondent’s experts, Drs.
Rosé and Zweiman, proposed their alternative theory (based on their reading of the
record) that Ms. Godfrey’s JAS developed spontaneously, largely the result of her strong
genetic predisposition to the disease (a factor that all parties acknowledged underlies
JAS). Entitlement Decision at *21.18 According to Dr. Rosé, this gave her a one-in-five
chance of developing JAS; a condition found in about seven of every 100,000 individuals.
Id. at *22. She also had a known trigger in her history (her cheerleading activity) that
rendered her susceptible to chronic micro-trauma in hips and ankles. Id. Respondent also
offered epidemiologic evidence suggesting Gardasil is not associated with JAS that the
former Chief Special Master observed amounted to unrebutted “circumstantial evidence”
against causation. Id. at *17.
Respondent thus offered persuasive evidence based on objective record facts to
support her assertion that Petitioner’s genetic makeup was itself sufficient to be the actual
“but-for” cause of her JAS. While this evidence itself may not have been enough to prove
17
Although this constitutes, in my review of the matter, the most substantive basis for finding that Dr.
McCabe’s theory did not satisfy the first Althen prong, the trial transcript and record (as highlighted in the
former Chief Special Master’s Entitlement Decision) identifies many other deficiencies with the theory as
applied to the facts in this case. For example, Dr. McCabe was inconsistent and confusing in explaining his
views about how cytokine production in response to the HPV vaccine impacted Ms. Godfrey’s JAS.
Entitlement Decision at *14. He also could not deny that there was no epidemiologic evidence favoring his
theory (Id. at *16); at best, he attempted to distinguish such evidence when offered by the Respondent as
insufficiently powered (given the sample size of studied individuals) to disprove his theory.
18
Although the trial transcript evidences some discussion about the fact that most people with HLA-B27 do
not develop JAS or similar diseases, the very high percentage of those who do develop JAS as children
(one study indicated that in children with JAS, 97 percent carry the HLA-B27 marker (Lin, Pet. Ex. 56, at
577)), coupled with Ms. Godfrey’s inherited HLA-B27 marker and a first degree relative with Crohn’s
disease, are all strong indications of her high genetic predisposition to developing JAS.
16
preponderantly the most likely cause of her JAS, Respondent can (in asserting that a
petitioner has not met her prima facie burden) offer evidence in Vaccine Act proceedings
that merely undermines Petitioner’s own proposed causation theories or evidence,
without having to meet the preponderant evidence standard of a “factor unrelated” as the
more likely cause. Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373, 1379 (Fed.
Cir. 2012) (“[o]ur decisions support the commonsense proposition that evidence of other
possible sources of injury can be relevant not only to the “factors unrelated” defense, but
also to whether a prima facie showing has been made that the vaccine was a substantial
factor in causing the injury in question”); La Londe v. Sec’y of Health & Human Servs.,
110 Fed. Cl. 184, 198 (2013) (“[r]egardless of whether the burden ever shifts to the
respondent, the special master may consider the evidence presented by the respondent”
when determining if petitioner’s initial burden has been met), aff’d, 736 F.3d 1334 (Fed.
Cir. 2014). In any event, the record indicates that such evidence was not effectively
rebutted by Petitioner.
I thus find insufficient evidence in the record that a genetic susceptibility to JAS
also encompasses a susceptibility to increases in pro-inflammatory cytokines, or that a
vaccine such as Gardasil could cause a sufficient cytokine level increase to trigger the
disease processes proposed by Petitioner. Rather, the evidence and expert testimony
illustrated only that Gardasil produces at best a transient increase in cytokine levels no
different than other kinds of mundane activities, such as sun exposure. Entitlement
Decision at *18, citing Tr. at 116-17, 158-59, and 161-62. This was the theory offered in
this case, and the record supports the conclusion that the theory was appropriately found
wanting, despite the suggestion from Koehn (in a case involving a different disease,
different factual circumstances, and different proof) that a similar theory might have been
legally preponderant.
This is not the first time that a petitioner has invoked Koehn as controlling in a case
alleging injury based on administration of the HPV vaccine – nor the first time such an
argument has been rejected based on inherent factual differences between the cases
and the resulting nature of the precise theories alleged therein. See, e.g., McGuire v.
Sec’y of Health & Human Servs., No. 10-609V, 2015 WL 6150598, at *13 (Fed. Cl. Spec.
Mstr. Sept. 18, 2015) (rejecting application of Koehn causation theory to argument that
HPV vaccine caused chronic headaches). And there is nothing legally troubling about
such an outcome, given the context: the Vaccine Program. As the Federal Circuit has
acknowledged, factually similar Vaccine Act cases often yield different results as reflected
at the level of a special master’s decision. Moberly v. Secretary of Health & Human Servs.,
592 F.3d 1315 (Fed. Cir. 2010).19 Even cases involving the same vaccinations or similar
19In Moberly, the Federal Circuit rejected the petitioners’ contention that they were entitled to compensation
because their case was similar to Andreu, where compensation had been awarded. In both Andreu and
Moberly, the children in question suffered seizures after receiving DPT vaccinations. However, petitioners
in Andreu presented testimony by treating physicians supporting their causation theory, and the
government’s witness did not dispute the plausibility of that theory. In contrast, the Moberly petitioners were
unable to present testimony of a treating physician supporting their causation theory, and, further, their own
witness called into question the plausibility of their causation theory. Moberly, 592 F.3d at 1325. There were
17
injuries may turn out differently, as no two cases are truly identical. This is to be expected,
as different records can lead to different outcomes despite facial similarities between
cases. Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1366 (Fed. Cir. 2000)
(“a special master's task is to make a factual determination of causation based on the
evidence in a particular case. A study of many individual cases may be useful evidence
as to causation, but it does not compel the finder of fact to find causation in a particular
case”).
C. Bases for Denying Entitlement Independent of Petitioner’s Theory.
Even if I were to assume for sake of argument that (adopting the viewpoint of
Koehn’s dicta) Ms. Godfrey established the first of the three Althen prongs via Dr.
McCabe’s theory, there is still ample, persuasive, and/or unrebutted evidence supporting
the conclusion that the Petitioner in this case failed to establish by preponderant evidence
an entitlement to a damages award.
Thus, it was undisputed that none of Ms. Godfrey’s treaters linked the single dose
of Gardasil she received to her subsequent illness (other than noting the temporal
relationship between the two – a fact well understood to be insufficient to establish
causation). Godfrey, 2014 WL 3058353 at *23, citing Grant v. Sec’y of Health & Human
Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). Respondent’s experts also noted that (in
addition to the genetic risk factor that Ms. Godfrey had) Petitioner’s familial history of
Crohn’s disease increased her risk of developing JAS fourfold, given the demonstrated
relationship between gut inflammation (itself associated with Crohn’s disease) and JAS.
Entitlement Decision at *17, citing Tr at 144; see also Burgos–Vargas, Pet. Ex. 61, at iii
34.
Furthermore, the factual record does not contain the kind of evidence (such as test
results) that would lend credence to Dr. McCabe’s theory by showing it “working” in real
time. Thus, there was no testing performed to measure Ms. Godfrey’s cytokine levels after
her single HPV vaccine, and no evidence that she experienced an inflammatory incident
in the time period Dr. McCabe suggested the immune response should have occurred.
Entitlement Decision at *15-*16. And it was unrebutted that Petitioner’s physical activity
as a cheerleader had the potential to injure her sacroiliac joints (Tr. at 162-63), since
strenuous physical activity is a known environmental risk factor for JAS. Entitlement
Decision at *17, citing Tr. at 109-11, 113-15, and 162-63.20 All of the above factors are
therefore key differences between the Moberly and Andreu petitioners as well as the cases’ respective
records, and thus the results in the earlier case did not compel a similar result in the later one. Id.
20
The Opinion remanding this matter mentions in a footnote that the former Chief Special Master made a
fact finding as to a “more likely alternative environmental trigger” for Petitioner’s JAS. Remand Decision at
*7 n.10. I could not identify discussion of such a finding in the Entitlement Decision or the trial transcript.
But the record strongly supports the general conclusion (unrebutted by Petitioner, as discussed above) that
it was “more likely than not” that Ms. Godfrey’s genetic susceptibility to JAS was the basis for the disease’s
pathogenesis, and that any increase in proinflammatory cytokine production was insufficient to trigger the
disease.
18
sufficient to conclude that Petitioner did not meet the second Althen “did cause” prong
under the circumstances presented by this case.
Regarding the third prong (which focuses on the timing of the injury after
vaccination and inquires if the period is medically acceptable), Dr. McCabe opined that
the four-week interval between Ms. Godfrey’s first symptoms and her single HPV vaccine
dose was medically acceptable. Entitlement Decision at *14, citing Tr. at 79. But in so
doing, he highlights a particularly inconvenient equivalence between the theory espoused
herein and in Koehn. Thus, Dr. McCabe argued in this case that “the expected interval
between vaccination and the onset of the autoinflammatory trigger is predicted by the
time period that measurable changes in the immune response are known to be elicited.”
Tr. at 75-76. Because onset was within one month of the single HPV dose, under Dr.
McCabe’s theory one month was also the “medically acceptable” period.
Dr. McCabe made the same argument in Koehn to defend a longer, seven-month
interval between first symptom and onset of SJIA, but failed to explain therein why the
period of time it took for the immune response to occur aligned precisely with the onset
of symptoms in that case, instead simply assuming the periods were the same. The
Federal Circuit explicitly rejected his reasoning as a “proposition . . . without any
evidentiary support,” leading it to uphold the special master’s denial of entitlement in spite
of its other criticisms. Koehn, 773 F.3d at 1244.
If Petitioner is to hold out Koehn as exemplifying the conclusion I should adopt
when taking into account Dr. McCabe’s theory in this case, then she must also ask me to
consider the entirety of that decision. She cannot selectively invoke the portions that
benefit her argument while ignoring the rest of the opinion – especially the aspect of it
that is the very basis for its holding. See McGuire, 2015 WL 6150598, at *21 n.25 (“[i]f
[petitioner’s] reliance on Koehn to establish prong one were correct, then it would seem
to follow that [petitioner] would also be bound by Koehn on prong three”).
V. Conclusion.
Despite the facial similarities between the theories advanced by Dr. McCabe in this
case and Koehn, I do not find that the Federal Circuit’s dicta in that intervening decision
compels a finding favorable to the Petitioner, given the many relevant factual distinctions
between the two matters. The record from this case, as discussed in detail in the former
Chief Special Master’s decision, simply did not support the theory proposed by Petitioner
– nor in this case did the theory itself prove to be sufficiently reliable. As a result, I do not
find that the suggestion from Koehn that the same theory should have been deemed
reliable when applied to a related disease compels the same outcome herein.
Accordingly, Petitioner still fails to meet the burden of persuasion on any of the
Althen prongs by preponderant and reliable evidence. The petition for compensation is
therefore DENIED. The clerk is directed to enter judgment accordingly, and is instructed
19
to transmit this Remand Decision to the presiding judge in accord with Vaccine Rule
28.1(a).
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Special Master
20