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.

This text is long and has been trimmed here. Open the source document for the complete record.