           IN THE UNITED STATES COURT OF FEDERAL CLAIMS

                           OFFICE OF SPECIAL MASTERS

**********************
LAUREN SHORTNACY,        *                           No. 10-827V
                         *                           Special Master Christian J. Moran
             Petitioner, *
                         *                           Filed: September 15, 2014
v.                       *
                         *                           Decision on the record; statute of
SECRETARY OF HEALTH      *                           limitations; insufficient
AND HUMAN SERVICES,      *                           proof of causation; human
                         *                           papillomavirus vaccine (“HPV”);
                         *                           nodular sclerosing Hodgkin’s
             Respondent. *                           disease.
**********************

Patricia Leigh O’Dell, Beasley, Allen, et al., Montgomery, AL, for petitioner;
Ann Martin, United States Dep’t of Justice, Washington, DC, for respondent.

            PUBLISHED DECISION DENYING COMPENSATION1

       Lauren Shortnacy filed a petition under the National Childhood Vaccine
Injury Act, 42 U.S.C. §300aa—10 through 34 (2006), on December 2, 2010. Ms.
Shortnacy alleges that the doses of the human papillomavirus (“HPV”) vaccine she
received on July 23, 2007, September 26, 2007, and January 28, 2008, caused her
to suffer nodular sclerosing Hodgkin’s disease (“Hodgkin’s”).

      In support of her claim, Ms. Shortnacy has submitted opinions from her
experts, Michael McCabe, Ph.D., a toxicologist and immunologist, and Stephen L.
Davidson, M.D., an oncologist. Dr. McCabe provided a theory to explain how the
HPV vaccine could have caused Ms. Shortnacy’s Hodgkin’s. Dr. Davidson
provided an opinion on the onset of Ms. Shortnacy’s Hodgkin’s in response to the
       1
          The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17,
2002), requires that the Court post this decision on its website. Pursuant to Vaccine Rule 18(b),
the parties have 14 days to file a motion proposing redaction of medical information or other
information described in 42 U.S.C. § 300aa—12(d)(4). Any redactions ordered by the special
master will appear in the document posted on the website.
Secretary’s argument that the case was untimely filed and barred by the Vaccine
Act’s statute of limitations. In opposition to Ms. Shortnacy’s expert opinions, the
Secretary offered the opinion of Kenneth L. McClain, Ph.D., M.D., an oncologist.
In lieu of proceeding with a previously scheduled entitlement hearing, Ms.
Shortnacy filed a motion for a ruling on the record on July 7, 2014. For the
reasons set forth below, Ms. Shortnacy’s petition is untimely and she has not
demonstrated that she is entitled to compensation.

I.    Background

      A.     Medical History

       Ms. Shortnacy received doses of the HPV vaccine on July 23, 2007,
September 26, 2007, and January 28, 2008. On November 21, 2007, Ms.
Shortnacy went to a clinic where she reported a cough, congestion, sore throat, and
swollen lymph nodes. Ms. Shortnacy did not complain of itchiness. Findings of
Fact, issued Mar. 30, 2012, at 6.

      On December 3, 2007, Ms. Shortnacy saw her pediatrician, Dr. Paris, where
she complained of swollen lymph nodes in her neck area and dry, itchy skin. Id.
By mid-December 2013, the swelling in Ms. Shortnacy’s lymph nodes decreased,
but her lymph nodes did not return to normal size. Id. at 11. After the swelling
returned, Ms. Shortnacy saw Dr. Paris on January 7, 2008, complaining of swollen
glands under her left armpit. Id. Ms. Shortnacy underwent a lymph node biopsy
and was diagnosed with Hodgkin’s on February 1, 2008. Id. at 11-12.

       Ms. Shortnacy received treatment at the AFLAC Cancer Center and Blood
Disorders Service at Children’s Health Care of Atlanta and underwent six rounds
of chemotherapy by July 2008. Exhibit 5 at 324. After completing chemotherapy,
Ms. Shortnacy received treatment for intracranial hypotension and avascular
necrosis. Exhibit 10 at 3-5, 14-16, 26. By her December 14, 2010 cancer survivor
consultation, Ms. Shortnacy reported that she was doing well and studying nursing
as a sophomore in college. Id. at 44.

      B.     Procedural History

       The events associated with the prosecution of Ms. Shortnacy’s claim are set
forth in the sections below beginning with the factual development of her case
followed by the submission of expert opinions and preparation for hearing.

                                         2
            1.     Factual Development

       In support of her December 2, 2010 petition, Ms. Shortnacy filed medical
records (exhibits 1-10) on February 15, 2011, and March 31, 2011. Her February
15, 2011 filing also included an amended petition, changed only in marking her
exhibits as numbered rather than lettered. A status conference was held on April 6,
2011, during which respondent indicated that Ms. Shortnacy’s medical histories
suggest her symptoms began prior to December 2007. In response, Ms. Shortnacy
proposed providing an affidavit from Dr. Paris, her doctor in December 2007. Ms.
Shortnacy was ordered to submit an affidavit from herself and Dr. Paris describing
her condition before December 2007. Order, issued Apr. 6, 2011. Ms. Shortnacy
filed the affidavits (exhibits 11-12) and a report from Dr. McCabe (exhibit 13) in
early July 2011.

      A status conference was held on July 11, 2011. During this conference, the
Secretary again raised her concern over the timeliness of Ms. Shortnacy’s petition
and proposed a fact hearing to resolve the onset of her symptoms. Consequently,
the parties began planning for a fact hearing.

      Ms. Shortnacy filed additional records from Columbus Clinic and Acute
Care on July 19, 2011 (exhibit 14). On August 19, 2011, Ms. Shortnacy filed a
second amended petition in which she changed the characterization of her
December 3, 2007 itching from “extreme” to “mild.” Compare Pet., filed Dec. 2,
2010, ¶ 3 with 2d Am. Pet., filed Aug. 19, 2011, ¶ 3.

       The Secretary assessed Ms. Shortnacy’s claim in her report and concluded
that Ms. Shortnacy was not entitled to compensation for two separate reasons.
Resp’t’s Rep., filed Aug. 26, 2011, at 2. First, notwithstanding the shift in
allegations from severe itching to mild itching, the Secretary concluded Ms.
Shortnacy was displaying symptoms of Hodgkin’s more than 36 months before she
filed her petition. As such, the statute of limitations barred Ms. Shortnacy’s
petition. Id. at 11-13.

      In addition to asserting that Ms. Shortnacy’s petition was time-barred, the
Secretary also concluded that Ms. Shortnacy failed to fulfill the criteria for a
Vaccine Table injury, or demonstrate by a preponderance of the evidence her
Hodgkin’s was caused by the HPV vaccines she received. Id. at 13-16.

       A status conference was held on September 1, 2011, during which the
parties discussed proceeding with a November 2011 fact hearing in light of
                                         3
respondent’s Rule 4 report. In an order issued following the conference, Ms.
Shortnacy was directed to file affidavits from herself and her mother detailing the
severity of her fatigue from July to December 2007, and whether her itching
started before December 3, 2007.

      In response to the September 1, 2011 order, Ms. Shortnacy filed affidavits
(exhibit 15-21), as well as school and employment records (exhibits 19-20). The
affidavits generally described Ms. Shortnacy’s fatigue and itching as beginning in
late December 2007.

      A factual hearing was held on November 1, 2011. Ms. Shortnacy, her
mother, father, Dr. Paris, and a family friend testified via videoconferencing at the
hearing. The parties completed submitting their posthearing briefs in February
2012.

       On March 30, 2012, the findings of fact were issued stating that Ms.
Shortnacy was experiencing “an unusual amount” of itchiness on December 3,
2007. Findings of Fact at 7. Additionally, Ms. Shortnacy’s itchiness began prior
to her December 3, 2007 visit. Id. at 9. These findings did not resolve the date of
onset of Ms. Shortnacy’s Hodgkin’s disease.

              2.     Expert Opinions

        As noted above, early in the case, Ms. Shortnacy filed a report from Dr.
McCabe about causation (exhibit 13). In this report, Dr. McCabe opined that Ms.
Shortnacy’s Hodgkin’s resulted from stimulation of her immune system by Virus-
Like Particles (“VLPs”) and the alum adjuvant contained in the HPV vaccine.
Exhibit 13 at 5-8. Dr. McCabe concluded that the VLPs and adjuvant “promoted a
favorable microenvironment… that promoted malignant transformation and/or
survival of HRS cells thereby leading to [Ms.] Shortnacy's Hodgkin's lymphoma.”
Id. at 7.2 Dr. McCabe additionally opined that it was reasonable to expect that the
immune response generated by the HPV vaccine also transformed HRS cell
precursors harboring latent Epstein-Barr virus (“EBV”) into malignancies.3


       2
       HRS, or Hodgkin Reed Sternberg, cells are a common histologic characteristic of
Hodgkin’s disease. Dorland’s Illustrated Medical Dictionary 322 (32nd ed. 2012).
       3
        Dr. McCabe cited to Ms. Shortnacy’s medical records documenting antibody reactivity
to EBV and varicella zoster. Exhibit 13 at 2 (discussing exhibit 7 at 23).

                                             4
        Following an April 19, 2012 status conference, Ms. Shortnacy was ordered
to file an expert report by July 18, 2012. Since Dr. McCabe is not a medical
doctor, he lacked the qualifications to discuss when a disease began. Thus, Ms.
Shortnacy needed to find a new expert. Order, issued Apr. 19, 2012. After three
extensions of time, Ms. Shortnacy filed her report from Dr. Davidson on
November 12, 2012 (exhibit 26).

       In his report, Dr. Davidson stated that “my honest assessment is that Lauren
likely systemically developed Hodgkin's disease prior to November 2007” and that,
in his opinion, “the first clearly established symptoms and manifestations of the
onset of the disease” was in early January 2008. Exhibit 26 at 3.

       A status conference was held on January 30, 2013, during which the
Secretary raised again the issue of timeliness and requested a supplemental report
from Dr. Davidson regarding symptom onset. Ms. Shortnacy was ordered to file a
supplemental report as the Secretary requested. Order, issued Jan. 31, 2013. For
this report, Ms. Shortnacy was instructed to have Dr. Davidson address the
undersigned’s March 30, 2012 Findings of Fact and to clarify whether Ms.
Shortnacy’s December 3, 2007 symptoms (swollen lymph nodes and dry, itchy
skin) were manifestations of the onset of her Hodgkin’s disease. Id.

      In his supplemental report (exhibit 28, filed Feb. 26, 2013), Dr. Davidson
maintained that Ms. Shortnacy’s early January 2008 symptoms, not her December
3, 2007 symptoms, were the first onset symptoms of her Hodgkin’s disease.
Exhibit 28 at 1.

       During a status conference held on March 5, 2013, the Secretary stated that
she intended to file a report from Dr. McClain, an oncologist, responding to Dr.
Davidson’s onset opinion. Ms. Shortnacy was ordered to provide this report to Dr.
Davidson and report his initial impressions at the next status conference. Order,
issued Mar. 5, 2013.

       On April 16, 2013, the Secretary filed the report on onset from Dr. McClain
(exhibit B). In his report, Dr. McClain concluded that “the lymphadenopathy and
pruritus present on 12-3-2007 were most likely symptoms of Hodgkin lymphoma.”
Exhibit B at 2.

       During the status conference following Dr. McClain’s report, the Secretary
stated that bifurcating the statute of limitations issue from the causation issue was

                                           5
not necessary. The Secretary offered to file a report from Dr. McClain on the issue
of causation. Order, issued May 2, 2013.

      In his second report (exhibit E, dated June 19, 2013), Dr. McClain strongly
opposed Dr. McCabe’s immune stimulation theory. Dr. McClain opined that while
immune stimulating cells surrounding pathologic HRS cells do impact their
survival, this is secondary to the primary cause of Hodgkin’s: multiple genetic
mutations in key cell signaling pathways. Exhibit E at 1. Dr. McClain disagreed
with Dr. McCabe’s opinion that immunizations prompt the production of signals
from immune cells that can cause Hodgkin’s. Rather, Dr. McClain stated that the
multiple genetic mutations that cause Hodgkin’s also paralyze the very same
immune system signaling on which Dr. McCabe relied. Furthermore, Dr. McClain
indicated that Dr. McCabe’s HRS cell proliferation theory was not genetically
possible given the fact that HRS cells do not possess functional versions of the
necessary genes. Id. at 3.

       Dr. McClain cited to literature for evidence that EBV’s role in stimulating
HRS cell malignancies is secondary to genetic events that occur prior to viral
infection. Id. (citing exhibit X (Enrico Tiacci et al., Analyzing primary Hodgkin
and Reed-Sternberg cells to capture the molecular and cellular pathogenesis of
classical Hodgkin lymphoma, 120(23) Blood 4609 (2012)). Moreover, Dr.
McClain stated that although Ms. Shortnacy’s records indicate a past EBV
infection, there was no evidence for assuming that EBV had a role in causing her
Hodgkin’s without Epstein-Barr Encoded RNA (“EBER”) staining of her lymph
node biopsy to document the presence of EBV in her HRS cells.

      In response to Dr. McClain’s report, Ms. Shortnacy was ordered to file a
responsive report from Dr. McCabe as well as a status report on the availability of
a pathology sample for EBER staining. Order, issued July 16, 2013. Ms.
Shortnacy reported that she had ordered the requested pathology slides and
arranged for their storage. Pet’r’s Status Rep., filed Aug 28, 2013.

       On August 30, 2013, Ms. Shortnacy filed a supplemental report from Dr.
McCabe (exhibit 33) in which he argued that Dr. McClain had mischaracterized his
immune stimulation theory. Exhibit 33 at 2. Dr. McCabe clarified that he did not
suggest that the HPV vaccine could cause Hodgkin’s by giving rise to B cell
mutation. Id. Dr. McCabe asserted that Dr. McClain ignored “a large body of
research and scientific consensus that inflammation is a promoter in the process of
carcinogenesis[,]” but provided no citation to such research. Id. at 2. Dr. McCabe
then restated his theory that Ms. Shortnacy’s Hodgkin’s was caused by an HPV
                                         6
vaccine-elicited immune response which triggered malignancy in HRS precursor
cells. Dr. McCabe cited studies by Frazer and Pinto et al. as evidence of the
immune response elicited by HPV vaccination. Id. at 3 (citing exhibit 34 (Ian
Frazer, Correlating immunity with protection for HPV infection, 11 (Supp. 2) Int’l
J. Infectious Diseases S10 (2007); exhibit 35 (Ligia A. Pinto et al., HPV-16 L1
VLP vaccine elicits a broad-spectrum of cytokine responses in whole blood, 23
Vaccine 3555 (2005)).

       On November 21, 2013, the Secretary filed a supplemental report from Dr.
McClain (exhibit BB) responding to Dr. McCabe (exhibit 33). In this report, Dr.
McClain asserts that Dr. McCabe’s theory in which a potent vaccine response
causes growth of lymphomas is “not scientifically reliable.” Exhibit BB at 1. Dr.
McClain also reviewed the literature cited by Dr. McCabe and provided
interpretations contradicting those of Dr. McCabe. In particular, Dr. McClain
found that the Pinto et al. study (exhibit 35), which Dr. McClain cited as evidence
of an “active and ongoing” immune response following HPV vaccination, actually
supports the opposite conclusion that immune responsive cells are in fact not
continuously active.

      Dr. McClain concluded that:

      Ms. Shortnacy had a mutation in a germinal center B cell that became
      a Hodgkin Lymphoma cell. It activated the immune cells around it
      which supported the malignant cell with cytokines and chemokines[;]
      the malignant cells grew, migrated, and caused her Stage IIIA
      Hodgkin Lymphoma. [The HPV] immunization had nothing to do
      with this process[;] it was merely coincidental.

Exhibit BB at 3.

        Ms. Shortnacy was ordered to file the EBER staining results as well as a
status report indicating if Dr. McCabe would be filing a response to Dr. McClain.
See order, issued Jan. 16, 2014. Ms. Shortnacy reported that an additional report
from Dr. McCabe would not be helpful. Pet’r’s Rep., filed Jan. 27, 2014. On
February 12, 2014, Ms. Shortnacy filed a status report seeking “the Court’s
assistance in discussing additional avenues for mediation.” Pet’r’s Rep., filed Feb.
12, 2014.

     Ms. Shortnacy filed the EBER test results (exhibit 42) on February 18, 2014.
During a status conference held later that same date, the parties agreed to file
                                         7
supplemental expert reports in light of the negative EBER results. Additionally,
the parties discussed Ms. Shortnacy’s request for mediation, to which respondent
stated that she did not believe mediation would be productive considering
petitioner’s claim. Order, issued Feb. 19, 2014.

      On March 4, 2014, the Secretary filed another supplemental report from Dr.
McClain (exhibit EE) stating that the negative EBER result nullified Dr. McCabe’s
theory. Exhibit EE at 1 (discussing Dr. McCabe’s report, exhibit 13 at 5). On
March 21, 2014, Ms. Shortnacy filed a supplemental report from Dr. McCabe
(exhibit 43) stating that the negative EBER result had no effect on his theory as it
was never contingent on the presence of Epstein-Barr virus. Exhibit 43 at 1-2.

                 3.      Preparation for Hearing

       Pursuant to an earlier order, the hearing was set for June 19-20, 2014.
Order, issued Oct. 9, 2013. The parties were ordered to file prehearing briefs in
preparation for hearing. Order, issued Apr. 4, 2014. In this order for prehearing
briefs, the undersigned detailed the issues of Ms. Shortnacy’s case in regard to
timeliness and the Althen prongs and directed the parties to address these issues in
their briefs. The parties were directed to confirm that each of their experts had
completely disclosed their opinions before the hearing, and to inform the court if
additional supplemental reports were required. Id. The parties submitted their
briefs by the end of May 2014.

       On June 2, 2014, the undersigned issued an order stating that upon his
review of the case material, including the parties’ prehearing briefs, he had reached
a tentative conclusion that petitioner was unlikely to prevail on either the
timeliness of her petition or that the HPV vaccine caused her Hodgkin’s. The
undersigned discussed the weaknesses of Ms. Shortnacy’s case including the
disparity between the qualifications of the testifying witnesses. In light of the
problems with Ms. Shortnacy’s case, the undersigned expressed the concern that
proceeding to a hearing might lack reasonable basis.

       By the June 10, 2014 prehearing status conference, the hearing schedule had
been slightly amended to accommodate Ms. Shortnacy’s expert, Dr. Davidson.4 At
that status conference, Ms. Shortnacy proposed that the undersigned provide a

        4
            Dr. Davidson was no longer able to testify on June 19-20, 2014, due to an unavoidable
conflict.

                                                  8
decision on the statute of limitations issue before proceeding with a causation
hearing. Additionally, Ms. Shortnacy acknowledged the difference in credentials
between Dr. McCabe and Dr. McClain and stated that she may wish to retain an
oncologist to opine on causation.

       The Secretary opposed Ms. Shortnacy’s proposal to retain an oncologist and
stated that the difference between Dr. McClain’s and Dr. McCabe’s qualifications
was not new and that considerable time and resources had already been invested in
prosecuting Ms. Shortnacy’s claim. Ms. Shortnacy requested the remainder of the
day to consider whether to proceed with the hearing.

      A follow-up status conference was held the next day. At this conference,
Ms. Shortnacy confirmed that she did not want to proceed with the scheduled
hearing and instead intended to file a motion for a ruling on the record. The
Secretary did not object. See order, issued June 11, 2014.

      On June 25, 2014, Ms. Shortnacy moved for a decision on the written
record. In her motion, Ms. Shortnacy states that although she is able to
demonstrate causation for her Hodgkin’s, she “has decided not to move forward
with a hearing.” Pet’r’s Mot., filed June 25, 2014, at 8.

       Respondent filed a response stating “[a] preponderance of the evidence does
not support a finding that petitioner’s case was timely filed. Even assuming
arguendo that petitioner’s case were timely filed, there is not a preponderance of
reliable scientific evidence to support a finding that petitioner’s HPV vaccine(s)
caused the development of her Hodgkin’s Lymphoma.” Resp’t’s Resp., filed July
7, 2014, at 18. Ms. Shortnacy did not file a reply to respondent’s response.
Accordingly, this case is now ready for adjudication.

II.   Ruling on the Record

       In establishing the Vaccine Program, Congress instructed the Court of
Federal Claims to promulgate rules, including a rule for “the opportunity for
parties to submit . . . evidence on the record without requiring routine use of oral
presentations, cross examinations, or hearings.” 42 U.S.C. § 300aa—12(d)(2)(D).
In accord with this statutory directive, “the special master may decide a case on the
basis of written submissions without conducting an evidentiary hearing.” Vaccine
Rule 8(d).



                                          9
       The Court of Federal Claims has interpreted Congress’ intent as not
requiring routine oral presentations, but rather that interested parties be afforded
only the opportunity to submit relevant written information. Hale v. Sec’y of
Health & Human Servs., 22 Cl. Ct. 403, 407 (1991). Furthermore, the Vaccine
Program was designed to “avoid hearings and dispose of cases quickly.” Boley v.
Sec’y of Health & Human Servs., 05-420V, 2008 WL 4615034, at *2 (Fed. Cl.
Sept. 9, 2008), mot. for rev. denied, 86 Fed. Cl. 294 (2009).

      Although a hearing was scheduled, Ms. Shortnacy stated that she did not
want to proceed to trial and moved for a ruling on the record. Pet’r’s Mot., filed
June 25, 2014. The parties have had an opportunity to present their cases and the
record is adequate for making a decision.

       The procedural posture of the case is that of a ruling on the record, not a
motion for summary judgment. As such, Ms. Shortnacy is not entitled to
inferences in her favor. She must establish her case by preponderant evidence.
Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir.
2010). Ms. Shortnacy’s claim for compensation is discussed below beginning with
the timeliness of her petition, followed by a causation analysis.

III.   Statute of Limitations

       A living petitioner has 36 months to file a petition for compensation from
the first symptom or manifestation of onset of an injury. 42 U.S.C. §300aa—
16(a)(2) (2006). The statute of limitations can be triggered by either a symptom of
the injury or a manifestation of onset, “whichever is first.” Markovich v. Sec’y of
Health & Human Servs., 477 F.3d 1353, 1357 (Fed. Cir. 2007).

       The day of onset is excluded in calculating the statute of limitations and
accrual begins the following day. Spohn v. Sec’y of Health & Human Servs., No.
95-0460V, 1996 WL 532610, at *3 (Fed. Cl. Spec. Mstr. Sept. 5, 1996)
(determining the statute of limitations for claim based upon symptoms starting July
17, 1992, expired on July 17, 1995, and dismissing petition based upon a filing one
day after the expiration of the statute of limitations), mot. for rev. denied in
unpublished op. (Fed. Cl. Jan. 10, 1997), aff’d, 132 F.3d 52 (Fed. Cir. 1997)
(table). Ms. Shortnacy filed her petition on December 2, 2010. In order for Ms.
Shortnacy to have filed her petition within the statute of limitations, the first
manifestation of onset must have occurred on or after December 2, 2007.



                                         10
       The medical field must recognize the symptom or manifestation of onset as
part of the condition for which compensation is sought. Cloer v. Sec’y of Health &
Human Servs., 654 F.3d 1322, 1335 (Fed. Cir. 2011) (en banc), cert. denied, 132
S.Ct. 1908 (2012). At least two symptoms could be viewed as heralding the onset
of Ms. Shortnacy’s Hodgkin’s. These are swollen lymph nodes and itchiness.
Exhibit B at 2-3; exhibit 26 at 2.

      Ms. Shortnacy’s expert, Dr. Davidson, acknowledged that she “likely
systemically developed Hodgkin's disease prior to November 2007.” Exhibit 26 at
3. Dr. Davidson opined that the upper respiratory infection Ms. Shortnacy suffered
in November 2007, was likely a result of her immune system being compromised
by Hodgkin’s disease. Id. However, Dr. Davidson argues that Ms. Shortnacy’s
Hodgkin’s was not “clinically apparent” until early January 2008, when her
bloodwork showed atypical lymphocytes and her lymph nodes enlarged for the
second time in association with pruritus and fatigue. Exhibit 26 at 3; exhibit 28
at 1.

       In light of his opinion that Ms. Shortnacy’s disease likely began before
November 2007, Dr. Davidson’s opinion regarding Ms. Shortnacy’s swollen
lymph nodes is unclear. Ms. Shortnacy was observed to have swollen lymph nodes
on November 21, 2007, and December 3, 2007. Exhibit 14 at 4; exhibit 2 at 62.
Despite opining that her November 2007 infection was likely due to her
Hodgkin’s, Dr. Davidson maintains that Ms. Shortnacy’s symptoms on November
21, 2007, were consistent with an infectious process and that her Hodgkin’s was
not clinically apparent. Exhibit 26 at 3. Dr. Davidson does not dismiss Ms.
Shortnacy’s swollen nodes on December 3, 2007, but instead states that her
symptoms of January 2008 were “more clinically apparent” for diagnosing
Hodgkin’s. Id. Dr. Davidson finds the swelling significant only in January 2008,
when the swollen lymph nodes were also present in the axilla and they were
accompanied by bloodwork showing atypical lymphocytes. Id.; exhibit 2 at 50-52;
exhibit 3 at 4. Although Dr. Davidson provides some basis for not accepting Ms.
Shortnacy’s November and December 2007 swollen nodes as the onset of her
Hodgkin’s, he does not provide a basis for dismissing her December 2007
itchiness. See exhibit 26; see also exhibit 28.

       Dr. Davidson’s silence regarding Ms. Shortnacy’s early December 2007
itchiness is a weakness. It is difficult to follow Dr. Davidson’s reasoning that Ms.
Shortnacy’s disease began prior to November 2007, but was not clinically apparent
until January 2008, despite complaints of similar symptoms in the two previous
months.
                                         11
       On the other hand, the Secretary’s expert, Dr. McClain, opined that Ms.
Shortnacy’s itchiness and swollen lymph nodes on December 3, 2007, were most
likely symptoms of Hodgkin’s. Exhibit B at 2. Dr. McClain cited to literature
underscoring the importance of pruritus in diagnosing Hodgkin’s. Id. (citing
exhibit D (Paolo G. Gobbi et al., Reevaluation of Prognostic Significance of
Symptoms in Hodgkin's Disease, 56 Cancer 2874 (1985) (identifying pruritus as an
important finding in 10% of Hodgkin’s cases)). In addition to establishing pruritus
as a symptom, Gobbi et al. describe the type of itchiness as severe and resistant to
local and systemic antipruritics, which Dr. McClain found to describe the itching
Ms. Shortnacy experienced accurately. Id.

       Additionally, Dr. McCabe, though not a doctor of medicine, described itchy
skin as a symptom of Hodgkin’s in a background summary of the disease compiled
from major medical journals and texts. Exhibit 13 at 3 (citing exhibits 44-49). The
literature cited by Dr. McClain and Dr. McCabe contradicts Dr. Davidson’s
implicit opinion that Ms. Shortnacy’s December 3, 2007 itching was not a
manifestation of her Hodgkin’s. Thus, a preponderance of the evidence supports a
finding that itchiness is a manifestation of Hodgkin’s.

       Since Ms. Shortnacy experienced an unusual amount of itchiness the
morning of December 3, 2007, her itchiness must have begun prior to that date
because it was bothersome enough to schedule a morning appointment with Dr.
Paris.5 Exhibit 2 at 9; Findings of Fact at 7-9. Dr. McClain stated that by
December 3, 2007, Ms. Shortnacy’s itchiness had “intensified to the point where it
was a major symptom.” Exhibit B at 2. Dr. McClain’s inference is persuasive and
suggests that Ms. Shortnacy’s itchiness began some time prior to her appointment.
See exhibit 4 at 9 (February 20, 2008 statement that Ms. Shortnacy had “severe
itching, November 2007”); Second Amended Ex. 2 at 7 (March 11, 2008 letter,
stating “[a]t Thanksgiving 2007, [Ms. Shortnacy] noticed swelling in her leck neck
area. She also developed pruritus”). Thus, Ms. Shortnacy’s itchiness began before
December 2, 2007.


       5
          In her motion, Ms. Shortnacy cites only to a portion of her hearing testimony in which
she stated that the itchiness began after Christmas. Pet’r’s Mot. at 2 (citing Tr. 26-28, 47-48).
But, this testimony was not accepted in the ruling finding facts which determined that Ms.
Shortnacy experienced an unusual amount of itchiness on December 3, 2007. See Findings of
Fact, issued Mar. 30, 2012, at 7.


                                                12
       Because Ms. Shortnacy experienced her first manifestation of Hodgkin’s
(extreme itchiness and swollen lymph nodes) more than 36 months before she filed
her petition, Ms. Shortnacy’s petition was filed outside of the statute of
limitations.6 This finding means that she is not entitled to compensation.

IV.    Causation

       Even if Ms. Shortnacy filed her petition within the time permitted by the
statute of limitations, she has another hurdle. To receive compensation under the
National Vaccine Injury Compensation Program, a petitioner must prove either 1)
that she suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury
Table – corresponding to the HPV vaccine, or 2) that she suffered an injury that
was actually caused by a vaccine. See §§ 300aa—13(a)(1)(A) and 300aa—
11(c)(1). An examination of the record did not uncover any evidence that Ms.
Shortnacy suffered a “Table Injury.”7 Further, Ms. Shortnacy does not argue that
her Hodgkin’s was significantly aggravated by the HPV vaccines.

       The elements of Ms. Shortnacy’s case were set forth by the Federal Circuit:
“(1) a medical theory causally connecting the vaccination and the injury; (2) a
logical sequence of cause and effect showing that the vaccination was the reason
for the injury; and (3) a showing of a proximate temporal relationship between
vaccination and injury.” Althen v. Sec'y of Health & Human Servs., 418 F.3d
1274, 1278 (Fed. Cir. 2005). The burden of proof is preponderance of the
evidence. Id.

       Under the Act, petitioners may not be awarded compensation based solely
on the petitioner’s claims alone. Rather, the petitioner’s claims must be supported
by either medical records or by medical opinion. 42 U.S.C. § 300aa--13(a)(1).
Ms. Shortnacy relies on the opinion of Dr. McCabe. Pet’r’s Mot., citing exhibits
13, 33, 43.8 The Secretary relies on the opinion of Dr. McClain. Resp’t’s Resp.,
citing exhibits B, E, EE.


       6
         Ms. Shortnacy has not claimed the she is entitled to equitable tolling of the statute of
limitations.
       7
           No injuries are associated with any HPV vaccine. See 42 C.F.R. § 100.3.
       8
        Dr. Davidson has not expressed an opinion that the HPV vaccine caused Ms.
Shortnacy’s Hodgkin’s.

                                                 13
       In weighing the persuasiveness of opinion testimony, special masters may
consider the background of the person offering the opinion. See Snyder v. Sec'y of
Health & Human Servs., 553 F. App'x 994, 1000-02 (Fed. Cir. 2014) (special
master’s finding that respondent’s experts were more persuasive due in part to their
current practice in neurology compared to petitioner’s expert who had no recent
practice was not arbitrary or capricious); see also Locane v. Sec’y of Health &
Human Servs., 99 Fed. Cl. 715, 727 (2011), aff’d, 685 F.3d 1375 (Fed. Cir. 2012).

      Dr. McCabe’s academic background has focused on topics other than
diseases of the human lymph system. Dr. McCabe earned his Ph.D. in
Microbiology and Immunology from Albany Medical College in 1991. He
completed his postdoctoral research with the Karolinska Institute in Stockholm,
Sweden in 1992, and then taught as an assistant professor at Wayne State
University where he later served as the director of the school’s flow cytometry
center. Exhibit 13 at 2. Since 2000, Dr. McCabe has taught and conducted
research “centered on mechanistic metal toxicology and immunotoxicology” at the
University of Rochester School of Medicine and Dentistry. Id. at 1. As an
associate and (later) adjunct professor in Rochester’s Department of Environmental
Medicine, Dr. McCabe has taught courses in metal toxicity, cell signaling,
immunity, and ethics. Dr. McCabe has been a contributing author on
approximately 40 peer-reviewed publications, many relating to the toxicity of
metals. Dr. McCabe was the lead author on approximately 13 of these
publications. Exhibit 13 at 18-21.

        In 2009, Dr. McCabe joined Robson Forensic, Inc., where he is currently
employed. At Robson, Dr. McCabe provides “technical investigations, analysis,
reports, and testimony toward the resolution of commercial and personal injury
litigation of toxicology” and “human health assessments” involving environmental
and occupational exposures to metals, solvents and other agents. Id. at 1.9 Dr.
McCabe’s reports linking HPV vaccine to Hodgkin’s appear to flow exclusively
from his work as a professional testifying expert. 10 Nothing in his curriculum


       9
         Dr. McCabe’s CV does not indicate any vaccine related “agents” in the list of human
health assessments he conducts through Robson Forensic, Inc.
       10
          The fact that Dr. McCabe’s income is nearly completely derived from providing expert
opinions has factored into assessments of his reliability. Godfrey v. Sec'y of Health & Human
Servs., 10-565V, 2014 WL 3058353, at *22 (Fed. Cl. Spec. Mstr. June 11, 2014). Trial judges
may apply the Daubert factors more rigorously when evaluating “for hire” experts. Johnson v.
                                                                                     (…continued)
                                               14
vitae indicates that he studied Hodgkin’s or related diseases previously. See
exhibit 13.

      Dr. McClain received his Ph.D. (1971) and M.D. (1972) from the University
of Chicago School of Medicine. He completed his residency at The Johns Hopkins
Hospital in Baltimore, MD in 1976. Exhibit C at 1.

        Dr. McClain has coauthored more than195 peer-reviewed articles, in 80 of
which he was the primary author. Notably, Dr. McClain authored several
“UpToDate” physician’s reference articles including coauthoring the 2003
Hodgkin’s Diseases article. Exhibit C at 22. Dr. McClain has received millions of
dollars in research funding from sources such as the National Institutes of Health
and the National Cancer Institute for his work in Langerhan’s cell histiocytosis.11
Id. at 5-9. He has lectured internationally on Hodgkin’s (exhibit C at 45) and is a
tenured professor in the Department of Pediatrics at Baylor College of Medicine
and Director of the Histiocytosis Program at Texas Children’s Cancer and
Hematology Centers (exhibit C at 1, 3). Dr. McClain is currently practicing and
has more than 34 years of experience caring for children with lymphomas and
lymphoproliferative diseases caused by the Epstein Barr Virus. Exhibit B at 1-2.

      Here, the difference in background is vast. Although Dr. McCabe has a
background in toxicology, he is not a medical doctor. Exhibit 13. Dr. McClain,
however, is an award-winning medical doctor who specializes in treating
lymphoma. Exhibit C.

       The difference in experience is reflected in the reports from the experts. The
Secretary’s expert, Dr. McClain, wrote reports that are among the best the
undersigned has reviewed. The multitude of citations to peer-reviewed articles
reflects an intimate familiarity with the subject of lymphomas, commensurate with
more than three decades of work in the field of pediatric cancers. He is truly an
expert, a source of information to other doctors treating patients.


Manitowoc Boom Trucks, Inc., 484 F.3d 426, 435 (6th Cir. 2007) (citing Daubert v. Merrell
Dow Pharm., Inc., 43 F.3d 1311, 1316 (9th Cir. 1995)).
       11
         Langerhan’s cells are antigen-presenting cells found in the lymph nodes, among other
places. Dorland’s at 320. Langerhan’s cell histiocytosis is defined as a malignancy-like
overgrowth of Langerhan’s cells. Robert M. Kliegman et al., Nelson Textbook of Pediatrics
1773 (19th ed. 2011).

                                              15
       In contrast, Ms. Shortnacy’s expert, Dr. McCabe, qualifies as an expert in
immunology on the basis of his Ph.D. and career experience, which has focused
mainly on toxicological effects of metals. He has been found qualified to opine
about immunology and toxicity of metals. Koehn v. Sec'y of Health & Human
Servs., 11-355V, 2013 WL 3214877, at *32 (Fed. Cl. May 30, 2013), mot. for
review denied sub nom. C.K. v. Sec'y of Health & Human Servs., 113 Fed. Cl. 757
(2013), appeal docketed, No. 14-5054 (Fed. Cir. Feb. 18, 2014); Snyder v. Sec'y of
Health & Human Servs., 01-162V, 2009 WL 332044, at *19 (Fed. Cl. Spec. Mstr.
Feb. 12, 2009), mot. for review denied, 88 Fed. Cl. 706 (2009); Hazlehurst v. Sec'y
of Health & Human Servs., 03-654V, 2009 WL 332306, at *11 (Fed. Cl. Spec.
Mstr. Feb. 12, 2009), mot. for review denied, 88 Fed. Cl. 473 (Fed. Cl. 2009),
aff’d, 604 F.3d 1343 (Fed. Cir. 2010). But, in offering an opinion that a vaccine
can and did cause a lymphoma, Dr. McCabe is leaving the fields of science where
he is most knowledgeable.

      Dr. McCabe’s reports illustrate his relative lack of knowledge about
lymphomas. Although Dr. McCabe cited articles throughout his reports, Dr.
McClain has persuasively shown that Dr. McCabe took passages out of context and
did not fully appreciate the nuances of the studies.

        Flaws in Dr. McCabe’s reports are apparent in all the Althen prongs. The
first Althen prong asks whether the vaccine could cause the alleged injury. See
Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352, 1356 (Fed. Cir. 2006)
(affirming special master’s use of “can cause” and “did cause” as consistent with
the Althen test); Veryzer v. Sec'y of Health & Human Servs., 100 Fed. Cl. 344, 352
(2011) (describing the first prong of Althen as presenting the question of general
causation). Dr. McCabe’s reports are convoluted and not easily summarized, but,
essentially, he argues that the HPV vaccine causes the proliferation and survival of
initiated HRS precursors which results in the proliferation of Hodgkin’s
lymphoma. Pet’r’s Prehr’g Br. at 11 (citing exhibit 33 at 2).

       But, Dr. McClain contradicts this postulate and asserts that it is “not
scientifically reliable.” Exhibit BB at 1. According to Dr. McClain, Ms.
Shortnacy’s Hodgkin’s was a result of genetic mutations arising in her germinal B
cells independent of vaccination and that these mutations forestalled the immune
signals implicated in Dr. McCabe’s theory. Id. at 2; exhibit E at 3-4. Dr. McClain
challenged Dr. McCabe’s claim that HPV vaccine could cause HRS cell
proliferation since these cells lack functional genes necessary for such stimulation.
Exhibit E at 3. Moreover, Dr. McClain summarily showed that Dr. McCabe’s
claim of EBV involvement was an incorrect assumption given current literature
                                          16
and available laboratory analysis of Ms. Shortnacy’s biopsy. Exhibit E at 3 (citing
exhibit X (Tiacci)). Dr. McClain’s awareness regarding EBER staining is also
telling of his greater familiarity of the subject matter.

        Another deficiency in Dr. McCabe’s report is his opinion regarding timing,
which corresponds to the third Althen prong.12 Ms. Shortnacy must show that the
first manifestation of her Hodgkin’s occurred in a medically appropriate timeframe
to infer causation. Dr. McCabe provided a vague opinion on timing stating that
“the expected interval between vaccination and the onset of HL is predicted by the
time period that measur[]able changes in the immune response are known to be
elicited by the vaccine.” Exhibit 33 at 2-3. Dr. McCabe cited to the time points
used by Frazer and Pinto to define the “time period” of HPV elicited immune
response during which Hodgkin’s might arise. Dr. McCabe estimated that
increased cytokine production occurred up to seven months following vaccination.
Id. (citing exhibit 34 (Frazer); exhibit 35 (Pinto)). However, Dr. McClain
persuasively showed that Dr. McCabe misinterpreted the Frazer and Pinto studies
such that they did not support Dr. McCabe’s assumption regarding increased
cytokine production up to seven months following vaccination. Exhibit BB at 2-3.

       On the remaining Althen prong, Ms. Shortnacy’s evidence is similarly
unimpressive. The second Althen prong requires Ms. Shortnacy to establish by
preponderant evidence “a logical sequence of cause and effect” showing that the
HPV vaccine caused her Hodgkin’s. Althen, 418 F.3d at 1274. Factors that can
make Ms. Shortnacy’s case “logical” include evidence showing that her Hodgkin’s
arose by the means predicted by her expert’s theory and the views of her treating
physicians. LaLonde v. Sec'y of Health & Human Servs., 746 F.3d 1334, 1340
(Fed. Cir. 2014) (special master did not err in requiring some proof that petitioner’s
theory actually explained petitioner’s injury) (citing Hibbard v. Sec'y of Health &
Human Servs., 698 F.3d 1355, 1365 (Fed. Cir. 2012) (petitioner required to show
both the likelihood of her theory of causation and that the alleged injury was
consistent with that theory)); Moberly, 592 F.3d at 1324-25.

      Dr. McCabe suggested that Ms. Shortnacy’s previously observed titers for
EBV may have played a role in facilitating the HPV vaccination in causing
Hodgkin’s. Exhibit 13 at 4-5. However, the EBER testing done at Dr. McClain’s
suggestion showed that no EBV was present in Ms. Shortnacy’s biopsy. See

       12
         Dr. McCabe has had previous trouble establishing the third prong of Althen. See
Koehn, 2013 WL 3214877, at *32; see also Godfrey, 2014 WL 3058353, at *23.

                                              17
exhibit 42; see also exhibit E at 3; exhibit EE. Ms. Shortnacy has not provided
other evidence that the remainder of Dr. McCabe’s theory was likely at work in
causing her Hodgkin’s.

      In sum, Ms. Shortnacy has not demonstrated the persuasiveness of Dr.
McCabe’s opinion regarding any Althen prong. On the simplest level, Dr. McCabe
is much, much less knowledgeable about Hodgkin’s than Dr. McClain. Ms.
Shortnacy has presented no persuasive reason that her expert, who has never
studied Hodgkin’s, should be credited over the Secretary’s expert, who is probably
among this country’s most knowledgeable doctors on Hodgkin’s.

V.    Conclusion

       Ms. Shortnacy seeks compensation in the Vaccine Program alleging that the
HPV vaccines she received caused her Hodgkin’s disease. Ms. Shortnacy has
failed to demonstrate by a preponderance of the evidence that the onset of her
Hodgkin’s occurred within the time allowed under the statute of limitations or that
her Hodgkin’s was caused-in-fact by the HPV vaccines she received.
Consequently, she is not entitled to compensation.

      The Clerk’s Office is instructed to issue judgment in accord with this
decision.

      IT IS SO ORDERED.
                                              s/Christian J. Moran
                                              Christian J. Moran
                                              Special Master




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