      In the United States Court of Federal Claims
                                                          OFFICE OF SPECIAL MASTERS
                                                              Filed: December 8, 2014

*************************************                                      PUBLISHED
NATALIE ROWAN,                      *
                                    *                                      No. 10-272V
                  Petitioner,       *
                                    *                                      Special Master Dorsey
 v.                                 *
                                    *
SECRETARY OF HEALTH                 *                                      Entitlement; Human Papillomavirus
AND HUMAN SERVICES,                 *                                      Vaccine (“HPV”) or Gardasil; Headaches;
                                    *                                      Migraines; Chronic Fatigue Syndrome.
                  Respondent.       *
                                    *
*************************************

Patricia Ann Finn, Piermont, NY, for petitioner.
Darryl J. Wishard, U.S. Department of Justice, Washington, DC, for respondent.

                                                   DECISION DENYING ENTITLEMENT1

I.            Introduction

        On May 3, 2010, Michael Rowan, on behalf of his daughter, Natalie Rowan2
(“petitioner” or “Ms. Rowan”), filed a petition for compensation under the National Vaccine
Injury Compensation Program (“the Program”)3 alleging that the human papillomavirus (“HPV”
                                                            
1
  Because this published decision contains a reasoned explanation for the action in this case, the
undersigned intends to post this decision on the website of the United States Court of Federal
Claims, in accordance with the E-Government Act of 2002 § 205, 44 U.S.C. § 3501 (2006). In
accordance with the Vaccine Rules, 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). Further, consistent with the rule requirement, a motion for redaction must include a
proposed redacted decision. If, upon review, the undersigned agrees that the identified material
fits within the requirements of that provision, such material will be deleted from public access.
2
   Michael Rowan filed a motion to Amend the Caption on December 12, 2013, as Ms. Rowan
had attained the age of majority. The motion was granted the next day.  
 
3
 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42
U.S.C. §§ 300aa-10 et seq. (“the Act”). Hereafter, individual section references will be to 42
U.S.C. § 300aa.
                                                                       1
 
or “Gardasil”) vaccines that his daughter, Natalie Rowan, received on August 21, 2007,
November 12, 2007, and July 14, 2008, caused her to develop headaches, including migraines,
difficulty walking, abdominal pain, dizziness, weight loss, bronchial spasms, and an inability to
leave her bed. Petition at 1-2. Respondent recommended against compensation, arguing that
petitioner had not presented adequate evidence demonstrating causation. See Respondent’s
Report (“Resp’t’s Rep’t”), filed October 29, 2010, at 15. The parties submitted expert reports.
An entitlement hearing was held in New York, NY, on January 14, 2014, and in Washington
D.C. from January 15 to 16, 2014. Michael Rowan, Natalie Rowan and the parties’ respective
experts testified. Petitioner filed her post-hearing brief on July 8, 2014, and respondent filed her
post-hearing brief on August 29, 2014. This matter is now ripe for adjudication.

        The parties agree that the issues to be decided are: (1) whether petitioner has presented
preponderant evidence that she had a “medically-recognized autoimmune condition,” and (2) if
so, whether petitioner has presented preponderant evidence of vaccine causation of the injuries.
See Jt. Sub. at 4. After a review of the entire record, see § 300aa-13(a)(1), the undersigned finds
that petitioner has provided preponderant evidence of illness or injury.4 She has failed,
however, to establish by a preponderance of the evidence that the Gardasil vaccinations caused
her injuries. Accordingly, petitioner is not entitled to compensation and her petition must be
dismissed.


II.           Standards for Adjudication

         The Vaccine Act established the Program to compensate vaccine-related injuries and
deaths. § 300aa-10(a). “Congress designed the Vaccine Program to supplement the state law
civil tort system as a simple, fair and expeditious means for compensating vaccine-related
injured persons. The Program was established to award ‘vaccine-injured persons quickly, easily,
and with certainty and generosity.’” Rooks v. Sec’y of Health & Human Servs., 35 Fed. Cl. 1, 7
(1996) (quoting H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).

        Petitioner’s burden of proof is a preponderance of the evidence. § 300aa-13(a)(1). The
preponderance of the evidence standard, in turn, has been interpreted to mean that a fact is more
likely than not. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir.
2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs.,
931 F.2d 867, 873 (Fed. Cir. 1991). A petitioner who satisfies this burden is entitled to
compensation unless respondent can prove, by a preponderance of the evidence, that the
vaccinee’s injury is “due to factors unrelated to the administration of the vaccine.” § 300aa-
13(a)(1)(B).




                                                            
4
     While the parties stipulated that the first issue to be decided is whether petitioner had a
“medically-recognized autoimmune condition,” the undersigned did not limit her analysis to just
autoimmune conditions, but considered whether petitioner could recover for any illness or injury.
See § 300aa-11(c)(1)(C)(ii)(I).  
                                                               2
 
III.   Summary of Relevant Facts

        Ms. Rowan was born on October 11, 1995. She had asthma, but was otherwise noted to
be a well-child. Petitioner’s Exhibit (“Pet. Ex.”) 3 at 1. Prior to receiving her first HPV
vaccination, there were two documented occasions when Ms. Rowan complained of headaches.
Ms. Rowan complained of a headache on December 7, 2005, which was associated with an upper
respiratory infection. Jt. Sub. at 2. On March 6, 2007, Ms. Rowan saw Dr. Joanne Fogarty, her
primary care provider, for a chief complaint of a headache associated with complaints of
abdominal pain and strep pharyngitis. Jt. Sub. at 2; Pet. Ex. 4 at 1.

       Ms. Rowan received her first HPV vaccine on August 21, 2007. There were no
documented adverse events associated with that vaccine. Petition at 1; Pet. Ex. 1 at 3. She
received her second HPV vaccine on November 12, 2007. Id. On November 21, 2007, she
presented to Dr. Fogarty with complaints of a headache and stomach ache. Pet. Ex. 4 at 1. Dr.
Fogarty diagnosed petitioner with a “viral syndrome.” Id.

        Approximately six months later, on May 15, 2008, petitioner saw Dr. Fogarty and
complained of “headaches since Monday.” Pet. Ex. 4 at 3. Dr. Fogarty documented that
petitioner started her menses in March of 2008, and noted a family history of migraines. Id. Dr.
Fogarty diagnosed petitioner with headaches, prescribed Advil and Fiorcet and advised Ms.
Rowan to increase her fluids. Id.

        Ms. Rowan’s third HPV vaccine was administered on July 14, 2008. Petition at 1; Pet.
Ex. 1 at 1. On September 24, 2008, Ms. Rowan saw Dr. Fogarty with complaints of a sore throat
and Dr. Fogarty noted petitioner’s history of migraines. Pet. Ex. 4 at 4. Dr. Fogarty diagnosed
petitioner with pharyngitis. Id.; Jt. Sub. at 2. On October 28, 2008, November 3, 2008, and
November 14, 2008, Ms. Rowan saw Dr. Fogarty for ongoing complaints of headaches. Dr.
Fogarty prescribed medication and physical therapy. Pet. Ex. 4 at 6-10.

        On December 30, 2008, Ms. Rowan saw neurologist Dr. Karen Powers for complaints of
headaches. Pet. Ex. 3 at 1. Dr. Powers noted that Ms. Rowan had been experiencing headaches
since October 2008, and that she complained that the headaches were causing her to have
difficulty concentrating in school and causing school absences. Id. Ms. Rowan’s father
provided a history to Dr. Powers of petitioner’s migraines stating that the headaches began after
petitioner’s first menstrual cycle in March of 2008. Jt. Sub. at 2; Pet. Ex. 3 at 1. Medications,
including “naproxen, hydrocodone, butalbital APAP, cyclobenzaprine, and Imitrex” were
ineffective. Jt. Sub. at 2. Dr. Powers diagnosed petitioner with “chronic daily headache, with
some intermittent headaches with more migraine features, as well as a strong family history of
migraines.” Pet. Ex. 4 at 3. Ms. Rowan was prescribed Topamax for her headaches. Jt. Sub. at
2.

       Petitioner continued to see Dr. Powers and Dr. Fogarty for her headaches throughout
2009. In February and March 2009, Ms. Rowan saw Dr. Fogarty for complaints of abdominal
pain. Pet. Ex. 4 at 9-11. An abdominal scan was performed and remarkable only for
constipation. Jt. Sub. at 3. Also in March 2009, petitioner reported that she had no benefit from



                                                3
 
trying a gluten-free diet. Id. On March 26, 2009, Dr. Powers’s diagnosis was “primary
headache syndrome consistent with a new daily persistent headache.” Pet. Ex. 3 at 7.

        In May 2009, Mr. Rowan filed a VAERS report on behalf of his daughter. Pet. Ex. 1 at
2. Also in May 2009, Ms. Rowan consulted with Dr. Charles Argoff regarding Botox treatment
and in June she consulted with physicians at Albany Medical Center. Jt. Sub. at 2; Pet. Ex. 3 at
22. On September 29, 2009, petitioner had a low white blood count (“WBC”) of 3.2 with
elevated lymphocytes of 54. Pet. Ex. 2 at 1. Ms. Rowan saw Dr. Joanne Porter, a pediatric
hematologist, in October 2009. Pet. Ex. 3 at 20-21. Mr. Rowan told Dr. Porter that he believed
that his daughter’s headaches began after her last HPV vaccine. Id. Ms. Rowan continued to
seek treatment for her headaches throughout 2009. Pet. Ex. 3 at 17-18; Pet. Ex. 4 at 16.

         On January 14, 2010, Dr. Powers noted that Ms. Rowan continued to experience
headaches. Pet. Ex. 6 at 20. Dr. Powers’s impression was that Ms. Rowan’s symptoms, which
began as headaches, had “evolved into multiple somatic complaints of headache, leg weakness,
difficulty walking, gastrointestinal pain, and what appears to be depression.” Pet. Ex. 6 at 21.
Ms. Rowan underwent a diagnostic workup for her complaints of headaches. The results
included a negative Lyme test, a normal sinus and CT scan, a normal MRI of the brain, a normal
MR angiography and venogram of the head, a negative cervical spine x-ray, and normal lab
results from a lumbar puncture. Jt. Sub. at 3. In March 2010, Ms. Rowan saw Dr. Barbara
Shapiro, who examined the petitioner and performed an EMG. Tr. 41. The results of the EMG
were normal although petitioner was unable to ambulate at the time and was in a wheelchair.
Pet. Ex. 44 at 4. Ms. Rowan’s diagnostic testing was normal; however, she had an elevated IgE
level, likely due to her asthma. Tr. 465, 469-70.

        Petitioner’s complaints and headaches continued until June or July 2010, when her family
sought advice from a lawyer, Lloyd Phillips, who was recommended by another parent who said
that her daughter had been injured by the Gardasil vaccine. Mr. Rowan testified that Mr. Phillips
recommended that Ms. Rowan begin a vitamin regimen which included a specific type of
vitamin K. Tr. 49-52. Within several weeks of beginning a specialized diet and the vitamin
regimen, Ms. Rowan’s condition gradually improved. Tr. 52-62. By mid-2011, Ms. Rowan had
returned to her baseline, and “was like her old self.” Tr. 63.

        Ms. Rowan testified at the hearing on January 14, 2014. She testified that she was
attending college, and living on campus. Tr. 120. Ms. Rowan appeared healthy and well-
spoken. She also testified that her condition had improved and she is feeling better now. Tr.
121.


    IV.   Has Petitioner Presented Preponderant Evidence of Illness or Injury?

        The parties first dispute whether Ms. Rowan has presented preponderant evidence that
she suffered illness or injury. See Jt. Sub. at 4, and footnote 4. The medical records, including
but not limited to those facts set forth in the above summary, and the testimony of petitioner’s
expert, Dr. Yehuda Shoenfeld, provide relevant evidence on the issue of Ms. Rowan’s diagnosis.



                                                4
 
         Petitioner’s expert, Dr. Yehuda Shoenfeld, testified that Ms. Rowan was seen by
approximately “13 different physicians,” but because she did not “have any organic
manifestation,” she was never given a diagnosis. Tr. 208. Ms. Rowan was seen by neurologists,
an infectious disease specialist, a physical medicine rehabilitation specialist, a pain management
specialist, a hematologist and oncologist, and a Lyme disease specialist. Tr. 229. Dr. Shoenfeld
testified that instead of diagnosing petitioner, the treating physicians merely “diagnosed the
symptoms.” Tr. 218-19, 222, 258. Ms. Rowan underwent many “examinations, quite
sophisticated, and all of them were interpreted as normal.” Tr. 209. He testified that petitioner’s
diagnosis, “post factum” was “chronic fatigue syndrome.” Tr. 210, 221. Dr. Shoenfeld defined
chronic fatigue syndrome (“CFS”) as “chronic fatigue and [] unrefreshing sleep on waking”
lasting for six months. Tr. 221; see also Pet. Ex. 15 at 3. Dr. Shoenfeld rejected any notion that
Ms. Rowan’s abdominal pain was a vaccine-related symptom. Tr. 223.

       Based on a review of the records and expert testimony at hearing, the undersigned finds
that Ms. Rowan has presented preponderant evidence that she was diagnosed and treated for
headaches. There is not preponderant evidence that she has chronic fatigue syndrome.5 See
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1275, 1278 (Fed. Cir. 2005).


    V.            Causation Analysis

       The parties next dispute whether Ms. Rowan has presented preponderant evidence under
Althen, 418 F.3d at 1278, that the Gardasil vaccines caused her alleged injuries. Jt. Sub. at 4-6.

                             A. Legal Framework

        To receive compensation under the Program, petitioner must prove either: (1) that she
suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a
vaccine that she received, or (2) that she suffered an injury that was actually caused by the HPV
vaccine. See §§ 300aa-13(a)(1)(A) and 11(c)(1); Capizzano v. Sec’y of Health & Human
Servs., 440 F.3d 1317, 1319-20 (Fed. Cir. 2006). Petitioner must show that the vaccine was “not
only a 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)).

       Because petitioner does not allege she suffered a Table injury, she must prove that the
HPV vaccines she received caused her injuries. To do so, she must establish, by preponderant
evidence: (1) a medical theory causally connecting the vaccine and her injury (“Althen Prong
One”); (2) a logical sequence of cause and effect showing that the vaccine was the reason for her

                                                            
5
  Petitioner also alleged that the vaccinations caused her to experience difficulty walking,
abdominal pain, dizziness, weight loss, bronchial spasms, and ultimately led to her becoming
bedridden. Petitioner, however, did not provide preponderant evidence that these other
conditions were allegedly related to her vaccinations. Even if petitioner had proven by a
preponderance of evidence that she suffered from all of the conditions that she has alleged, the
undersigned’s ruling as to causation would be the same.  
                                                               5
 
injury (“Althen Prong Two”); and (3) a showing of a proximate temporal relationship between
the vaccine and her injury (“Althen Prong Three”). Althen, 418 F.3d at 1278; § 300aa–13(a)(1).

         The causation theory must relate to the injury alleged. Thus, a petitioner must provide a
reputable medical or scientific explanation that pertains specifically to the vaccinee’s case,
although the explanation need only be “legally probable, not medically or scientifically certain.”
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Petitioner
cannot establish entitlement to compensation based solely on her assertions. Rather, a vaccine
claim must be supported either by medical records or by the opinion of a medical doctor. §
300aa-13(a)(1). In determining whether petitioner is entitled to compensation, the special master
shall consider all material contained in the record, § 300aa-13(b)(1), including “any . . .
conclusion, [or] medical judgment . . . which is contained in the record regarding . . . causation . .
. of the petitioner’s illness.” § 300aa-13(b)(1)(A). The undersigned must weigh the submitted
evidence and the testimony of the parties’ offered experts and rule in petitioner’s favor when the
evidence weighs in his favor. See Moberly, 592 F.3d at 1325-26 (“Finders of fact are entitled—
indeed, expected—to make determinations as to the reliability of the evidence presented to them
and, if appropriate, as to the credibility of the persons presenting that evidence”); Althen, 418
F.3d at 1280-81 (“close calls” are resolved in petitioner’s favor).

        Another important aspect of the causation-in-fact case law under the Program concerns
the factors that a special master should consider in evaluating the reliability of expert testimony
and other scientific evidence relating to causation issues. In Daubert v. Merrell Dow
Pharmaceutical, Inc., 509 U.S. 579 (1993), the Supreme Court listed certain factors that federal
trial courts should utilize in evaluating proposed expert testimony concerning scientific issues.
In Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999), the Federal
Circuit ruled that it is appropriate for special masters to utilize Daubert’s factors as a framework
for evaluating the reliability of causation-in-fact theories presented in Program cases.


               B. Althen Analysis

                       (1) Althen Prong One: Petitioner’s Medical Theory

       Under Althen Prong One, petitioner must set forth a medical theory explaining how the
HPV vaccine could have caused her alleged injury. Andreu v. Sec’y of Health & Human Servs.,
569 F.3d 1367, 1375 (Fed. Cir. 2009). Pafford v. Sec’y of Health & Human Servs., 451 F.3d
1352, 1355-56 (Fed. Cir. 2006).

        Petitioner’s theory of causation must be informed by a “sound and reliable medical or
scientific explanation.” Knudsen, 35 F.3d at 548; see also Veryzer v. Sec’y of Health & Human
Servs., 98 Fed. Cl. 214, 223 (2011) (noting that special masters are bound by both § 300aa-
13(b)(1) and Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and
“reliable”). If petitioner relies upon a medical opinion to support her theory, the basis for the
opinion and the reliability of that basis must be considered in the determination of how much
weight to afford the offered opinion. See Broekelschen v. Sec’y of Health & Human Servs., 618
F.3d 1339, 1347 (Fed. Cir. 2010) (“The special master’s decision often times is based on the
credibility of the experts and the relative persuasiveness of their competing theories.”); Perreira

                                                  6
 
v. Sec’y of Health & Human Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (“An expert
opinion is no better than the soundness of the reasons supporting it.”) (citing Fehrs v. United
States, 620 F.2d 255, 265 (Ct. Cl. 1980)).

                                                   a. Petitioner’s Expert, Dr. Yehuda Shoenfeld

        Dr. Yehuda Shoenfeld graduated from the Hadassah Medical School in Israel in 1972.
He was appointed lecturer in internal medicine at the Tel Aviv University Medical School in
1975 and then advanced to senior lecturer in 1980. He received a diploma cum laude for his
studies in internal medicine at the Postgraduate Medical School of Tel Aviv University in 1978.
Beginning in 1976, he served as senior resident in the Department of Internal Medicine and the
Out Patient Clinic of Hematology and Immunology of Beilinson Medical Center in Israel. Dr.
Shoenfeld conducted research in hematology and internal medicine there, and became head of
those departments in 1985. Between 1976 and 1982, Dr. Shoenfeld also participated in clinical
fellowships in hematology/oncology at City of Hope, in Duarte, California; at the Tufts New
England Medical Center of Boston, Massachusetts; and at the Cornell Medical Center of New
York. See Shoenfeld Curriculum Vitae (2013) - Exhibit to Witness List filed on November 19,
2013; Tr. at 151-52.

       In 1984, Dr. Shoenfeld became head of the Department of Medicine at the Sheba Medical
Center of Tel Aviv University, where he continued to serve at the time of his testimony in this
case. He received an academic appointment as Associate Professor in 1985, then Professor of
Medicine in 1990, at the Tel Aviv University Medical School, Sackler Faculty of Medicine.
Concurrently, he was the head of the Hybridoma Unit and Research Laboratory for Autoimmune
Diseases of the Soroku Medical Center of Ben Gurion University of the Negev. In that capacity,
he founded the Center for Autoimmune Diseases, and continues to serve as its Director. See
Shoenfeld Curriculum Vitae (2013) - Exhibit to Witness List filed on November 19, 2013; Tr. at
152; Pet. Ex. 12 at 1-2.

         Dr. Shoenfeld's 2013 curriculum vitae includes more than 1750 published professional
articles, 60 books, and 130 chapters in medical texts, which he authored or co-authored, many of
them focusing on autoimmune diseases. He served on the editorial boards of numerous medical
journals, primarily concerning autoimmunology and rheumatic diseases. He has also been an
organizer of many medical conferences, and a member of numerous professional organizations,
both in Israel and internationally. See Shoenfeld Curriculum Vitae (2013) - Exhibit to Witness
List filed on November 19, 2013; Tr. at 151-52.

       Dr. Shoenfeld’s causation theory in this case is “Adjuvant Induction of Autoimmune
Disease” or ASIA.6 Tr. 187-88, 230. While Dr. Shoenfeld has previously used ASIA syndrome

                                                            
6
  Also referred to as “Autoimmune/inflammatory syndrome induced by adjuvants.” See Pet. Ex.
16. During the hearing, Dr. Shoenfeld testified that ASIA is not his theory in this case. Tr. at
230. However, Dr. Shoenfeld’s expert reports, petitioner’s pleadings and her counsel’s
arguments frequently cite to ASIA as petitioner’s theory of causation. See Tr. at 230-35 (Dr.
Shoenfeld testified that ASIA “is not the theory in this case,”) but see Jt. Sub. at 4 (“ASIA as
applied to the instant matter is a plausible medical [] explanation.”); Tr. at 11 (Ms. Finn states
                                                                      7
 
to describe illness associated with silicone implants and other conditions, he uses it here to
describe “adjuvant-induced side effects of vaccines.” Tr. 232-33. Although Dr. Shoenfeld posits
ASIA as the applicable medical theory, he acknowledges that ASIA is not a proven theory, and
that the data only “suggest the possibility of accelerated autoimmunity/inflammation following
vaccination.” Pet. Ex. 16 at 4-5.7

        “An adjuvant…is an agent that may stimulate the immune system and increase the
response to a vaccine, without having any specific antigenic effect in itself.”8 Adjuvants are
added to vaccines to “induce protective antibodies” and enhance the immunological reaction that
protects against the virus, which in this case is HPV. Tr. 175. Without the use of adjuvants, the
body will not “mount an immunological reaction…namely, [production of] protecting antibodies,
which …neutralize the virus if the virus is encountered by the vaccinee in the future.” Id.

        Aluminum is the adjuvant used in the HPV vaccine. Tr. 175-77. Dr. Shoenfeld describes
aluminum as a toxin that accumulates with each administration of the HPV vaccine. Id. at 177-
78. Phagocytes from the “reticuloendothelial system” rid the body of aluminum, but the process
is not very efficient. Id. at 178-79. Dr. Shoenfeld testified that phagocytes take aluminum from
the vaccine injection site to the brain, and, in the brain, aluminum is toxic. Tr. 179. Dr.
Shoenfeld is unable to state whether the aluminum only causes injury. Tr. 180-81.

        Dr. Shoenfeld explained that precisely how adjuvants cause autoimmune illness “is not
always known.” Pet. Ex. 11 at 3; see also Pet. Ex 13.9 “[A]djuvants seem to modulate a
common set of genes, promote antigen-presenting cell recruitment and mimic specific sets of
conserved molecules…thus increasing the innate and adaptive immune responses to the injected
antigen.” Pet. Ex. 14 at 2. The primitive immune system, which fights infections, has “toll-like
receptors” which “start the cascade of the immune system.” Tr. 186. Dr. Shoenfeld posits a
mechanism where aluminum stimulates the “toll-like receptor 4.” Tr. 186-87. Once stimulated,
these receptors induce the secretion of inflammatory cytokines. Tr. 187.

       Dr. Shoenfeld opines that “the aim of an adjuvant is to chronically stimulate the immune
system.” Tr. 167. This “chronic stimulation of the immune system can induce chronic
fatigue…[and] headache.” Tr. 187. Dr. Shoenfeld compares his theory of chronic stimulation of

                                                                                                                                                                                                
“Dr. Shoenfeld will explain this, but under the ASIA theory, which is Petitioner’s theory of
causation…”); Petitioner’s Pre-Hearing Brief (“Pet. Br.”) at 5 (“the symptoms Dr. Shoenfeld
asserts demonstrate ASIA syndrome ‘appeared only after the vaccines were delivered’”) and 8
(“The expert report from Dr. Shoenfeld stated that the symptoms [petitioner] experienced can
follow from administration of the HPV vaccine based on the ASIA medical disorder and
illness”); Tr. at 10 (“[o]ur theory is that Natalie is experiencing -- her injuries were caused by
what’s known as ASIA, and that’s an Autoimmune Syndrome Induced by Adjuvants”). For
purposes of this decision, ASIA, “adjuvant induced” and similar phrases will be used
interchangeably; they all refer to the theory set forth by Dr. Shoenfeld.
7
    Shoenfeld Y., et al., ‘ASIA – Autoimmune/inflammatory syndrome induced by adjuvants,
Journal of Autoimmunity 36 (2011) 4-8.
8
   Israeili E., et al., Adjuvants and Autoimmunity, Lupus (2009); 1217-1225. 
9
   Israeili E., et al., Adjuvants and Autoimmunity, Lupus (2009); 1217-1225. 

                                                                                              8
 
the immune system caused by vaccines to the process by which infection leads to atherosclerosis,
as discussed by Espinola-Klein.10 But that comparison is inapt because the study looked at viral
and bacterial infectious pathogens and not adjuvants; the authors never discussed the notion of
chronic stimulation of the immune system by adjuvants. In the study, patients were tested for
antibodies to determine whether they had experienced prior infection with one or more of eight
different viruses and bacteria (the HPV virus was not studied). The authors found “an
association between the extent of atherosclerosis” and exposure to an increased number of
infectious pathogens. Id. at 17. Based on the results of the study, the authors hypothesize that
there is a relationship between “the number of infectious pathogens to which an individual has
been exposed and the extent of atherosclerosis.” Id. at 19. Dr. Shoenfeld attempts to draw an
analogy between the burden of infections and the burden of adjuvants, suggesting that both lead
to disease, but this article does not provide support for petitioner’s argument that the adjuvant in
the HPV vaccine causes disease.

        Because ASIA syndrome is characterized by chronic stimulation, Dr. Shoenfeld opines
that the condition is progressive, taking months or even years to cause disease. Pet. Ex. 12 at 7.
Usually, the syndrome begins with an “immediate allergic reaction to the vaccine.” Id. at 6. But
there may be illness after the second or third vaccine (the “boost effect”). Id. at 7. Regardless
of how the syndrome begins, there is a “slow progression of the disease from few clinical
manifestations . . .to a full-blown disease.” Id. Dr. Shoenfeld opines that the “full blown
diseases” caused by ASIA include systemic lupus erythematosus (SLE), rheumatoid arthritis
(RA), and multiple sclerosis (MS). Id.

        In support of his opinion that adjuvants may cause disease, Dr. Shoenfeld relies on
studies performed by Reeves et al.,11 where mice were injected with an adjuvant, which led to
the production of cytokines and autoantibodies. The mice eventually developed autoimmune
diseases like SLE and RA. Tr. 187-88; see also Pet. Exs. 12, 24, 29, 81. Dr. Shoenfeld
conceded, however, that the adjuvant used in the studies was pristane,12 not aluminum. Tr. 264-
65. Dr. Shoenfeld also acknowledged that while the mice developed lupus-like disease or RA, tr.
265, and petitioner did not have either of these conditions. Tr. 266.

     Dr. Shoenfeld also relies upon a condition known as macrophagic myofasciitis syndrome
(“MMF”) to support his medical theory based on adjuvants. See Pet. Ex. 16 at 4. MMF was

                                                            
10
   Espinola-Klein, C., et al., Impact of Infectious Burden of Extent and Long-Term Prognosis of
Atherosclerosis. Circulation (2002); 105: 15-21. Petitioner inadvertently failed to file this
exhibit; it is filed as Court Exhibit A.
11
   Satoh M., et al., Induction of Lupus-Associated Autoantibodies in BALB/c Mice by
Intraperitoneal Injection of Pristane, J. Exp. Med. Dec. 1, 1994; 180(6); 2341-46.
12
   Pristane is a hydrocarbon oil which “induces chronic inflammation when introduced into the
peritoneal cavity…causing a “lupus-like disease in mice.” Pet. Ex. 24 at 2. “In humans,
inadvertent cutaneous injection of it causes an “intense inflammatory reaction, often with skin
necrosis, permanent loss of hand function, or the need for amputation of affected digits.” Id;
Reeves et al., Induction of autoimmunity by pristane and other naturally-occurring hydrocarbons.
Trends Immunol. Sept. 2009; 30(9); 455-64.


                                                               9
 
identified and described by Gherardi,13 et al. in 1993, as an “emerging condition of unknown
cause, detected in patients with diffuse arthromyalgias and fatigue, characterized by muscle
infiltration by …macrophages” based on deltoid muscle biopsy. Resp’t’s Ex. O, Tab 13, at 1.
An MMF lesion may be seen in patients who have had an “intramuscular injection of aluminum
hydroxide-containing vaccines.” Id. All of the patients studied by Gherardi had received
vaccines containing aluminum hydroxide adjuvants (although none received HPV vaccines). In
addition to positive muscle biopsy findings, MMF patients may have abnormal diagnostic tests,
including abnormal electromyogram, elevated creatine kinase, and abnormal Gallium
scintigraphy studies. Id. at 9. Gherardi and his colleagues did not conclude that MMF lesions
cause systemic symptoms, but recommended further study of MMF patients. Id. at 9.

         Regarding the issue of whether the HPV vaccine can cause headaches, Dr. Shoenfeld
testified that he reviewed VAERS reports which show that patients receiving the Gardasil
vaccine were twice as likely to have migraine headaches as compared to those receiving the
Menactra vaccine.14 Tr. 215. But in a study done by Klein, et al.,15 a Kaiser Permanente study
of 346,972 doses of HPV administered to 189,629 females, the authors did not report an
association between HPV and headaches or the other illnesses alleged by petitioner. The study
did not reveal safety concerns other than “same day syncope and skin infections.” Resp’t’s Ex.
M at 5.

        Fundamental to Dr. Shoenfeld’s theory of causation is that there must be a genetic
predisposition for one to develop an “autoimmune disease or chronic fatigue.” Tr. 266; Pet. Ex.
14 at 2. Thus, he believes there was a “concert action” of genetics and environmental factors at
play in Ms. Rowan’s case. Tr. 195.

                                                   b. Respondent’s Expert, Dr. James L. Whitton

        Dr. James Lindsay Whitton was born in Scotland and obtained his medical training from
the University of Glasgow in Scotland in 1979. Five years later, he obtained a Ph.D. after
studying herpes virus transcription. In 1989, he joined the Scripps Research Institute in La Jolla,
California. At that institution, he taught neuropharmacology and immunology. Dr. Whitton has
acted as the editor of Virology since January 2006. He has written more than 160 articles
published in peer-reviewed journals. See Resp’t’s Ex. G at 2–13; Tr. 295–302. He is an expert
in the areas of virology and immunology. Tr. 302-05.

       Dr. Whitton was called by respondent to testify about petitioner’s medical theory, i.e.,
Althen Prong One. When asked whether the adjuvant in the vaccines Ms. Rowan received


                                                            
13
   Gherardi, R.K., et al., Macrophagic myofasciitis lesions assess long-term persistence of
vaccine-derived aluminum hydroxide in muscle. Brain (2001); 124: 1821-31.
14
   Dr. Shoenfeld testified that he selected the Menactra vaccine as a comparison because that
particular vaccine is given to the same age group as the Gardasil vaccine.
15
   Klein, N., et al., Safety of Quadrivalent Human Papillomavirus Vaccine Administered
Routinely to Females, Arch. Pediatr. Adolesc. Med. October 1, 2012; published online:
10.001/archpediatrics.2012.1451.  
                                                                     10
 
caused her injury, Dr. Whitton opined that there is “no biologically plausible pathway by which
the aluminum adjuvant could have done so.” Tr. 345.

         As background information, Dr. Whitton, like Dr. Shoenfeld, explained the purpose of
using adjuvants in vaccines. “Adjuvants are substances added to vaccines to enhance and direct
the immune response.” Resp’t’s Ex. K Tab 9 at 1. Adjuvants induce the “innate part of the
immune system” to “produce cytokines…which are soluble proteins.” Tr. 310-11. These
proteins communicate with the “adaptive immune system and instruct the cells to divide and
multiply… . [to] generate a very strong, vaccine-specific, antigen-specific response.” Tr. 311. It
is this response which protects the body against the pathogen (here HPV) if the body encounters
it in the future. Tr. 311. The aluminum adjuvant also serves a “depot function.” Tr. 334. The
adjuvant “holds the antigen and prevents it from dispersing, allowing the induction of a stronger
[] immune response…. ” Tr. 334; see also Resp’t’s Ex. K-Tab 9 at 1 and 4. While Dr. Whitton
agreed with Dr. Shoenfeld that the purpose of adjuvants in vaccines is to “increase the antigen-
specific immune response,” Dr. Whitton disagreed that aluminum adjuvants are harmful or that
they cause injury. Tr. 306, 315, 357-58.

        Dr. Whitton bases his opinion that aluminum used as an adjuvant does not cause injury
on the following. First, aluminum is a commonly used adjuvant that has been rigorously tested
and found to be safe when used as an adjuvant in vaccines. Tr. 307; see also Resp’t’s Ex. N at 9.
In his report, Dr. Whitton cites to the World Health Organization (“WHO”) Global Advisory
Committee on Vaccine Safety (GACVS) which states “[a]t present there is no evidence of a
health risk from aluminum-containing vaccines.” Resp’t’s Ex. N at 11. Moreover, Dr. Whitton
is not aware of any medical literature or studies that suggest that aluminum, when used as an
adjuvant in vaccines, causes any injury. Tr. 357-58.

        As described above, Dr. Shoenfeld relied on the Reeves studies where pristane was
injected in mice, inducing autoimmune diseases (SLE and RA). Dr. Whitton did not agree that
the results from those studies supported Dr. Shoenfeld’s theory. Tr. 308. Dr. Whitton explained
that pristane is a hydrocarbon and a “relatively toxic compound,” and there is no evidence to
suggest that aluminum causes SLE or arthritis. Tr. 308.

        Dr. Whitton also disagreed with Dr. Shoenfeld’s argument that MMF provides evidence
of a systemic disease caused by aluminum adjuvant in vaccines. Tr. 316. Dr. Whitton explained
that MMF is simply a histological finding, i.e., a lesion that is located at the site of vaccination in
the arm. Tr. 316, 336. There is no proof that an MMF lesion causes systemic disease. Tr. 317.
Dr. Whitton testified that follow-up animal studies were done by Verdier et al., to investigate
whether MMF lesions cause disease. Tr. 318; Resp’t’s Ex. O. The studies found that MMF
lesions decreased over time, suggesting that the lesion ultimately cleared without causing
systemic disease.16 Tr. 318-19; see also Resp’t’s Ex. O, Tab 14 (“no correlation between
histological findings of macrophagic myofasciitis in biopsies and the clinical symptoms”);

                                                            
16
   Verdier F., et al., Aluminum assay and evaluation of the local reaction at several time points
after intramuscular administration of aluminum containing vaccines in the Cynomolgus monkey,
Vaccine 23 (2005) 1359-67.


                                                               11
 
Resp’t’s Ex. O, Tab 21, 22. And importantly, as it relates to this case, Dr. Whitton emphasized
there is no allegation or evidence that petitioner ever had an MMF lesion. Tr. 316.

         In another paper related to MMF, by Guis et al.,17 ten patients with diagnosed muscular
diseases were found to have an MMF lesion after vaccination. These patients were also found to
have genetic abnormalities associated with autoimmune diseases. Tr. 319-21. Dr. Whitton
testified that Dr. Shoenfeld used the Guis study to suggest that MMF was associated with
autoimmune systemic disease. Id.; Resp’t’s Ex. N at 7. But Dr. Whitton believes the Guis study
is “flawed” because the participants of the study already had autoimmune diseases and as such
were “preselected…in favor of having a genetic predisposition.” Tr. 355-56. (Dr. Whitton notes
that Dr. Shoenfeld ultimately agrees with Dr. Whitton’s statement that there was not an
appropriate control group in the Guis study). See Resp’t’s Ex. N at 8.

         Dr. Whitton also disagreed that adjuvants induce chronic stimulation of the immune
system. Tr. 332. Dr. Whitton explained that Dr. Shoenfeld could easily demonstrate this
premise with a study, but no such study has been performed. Tr. 350-51. Dr. Whitton further
explained that if Dr. Shoenfeld’s statement were true, then second and third doses of vaccines,
i.e., boosters, would not be needed. Tr. 332. Moreover, any symptoms of adjuvant activation of
the immune system are usually of short duration (i.e., “achy, sore arm”) and not chronic. Tr.
332-33.

        Dr. Whitton agreed with Dr. Shoenfeld that there is a “very clear genetic predisposition”
for some autoimmune diseases. Tr. 353. Both experts agree that a number of autoimmune
conditions are related to human leukocyte antigen (HLA) genes. Id. Autoimmune diseases
known to be associated with a genetic predisposition include ankylosing spondylitis, Reiter’s
syndrome, and SLE. Tr. 313. But Dr. Whitton is not aware of any overlap between genetic
predisposition, autoimmune disorders, and adjuvants, akin to what Dr. Shoenfeld posits here. Tr.
354.

       Lastly, Dr. Whitton testified that ASIA is not a generally accepted medical theory,
diagnosis or syndrome, within the medical community. Tr. 306. Dr. Whitton characterized it as
“a hypothesis…rather than an established syndrome.” Tr. 313. As an example of the fact that
ASIA is not an accepted theory, Dr. Whitton cited a 2013 comprehensive review article covering
adjuvants, authored by Reed, a “world expert” on adjuvants.18 See Tr. 341. There is no
reference to ASIA or the ASIA syndrome in the review article. Tr. 341; Resp’t’s Ex. R.

                                                   c. Respondent’s Expert, Dr. Edward W. Cetaruk

       Dr. Edward Cetaruk is an emergency medicine physician and a medical toxicologist at
Porter Hospital in Denver, Colorado. Tr. at 368. Dr. Cetaruk teaches at the University of
Colorado Medical Center in the Medical Toxicology Fellowship Program. He graduated from

                                                            
17
   Guis S., et al., HLA-DRB1*01 and macrophagic myofasciitis, Arthritis & Rheumatism, Vol.
46, No. 9, September 2002, pp. 2535-37.
18
   Reed S.G., et al., Key Roles of adjuvants in modern vaccines. Nature Medicine, Vol. 19, No.
12, December 2013, pp1597-1608.
                                                                    12
 
the School of Medicine at New York University in 1991. Dr. Cetaruk received advanced
training in emergency medicine. In 1996, he completed a fellowship in medical toxicology. The
American Board of Emergency Medicine recognized him as having special qualifications in
medical toxicology in 2000. He became a fellow in the American College of Medical
Toxicology in 2009. Resp’t’s Ex. S at 1-2.

       Like Dr. Whitton, Dr. Cetaruk was offered as an expert as to Althen Prong One, to
address petitioner’s medical theory regarding aluminum adjuvants. Dr. Cetaruk also provided
background information about aluminum and aluminum adjuvants. Tr. 377.

        Dr. Ceturak testified that aluminum has been used as an adjuvant in vaccines for over 70
years and has a safe record with a “low incidence of reported adverse events.” Resp’t’s Ex. K-
Tab 5 at 1. Dr. Ceturak is not aware of any other evidence which suggests that aluminum used
as an adjuvant in vaccines causes systemic illness or disease. Tr. 399-400. The adjuvant used in
the HPV vaccine, he observed, is 225 µg (nanograms) of aluminum hydroxy sulfate, an
aluminum salt. Tr. 379-80. Dr. Cetaruk explained that all humans are exposed to aluminum
even before birth with the primary route of exposure being ingestion, through food and water.
Tr. 380-83; see also Resp’t’s Ex. K, Tab 9 at 8. Other sources of aluminum include medications
such as aspirin and antacids. Tr. 381. Another route of exposure of aluminum is by inhalation.
Welders are exposed to inhaled aluminum by virtue of their work environment. Tr. 381.
Transdermal exposure is limited but occurs from use of antiperspirants. Tr. 381–82. The daily
average intake of aluminum is between 7 to 10 milligrams (“mg”) per day. Tr. 383.

         Dr. Cetaruk testified that most of the aluminum we ingest is not absorbed into the body,
but is instead excreted by the kidneys. Tr. 384–85; Resp’t’s Ex. K, Tab 9 at 8. More than 90%
of the aluminum that is absorbed in the systemic circulation is bound to a protein called
transferrin, or other smaller proteins, and distributed throughout the tissues of the body. Tr. 385-
86. More than half is distributed to bone, with the balance distributed to other organs such as the
spleen, liver, brain and muscle. Tr. 386. Citing the study by Priest,19 Cetaruk testified that 54%
of aluminum is in bones, 13% in skin tissues, and 14% in muscle. Resp’t’s Ex. K, Tab 17, at 9;
Tr. at 387-88. Only 1% is found in the central nervous system. Id. In the brain, aluminum is
incorporated into extracellular fluid where it can remain for a period of time. Tr. 388-89.
Aluminum continuously comes into and out of the brain. Tr. 389-90.

        When a vaccine containing an aluminum adjuvant is injected, the surrounding tissue
responds and interacts with the immune system (as described above by Dr. Whitton). Tr. 391.
Macrophages respond by engulfing and “eat[ing] the adjuvant.” Tr. 391. Then, the
“macrophage[s] migrate away from the immunization site… go[] out to lymph nodes and [] out
to the circulation.” Tr. 392. Eventually, the macrophage undergoes cell death, and aluminum is
released from the cell. That “aluminum goes back into circulation….” Tr. 392. It then gets
“handled the same way as aluminum that would have been ingested orally or inhaled or ingested

                                                            
  Priest N.D., The biological behavior and bioavailability of aluminum in man, with special
19

reference to studies employing aluminum-26 as a tracer: review and study updated, J. Environ.
Monit., 2004, 6, 375-403.


                                                               13
 
through [the] skin.” Tr. 393. Once aluminum is picked up by macrophages and carried out to
the tissues, it no longer has an adjuvant effect. Tr. 398.

         The HPV vaccine in this case, contains approximately 225 µg (nanograms) of aluminum
adjuvant. Tr. 399. A person normally absorbs between 200-500 µg of aluminum daily through
ingestion.20 Tr. 398. Normal serum levels of aluminum are in the range of 5 to 6 micrograms
per liter) (“mcg/L”). Tr. 428-29. Aluminum toxicity may occur when aluminum levels reach
twenty or more times higher than normal. Tr. 428–29. But Dr. Ceturak testified that he has not
seen chronic fatigue syndrome associated with elevated levels of aluminum. Tr. 430. Likewise,
Dr. Ceturak has not seen elevated levels of aluminum cause headaches unless levels are very
high. Tr. 430–31.

        Dr. Cetaruk testified that dialysis patients are prone to aluminum toxicity because their
kidney function is impaired and unable to rid the body of excess aluminum. Also, the fluid used
in the dialysis procedure (dialysate) contains a significant amount of aluminum. Tr. 393–94.
Signs and symptoms of aluminum toxicity include anemia, abnormal bone development, and
sometimes encephalopathy.21 Tr. 395-96. Blood, serum, or plasma may be tested to diagnose
aluminum toxicity. Tr. 396–97.

                                                   d. Petitioner’s Treating Physicians

        Ms. Rowan’s primary care physician, Dr. Fogarty, treated petitioner for ongoing
headaches beginning in 2007. Dr. Fogarty conducted tests and prescribed medications which
resulted only in minimal relief. On February 9, 2009, Ms. Rowan followed up with Dr. Fogarty
for headaches and it was noted at that visit that petitioner’s parents were concerned about a link
to the HPV vaccines. Dr. Fogarty did not conclude, however, that the vaccines caused or
contributed to Ms. Rowan’s symptoms.

        In late December 2008, Ms. Rowan began seeing Dr. Powers, a neurologist, for
headaches. After reviewing her medical history, Dr. Powers diagnosed Ms. Rowan with chronic
daily headaches and prescribed Topamax. Ms. Rowan continued to follow up with Dr. Powers
from March 2009 to January 2010. The records do not note that Dr. Powers drew any
association between the HPV vaccines and Ms. Rowan’s symptoms.

        Ms. Rowan began seeing Dr. Porter, a pediatric hematologist, in October 2009. Pet. Ex.
3 at 20-21. Although Dr. Porter was advised by Ms. Rowan’s father that he believed Ms.
Rowan’s headache symptoms all dated back to her last HPV vaccine, Dr. Porter did not attribute
Ms. Rowan’s symptoms to the vaccine.



                                                            
20
    Dr. Cetaruk testified that the average person takes in 7-10 mg. of aluminum per day, but
absorbs 200-500 mcg per day via their gastrointestinal tract.
21
    Dr. Cetaruk defines encephalopathy as “abnormal brain function . . . deterioration of cognitive
function, and as it gets more severe, more basic functions manifesting as altered mental status,
delirium, confusion . . . . [and] poor functioning of the brain.” Tr. 435.  
                                                                      14
 
       During the hearing, Mr. Rowan described Dr. Shapiro’s involvement with his daughter’s
diagnosis and treatment. Mr. Rowan testified that in March 2010, he brought petitioner to see
Dr. Shapiro, who examined her and conducted an EMG. Tr. 41. The EMG showed that there
were no abnormalities, although at the time Ms. Rowan was not walking and was using a
wheelchair. Pet. Ex. 44 at 2. Mr. Rowan testified that Dr. Shapiro thought that Ms. Rowan
would be able to walk again but would need physical therapy in order to do so. Tr. 43. There is
no evidence in the record indicating that Dr. Shapiro associated Ms. Rowan’s condition with her
HPV vaccines.

        During the hearing, Mr. Rowan testified that none of Ms. Rowan’s treating physicians
attributed her condition to the HPV vaccines. Tr. 44.

                          e.   Evaluation of the Evidence

       Althen Prong One requires a petitioner to set forth a medical theory explaining how the
received vaccine could have caused the alleged injury. Dr. Shoenfeld failed to provide
persuasive or reliable evidence to support his theory that the adjuvant aluminum in the HPV
vaccine chronically stimulates the immune system in a person with a genetic predisposition,
causing ongoing headache.

        Dr. Shoenfeld concedes that ASIA is not a proven theory and that the mechanism
whereby adjuvants cause autoimmune illness is not known. He is unable to state whether the
aluminum adjuvant, or the virus-like particles in the vaccine, or both, cause injury. Petitioner
also failed to provide an evidentiary foundation or factual support for the premise that an
aluminum adjuvant causes chronic stimulation of the immune system that in turn causes
headaches or the other illnesses alleged.

        Moreover, Dr. Shoenfeld relied on studies involving the adjuvant pristane, a toxic
hydrocarbon which is not comparable to aluminum. Thus, the adjuvant studies he cited are not
relevant to the facts and circumstances of this case. Dr. Shoenfeld argued that MMF is evidence
of adjuvant-induced injury but the authors of the relevant studies did not reach that conclusion.
Further, since petitioner did not have MMF, the argument based on those studies is not relevant
to the facts here. Most importantly, Dr. Shoenfeld provided no evidence that the doses of
aluminum used in the vaccinations at issue were toxic or caused the illnesses alleged by
petitioner. Likewise, he provided no evidence of any genetic disorder that would predispose one
to an immune disorder given the set of facts and circumstances relevant to this case.

       Lastly, none of petitioner’s treating physicians opined that HPV vaccines can cause
headaches or any other condition experienced by petitioner. In summary, petitioner failed to
provide preponderant evidence to support Prong One of Althen.

                       (2) Althen Prong Two: Logical Sequence of Cause and Effect

        Under Althen Prong Two, a petitioner must prove that there is a “logical sequence of
cause and effect showing that the vaccination was the reason for the injury.” Capizzano, 440
F.3d at 1324 (citing Althen, 418 F.3d at 1278). “Petitioner must show that the vaccine was the


                                                15
 
‘but for’ cause of the harm … or in other words, that the vaccine was the ‘reason for the injury.’”
Pafford, 451 F.3d at 1356 (citations omitted).

                              a. Petitioner’s Expert, Dr. Shoenfeld

        Dr. Shoenfeld testified that the aluminum adjuvant in the HPV vaccine induced
petitioner’s chronic fatigue and headaches via the ASIA mechanism. Dr. Shoenfeld argued that
petitioner’s symptoms are like those seen with MMF. Pet. Ex. 12 at 5-6. He explained the
process as follows: “The aluminum is deposited in the muscles and can induce muscle fiber
necrosis and hence the severe fatigue … (and) nanoparticles of the aluminum are diffused to the
brain to induce … headaches.” Id. at 6. But petitioner’s medical records do not document that
Ms. Rowan had MMF or muscle fiber necrosis. Further, Dr. Shoenfeld does not provide any
facts from the petitioner’s medical records or any other evidentiary foundation to support his
conclusion that petitioner’s headaches were caused by nanoparticles of aluminum in her brain.

         Organ or tissue biopsies can be performed to verify the diagnosis of MMF, tr. 242-43, but
no such biopsies were ordered by any of petitioner’s treating physicians, and there is no evidence
in the record to suggest that petitioner had MMF. Dr. Shoenfeld agreed that the results of the
following studies were normal: X-rays and MRI studies performed on petitioner’s brain and
lumber spine, MR venogram studies, CT scans of her head and sinuses, and EMG studies. All of
these diagnostic studies were normal. Tr. 223-28. Petitioner’s ANA test was also normal. Tr.
225. Dr. Shoenfeld agreed that petitioner’s CSF was normal. Tr. 227. Dr. Shoenfeld conceded
that there are no antibodies specific for aluminum in any of petitioner’s test results. Tr. 244. He
testified that there is a blood test for aluminum but the petitioner was never tested. Tr. 286-87.
Petitioner went “through a lot of examinations, quite sophisticated, [] all of them were
interpreted as normal.” Tr. 209.

       Petitioner’s only abnormal lab work was a low white blood count of 3.2, with elevated
lymphocytes of 54, drawn on September 29, 2009. Pet. Ex. 2 at 1. Dr. Shoenfeld testified that
the high lymphocyte level was evidence of stimulation of the immune system. Tr. 206.

        One of the basic principles of Dr. Shoenfeld’s medical theory is that one must be
genetically predisposed to develop an autoimmune illness. Tr. 194- 95; 266. Dr. Shoenfeld
conceded, however, that there was no evidence to suggest that the petitioner had any abnormal
genetic predisposition, and, in fact, none of her physicians ever ordered that she undergo genetic
testing. Tr. 266. Moreover, pursuant to Dr. Shoenfeld’s theory of adjuvant-induced autoimmune
disease, initial symptoms progress to “full-blown disease” such as SLE, RA, MS, or another
similar disease. See Pet. Ex. 12 at 7. Here, petitioner never developed one of these chronic
illnesses, but instead, after a diet and vitamin regimen, she recovered and returned to her baseline
health.

                              b. Respondent’s Expert, Dr. Stephen J. McGeady

       Dr. Stephen McGeady is a retired board certified immunologist who practiced at the
Nemours Foundation/Alfred I. duPont Hospital for Children in Wilmington, Delaware. Tr. 448;
Resp’t’s Ex. B. Although he has retired from his position as an attending physician in the


                                                16
 
Department of Allergy and Immunology in the Department of Pediatrics at the Nemours
Foundation, Dr.McGeady remains a professor of pediatrics at Thomas Jefferson University in
Philadelphia, Pennsylvania. Tr. 440. He graduated from the Creighton University School of
Medicine in 1967. He received specialized training in pediatrics and allergy and is board-
certified in pediatrics, allergy and immunology, and diagnostic laboratory immunology. Tr. 441.
He served as the Chief of the Division of Allergy and Immunology in the Department of
Pediatrics at duPont Hospital from 1989 until 2007. Dr. McGeady has published over 60 articles
in peer-reviewed journals. See Resp’t’s Ex. B.

        Dr. McGeady opined that petitioner’s HPV vaccine did not cause her to suffer from any
autoimmune or auto-inflammatory condition or disease. Tr. 450. He did not believe that
petitioner’s complaints of headache, fatigue, paralysis, abdominal pain, or weight loss were
related to the HPV vaccines. Tr. 472. As for petitioner’s headaches, Dr. McGeady testified that
those symptoms experienced pre-vaccination were associated with “recurrent viral or bacterial
infection[s]…[including] strep throat on one occasion.” Tr. 451; 488. Petitioner’s headaches in
March 2008 were associated with the onset of petitioner’s menses. Tr. 452. As for daily
headaches, those did not occur until October 2008, based upon the testimony of petitioner’s
father. Pet. Ex. 1; Tr. 452. Dr. McGeady testified that petitioner’s headaches at that time were
“very classic for migraine headaches” in that she had sensitivity to light and sound, although
another feature of petitioner’s headaches, the sensation of “something pushing down on her
head,” was not typical for migraines. Tr. 468.

        Dr. McGeady also testified that petitioner’s diagnostic tests were normal and did not
show evidence of any autoimmune disease process. Tr. 454. The MRIs performed in 2009 were
normal, as were the results from the CT, EMG, and Lyme testing. Tr. 454-55. Cerebrospinal
fluid was normal. Tr. 456. Nonspecific testing for the presence of autoantibodies, such as ANA,
that often occur in autoimmune illnesses was normal. Tr. 457. Likewise, testing for C-reactive
protein was normal. Tr. 457. Petitioner had an abnormal white blood cell count in September
2009, but Dr. McGeady testified that petitioner had a cough and sore throat, and did not feel
well, indicating that petitioner had a viral infection. Tr. 487-488. Dr. McGeady attributed the
minor abnormality in petitioner’s white blood counts to her viral infection and not to any adverse
reaction to vaccination. Id.

        By March of 2010, petitioner’s condition had worsened and she was unable to walk. Tr.
469. Diagnostic testing during the March 4, 2010 admission was normal, including but not
limited to tests for celiac disease, cortisol levels, Lyme’s disease, cryptococcal disease, and CSF
fungal disease. Tr. 465. EMG studies were also normal. Tr. 469-70. Petitioner did have an
elevated IgE, which Dr. McGeady attributed to petitioner’s history of asthma. Tr. 465.
Petitioner’s discharge diagnoses from that admission were: “Head pain of uncertain etiology;
flaccid paralysis of lower extremities without organic or neurological markers, uncertain
etiology; and possible conversion disorder.” Tr. 466; Pet. Ex. 8. Dr. McGeady testified that
petitioner may have had a functional illness, or an illness that was psychologically based. Tr.
473.




                                                17
 
       Numerous medications, including steroids, were administered to petitioner for her
headaches, without success, and Dr. McGeady testified that the fact that the medications did not
work supported his opinion that petitioner did not have an organic condition. Tr. 467.

        As for petitioner’s allegation that she suffered from CFS due to her vaccines, Dr.
McGeady testified that he did not see any support for this diagnosis in petitioner’s medical
record. Tr. 471.

                                                           c. Evaluation of the Evidence

        The basic problem with petitioner’s argument as to Althen Prong Two is that there is no
evidence to support a finding that petitioner had an adjuvant-induced illness. Petitioner did not
have any symptoms of aluminum toxicity, and none of her treating physicians suspected or
diagnosed her with that condition. Petitioner underwent extensive testing, but there was no
evidence of chronic stimulation of petitioner’s immune system. Petitioner did not have an
immediate allergic reaction to the vaccine. Her condition did not progress to a chronic illness as
described by Dr. Shoenfeld to occur with ASIA such as SLE or RA. There is no evidence that
petitioner had MMF and no evidence of a genetic predisposition.

        Dr. Shoenfeld’s opinion that petitioner had an adjuvant-induced illness in spite of the fact
that she had no abnormal diagnostic studies is in stark contrast with a patient he describes in a
medical article.22 The patient described in the article had a silicone breast implant, and
developed CFS following an injury to the breast that resulted in a silicone leak. Confounding the
picture was the fact that the patient’s illness also followed the second dose of hepatitis B vaccine.
Dr. Shoenfeld and co-author Agmon-Levin concluded that “co-exposure to vaccine and silicone
created an augmented adjuvant effect, leading to CFS.” Pet. Ex. 15 at 3. But unlike petitioner,
that patient had an abnormal physical examination (Raynaud symptoms and lymphadenopathy)
and numerous abnormal tests (polyclonal gammopathy, elevated anti-adrenal hormone, anti-
striated and anti-smooth muscle antibodies, elevated rheumatoid factor titers and abnormal
immune complex blood work). The patient’s brain MRI was also abnormal and revealed
“multiple scattered T2 signal hyper intensities in the frontal and parietal occipital deep while
matter and sub-cortical while matter.” Pet. Ex. 15 at 3. The patient’s CSF showed elevated IgA
and albumin. Id.

       In contrast to the patient described above, Ms. Rowan had no abnormal physical findings
and no abnormal blood work to evidence an immune disorder. The only abnormality referenced
by Dr. Shoenfeld is an abnormal WBC count of 3.2, with elevated lymphocytes reported in
September 2009, over one year after the administration of Ms. Rowan’s last HPV vaccine.
According to Dr. Shoenfeld, this abnormal finding indicated stimulation of petitioner’s immune
system. Tr. 206. But Dr. Shoenfeld offered no medical literature or other support for his
argument that this sole abnormality is sufficient evidence to support his theory that the HPV
vaccinations caused a chronic dysfunction of petitioner’s immune system leading to headaches

                                                            
22
  Agmon-Levin N., Chronic fatigue syndrome with autoantibodies- The result of an augmented
adjuvant effect of hepatitis-B vaccine and silicone implant. Autoimmunity Reviews 8 (2008)
(52-55) (Pet. Ex. 15).
                                                                          18
 
and CFS. Dr. McGeady’s explanation that petitioner’s isolated WBC results were due to a viral
infection and not to any adverse reaction to vaccination is much more credible, given the lack of
any other supportive evidence to the contrary.

        In summary, petitioner has not provided any foundational support to show that she
suffered an adjuvant- induced illness, and therefore the undersigned finds that petitioner has
failed to provide preponderant evidence of a logical sequence of cause and effect showing that
the HPV vaccines were the reason for petitioner’s alleged injuries.

                                            (3) Althen Prong Three: Proximate Temporal Relationship

       Under Althen Prong Three, petitioner must provide “preponderant proof that the onset of
symptoms occurred within a timeframe for which, given the understanding of the disorder’s
etiology, it is medically acceptable to infer causation-in-fact.” De Bazan v. Sec’y of Health &
Human Servs., 539 F.3d 1347, 1352 (citing Pafford, 451 F.3d at 1358). The acceptable temporal
association will vary according to the particular medical theory advanced in the case. See
Pafford, 451 F.3d at 1358.

                             a.       Petitioner’s Expert, Dr. Shoenfeld

        Dr. Shoenfeld testified that petitioner received multiple vaccines, including the HPV
vaccines that contained the adjuvant aluminum. Tr. 234. In his opinion, the accumulation of
aluminum after the third HPV vaccine led to her condition. Tr. 234. Petitioner received her first
HPV vaccine on August 21, 2007, and her second HPV vaccine on November 12, 2007. Pet. Ex.
1 at 3. “There were no reported adverse reactions from either of these HPV vaccines.” Pet. Ex.
12 at 2. Petitioner’s third HPV vaccine was given on July 14, 2008. More than three months
later, on October 20, 2008, petitioner complained of fatigue, sore throat and nasal congestion. P.
Ex. 4 at 5. On October 28, 2008, petitioner returned to her primary care physician, Dr. Fogarty,
complaining of ongoing headache and fatigue. Pet. Ex. 4 at 5; see also Pet. Ex. 12 at 2. Dr.
Shoenfeld testified that petitioner therefore developed ASIA syndrome “two months after the
third Gardasil injection.” Tr. 245. Dr. Shoenfeld opined that the temporal relationship between
the third vaccine administered on July 14, 2008 and the petitioner’s onset of symptoms (ongoing
headache and fatigue) in October 2008 was appropriate. Pet. Ex. 11 at 2.

       Dr. Shoenfeld testified that ASIA syndrome is characterized by a “high incidence of
immediate allergic reaction to the vaccine, followed by “chronic and persistent stimulation of the
immune system by the adjuvant.” Pet. Ex. 11 at 3. In some patients the adverse reaction does
not appear for days, weeks, months, or years. Id. at 4; Tr. 245, 251.

      Dr. Shoenfeld relied upon papers by Hernan and Mikaeloff23 published in the Journal of
Neurology “which show that multiple sclerosis can appear after two and a half to three years in


                                                            
23
   Hernan M. et al., Recombinant Hepatitis B Vaccine and the Risk of Multiple Sclerosis: A
Prospective Study. Neurology 2004; 63: 838-42; Mikaeloff, Y. et al., Hepatitis B vaccine and
risk of CNS inflammatory demyelination in childhood. Neurology 2009; 72: 873-80.
                                                                 19
 
patients with HPV vaccine.” Tr. 246-47, 249. Dr. Shoenfeld conceded that these articles deal
with demyelinating illnesses, and that petitioner did not have a demyelinating illness. Tr. 249-50.

               b. Respondent’s Expert, Dr. McGeady

        Dr. McGeady testified that the timeframe of petitioner’s onset of injuries, particularly
those occurring October 2008 and later, and which occurred three months or more after
petitioner’s last HPV vaccination, was not persuasive evidence of an association with the
vaccinations. Tr. 473.

               c. Evaluation of the Evidence

        Petitioner’s expert failed to provide a medically appropriate timeframe for onset given his
proposed theory. According to Dr. Shoenfeld, any timeframe appears to be acceptable, from
days to weeks to years. However, Dr. Shoenfeld did not offer any facts or basis to support his
opinion that the timeframe from vaccine to onset should be so variable. And he offered no
explanation for why the timeframe from petitioner’s third HPV vaccine to the onset of symptoms
in October 2008, nearly three months later, was appropriate.

        Moreover, Dr. Shoenfeld did not explain the inconsistency between a significant tenet of
his proposed theory and Ms. Rowan’s clinical course. Dr. Shoenfeld testified that a high
incidence of patients with an adjuvant-induced injury have an immediate allergic reaction to the
vaccine, but that did not occur in petitioner’s course. Petitioner had no adverse reactions to her
first and second HPV vaccines, and no reaction to the third dose until October 2008, based on
Dr. Shoenfeld’s testimony and expert reports. Dr. Shoenfeld also gave no explanation to
support his opinion that the onset of ASIA is so variable.

       Even assuming that the petitioner had provided evidence that would meet her burden
under Althen Prong Three, petitioner has failed to establish by a preponderance of the evidence
Althen Prongs One and Two, and she is therefore not entitled to compensation.

    VI.    Conclusion

        For the reasons discussed above, the undersigned finds that petitioner has not established
entitlement to compensation and her petition must be dismissed. In the absence of a timely filed
motion for review filed pursuant to Vaccine Rule 23, the clerk is directed to enter judgment
consistent with this decision.

          IT IS SO ORDERED.

                                                             s/Nora Beth Dorsey
                                                             Nora Beth Dorsey
                                                             Special Master 




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