Cottingham v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
*********************
KASEY COTTINGHAM, *
* No. 15-1291V
Petitioner, * Special Master Christian J. Moran
*
v. *
* Filed: September 27, 2021
SECRETARY OF HEALTH *
AND HUMAN SERVICES, * attorneys’ fees and costs, reasonable
* basis, remand
Respondent. *
*********************
Andrew D. Downing, Van Cott & Talamante, PLLC, Phoenix, AZ, for petitioner;
Voris Johnson, United States Dep’t of Justice, Washington, DC, for respondent.
PUBLISHED DECISION DENYING ATTORNEYS’ FEES AND COSTS1
An October 30, 2015 petition alleged that the human papillomavirus
(“HPV”) vaccine harmed Kasey Cottingham and sought relief pursuant to the
National Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-10 through 34 (2012).
However, the case was dismissed within a year of its filing. Cottingham v. Sec’y
of Health & Human Servs., No. 15-1291V, 2016 WL 6575170 (Fed. Cl. Spec.
Mstr. Oct. 13, 2016).
Although Ms. Cottingham did not receive compensation, she is requesting
an award of attorneys’ fees and costs as permitted by the Vaccine Act. 42 U.S.C.
§ 300aa–15(e). After three rounds of adjudications in both the Office of Special
Masters and the Court of Federal Claims, as well as a fourth round of adjudication
1
The E-Government Act, 44 U.S.C. § 3501 note (2012) (Federal Management and
Promotion of Electronic Government Services), 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.
as a result of a remand from the Federal Circuit, the Court of Federal Claims has
remanded the case for an additional (fifth) review of evidence that might support a
finding of reasonable basis. Because she has failed to meet this predicate showing,
Ms. Cottingham is not eligible for an award of attorneys’ fees and costs.
Therefore, her motion is denied.
I. Background2
The series of events about Ms. Cottingham’s health is set out in section A,
below. The history of her claim through the Decision Dismissing Case is
discussed in section B, below. The lengthy history of decisions and appellate
opinions regarding the still pending motion for attorneys’ fees and costs is
presented in section C, below.
Medical Chronology
Ms. Cottingham was born in 1998. Her health through 2011 was relatively
routine and overall good.
In March 2012, a doctor at the Middle Creek Urgent Care facility diagnosed
Ms. Cottingham with mononucleosis. A week later, Ms. Cottingham’s regular
pediatrician saw her. Ms. Cottingham stated that her throat was hurting, she felt
tired, and she had headaches. The doctor diagnosed her as having a viral illness on
top of the mononucleosis. Exhibit 3 at 55-56.
Before starting high school, Ms. Cottingham returned to the pediatrician’s
office. The doctor did not record any significant health concerns. During this
appointment, which occurred on July 5, 2012, Ms. Cottingham received three
vaccinations – the hepatitis A vaccine, the meningococcal conjugate vaccine, and
the HPV vaccine. More specifically, Ms. Cottingham received the “quadrivalent”
HPV vaccine. Exhibit 3 at 99-100. Ms. Cottingham’s claim in the Vaccine
Program rested upon the HPV vaccine.
Approximately one month later, while performing as a majorette in her
school’s band, Ms. Cottingham twisted her right knee. The pediatrician recorded
that except for the problem with her right knee, a review of symptoms was
2
Substantial portions of the present decision repeat material in the January 7, 2021
decision because the Court vacated the January 7, 2021 decision and, thus, the information needs
to be stated again in the present decision. See Cottingham v. Sec’y of Health & Human Servs.,
971 F.3d 1337, 1345 n. 2 (Fed. Cir. 2020) (“we review only the [most recent] decision”).
2
“negative.” Exhibit 3 at 64. For the knee injury, Ms. Cottingham went to physical
therapy. Exhibit 5.
On October 10, 2012, Ms. Cottingham went to the Children’s Hospital of
Alabama where she saw a pediatric gynecologist. The history of present illness
from this visit states:
She has periods that are monthly. Sometimes there are 2
weeks in between and sometimes they are a full month in
between. When they do occur she does have to wear
double protection on her for a few days because of the
menorrhagia. Her periods last for about 2 days and they
are off for about 2 days and they come back for about 4-5
days.
Exhibit 9 at 4. Except as noted in the history of present illness, the doctor’s review
of symptoms was “negative times 10.” Id. The gynecologist prescribed oral
contraception to control Ms. Cottingham’s monthly cycle.
According to an affidavit Ms. Cottingham signed for this litigation, her
health changed on November 1, 2012 (almost four months after her receipt of the
HPV vaccination). Ms. Cottingham stated: “I began getting regular weekly
headaches. Over the next few weeks, not only did the frequency of headaches
increase but I also began to experience episodes of near black-outs where my
vision became temporarily impaired.” Exhibit 1 ¶ 5. Ms. Cottingham’s attorney
asserted that November 1, 2012, marked the onset of the problems the HPV
vaccine allegedly caused in Ms. Cottingham. Pet’r’s Mot. for Attorneys’ Fees and
Costs, filed Oct. 26, 2016, at 5.
On November 30, 2012, Ms. Cottingham returned to her pediatrician’s
office. She complained about having a fever, yellow mucous, a sore throat in the
mornings, and headaches “off and [on] all week.” The doctor diagnosed her as
having “acute sinusitis.” Exhibit 3 at 87-88. Ms. Cottingham’s affidavit stated
that during the November 30, 2012 appointment, she told her doctor about her
“symptoms” without specifying what those symptoms were. The affidavit also
recounts that the doctor prescribed an antibiotic and recommended that she drink
plenty of water. Exhibit 1 ¶ 6. The doctor’s November 30, 2012 note did not
characterize the headaches as ongoing or chronic.
According to Ms. Cottingham’s affidavit, her “headaches, low-grade fevers
and near black-outs continued.” In addition, during practices for majorettes, Ms.
3
Cottingham “need[ed] to stop because [she] was feeling dizzy.” Nevertheless, Ms.
Cottingham “didn’t want to complain because [she] was taught to tough out what
[she] thought was a temporary condition.” Id. ¶¶ 7-8.
Approximately two months later, Ms. Cottingham had another appointment
with her pediatrician. The history of present illness states that Ms. Cottingham
comes in today with 2 days of runny nose and
congestion. Today she’s had low-grade fever of 100.4,
she has also had [a] sore throat along with runny nose
and congestion. Has had a headache today as well. No
cough, increased work of breathing or shortness of
breath. No vomiting or diarrhea.
Exhibit 3 at 78 (record created Jan. 31, 2013). The doctor’s assessment was
“rhinitis” and “acute viral pharyngitis.” Id. at 79. This record, however, does not
indicate that Ms. Cottingham was experiencing near black-outs or low-grade
fevers. The doctor also did not memorialize that Ms. Cottingham has having
headaches frequently after November 1, 2012. Ms. Cottingham’s affidavit does
not question the accuracy of this medical record. See exhibit 1 ¶ 9.
On March 29, 2013, Ms. Cottingham “fainted upon getting up this
morning.” Exhibit 3 at 80. She also had a “fever and dizziness,” and “[v]omited
once.” Id. The doctor’s assessment was “gastroenteritis” and “dehydration.” Id. at
81. The doctor believed that Ms. Cottingham was “at the early stage of an
intestinal virus.” Id. at 80-81. March 29, 2013 is 267 days (nearly 9 months) after
July 5, 2012, the date of the first HPV vaccination.
Ms. Cottingham fainted again on May 23, 2013, while at a pool. The history
of present illness from her treatment after this incident states that after waking up
that morning, Ms. Cottingham did not have anything to eat or drink. When at the
pool with a friend, Ms. Cottingham felt “very hot” and “hungry” “so she stood up
quickly to go get something to eat. She says at that point her vision became black
and she felt very light headed. Soon after she fell backwards.” Exhibit 3 at 70.
The doctor thought that Ms. Cottingham “was dehydrated prior to this event. [She]
also [thought] laying out in the sun may have contributed.” Id. at 71. The doctor
recommended that Ms. Cottingham increase her intake of fluids. Id.
On July 10, 2013, Ms. Cottingham had an appointment with her pediatrician
(Dr. Simpson) for two reasons. The visit was, in part, for Ms. Cottingham’s 15-
year-old checkup. Ms. Cottingham’s mother also raised a concern about the two
4
episodes of fainting and asked about an echocardiogram. Exhibit 3 at 96. Ms.
Cottingham stated that she was having monthly menses. Id. Dr. Simpson
confirmed that Ms. Cottingham should eat breakfast and should drink fluids
throughout the day. Id. at 97. He also referred Ms. Cottingham to a cardiologist.
Id. The only mention of vaccines in the note from July 10, 2013 is under
“Counseling / Education,” a statement that “Anticipatory guidance given and
immunizations reviewed.” Id.
On July 25, 2013, Ms. Cottingham visited the pediatric cardiology clinic of
the University of Alabama-Birmingham. The history of present illness recounts
the two incidents of fainting from March and May. In addition, it stated that Ms.
Cottingham “has had other episodes of dizziness and near passing out. With all the
episodes, she is standing or walking. She does not participate in any competitive
athletics. She does participate as a majorette. She has not had any dizziness or
syncope with physical activity.” Exhibit 3 at 111. She further reported that “one
time her episode improved when she sat down.” Id. The doctor conducted various
tests and determined that she had a “structurally and functionally normal heart.
This syncope/presyncope is consistent with a vasovagal etiology.” Id. at 112. The
doctor “emphasized aggressive fluid hydration.” Id. The cardiologist diagnosed
Ms. Cottingham with vasovagal syncope. Id. The cardiologist did not refer her for
autonomic testing.
Following the July 25, 2013 visit with the pediatric cardiologist, nearly eight
months passed before the next medical record. On March 14, 2014, Ms.
Cottingham went to the office of her pediatrician. Her chief complaint was listed
as “cough, congestion, [sore throat], low-grade fever.” Exhibit 3 at 106. The
doctor’s assessment was “cough,” “acute viral pharyngitis,” and “acute upper
respiratory infection.” Id.
Ms. Cottingham again saw a pediatrician for a checkup on August 18, 2014.
The history of present illness states: “Been doing well. No concerns.” Exhibit 3 at
109. The office notes also indicate that the date of Ms. Cottingham’s last
menstruation was July 25, 2014. They also say that an oral contraceptive was
discontinued, although the date of discontinuance was not given. At this
appointment, Ms. Cottingham received another dose of the hepatitis A vaccine,
another dose of the meningococcal conjugate vaccine, and another dose of the
HPV vaccine. Id. at 109-10.
Pursuant to a history given to a gynecologist in April 2015, Ms. Cottingham
took oral contraceptives until October or November 2014 when her prescription
ran out. This same history reports that Ms. Cottingham had a menstrual period in
5
December 2014, but none since that month. Exhibit 7 at 7.3 The review of
systems indicated that Ms. Cottingham reported “cold intolerance.” Id. at 8.
During the April 28, 2015 appointment, the gynecologist came to the impression
that Ms. Cottingham was suffering from “secondary amenorrhea.” Id. at 9. The
doctor also indicated that polycystic ovarian syndrome was possible. The doctor
ordered an ultrasound. Id.
Because of problems scheduling the ultrasound, Ms. Cottingham’s mother
called the office of Ms. Cottingham’s pediatrician on May 14, 2015. Ms.
Cottingham’s mother was “concerned that the Gardasil series may have had
something to do with the recent changes noted in [Ms. Cottingham’s] menstrual
cycle. Mom is requesting that a note be made in [her] chart regarding this
concern.” Exhibit 3 at 175.
The day after this May 2015 phone call, Ms. Cottingham’s mother retained
the petitioner’s current attorney, Andrew Downing. Pet’r’s Mot., filed Oct. 26,
2016, at 4. Within a few days, a paralegal was requesting information from Ms.
Cottingham’s mother to obtain medical records. Timesheets, pages 9-10.
Ms. Cottingham returned to the pediatric gynecology clinic of the University
of Alabama-Birmingham on July 8, 2015. The doctor recorded that her abnormal
uterine bleeding was now resolved with the use of oral contraceptives. The doctor
continued the prescription. Exhibit 7 at 11-13.
Procedural History regarding Litigation’s Entitlement Phase
At the law firm, a paralegal continued the process of requesting and
obtaining medical records throughout the summer of 2015. On October 16, 2015,
Mr. Downing reviewed the medical records received to date. Timesheets at 1.
Shortly thereafter, Mr. Downing and his paralegal began working on a witness
statement and drafting a petition. Timesheets at 1, 6.
Mr. Downing submitted the petition on October 30, 2015. He maintained in
it that Ms. Cottingham first experienced symptoms of a condition the HPV vaccine
caused on November 1, 2012. Therefore, in Mr. Downing’s view, the 36-month
statute of limitations expired on November 1, 2015. Pet’r’s Mot. for Rev., filed
Apr. 27, 2017, at 5.
3
A duplicate of this record appears as exhibit 10, page 4.
6
The petition was not very specific. The introductory paragraph alleged that
Ms. Cottingham suffered “a severe adverse reaction.” Paragraph four of the
petition references headaches that began on November 1, 2012. Paragraphs six
and seven refer to episodes of fainting in March and May 2013, respectively.
Paragraph eight recounts that Ms. Cottingham’s mother was concerned about
“autonomic dysfunction.” Paragraph nine asserts that Ms. Cottingham began
having menstrual problems in the latter part of 2013.
Over the next few months, Mr. Downing’s office obtained more medical
records and filed them. On March 15, 2016, Mr. Downing submitted a statement
of completion, representing that Ms. Cottingham had filed all the medical records
of which she was aware.
On March 28, 2016, a status conference was held. The Secretary stated that
he was concerned about the reasonable basis for the petition. In response, Mr.
Downing stated that Ms. Cottingham would attempt to retain an expert. See order,
issued Mar. 28, 2016.
Mr. Downing called one doctor, whom Mr. Downing has retained in other
Vaccine Program cases, Dr. Nemechek. However, Dr. Nemechek did not provide
a favorable opinion. After consulting Ms. Cottingham’s mother, Mr. Downing
consulted a second expert, Dr. Lee. However, Dr. Lee also could not provide a
favorable opinion. See Pet’r’s Mot., filed Oct. 26, 2016, at 6-7.
On October 6, 2016, Ms. Cottingham filed a motion for a decision. Ms.
Cottingham’s case was dismissed due to a lack of evidence. See Decision
Dismissing Case, 2016 WL 6575170.
Procedural History Relating to Petitioner’s
Motions for Attorneys’ Fees and Costs
1. Initial Motion through Special Master’s Initial Adjudications
Ms. Cottingham filed her first motion for attorneys’ fees and costs on
October 26, 2016. She devoted one section of her accompanying brief to an
argument that reasonable basis supported her petition. Ms. Cottingham primarily
contended that her attorney was required to file her petition before the expiration of
the time set by the statute of limitations. Therefore, the standard for evaluating
reasonable basis should be more lenient. Pet’r’s Mot. for Attorneys’ Fees and
Costs, filed Oct. 26, 2016, at 7. While the thrust of Ms. Cottingham’s argument in
favor of a finding of reasonable basis was the looming statute of limitations, Ms.
Cottingham also mentioned that she was diagnosed with syncope. Id. at 4 (citing
7
exhibit 3 at 111 (record dated July 25, 2013)). Ms. Cottingham continued:
“Syncope is listed on the Gardasil product monograph as a known potential result
of this vaccination, as well as a frequently reported side effect in the post-
marketing experience.” Id. Although Ms. Cottingham provided an internet link to
the product monograph, she did not file it as an exhibit.
After this discussion about the requirements to be eligible for attorneys’ fees
and costs, Ms. Cottingham discussed the amount of attorneys’ fees and costs that
would be reasonable. Id. at 8-21. Ms. Cottingham concluded that a reasonable
amount was $10,363.00 in attorneys’ fees and $1,105.77 in costs. Ms. Cottingham
supported her request with timesheets, invoices, and a memorandum approximately
10 pages in length. Ms. Cottingham’s October 26, 2016 motion requested
compensation for Mr. Downing’s work through October 18, 2016, when the
entitlement phase of Ms. Cottingham’s case ended. In other words, the October
26, 2016 motion did not request any fees for preparing the fee application itself.
The Secretary argued that Ms. Cottingham’s case lacked a reasonable basis.
Resp’t’s Resp., filed Nov. 14, 2016. The Secretary’s analysis was contained in two
parts. First, the Secretary maintained “[t]he record contains no evidence to support
a finding of reasonable basis.” Id. at 4. The Secretary reviewed five pieces of
evidence that Ms. Cottingham had cited in her motion. In this context, the
Secretary filed a product monograph as exhibit A. See id. at 5 n.1. The Secretary
maintained that the product monograph did not support a reasonable basis because
“the relevant period of concern addressed in the document is ‘15 minutes after
administration.’” Id. at 8 (citing exhibit A). In contrast, Ms. Cottingham’s
episodes of syncope occurred eight and ten months after vaccination and the
doctors who treated her associated those syncopal episodes with dehydration.
The Secretary’s second point against a finding of reasonable basis concerned
the statute of limitations. To the Secretary, the pendency of the statute of
limitations did not affect the analysis of reasonable basis. Id. at 11-13.
Ms. Cottingham submitted a reply, reinforcing and repeating her arguments
regarding reasonable basis. Pet’r’s Reply, filed Nov. 28, 2016. Ms. Cottingham
added that an attorney’s leaving a potential petitioner with only a short time either
to find a new attorney to represent her or to file a case pro se would be tantamount
to an ethical violation. Id. at 4 (citing Simmons v. Secʼy of Health & Human
Servs., No. 13-825V, 2016 WL 59378528, at *3 (Fed. Cl. Spec. Mstr. Apr. 14,
2016)). Ms. Cottingham also replied to the Secretary’s discussion of the evidence.
Id. at 4-8. To Ms. Cottingham, the Secretary was “comingling the analyses for
entitlement and reasonable basis.” Id. at 4. Ms. Cottingham asserted that an article
8
by S. Blitshteyn supported a claim that the HPV vaccination can cause syncope
“well outside of the 15-minute window.” Id. at 7. However, Ms. Cottingham did
not file this article.
Respondent submitted a sur-reply noting that the Court granted a motion for
review in Simmons. Resp’t’s Notice of Add’l Auth., filed Nov. 28, 2016. The
Court in Simmons stated: “[A] statute of limitations deadline does not excuse
counsel from endeavoring to confirm that the vaccine injury alleged has occurred
by producing supporting evidence.” Simmons v. Sec’y of Health & Human Servs.,
128 Fed. Cl. 579, 584 (2016).
The undersigned found that Ms. Cottingham did not satisfy the reasonable
basis standard for two reasons. Cottingham v. Sec’y of Health & Human Servs.,
No. 15-1291V, 2017 WL 1476242 (Fed. Cl. Spec. Mstr. Mar. 30, 2017), vacated
and remanded, 134 Fed. Cl. 567 (2017) [hereinafter “First Fees Decision”]. First,
the undersigned interpreted the Vaccine Act as not allowing the reasonable basis
standard to change because a statute of limitation was looming. Id. at *9-10.
Second, the undersigned found that the evidence did not support a finding of
reasonable basis. The First Fees Decision looked to see whether “medical records
or medical opinions” supported the claims in the petition. Id. at *11. Because
neither medical records nor medical opinions supported the assertion that the HPV
vaccination caused Ms. Cottingham’s headaches, fainting, or menstrual problems,
the First Fees Decision did not award attorneys’ fees and costs.4 Id. at *6-11.
Ms. Cottingham sought reconsideration. Ms. Cottingham opened by arguing
that an “evidence based standard” for evaluating reasonable basis “constitutes [an]
error of law” and “violates the spirit and intent of the Vaccine Act[].” Pet’r’s Mot.
for Recons., filed April 7, 2017, at 1. Ms. Cottingham developed her argument
that the statute of limitations should affect the reasonable basis analysis. Id. at 1-5.
She also maintained that the undersigned “inappropriately applied an entitlement
analysis.” Id. at 5. Under this argument, Ms. Cottingham reviewed medical
records, organized by whether her counsel received them before or after he filed
the petition. A point of emphasis was that Ms. Cottingham submitted an affidavit
about her headaches, which could have been credited despite its inconsistency with
the medical records. Ms. Cottingham also maintained that when she started to
experience symptoms was not part of the reasonable basis analysis because the
4
The First Fees Decision also looked at the attorney’s conduct. But, given later
developments in Federal Circuit law, the attorney’s conduct is no longer relevant in determining
reasonable basis.
9
“appropriateness of onset under Althen prong 3 is a question for experts – not an
attorney.” Id. at 14. In this context, Ms. Cottingham quoted, but did not file, an
article by Dr. Poser from 1982. Id.
The undersigned found that Ms. Cottingham’s case did not warrant
reconsideration. Cottingham v. Sec’y of Health & Human Servs., No. 15-1291V,
2017 WL 2209904 (Fed. Cl. Spec. Mstr. Apr. 20, 2017). The analysis was, again,
split into two parts. The first issue was the continuing dispute over whether the
pendency of the statute of limitations affects the analysis of reasonable basis. The
second part was a review of the evidence. Although Ms. Cottingham had
maintained that the First Fees Decision “cherry pick[ed] the evidence,” she did not
identify any records that were not discussed in the First Fees Decision. Id. at *3.
Although Ms. Cottingham had maintained that her affidavit regarding the onset of
her allegedly weekly headaches could have been credited, the lack of discussion in
any medical record about “regular weekly headaches” made her affidavit “strain
credibility.” Id. at *4. Finally, Ms. Cottingham had not established that the First
Fees Decision improperly considered the temporal relationship between the
vaccination and the alleged onset of different conditions. Consequently, Ms.
Cottingham’s motion for reconsideration was denied.
2. First Motion for Review, First Opinion, and Second Fees
Decision
Ms. Cottingham filed a motion for review. She argued that the looming
statute of limitations and the conduct of an attorney for petitioners affected the
analysis of reasonable basis. Pet’r’s Mot. for Rev., filed April 27, 2017, at 2-6.
Ms. Cottingham also argued that the special master erred by evaluating the case
“under an elevated entitlement standard, not a reasonable basis standard.” Id. at 8.
Much of this aspect of the motion for review repeats arguments in the motion for
reconsideration. Ms. Cottingham emphasized the value of her affidavit,
particularly in regard to her allegation that she experienced headaches on a weekly
basis. See, e.g., id. at 14. Ms. Cottingham argued that her attorney was not
responsible for determining whether the onset of her various conditions fell within
a medically appropriate time. Id. at 15-17. In this context, Ms. Cottingham again
quoted a Poser article, which was not an exhibit. Id. at 17. Ms. Cottingham’s
April 27, 2017 motion for review did not reference the Blitshteyn article, which
was not an exhibit, or the product monograph, which is exhibit A.
The Secretary responded to both themes. First, the Secretary argued that an
evidence-based standard was appropriate for evaluating reasonable basis. Resp’t’s
Resp., filed May 26, 2017, at 9-17. Second, the Secretary maintained that the
10
special master’s finding that Ms. Cottingham did not satisfy the reasonable basis
standard under the totality of circumstances test was not arbitrary or capricious. Id.
at 17-20. As part of this argument, the Secretary contended that “[b]ecause the
petition was alleging injuries [Ms. Cottingham] did not have and timeframes
between vaccination and onset that were facially suspect and unsupported by any
medical opinion or prior case decisions, a ‘reasonable basis’ for the petition’s filing
did not exist.” Id. at 19.
Ms. Cottingham replied. She continued to press the value of her affidavit.
Pet’r’s Reply, filed June 2, 2017, at 2 (citing Vaccine Rule 2(c)(2)(B)). To Ms.
Cottingham, the special master “baffl[ingly] . . . ignore[d] under-oath testimony.”
Id. Ms. Cottingham asserted that the undersigned “is the only Special Master to
continue to espouse an evidence-based standard” for evaluating reasonable basis.
Id. at 2. With respect to the evidence, Ms. Cottingham asserted that three articles
connected the human papillomavirus vaccine to autonomic dysfunction. Id. at 9-
10. However, the three articles (Martinez-Lavin, Kinoshita, and Brinth) were not
filed as exhibits. Ms. Cottingham did not cite the product monograph, although
she referred to the Vaccine Injury Table, which associates HPV vaccination with
syncope that occurs within one hour. Id. at 10.
The Court granted the motion for review. Cottingham v. Sec’y of Health &
Human Servs., 134 Fed. Cl. 567 (2017) [hereinafter “First Opinion”]. For each of
the two reasons the First Fees Decision gave for finding that there was not a
reasonable basis for the claim set forth in the petition, the Court stated that the
standard was not correct. With respect to the discrepancy between Ms.
Cottingham’s affidavit and the contemporaneously created medical records, the
Court stated: “To interpret these medical records to vitiate any reasonable basis for
the claim places too onerous a burden on counsel at the pleading stage.” Id. at 576.
The Court continued: “Insisting that an injured claimant’s testimony precisely
mesh with medical records is too exacting a standard to apply in assessing whether
a claim has a reasonable basis.” Id.
The Court’s ruling with respect to the temporal relationship between the
vaccination and the onset of symptoms was similar. “The Special Master’s
conclusion that Petitioner’s counsel was required to marshal evidence and
precedent on the timing of onset of [HPV] vaccine injuries to establish a
reasonable basis for filing a claim asks too much.” Id. Accordingly, the Court
vacated the First Fees Decision and remanded for additional adjudication under the
standard articulated in its ruling.
11
After the Court issued its First Opinion, Ms. Cottingham filed a
supplemental motion for attorneys’ fees and costs. This motion captures efforts of
Mr. Downing and others beginning October 21, 2016. The motion encompassed
work on the October 26, 2016 motion for attorneys’ fees and costs, the reply brief,
the motion for reconsideration, and the motion for review. Ms. Cottingham sought
$20,182.50 for attorneys’ work in litigating the fee dispute as well as an additional
$1,758.09 in costs. Pet’r’s Supp’l Mot., filed Sept. 19, 2017. Following an
informal request from the undersigned, Ms. Cottingham submitted her General
Order #9 statement on November 6, 2017, indicating that Ms. Cottingham had not
incurred any costs personally.
The undersigned found that under the Court’s standard, Ms. Cottingham
satisfied the reasonable basis standard. The undersigned did not consider the
discrepancies between the medical records and Ms. Cottingham’s affidavit. The
undersigned also did not consider the latency between vaccination and the onset of
Ms. Cottingham’s headaches, fainting, or menstrual difficulties. Under the Court’s
standard, “[Ms. Cottingham’s] affidavit, by itself, carries Ms. Cottingham’s burden
to establish a reasonable basis.” Cottingham v. Sec’y of Health & Human Servs.,
No. 15-1291V, 2017 WL 6816709 (Fed. Cl. Spec. Mstr. Dec. 12, 2017), vacated
and remanded, 139 Fed. Cl. 88 (2018) [hereinafter “Second Fees Decision”].
With respect to the amount of attorneys’ fees and costs, the Second Fees
Decision awarded Ms. Cottingham $32,909.36.
3. Second Motion for Review, Second Opinion, and Third Fees
Decision
This time, the Secretary challenged the undersigned’s decision. The
Secretary argued that the Court should vacate its September 18, 2017 [First]
Opinion and reinstate the First Fees Decision, issued on March 30, 2017. The
basis for this argument was that in a precedential opinion, the Federal Circuit held
that neither a looming statute of limitations nor the actions of counsel were part of
the examination into reasonable basis. The Federal Circuit, instead, required an
“objective inquiry.” Resp’t’s Mot. for Rev., filed Jan. 10, 2018, at 9 (citing
Simmons v. Sec’y of Health & Human Servs., 876 F.3d 632 (Fed. Cir. 2017)).
After discussing Simmons, the Secretary turned to the record in Ms.
Cottingham’s case. Referring the First Fees Decision, the Secretary maintained
that “[b]ecause petitioner submitted no evidence to support the causation claim, the
Special Master did not abuse his discretion in finding that the petitioner lacked a
reasonable basis.” Resp’t’s Mot. for Rev. at 14. In other words, “without any
12
evidence to support the causation claim, it is clear that petitioner fails to satisfy her
burden for entitlement to compensation for attorneys’ fees and costs under the
reasonable-basis standard.” Id. at 15 (emphasis in original). The Secretary further
argued that “neither the affidavits nor [Ms. Cottingham’s] medical records support
a finding of reasonable basis.” Id. (capitalization changed without notation). In
doing so, the Secretary “respectfully object[ed]” to the Court’s faulting the special
master for expecting an affidavit to mesh with the medical records. Id. at 17.5
Similarly, the Secretary also “respectfully object[ed]” to the First Opinion’s
determination that the special master wrongly required petitioner “to marshal
evidence and precedent on timing of [Gardasil] vaccine injuries to establish a
reasonable basis for filing a claim.” Id. at 15.6 Accordingly, the Secretary
concluded that the Court should vacate its First Opinion and reinstate the First Fees
Decision.
Ms. Cottingham argued that the Court should affirm the Second Fees
Decision. Ms. Cottingham stated that Simmons was distinguishable from her case
in that in Simmons, the petition was accompanied “by nothing – no medical
records or affidavits.” Pet’r’s Resp. to Mot. for Rev., filed Feb. 5, 2018, at 5. In
contrast, Ms. Cottingham “produced both sworn statements . . . as well as
objective, medical evidence supporting [her] complaints.” Id. at 6. “When [Ms.
Cottingham’s] affidavit is considered in context with her medical records, there is
certainly evidence supporting the Petition’s allegations. Furthermore, to say that
Petitioner’s filing in the Vaccine Program was not supported by any evidence is
simply a mischaracterization of the facts.” Id. at 8.
Ms. Cottingham also argued that in the Secretary’s motion for review, the
Secretary wrongly “comingles the causation and reasonable basis analysis.” Id. at
9. The Secretary’s approach, in Ms. Cottingham’s view, was an attempt “to hold
Petitioners to too high of a standard on reasonable basis.” Id. at 10.
Finally, Ms. Cottingham addressed questions about temporal proximity.
Citing the product monograph (exhibit A), she asserted that “the medical literature
supports autonomic dysfunction as an adverse reaction that occurs well outside of
5
The Secretary maintained this position, in part, to preserve the issue for potential
Federal Circuit review. Id. at 12.
6
Again, the Secretary noted that a Federal Circuit appeal on this issue was possible. Id.
at 15.
13
the 15-minute window.” Id. at 10. Ms. Cottingham again cited, but did not file,
articles by Blitshteyn, Martinez-Lavin, Kinoshita, and Brinth. Id. at 10-11.
The Court granted the motion for review and vacated the Second Fees
Decision. The Court ruled in an opinion issued on May 31, 2018, that the
undersigned misinterpreted the Court’s First Opinion in that “the Court did not find
that [Ms. Cottingham’s] affidavit alone would suffice to establish a finding of
reasonable basis. Rather, this Court held that the medical records could be
reconciled with the relevant testimony, and the two were not necessarily
inconsistent.” Cottingham v. Sec’y of Health & Human Servs., 139 Fed. Cl. 88, 94
(2018). Accordingly, the Court remanded with these instructions and to consider
the effect of Simmons.
After reviewing the evidence again, the undersigned found that Ms.
Cottingham did not satisfy the reasonable basis standard. Based upon Simmons,
the Third Fees Decision looked for evidence relating to claims set forth in the
petition. The Third Fees Decision defined the claims set forth in the petition as
“the HPV vaccination caused headaches within about four months, the HPV
vaccination caused fainting roughly nine months later, and the HPV vaccination
caused menstrual difficulties starting approximately 18 months later.” Cottingham
v. Sec’y of Health & Human Servs., No. 15-1291V, 2018 WL 3432638, at *5 (Fed.
Cl. Spec. Mstr. June 20, 2018), mot. for rev. denied, 141 Fed. Cl. 85 (2018),
vacated and remanded, 971 F.3d 1337 (Fed. Cir. 2020) [hereinafter “Third Fees
Decision”]. To the undersigned, the key topic was “causation.” Accordingly, the
undersigned looked for either a medical record or a medical opinion in which a
medical doctor associated a vaccination with a medical problem. The undersigned
found neither a medical opinion from a retained expert nor a medical record from a
treating doctor. Accordingly, the undersigned found that Ms. Cottingham did not
meet the reasonable basis standard. The undersigned did not discuss the product
monograph, which had been filed as exhibit A. The undersigned also did not
discuss the articles to which Ms. Cottingham had referred but had not filed.
4. Third Motion for Review and Third Opinion
Ms. Cottingham filed her second motion for review on July 19, 2018, in
which she requested the Court reverse the June 20, 2018 Fees Decision and award
the petitioner $32,909.36 in attorneys’ fees. Pet’r’s 2d Mot. for Rev., filed July 19,
2018, at 2. Ms. Cottingham developed her arguments in a memorandum filed in
conjunction with the motion.
14
To Ms. Cottingham, the Court’s First Opinion should have dictated the
result. According to Ms. Cottingham, the Court did the following:
1) construed the nature of the medical claims made; 2)
documented that the symptoms and nature of the medical
claims being made were reflected in the medical chart; 3) found
that the medical chart corroborated the under-oath testimony
from Petitioner, and 4) timing was acceptable – especially given
that the onset timing for Gardasil injuries is not established.
Pet’r’s Mem. Supporting Pet’r’s 2d Mot. for Rev. at 7. Ms. Cottingham argued
that the undersigned ignored these instructions and wrongly expanded the analysis
of reasonable basis “into a causation analysis.” Id. Ms. Cottingham maintained
that she “provided medical records that substantiate her claims of vaccine injury
causing harm.” Id. at 8. (However, Ms. Cottingham did not cite any medical
records in this portion of her brief.) Ms. Cottingham also challenged the
proposition that supplying a medical opinion or medical record was the standard
for evaluating reasonable basis. Id. In addition, Ms. Cottingham argued that the
special master “failed to consider the novelty of the Gardasil vaccination and the
ever-increasing body of medical literature supporting insidious onset of Gardasil
injuries.” Id. at 6.
In contrast, the Secretary defended the June 20, 2018 decision. According to
the Secretary, the “Special Master correctly observed that in this case, petitioner
had not submitted any evidence to support her claim that [an] HPV vaccine caused
[her] to suffer headaches, fainting, and/or menstrual problems.” Resp’t’s Resp. to
Pet’r’s 2d Mot. for Rev., filed Aug. 20, 2018, at 2. The Secretary elaborated:
“Because petitioner submitted no evidence to support causation, the Special Master
necessarily concluded that petitioner failed to establish a reasonable basis for the
claim for which the petition was brought under the objective inquiry for reasonable
basis endorsed by Simmons.” Id. at 2-3 (emphasis in original).
The Secretary disputed Ms. Cottingham’s argument that the undersigned
disregarded the Court’s previous guidance. To the Secretary, the undersigned
“weighed the affidavit evidence favorably, as previously directed.” Id. at 5-6. But,
to the Secretary, Ms. Cottingham had not produced any evidence that the HPV
vaccination caused any problem in her. “In any off-Table case, petitioner must do
more than establish that the alleged injuries occurred; petitioner’s burden is to
prove that the alleged injuries occurred and the vaccine was their cause.” Id. at 7
(emphasis in original).
15
The Secretary further argued that “there is no objective evidence that [Ms.
Cottingham] suffered chronic headaches beginning four months after her HPV
vaccine.” Id. at 11. Similarly, the Secretary maintained that the onset of fainting (8
and 10 months after vaccination) and menstrual difficulties (18 months after
vaccination) “appear too remote in time from her HPV vaccine to be considered
temporally proximate.” Id. at 12. For both points, the Secretary advised that he
wanted to preserve any objection for a possible appeal to the Federal Circuit.
In reply, Ms. Cottingham argued requiring “evidence of vaccine causation to
find reasonable basis . . . is simply not the law.” Pet’r’s Reply, filed Aug. 27,
2018, at 2. Consistent with this view of the law, Ms. Cottingham stated the “fact
that her medical chart does not say ‘HPV vaccination is the cause’ is not a
requirement of a reasonable basis test.” Id. at 4. Instead, Ms. Cottingham
maintained that “[t]here is objective evidence in this record regarding symptoms
present and their correlation back to vaccination.” Id. at 3. However, Ms.
Cottingham did not cite any evidence in this passage. After making additional
arguments, Ms. Cottingham concluded by requesting that the Court reverse the
Third Fees Decision and award her $32,909.36 in attorneys’ fees and costs, or,
alternatively, remand for further proceedings for an award of reasonable attorneys’
fees and costs. Id. at 7.
The Court denied the motion for review. The Court ruled that the special
master did not impose too high a burden of proof to establish reasonable basis. In
the Court’s view, the special master did not require Ms. Cottingham “to satisfy the
Althen factors or otherwise demonstrate causation in fact.” Cottingham v. Sec’y of
Health & Human Servs., 141 Fed. Cl. 85, 88 (2018), vacated and remanded, 971
F.3d 1337 (Fed. Cir. 2020) [hereinafter “Third Opinion”]. “Rather, in concluding
that Petitioner’s claim lacked a reasonable basis, the Special Master focused on the
lack of evidence in Petitioner’s medical records and the treating physicians’
diagnosis, along with the absence of any expert opinion or supporting literature.”
Id. at 88-89.
In addition, the Court disagreed with Ms. Cottingham’s argument that the
special master disagreed with an earlier finding from the Court. “Contrary to
Petitioner’s argument, this Court did not reassess the sufficiency of Petitioner’s
offered evidence or find that Petitioner had in fact provided sufficient evidence to
demonstrate that her claim had a reasonable basis.” Id. at 88. Thus, on December
28, 2018, a judgment denying her attorneys’ fees and costs was entered.
16
5. Federal Circuit
Ms. Cottingham appealed the judgment to the Federal Circuit. Ms.
Cottingham argued that to establish reasonable basis, petitioners must present
evidence that is “‘markedly less than needed to prove causation.’” Br. of Pet’r-
Appellant, filed May 14, 2019, at 16 (quoting Bekiaris v. Sec’y of Health &
Human Servs., 140 Fed. Cl. 108, 114 (2018)). Ms. Cottingham further argued that
she met this standard because “she provided evidence demonstrating her receipt of
a covered vaccination. Petitioner presented evidence in her medical chart
documenting the very injuries and symptoms which she claimed was related to her
receipt of said vaccination. Petitioner articulated a rational and reasonable causal
connection between the two. Reasonable basis exists.” Id.Ms. Cottingham directed the Federal Circuit to earlier briefs (discussed
above) in which she cited medical articles by Blitshteyn, Martinez-Lavin,
Kinoshita, and Ozawa. Id. at 17-18. Ms. Cottingham also asserted that the HPV
vaccination was a novel vaccination. Ms. Cottingham next reviewed the material
contained in medical records and maintained that medical records support the
assertions in her affidavit. See id. at 20-25. In this context, Ms. Cottingham stated
that the product monograph for Gardasil “connect[s]” the HPV vaccine with
“headache, nausea, syncope, abdominal pain and dizziness.” Id. at 23. In
conclusion, based upon those arguments, Ms. Cottingham requested that the
Federal Circuit vacate the decision and “remand with instructions to award
attorneys’ fees and costs.” Id. at 27.
In response, the Secretary urged the Federal Circuit to confirm that
Simmons, in his view, had rejected the “totality of the circumstances test.” Br. of
Resp’t-Appellee, filed June 5, 2019, at 12-17. In terms of Ms. Cottingham’s case,
the Secretary maintained the decision that the petition lacked a reasonable basis
should be affirmed because she “submitted no evidence on a critical element –
specifically, vaccine-causation.” Id. at 17. To the Secretary, although Ms.
Cottingham “discusses certain medical records that allegedly ‘support [her] injury
claim,’ those records merely document that [she] was experiencing certain
symptoms in the several months after her vaccination; they do not causally relate
those symptoms to the Gardasil vaccine.” Id. at 19 (quoting Br. of Pet’r-Appellant
at 9).
The Secretary reviewed various pieces of evidence on which Ms.
Cottingham relied. The Secretary maintained that the alleged onset of headaches
(approximately four months after the vaccination) presented an immediate and
obvious “obstacle to proving causation.” Id. at 21. The Secretary disputed Ms.
17
Cottingham’s characterization of the HPV vaccination as “novel.” Id. The
Secretary noted that the articles on which Ms. Cottingham was relying were not
part of the record and that the articles, by their titles, addressed different
conditions. Id. at 22-23. The Secretary, however, did not address the product
monograph, which the Secretary had filed into the record as exhibit A.
The Federal Circuit granted Ms. Cottingham some, but not all, of the relief
she sought. The Federal Circuit vacated the December 28, 2018 judgment.
However, as discussed below, the Federal Circuit did not order an award of
attorneys’ fees, remanding that question.
As to the question regarding whether special masters may consider “the
totality of the circumstances,” the Federal Circuit stated that Simmons did not
reject this test. Cottingham v. Sec’y of Health & Human Servs., 971 F.3d 1337,
1344-45 (Fed. Cir. 2020). Petitioners can satisfy the “objective test” of reasonable
“through objective evidence.” Id. at 1344.
The Federal Circuit further explained that petitioners “must point to
evidence of a causal relationship between the administration of the vaccine and
[their] injuries in order to establish that a reasonable basis for the claim existed
when the petition was filed.” Id. at 1346. This evidence is lower than the
preponderance of evidence standard. “Indeed, more than a mere scintilla but less
than a preponderance of evidence could provide sufficient grounds for a special
master to find reasonable basis.” Id.
When the Federal Circuit measured the information that Ms. Cottingham had
provided, the Federal Circuit deemed the undersigned’s statement that Ms.
Cottingham had “presented ‘no evidence’ that supported [her] assertion that the
Gardasil vaccination caused [her] injuries” constituted reversible error in that it
“rests on a clearly erroneous fact finding.” Id. at 1344-45.
6. Remand After Federal Circuit Opinion, Fourth Decision, and
the Federal Circuit’s Opinion in James-Cornelius
After the Federal Circuit issued its mandate and an order was issued
remanding the case back to the undersigned on October 14, 2020, the undersigned
issued an order setting out a briefing schedule on October 15, 2020. The parties
filed initial briefs on November 19, 2020, and filed reply briefs on December 7,
2020. The undersigned then scheduled an oral argument for December 14, 2020,
and issued some guidance on the content of the oral argument on December 11,
2020. Oral argument was held remotely via videoconferencing on December 14,
18
2020. Oral argument proved helpful in extrapolating the parties’ various points on
remand.
The undersigned issued a decision on January 7, 2021, again denying Ms.
Cottingham’s motion for attorneys’ fees and costs. Cottingham v. Sec’y of Health
& Human Servs., No. 15-1291V, 2021 WL 347020 (Fed. Cl. Spec. Mstr. Jan. 7,
2021), vacated and remanded, No. 15-1291V, 2021 WL 3085502 (Fed. Cl. July 21,
2021[hereinafter “Fourth Fees Decision”]. In this decision, the undersigned re-
assessed certain pieces of evidence highlighted by the Federal Circuit, including:
(1) certain medical records, (2) affidavit testimony, and (3) the package insert. Id.
at *19-27. The undersigned also considered additional medical articles filed by
Ms. Cottingham. Id. at *27-31. The undersigned found that, while Ms.
Cottingham had supplied some evidence regarding reasonable basis, under the
totality of the circumstances, she had not met her burden to show that her claim
was properly supported by a reasonable basis.
The next day, the Federal Circuit issued its opinion in James-Cornelius v.
Secretary of Health & Human Services, 984 F.3d 1374 (Fed. Cir. 2021). In this
decision, the Federal Circuit re-examined the reasonable basis standard,
specifically focusing on evaluation of affidavits and testimony as evidence of
reasonable basis, as well as the necessity (or lack thereof) of an expert medical
opinion to establish reasonable basis. Most notably, the Federal Circuit
emphasized that medical records, affidavits, and sworn testimony all constitute
objective evidence. James-Cornelius, 984 F.3d at 1379-81. Therefore, special
masters must consider these forms of evidence in evaluating reasonable basis.
Additionally, the Federal Circuit stated that “absence of an express medical
opinion on causation is not necessarily dispositive of whether a claim has
reasonable basis.” Id. at 1379 (citing Cottingham, 971 F.3d at 1346). Thus, as the
Court ruled, medical records without support from an expert opinion can satisfy the
reasonable basis standard because “the lack of an express medical opinion on
causation d[oes] not by itself negate the claim’s reasonable basis.” Id. at 1380.
The undersigned has incorporated the dictates of the James-Cornelius
opinion into his analysis on this remand. In doing so, the undersigned has
considered and weighed all objective evidence of reasonable basis, including
affidavit evidence. The undersigned has also considered the medical records and
literature separate from the lack of express medical opinion in this case. That is,
the undersigned does not treat the absence of a medical opinion in this case as
dispositive of the issue of reasonable basis.
19
7. Fourth Motion for Review
On February 5, 2021, Ms. Cottingham filed a motion for review. She argued
first that the Federal Circuit’s decision in James-Cornelius, issued one day after the
undersigned issued the fourth Cottingham decision on remand, further clarified the
reasonable basis standard and that the combination of medical records, product
insert, and affidavit testimony present in her case provided objective evidence of
causation, as in James-Cornelius. Pet’r’s Mot. for Rev., filed Feb. 5, 2021, at 4-8.
Second, Ms. Cottingham argued that the undersigned’s weighing of certain pieces
of evidence amounted to a violation of the standards set out by the Federal Circuit
in Cottingham and James-Cornelius by elevating the burden associated with the
reasonable basis standard. Id. at 8-19.
In response, the Secretary argued first that the undersigned thoroughly
considered and discussed the pieces of evidence highlighted by the Federal Circuit,
as well as additional medical articles, and rationally made a determination based on
the totality of the circumstances. Resp’t’s Resp., filed Mar. 8, 2021, at 8-14.
Second, the Secretary argued that, in considering all evidence, including affidavit
testimony—and not relying solely on the absence of a medical opinion in the
ultimate determination—the undersigned weighed the evidence in accordance with
Cottingham and James-Cornelius. Id. at 14-20.
Ms. Cottingham filed a reply on March 15, 2021. In this reply, Ms.
Cottingham homed in specifically on what she characterizes as an over-emphasis
and erroneous reliance on the lack of opinions of treating physicians or expert
witnesses in the reasonable basis analysis. Pet’r’s Reply, filed Mar. 15, 2021, at 2-
4. She also argues against the “undermining” of the weight of the package insert
as objective evidence of reasonable basis. Id. at 4-5. Ms. Cottingham emphasized
the relevance of the affidavit testimony, as well as certain medical articles filed.
Id. at 5-7. Finally, she argues against what she deems a “conflation” of the
reasonable basis and entitlement standards by the Secretary in his response and the
undersigned in his decision. Id. at 7.
The Court granted the motion for review and vacated the Fourth Fees
Decision. The Court ruled in an opinion issued on July 21, 2021, that the
undersigned “erred in requiring Petitioner to adduce medical opinions from
treating physicians or experts to establish reasonable basis.” Cottingham v. Sec’y
of Health & Human Servs., No. 15-1291V, 2021 WL 3085502 (Fed. Cl. July 21,
2021) [hereinafter “Fourth Opinion”]. The Court remanded the case “for a
reassessment of reasonable basis without requiring a medical or expert opinion
20
supporting causation.” The Court provided the following instructions as
assessments for the undersigned to undertake on remand:
1) shall evaluate the totality of the circumstances, including:
a. The import of James-Cornelius;
b. The import of the Gardasil package insert, considering 21 C.F.R. §
201.57;
c. The policies of the Vaccine Act encouraging petitioners to file and
obtain qualified counsel to assist them; and
2) need not focus exclusively on the Althen factors but may consider other
pertinent factors such as the novelty of the vaccine and the claimed
injuries.
Fourth Opinion, 2021 WL 3085502, at *8. After the Court of Federal Claims
issued its order remanding the case back to the undersigned on July 6, 2021, the
undersigned held a status conference with the parties and issued an order setting
out a briefing schedule on July 8, 2021.
8. Summary of the Arguments after Fourth Remand
After the remand order was issued, the parties filed simultaneous briefs on
August 9, 2021, and Ms. Cottingham filed a reply brief on August 23, 2021.
Ms. Cottingham structured her brief by addressing each of the areas of
consideration outlined by the Court of Federal Claims in turn: (1) the effect of the
Federal Circuit’s opinion in James-Cornelius; (2) regulations pertaining to package
inserts; (3) policy considerations; and (4) novelty. First, Ms. Cottingham
emphasized the two major points from the James-Cornelius opinion: that affidavits
constitute objective evidence of reasonable basis, and that a lack of a medical
opinion is not dispositive in determining whether a reasonable basis exists. Ms.
Cottingham argues that she has provided an under-oath affidavit as well as medical
records that provide objective evidence of reasonable basis and need not be
corroborated or supported by an expert opinion according to the standard set out in
James-Cornelius. See Pet’r’s Br., filed Aug. 9, 2021, at 4. Ms. Cottingham quoted
the Federal Circuit’s opinion in stating: the “absence of an express medical opinion
on causation is not necessarily dispositive of whether a claim has a reasonable
basis, especially when the case is in its early stages and counsel may not have had
the opportunity to retain qualified experts.” Id. at 2 (quoting James-Cornelius, 984
F.3d at 1379). Ms. Cottingham pointed out that the vaccinee in James-Cornelius
complained about injuries, headache and syncope, that are “the exact same injuries
at issue here.” Id. Ms. Cottingham noted that James-Cornelius “clarified the
21
standard that affidavits are objective evidence in the reasonable basis analysis.” Id.
at 4. Finally, Ms. Cottingham commented that the special master on remand in
James-Cornelius awarded attorneys’ fees and costs.
Second, with respect to consideration of package inserts, Ms. Cottingham
cites 21 C.F.R. § 201.57(c)(7) in emphasizing that “adverse events” as defined for
the purposes of product inserts include “only those adverse events for which there
is some basis to believe there is a causal relationship between the drug and the
occurrence of the adverse event.” Id. at 5 (quoting 21 C.F.R. § 201.57(c)(7)). Ms.
Cottingham thus argues that, based on this definition, any adverse events indicated
by product inserts that match symptoms contained in Ms. Cottingham’s medical
records at least meet the relatively lower standard to establish reasonable basis. Id.
at 5-6 (“As the Federal Circuit clearly stated, symptoms contained in the
Petitioner’s medical chart that are also listed in the product monograph is
important evidence of reasonable basis.”). Ms. Cottingham also contended that
any examination of the product insert was not appropriate in determining whether
reasonable basis supports her claims. Questions about the “time frames measured
during the clinical trials” and whether the petitioner’s symptoms “are exactly like
what others experienced” could be addressed only during an entitlement hearing,
not in a reasonable basis inquiry. Id. at 15. Ms. Cottingham summed up her
comments about the package insert by quoting the Federal Circuit’s opinion in this
case: “K.C.’s medical records paired with the Gardasil package insert thus
constitute at minimum circumstantial, objective evidence supporting causation.”
Id. at 6, quoting Cottingham v. Sec’y of Health & Human Servs., 917 F.3d 1337,
1346 (Fed. Cir. 2020).
Third, with respect to policy considerations, Ms. Cottingham argues that the
attorneys’ fees and costs structure in place is set up to ensure petitioners’ access to
competent counsel and cites multiple cases to support this point. Id. at 6-7
(quoting Avera v. Sec’y of Health & Human Servs., 515 F.3d 1343, 1352 (Fed.
Cir. 2008); Saunders v. Sec’y of Health & Human Servs., 25 F.3d 1031, 1035 (Fed.
Cir. 1994); McKellar v. Sec’y of Health & Human Servs., 101 Fed. Cl. 297, 302
(2011); Sheppard v. Sec’y of Health & Human Servs., No. 19-632V, 2021 WL
2210664, at *4 (Fed. Cl. Spec. Mstr. May 3, 2021)). Ms. Cottingham also states
that a finding against reasonable basis in this case will contribute to a “chilling
effect on an injured person’s access to Counsel.” Id. at 8.
Finally, regarding the role of novelty in this case, Ms. Cottingham states that
the HPV vaccine is the most novel of the vaccines dealt with in the Program and
that “there has been an explosion of medical literature over the past few years
regarding the adverse effects of the HPV vaccination.” Id. She points to exhibits
22
11-15 in this case as emerging research findings that provide evidence of her claim
and further contribute to reasonable basis. Id. at 8-11.7
In his brief filed simultaneously with Ms. Cottingham’s, the Secretary
focuses mainly on policy considerations and the effect of James-Cornelius in
according special masters wide discretion in weighing evidence to determine the
issue of reasonable basis. The Secretary defers to the undersigned’s previous
findings regarding the effect of the package inserts. See Resp’t’s Br., filed Aug. 9,
2021, at 7 n.3. He also briefly addresses novelty by stating that, unlike claims that
are routinely found to be meritorious, novel claims like the one in this case could
require some specific evidence of causation to establish reasonable basis. Id. at 7
n.4.
Regarding policy considerations, the Secretary acknowledges that awards of
attorneys’ fees and costs are made potentially available in uncompensated cases to
encourage petitioners’ access to competent counsel. However, the Secretary
emphasizes that requiring a reasonable basis for uncompensated claims serves
another policy goal: “encouraging petitioners and their counsel to exercise
appropriate diligence and judgment, and only bring claims that have some basis in
science, fact, and law.” Id. at 3. Furthermore, the Secretary cites to the number of
attorneys listed on the Court of Federal Claims website as practicing vaccine injury
law, as well as the increasing number of petitions filed in the Program, as evidence
that the limitation of the reasonable basis standard is not having a practical effect
on petitioners’ access to counsel practicing in the Vaccine Program. Id. at 4. The
Secretary also argues that because reasonable basis should be determined based on
“objective evidence,” policy considerations should ultimately have no bearing on
the reasonable basis determination in this case because they are inherently
subjective in nature. Id. at 6.
Finally, the Secretary characterizes the effect of James-Cornelius as defining
what constitutes objective evidence of reasonable basis, while allowing for wide
discretion with respect to the special master’s weighing of this evidence to make an
ultimate determination. The Secretary further argues that the undersigned has
acted within his discretion in previously articulating multiple rational reasons for a
7
As discussed in more detail in section V.C., the evidence supporting the “explosion” of
literature consists of (1) an article published in 2014 regarding postural orthostatic tachycardia
syndrome, (2) an article by Japanese researchers also published in 2014, (3) another article about
postural orthostatic tachycardia syndrome published in 2015, (4) an article about small fiber
neuropathy published in 2015, and (5) a second article by the Japanese researchers published in
2017.
23
denial of fees based on a lack of reasonable basis, and cites a Supreme Court case
that states that appellate courts “must give substantial deference” to determinations
regarding fee-shifting. Id. at 8-9 (quoting Fox v. Vice, 563 U.S. 826, 838 (2011)).
In her reply brief, Ms. Cottingham responds to the Secretary’s alternate
policy arguments, as well as the application of the standards articulated in James-
Cornelius to this case. First, Ms. Cottingham argues that the standard the Secretary
would impose to serve the policy goal articulated in his brief is “overly
burdensome” and distinguishes the Secretary’s partial reliance on Simmons by
emphasizing the total lack of objective evidence in that case. See Pet’r’s Reply,
filed Aug. 23, 2021, at 1-2. Ms. Cottingham also takes issue with the Secretary’s
characterization that there is a large number of petitioners’ attorneys practicing in
the Vaccine Program, citing data and arguing that the argument that “Vaccine Act
work is a flourishing area of legal practice” is “baseless.” Id. at 3-4.
Finally, in responding to the Secretary’s application of James-Cornelius, Ms.
Cottingham ultimately reiterates that she has provided sufficient objective evidence
to support a finding of reasonable basis in the form of “under-oath testimony,
medical records, vaccination product information, and medical literature
connecting the injury back to the vaccination given.” Id. at 2. Furthermore, the
novelty of the claim, Ms. Cottingham argues, should only add to the evidence of
reasonable basis. Id.
II. Scope of Remand
The January 7, 2021 decision described the parties’ conflicting
interpretations about the degree, if any, of discretion for the undersigned to
determine reasonable basis. Ultimately, the undersigned held that the Federal
Circuit’s opinion did not dictate a result.
Preliminarily, the parties dispute the scope of the Federal
Circuit’s remand. To Ms. Cottingham, a denial of attorneys’
fees would constitute “legal error.” Pet’r’s Br., filed Nov. 19,
2020, at 4. Ms. Cottingham bases this argument on Federal
Circuit statements such as “the record does contain objective
evidence of causation supporting a reasonable basis,” and “[Ms.
Cottingham’s] medical records paired with the Gardasil
package insert thus constitute at minimal circumstantial,
objective evidence supporting causation.” Id. at 3-4 (quoting
Cottingham v. Sec’y of Health & Human Servs., 917 F.3d
1337, 1346 (Fed. Cir. 2020)); accord id. at 17.
24
On the other hand, the Secretary maintains the “Special Master
absolutely possesses discretion on remand to find that petitioner
has not satisfied the reasonable basis standard.” Resp’t’s Br.,
filed Nov. 19, 2020, at 1. To the Secretary, the key passage
from the Federal Circuit is the statement: “To be clear, we make
no determination on the weight of the objective evidence in the
record or whether that evidence establishes reasonable basis, for
these are factual findings for the Special Master, and not this
court.” Id. (quoting Cottingham, 917 F.3d at 1346-47).
As a subordinate tribunal, the undersigned must abide by the
mandate of a reviewing appellate authority. The undersigned
interprets the Federal Circuit’s opinion as not dictating a result
on remand.
In other cases, the Federal Circuit has defined its scope of
review. Ordinarily, the Federal Circuit does not find facts.
Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d 1363,
1366 (Fed. Cir. 2013); Munn v. Sec’y of Health & Human
Servs., 970 F.2d 863, 868-71 (Fed. Cir. 1992). But see Andreu
v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1375 (Fed.
Cir. 2009) (finding that petitioners were entitled to
compensation).
“Upon return of its mandate, the district court cannot give relief
beyond the scope of that mandate, but it may act on matters left
open by the mandate.” Laitram Corp. v. NEC Corp., 115 F.3d
947, 951 (Fed. Cir. 1997) (quoting Caldwell v. Puget Sound
Elec. Apprenticeship & Training Tr., 824 F.2d 765, 767 (9th
Cir. 1987)) (internal quotation marks omitted). Here, as the
Secretary points out, see Resp’t’s Br. at 1, the Federal Circuit
did not reverse the outcome. Instead, the Federal Circuit
vacated and remanded.
Accordingly, the undersigned interprets the Federal Circuit’s
opinion and mandate as requiring a re-examination of the
evidence under the totality of circumstances to determine
whether Ms. Cottingham possessed a reasonable basis for the
claim set forth in the petition. The undersigned understands the
Federal Circuit did not require a particular result.
25
Fourth Fees Decision, 2021 WL 347020, at *12-13.
After this fourth decision, the Court of Federal Claims again remanded the
case and this remand also raises questions about latitude on remand because a
statement from the Court of Federal Claims is binding on the assigned special
master on remand. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625,
630 (1998) (“Special masters are neither bound by their own decisions nor by cases
from the Court of Federal Claims, except, of course, in the same case on
remand.”).
In its Fourth Opinion, it appears that the Court of Federal Claims also did
not state the outcome to the reasonable basis inquiry. The Court stated: “On
remand, the Special Master shall determine whether Petitioner established a
reasonable basis for her claim.” Fourth Opinion, 2021 WL 3085502, at *8. For
their part, the parties do not argue that the Court’s July 6, 2021 Opinion requires a
result.
III. Standards for Adjudication
When a petitioner does not receive compensation (like Ms. Cottingham
here), a petitioner remains eligible for an award of attorneys’ fees and costs when a
special master “determines that the petition was brought in good faith and there
was a reasonable basis for the claim for which the petition was brought.” 42
U.S.C. § 300aa–15(e). Here, the Secretary has not raised a challenge to Ms.
Cottingham’s good faith. Thus, the disputed issue is reasonable basis.
The precise standard by which special masters should evaluate claims of
reasonable basis is still being fleshed out. However, some points about reasonable
basis have been established in the last few years. The evidentiary standard for
determining reasonable basis is less than the preponderance of the evidence.
Chuisano v. Sec’y of Health & Human Servs., No. 07-452V, 2013 WL 6324660, at
*12-13 (Fed. Cl. Spec. Mstr. Oct. 25, 2013), mot. for rev. denied, 116 Fed. Cl. 276(2014).
When a petitioner submits literally no evidence, then a petitioner lacks a
reasonable basis. Simmons v. Sec’y of Health & Human Servs., 875 F.3d 632(Fed. Cir. 2017). Simmons, thus, clarified that petitioners meet their burden to
establish reasonable basis by presenting objective evidence. Id. at 635-36.8
8
As outlined in the procedural history, much of the parties’ arguments in earlier portions
of the case concerned whether Ms. Cottingham’s affidavit constituted evidence supporting
26
In cases in which petitioners submit some objective evidence, Simmons does
not control the result. The Federal Circuit saw the present case as one in which
Ms. Cottingham had presented some evidence of reasonable basis. Thus, the
Federal Circuit reasoned “more than a mere scintilla but less than a preponderance
of proof could provide sufficient grounds for a special master to find reasonable
basis.” Cottingham, 917 F.3d at 1346.
The operative word in that quotation is “could.” The presence of “more than
a mere scintilla” of evidence does not mandate a finding of reasonable basis. This
lesson is demonstrated by the Federal Circuit’s earlier precedential opinion on
reasonable basis, Perreira v. Secretary of Health & Human Services. In that case,
the Perreiras alleged that a 1982 administration of the diphtheria-pertussis-tetanus
(“DPT”) vaccine harmed their daughter, Carly. Initially, the Perreiras maintained
that Carly started having seizures four days after the second dose of DPT, based
upon the testimony of Carly’s mother. The former Chief Special Master declined
to credit Ms. Perreira’s testimony and found, instead, that the seizures started 20
days after the second dose of DPT. Perreira v. Sec’y of Health & Human Servs.,
No. 90-847V, 1991 WL 117740, at *1, 1 n.2 (Cl. Ct. Spec. Mstr. June 13, 1991).
Given this fact finding regarding the sequence of events, the Perreiras
attempted to establish a significant aggravation claim. They based this alternative
claim on the contention that two weeks after the third dose of DPT, Carly had more
seizures. The Chief Special Master rejected the Perreiras’ claim because there was
no support for their expert’s opinion that DPT causes harm that would first appear
two weeks later. Id.After the entitlement proceedings concluded, the Perreiras sought an award
for their attorneys’ fees and costs. The Chief Special Master found that the
Perreiras had a reasonable basis for filing their petition. Perreira v. Sec’y of Health
& Human Servs., No. 90-487V, 1992 WL 164436, at *2 (Cl. Ct. Spec. Mstr. June
12, 1993).
The decision does not provide a reason for finding reasonable basis.
However, the Chief Special Master explicitly found that a reasonable basis no
longer existed after the expert submitted a report, noting that the expert’s theory
reasonable basis. But, after the Federal Circuit opinion in Cottingham, the Federal Circuit held
that a petitioner’s affidavit regarding his or her symptoms is one form of “objective evidence” a
special master must consider in determining reasonable basis. James-Cornelius, 984 F.3d at
1379-81.
27
“amounted to his own unsupported speculation[,]” and that the Perreiras’ attorney
should have recognized that the expert’s theory “was legally insufficient to
establish causation.” Id. at *1-2. The Chief Special Master also stated that the
Perreiras’ attorney recognized that this case “was a ‘bad case.’” Id.
The Perreiras filed a motion for review of the denial of a portion of the
attorneys’ fees and costs. In finding the former Chief Special Master's
determination not arbitrary, the Court of Federal Claims rejected the petitioners’
arguments, including an argument that “counsel had an absolute right to rely on the
expert’s opinion in pursuing the case.” Perreira v. Sec'y of Health & Human
Servs., 27 Fed. Cl. 29, 33 (1992).
These decisions form the background for the Federal Circuit’s discussion of
“reasonable basis” in its Perreira opinion. Affirming the original decision, the
Federal Circuit held that the Chief Special Master could determine that a petitioner
lacked reasonable basis, despite an expert report, because “the expert opinion was
grounded in neither medical literature nor studies.” Perreira v. Sec’y of Health &
Human Servs., 33 F.3d 1375, 1377 (Fed. Cir. 1994). The Federal Circuit explained
that “[t]he special master did not require counsel to verify the validity of the
expert's opinion, but only required the opinion to be more than unsupported
speculation.” Id.“Perreira demonstrates that special masters enjoy discretion to find that a
claim lacked a reasonable basis when the evidence on which the petitioners relies
(there, an expert’s report) is rooted in unsupported speculation.” Ellis v. Sec’y of
Health & Human Servs., No. 13-336V, 2019 WL 3315326, at *4 (Fed. Cl. Spec.
Mstr. June 24, 2019). The Federal Circuit guided the “reasonable basis” standard
by declaring: “Congress must not have intended that every claimant, whether
being compensated or not under the Vaccine Act, collect attorneys’ fees and costs
by merely having an expert state an unsupported opinion.” 33 F.3d at 1377.
It appears that the testimony of an expert constitutes “more than a mere
scintilla” of evidence. If so, then Perreira demonstrates that a petitioner could
present some evidence regarding causation and yet not satisfy the reasonable basis
standard.
While the Federal Circuit did not cite Perreira in Cottingham or James-
Cornelius, the Federal Circuit’s use of the term “could” in Cottingham also
suggests that special masters can reach different outcomes and those disparate
outcomes might all be rational. In the context of determining whether petitioners
28
have met their burden to present preponderant evidence supporting causation,
appellate authorities have recognized that questions of causation turn on the
evidence presented, and reasonable special masters may weigh evidence
differently. Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1368 (Fed.
Cir. 2000); Estep v. Sec’y of Health & Human Servs., 28 Fed. Cl. 664, 669 (1993).
Different outcomes among special masters as to the weight and “utility” of
scientific and factual evidence are “within Program standards.” Sharpnack v.
Sec’y of Health & Human Servs., 27 Fed. Cl. 457, 461 (1993); see also Snyder v.
Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 720 (2009) (“The special
masters were free to reach different conclusions based on the same evidence.”)
(citing Sharpnack, 27 Fed. Cl. at 461). Thus, special masters’ adjudications on
entitlement do not dictate outcome in other cases. Boatmon v. Sec’y of Health &
Human Servs., 941 F.3d 1351, 1358 (Fed. Cir. 2019).
The possibility that different finders of fact can reach different outcomes on
entitlement also appears to extend to questions of reasonable basis. See Silva v.
Sec’y of Health & Human Servs., 108 Fed. Cl. 401, 402 (2012) (stating, before
Simmons, Cottingham, and James-Cornelius that the Vaccine Act gives a special
master “maximum” discretion in determining reasonable basis). This discretion to
weigh evidence differently and to reach different conclusions regarding reasonable
basis (or the lack thereof) means that decisions of other special masters do not
constitute binding precedent.
While special masters seem to enjoy latitude in how they evaluate evidence,
special masters must conform to legal standards set by appellate authorities. After
the Federal Circuit’s remand in Ms. Cottingham’s case, the parties continued to
dispute at least two related questions of law. First, the parties offered competing
understandings of the terms “feasibility” and “feasible” in the context of
reasonable basis. Second, the parties differed on whether, to establish a reasonable
basis for the claims set forth in a petition, petitioners must present some evidence
that a vaccination caused this particular vaccinee’s problem via a treating doctor or
retained expert.
Ms. Cottingham maintained that a claim possesses reasonable basis when a
petitioner: “(1) receives a covered vaccination; (2) produces medical records
demonstrating the complaints alleged; and (3) it is feasible to think that the
documented complaints could have been caused by the vaccination at issue.”
Pet’r’s Br., filed Aug. 9, 2021, at 5. While at this portion of her brief Ms.
Cottingham cites no authority for this definition, she later relates her understanding
of “feasible” to the Federal Circuit’s statement that “[Ms. Cottingham’s] injuries
paired with the Gardasil package insert thus constitute a minimum circumstantial,
29
objective evidence supporting causation.” Id. at 5 (quoting Cottingham, 917 F.3d
at 1346).
The Secretary used “feasible” differently. To the Secretary, a claim may
satisfy the reasonable basis standard when a petitioner can “point to some objective
evidence to support each of the Althen prongs because an absence of evidence as
to any necessary element of the petitioner’s prima facie case necessarily means the
claim has no feasibility of success.” Resp’t’s Br., filed Aug. 9, 2021, at 5. The
Secretary analogized the reasonable basis standard to the summary judgment
standard in which a failure of proof on an element of a nonmoving party’s case
warrants judgment as a matter of law. Id. (citing Celotex Corp. v. Catrett, 477 U.S.
317, 323 (1986)); see also id. at 8 (maintaining that before Ms. Cottingham filed a
motion to dismiss her case voluntarily, the Secretary was entitled to judgment as a
matter of law).
The Secretary’s linking “feasibility” to the prongs found in Althen v.
Secretary of Health & Human Services, 418 F.3d 1274, 1278 (Fed. Cir. 2005),
introduced the second legal question on which the parties differed. Ms.
Cottingham argued: “Delving into a causation under Althen is an improper
elevation of the reasonable basis standard. . . . [Petitioner] does not need to prove
either Althen prongs 1 or 2 by a preponderance of evidence.” Pet’r’s Br. at 5. Ms.
Cottingham expanded this argument to include the timing prong of Althen as well:
“Requiring [petitioner] to satisfy Althen prong 3 for a finding of reasonable basis
would constitute legal error.” Id. at 10.
The Secretary offered a different view. To satisfy the reasonable basis
standard, “a petitioner must present objective evidence to support each of the
Althen prongs, along with the other essential elements laid out in Section 11(c) of
the [Vaccine] Act.” Resp’t’s Br. at 5. The Secretary’s conclusion is based upon
the Federal Circuit’s summary of what the Vaccine Act (42 U.S.C. § 300aa–
11(c)(1)) requires in a petition. Id. at 3. In particular, the third of five statutory
elements requires that the vaccinee have “sustained . . . an injury . . . that was
caused by the vaccine.” Cottingham, 971 F.3d at 1345-46. The Federal Circuit
mandated that Ms. Cottingham “must point to evidence of a causal relationship
between the administration of the vaccine and her injuries in order to establish that
a reasonable basis for the claim existed when the petition was filed.” Id. at 1346.
The “causal relationship,” in turn, is defined as the three-part test in Althen, 418
F.3d at 1278.
Althen’s three-part test might take significance with respect to prong 2.
Prong 2 of Althen requires, for purposes of entitlement, that a petitioner
30
demonstrate with preponderant evidence “a logical sequence of cause and effect
showing that the vaccination was the reason for the injury.” 418 F.3d at 1278. The
Secretary argued that “the record in this case is devoid of any evidence to address
the second prong of the Althen test. Accordingly, petitioner has failed to present
even a scintilla of evidence to address an essential element of her claim.” Resp’t’s
Br. at 3. Similarly, during the December 14, 2020 oral argument conducted before
the Federal Circuit’s opinion in James-Cornelius, the Secretary maintained that in
an off-Table case, petitioners are required to have “some medical expert, whether
that’s a treating physician or an expert, tie the vaccination to the alleged injuries,”
Tr. 67, and that the lack of a report from a treating doctor or retained expert affects
the reasonable basis analysis.
While the January 7, 2021 decision evaluated those legal arguments, the
undersigned did not have the benefit of the Federal Circuit’s opinion in James-
Cornelius.
Preliminarily, although the parties used the terms “feasibility” and “feasible”
to evaluate reasonable basis, the appropriateness of this terminology is unclear.
Simmons directs special masters to look at objective evidence. Simmons, 875 F.3d
at 635-36. The Federal Circuit in Simmons did not use the terms “feasibility” or
“feasible.” Similarly, the Federal Circuit in Cottingham also did not use the terms
“feasibility” or “feasible.” In James-Cornelius, the Federal Circuit used the term
“feasible” only in summarizing the special master’s decision.
Cottingham advances the jurisprudence around reasonable basis by directing
special masters to look for Simmons’s “objective evidence” in the elements
comprising a petitioner’s case-in-chief, that is, the five elements listed 42 U.S.C.
§ 300aa–11(c)(1). One of those statutorily required elements (paragraph (C)) is a
showing of causation.
For cases in which petitioners (like Ms. Cottingham) allege an off-Table
injury, the Federal Circuit defined how petitioners demonstrate causation-in-fact in
Althen v. Secretary of Health & Human Services, 418 F.3d 1274, 1278 (Fed. Cir.
2005). According to Hibbard v. Secretary of Health & Human Services, 698 F.3d
1355, 1366 (Fed. Cir. 2012), the en banc Federal Circuit opinion in Cloer v.
Secretary of Health & Human Services, 654 F.3d 1322, 1334 n.4 (Fed. Cir. 2011),
“characterized Althen as setting forth ‘three pleading requirements for a non-Table
31
injury petition.’”9 Cloer, itself, explained that in off-Table cases, “a petitioner
must file an affidavit and supporting documentation demonstrating that the
‘vaccine-related injury’ for which compensation is sought was caused by a
vaccine.” Cloer, 654 F.3d at 1334.
It would seem that the Federal Circuit’s statement that Ms. Cottingham
“must point to evidence of a causal relationship between the administration of the
vaccine and her injuries in order to establish that a reasonable basis for the claim
existed when the petition was filed,” Cottingham, 917 F.3d at 1346, must be
importing the Althen factors into the reasonable basis analysis. However,
Cottingham does not refer to Althen at all.
As set forth above, the Secretary’s position was (at least before James-
Cornelius) that an analysis of the “objective evidence” must account for all the
Althen factors. Ms. Cottingham’s position on this point, however, is not clear due
to some rhetorical sleight-of-hand. Ms. Cottingham argues in the reasonable basis
context, a petitioner “does not need to prove either Althen prongs 1 or 2 by a
preponderance of evidence.” Pet’r’s Br. at 5 (emphasis added). Additionally, Ms.
Cottingham maintains that “[r]equiring [petitioner] to satisfy Althen prong 3 for a
finding of reasonable basis would constitute legal error.” Id. at 10 (emphasis
added).
What Ms. Cottingham has stated is literally accurate, but misdirected. The
preponderance of evidence standard is the standard by which special masters
determine whether petitioners are entitled to compensation. 42 U.S.C. § 300aa–13.
The preponderance of the evidence standard is not the correct standard for
determining whether petitioners established a reasonable basis for the claims set
forth in the petition. By referring to the “preponderance of the evidence” standard,
Ms. Cottingham has muddied the waters on the question as to whether the “more
than a mere scintilla of evidence” standard applies to each of the Althen prongs.
Given Cottingham’s focus on “causation,” as well as the wide-spread
acceptance of the Althen three-part test for causation-in-fact cases, the undersigned
holds that an examination of reasonable basis should include an analysis to see
whether objective evidence supports a petition’s claim with respect to each of the
9
While the Althen test might be pleading elements, Ms. Cottingham’s petition does not
include assertions about specific parts of the Althen test.
32
Althen prongs.10 This holding is consistent with a conclusion of a judge of the
Court of Federal Claims in an opinion issued after Simmons but before
Cottingham. The Court reasoned: “Because causation was a necessary element of
[the petitioner’s] claim, she had to provide some evidence of a causal relationship
between administration of the vaccine and her injuries to establish a reasonable
basis for the claim. The type and amount of such evidence has never been
delineated with specificity, and it can vary depending on the vaccine administered
and the injury suffered. Nonetheless, it can be said with confidence that the
quantum of evidence of causation to show reasonable basis is markedly less than
that needed to prove entitlement.” Bekiaris v. Sec’y of Health & Human Servs.,
140 Fed. Cl. 108, 114 (2018). The evidentiary support on any of the three Althen
prongs does not have to satisfy the preponderance of the evidence standard. But,
the evidentiary support on all the three prongs must be “more than a mere
scintilla.”
The statement that the reasonable basis analysis should encompass each of
the Althen prongs is a small clarification in the sense that it would seem that the
causation element found in section 11(c)(1)(C) would be undefined without the
Althen test. Althen’s interpretation of the causation standard illuminates the
meaning of the Vaccine Act. To jettison the Althen test for purposes of reasonable
basis would leave litigants and special masters in the dark.
While in the January 7, 2021 decision the undersigned held that as part of
the analysis of Althen prong 2 the undersigned could see whether petitioner
presented medical records or medical opinions, Fourth Fee Decision, 2021 WL
347020, at*18-19, this statement was made without the benefit of the Federal
Circuit’s opinion in James-Cornelius. There, the Federal Circuit stated:
“[A]bsence of an express medical opinion on causation is not necessarily
dispositive of whether a claim has a reasonable basis.” James-Cornelius, 984 F.3d
at 1379.
Similarly, in reviewing the January 7, 2021 decision, the Court of Federal
Claims held that the undersigned erred in requiring that Ms. Cottingham supply a
medical or expert opinion on causation to establish a reasonable basis. Fourth
Opinion, 2021 WL 3085502, at *8. In accord with these dictates from appellate
authorities, the lack of a direct statement from a treating doctor and/or a doctor
10
If Cottingham intended the causation element for off-Table cases to mean something
other than the Althen test, Cottingham did not set forth any alternative way of reviewing
causation.
33
retained for purposes of litigation is not a factor affecting the analysis of
reasonable basis.
The Court’s July 21, 2021 opinion expands upon the meaning of the term
“scintilla of evidence” by discussing a case from the Federal Circuit and a case
from the Fourth Circuit. The Court stated:
In Saposnekoo v. Department of Navy, the Federal Circuit
noted that “Black’s Law Dictionary (4th ed. 1951) defines
‘scintilla of evidence’ as ‘a spark of evidence . . . . A
metaphorical expression to describe a very insignificant or
trifling item or particle of evidence . . . .” 835 F.2d 871, 871 n.2
(Fed. Cir. 1987) (unpublished table decision) (alteration in
original). The Federal Circuit in Saposnekoo found that it
would be improper to “equate substantial evidence ‘with more
than a scintilla of evidence,’” because the standard for
substantial evidence “is higher than that minimal one [more
than a scintilla]—it must be ‘such relevant evidence as a
reasonable mind might accept as adequate to support a
conclusion,’ or evidence ‘enough to justify, if the trial were to a
jury, a refusal to direct a verdict when the conclusion sought to
be drawn from it is one of fact for the jury.’” Id. at 871 (quoting
Consolo v. Fed. Mar. Comm’n, 383 U.S. 607, 620 (1966)); see
also Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1360 (Fed.
Cir. 2016).
* * *
Determining what constitutes “more than a mere scintilla” of
evidence is a daunting task. As the Fourth Circuit recently
noted:
Standards are easy to recite, but harder to apply. Part of
that difficulty, at least for summary judgment standards,
lies with confusing terminology like “a scintilla of
evidence.” After all, what in the world is a “scintilla?”
Given federal courts, as noted above, require more than a
scintilla of evidence to avoid summary judgment,
understanding what a scintilla is seems necessary to
understand if a party has exceeded it. But dating back to
the nineteenth century, courts have struggled with the
34
“distinction between what is a scintilla” and what is not.
Boing v. Raleigh & G.R. Co., 87 N.C. 360 (N.C. 1882)
(remarking that the distinction “is so narrow that it is
often very difficult for a court to decide upon which side
of the line” evidence falls). . . . Compare Kurtz v. Fels,
63 Wash. 2d 871, 389 P.2d 659, 663 (1964) (holding that
proof beyond a mere scintilla requires “facts to be
assessed by the senses” and something “tactile” rather
than calculations), with Gibson v. Epting, 426 S.C. 346,
827 S.E.2d 178, 181 (2019) (describing scintilla as “a
perceptible amount” and “not something conjured up by
the shadows”), and Davies v. McDowell Nat. Bank, 407
Pa. 209, 180 A.2d 21, 30 (1962) (dissent) (“‘Scintilla’
means spark.”).
Sedar v. Reston Town Ctr. Prop., LLC, 988 F.3d 756, 761 n.3
(4th Cir. 2021). In Sedar, the Fourth Circuit ruled that summary
judgment was not appropriate because the appellant had
adduced more than a mere scintilla of evidence, which the
Court characterized as “evidence beyond speculation that
provides a sufficient basis for a reasonable inference of
causation.” Id. at 765 (quoting Penley v. McDowell Cnty. Bd.
of Educ., 876 F.3d 646, 655 (4th Cir. 2017)).
Fourth Opinion, 2021 WL 3085502, at *4-5.
The Court then listed various factors for consideration, including “the import
of James-Cornelius,” “the import of the Gardasil package insert, considering 21
C.F.R. § 201.57,” “the policies of the Vaccine Act encouraging petitioners to file
petitions and obtain qualified counsel to assist them,” possibly the Althen factors,
and “other pertinent factors such as the novelty of the vaccine.” Id. at *8.
IV. Topics the Court of Federal Claims Identified
Policy
The Court’s July 21, 2021 Opinion directed the undersigned to consider
“[t]he policies of the Vaccine Act encouraging petitioners to file petitions and
obtain qualified counsel to assist them.” Fourth Opinion, 2021 WL 3085502, at *8
(Fed. Cir. July 21, 2021). This topic is both simple and complicated.
35
The simple answer is that a policy to encourage petitioners to obtain
qualified counsel supports paying all attorneys in all cases. Such a broad
generalization encompasses paying Mr. Downing in Ms. Cottingham’s case and
the way to accomplish that policy goal is to find reasonable basis.
However, a more complete answer might be more complicated in at least
two respects. First, the Secretary argues that the policy of encouraging attorneys to
represent petitioners should not be a part of the undersigned’s analysis as to
whether reasonable basis supported the claims set forth in Ms. Cottingham’s
petition. The Secretary’s argument starts from the point settled in Simmons that
the reasonable basis standard is met with objective evidence. Resp’t’s Br., filed
Aug. 8, 2021, at 6; see also Simmons, 875 F.3d at 636. From that beginning, the
Secretary reasons that “including policy considerations in the reasonable basis
analysis cannot be squared with the holding, affirmed in both James-Cornelius and
this case, that reasonable basis is only established with objective evidence.”
Resp’t’s Br. at 7.11
It would seem that the appellate courts in interpreting the Vaccine Act’s
“reasonable basis” provision might weigh the policy consideration in setting a bar
or standard by which special masters should evaluate arguments regarding
reasonable basis. For example, there remains, at least to the undersigned,
uncertainty over the evidentiary standard. Clearly, the reasonable basis standard
does not require petitioners to present preponderant evidence. Chuisano v. Sec’y
of Health & Human Servs., No. 07-452V, 2013 WL 6234660, at *13 (Fed. Cl.
Spec. Mstr. Oct. 25, 2013), mot. for rev. denied, 116 Fed. Cl. 276 (2014). At the
other end of the spectrum, Simmons teaches that a case with zero evidence fails the
reasonable basis standard. Simmons v. Sec’y of Health & Human Servs., 128 Fed.
Cl. 579, 583 (2016), aff’d, 875 F.3d 632 (Fed. Cir. 2017). But, the undersigned
respectfully submits, the strength and quality of objective evidence can range from
barely above a scintilla to nearly a preponderance. While the Federal Circuit in
Cottingham stated that “more than a mere scintilla but less than a preponderance of
proof could provide sufficient grounds for a special master to find reasonable
basis,” 971 F.3d at 1346, did the Federal Circuit also determine, as a matter of law,
11
The Secretary extends this argument to say “the reasonable basis standard should be
described as a ‘totality of the evidence’ test, rather than a ‘totality of the circumstances’ test. If
subjective considerations are excluded from the analysis, then by definition, the analysis cannot
include a totality of the circumstances.” Resp’t’s Br. at 8. However, as Ms. Cottingham
correctly stated in her reply, the “Federal Circuit, in this case, has already rejected Respondent’s
argument.” Pet’r’s Reply, filed Aug. 23, 2021, at 3.
36
that in every case in which a petitioner presents more than a mere scintilla of
evidence, the special master must find reasonable basis? If the presence of more
than a mere scintilla of evidence does not confer reasonable basis automatically,
then where in the span between “more than a scintilla” and “less than a
preponderance” does the line rest? Conceivably, an appellate court might set the
line nearer to the scintilla level. Or an appellate court might set the line closer to
the preponderance level. These are choices for an appellate court. Then, after the
appellate court determines the standard, the special master determines how the
evidence weighs. See Althen, 418 F.3d at 1280 (“The special master’s role is to
apply the law.”).
The second complication in examining the policies animating the Vaccine
Act and the reasonable basis standard is the Supreme Court’s statement that “it is
quite mistaken to assume, as petitioners would have us, that ‘whatever’ might
appear to ‘further[] the statute’s primary objective must be the law.’ . . .
Legislation is, after all, the art of compromise, the limitations expressed in
statutory terms often the price of passage, and no statute yet known ‘pursues its
[stated] purpose [] at all costs.’” Henson v. Santander Consumer USA Inc., 137 S.
Ct. 1718, 1725 (2017). In a relatively recent order denying a rehearing en banc, six
judges of the Federal Circuit quoted this passage. Kisor v. McDonough, 995 F.3d
1347, 1351-52 (Fed. Cir. 2021).
A review of Federal Circuit jurisprudence shows that the Federal Circuit has
not always interpreted the attorneys’ fees provision in a way that promotes
payment of attorneys to foster representation of petitioners. A prominent example
is Simmons.
In Simmons, the petitioner’s attorney filed a petition to prevent the statute of
limitations from expiring. 875 F.3d at 634. The special master justified a finding
of reasonable basis on the looming statute of limitations. Id. at 635 (citing 2016
WL 2621070, at *3). The special master’s reliance on the statute of limitations
was similar to reasoning in other cases. See, e.g., Hippo v. Sec’y of Health &
Human Servs., No. 10-462V, 2012 WL 1658252 (Fed. Cl. Spec. Mstr. Apr. 18,
2012); Lamar v. Sec’y of Health & Human Servs., No. 99-584V, 2008 WL
3845157 (Fed. Cl. Spec. Mstr. July 30, 2008); Hamrick v. Sec’y of Health &
Human Servs., No. 99-683V, 2007 WL 4793152 (Fed. Cl. Spec. Mstr. Nov. 19,
2007); Peca v. Sec’y of Health & Human Servs., No. 90-122V, 1992 WL 30423(Fed. Cl. Spec. Mstr. Feb. 3, 1992). (The pending statute of limitations also
happens to be the primary argument that Ms. Cottingham initially advanced in
support of her claim for reasonable basis. Pet’r’s 1st Mot. for Rev. at 2-6.) But,
37
the judge at the Federal Circuit rejected this argument. Simmons v. Sec’y of
Health & Human Servs., 128 Fed. Cl. 579, 584 (2016).
At the Federal Circuit, the petitioner-appellant in Simmons advanced an
argument based upon policy to justify reliance on a looking statute of limitations:
If Judge Firestone’s ruling stands, on the other hand, it would
have a chilling effect on any petitioner who seeks
representation on the eve of the statute of limitations by
restricting the pool of competent counsel willing to represent
such petitioners. This would, at best, create an influx of pro se
petitioners into the Program and, at worst, result in meritorious
petitions being left unfiled, thereby thwarting a primary purpose
of the Program that vaccine-injured individuals have access to
competent counsel.
Br. of Pet’r-Appellant at 19, No. 2017-1405, 2017 WL 1033932 (Fed. Cir. Mar. 6,
2017). Nevertheless, despite the plea that an adverse outcome at the Federal
Circuit would deprive petitioners of access to competent counsel, the Federal
Circuit affirmed the denial of fees. 875 F.3d at 636.
Another example concerns the hourly rate at which attorneys are
compensated. At one time, attorneys representing petitioners requested that special
masters compensate them at rates set out in the Laffey matrix for attorneys in
Washington, DC. The Laffey matrix rates exceeded, sometimes greatly exceeded,
the rate at which the attorney was typically paid. After a special master found that
the Laffey matrix rates were not useful, a case reached the Federal Circuit. The
petitioner-appellant argued: “The use of the Laffey Matrices . . . will have the
effect of attracting counsel who are highly capable and can help fulfill the
important purposes of the Vaccine Act.” Br. of Pet’r-Appellant at 36, No. 2010-
5093, 2010 WL 2661681 (Fed. Cir. June 16, 2010). While the Federal Circuit
acknowledged that the petitioner “argues that there are strong policy rationales for
using the Laffey and Adjusted Laffey matrices,” the Federal Circuit upheld the
special master’s decision not to compensate attorneys at the Laffey rates.
Rodriguez v. Sec’y of Health & Human Servs., 632 F.3d 1381 (Fed. Cir. 2011).
A third example of a Federal Circuit opinion that did not advance the policy
goal of paying attorneys to foster a bar of competent attorneys is Perreira. There,
the petitioners paid an expert to review the case and to testify at a hearing. 33 F.3d
at 1376. Despite an expert’s testimony, the chief special master found that the
petitioners lacked a reasonable basis to proceed to a hearing. On appeal to the
38
Federal Circuit, the petitioners-appellants argued “that the intent of Congress is
violated by requiring counsel to support expert opinions as a requisite to receiving
attorneys fees and costs under the Act.” Id. at 1376. The Federal Circuit rejected
this argument, stating “Congress must not have intended that every claimant,
whether being compensated or not under the Vaccine Act, collect attorney fees and
costs by merely having an expert state an unsupported opinion that the vaccine was
the cause in-fact of the injury.” Id. at 1377.
Simmons, Rodriguez, and Perreira, thus, serve as examples in which the
Federal Circuit have turned away efforts to advance one purpose of the Vaccine
Act, which is to attract qualified attorneys to represent petitioners. To be sure,
other cases buttressed this policy. E.g., Avera v. Sec’y of Health & Human Servs.,
515 F.3d 1343, 1351 (Fed. Cir. 2008) (holding that petitioners may receive awards
of attorneys’ fees and costs on an interim basis); Sanders v. Sec’y of Health &
Human Servs., 25 F.3d 1031, 1035-36 (Fed. Cir. 1994) (holding that petitioners
who rejected the entitlement judgment may still receive a separate decision
awarding them attorneys’ fees and costs).
For their part, the parties offer various arguments why a finding regarding
(the lack of) reasonable basis would or would not advance policies at the
foundation of the Vaccine Act. Ms. Cottingham argues that the structure in place
for awarding attorneys’ fees is set up to ensure that petitioners in the Program have
access to competent counsel and states that a finding against reasonable basis in
this case will have a “chilling effect” on this access. Pet’r’s Br., filed Aug. 9.
2021, at 6-8. The Secretary argues in response that the reasonable basis limitation
on awards of attorneys’ fees serves that competing policy goal of encouraging
diligence by attorneys in the Program and ensuring attorneys “only bring claims
that have some basis in science, fact, and law.” Resp’t’s Br., filed Aug. 9, 2021, at
3. The Secretary also points to statistics to show that there has been no practical
effect on petitioners’ access to counsel in the Program, which Ms. Cottingham
challenged in her reply. Id. at 4; Pet’r’s Reply, filed Aug. 23, 2021, at 3-4.
Ultimately, the Secretary also argues that policy considerations are, by definition,
subjective evidence, which should not be considered in evaluating reasonable basis
given the requirement of “objective evidence” set out in Simmons, Cottingham,
and James-Cornelius. Resp’t’s Br. at 6.
As a judicial officer whose duties are solely to oversee and to adjudicate
claims in the Vaccine Program, the undersigned has seen a few cases in which
experienced attorneys have brought cases that lacked a reasonable basis. See, e.g.,
Gordon v. Sec’y of Health & Human Servs., No. 18-40V, 2021 WL 1957509 (Fed.
Cl. Spec. Mstr. Apr. 16, 2021) (finding a lack of reasonable basis where petitioner
39
failed to submit proof of vaccination). On the other hand, the undersigned would
be hard-pressed to identify any resolved cases in which a pro se petitioner had even
a vaguely meritorious claim. This observation suggests, but certainly does not
prove, that people with valid claims that a vaccine harmed them are finding
attorneys to represent them.12
On the whole, the policies animating the Vaccine Program have little, if any,
effect on the outcome. If Ms. Cottingham presents sufficient evidence to fulfill the
reasonable basis standard, then she will receive attorneys’ fees and costs.13 If Ms.
Cottingham does not present sufficient evidence for reasonable basis, then she will
not receive attorneys’ fees and costs.14
Novelty
The Court’s July 7, 2021 Opinion directed the undersigned to consider
novelty. Fourth Opinion, 2021 WL 3085502, at *8. The parties have spent
relatively little time on this topic.
In her brief in response to the most recent remand, Ms. Cottingham stated
that the HPV vaccine is the most novel vaccine dealt with in the Vaccine Program
and points to exhibits 11-15 as examples of emerging research findings that
support the reasonable basis of her claim. Pet’r’s Br., filed Aug. 9, 2021, at 8-11.
The Secretary briefly addressed the issue of novelty by stating that, unlike types of
claims routinely found to be meritorious, the claim in this case should require some
specific evidence of causation to show reasonable basis. Resp’t’s Br., filed Aug. 9,
2021, at 7 n.4. Ms. Cottingham responded by stating in her reply that, conversely,
the novelty of the claim combined with the evidence submitted should only help
produce a finding of reasonable basis. Pet’r’s Reply, filed Aug. 23, 2021, at 2.
Although the Federal Circuit stated that special masters may consider the
“novelty” of a vaccine, Cottingham, 971 F.3d at 1347, how “novelty” fits within a
scheme in which decisions about reasonable basis are based upon objective
12
A confounding factor is that some people with valid claims may not file claims in the
Vaccine Program and, thus, remain unknown.
13
The Secretary’s suggestion that a special master might (a) find reasonable basis and (b)
still decline to award attorneys’ fees and costs is discussed in section VII, below.
14
The undersigned hopes that it is unnecessary to say that neither animosity nor
favoritism toward counsel plays any role in the adjudications. Both Mr. Downing and Mr.
Johnson advocate for their clients passionately, effectively, and ethically.
40
evidence is not clear. Despite the parties’ relative lack of attention on novelty,
some objective evidence about the HPV vaccine is available.
In the May 27, 2005 issue of Morbidity and Mortality Weekly Report, The
Centers for Disease Control and Prevention recommended the HPV vaccine and on
April 20, 2007, the Secretary announced that the Vaccine Program would
compensate people harmed by the HPV vaccine. 72 Fed. Reg. 19937. According
to information from the Clerk’s Office, from that date until October 30, 2015, 209
cases were filed using a nature of suit code for the HPV vaccine. Ms. Cottingham
filed her petition on October 30, 2015. So, in other words, before Ms. Cottingham
filed her petition, approximately 200 other petitioners filed claims based upon the
HPV vaccine.
“Novelty,” to Ms. Cottingham, may refer to the number of studies that
evaluated the safety of the HPV vaccine. However, for “objective” evidence, the
present record contains relatively little information about the ways in which the
federal government determined that the HPV vaccine was safe enough to
authorize.15 Ms. Cottingham, as discussed below, has submitted five medical
articles about the HPV vaccine. From the undersigned’s experience, the
undersigned is aware of additional studies that are not part of the record. See Tr.
40 (discussing Chao article).
While it is easy to imagine that the upcoming years will bring new studies
involving the HPV vaccine, predicting what those studies will show is difficult.
Future studies might reveal that the HPV vaccine causes more adverse reactions
than previously suspected. Or, the future studies might demonstrate that the HPV
vaccine is safe and causes very few, if any, adverse reactions.16 It would seem that
basing a decision about the reasonable basis for the claims set forth in Ms.
Cottingham’s petition on speculation about future studies would not be consistent
with the instruction to rely upon objective evidence.
15
The package insert compares a 9-valent HPV vaccine to the original quadrivalent HPV
vaccine. See exhibit A.
16
Delaying adjudication of claims of entitlement has not always worked to the benefit of
petitioners. Snyder v. Sec’y of Health & Human Servs., No. 02-162V, 2009 WL 332044, at
*147 (Fed. Cl. Spec. Mstr. Feb. 12, 2009) (“The science has developed in the intervening years,
but not in the OAP petitioners’ favor.”), mot. for rev. denied, 88 Fed. Cl. 706 (2011).
41
James-Cornelius
The Federal Circuit’s opinion in James-Cornelius brings forward at least
three points warranting consideration. However, on a critical point, the guidance
remains unclear.
First, James-Cornelius held that a petitioner’s affidavit about when he or she
experienced various symptoms constitutes a type of objective evidence that a
special master must consider in evaluating reasonable basis. One reason the
Federal Circuit vacated the judgment was to allow the special master to consider
the petitioner’s affidavit. 984 F.3d at 1380.
This holding, while important in other cases, has little effect on Ms.
Cottingham’s case. The undersigned has accepted, for purposes of determining
reasonable basis, the accuracy of Kaci Cottingham’s affidavit attesting that she
began having regular weekly headaches and occasional low-grade fever starting on
November 1, 2012.17 Exhibit 1 ¶ 5. In this sense, Ms. Cottingham’s affidavit
roughly aligns with the medical records from Vestavia Pediatrics, which suggest
that the symptoms started slightly later. See exhibit 3 at 87-88. Thus, the
undersigned respectfully suggests that the value of Ms. Cottingham’s affidavit is
not the source of trouble.
Second, James-Cornelius held that the “absence of an express medical
opinion on causation is not necessarily dispositive of whether a claim has a
reasonable basis, especially when the case is in its early stages and counsel may
not have had the opportunity to retain qualified experts.” 984 F.3d at 1379. The
key word appears to be “necessarily.” In the Secretary’s response to the most
recent motion for review, the Secretary stated that the Federal Circuit “panel only
held that a causation opinion is not ‘necessarily’ required to establish reasonable
basis, which essentially means that, in some cases, a causation opinion is
required.” Resp’t’s Resp. to Mot. for Rev., filed Mar. 8, 2021, at 18. In her reply,
Ms. Cottingham did not address this argument. See Pet’r’s Reply, filed Mar. 15,
2021.
To the undersigned, the Secretary’s interpretation of the Federal Circuit’s
phrase “absence of an express medical opinion on causation is not necessarily
dispositive of whether a claim has a reasonable basis” seems persuasive and
17
The presence of black outs at this time, as stated in Ms. Cottingham’s affidavit, is less
clear from the medical records. However, the undersigned accepts Ms. Cottingham’s statement
regarding onset of headaches and an occasional low-grade fever.
42
logical. By inserting the adverb “necessarily,” the Federal Circuit seems to be
implying that the lack of an express medical opinion could be at least one point in
determining whether reasonable basis supports the claims set forth in the petition.
But, it is unclear when special masters should consider the lack of “express
medical opinion on causation.”18 Thus, to extend to Ms. Cottingham the benefit of
the doubt and to minimize potential issues for further appellate review, the
undersigned will not consider the “absence of an express medical opinion on
causation.”
Third, James-Cornelius also remanded the case with instructions for the
special master to reevaluate the evidence. This outcome seems consistent with the
outcome in the present case.
While the Court’s July 6, 2021 Opinion directed the undersigned to consider
the effect of the Federal Circuit’s opinion in James-Cornelius, the special master
assigned to James-Cornelius issued a decision on remand on July 27, 2021. See
Pet’r’s Br., filed Aug. 9, 2021, at 4 (citing this decision). There, the special master
construed the Federal Circuit’s opinion as holding that the Federal Circuit
determined petitioner “ha[d] presented multiple pieces of objective evidence and
that those pieces of evidence amount to ‘more than a mere scintilla’ of evidence
sufficient to establish reasonable basis.” James-Cornelius v. Sec’y of Health &
Human Servs., No. 17-1616V, 2021 WL 3598347, at *2 (Fed. Cl. Spec. Mstr. July
27, 2021).
18
The Federal Circuit’s potential limitation “especially when the case is in its early stages
and counsel may not have had the opportunity to retain qualified experts” also raises questions
regarding how or whether to consider this evidence (or lack thereof). One question is whether
the case enters an “early stage[]” when the petitioner first consults the attorney or whether the
case starts an “early stage[]” after the litigation is initiated by filing the petition. See Austin v.
Sec’y of Health & Human Servs., No. 10-362V, 2013 WL 659574, at *9-10 (Fed. Cl. Spec. Mstr.
Jan. 31, 2013) (“There exists a tension between supporting the policy behind the award of fees to
unsuccessful litigants and discouraging ‘gaming the system.’”). Another question is what
happens when counsel has had the opportunity to retain qualified experts. In Ms. Cottingham’s
case, Mr. Downing did consult experts who declined to offer an opinion supporting causation.
Third, if reasonable basis sets a standard that is met with evidence, does that evidentiary standard
change because the case ages? Finally, any extended discussion of counsel’s (lack of) efforts to
retain a qualified expert seems dangerously close to considering the conduct of any attorney
during the analysis of reasonable basis. See James-Cornelius, 984 F.3d at 1381 (finding that the
special master misapplied the reasonable basis standard “[b]y going beyond the allegations an
evidence in the petition, and instead looking to counsel’s conduct and state of mind”).
43
But, the undersigned has already interpreted the Federal Circuit’s opinion in
this case as permitting the undersigned discretion in determining whether the
objective evidence supported the claims in Ms. Cottingham’s petition. Fourth Fees
Decision, 2021 WL 347020, at *15. In Ms. Cottingham’s fourth motion for
review, she did not argue that the undersigned’s interpretation of the panel’s
opinion was erroneous. See Pet’r’s Mot., filed Feb. 5, 2021. Thus, the special
master’s July 27, 2021 decision in James-Cornelius does not control the outcome
of this case.19
Package Insert
The Federal Circuit remanded, in part, for the special master to evaluate the
package insert in determining whether a reasonable basis supported the claims set
forth in Ms. Cottingham’s petition. The Federal Circuit indicated that the package
insert, as part of the record, should have been analyzed explicitly. Cottingham,
971 F.3d at 1346. Thus, the Fourth Fees Decision examined this issue across five
pages and that analysis is repeated:
1. Citations to Product Insert in this Litigation
As discussed in the procedural history, Ms. Cottingham did not submit the
package insert during her case-in-chief regarding entitlement. She also did not file
the product monograph to support her argument regarding reasonable basis,
although Ms. Cottingham provided an internet link to it. Pet’r’s Mot. for
Attorneys’ Fees and Costs, filed Oct. 26, 2016, at 4. The Secretary, however,
provided a product monograph as exhibit A. Resp’t’s Resp., filed Nov. 14, 2016,
19
In addition to the procedural differences, the evidence supporting reasonable basis was
much stronger in James-Cornelius, according to Mr. Downing, the attorney representing
petitioners in both cases. During the oral argument in James-Cornelius, he told the Federal
Circuit panel: “This case is even stronger than Cottingham. Here, after the symptoms were
present for an extended period of time, . . . after clinical examination, the treating physician
contemplated filing a VAERS form . . . indicating that at a minimum, . . . this physician is
contemplating reporting a vaccine adverse event to the CDC. That is far beyond the evidence
that was present in Cottingham and it may very well be the most important piece of evidence
here.” Oral Argument at 6:05, James-Cornelius v. Sec’y of Health & Human Servs., 984 F.3d
1374 (2021) (No. 2019-2404), http://www.cafc.uscourts.gov/oral-argument-
recordings?title=&field case number value=2019-
2404&field_date_value2%5Bvalue%5D%5Bdate%5D=. On rebuttal, Mr. Downing reiterated:
“This case is very similar to Cottingham . . . I think this case is actually stronger than
Cottingham given the treating doctor’s contemplation of reporting a vaccine adverse event to the
CDC.” Id. at 35:02.
44
at 5 n.1. As mentioned in the December 14, 2020 oral argument, exhibit A is the
product monograph for Gardasil 9. Tr. 27. Ms. Cottingham did not receive this
vaccine. She received a quadrivalent version. Exhibit 3 at 100. However, the
“vaccines are manufactured similarly and contain the same antigens from HPV
types 6, 11, 16, and 18,” exhibit A at 9, and the parties appear to have overlooked
any difference between the two types of vaccines.
Thereafter, the product monograph appears sporadically in briefing from Ms.
Cottingham. Ms. Cottingham did not cite the product monograph in briefs
associated with her first motion for review. See Pet’r’s Mot. for Rev., filed Apr.
27, 2017; Pet’r’s Reply, filed June 2, 2017. In defending the Second Fees Decision
against the Secretary’s motion for review, Ms. Cottingham relied upon the product
insert to show autonomic dysfunction occurring outside of a 15-minute window.
Pet’r’s Resp. to Mot. for Rev., filed Feb. 5, 2018, at 10. In challenging the Third
Fees Decision, which had found no reasonable basis, Ms. Cottingham did not cite
the product monograph. See Pet’r’s Mem. Supporting Pet’r’s 2d Mot. for Rev.,
filed July 19, 2018; Pet’r’s Reply, filed Aug. 27, 2018. In sum, across five briefs
to the Court of Federal Claims filed in conjunction with three motions for review,
Ms. Cottingham alluded to the product monograph once.
At the Federal Circuit, Ms. Cottingham argued that the product monograph
for the HPV vaccine “connect[s]” the HPV vaccine with “headache, nausea,
syncope, abdominal pain and dizziness.” Br. of Pet’r-Appellant, filed May 14,
2019, at 23. However, the Secretary did not respond to Ms. Cottingham’s assertion
by discussing the product monograph. See Br. of Resp’t-Appellee, filed June 5,
2019.
In the Federal Circuit’s Opinion, the Federal Circuit ruled that the package
insert merited discussion. The Federal Circuit declared that “The Gardasil package
insert links [Ms. Cottingham’s] injuries to adverse reactions associated with
Gardasil’s administration.” Cottingham, 917 F.3d at 1346.
In sending the case back to the special master, the Federal Circuit corrected
a legal error the undersigned made. Before Cottingham, the undersigned believed
that the evidence that could support a finding of reasonable basis consisted of
medical records or medical opinions. For a lengthy, if erroneous, discussion, see
Silva v. Sec’y of Health & Human Servs., No. 10-101V, 2012 WL 2890452 (Fed.
Cl. Spec. Mstr. June 22, 2012) (discussing 42 U.S.C. § 300aa–11(c)), mot. for rev.
denied, 108 Fed. Cl. 401 (2012); see also Carter v. Sec’y of Health & Human
Servs., No. 16-852V, 2018 WL 6322447, at *10 (Fed. Cl. Spec. Mstr. Oct. 16,
2018) (finding petitioner did not satisfy the reasonable standard when the child’s
45
treating doctors did not link vaccinations to developmental delay and petitioner did
not file an expert report). Under this erroneous understanding, the undersigned did
not discuss the package insert because the package insert constitutes neither a
“medical record” nor a “medical opinion.”
Relatedly, the undersigned also understood that special masters could
disregard medical articles about which “there was not testimony offered by any
expert as to the validity or import of such article.” Cedillo v. Sec’y of Health &
Human Servs., 617 F.3d 1328, 1347 (Fed. Cir. 2010). Because neither Ms.
Cottingham nor the Secretary had supplied an expert to explain the significance of
the product monograph, it appeared that the product monograph was not a
meaningful aspect of Ms. Cottingham’s argument that a reasonable basis supported
the claims set forth in her petition. Cf. Moriarty v. Sec’y of Health & Human
Servs., 844 F.3d 1322, 1330-31 (Fed. Cir. 2016) (requiring special master to
address articles to which an expert referred in his report). However, pursuant to
the Federal Circuit’s Opinion in Cottingham, the parties may introduce evidence,
potentially favoring or potentially undermining a finding of reasonable basis for
the claims set forth in the petition, that is not a medical record or a medical
opinion.
After the Federal Circuit’s correction, the undersigned directed the parties to
discuss the product insert. Order, issued Oct. 15, 2020, ¶ 7. The parties responded
in their briefs. Given this history of how the product insert was used and not used
in Ms. Cottingham’s case, the undersigned next discusses how product inserts are
created.
2. Creation of Product Inserts20
Before a manufacturer can sell a prescription drug, the Food and Drug
Administration (“FDA”) must approve it. 21 U.S.C. § 355(a). The FDA
determines whether the drug is both effective and safe. 21 U.S.C. § 360c(a)(1)(C).
The process by which the FDA investigates the effectiveness and safety of a
new drug begins when the manufacturer submits a “new drug application.” The
manufacturer submits “adequate and well-controlled investigations, including
clinical investigations, by experts qualified by scientific training and experience.”
20
Information is primarily drawn from James M. Beck & Anthony Vale, Drug and
Medical Device Product Liability Deskbook § 4.01 (ALM 2004). The undersigned also relies, in
part, upon the “accumulated expertise” in learning about the FDA process for approving vaccines
in many hearings.
46
21 U.S.C. § 355(d). These investigations occur through a series of clinical trials
(commonly known as “phase I,” “phase II,” and “phase III”), in which the number
of human participants expands. 21 C.F.R. § 312.21. Some drugs also undergo a
“phase IV” or post-marketing trial.
The process of FDA approval includes a review of the drug’s labeling. The
FDA defines the content and format of labeling. 21 C.F.R. § 201.56. The label, in
turn, must present information about contraindications, warnings and precautions,
and adverse reactions. In the context of labels for prescription drugs, “an adverse
reaction” is “an undesired effect, reasonably associated with the use of the drug,
that may occur as part of the pharmacological action of the drug or may be
unpredictable in its occurrence.” 21 C.F.R. § 201.57(c)(7). The FDA
distinguishes “adverse reactions” from “adverse events.” The requirement to
report “adverse reactions” is limited to “only those adverse events for which there
is some basis to believe there is a causal relationship between the drug and the
occurrence of the adverse event.” Id.; see also 44 Fed. Reg. 37434, 37447 (June
29, 1979) (defining “reasonable evidence of association” as evidence “on the basis
of which experts qualified by scientific training and experience can reasonably
conclude that the hazard is associated with the drug”).21
As part of the label’s section on “adverse reactions,” the manufacturer must
distinguish between adverse reactions observed in clinical trials and adverse
reactions gained in the post-marketing experience. 21 C.F.R. § 201.57(c)(7)(ii).
After the FDA approves a prescription drug or biological product, a licensed
manufacturer is required to report to the FDA any “adverse experience
information.” 21 C.F.R. § 600.80(c). The term “adverse experience” means “Any
adverse event associated with the use of a biological product in humans, whether
or not considered product related, including the following: An adverse event
occurring in the course of the use of a biological product in professional practice.”
21 C.F.R. § 600.80(a).
While manufacturers must report adverse experiences associated with its
product to the FDA, “[a] report or information submitted by a licensed
manufacturer . . . does not necessarily reflect a conclusion by the licensed
manufacturer or FDA that the report or information constitutes an admission that
21
The FDA’s standard is not the same as the standard used in civil litigation because the
FDA attempts to prevent the public from exposure to harmful substances. Glastetter v. Novartis
Pharm. Corp., 252 F.3d 986, 991 (8th Cir. 2001) (applying Missouri law).
47
the biological product caused or contributed to an adverse effect.” 21 C.F.R.
§ 600.80(l).
Manufacturers, however, are not the only entities that may report adverse
events. Healthcare professionals and consumers may also report adverse events to
the FDA. When healthcare professionals and consumers report adverse events to a
manufacturer, the manufacturer is required to submit the report to the FDA. 21
C.F.R. § 600.80(c)(1)(iii).
3. Precedent regarding Product Inserts in the Vaccine Program
In different settings, judicial officers have discussed the value of FDA-
required manufacturer’s inserts and associated regulations.22 Special masters have
considered whether product inserts can support an expert’s opinions that a vaccine
can cause a condition.
Consequently, the cases discussed below do not match the exact
circumstances of Ms. Cottingham’s case in at least two respects. Here, the only
evidence regarding the product insert is the product insert. There are no experts.
No one has submitted testimony about the product insert. Second, Ms. Cottingham
is attempting to establish the reasonable basis for the claim set forth in her petition.
The evidentiary standard for reasonable basis is, as set forth above, lower than the
preponderance of the evidence standard. Nevertheless, other judicial officials’
considerations in evaluating the evidentiary value of product inserts are
informative here to the extent that cases look at the post-marketing adverse events
portion of product inserts.
The Secretary cites multiple cases supporting the conclusion that statements
in package inserts do not constitute reliable evidence of causation and should not
be considered admissions on the part of the manufacturers that a given product can
or does cause a given injury. However, all but one of the cases cited by respondent
ultimately rely on the statement in Werderitsh v. Secretary of Health & Human
Services that “federal regulations specifically preclude the contents of drug product
labels . . . from serving as admissions regarding causation.” No. 99-319V, 2005
WL 3320041, at *8 (Fed. Cl. Spec. Mstr. Nov. 10, 2005).
22
The Federal Circuit touched upon these regulations in the context of safe harbor
provisions. See Momenta Pharms., Inc. v. Amphastar Pharms., Inc., 686 F.3d 1348, 1358 (Fed.
Cir. 2012).
48
Werderitsh arose in a much different context. In that case, the petitioner
sought to compel the production of VAERS files. Id. at *1. The petitioner
contended, among other points, that the requested VAERS files underlie the entries
in the Physician’s Desk Reference. Id. at *8. (The Physician’s Desk Reference, in
turn, reproduces the FDA-approved product inserts. Id. at *8 n.22.) The petitioner
apparently reasoned that the VAERS reports would shore up the “admissions” the
government allegedly made in adopting the product insert. The special master
rejected this argument because any information derived from VAERS reports
would not constitute an admission from the government.
Although not expressly explained in Werderitsh, VAERS reports constitute a
form of post-marketing experience. As a type of post-marketing information, the
VAERS reports and any information communicated in the product insert based
upon the VAERS reports would not constitute an admission that the vaccine
caused an injury described in a VAERS report. 21 C.F.R. § 600.80. Werderitsh
did not consider statements that appear in the product insert as a result of clinical
trials.
The Secretary relies heavily on the statement in Sullivan v. Secretary of
Health & Human Services that “[s]tatements contained in vaccine package inserts
do not constitute reliable proof of causation, and cannot be deemed admissions that
the vaccine in question has the capacity to harm a particular petitioner in a specific
manner.” No. 10-398V, 2015 WL 1404957, at *20 (Fed. Cl. Spec. Mstr. Feb. 13,
2015). This conclusion was derived directly from the preceding statement in
Werderitsh but applied generally to “package inserts.” The other cases cite to
Sullivan and/or Werderitsh for this proposition. While some cases apply it to the
general term “package inserts,” encompassing clinical trial information and post-
marketing reported events, see Carter v. Sec’y of Health & Human Servs., No. 16-
852V, 2018 WL 6322447, at *8 n.10 (Fed. Cl. Spec. Mstr. Oct. 16, 2018);
Rolshoven v. Sec’y of Health & Human Servs., No. 14-439V, 2018 WL 1124737,
at *20 (Fed. Cl. Spec. Mstr. Jan. 11, 2018); Morris v. Sec’y of Health & Human
Servs., No. 13-601V, 2017 WL 2461226, at *11 (Fed. Cl. Spec. Mstr. May 9,
2017), some apply the statement to post-marketing adverse events only, see
Mondello v. Sec’y of Health & Human Servs., No 15-972V, 2018 WL 947449, at
*11 (Fed. Cl. Spec. Mstr. Jan. 24, 2018) (applying the statement in a context
involving reported adverse events); Bender v. Sec’y of Health & Human Servs.,
No. 11-693V, 2018 WL 3679637, at *1 (Fed. Cl. July 2, 2018) (applying the
statement in the context of determining reliability of VAERS reports), mot. for rev.
denied, 141 Fed. Cl. 262 (2019). None of these cases apply this statement of
unreliability explicitly to clinical trials information contained in the product insert.
49
A nuanced analysis of the product insert would distinguish between, on the
one hand, information provided in the sections for “contraindications,” “warnings
and precautions,” and “adverse reactions” from clinical trials and, on the other
hand, information provided in the post-marketing experience. The three former
sections (sections 4, 5, and 6.1) comprise a notice from the vaccine manufacturer
that some scientific basis supports a conclusion that the vaccine caused the listed
problem. 21 C.F.R. § 201.57(c)(7). In contrast, the manufacturer’s presentation of
problems in the section on post-marketing experience (section 6.2) does not
necessarily reflect a scientific basis.
4. Product Insert for HPV Vaccine
In this case, the more meaningful sections of the product insert provide a
sliver of support for Ms. Cottingham’s argument that the HPV vaccination harmed
her. The product manufacturer warns that “Because vaccinees may develop
syncope, sometimes resulting in falling with injury, observation for 15 minutes
after administration is recommended.” Exhibit A at 3 (section 5.1). In clinical
trials, some women reported having headaches within 15 days after the
vaccination. Id. at 6.
The less valuable section of the product insert, the report on post-marketing
experience, lists more than 20 conditions spread across nine categories. The
category “nervous system disorders” includes “headache” and “syncope (including
syncope associated with tonic-clonic movements and other seizure-like activity).”
Exhibit A at 9-10.
The manufacturer’s insert does not contain any information linking the HPV
vaccine to menstrual difficulties. See Tr. 31. It also does not list the HPV vaccine
as causing dysautonomia or autonomic dysfunction by name. See Tr. 32.
5. Events after the January 7, 2021 Fourth Fees Decision
In the parties’ briefs associated with the fourth motion for review, the parties
presented relatively few arguments about the package insert. See Pet’r’s Br., filed
Feb. 5, 2021; Resp’t’s Resp., filed Mar. 8, 2021; Pet’r’s Reply, filed Mar. 15,
2021. The Court’s opinion did not identify any specific errors in the undersigned’s
previous analysis of the package insert, but directed another examination of the
package insert. Fourth Opinion, 2021 WL 3085502, at *8. In their most recent
briefs, the parties essentially did not introduce any new arguments regarding the
package insert.
50
After evaluation of the parties’ briefs in conjunction with the fourth motion
for review, the Court’s July 7, 2021 Opinion, and the most recent briefs, the
undersigned confirms the statements regarding the package insert. The package
insert shows that syncope might develop within 15 minutes of vaccination and that
headaches might develop within 15 days of vaccination. The package insert does
not say anything about menstrual difficulties or dysautonomia by name.
V. Re-Assessment of Evidence Potentially Relevant to Reasonable Basis
Ms. Cottingham presented evidence, falling into three categories. First, she
presented her medical records. While section I.A., above, discusses her medical
records, they are again discussed in section A below to evaluate whether they
support the claims contained in the petition. Second, section B below reviews her
affidavit. Finally, an analysis of the medical articles is found in Section C.23
Medical Records
The Federal Circuit directed a more detailed analysis of certain medical
records. Cottingham, 971 F.3d at 1346. Accordingly, the parties were directed to
address them. Order, issued Oct. 15, 2020, ¶¶ 15-16. They are discussed in
chronological order starting with the earliest created record. For reference, Ms.
Cottingham received the allegedly causal vaccination on July 5, 2012.
November 30, 2012
Ms. Cottingham, who was 14 years old, saw a pediatrician, John Simpson.
Ms. Cottingham reported that she was suffering from fever, yellow mucous,
congestion, headaches “off and [on] all week,” and a sore throat in the mornings.
Exhibit 3 at 87-88 (appearing in the Joint Appendix at 35). When Dr. Simpson
examined Ms. Cottingham, her nose and throat were “moderately congested and
erythematous with some purulent postnasal discharge.” Id. at 87. Dr. Simpson
diagnosed Ms. Cottingham with cough, fever, and acute sinusitis. He prescribed
Amoxil and discussed symptomatic care. Id. at 88; J.A. 35.
In treating Ms. Cottingham for congestion, headaches, and a sore throat, Dr.
Simpson did not discuss the HPV vaccine. Dr. Simpson did not suggest that the
HPV vaccine caused any of these symptoms.
23
A fourth type of evidence, the product insert, was just discussed.
51
January 31, 2013
Ms. Cottingham returned to the pediatrician’s group and saw a different
pediatrician, Elizabeth Crum. The complaints were that Ms. Cottingham suffered
from runny nose and congestion for two days, a low-grade fever, a sore throat, and
a headache “today.” Exhibit 3 at 78. Ms. Cottingham was not having a cough,
shortness of breath, vomiting, or diarrhea. Id. Dr. Crum diagnosed Ms.
Cottingham with rhinitis and acute viral pharyngitis. Id. at 79. Dr. Crum
prescribed a course of Zyrtec and planned for symptomatic care. Id.; J.A. 61.
Dr. Crum did not mention the HPV vaccination in the note for the
appointment for Ms. Cottingham’s runny nose, congestion, fever, sore throat, and
headache. Dr. Crum did not indicate that the HPV vaccination caused any of these
symptoms.
March 29, 2013
Ms. Cottingham acutely experienced “fever and dizziness” the morning of
this appointment. Exhibit 3 at 80. She stated that she fainted that morning. She
also stated that she vomited once but had no diarrhea. Id. A urinalysis showed
“very slight dehydration.” Id. The doctor who examined Ms. Cottingham, Richard
Stone, diagnosed her with gastroenteritis and dehydration. He indicated that Ms.
Cottingham was “at the early stage of an intestinal virus.” Id. at 81; J.A. 62.
Dr. Stone did not say anything about the HPV vaccination. Dr. Stone did
not opine that the HPV vaccination contributed to Ms. Cottingham’s fainting or
dehydration.
May 23, 2013
Ms. Cottingham informed Dr. Crum that she did not eat or drink anything
when she woke up. She and a friend went to lay out at a pool. She felt hot. When
she got up quickly to get something to eat, her vision became black and she felt
lightheaded. Her friend witnessed her fall backwards and hit her head on the
ground. The history noted that Ms. Cottingham had a similar episode in March
2013. Ms. Cottingham “does not have a history of syncope with exercise.”
Exhibit 3 at 70. Dr. Crum examined her and found a “[c]ompletely normal
neurologic exam. . . . Five out of five motor strength in all extremities.” Id. at 71.
Dr. Crum tested Ms. Cottingham’s orthostatic blood pressure and it remained
stable. But, Ms. Cottingham’s “heart rate did increase from 80 to 100 when going
from laying to standing.” Id. Dr. Crum determined that Ms. Cottingham was
dehydrated and assessed her with fainting. Dr. Crum recommended that Ms.
52
Cottingham increase her intake of fluids and eat breakfast. Dr. Crum commented,
“if these events continue to occur I would consider further evaluation at that time,
but do feel like [these] are likely two isolated events related to dehydration.” Id.;
J.A. 63-64.
At this appointment for another episode of fainting, Dr. Crum did not
mention the HPV vaccination. Dr. Crum did not suggest that the HPV vaccination
contributed to Ms. Cottingham’s episodes of fainting.
July 25, 2013
Upon a referral from Dr. Simpson, Ms. Cottingham saw a pediatric
cardiologist, Waldemar Carlo. Ms. Cottingham told Dr. Carlo that she “had
several episodes of dizziness and passing out” beginning in March. Exhibit 3 at
111. With all the episodes, Ms. Cottingham “is standing or walking.” “She has
not had any dizziness or syncope with physical activity.” Id. Dr. Carlo performed
an electrocardiogram and echocardiogram. After testing, he determined that Ms.
Cottingham’s heart was structurally normal and functioning normally. Dr. Carlo
diagnosed her with vasovagal syncope and urged Ms. Cottingham to hydrate
aggressively. Id. at 112. Dr. Carlo specifically declined to schedule a follow-up
appointment but noted he would see her again if any new signs or symptoms
developed. Id.; J.A. 36, 65.
Dr. Carlo did not discuss the HPV vaccination in his note for this
appointment about dizziness and passing out. Dr. Carlo did not say that the HPV
vaccination might have caused Ms. Cottingham’s problems.
May 14, 2015
Ms. Cottingham’s mother called the pediatrician’s office to report that her
daughter had not had a menstrual cycle in six months. Ms. Cottingham’s mother
also stated that “the Gardasil series may have something to do with the recent
changes noted in [her daughter’s] menstrual cycle.” Exhibit 3 at 175. The nurse
advised Ms. Cottingham’s mother that “a note will be made.” Id.; J.A. 60.
The medical record does not contain any response from a physician. No
record indicates that the pediatrician who received the note about the concern of
Ms. Cottingham’s mother thought that the HPV vaccination may have caused
changes in Ms. Cottingham’s menstrual cycle.
53
Assessment
The Secretary argues that Ms. Cottingham’s “medical records indicate that
none of her treating physicians implicated the Gardasil vaccine as contributing to
petitioner’s various complaints in any way.” Resp’t’s Br., filed Nov. 19, 2020, at
7. This assessment appears accurate.
Ms. Cottingham relies upon passages from the Federal Circuit. See Pet’r’s
Br., filed Nov. 19, 2020, at 15. “Here, the record contains seven medical-
examination reports detailing [Ms. Cottingham’s] medical history that address
injuries she suffered. The Gardasil package insert links [her] injuries to adverse
reactions associated with Gardasil’s administration.” Cottingham, 917 F.3d at
1346. Ms. Cottingham argues that these medical records “identify the exact
conditions alleged to have been triggered by the vaccination at issue. They are the
exact conditions reflected in the Gardasil product monograph, and they are the
exact conditions documented in the cited medical literature as constituting post-
Gardasil adverse events.” Pet’r’s Br. at 15.24
Because the treating doctors did not link any condition in Ms. Cottingham to
the HPV vaccination, the undersigned earlier stated that Ms. Cottingham produced
“no evidence” supporting causation. Third Decision, 2018 WL 3432638, at *5;
accord Resp’t’s Resp., filed Nov. 14, 2016, at 4; Resp’t’s Mot. for Rev., filed Jan.
10, 2018, at 14. However, on appeal, the Federal Circuit held that the “no
evidence” determination “rests on a clearly erroneous fact finding.” Cottingham,
971 F.3d at 1345.
In light of the Federal Circuit’s vacatur and remand, the undersigned has
examined the medical records the Federal Circuit identified and looked to the
totality of the circumstances in evaluating the weight of this evidence to the
question of reasonable basis. These records show that at some time (in some
instances many many months) after the vaccination, Ms. Cottingham experienced
health problems. Thus, the sequence of events in which the vaccination preceded
the onset of the headaches, fainting, and menstrual problems makes it logically
possible for Ms. Cottingham to assert that the vaccination caused the headaches,
fainting, and menstrual problems. By way of contrast, if Ms. Cottingham had
experienced a pattern of headaches, fainting, and menstrual problems before the
24
Ms. Cottingham’s assertion that the medical records document conditions “reflected in
the Gardasil product monograph” is partially correct. As discussed above, the product insert
does not discuss menstrual difficulties or dysautonomia.
54
vaccination, then she could not logically allege that the vaccination caused those
problems. Locane v. Sec’y of Health & Human Servs., 685 F.3d 1375, 1380-81
(Fed. Cir. 2012). Under the guidance from the Federal Circuit, the undersigned
recognizes that the medical records showing Ms. Cottingham suffered maladies
after the vaccination constitute some evidence that is consistent with a finding of
causation.
In the context of determining whether petitioners are entitled to
compensation in which special masters look for preponderant evidence, numerous
cases have stated that a sequence of events in which the vaccination came before
the onset of the injury does not establish the causal relationship. The Federal
Circuit articulated this principle in one of the earliest cases from the Vaccine
Program at the Federal Circuit. Grant v. Sec’y of Health & Human Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992).
While Grant resolved questions of entitlement, the same evidence of a
sequence of events in which the vaccination preceded the onset of a disease or
disorder was determined not to confer reasonable basis by itself. “Temporal
proximity is necessary, but not sufficient.” Chuisano v. United States, 116 Fed. Cl.
276, 287 (2014).25 “[T]o establish a reasonable basis for the claim, petitioner was
obliged to adduce medical evidence going to causation beyond temporal
proximity.” Bekiaris v. Sec’y of Health & Human Servs., 140 Fed. Cl. 108, 115
(2018).
25
To some extent, the reasoning in Chuisano (that timing is necessary but not sufficient)
is inconsistent with the reasoning in Harding v. Sec’y of Health & Human Servs., 146 Fed. Cl.
381 (2019). Ms. Harding was suffering from a disease known as Wegener’s granulomatosis
(also known as granulomatosis polyangiitis) when she received doses of the HPV vaccine in
October and November 2014. 146 Fed. Cl. at 387-88. Within approximately three weeks of the
November 2014 dose, Ms. Harding’s condition was worse. Id. at 388. Ms. Harding alleged that
the vaccinations significantly aggravated her pre-existing disease, but eventually filed a motion
to dismiss her case voluntarily without filing an expert report.
The special master found that Ms. Harding satisfied the reasonable basis standard
because, in part, “‘the medical records document[ed] a flare of an autoimmune disease shortly
after administration of a covered vaccine.’” Id. at 392 (quoting Harding v. Sec’y of Health &
Human Servs., No. 17-1580V, 2019 WL 3215974, at *7 (Fed. Cl. Spec. Mstr. June 18, 2019)).
The Court of Federal Claims ruled that the special master (1) considered the relevant evidence,
(2) drew plausible inferences, and (3) stated a rational basis for the outcome and, accordingly,
denied the Secretary’s motion for review. Id. at 404.
55
Affidavits
In addition to providing medical records created contemporaneously with
some events described in the medical records, Ms. Cottingham also submitted an
affidavit she signed on October 28, 2015. Exhibit 1 at 3. In some ways, Ms.
Cottingham’s testimony is consistent with information contained in the medical
records. For example, Ms. Cottingham avers that she received a dose of the HPV
vaccination on July 5, 2012. Id. ¶ 3.
After the Federal Circuit’s opinion ordering a remand in Cottingham, the
next Federal Circuit’s opinion clarified the value of affidavits in the context of
determining reasonable basis. The Federal Circuit stated: “Medical records
related to [] symptoms would likely be based on the statements of those who
experienced them. And while such medical records may indeed serve as important
corroborating evidence for evaluating testimony’s credibility, we reject the Special
Master’s broad pronouncement that petitioners’ affidavits are categorically ‘not
“objective” for the purposes of evaluating reasonable basis.’” James-Cornelius,
984 F.3d at 1380.
In accord with James-Cornelius, the undersigned has reassessed the value of
Kaci Cottingham’s affidavit. Ms. Cottingham’s affidavit provides a scintilla of
support that in November 2012, she “began to experience episodes of near black-
outs.” Exhibit 1 ¶ 5.
However, Ms. Cottingham’s statement regarding an onset of near black-outs
in November 2012 is worth, in the undersigned’s experience, no more than a
scintilla. See Whitecotton v. Sec’y of Health & Human Servs., 81 F.3d 1099, 1104
(Fed. Cir. 1996) (noting that special masters may use their accumulated expertise
in evaluating cases). Although Ms. Cottingham is competent to assert when she
experienced health problems, Kirby v. Sec’y of Health & Human Servs., 997 F.3d
1378 (Fed. Cir. 2021), Ms. Cottingham’s assertions do not have to be accepted at
face value automatically.
When considered as a whole, see 42 U.S.C. § 300aa–13(a), the record
suggests that Ms. Cottingham’s assertion that she began to experience near black
outs in November 2012 is highly implausible. See Order Denying
Reconsideration, 2017 WL 2209904, at *4 (indicating that in 2017 the undersigned
found Ms. Cottingham’s affidavit “strain[ed] credibility”). It seems likely that if a
14-year-old young woman nearly blacked out repeatedly, she would be likely to
tell (a) her parents, (b) a medical professional, such as a doctor or school nurse, or
(c) her parents and medical professionals. Parents, in turn, are likely to be attentive
56
to a potentially serious health concern as Ms. Cottingham’s mother did after Ms.
Cottingham fainted twice. In the July 10, 2013 medical appointment with Dr.
Simpson, Ms. Cottingham’s mother requested an echocardiogram. Exhibit 3 at 96.
Upon learning that an otherwise healthy adolescent was nearly blacking out,
a medical professional would, in the undersigned’s experience, document that
report and investigate it. For example, when Ms. Cottingham first informed a
doctor about blacking out on May 23, 2013, Dr. Crum determined that it was likely
due to dehydration but cautioned that if the episodes repeated, she should seek
additional medical attention. Exhibit 3 at 70.
The history that Dr. Crum obtained suggests that medical professionals
investigate reports of blacking out thoroughly. Dr. Crum recorded that Ms.
Cottingham reported a prior episode in March 2013. Exhibit 3 at 70. This history
does not say that Ms. Cottingham has had prior episodes of near black outs going
back six months to November 2012. It seems likely that if Ms. Cottingham
continued to have near black outs for multiple months as her affidavit asserts,
exhibit 1 ¶ 7, then she would have communicated this information to Dr. Crum.
Likewise, Dr. Simpson memorialized that Ms. Cottingham “has had two
syncopal spells, one in March 2013 and a second in May 2013.” Exhibit 3 at 96.
Considering that one purpose of the visit with Dr. Simpson on July 10, 2013 was to
evaluate these fainting episodes, it seems likely that Dr. Simpson would have
asked how often Ms. Cottingham had episodes of dizziness, nearly passing out, or
fainting. Dr. Simpson’s notation that Ms. Cottingham had “two syncopal spells”
constitutes evidence that she did not have three. If Ms. Cottingham did have more
episodes of fainting (or nearly fainting) as she asserted in her affidavit, then she
would have told Dr. Simpson.
It seems rather much more likely that Ms. Cottingham’s memory about
when she experienced near black outs is inaccurate. After all, her October 28,
2015 affidavit was prepared approximately three years after the asserted onset of
near black outs (November 2012). Multiple judicial opinions have recognized the
commonly known fact that memories fade over time.26 See Reusser v. Sec’y of
26
To be sure, if the case had proceeded, Ms. Cottingham, her mother, the pediatrician
who created medical records about Ms. Cottingham on November 30, 2012 (Dr. John Simpson),
and Dr. Crum might have testified at a hearing. During this hearing, Mr. Downing may have
impeached the doctor’s ability to create accurate medical records, leading to a finding that Ms.
Cottingham’s 2015 affidavit about the onset of her near black outs was more accurate than
medical records created in 2012 and 2013. But, this outcome was not likely.
57
Health & Human Servs., 28 Fed. Cl. 516, 523 (1993) (stating that “written
documentation recorded by a disinterested person at or soon after the event at issue
is generally more reliable than the recollection of a party to a lawsuit years later”);
Sullivan v. Sec’y of Health & Human Servs., No. 10-398V, 2013 WL 4011056, at
*10-11, 14 (Fed. Cl. Spec. Mstr. June 30, 2013) (crediting medical records over
affidavit testimony in part because of the faultiness of memory in recollecting
specific events); Thomas v. Sec’y of Health & Human Servs., No. 01-645V, 2007
WL 470410, at *15 (Fed. Cl. Spec. Mstr. Jan. 23, 2007) (stating that the Court may
find statements unreliable where “recollections are imprecise as to the specific
timing of particular events”).
Medical Articles
“Medical articles,” in this context differ from the product insert. As
explained above, the Secretary filed the product insert as exhibit A, and the product
insert, accordingly, was in the record before the Federal Circuit. But, Ms.
Cottingham only cited various articles and did not file them into the record before
the appeal to the Federal Circuit. Thus, the Federal Circuit did not explicitly direct
a consideration of these articles in its Order.
After the remand, Ms. Cottingham filed five articles, discussed below. The
Secretary acquiesced to their inclusion by not filing a motion to strike. See
Resp’t’s Br., filed Nov. 19, 2020, at 12. Accordingly, the parties were directed to
address the articles. Order, issued Oct. 15, 2020, ¶¶ 8-9.
Ms. Cottingham refers to her June 2, 2017 reply in support of her first
motion for review, which is CM/ECF entry 53. Pet’r’s Br., filed Aug. 9, 2021, at
9. In that reply, Ms. Cottingham argued that the Martinez-Lavin, Kinoshita, and
Brinth articles connected the human papillomavirus vaccine to autonomic
dysfunction. She maintains that position in her November 19, 2020 brief, asserting
that “Autonomic dysfunction (dysautonomia) has been connected to vaccination,
particularly Gardasil.” Id.. In the December 14, 2020 oral argument, Ms.
Cottingham explained that she offered the articles for the limited purpose of
showing that her claim is “not novel.” Tr. 37. She has presented, in her words, “a
bunch of case reports” that resemble her situation. Id. at 38. Ms. Cottingham
maintains that the similarities between the facts of her case and the reports in
articles she cited bolsters her contention that a reasonable basis supports the claims
set forth in her petition.
The Secretary makes multiple arguments against the value of the articles.
Resp’t’s Br, filed Nov. 19, 2020, at 12-13. One argument is that four articles
58
discuss conditions with which Ms. Cottingham was not diagnosed. Id. at 13. The
Secretary maintained that “There is no evidence in the medical records of [Ms.
Cottingham] being diagnosed with autonomic dysfunction.” Id. at 7. Another
general argument is that the articles need to be tied to the facts of Ms.
Cottingham’s case. Tr. 38-39.
Review of Articles
To address the value of the five medical articles Ms. Cottingham submitted,
each is reviewed below. The sequence begins with the earliest published article.
S. Blitshteyn reported “six previously healthy young women [who]
developed symptoms of POTS [postural orthostatic tachycardia syndrome] within
6 days to 2 months after immunization with Gardasil vaccine.” S. Blitshteyn,
Postural tachycardia syndrome following human papillomavirus vaccination, 21
Euro. J. Neuro. 135 (2014), filed as exhibit 14, at 138. In addition to being
diagnosed with POTS, three of the patients also had neurocardiogenic syncope. Id.
Dr. Blitshteyn concluded “Further studies are necessary to investigate whether
there is a causal relationship.” Id. at 139.27
The Blitshteyn article describes patients as suffering headaches and
neurocardiogenic syncope after HPV vaccination. According to Ms. Cottingham,
it offers some support for the reasonable basis of her claim that the HPV
vaccination caused her to suffer headaches and fainting. Tr. 42. However, with
regard to headaches and fainting, the subjects in the Blitshteyn article experienced
those problems much closer in time to the vaccination than Ms. Cottingham. See
exhibit 14 at 136 (table 1 listing onset of various problems between two weeks and
two months after the vaccination). The Blitshteyn article does not help with Ms.
Cottingham’s claim for menstrual problems and dysautonomia. Tr. 46.
Kinoshita and colleagues observed that over the course of approximately
nine months, they treated 40 girls, who complained that they had symptoms after
receiving a vaccination against human papillomavirus. (About one-quarter of this
27
Dr. Blitshteyn has participated in Vaccine Program proceedings as an expert witness.
See McCulloch v. Sec’y of Health & Human Servs., No. 09-293V, 2015 WL 3650610 (Fed. Cl.
Spec. Mstr. May 22, 2015) (finding petitioner was entitled to compensation); Turkupolis v. Sec’y
of Health & Human Servs., No. 10-351V, 2014 WL 2872215, at *21 (Fed. Cl. Spec. Mstr. May
30, 2014) (denying compensation and stating “Dr. Blitshteyn proffers her conclusion and then
speculates it must be because it happens to other people with diseases that petitioner does not
have. Speculation is unacceptable as credible proof.”).
59
population received the same brand, Gardasil, as Ms. Cottingham received.) The
average age of this population was 13.7 years. Tomomi Kinoshita et al.,
Peripheral Sympathetic Nerve Dysfunction in Adolescent Japanese Girls
Following Immunization with the Human Papillomavirus Vaccine, 53 Internal
Medicine 2185 (2014), filed as exhibit 13, at 2.
These patients reported various symptoms. The most common symptom
was headaches, followed by general fatigue. Orthostatic fainting and disturbed
menstruation were also reported. Id. “The average incubation period after the first
dose of vaccine was 5.47±5.00 months.” Id. Kinoshita and colleagues diagnosed
most of the young girls as suffering from chronic regional pain syndrome and/or
orthostatic problems. Id. at 10; see also id. at 13 (table 5).
With respect to etiology, “[b]ased on the temporal relationship between
immunization and the development of symptoms, [the authors] cannot deny the
possibility that immunization with HPV vaccines may secondarily induce
sympathetically mediated disorders, including CRPS-I [chronic regional pain
syndrome], OH [orthostatic hypotension] and POTS [postural tachycardia
syndrome].” Id. at 15. They concluded: “Studies with large-scale investigations
and experimental approaches are needed to further answer these questions.” Id.
Ms. Cottingham downplayed the diagnoses given to the patients in the
Kinoshita article, calling them “labels.” Tr. 49. Ms. Cottingham viewed the
symptoms that Kinoshita and colleagues reported as more germane to her
argument. Accordingly, Ms. Cottingham pointed out that more than half the
population in the Kinoshita review reported headaches. Tr. 48. Ms. Cottingham
also emphasized that the average temporal interval “5.47 months” was “peg[ged]”
to her case. Tr. 52, 85.
Blitshteyn and Kinoshita were included in the introductory section of
Brinth. Louise S. Brinth et al., Orthostatic intolerance and postural tachycardia
syndrome as suspected adverse effects of vaccination against human
papillomavirus, 33 Vaccine 2602 (2015), filed as exhibit 12, at 2602. The Brinth
team evaluated 35 patients who had been referred to their syncope unit for further
evaluation for “a suspected adverse event following vaccination with the
quadrivalent HPV vaccine.” Id. The 35 females had an average age of 23.3 years.
“The mean delay between vaccination and onset of symptoms was 9.3 days (range:
0–30).” Id. “Mean time between onset of symptoms and examination was 1.9
years (range: 0–5).” Id. After testing, the researchers determined that 60 percent
of the group suffered from POTS. Id. at 2604. The authors proposed their group
60
might “possibly constitut[e] a post vaccination syndrome on an autoimmune basis
in a specific group of young women.” Id.
Brinth and colleagues acknowledged three limitations to their study. The
first was a “lack of a control group.” Id. The second was “the long and variable
delay between the onset of symptoms and orthostatic testing.” Id. The third was
the use of a ten-minute tilt-table test might miss other forms of chronic orthostatic
intolerance. The authors concluded that: “Our findings do not confirm or dismiss a
causal link to the HPV-vaccine—but suggest that further research is urgently
warranted.” Id.
Ms. Cottingham argued that like the Kinoshita article, the Brinth article
supported Ms. Cottingham’s presentation of symptoms. Tr. 51. However, Ms.
Cottingham acknowledged that average latency between vaccination and the onset
of symptoms in Brinth (9.3 days) was much different from the average reported in
Kinoshita and much different from her experience. Tr. 52.
The next article, Martinez-Lavin, starts with observations from Blitshteyn,
Kinoshita, and Brinth, as well as others. The Martinez-Lavin article proposed “as
a hypothesis that small fiber neuropathy may also explain the pain and autonomic
dysfunction seen in post HPV vaccination syndrome.” Manuel Martinez-Lavin,
Hypothesis: Human papillomavirus vaccination syndrome—small fiber neuropathy
and dysautonomia could be its underlying pathogenesis, 34 Clin. Rheumatol. 1165
(2015), filed as exhibit 11, at 3. In oral argument, Ms. Cottingham recognized that
she was not diagnosed as suffering from small fiber neuropathy. Tr. 54. This
concession reduces the value of the Martinez-Lavin article.
The most recently published article is by Kazuki Ozawa and colleagues.
Kazuki Ozawa et al., Suspected Adverse Effects After Human Papillomavirus
Vaccination: A Temporal Relationship Between Vaccine Administration and the
Appearance of Symptoms in Japan, 40 Drug Saf. 1219 (2017), filed as exhibit 15.
These researchers built upon their earlier report, Kinoshita, which is reference 10
in Ozawa. The purpose of Ozawa’s work was “to clarify the temporal relationship
between human papillomavirus vaccination and the appearance of post-vaccination
symptoms.” Id. at 1. For this study, Ozawa and group created a set of diagnostic
criteria. However, the validity and reliability of the newly created diagnostic
criteria “have not been established.” Id.
In oral argument, when asked whether Ozawa constituted “reliable”
evidence pursuant to Vaccine Rule 8(b)(1), Ms. Cottingham maintained that
Ozawa was reliable “for the purpose for which this article is being offered.” Tr.
61
55. The purpose of the article, in turn, is that Ozawa “details the syndrome of
symptoms that you may see following” the HPV vaccine. Tr. 56. The Secretary
asserted that the Ozawa article cannot be relied upon. Tr. 60.
Using their diagnostic criteria, Ozawa and colleagues diagnosed 30 patients
with “definite vaccine-related symptoms” and another 42 patients with “probable”
vaccine-related symptoms. Exhibit 15 at 1. This group of 72 patients came from a
starting group of 163 patients. Id. The average age at vaccination for these 72
patients was 13.6 years. “The time to onset after the first vaccine dose ranged from
1 to 1532 days (average 319.7 ± 349.3 days).” Id.
The researchers asked the participants to answer questionnaires, obtained
medical records from other facilities when available, and conducted tests on the
participants. Id. at 3. “Symptoms or signs frequently observed in these 72 girls
were prolonged general fatigue, chronic headache, widespread pain, limb shaking,
dysautonomic symptoms, motor dysfunction, abnormal sensation, sleep
disturbance, learning impairment, and menstrual abnormality.” Id. at 5.
“Dysautonomic symptoms included frequent squatting or syncope during their
daily activities.” Id.
The Ozawa researchers recognized some limitations in their study. These
included not having a control group and having a relatively small number of
subjects, all of whom were referred to the authors. Id. at 9. The authors stated that
“HPV vaccination is temporally related to the development of these symptoms in
Japanese adolescent girls. Further large-scale studies are required to clarify the
pathophysiology of these symptoms.” Id. at 9.
Ms. Cottingham offered the Ozawa article for the limited purpose of
showing that her report of symptoms after receiving the HPV vaccine was typical.
Tr. 55-56. Ms. Cottingham explicitly disclaimed any reliance on Ozawa’s report
of temporality, which extended from 1 to 1532 days. Tr. 62. As the Secretary
pointed out, 1532 days is more than 4 years after vaccination. Tr. 60. Ms.
Cottingham’s attorney acknowledged that he would not endorse a claim that the
HPV vaccination caused an injury appearing “3 years” after vaccination. Tr. 53.
However, the attorney was not asked to reconcile this position with the information
in the Ozawa article.
Cases Evaluating these Articles
The “accumulated expertise” on which special masters may rely in deciding
cases, see Whitecotton v. Sec’y of Health & Human Servs., 81 F.3d 1099, 1104
62
(Fed. Cir. 1996), includes an awareness of how issues have been resolved
previously. These previous dispositions are not binding. Boatmon v. Sec’y of
Health & Human Servs., 941 F.3d 1351, 1358-59 (Fed. Cir. 2019). But the non-
binding value of those informed considerations should not negate their value,
especially when the parties have not presented any testimony from an expert about
the articles.28
In general, special masters have found this set of articles not sufficiently
persuasive to assist any petitioners in meeting their burden to show, by a
preponderance of the evidence, the HPV vaccine can cause different injuries. A
thorough analysis appears in Balasco v. Secretary of Health & Human Services,
No. 17-215V, 2020 WL 1240917 (Fed. Cl. Spec. Mstr. Feb. 14, 2020).
Represented by Mr. Downing, Julia Balasco alleged that the HPV vaccine caused
her to suffer “autonomic dysfunction, postural orthostatic tachycardia syndrome
(POTS), fibromyalgia, and orthostatic intolerance (OI).” Id. at *1. To advance her
claim, Ms. Balasco submitted reports from Yehuda Shoenfeld and Mitchell Miglis.
Id. at *2. (Dr. Shoenfeld and Dr. Miglis have testified for petitioners in other cases
as well.) The Secretary opposed the claim and offered contrary reports.
After considering the five articles discussed above as well as additional
evidence, the special master did not find “preponderant evidence of any HPV
Syndrome or that the above-discussed literature, considered individually or as a
whole, provides a basis for [Ms. Balasco] to assert a claim for an adverse reaction
to her HPV vaccine.” Id. at *32. In addition, the special master rejected Ms.
Balasco’s argument that she satisfied the Ozawa criteria. Id. at *29.
In Johnson v. Secretary of Health & Human Services, No. 14-254V, 2018
WL 2051760 (Fed. Cl. Spec. Mstr. Mar. 23, 2018), the special master reached a
similar conclusion. In Johnson, the special master heard testimony from Dr.
Shoenfeld and Kenneth Mack, a doctor the Secretary had retained, regarding Ms.
Johnson’s claim that she suffered a variety of injuries, including POTS. In
reference to the Blitshteyn, Brinth, Kinoshita, and Ozawa articles, the special
master found that “Dr. Mack convincingly explained in particular why many of the
items of literature that relied on such case study data were untrustworthy—the
studied subjects voluntarily had sought treatment for their orthostatic symptoms,
28
The special masters had not decided cases like Balasco until after Ms. Cottingham had
filed and dismissed her petition. On the other hand, Ms. Cottingham did not file the articles into
this case until October 13, 2020. CM/ECF No. 86.
63
making the studied group too self-selected to draw conclusions from correlations
observed with respect to that population.” Id. at *24.
Other cases have refrained from crediting the articles Ms. Cottingham
advances, though with less robust analyses. See Yalacki v. Sec’y of Health &
Human Servs., No. 14-278V, 2019 WL 1061429, at *14 n.21 (Fed. Cl. Spec. Mstr.
Jan. 31, 2019) (mentioning Dr. Shoenfeld’s reliance on the Martinez-Lavin article
despite the petitioner’s lack of small fiber neuropathy); Combs v. Sec’y of Health
& Human Servs., No. 14-878V, 2018 WL 1581672, at *18 (Fed. Cl. Spec. Mstr.
Feb. 15, 2018) (finding the Kinoshita article not persuasive because it involved “a
very limited number of case studies”). The undersigned identified only one case in
which this set of articles was filed and the petitioner was found entitled to
compensation. But, in that case, the petitioner’s expert disclaimed any reliance on
an autonomic injury. See B.A. v. Sec’y of Health & Human Servs., No. 11-51V,
2018 WL 6985218, at *27-29 (Fed. Cl. Spec. Mstr. Dec. 6, 2018) (finding
petitioner established that the HPV vaccination caused her headaches via
molecular mimicry).
Balasco and Johnson point out that essentially, the Blitshteyn, Brinth,
Kinoshita, and Ozawa articles present a series of case reports. Although the
articles, particularly the Ozawa article, discuss findings on more than an isolated
case, the articles all suffer from a lack of control group. Case reports provide little,
if any, value to an analysis of causation. See Porter v. Sec’y of Health & Human
Servs., No. 99-639V, 2008 WL 4483740, at *13 (Fed. Cl. Spec. Mstr. Oct. 2,
2008), set aside on other grounds by Rotoli v. Sec’y of Health & Human Servs., 89
Fed. Cl. 71 (2009), reinstated, 663 F.3d 1242, 1254 (Fed. Cir. 2012) (stating the
“special master’s decision reveals a thorough and careful evaluation of all of the
evidence, including . . . reports and medical literature”); W.C. v. Sec’y of Health &
Human Servs., No. 07-456V, 2011 WL 4537887, at *13 (Fed. Cl. Spec. Mstr. Feb.
22, 2011) (“[C]ase reports are generally weak evidence of causation because [they]
cannot distinguish a temporal relationship from causal relationship.”), mot. for rev.
denied, 100 Fed. Cl. 440 (2011), aff’d, 704 F.3d 1352 (Fed. Cir. 2013). Given the
methodological limitations that are contained within the text of the articles, the
undersigned cannot give these articles more than a trifle of weight.
But, even the very small value of these articles diminishes in the context of
Ms. Cottingham’s claim. As the Secretary argues, see Resp’t’s Br. at 12-13, Ms.
Cottingham does not suffer from the conditions primarily discussed in those
articles. Blitshteyn investigated six young women who suffered from POTS.
Exhibit 14 at 138. Orthostatic problems and chronic regional pain syndrome were
the primary diagnoses in Kinoshita. Exhibit 13 at 10. In Brinth, 60 percent of the
64
subjects suffered from POTS. Exhibit 12 at 2604. Martinez-Lavin proposed that
autonomic dysfunction was explained by small fiber neuropathy. Exhibit 11 at 3.
However, Ms. Cottingham has not presented any evidence that she suffers from
POTS, chronic regional pain syndrome, orthostatic problems, or small fiber
neuropathy. Ms. Cottingham has also not presented any evidence (as opposed to
attorney argument) for why, for example, an article about chronic regional pain
syndrome informs an analysis of the reasonable basis for a claim that a vaccination
caused her to suffer, for example, syncope.29
VI. Assessment of Whether Reasonable Basis Supports the Claims Set forth
in the Petition
Having evaluated the evidence Ms. Cottingham and the Secretary submitted
as the Federal Circuit directed and the additional topics the Court of Federal
Claims identified, the undersigned next turns to determining whether, based on the
totality of the circumstances, Ms. Cottingham supported the claims set forth in her
petition. The structure of this analysis borrows from the structure used in off-
Table cases to determine whether a petitioner is entitled to compensation.
However, and this qualification is important, the burden of proof for determining
whether a petitioner establishes a reasonable basis for the claims set forth in the
petition is lower than the burden of proof to establish entitlement to compensation.
Petitioners can more easily satisfy the reasonable basis standard than the
preponderance of the evidence standard.
Ms. Cottingham’s October 30, 2015 petition asserted that the HPV
vaccination caused her four different problems. The easiest to evaluate is the claim
that the HPV vaccination caused Ms. Cottingham to suffer dysautonomia. Thus,
that condition is evaluated first in section A below. The remaining three
conditions are evaluated on the basis by which Ms. Cottingham began to
29
Conceivably, an expert might be able to connect the dots. However, speculating about
what could have happened would violate the requirement in Simmons to evaluate objective
evidence.
When an expert has offered an opinion that an HPV vaccine harmed a petitioner based
upon these articles, special masters have found that the petitioners were entitled to attorneys’
fees and costs. See Pet’r’s Reply in Support of Fourth Mot. for Rev., filed March 15, 2021, at 7,
citing Balasco v. Sec’y of Health & Human Servs., No. 17-215V, 2020 WL 2461911 (Fed. Cl.
Spec. Mstr. Apr. 16, 2020) and Combs v. Sec’y of Health & Human Servs., No. 14-878V, 2018
WL 2772218 (Fed. Cl. Spec. Mstr. Apr. 23, 2018). The outcomes in those cases can be
reconciled to the outcome in this case because in Balasco and Combs, the petitioners made a
stronger evidentiary showing.
65
experience the condition, starting with the earliest. The claim that the HPV
vaccination caused Ms. Cottingham to have headaches is in section B below. The
claim regarding fainting is in section C below. The claim regarding menstrual
difficulties is in section D below.
Dysautonomia
The petition asserts “[Ms. Cottingham]’s mom decided that she did not want
[her] to have any further Gardasil shots due to a potential connection with
autonomic dysfunction, and declined them at [her] July 7, 2013 annual physical.”
Pet. ¶ 8. The citation for this assertion is Ms. Cottingham’s affidavit, exhibit 1.
Ms. Cottingham’s annual physical was actually July 10, 2013. Exhibit 3 at
96-98. During this appointment, Dr. Simpson (a pediatrician) discussed the two
episodes of fainting and recommended that she eat breakfast and drink regularly.
He also referred Ms. Cottingham to a pediatric cardiologist. The records from this
appointment do not refer to Ms. Cottingham as possibly suffering from autonomic
dysfunction. Id. Likewise, Ms. Cottingham’s affidavit to which the petition refers
does not use the term “autonomic dysfunction,” although the affidavit otherwise
discusses a July 7, 2013 physical examination. See exhibit 1 ¶ 14.
The October 15, 2020 order directed Ms. Cottingham to specify the claims
for which the petition was brought and to identify the evidence showing that Ms.
Cottingham suffered from those conditions. Order, issued Oct. 15, 2020, ¶¶ 5-6.
In response, Ms. Cottingham stated that the “‘claim for which the petition was
brought’ includes autonomic dysfunction manifesting as headaches,
lightheadedness described as near black-outs, syncope, and menstrual problems.”
Pet’r’s Br. at 6. She continued: “These can constitute separate conditions or well-
documented symptoms of her overarching condition of autonomic dysfunction.”
Id. In oral argument, Ms. Cottingham’s attorney, Mr. Downing, amplified his
perspective about Ms. Cottingham’s diagnosis. Mr. Downing stated: “I do think
that she has dysautonomia.” Tr. 47. The Ozawa article attempts “to define the
syndrome by a collection of symptom sets in the body systems that appear to be
disconnected, but they’re not.” Tr. 56; accord Tr. 138.
In contrast, the Secretary responded: “There is no evidence in the medical
records of petitioner being diagnosed with autonomic dysfunction.” Resp’t’s Br. at
7. The Secretary rejected Mr. Downing’s attempt to diagnose Ms. Cottingham as
suffering from dysautonomia or a syndrome because doctors who treated her are
“the more reliable source for what is going on with Ms. Cottingham.” Tr. 77.
66
Establishing that the vaccinee suffers from the condition a vaccination
allegedly caused is a fundamental aspect of a claim. Broekelschen v. Sec’y of
Health & Human Servs., 618 F.3d 1339, 1346 (Fed. Cir. 2010).
Here, even under a standard of proof that is less than the preponderance of
the evidence standard, Ms. Cottingham has not presented a reasonable basis for the
petition’s claim that she suffered “autonomic dysfunction.”30 The crucial point is
that Ms. Cottingham presented no evidence in which a doctor diagnosed her as
suffering from “autonomic dysfunction.” Even the petition states that Ms.
Cottingham’s mother was concerned about “a potential connection with autonomic
dysfunction.” Pet. ¶ 8. The petition does not elaborate on the basis for Ms.
Cottingham’s mother’s concern.
The belief of Ms. Cottingham’s mother, regardless of its foundation, seems
to be a subjective quality that falls into the category of “good faith.” By way of
contrast, Ms. Cottingham’s mother’s worry about “autonomic dysfunction” is not a
form of “objective evidence” on which decisions about reasonable basis turn. Ms.
Cottingham’s attorney points to headaches in the context of a diagnosed viral
infection approximately four months after vaccination, two episodes of fainting
reported in the medical records in the context of being dehydrated and not eating
approximately eight and ten months after vaccination, and menstrual difficulties
beginning five months after the second vaccination, as evidence of a sequence of
symptoms amounting to autonomic dysfunction. However, the perception of Ms.
Cottingham’s attorney that the series of symptoms Ms. Cottingham experienced
actually constitute a syndrome is also not grounded in sufficient objective evidence
to have a reasonable basis. Cf. Rothschild Connected Devices Innovations, LLC v.
Guardian Prot. Servs., Inc., 858 F.3d 1383, 1389 (Fed. Cir. 2017) (stating, in the
context of finding that a district court abused its discretion in not finding a patent
case exceptional, “[t]he conclusory and unsupported statements from Rothschild’s
counsel and founder that claim 1 of the ‘090 patent is valid have no evidentiary
value”).
30
In the context of determining whether a petitioner was entitled to compensation, a
special master evaluated the articles on which Ms. Cottingham is relying and found a lack of
persuasive evidence “establishing ‘HPV syndrome’ as a cognizable injury.” Balasco v. Sec’y of
Health & Human Servs., No. 17-215V, 2020 WL 1240917, at *30 (Fed. Cl. Spec. Mstr. Feb. 14,
2020). Balasco does not control the outcome of Ms. Cottingham’s case because it was a decision
about entitlement, not reasonable basis and because Ms. Cottingham’s petition does not set forth
the claim that she suffered from “HPV syndrome.”
67
The critical factor is that a person with a medical degree, who has the
training and experience to diagnose medical problems, did not diagnose Ms.
Cottingham with autonomic dysfunction. Ms. Cottingham has not cited, and
independent research has not located, any Vaccine Program case in which a non-
medically trained petitioner’s opinion regarding diagnosis has been credited. This
conclusion is consistent with the Federal Circuit’s opinion in James-Cornelius.
There, although the Court of Appeals recognized that lay people are competent to
state when they experienced symptoms, the Federal Circuit did not extend this
competency to more complicated medical questions such as diagnosis and
causation. James-Cornelius, 984 F.3d at 1380. Without any evidence from a
person qualified to diagnose diseases, Ms. Cottingham’s assertion that she suffered
autonomic dysfunction amounts to “unsupported speculation.” See Perreria, 33
F.3d at 1377; see also Sedar, 988 F.3d at 765 (finding an expert’s report that a
structural defect caused the plaintiff to trip and to fall was more than a scintilla of
evidence such that granting a motion for summary judgment was erroneous).
Headaches
The petition alleges that the HPV vaccine caused Ms. Cottingham to
experience headaches. Pet. ¶ 4. According to the petition, on November 1, 2012,
Ms. Cottingham “began to have headaches unlike anything she experienced
before.” Id. November 1, 2012 is approximately four months after Ms.
Cottingham received the HPV vaccination on July 5, 2012. Exhibit 3 at 99-100
(vaccination record).
The petition’s assertion that Ms. Cottingham’s problems began on
November 1, 2012, is supported by her affidavit. Exhibit 1. However, the first
medical records created after the vaccination indicate that Ms. Cottingham’s
pediatrician was informed, on November 30, 2012, that Ms. Cottingham had
headaches “off and [on] all week.” Exhibit 3 at 87. Whether Ms. Cottingham’s
headaches began around November 23, 2012, as suggested in the pediatrician’s
November 30, 2012 medical record or Ms. Cottingham’s headaches began about
three weeks earlier as suggested in her affidavit does not affect the outcome. Even
under Ms. Cottingham’s version of events, her headaches began approximately
four months after the vaccination.
The latency between the vaccination and the onset of headaches influences
the outcome to a great degree. Through the package insert, Ms. Cottingham has
presented some evidence that the HPV vaccination can cause headaches. But, as
the Secretary argues, see Resp’t’s Br., filed Nov. 19, 2020, at 10, the package
insert indicates that the clinical trials link the vaccination to headaches that occur
68
within 15 days of the vaccination. Specifically, the manufacturer reported that
among a population of approximately 7,000 women aged 16-26 years old who
received the Gardasil vaccine, 13.7 percent reported headaches within 1 to 15 days.
Exhibit A at 6 (table 2).31 Thus, within the “adverse reports” section, the
manufacturer included, among other problems, “headaches.” Id. at 1.32 Thus, the
evidence supports a finding at the lower-than-preponderance standard, that Ms.
Cottingham possessed a reasonable basis for alleging that the HPV vaccine can
cause headaches.
After a petitioner demonstrates that some evidence supports a finding that
there is a reasonable basis for alleging that the vaccine can cause an injury, the
next step is to consider whether the injury arose in an “appropriate” time. The
package insert indicates 1 to 15 days is an appropriate time. Exhibit A at 6 (table
2).
While Ms. Cottingham, as discussed above, argues that an evaluation of the
timing is not appropriate in the context of determining whether reasonable basis
supports the claims set forth in the petition, see Pet’r’s Br., filed Nov. 19, 2020, at
10, Ms. Cottingham also argues that the appropriate onset extends to 5.47 months.
Id. at 12 n.1 (citing exhibit 13 (Kinoshita) at 2); see also Tr. 84-85.
Ms. Cottingham’s reliance on the Kinoshita article seems unclear. At one
point, Ms. Cottingham maintained that the set of medical articles were being
offered for the limited purpose of showing that other people have reported
experiencing symptoms similar to the symptoms that Ms. Cottingham experienced
after the HPV vaccine. Tr. 48. Yet, Ms. Cottingham also offered the Kinoshita
article to serve as a reliable indicator for the appropriate interval between
vaccination and onset. Tr. 52.
Ms. Cottingham, as the proponent of the evidence and as the party with the
burden of proof regarding reasonable basis, McKellar v. Sec’y of Health & Human
Servs., 101 Fed. Cl. 297, 305 (2011), has not established that the Kinoshita article
is a reliable source of information for the appropriate interval between vaccination
31
The clinical trial appears not to have considered the number of women who did not
receive a vaccination and had a headache.
32
The manufacturer also reported “headaches” as an “adverse experience”
“spontaneously reported during post-approval use of GARDASIL.” Exhibit A at 9 (section 6.2).
But, for the reasons discussed above, statements in the post-marketing section carry much less, if
any, weight regarding causation.
69
and onset. Ms. Cottingham may legitimately point to publication in a journal that
subjects manuscripts to peer review before publication.33 However, peer review is
not dispositive about reliability. Daubert v. United States, 509 U.S. 579, 593-94
(1993) (“The fact of publication (or lack thereof) in a peer reviewed journal thus
will be relevant, though not dispositive, consideration in assessing the scientific
validity of a particular technique or methodology on which an opinion is
premised.”); see also Terran v. Sec’y of Health & Human Servs., 41 Fed. Cl. 330,
336 (1998) (highlighting the usefulness of the Daubert standards in evaluating
reliability of scientific evidence in Vaccine Program cases), aff’d, 195 F.3d 1302,
1316 (Fed. Cir. 1999).
A problem with assigning the Kinoshita article more than a scintilla of
weight as to the appropriate temporal interval is the methodology of the Kinoshita
researchers. In essence, the Kinoshita article is a series of (forty) case reports.
Isolated case reports are the weakest type of evidence regarding causation,
meriting little, if any, weight. See Porter v. Sec’y of Health & Human Servs., 663
F.3d 1242, 1254 (Fed. Cir. 2011) (stating the “special master’s decision reveals a
thorough and careful evaluation of all of the evidence, including . . . reports and
medical literature”).
Kinoshita’s suggestion that the HPV vaccine might cause symptoms that
first appear, on average, approximately five months after vaccination is also not
consistent with the undersigned’s experience as a special master. Setting aside
cases in which petitioners appear pro se, petitioners do not typically file petitions
in which the latency between vaccination and onset of symptoms is as long as the
interval asserted here. When asked during oral argument whether any cases
supported an interval of more than four months, Ms. Cottingham’s attorney stated
that he did not perform that research. Tr. 93. Thus, Ms. Cottingham has not cited
any analogous cases.
In the context of determining entitlement, special masters have rejected the
time Ms. Cottingham proposes. See, e.g., Phillips v. Sec’y of Health & Human
Servs., No. 16-906V, 2020 WL 7767511, at *30 (Fed. Cl. Spec. Mstr. Nov. 23,
2020) (finding a sixteen-week onset in an HPV-ITP case medically not
appropriate); Caron v. Sec’y of Health & Human Servs., No. 15-777V, 2017 WL
4349189, at *10 (Fed. Cl. Spec. Mstr. Sep. 7, 2017) (rejecting five-month interval
in context of multiple vaccines and the onset of a form of osteomyelits), mot. for
33
The publisher’s website describes the Journal of Internal Medicine as peer-reviewed.
https://onlinelibrary.wiley.com/journal/13652796?tabActivePane=
70
rev. denied, 136 Fed. Cl. 360, 389-90 (2018). In fact, special masters tend to draw
a line at a two-month onset. See Conte v. Sec’y of Health & Human Servs., No.
17-403V, 2020 WL 5743696, at *26 (Fed. Cl. Spec. Mstr. July 27, 2020) (rejecting
a twelve-week onset in a flu-CIDP case and remarking that eight weeks appears to
be the maximum onset time frame deemed reasonable in the Vaccine Program);
Pearson v. Sec’y of Health & Human Servs., No. 16-9V, 2019 WL 3852633, at
*16 (Fed. Cl. Spec. Mstr. July 31, 2019) (finding, in a flu-TM case, that a “74-day
onset period is medically and scientifically unacceptable”) (citing cases); Kamppi
v. Sec’y of Health & Human Servs., No. 15-1013V, 2019 WL 5483161, at *11
(Fed. Cl. Spec. Mstr. July 24, 2019) (stating that “[s]pecial masters in the Program
have not awarded compensation when onset occurs more than two months after
vaccination” in flu-GBS cases) (citing cases); Harrington v. Sec’y of Health &
Human Servs., No. 14-43V, 2018 WL 4401976, at *35 (Fed. Cl. Spec. Mstr. Aug.
14, 2018) (rejecting, in the alternative, a two-month onset in a claim involving the
HPV vaccine); Koehn v. Sec’y of Health & Human Servs., No. 11-355V, 2013 WL
3214877, at *28 (Fed. Cl. Spec. Mstr. May 30, 2013) (rejecting two-month onset in
claim involving HPV vaccine), mot. for rev. denied sub. nom., C.K. v. Sec’y of
Health & Human Servs., 113 Fed. Cl. 757 (2013), aff’d, 773 F.3d 1239 (Fed. Cir.
2014). Onset of neurologic conditions more than roughly two months after a swine
flu vaccination also contributed to rejection of claims in the swine flu
compensation program. See, e.g., Kenneda v. United States, 815 F. Supp. 926, 932
(S.D.W. Va. 1993) (rejecting an onset time frame between 2-3 months in a case
involving the swine flu vaccination); Benedict v. United States, 785 F. Supp 97, 99
(N.D. Ohio 1991) (same). In some instances, special masters have also rejected
time frames shorter than two months. See, e.g., Greene v. Sec’y of Health &
Human Servs., 146 Fed. Cl. 655, 667-68 (2020) (affirming the special master’s
finding that a 41-day onset was “medically unreasonable” in a tetanus-diphtheria
vaccine-brachial neuritis case), aff’d, 841 Fed. App’x 195 (Fed. Cir. 2020).
Although those cases addressed timing in the context of determining
entitlement, special masters have considered the latency between the vaccination
and the onset of symptoms in determining whether reasonable basis supports the
claims set forth in the petition. See Kamppi v. Sec’y of Health & Human Servs.,
No. 15-1013V, 2020 WL 7767513, at *11-12 (Fed. Cl. Spec. Mstr. Nov. 6, 2020)
(finding no reasonable basis); Harding v. Sec’y of Health & Human Servs., No. 17-
1580V, 2019 WL 3215974, at *7 (Fed. Cl. Spec. Mstr. June 18, 2019) (finding
reasonable basis because the petitioner’s autoimmune disease worsened within 30
days of receiving a vaccine), mot. for rev. denied, 146 Fed. Cl. 381 (2019); Carter
v. Sec’y of Health & Human Servs., No. 16-852V, 2018 WL 6322447, at *9 (Fed.
Cl. Spec. Mstr. Oct. 16, 2018) (finding no reasonable basis because, in part, of the
71
10-month delay between childhood vaccinations and the onset of developmental
delay).
Ms. Cottingham contends other cases do not inform whether there was a
reasonable basis for her (implicit) claim that a medically appropriate interval
between an HPV vaccination and the onset of headaches extends to four months.
See Pet’r’s Br., filed Nov. 19, 2020, at 10-12; Tr. 93. Those other cases are
distinguishable because they involve different vaccines allegedly causing different
illnesses.
Ms. Cottingham’s distinction is a fair point. However, Ms. Cottingham has
not identified any case involving any vaccine-injury combination remotely
resembling her claim that a latency of approximately four months is appropriate.
Indeed, at some point, the period between a vaccination and an injury can become
inherently unreasonable given the basic scientific understanding of how vaccines
trigger the immune system. For example, in the December 11, 2020 oral argument,
Mr. Downing explicitly disclaimed any reliance in this case on Ozawa’s report of
temporality, which extended from 1 day to 1532 days, an unreasonably long period
of latency between vaccination and injury. Tr. 62. The deviation from the norm
present in Ms. Cottingham’s case, combined with the relatively commonplace
nature of headaches (for example, Ms. Cottingham experienced headaches before
she received the HPV vaccination, see exhibit 3 at 55-56 (Mar. 6, 2012)), would
seem to heighten the need for some reliable evidence to explain why an
approximately four-month latency is reasonable.
Finally, if Ms. Cottingham had presented some reliable evidence that four
months is a reasonable latency, Ms. Cottingham’s next step as part of a showing of
causation in the entitlement phase would be to show “a logical sequence of cause
and effect” (Althen prong 2). For prong two, probative evidence can come from
treating doctors. Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317,
1326 (Fed. Cir. 2006). The two doctors who treated Ms. Cottingham when she
complained about headaches attributed the headaches to infections. Exhibit 3 at
87-88 (Nov. 30, 2012), 78 (Jan. 31, 2013). Thus, for Ms. Cottingham’s claim that
the HPV vaccination caused her headache, the evaluations from the treating
doctors cut against a finding of reasonable basis.34
34
The undersigned is aware that James-Cornelius ruled that: “[A]bsence of an express
medical opinion on causation is not necessarily dispositive of whether a claim has a reasonable
basis[.]” James-Cornelius, 984 F.3d at 1379. Consistent with this statement, the undersigned is
not requiring Ms. Cottingham to point to affirmative evidence from a medical professional who
72
Thus, in short, the package insert, which shows some people developed
headaches within approximately two weeks of an HPV vaccination, and the
medical records and affidavit, which show Ms. Cottingham developed headaches
approximately four months after vaccination, constitute more than a scintilla of
evidence on the proposition that the vaccination caused Ms. Cottingham’s
headaches. Cottingham, 971 F.3d at 1346 (the “medical records paired with the
Gardasil package insert constitutes objective evidence supporting causation”); see
also Fourth Opinion, 2021 WL 3085502, at *4 (defining scintilla). But, even at a
standard in which petitioners do not have to establish their claims by a
preponderance of the evidence, the evidence does not support a finding that Ms.
Cottingham carried her burden to present a reasonable basis for the claim that the
vaccination caused her headaches.
Fainting
Ms. Cottingham next alleges that the July 5, 2012 HPV vaccination caused
her to suffer fainting episodes on March 29, 2013 and May 23, 2013. Pet. ¶¶ 6-7.
Ms. Cottingham’s petition seems to link these two fainting episodes to a series of
near black outs that began in November 2012. Pet. ¶ 5.
In the context of discussing the affidavit (section V.B above), the
undersigned explained why the affidavit’s assertion regarding a series of near black
outs continuing for months without report in medical records created
contemporaneously is unlikely to be credible. Nevertheless, for purposes of
examining the reasonable basis for a claim that the July 5, 2012 vaccination caused
Ms. Cottingham to suffer fainting, the undersigned will assume the accuracy of the
statement that Ms. Cottingham experienced black outs beginning in November
2012.
Even crediting Ms. Cottingham’s assertion, the objective support for this
claim remains insufficient to find reasonable basis. Like the claim for headaches,
the shortest latency for “near black outs” is approximately four months. As
explained in the previous section, Ms. Cottingham has not identified any case in
which special masters have found, in the entitlement stage, any vaccine can cause
stated that the vaccination caused her headache. For Ms. Cottingham, the treating doctors
identified a cause for her headaches, other than the vaccination. James-Cornelius does not
prevent special masters from considering the value of statements from treating doctors that tend
to exculpate the vaccine as a cause for a particular condition. See 42 U.S.C. § 300aa–
13(a)(requiring special masters to decide issues based on the record as a whole).
73
black outs starting approximately four months after the vaccination. Thus, Ms.
Cottingham’s claim remains an outlier.
If the two reported incidents of fainting were considered independent of Ms.
Cottingham’s assertions of near black outs, the claim that the HPV vaccination
caused those fainting episodes becomes even more far-fetched. The two reported
incidents of fainting occurred approximately eight months and approximately ten
months after the vaccination. Eight and ten months is much longer than the time
listed on the product insert. The HPV vaccine’s manufacturer warned that vaccine-
recipients should be observed for “15 minutes” because syncope might develop.
Exhibit A at 3 (section 5.1). The manufacturer did not report syncope in
association with the results of clinical trials. Id. at 4-9 (section 6.1).35
In oral argument, Ms. Cottingham attempted to distinguish what the
manufacturer reported on the product insert from what she experienced. This
attempt was largely unsuccessful. Ms. Cottingham stated that the manufacturer
was reporting a type of syncope known as “vasovagal syncope.” Tr. 19. The
evidentiary basis for this assertion is not readily apparent as the product insert uses
neither “vaso” nor “vagal.” See exhibit A.
Ms. Cottingham’s attempted distinction asserts that the syncope she
experienced approximately eight and approximately ten months later was a type of
syncope known as “postural” syncope. Tr. 19. The “postural” nature of Ms.
Cottingham derives, in her view, from the reports in medical records that the
syncope is associated with standing and alleviated on sitting. Id.; see also exhibit 3
at 70-71, 80-81, 111. However, Ms. Cottingham informed the cardiologist who
treated her about the context in which syncope and near-syncopal episodes
occurred. Even with this information, the cardiologist diagnosed her as suffering
from vasovagal syncope. Exhibit 3 at 112. While during oral argument Ms.
Cottingham dismissed this diagnosis as not supported, Tr. 79-80, Ms. Cottingham
has not cited any evidence from a medical professional (as opposed to her
attorney’s argument) that the syncope she suffered approximately eight and
approximately ten months after vaccination was postural.
Even if a medical professional had classified Ms. Cottingham’s fainting
episodes as “postural,” the latency between the HPV vaccination and the earliest
fainting episode is long. In Brinth, the “mean delay between vaccination and onset
35
Syncope is included as part of the post-marketing experience. Id. at 9 (section 6.2).
However, no time frame is listed.
74
of symptoms was 9.3 days (range: 0-30).” Exhibit 12 at 2603. In Blitshteyn, the
longest onset between vaccination and the onset of symptoms was two months.
Exhibit 14 at 136 (table 1: patient 2). Two months is approximately six months
faster than the onset of Ms. Cottingham’s first fainting episode. Even two months
is a long latency between vaccination and syncope. When the onset of a seizure
was eight weeks after vaccination, Dr. Blitshteyn declined to provide an opinion in
support of causation. Leonard v. Sec’y of Health & Human Servs., No. 13-668V,
2014 WL 1324596 (Fed. Cl. Spec. Mstr. March 13, 2014). Similarly, a special
master was not arbitrary in crediting the opinion of a cardiologist the Secretary had
retained who opined that “‘10 to 12 hours between vaccination and syncope is too
long for there to be a causative relationship.’” Hopkins v. Sec’y of Health &
Human Servs., 62 Fed. Cl. 333, 335 (2004) (denying motion for review).
Delays of approximately eight and approximately ten months are well
outside patterns commonly presented in Vaccine Program petitions. This latency
is a primary reason for finding that Ms. Cottingham’s claim that the HPV
vaccination caused her fainting episodes lacks reasonable basis.
The other reason for finding that Ms. Cottingham’s claim that the HPV
vaccine caused her to suffer syncopal episodes is that on both occasions the doctor
who treated Ms. Cottingham proposed causes other than the HPV vaccine.
Specifically, on March 29, 2013, the doctor assessed Ms. Cottingham as suffering
from “gastroenteritis” and “dehydration.” Exhibit 3 at 81. Similarly, on May 23,
2013, the doctor stated that Ms. Cottingham suffered from dehydration and noted
that she did not eat or drink that morning. Id. at 70. These statements from
treating doctors constitute “objective evidence,” weighing against a finding that
Ms. Cottingham possessed a reasonable basis to assert that the HPV vaccine
caused her syncopal episodes.
To be sure, a treating doctor’s assessment is just one factor and special
masters must consider the record as a whole as well as the totality of circumstances
in determining whether objective evidence supports finding a reasonable basis for
claims set forth in a petition. Thus, a treating doctor’s indication that something
other than the vaccine caused an injury merits some consideration. Likewise, a
treating doctor’s statement that a vaccine caused some injury also carries value.
But, neither negative nor affirmative statements resolve the issue by themselves.
Here, Ms. Cottingham has not identified any objective evidence suggesting
that the diagnostic conclusions Ms. Cottingham’s doctors reached on March 29,
2013, and May 23, 2013, were erroneous. Indeed, when Ms. Cottingham saw a
cardiologist for the purpose of exploring the reasons for her syncope, the
75
cardiologist seemed to endorse the previous diagnoses as the cardiologist also
“emphasized aggressive fluid hydration.” Exhibit 3 at 112.
To summarize, the package insert, which shows some people developed
syncope within approximately 15 minutes of an HPV vaccination, and the medical
records and affidavit, which show Ms. Cottingham developed near black outs
approximately four months after vaccination (at best), constitute more than a
scintilla of evidence on the proposition that the vaccination caused Ms.
Cottingham’s headaches. Cottingham, 971 F.3d at 1346 (the “medical records
paired with the Gardasil package insert constitutes objective evidence supporting
causation”); see also Fourth Opinion, 2021 WL 3085502, at *4 (defining scintilla).
But, even at a standard in which petitioners do not have to establish their claims by
a preponderance of the evidence, the evidence does not support a finding that Ms.
Cottingham carried her burden to present a reasonable basis for the claim that the
vaccination caused her fainting.
Menstrual Difficulties
From the group of conditions for which Ms. Cottingham has a diagnosis
from a treating doctor, the remaining problem is menstrual difficulties. Ms.
Cottingham’s petition alleges that the HPV vaccine caused her to suffer menstrual
problems in the “latter part of 2013.” Pet. ¶ 9. For this assertion, the petition cites
Ms. Cottingham’s affidavit, exhibit 1.
The medical records are not consistent with the affidavit’s assertion as to
when Ms. Cottingham experienced menstrual difficulties. Ms. Cottingham has not
identified any medical records showing menstrual difficulties in the latter part of
2013.36 On August 18, 2014, Ms. Cottingham’s pediatrician noted that she had her
last menstruation on July 25, 2014. Exhibit 3 at 109. This record does not suggest
that Ms. Cottingham experienced any menstruation problems close in time to that
appointment.
Instead, Ms. Cottingham’s medical records indicate that she had a menstrual
period in December 2014, but did not have one in January 2015. Exhibit 7 at 7.
36
The discrepancy between the affidavit and the medical records might be explained by
the chronology of when Mr. Downing received medical records. Mr. Downing’s timesheets
show that a paralegal (RWC) received some records from the University of Alabama-
Birmingham Department of Obstetrics and Gynecology on August 4, 2015. After additional
inquiries, this same paralegal received additional records on December 15, 2015. Ms.
Cottingham signed her affidavit on October 28, 2015. Exhibit 1.
76
After a doctor prescribed oral contraceptives on April 28, 2015, id. at 9, Ms.
Cottingham seemed to return to a “regular” menstrual cycle with the help of oral
contraceptives by July 8, 2015. Id. at 11-13 (stating that Ms. Cottingham was
“currently using [a contraceptive] for cycle control . . . and is cycling regularly”).
The support for the proposition that the HPV vaccination can cause
menstrual difficulties rests on potentially unreliable evidence. The manufacturer’s
product insert does not list any problems with menstrual difficulties either
following clinical trials or in the post-marketing experience. See exhibit A.
Similarly, the articles from the United States and Denmark do not report recipients
of the HPV vaccine began to experience menstrual problems after the vaccination.
See exhibit 14 (Blitshteyn), exhibit 12 (Brinth).37
On the other hand, the two sequential reports from Japan do report menstrual
problems after the HPV vaccination. In the earlier study, Kinoshita and colleagues
stated that 35 percent (14 out of 44 women) had “disturbed menstruation.” Exhibit
13 at 2. In the follow-up study, Ozawa and colleagues found that nearly 50 percent
of the 72 participants suffered menstrual abnormalities. Exhibit 15 at 5 (table 2).
Ozawa and colleagues listed menstrual abnormalities among their unverified
diagnostic criteria. Id. at 4 (table 1). Neither Kinoshita nor Ozawa report any
information about the latency between the HPV vaccination and the beginning of
menstrual problems specifically.
In Ms. Cottingham’s case, the amount of time between her July 5, 2012
HPV vaccination and the onset of menstrual difficulties around January 2015 is
approximately two and a half years. It is difficult to fathom how the July 5, 2012
HPV vaccine can cause a problem that started more than two years later. This
temporal relationship is quite possibly the longest temporal interval proposed in
any case in which an attorney represented a petitioner in the undersigned’s tenure.
The undersigned is not aware of any credible medical theory, offered in any
circumstance, that might come close to explaining how the latency could extend to
30 months.
To be fair, the October 30, 2015 petition does not allege that the July 5, 2012
HPV vaccination caused menstrual difficulties beginning in January 2015. The
petition actually alleges that the menstrual difficulties began near the end of 2013.
37
Based upon the questionnaires the participants answered, the Brinth researchers
reported that before the vaccination, all participants either used oral contraceptives or had
irregular periods. Exhibit 12 at 2604. The Brinth group did not report any aggravation of
menstrual problems.
77
Pet. ¶ 9. If this assertion were accurate, then the latency between the July 5, 2012
HPV vaccination and the onset of menstrual difficulties (assumed to be November
15, 2013) would be still be approximately 16 months. While 16 months is
obviously shorter than 30 months, 16 months remains far beyond the temporal
interval any special master has recognized.
Finally, to extend an extra benefit to Ms. Cottingham, it might be assumed
that after Ms. Cottingham’s attorney obtained additional records from the
gynecologist around December 15, 2015, Ms. Cottingham might have amended her
petition to allege that the second (not first) dose of the HPV vaccine caused her
menstrual difficulties.38 The second dose of the HPV vaccine was administered to
Ms. Cottingham on August 18, 2014. Exhibit 3 at 109-10. If it is assumed that
Ms. Cottingham’s menstrual difficulties began on January 1, 2015, then the latency
is approximately 4.5 months.
An interval of approximately 4.5 months is outside the scope of intervals
that special masters have credited for reasons explained above in the context of
Ms. Cottingham’s claim that the first dose of the HPV vaccine caused her
headaches. While a latency of 4.5 months falls within the range Kinoshita
reported, the Kinoshita methodology is suspect and has not been defended by any
witness in this case. Consequently, for an array of different intervals, Ms.
Cottingham has not met her burden of establishing the reasonable basis for alleging
her menstrual difficulties arose in a time for which an inference of causation is
appropriate.
VII. Additional Remarks, including Comments on Denying Fees despite a
Finding of Reasonable Basis as a Matter of Discretion
For the reasons explained above, Ms. Cottingham has not met her burden of
establishing a reasonable basis for the claims set forth in her petition. In reaching
this conclusion, the undersigned has attempted to comply with instructions from
appellate authorities at the Federal Circuit and the Court of Federal Claims. In this
respect, the undersigned has attempted to consider everything that a special master
is supposed to consider in evaluating whether a reasonable basis supports the
claims set forth in Ms. Cottingham’s petition. The list of considered topics
includes, but is not necessarily limited to, the petition, Ms. Cottingham’s affidavits,
the medical records, the Secretary’s report, the package insert, the medical articles
38
Ms. Cottingham did not amend her petition before filing a motion to dismiss on
October 6, 2016.
78
filed after the Federal Circuit’s remand, the opinions of the Federal Circuit and the
Court of Federal Claims in this case, all the parties’ briefs, the opinion of the
Federal Circuit in James-Cornelius, the policies underlying the Vaccine Act, the
novelty of the HPV vaccine, and the Althen factors for structure. Yet, at the same
time, the undersigned has attempted to refrain from considering factors that
appellate authorities have said special masters should not consider when evaluating
reasonable basis, such as the pendency of the statute of limitations, the lack of a
statement from a treating doctor who linked the vaccination to any health problem,
and the lack of an opinion from a doctor retained in this litigation supporting
causation.
In this regard, the undersigned acknowledges that the January 7, 2021
decision pointed to the lack of a report from a treating doctor or retained expert as
one reason for finding that Ms. Cottingham’s case lacked a reasonable basis.
Fourth Fees Decision, 2021 WL 347020, at *18. While the Federal Circuit’s use of
the term “necessarily” in the phrase “absence of an express medical opinion on
causation is not necessarily dispositive of whether a claim has a reasonable basis,”
James-Cornelius, 984 F.3d at 1379, raises questions about whether there are any
circumstances in which a special master may consider the lack of an explicit
statement from a treating doctor or retained expert saying a vaccine caused an
injury, the present decision does not rest in any respect on the lack of a statement
from a treating doctor or retained expert suggesting the vaccine caused any injury.
The main reason Ms. Cottingham’s case lacks a reasonable basis is that the
latency between the vaccination and the onset of any health conditions was
approximately four months at the shortest. The January 7, 2021 decision
emphasized: “The long latency weighs heavily.” Fourth Fees Decision, 2021 WL
347020, at *39. Neither the Federal Circuit’s opinion nor any of the remands from
the Court of Federal Claims bar the undersigned from evaluating the time between
the vaccination and the start of health problems.
In looking to the latency between the vaccination and the onset of the
various symptoms, the undersigned is following, in some respects, the path laid out
in Perreira. There, as noted above, the special master denied entitlement because
there was no support for their expert’s opinion that DPT causes harm that would
first appear two weeks later. Perreira, 1991 WL 117740, at *1, 1 n.2. Then, in
looking at whether there was a reasonable basis for the claim, the special master
found that the expert’s opinion was “unsupported speculation” and found no
reasonable basis. Perreira, 1992 WL 164436, at *2. On appeal, the Federal Circuit
79
determined that the special master was not arbitrary in finding that reasonable basis
was not established. Perreira, 33 F.3d at 1377.39
In somewhat similar fashion, the undersigned is also relying upon the
latency between the vaccination and the onset of various problems in Ms.
Cottingham’s case and finding that the proposed latency is far beyond the norm.
The undersigned’s view of what is typically proposed as an appropriate temporal
relationship derives from the experience in adjudicating cases. The January 7,
2021 decision also indicated that special masters should be allowed to rely upon
their experience in evaluating reasonable basis. Specifically, that decision stated:
The experience of the presiding judicial officer seems to be a
factor useful in evaluating whether the claims in a petition were
supported by reasonable basis. See Highmark Inc. v. Allcare
Health Mgmt. Sys., Inc., 572 U.S. 559, 564 (2014) (interpreting
a provision of the Patent Act, 35 U.S.C. § 285, authorizing
attorneys’ fees in “exceptional cases” and stating that district
courts are “better positioned to determine whether a case is
exceptional because it lives with the case over a prolonged
period of time”); Whitecotton v. Sec’y of Health & Human
Servs., 81 F.3d 1099, 1104 (Fed. Cir. 1996) (allowing special
masters to use their “accumulated expertise” in determining
whether to find entitlement to compensation); Saxton v. Sec’y
of Health & Human Servs., 3 F.3d 1517, 1521 (Fed. Cir. 1993)
(allowing special masters to use their experience in determining
the reasonableness of the amount of attorneys’ fees and costs);
cf. Silva v. Sec’y of Health & Human Servs., 108 Fed. Cl. 401(2012) (reviewing a finding of no reasonable basis under the
broad abuse of discretion standard). Based upon this
experience, Ms. Cottingham’s claim that the HPV vaccine
caused an injury that first appeared approximately four months
after the vaccination is an outlier.
39
As a precedential opinion from the Federal Circuit, Perreira remains binding.
However, it is not so easy to reconcile the outcome in Perreira, which determined that the special
master could find no reasonable basis despite the presence of an expert’s report with the
suggestion in James-Cornelius that a special master should not consider whether a petitioner
even has an expert report. See Strickland v. United States, 423 F.3d 1335, 1338 & n.3 (Fed. Cir.
2005) (discussing adherence to the reviewing court’s precedent).
80
Fourth Fees Decision, 2021 WL 347020, at *40. In Ms. Cottingham’s briefs
regarding the motion for review, Ms. Cottingham did not contest the proposition
that special masters may rely upon their experience. See Pet’r’s Br., filed Feb. 5,
2021; Pet’r’s Reply, filed Mar. 15, 2021. The Court’s Fourth Opinion also did not
bar the undersigned from relying upon experience in evaluating claims of
reasonable basis.
Other factors that contribute to the finding that Ms. Cottingham’s case
lacked a reasonable basis include the lack of diagnosis to support the assertion of
dysautonomia (meaning no unifying syndrome) and the presence of alternative
causes in the medical records (viral infections for the headaches and dehydration
for the fainting). These deficiencies are not cured by the subjective belief of Ms.
Cottingham or her attorney. As the Federal Circuit has stated, “the extent of a
party’s pre-suit investigation or how fervently it believed in its allegations does not
affect the objective strength of that party’s litigating position.” Nova Chems.
Corp. v. Dow Chem. Co., 856 F.3d 1012, 1018 (Fed. Cir. 2017) (affirming award
of attorneys’ fees), cert. denied, 138 S. Ct. 485 (2017).
Eliminating the lack of an explicit statement from a treating doctor or a
retained expert does not affect the other problems weighing against a finding of
reasonable basis. Thus, simply disregarding the omission of a direct statement
from a medical professional does not mandate a switch in outcome. See Carter v.
Sec’y of Health & Human Servs., 132 Fed. Cl. 372, 382 (2017) (denying motion
for review and indicating that special master’s consideration of lack of support
from doctors was harmless error because the evidence did not support a finding of
reasonable basis).
Nevertheless, the undersigned recognizes that appellate authorities might
reach different results on the evidentiary issue and conclude that the finding of no
reasonable basis here constituted an abuse of discretion. See, e.g., Adjustacam,
LLC v. Newegg, Inc., 861 F.3d 1353 (Fed. Cir. 2017) (ruling that district court
abused its discretion in finding a patent case not exceptional). A finding that
reasonable basis supports the claims set forth in Ms. Cottingham’s would make her
eligible for an award of attorneys’ fees and costs.
A petitioner’s eligibility for an award of attorneys’ fees and costs, however,
does not absolutely guarantee an award. The Vaccine Act states that upon a
finding of good faith and reasonable basis, a special master “may award”
reasonable attorneys’ fees and costs. 42 U.S.C. § 300aa–15(e)(1). The word
“may” differs from the word “shall,” which the Vaccine Act uses in the context of
directing special masters to award reasonable attorneys’ fees and costs to
81
petitioners who receive compensation. See Hellenbrand v. Sec’y of Health &
Human Servs., 999 F.2d 1565, 1570 (Fed. Cir. 1993) (distinguishing “shall” from
“may”). Thus, the Federal Circuit recognized that “even when these two
requirements [good faith and reasonable basis] are satisfied, a special master
retains discretion to grant or deny attorneys’ fees.” James-Cornelius, 984 F.3d at
1379. Citing this portion of James-Cornelius, the Secretary’s response to the most
recent motion for review argued that any error in the undersigned’s evaluation of
reasonable basis was harmless because the undersigned could have denied
attorneys’ fees and costs as a matter of discretion anyway. Resp’t’s Resp., filed
Mar. 8, 2021.
However, the undersigned is not aware of any case in which a special master
(a) found good faith and a reasonable basis for the claims set forth in the petition
and (b) denied attorneys’ fees. Thus, while it may be correct to say that a finding
of good faith and reasonable basis makes a petitioner “eligible” for an award of
reasonable attorneys’ fees and costs, in practice these twin findings have led to an
award of attorneys’ fees and costs. If there is an exception to this apparently
universal practice, the Secretary did not cite the case(s). In the circumstances of
Ms. Cottingham’s case, if the undersigned found that Ms. Cottingham had met her
burden of establishing a reasonable basis for the claims set forth in her petition---a
burden that is markedly less than the preponderance of the evidence standard---
then the undersigned would have awarded her reasonable attorneys’ fees and costs.
Accordingly, in recognition of the possibility that an appellate authority
might determine that Ms. Cottingham has satisfied the reasonable basis standard
and to promote judicial efficiency in any appellate process, the undersigned next
determines a reasonable amount of attorneys’ fees and costs to which Ms.
Cottingham would be entitled.
VIII. Reasonable Amount
As Ms. Cottingham has litigated her eligibility for an award of attorneys’
fees and costs, the amount that Ms. Cottingham has requested has, naturally,
increased. On this remand, she submitted an additional supplemental motion for
attorneys’ fees and costs on August 9, 2021.
In the decision issued on January 7, 2021, the undersigned determined a
reasonable amount of attorneys’ fees and costs for work performed prior to
October 12, 2020, totaled $85,177.62, consisting of $77,072.50 in attorneys’ fees
and $8,105.12 in attorneys’ costs.
82
Also in the January 7, 2021 decision, the undersigned assessed additional
reasonable attorneys’ fees and costs at $15,959.00 in attorneys’ fees and $1,106.58
in costs, based on the Ms. Cottingham’s supplemental motion filed on January 4,
2021. Therefore, the total reasonable attorneys’ fees and costs prior to this remand
proceeding came to $102,243.20.40
August 9, 2021 Motion for Supplemental Fees
Ms. Cottingham filed a supplemental motion for attorneys’ fees and costs on
August 9, 2021. The Secretary did not respond to this motion. In that motion, she
requested an additional $21,772.50 in attorneys’ fees and $2,633.61 in costs. The
undersigned finds both amounts reasonable. Therefore, when added to the
previously considered amounts, the total of attorneys’ fees and costs comes to
$126,649.11, representing $114,804.00 in fees and $11,845.31 in costs.
IX. Conclusion
For the reasons explained above, Ms. Cottingham’s petition asserts claims
that reasonable basis does not support. Accordingly, her motion for attorneys’ fees
and costs is DENIED. Pursuant to Vaccine Rule 28.1(a), the Clerk’s Office is
directed to provide this decision to the assigned judge.
IT IS SO ORDERED.
s/ Christian J. Moran
Christian J. Moran
Special Master
40
For a more detailed discussion of reasonable attorneys’ fees and costs requested prior
to this remand, see Fourth Fees Decision, 2021 WL 347020, at *40-42.
83