Jennings v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

*********************

DANIELLE JENNINGS, * No. 16-779V

* Special Master Christian J. Moran

Petitioner, *

* Filed: July 8, 2020

v. * Reissued: April 20, 2021

* entitlement; human papillomavirus

SECRETARY OF HEALTH * (“HPV”) vaccine; asthma/breathing

AND HUMAN SERVICES, * problems; chronic fatigue syndrome;

* gastrointestinal dysfunction

Respondent. *

*********************

Scott W. Rooney, Nemes, Rooney P.C., Farmington Hills, MI, for petitioner;

Darryl Wishard, U.S. Dep’t of Justice, Washington, DC, for respondent.

UNPUBLISHED DECISION DENYING COMPENSATION*

Danielle Jennings filed a petition for compensation under the National

Childhood Vaccine Injury Compensation Program (the “Vaccine Act” or

“Program”), 42 U.S.C. § 300aa—10 to 34 (2012), alleging that a human

papillomavirus (“HPV”) vaccine she received caused her to develop various

conditions, including asthma/breathing problems. Pet., filed June 30, 2016.

Because Ms. Jennings has not established that she suffered from many of the

conditions for which she seeks compensation and that the record supports a finding

that her asthma/breathing problems existed before the vaccination, she is not

entitled to compensation.

Procedural History

* The parties were informed that this decision would be made available to the public. Ms.

Jennings sought redaction of this decision, but her motions were denied. Orders, issued Oct. 19,

2020 and Sep. 15, 2020. After Ms. Jennings requested that the Court of Federal Claims review

the orders denying redaction, the Court denied the motion for review. Order, issued Feb. 8,

2021. Accordingly, this decision is being posted as originally submitted, except for modification

to this footnote.

Ms. Jennings began this case by filing a petition on June 30, 2016. 1 She

filed a collection of medical records. The petitioner filed the first of six affidavits

from Denise Jennings as exhibit 7 on October 3, 2016. In this October 3, 2016

affidavit, Ms. Jennings set forth a series of allegations about her daughter’s health

and school attendance. Exhibit 7. Some of the affidavit reproduces a chronology

that appears in a medical record from January 2014. Exhibit 14 at 23-27. While

the author of the chronology is not identified, the context suggests that Denise

Jennings prepared this chronology.

Petitioner periodically filed medical records and other documents over the

next six months. As discussed in the summary of events, the collection of medical

records was not ideal as petitioner did not produce records from every office of

every doctor who treated her. On April 5, 2017, petitioner represented that she was

waiting for only one more set of medical records. Otherwise, the record was

essentially completed. Pet’r’s Status Rep., filed Apr. 5, 2017.

This status report allowed the Secretary to review the submitted material.

The Secretary summarized the medical records. Resp’t’s Rep., filed May 1, 2017,

at 2-8. After reviewing the standards for entitlement, the Secretary argued that

petitioner had not established that Ms. Jennings was entitled to compensation. The

Secretary “disputes that petitioner has demonstrated that vaccine-related injury.”

Id. at 9. The Secretary indicated that neither a treating doctor nor a retained expert

offered any theory to explain how a vaccine caused Ms. Jennings’s injury. Id. The

Secretary also disputed the temporality in that some symptoms occurred before the

vaccination and some diagnoses occurred months after the vaccination. Id. at 11.

After the Secretary recommended against compensation, to facilitate the

drafting of reports from experts, the undersigned proposed a set of instructions for

the expert. Order, issued May 23, 2017. The draft instructions later became final.

Order, issued Aug. 2, 2017.

In a June 12, 2017 status conference, petitioner disputed the accuracy of

some of the medical records, which the Secretary had summarized. Thus, Ms.

1 Initially, Denise Jennings, the mother of Danielle Jennings, acted as petitioner because

Danielle had not reached the age of majority. However, Danielle eventually became the

petitioner. Order, issued Aug. 23, 2018. Whether Denise Jennings or Danielle Jennings was the

petitioner does not affect the outcome.

2

Jennings was given an opportunity to file an affidavit. She also requested an

opportunity to file an amended petition. Order, issued June 14, 2017.

Petitioner first filed her amended petition. The amended petition alleges that

Danielle Jennings “continues to suffer from a toxic reaction to the vaccinations as

identified above.” Am. Pet., filed June 21, 2017, ¶ 11. The amended petition does

not specify a particular disease or condition that the vaccinations allegedly caused.

However, the amended petition does assert that after the vaccinations, Ms.

Jennings experienced “hand numbness, headaches, handwriting difficulties, visual

comprehension difficulties” as well as “memory impairments and neurologic

impairments.” Id. ¶¶ 9-10.

Petitioner submitted affidavits from Denise Jennings on July 14, 2017

(exhibit 19) and September 1, 2017 (exhibit 20). The former discussed potential

sources of information about Danielle’s health in the relevant time. The latter

contested some of the material found in the medical records from Dr. Baptist.

Petitioner also filed more medical records and school records.

Petitioner announced an intention to retain an expert. Pet’r’s Status Rep.,

filed Oct. 12, 2017. After multiple enlargements of time, petitioner filed the first

report from Dr. Santoro on May 29, 2018. Exhibit 26. This report did not comply

with the August 2, 2017 Expert Instructions. For example, Dr. Santoro did not

define the condition that was affecting Danielle. Consequently, petitioner was

ordered to obtain a supplemental report. Order, issued June 25, 2018.

This supplemental report from Dr. Santoro was filed on August 23, 2018.

Exhibit 27. Dr. Santoro, again, did not reach a conclusion about Danielle’s

diagnosis. Order, issued Sept. 17, 2018. The Secretary intended to file an expert

report in response.

After similarly receiving multiple enlargements of time, the Secretary filed a

report from Dr. MacGinnitie on February 14, 2019. Exhibit A. Dr. MacGinnitie

challenged many aspects of Dr. Santoro’s opinion, including the lack of diagnosis.

Id. at 4-5, 9.

Petitioner’s response to Dr. MacGinnitie’s report took place in two forms.

Denise Jennings challenged some of Dr. MacGinnitie’s factual assertions in an

affidavit. Exhibit 39. Dr. Santoro disputed some of Dr. MacGinnitie’s medical

opinions in two more reports. Exhibits 40-41.

3

The Secretary filed another report from Dr. MacGinnitie on September 10,

2019. Exhibit P. 2 In the ensuing status conference, the parties stated that the stage

for developing expert reports was finished. Accordingly, the parties were directed

to file briefs regarding entitlement. Order, issued Sept. 25, 2019. This order

allowed the parties to file a limited amount of additional information, including

updated medical records for Danielle.

The parties complied. Petitioner filed her brief with additional evidence on

March 4, 2020. Exhibits 42-53. The Secretary filed his brief on March 27, 2020.

The Secretary, too, filed additional evidence. Exhibits U-Z. Although permitted

additional time, petitioner did not file a reply. The case is ready for adjudication.

Standards for Finding Facts

Petitioners are required to establish their cases by a preponderance of the

evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence

standard requires a “trier of fact to believe that the existence of a fact is more

probable than its nonexistence before [he] may find in favor of the party who has

the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of

Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations

omitted).

The process for finding facts in the Vaccine Program begins with analyzing

the medical records, which are required to be filed with the petition. 42 U.S.C.

§ 300aa–11(c)(2). Medical records that are created contemporaneously with the

events they describe are presumed to be accurate. Cucuras v. Sec’y of Health &

Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

Not only are medical records presumed to be accurate, they are also

presumed to be complete, in the sense that the medical records present all the

patient’s medical issues. Completeness is presumed due to a series of propositions.

First, when people are ill, they see a medical professional. Second, when ill people

see a doctor, they report all their problems to the doctor. Third, having heard about

the symptoms, the doctor records what he or she was told.

Appellate authorities have accepted the reasoning supporting a presumption

that medical records created contemporaneously with the events being described

2 The Secretary also designated another document as exhibit P, a disciplinary action

against Dr. Neuenschwander, that was filed on July 15, 2019.

4

are accurate and complete. A notable example is Cucuras in which petitioners

asserted that their daughter, Nicole, began having seizures within one day of

receiving a vaccination, although medical records created around that time

suggested that the seizures began at least one week after the vaccination. Cucuras,

993 F.3d at 1527. A judge reviewing the special master’s decision stated that “[i]n

light of [the parents’] concern for Nicole’s treatment . . . it strains reason to

conclude that petitioners would fail to accurately report the onset of their

daughter’s symptoms. It is equally unlikely that pediatric neurologists, who are

trained in taking medical histories concerning the onset of neurologically

significant symptoms, would consistently but erroneously report the onset of

seizures a week after they in fact occurred.” Cucuras v. Sec’y of Health & Human

Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F.2d 1525 (Fed. Cir. 1993).

Judges of the Court of Federal Claims have followed Cucuras in affirming

findings by special masters that the lack of contemporaneously created medical

records can contradict a testimonial assertion that symptoms appeared on a certain

date. See, e.g., Doe/70 v. Sec’y of Health & Human Servs., 95 Fed. Cl. 598, 608

(Fed. Cl. 2010) (stating “[g]iven the inconsistencies between petitioner’s testimony

and his contemporaneous medical records, the special master’s decision to rely on

petitioner’s medical records was rational and consistent with applicable law”),

aff’d sub nom. Rickett v. Sec’y of Health & Human Servs., 468 Fed. Appx. 952

(Fed. Cir. 2011) (non-precedential opinion); Doe/17 v. Sec’y of Health & Human

Servs., 84 Fed. Cl. 691, 711 (2008); Ryman v. Sec’y of Health & Human Servs.,

65 Fed. Cl. 35, 41-42 (2005); Snyder v. Sec’y of Health & Human Servs., 36 Fed.

Cl. 461, 465 (1996) (stating “The special master apparently reasoned that, if Frank

suffered such [developmental] losses immediately following the vaccination, it was

more likely than not that this traumatic event, or his parents’ mention of it, would

have been noted by at least one of the medical record professionals who evaluated

Frank during his life to date. Finding Frank’s medical history silent on his loss of

developmental milestones, the special master questioned petitioner’s memory of

the events, not her sincerity.”), aff’d, 117 F.3d 545, 547-48 (Fed. Cir. 1997).

The presumption that contemporaneously created medical records are

accurate and complete is rebuttable, however. For cases alleging a condition found

in the Vaccine Injury Table, special masters may find when a first symptom

appeared, despite the lack of a notation in a contemporaneous medical record. 42

U.S.C. § 300aa-13(b)(2). By extension, special masters may engage in similar

fact-finding for cases alleging an off-Table injury. In such cases, special masters

are expected to consider whether medical records are accurate and complete. To

overcome the presumption that written records are accurate, testimony is required

5

to be “consistent, clear, cogent, and compelling.” Blutstein v. Sec’y of Health &

Human Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June

30, 1998).

In determining the accuracy and completeness of medical records, special

masters will consider various explanations for inconsistencies between

contemporaneously created medical records and later given testimony. The Court

of Federal Claims has identified four such explanations for explaining

inconsistencies: (1) a person’s failure to recount to the medical professional

everything that happened during the relevant time period; (2) the medical

professional’s failure to document everything reported to her or him; (3) a person’s

faulty recollection of the events when presenting testimony; or (4) a person’s

purposeful recounting of symptoms that did not exist. La Londe v. Sec’y Health &

Human Servs., 110 Fed. Cl. 184, 203 (2013), aff’d, 746 F.3d 1334 (Fed. Cir.

2014).

When weighing divergent pieces of evidence, special masters usually find

contemporaneously written medical records to be more significant than oral

testimony. Cucuras, 993 F.2d at 1528. Testimony offered after the events in

question is less reliable than contemporaneous reports when the motivation for

accurate explication of symptoms is more immediate. Reusser v. Sec’y of Health

& Human Servs., 28 Fed. Cl. 516, 523 (1993). However, compelling oral

testimony may be more persuasive than written records. Campbell, 69 Fed. Cl. at

779 (“[L]ike any norm based upon common sense and experience, this rule should

not be treated as an absolute and must yield where the factual predicates for its

application are weak or lacking.”); Camery v. Sec’y of Health & Human Servs., 42

Fed. Cl. 381, 391 (1998) (this rule “should not be applied inflexibly, because

medical records may be incomplete or inaccurate”); Murphy v. Sec’y of Health &

Human Servs., 23 Cl. Ct. 726, 733 (1991) (“[T]he absence of a reference to a

condition or circumstance is much less significant than a reference which negates

the existence of the condition or circumstance.”) (citation omitted), aff’d, 968 F.2d

1226 (Fed. Cir. 1992).

Finding of Facts

Ms. Jennings was born in 2000 at 32 weeks gestation. Her early birth may

have contributed to some respiratory issues. See exhibit 8 at 10, exhibit 25 at 48-

49, 63. Otherwise, events in her first 12 years seem not to affect the outcome of

this case. For example, her pediatrician, Marcia Newcombe, assessed her as a well

6

child in an August 20, 2011 examination. Exhibit 25 at 6.3 Ms. Jennings’s general

good health had allowed her to play soccer since kindergarten. Id. at 29.

On March 9, 2013, the family brought home a golden Labrador Retriever.

Exhibit 14 at 24 (chronology Denise Jennings apparently created in conjunction

with an appointment on January 30, 2014).4 As discussed briefly below, the

Secretary’s expert suggested that an allergy to this dog could have been

responsible for Ms. Jennings’s breathing problems. Exhibit A at 5-6.

Following the August 20, 2011 well-child appointment, Ms. Jennings’s next

appointment with her pediatrician was on March 23, 2013. The chief complaint

was “pain in abdomen / chest / back after running for a few minutes x 1 month.”

Dr. Newcombe assessed her as having “exercise induced asthma” with “no vocal

cord paralysis.” Dr. Newcombe demonstrated how to use an inhaler and stated that

if Ms. Jennings were not better with an inhaler, then she should seek testing with a

pulmonologist. Exhibit 25 at 5. Dr. Newcombe recommended the first dose of the

HPV vaccine. Id.; see also exhibit 1. Ms. Jennings asserts she had a mild reaction

to the first dose of the HPV vaccine, given on March 23, 2013. However, she does

not claim compensation for any injury related to the first dose. See Pet’r’s Br. at

23, 38.5

In later medical records, doctors recorded histories from Ms. Jennings and

her mother that Ms. Jennings developed asthma and/or breathing difficulties after

the HPV vaccination. E.g., exhibit 6 at 10-13, 29-33. These histories are not

correct. The March 23, 2013 record establishes that Ms. Jennings came to Dr.

Newcombe because she was having breathing problems when she ran, resulting in

3 In June 2013, Ms. Jennings and her mother told a doctor that in January or February,

Ms. Jennings was ill and tested for strep. She recovered from it completely. Exhibit 25 at 29. In

August 2013, another doctor recorded a history that Ms. Jennings possibly had an influenza

infection in January 2013. Exhibit 25 at 57. Similarly, in January 2014, two doctors were

informed that in February 2013, Ms. Jennings experienced a febrile illness, either influenza or

mononucleosis. Exhibit 6 at 42-44, exhibit 14 at 22-28. However, the set of records from the

pediatrician contain no notes from January or February 2013, corroborating the accounts of

illness.

4 While much of the chronology is repeated in the initial affidavit of Denise Jennings

(exhibit 7), the information about the family getting a new dog is not in the affidavit.

5 The statute of limitations precludes compensation for an injury that developed shortly

after the first HPV vaccination.

7

a diagnosis of “exercise induced asthma,” and a recommendation to consult a

pulmonologist. Exhibit 25 at 5.

The pulmonologist whom Ms. Jennings saw was Martin Hurwitz from the

West Bloomfield Asthma, Allergy, and Pediatric Pulmonology Center on May 14,

2013. Ms. Jennings and her mother told Dr. Hurwitz that “Since the beginning of

the indoor soccer season last fall [2012], Danielle has experienced pressure

sensation on the chest and lightheadedness and almost near syncope after 10

minutes of hard running.” Exhibit 25 at 61. 6 While Ms. Jennings reported that her

symptoms were better during the outdoor soccer season, a bronchodilator inhaler

was not effective. Dr. Hurwitz recorded that Ms. Jennings “is not allergic to any

foods or medications” and that the family has two pet dogs. Id. at 62. Dr. Hurwitz

tested Ms. Jennings’s pulmonary function with a spirometry. The results were

below predicted rates. Dr. Hurwitz wanted an echocardiogram to see if Ms.

Jennings might have any structural abnormalities.

To obtain the echocardiogram, Ms. Jennings saw a pediatric cardiologist,

Elliott Weinhouse, on May 17, 2013. Dr. Weinhouse recounts that Ms. Jennings

was a “very precious, 12-year-old young lady,” who has a “recent onset of chest

pain with sports.” Exhibit 2 at 2; exhibit 25 at 34 (duplicate). Dr. Weinhouse

administered an echocardiogram, which detected a small antero-inferior pericardial

effusion. A “pericardial effusion” is the “accumulation of more than 50 mL of

pericardial fluid in the pericardium.” Dorland’s Illustrated Medical Dictionary 589

(32nd ed. 2012). After a follow-up examination a few days later, Dr. Weinhouse

opined that the pericardial infusion was a residual from a previous viral-like

illness. Exhibit 2 at 4. He recommended no vigorous sports or gym class until Ms.

Jennings was re-examined in a month.

Less than a month later, the family sought a second opinion regarding the

pericardial effusion with a different pediatric cardiologist, Daniel R. Turner.

Exhibit 3 at pdf 3-7. Dr. Turner’s report provides information about her

cardiopulmonary function as well as information directly relevant to Ms.

Jennings’s claim that the vaccination harmed her by causing her to develop

headaches. Ms. Jennings wanted a second opinion because she had upcoming

6 Dr. Hurwitz’s record is an example of the disorganization of medical records. His May

14, 2013 report appears in the set of records of Dr. Newcombe. However, the report of the

spirometry, a test to measure breathing, that Dr. Hurwitz administered is found in the high school

records. Exhibit 12 at 12. It appears that petitioner did not produce a set of records directly from

the West Bloomfield Asthma, Allergy, and Pediatric Pulmonology Center.

8

tryouts for a travel-league soccer team and wanted to know if exercise restrictions

were necessary. Id. at pdf 4.

With respect to Ms. Jennings’s breathing, Dr. Turner wrote that “Recently,

Danielle started a new indoor soccer league and both Danielle and her mother

noticed a marked difference in her exercise tolerance. . . . She sought medical

attention for this and was recommended an albuterol inhaler, but according to

Danielle it was tried and did not help.” Exhibit 3 at pdf 3-4. Dr. Turner

administered an electrocardiogram, echocardiogram, and exercise stress test. Id. at

pdf 5-6. Based upon these studies, Dr. Turner reached an impression that Ms.

Jennings had “Exercise-induced chest pain, noncardiac in nature, and likely related

to asthma with response to albuterol.” Id. at pdf 6. Dr. Turner referred Ms.

Jennings back to her pediatrician for management of her asthma.

In addition to this detailed assessment of Ms. Jennings’s cardiopulmonary

function, Dr. Turner conducted a review of systems. In this context, Dr. Turner

stated that Ms. Jennings “complains of headaches that occur every other day. They

occur in the frontal areas and occasionally will spread back to the parietal and

occipital areas in a band-like arrangement. . . . [S]he takes aspirin to treat the

problem.” Exhibit 3 at pdf 5. Dr. Turner’s report appears to be the first time a

doctor noted that Ms. Jennings was suffering headaches after the vaccination. Dr.

Turner did not record how long Ms. Jennings was having headaches.

Ms. Denise Jennings averred that her daughter collapsed during a soccer

game on or about June 8, 2013. Exhibit 7 at 1 (affidavit, sworn Oct. 3, 2016).

However, medical records do not corroborate this account. On October 29, 2013, a

pediatric neurologist, Iqbal Allarakhia, recorded a history that “About a year ago,

while playing soccer, [Ms. Jennings] collapsed on the field although she did not

lose responsiveness or awareness. She did not feel lightheaded or dizzy.” Exhibit

22 at 36. Dr. Allarakhia’s history is slightly supported by Dr. Turner’s June 5,

2013 report before the alleged collapse in which Dr. Turner stated “There was one

episode of near syncope when she [was] playing where she felt very dizzy. On that

day, she was not sure if she had hydrated appropriately.” Exhibit 3 at pdf 4. The

context of Dr. Turner’s report places this incident before 2013, possibly meaning

the fall 2012. Ms. Jennings’s expert, Dr. Santoro, does not cite this alleged

collapse in his medical history nor does he assert syncope as one of the symptoms

or injuries that Ms. Jennings suffered. Consequently, although Ms. Jennings may

have collapsed sometime during 2012, the assertion about collapsing during a

soccer game on or about June 8, 2013 is not credited.

9

Another reason for not accepting the assertion about a collapse on June 8,

2013, is that this incident is not memorialized in the well-child visit with Dr.

Newcombe on July 5, 2013, approximately one month later. See exhibit 25 at 4.

While the handwriting makes this report difficult to read, the doctor assessed Ms.

Jennings as a “well teen.” She also has “exercise induced asthma.” Id. Dr.

Newcombe recommended another dose of varicella and HPV. Id.; see also exhibit

1. This second dose, given on July 5, 2013, allegedly caused Ms. Jennings’s health

problems. See Pet’r’s Br. at 1, 38; footnote 5, above.

Once more, there are allegations that Ms. Jennings’s health declined after the

July 5, 2013 vaccination. E.g., exhibit 7 (Denise Jennings’s first affidavit) at 2;

exhibit 39 (Denise Jennings’s sixth affidavit). Some medical records provide this

history. Of this group, the earliest medical record was created by a holistic

practitioner on January 30, 2014. Exhibit 14 at 21. However, Ms. Jennings has

not submitted any medical records from later July or early August 2013, describing

any health problems.

Instead, the next medical record after the July 5, 2013 well-child visit is an

appointment with a pediatric pulmonologist, Lokesh Guglani, on August 27, 2013.

Exhibit 25 at 56. Dr. Guglani states that he is seeing Ms. Jennings and her older

sister, who provided a letter from their mother with a history, upon referral from

Dr. Turner, the cardiologist. Ms. Jennings reported having breathing difficulty

after 5-10 minutes of running during soccer games and requiring frequent

substitutions when she had been playing recently. After obtaining a history, which

is more-or-less consistent with the chronology above, and performing various tests,

Dr. Guglani opined that Ms. Jennings might be suffering from vocal cord

dysfunction, rather than exercise induced asthma. Id. at 59. He, accordingly,

recommended breathing exercises and a possible referral to a speech therapist. Id.

It appears that in January 2014, Denise Jennings created a chronology

stating that in early September 2013, her daughter’s “right hand was weak and she

had difficulty writing or grabbing anything with power.” Exhibit 14 at 26; accord

exhibit 7 (affidavit) at 4. However, in an October 29, 2013 medical record, a

doctor stated, “This patient and her mother have not noticed [a] change in

handwriting or clumsiness or any kind of subtle disequilibrium.” Exhibit 25 at 26.

The October 29, 2013 record is more reliable because it was created closer in time.

Ms. Jennings returned to her pediatrician on September 23, 2013. The chief

complaint was “chest pain x 1 night, pounding feeling, worse when walking,

headaches.” Additional details are provided in different handwriting: “HA

[headaches] 2-3x occurs while resting after CP [presumably chest pain] . . .

10

[positive] dizzy w/ HA, [no] abd. pain, pounding band-like HA; . . . ill 7 months

ago when CP began; . . . HA starts in occipital region.” Exhibit 25 at 3. Due to the

illegible handwriting, how Dr. Newcombe responded to the report of headaches is

not entirely clear. 7 She seems to have described Ms. Jennings as a “well looking

child.” Id.

An episode of chest pain while playing soccer prompted Ms. Jennings and

her family to seek treatment at the emergency department of the Detroit Medical

Center for the Children’s Hospital of Michigan on October 16, 2013. Exhibit 15 at

19-34. In one history, Ms. Jennings reported “‘shaking’ and ‘numbness’ of her

hands occasionally, when she has episodes of chest pain.” Id. at 27. None of the

reports from this emergency room visit suggest Ms. Jennings was having

headaches. Ms. Denise Jennings reported that her daughter had a URI in January

2013, and after which developed chest pain and difficulty breathing with exercise.

Id. One consulting physician–who might be a pulmonologist–stated, “I do think

some of her symptoms are related to vocal cord dysfunction and I encouraged her

to continue the relaxation exercises that were reviewed by Dr. Guglani and the

speech therapists.” Id. at 31. Tests, such as chest X-rays, electrocardiogram, and

pulmonology tests, were negative. See exhibit 14 at 26; exhibit 25 at 24.

After the visit to Children’s Hospital of Michigan, Ms. Jennings returned to

see Dr. Hurwitz, the pediatric pulmonologist. Ms. Jennings and her mother

informed Dr. Hurwitz that a doctor at the Children’s Hospital of Michigan

suggested that she might have vocal cord dysfunction. Thus, Dr. Hurwitz

requested records from the hospital so that he could evaluate the basis for that

suggestion. Dr. Hurwitz recorded that Ms. Jennings’s chief complaint was chest

pain with shortness of breath. Ms. Jennings also complained of “arm numbness

and [having] trouble opening jars with her right hand. This began several weeks

ago.” Exhibit 25 at 26. In addition to obtaining a release to acquire the records

from the hospital, Dr. Hurwitz prescribed a medication and anticipated seeing Ms.

Jennings about in one month.

7 Ms. Jennings’s retained expert, Dr. Santoro, stated that “The first manifestation of the

headaches post-vaccination was the report of September [2013]. Exhibit 25, p. 3.” Exhibit 27 at

4. However, Dr. Santoro appears to overlook Dr. Turner’s June 5, 2013 report that Ms. Jennings

was having headaches every other day. Exhibit 3 at pdf 5. Similarly, in an affidavit, Denise

Jennings averred that her daughter “began complaining of headaches within the first two weeks

after the vaccinations in July 2013.” Exhibit 39 ¶ 10. Ms. Jennings, too, seems to have missed

the report of headaches to Dr. Turner in June 2013.

11

Ms. Jennings went to her pediatrician on October 25, 2013. The chief

complaint was “R hand feels numb, headache.” Exhibit 25 at 2. Dr. Newcombe’s

notes, which remain difficult to read, indicate that Ms. Jennings is “lt [light]

sensitive” and has a “bad HA almost every day.” In reference to Ms. Jennings’s

recent trip to the Children’s Hospital of Michigan, Dr. Newcombe recorded that a

pulmonologist proposed vocal cord dysfunction, but the exercises were not

helping. Ms. Jennings also recounted that her “R hand feels numb from HA” and

she “can’t read handwriting.” It appears that Ms. Jennings was referred to a

neurologist and ordered an MRI. See exhibit 22 at 22 (results of MRI).

Before the appointment with the neurologist, Ms. Jennings saw a specialist

in allergies and immunology, Harvey Leo, on October 28, 2013. Exhibit 25 at 50. 8

Dr. Leo’s report begins with a statement that Ms. Jennings “has had a fairly

complex past medical history.” Exhibit 25 at 48. His report elaborates on this

topic in two respects. Dr. Leo recounts that Ms. Jennings “has been seen on

several occasions because of recurrent shortness of breath issues with exercise.

She has had a full cardiac workup and pulmonary workup by our pulmonology and

cardiology colleagues.” Id. Dr. Leo stated that “They [apparently Ms. Jennings

and her parents] also feel that symptoms worsened when the new dog . . . was

brought into the home in the past year.” Id.9 In addition, Dr. Leo noted that Ms.

Jennings “has currently been evaluated for migraine headaches” and that she plays

competitive soccer. Id.

Dr. Leo administered a skin prick test. The results showed “positive

reactivity to grasses predominantly.” Exhibit 25 at 49. Dr. Leo concluded that Ms.

Jennings “has evidence of allergic rhinitis, which is probably playing an overall

role in the possibility of asthma-like issues. We suspect she does have some true

asthma given her early birth history . . . . However, this may be confused with both

vocal cord dysfunction.” Id. Dr. Leo recommended different medications to help

when she had breathing difficulties.

8 Information about the date of this appointment is not consistent. While the last page

states that Dr. Leo digitally signed his report on September 17, 201 3, the appointment was on

October 28, 2013. Exhibit 25 at 50; see also exhibit 14 at 26.

Like the records from Dr. Hurwitz, reports from Dr. Leo appear in only the records of Dr.

Newcombe. It appears that petitioner did not file any records obtained directly from Dr. Leo’s

practice, Allergy & Immunology Associates of Ann Arbor, P.C.

9While Dr. Leo’s report does not specify when the Jennings took in a new dog, Denise

Jennings’s chronology states that this happened on March 9, 2013. Exhibit 14 at 24.

12

A pediatric neurologist, Iqbal Allarakhia, saw her on October 29, 2013. Dr.

Allarakhia’s record begins by stating that Ms. Jennings “two weeks ago had a

severe headache during which she developed numbness of the right hand and also

mild weakness of both hands, which lasted the whole day.” Exhibit 22 at 36. Dr.

Allarakhia provides details about Ms. Jennings’s headaches. The frequency of

severe headaches was “about once a month, usually in the morning.” Id. “The

headache starts in the occipital region, then develops like a band and involves the

frontal region, squeezing in nature, not pulsatile without nausea, vomiting.” Id.

“The headache intensity averages at about 8/10.” Id.

Dr. Allarakhia conducted an examination and reviewed the MRI, which Dr.

Newcombe had ordered. He assessed her as having “Complicated migraine with

numbness of the right hand.” Id. at 37. He recommended that she avoid migraine

triggers, such as insufficient fluid intake, skipping meals, stress, and insufficient

sleep. Because her headaches were not very frequent, Dr. Allarakhia did not

prescribe a prophylactic medication, but did prescribe Fioricet for when headaches

started. Id.

When Ms. Jennings, with her mother and father, returned to Dr.

Newcombe’s pediatric group on November 16, 2013, they saw Dr. Ada Kendall.

Exhibit 25 at 1. 10 Ms. Jennings or her parents were “very frustrated” by her lack of

progress. Her headaches were worse and causing concentration problems at

school.

Ms. Denise Jennings’s chronology and affidavit mentions one doctor for

which no records have been filed, Dr. Pittaway. Exhibit 14 at 26; exhibit 7 at 6.

On November 19, 2013, Dr. Pittaway tested Ms. Jennings’s digestive system and

recommended various supplements, which Ms. Jennings had not started to take.11

10 While Dr. Kendall’s full name does not appear in the medical records, Dr. Ada Kendall

is listed as one of the pediatricians in the same medical group as Dr. Newcombe, Providence

Park Pediatrics (https://healthcare.ascension.org/Locations/Michigan/MIDET/Novi-Ascension-

Medical-Group-Providence-Park-Pediatrics). Dr. Kendall also appears to have signed the

medical record for this visit. Exhibit 25 at 1.

11 Ms. Jennings appears to be referencing Dr. Kenneth Pittaway of the Institute of Natural

Health Sciences (http://www.institutenhs.com/). Dr. Pittaway is listed as having a N.D. (natural

doctor) degree and a Ph.D. (specialty not identified) but does not appear to have a M.D. (medical

doctor) degree. Ms. Jennings has not filed any records from the Institute of Natural Health

Sciences.

13

According to Denise Jennings’s chronology, Dr. Newcombe said “‘her brain

[was] misfiring and incorrectly signaling pain where none exists’” at a November

21, 2013 appointment. Exhibit 14 at 26. 12 Dr. Newcombe recommended seeing a

psychologist for consultation and treatment.

Around November or December, Ms. Jennings had “daydreams, tune outs,

and staring spells” that resolved by January 14, 2014. Exhibit 8 at 9. Around this

time, according to Denise Jennings’s chronology, her daughter’s teachers and

classmates noticed a change in her behavior and short-term memory loss. Exhibit

14 at 26. Ms. Denise Jennings wrote to her daughter’s teachers on December 17,

2013, that Danielle was making slow progress. Exhibit 24 at 7.

Ms. Jennings started hyperbaric oxygen therapy on December 13, 2013.

According to a patient information form, Ms. Denise Jennings learned about the

Oxford Hyperbaric Therapy Center from a “friend/relative” and the reason for

seeking treatment was “Gardasil Vaccination Poisoning.” Exhibit 9 at 6. This

notation appears to be the first instance Ms. Jennings, or a parent, linked Ms.

Jennings’s health problems with the vaccination. Ms. Jennings had 26 sessions of

hyperbaric oxygen, lasting until January 20, 2014. Id. at 5.

The connection to the vaccination is also mentioned in the next report from

the immunologist, Dr. Leo, on December 16, 2013. Ms. Jennings’s family “has

been very concerned about increasing episodes of memory loss, muscle weakness

and chest pain. . . . These symptoms have escalated and they are now concerned

about the amnesia and confusion as well as significant amount of sleep.” Exhibit

25 at 43. “The family was concerned if the Gardasil was the triggering factor for

these reactions. They would like to discuss the possibility of heavy metal testing

and other testing components of the Gardasil. We informed the parents that there

are no specific testing modalities at this time for the components of Gardasil aside

from limited skin prick testing, which would not answer the particular issues they

have.” Id.

Dr. Leo appears to have taken these complaints, “particularly the memory

loss issues and concerns about the vaccine” seriously. He suggested “several other

explanations that should be pursued first before we identify the vaccine as a major

cause.” One possibility was autoimmune disease and vasculitis. Therefore, Dr.

Leo ordered ANA profiles. Second, Dr. Leo wanted a sleep study to see whether

sleep issues could be contributing to fatigue and memory loss. Third, Dr. Leo

12The medical records for Dr. Newcombe’s medical group (exhibit 25) do not contain a

corresponding record for this appointment.

14

noted hypothyroidism was possible, although he doubted that problem because Ms.

Jennings’s weight had not changed. Fourth, Dr. Leo ordered tests to rule out

mononucleosis. Finally, Dr. Leo recommended formal neuropsychological testing

to document objectively any amnesia or memory loss. Exhibit 25 at 44.

A set of laboratory results from a blood draw on December 19, 2013, appear

as exhibit 6, pages 20-24. The ordering doctor was Cheryl A. Johnstone of the

Medical Clinic of Northville. In this context, there is no discussion of the

significance of any results.

The first appointment for Ms. Jennings in 2014 was at the Michigan Institute

for Neurological Disorders, where she saw John Manica, on January 14, 2014. Dr.

Manica addressed his letter to Dr. Johnstone.13 Dr. Manica obtained a history that

is generally consistent with the history recounted above. Ms. Jennings was

experiencing headaches daily that lasted all day. 14 Ms. Jennings further described

her headaches as “pressure-like” and sufficiently painful to “bring tears” and to

miss school one or two times per week. 15 Dr. Manica assessed her as

“experiencing adolescent migraine headaches. . . . Her neurological examination is

normal.” Exhibit 8 at 10. Dr. Manica instructed Ms. Jennings to keep a headache

journal and prescribed medication. He anticipated seeing Ms. Jennings again in

about one month.

Dr. Manica also ordered an MRI of Ms. Jennings’s brain and a routine

awake EEG with hyperventilation and photic stimulation. Both these tests were

normal. Exhibit 8 at 8, 13.

Ms. Jennings saw James Neuenschwander from the Bio Energy Medical

Center on January 30, 2014. Denise Jennings explained that they saw Dr.

13 Petitioner has not filed any records obtained directly from Dr. Johnstone’s office.

14Although Dr. Manica’s history states Ms. Jennings developed headaches since March

2013, the first report of headaches was Dr. Turner’s June 5, 2013 report.

15 The middle-school records for the 2013-2014 academic year show that Ms. Jennings

was absent from classes between 27 and 43 times per class. Denise Jennings’s affidavit provides

additional details about school absences. Exhibit 7 at 7-8. Nonetheless, all her grades were

either A’s or A minuses. Exhibit 24 at 3.

15

Neuenschwander because the family was having “difficulty getting a clear

diagnosis from providers.” Exhibit 39 ¶ 15.16

It appears that in advance of this appointment Ms. Jennings prepared a

detailed chronology to which this decision has cited. See exhibit 14 at 24-27.

Based upon this history and information communicated orally, Dr.

Neuenschwander assessed Ms. Jennings as suffering from reactive airway disease,

toxic encephalitis, allergies, and fatigue syndrome. Id. at 22. He recommended

various supplements. Id. at 23.

Following the January 30, 2014 appointment with Dr. Neuenschwander, it

appears that Ms. Jennings saw doctors much less frequently. For example, it

appears that Ms. Jennings did not have any appointments with her pediatrician, Dr.

Newcombe, after November 21, 2013. See exhibit 14 at 26.17 Similarly, Ms.

Jennings did not file any records showing treatment in 2014 with the immunologist

(Dr. Leo) or the pediatric pulmonologist (Dr. Hurwitz). A pediatric neurologist

was expecting to see Ms. Jennings, but was, on February 18, 2014, waiting for Ms.

Jennings to submit a headache questionnaire before scheduling an appointment.

Exhibit 6 at 18. Whether Ms. Jennings did not see doctors, or she did not file

records from doctors, such as Dr. Johnstone, whom she did see in this time, is

difficult to determine. In any event, the record shows that Ms. Jennings saw Dr.

Neuenschwander on March 31, 2014, and May 21, 2014. Exhibit 14 at 15, 18.

Around this time, Ms. Jennings also consulted with Mark Flannery, who is a

chiropractor in California. Dr. Flannery describes himself as having experience in

nutrition. On April 3, 2014, and May 8, 2013, Dr. Flannery ordered blood tests.

See exhibit 11 at 5-15. While Ms. Jennings filed these test results as part of Dr.

Flannery’s records, this exhibit contains no reports of office visits or evaluations.

However, on October 27, 2014, Dr. Flannery wrote a two-paragraph letter “To

Whom it May Concern,” which appears in Ms. Jennings’s high school records. Dr.

16 The Secretary filed a disciplinary complaint from the Michigan Department of

Licensing and Regulatory Affairs, Board of Medicine, alleging that Dr. Neuenschwander

improperly advised a patient regarding medical treatment. CM/ECF No. 133, attachment #1.

Dr. Neuenschwander later entered into a consent order admitting to one count of negligence or

failure to exercise due care and paid a punitive fine on May 20, 2015. (https://aca3.accela.com/

MILARA/GeneralProperty/LicenseeDetail.aspx?LicenseeNumber=4301050438&LicenseeType=

Medical%20Doctor).

17As noted above, the medical records for Dr. Newcombe’s pediatric group (exhibit 25)

do not contain a corresponding record for this appointment.

16

Flannery stated that Ms. Jennings “has been diagnosed with a reaction to the

Gardasil vaccine.” Exhibit 12 at 15.

Ms. Jennings saw a neurologist, Gireesh Velugubanti, on July 14, 2014.

Exhibit 6 at 28. 18 Dr. Velugubanti note begins that Ms. Jennings was well until the

first Gardasil vaccination on March 23, 2013 “when she developed difficulty in

breathing that again began shortly after the vaccination.” Exhibit 6 at 28. 19 Dr.

Velugubanti conducted a neurologic examination. His assessment included four

parts. First, to rule out a partial seizure disorder, he ordered long-term video

monitoring. Second, with respect to episodic memory loss, Dr. Velugubanti did

not detect any memory impairments in the working or declarative domain of

testing. Third, for headaches, Dr. Velugubanti recommended physical therapy.

Fourth, he wanted to rule out conversion disorder. He stated: “I have reviewed

side effects of Gardasil and did not identify any associations in the side effect

profile. Vaccine associated damage is being worked up through Bioenergy Dr.

Wine.” Id. at 32. 20

Ms. Jennings underwent a three-day EEG, beginning on August 1, 2014. Dr.

Velugubanti interpreted the EEG as “abnormal.” While the background was

normal, there were “occasional interictal diffuse spike and polyspike and wave

discharges throughout the recording.” Dr. Velugubanti suggested that Ms.

Jennings might suffer from “juvenile myoclonic epilepsy / primary generalized

primary epilepsy.” Exhibit 4 at 2. The next document from Dr. Velugubanti is a

“To Whom it May Concern” letter, dated January 28, 2015, which is nearly six

months later. While he states Ms. Jennings “has also been seen for multiple

medical appointments” regarding headaches and migraines, there are no reports

from any other appointment.

The neuropsychological evaluation recommended by Dr. Velugubanti was

performed on August 27, 2014, by Allison Myers, a psychologist, and Annette

Richard, an intern. Ms. Myers determined that Ms. Jennings’s performance on

memory was “variable and suspected to be impacted by suboptimal

18 Exhibit 6 is the set of records from the University of Michigan Health System. Dr.

Velugubanti’s July 14, 2014 report is a scanned or faxed copy. Records from the office of Dr.

Velugubanti, Michigan Neurology Associates PC, do not contain the July 14, 2014 report. See

exhibit 4.

19This report is not accurate. Dr. Newcombe recorded breathing problems on the day of

vaccination. Exhibit 25 at 5.

20 Dr. Neuenschwander’s organization is known as “Bio Energy.”

17

effort/disengagement.” Exhibit 5 at 5. Ms. Myers tied this performance to “a

discrepancy between self-reported symptoms and known patterns of brain function

as the patient reported frequent amnesia for recent events and sudden inability to

read, cognitive symptoms which are not consistent with epilepsy or other

neurological disorders.” Id. at 6. The diagnostic impressions were “unspecified

neurocognitive disorder” and “[rule out] conversion disorder.” Id. at 11.

Before Ms. Jennings had the neuropsychological evaluation, Ms. Jennings

saw another pediatric pulmonologist, Wan Chong Tsai, upon referral from Dr.

Newcombe. Exhibit 22 at 4-10.21 Dr. Tsai’s impressions included asthma, vocal

cord dysfunction, allergic rhinitis, and “possible Gardasil vaccine-related

neurologic adverse effect with report of new seizure onset under active evaluation

currently.” Id. at 9.

On two days in December 2014, Ms. Jennings underwent a second

neuropsychological evaluation at Dr. Velugubanti’s referral. Exhibit 12 at 16-25.

The evaluator was Angela K. DeBastos, a pediatric neuropsychologist. Id. at 25.22

Ms. DeBastos did not comment on Ms. Jennings’s effort or consistency of

responses. Ms. DeBastos found that the results of her testing are “consistent with a

cognitive disorder secondary to a history of non-convulsive seizure activity,

chronic headaches and fatigue, and possible mild traumatic brain injury.” Id. at 20.

At the end of 2014, Ms. Jennings was involved in a car accident, but this

accident does not affect her claim that a vaccine injured her. In 2015, Ms.

Jennings periodically saw Dr. Neuenschwander, but these appointments also are

not relevant. She may have seen Dr. Johnstone (see exhibit 6 at 48), but she did

not file any records from Dr. Johnstone.

In 2016, Ms. Jennings saw two doctors, whose reports have some relevance

to her claim. On April 29, 2016, she saw a doctor with a specialty in allergy and

immunology at the University of Michigan Health System, Alan P. Baptist. The

reason for the visit was “adverse reaction to HPV vaccine 3 years ago, this caused

immunology and allergy issues. She has seen many other doctor[s], allergists, and

The filed records from Dr. Newcombe do not contain any reports from visits shortly

21

before Ms. Jennings saw the pediatric pulmonologist.

22 Ms. DeBastos’s report is found in the school records and was a basis for aspects of the

section 504 plan. The school records do not contain the earlier neuropsychologic report from

Ms. Myers. Likewise, Ms. DeBastos does not mention the previous report from Ms. Myers.

18

Mom would like to try to find out how to fix the issues this has caused.” Exhibit 6

at 9.

Dr. Baptist’s history begins inaccurately. His report states: “Mother states

[Ms. Jennings] was doing well until the age of about 13. States that had no asthma,

and got HPV vaccine in 2013. Notes that in soccer about 2 months later was

having some breathing difficulties and was diagnosed w/ asthma. Also seemed to

develop headaches.” Id. at 10. This sequence of events is wrong because Dr.

Newcombe reported breathing problems on the day of the vaccination. See exhibit

25 at 6. Dr. Baptist also recounted that tests for allergies on multiple foods came

back positive. Exhibit 6 at 10. 23

Dr. Baptist’s history also states that Ms. Jennings “[h]as been diagnosed w/

chronic fatigue syndrome.” Id. at 10. This piece of information also appears

mistaken as the doctor who diagnosed Ms. Jennings with chronic fatigue syndrome

is not readily apparent. At best, Dr. Neuenschwander included a diagnostic code

for “other fatigue.” Exhibit 14 at 14.

For current problems, Dr. Baptist recorded that “all foods give problems –

fatigue, headache, abdominal pain.” Id. Ms. Jennings also has difficulty with

breathing, including shortness of breath. For the food allergies, Dr. Baptist

recommended a limited diet and then a food diary. Id. at 12. Dr. Baptist was

concerned that Ms. Jennings might suffer from chronic fatigue syndrome and he

recommended a pediatric rheumatologist.

For the family’s concern about the HPV vaccination, Dr. Baptist stated that

“he spent considerable time . . . going over the literature regarding the HPV

vaccine and autoimmune disease or neurologic disease. There are some studies

that do not seem to support any increased incidence of autoimmune disease nor of

neurologic disease after the vaccine.” Id.24 “It is difficult for me to assess whether

it truly was the vaccination or a coincidence that the symptoms occurred. There

unfortunately is no clear way to determine this other than giving the vaccine

[again] which of course the family is understandably reluctant to do.” Id. Dr.

Baptist concluded his letter to Dr. Johnstone by saying that he would see Ms.

23 Dr. Neuenschwander ran a comprehensive food panel on January 5, 2016. Exhibit 14

at 2.

24 Denise Jennings has challenged the accuracy of Dr. Baptist’s assertion that he reviewed

literature about adverse effects of the HPV vaccine. Exhibit 20.

19

Jennings again on as-needed basis. Dr. Baptist also referred Ms. Jennings to a

pediatric rheumatologist for treatment of possible chronic fatigue syndrome.

The second relevant record from 2016 was the record from a pediatric

rheumatologist, Mark Hoeltzel. Dr. Hoeltzel came to the impression that Ms.

Jennings suffers “numerous symptomatic complaints that do not fit well into a

recognized pattern of rheumatologic disease. However, given the fact that no

alternate etiology has been discovered, I think it is reasonable to perform [a]

preliminary screen for underlying autoimmune disease.” Exhibit 18 at 10.

Although Dr. Hoeltzel ordered laboratory testing, he planned not to see Ms.

Jennings again because she did not have an underlying autoimmune disease.

The foregoing records were available to the doctors the parties retained, Drs.

Santoro and MacGinnitie, when they wrote their reports. When the parties were

instructed to file briefs regarding entitlement, Ms. Jennings was also ordered to file

updated medical records. Order, issued Nov. 12, 2019.

In response, Ms. Jennings filed a single set of medical records, which were

from Edward Conley of the Fatigue and Fibromyalgia Clinic. The records contain

results of blood tests and Dr. Conley’s report of a visit on August 29, 2019.

Exhibit 53. 25 Dr. Conley’s assessment was: “Chronic Fatigue [rule out] CFIDS.

History of positive CMV? HHV6? Migraines. Asthma under treatment.

Cognitive dysfunction. History of Seizures. Multiple other diagnoses.” Id. at 9.

In Dr. Conley’s view, Ms. Jennings “had a neurological reaction to the Gardasil

vaccine causing weakness/seizures.” Dr. Conley recommended a series of

supplements. He also noted that Ms. Jennings was leaving for an unspecified

college in New York in 48 hours. Id.

Standards for Finding Entitlement

A petitioner is required to establish her case by a preponderance of the

evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence

standard requires a “trier of fact to believe that the existence of a fact is more

probable than its nonexistence before [he] may find in favor of the party who has

the burden to persuade the judge of the fact's existence.” Moberly v. Sec'y of

Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations

omitted). Proof of medical certainty is not required. Bunting v. Sec'y of Health &

Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).

25 Ms. Jennings did not file any records for 2017 or 2018.

20

Distinguishing between “preponderant evidence” and “medical certainty” is

important because a special master should not impose an evidentiary burden that is

too high. Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367, 1379-80

(Fed. Cir. 2009) (reversing special master's decision that petitioners were not

entitled to compensation); see also Lampe v. Sec'y of Health & Human Servs., 219

F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec'y of Health & Human Servs., 9 F.3d

958, 961 (Fed. Cir. 1993) (disagreeing with dissenting judge's contention that the

special master confused preponderance of the evidence with medical certainty).

An element of a petitioner’s case is to establish that the vaccinee suffered “at

least one defined and recognized injury” and “not merely a symptom of

manifestation of an unknown injury.” Lombardi v. Sec’y of Health & Human

Servs., 656 F.3d 1343, 1353 (Fed. Cir. 2011). An allegation that the vaccinee had

“dysethesia” or an “idiosyncratic severe reaction” does not satisfy this requirement.

Lasnetski v. Sec’y of Health & Human Servs., 128 Fed. Cl. 242, 263 (2016)

(denying motion for review), aff’d, 696 F. App’x 497 (Fed. Cir. 2017).

Analysis

Here, Ms. Jennings has put forward multiple problems that the HPV vaccine

allegedly caused. These problems can be grouped into two categories. For most

conditions, Ms. Jennings has not satisfied the requirement to demonstrate that she

suffers from a defined injury as explained in section A below. Thus, she cannot

receive compensation for any of them. The remaining category consists of the one

condition, breathing trouble, that she did suffer. While sufficient evidence

establishes she suffered from some respiratory ailment, her breathing problems

existed before the vaccination. See section B below. Finally, section C explains

why a ruling on the papers is appropriate and a hearing is not necessary.

A. Conditions Not Established

The issue of diagnosis has run throughout this case. The Instructions to

Experts particularly directed any expert to discuss the appropriate diagnosis by

including, among other points, the diagnostic criteria for any disease that the expert

proposes. Order, issued Aug. 2, 2017, ¶ 4. Dr. Santoro was required to prepare a

supplemental report because his first report did not present a diagnosis. Order,

issued June 25, 2018; see also exhibit 26 (Dr. Santoro’s first report). Once the

experts presented their opinions, the order for briefs in advance of adjudication

again raised this issue. Order, issued Nov. 12, 2019, at 5. Ms. Jennings’s brief did

not address the topic of diagnosis in a separate section of her brief, making

21

identification of the injury that she alleges a vaccination caused more difficult. See

Vaccine Rule 8(f) (waiver of arguments not specifically raised)

In one respect, the simplest point came from Dr. Santoro. He stated Ms.

Jennings’s “constellation of symptoms cannot be given a definitive disease

diagnosis.” Exhibit 41 at 1. This statement reflects the struggles of Ms. Jennings’s

treating doctors to identify the problem or problem from which she suffers. Ms.

Jennings alleged numerous symptoms in the amended petition: exercise

intolerance, asthma, hand numbness, headaches, handwriting difficulties, visual

comprehension difficulties, reading difficulties, memory impairments, neurological

impairments. Of those conditions, Dr. Santoro found support for headaches,

reactive airway disease, fatigue/chronic fatigue syndrome, non-convulsive

epilepsy, digestive disease, and cognitive/memory issues. Exhibit 27 at 2-8. On

the other hand, Dr. Santoro took no position on toxic encephalitis and did not posit

that petitioner suffered systemic inflammatory response syndrome. Id. at 5. Ms.

Jennings brief seemingly narrows the list of relevant diseases to (1) asthma /

allergic reaction, (2) chronic fatigue syndrome, and (3) gastrointestinal disease.

Pet’r’s Br. at 25-37 (discussing these conditions in the context of prong 2 of

Althen). These conditions are considered in turn.

Asthma / allergic reaction. Ms. Jennings suffered problems with breathing.26

Thus, resolution of this condition is deferred to section B below.

While Ms. Jennings links asthma to an allergic reaction, the claim that she

suffered an allergic reaction stands on much shakier ground. She argues that she is

allergic to a yeast component in the HPV vaccine and developed food allergies,

particularly to gluten. Pet’r’s Br. at 23-24. The brief cites no medical records to

support these arguments. Dr. Santoro’s August 21, 2018 report does not mention

“yeast,” and bases an opinion about food allergies on the affidavit from Denise

Jennings. See exhibit 27 at 6. Dr. Santoro’s June 4, 2019 report asserts that Ms.

Jennings “developed an adverse reaction to yeast proteins after the July 2013

vaccination,” exhibit 40 at 3, but provides no citation for this assertion. This report

26 Even for her breathing problems, the treating doctors appear not to have settled on a

specific diagnosis for Ms. Jennings. Her pediatrician, Dr. Newcombe, diagnosed her as having

“exercise induced asthma” on March 23, 2013. Exhibit 25 at 5. But after some attempts to treat

asthma did not succeed, a pediatric pulmonologist, Dr. Guglani, suggested that Ms. Jennings

might suffer from vocal cord dysfunction. Id. at 59. Dr. Leo noted that these conditions are

often confused. Id. at 49. Dr. Neuenschwander assessed Ms. Jennings as suffering from reactive

airway disease. Exhibit 14 at 22.

22

does not mention allergies. Finally, Dr. Santoro’s August 3, 2019 report discusses

neither yeast nor allergies. See exhibit 41.

In contrast, Dr. MacGinnitie has opined that Ms. Jennings has not

demonstrated that she suffered from food allergies. Exhibit A at 9. Dr.

MacGinnitie, who has specific expertise in allergy (see, exhibit B (curriculum

vitae)), discounted any findings made by Dr. Neuenschwander. Although the

testing from Dr. Neuenschwander could offer some superficial support that Ms.

Jennings is allergic to certain foods, any such minimal support is so tenuous that

neither Dr. Santoro nor Ms. Jennings has relied upon it.

Consequently, Ms. Jennings has not established, by preponderant evidence,

that she suffers from food allergies.

Chronic fatigue syndrome. In her brief, Ms. Jennings maintains that she was

diagnosed with chronic fatigue syndrome. However, these arguments are

erroneous.

Ms. Jennings presents arguments about chronic fatigue syndrome in two

places. First, she asserts she “has been diagnosed with Chronic Fatigue Syndrome

after the 2013 vaccination. Exh. 22, p. 5. The onset was shortly after the second

dosage.” Pet’r’s Br. at 24. This record does not support the proposition for which

it is cited.

Page 5 of exhibit 22 is part of a seven-page report from Wan Chong Tsai, a

pediatric pulmonologist, written on August 14, 2014. Page 5 contains no

discussion of fatigue. However, on page 6, Dr. Tsai recounts that Ms. Jennings

“denies any cough, wheezing, fatigue . . .” Exhibit 22 at 6. Consistent with Ms.

Jennings’s denial of fatigue, Dr. Tsai did not list chronic fatigue or anything like

chronic fatigue among his impressions. See id. at 9. Thus, the first basis for the

diagnosis of chronic fatigue syndrome does not sustain the argument.

Second, Ms. Jennings states she “did receive a diagnosis of chronic fatigue

syndrome at the University of Michigan.” Pet’r’s Br. at 30, citing exhibit 6 at 11;

accord exhibit 40 (Dr. Santoro’s report) at 3; Pet’r’s Br. at 9. This citation has

some basis as Dr. Baptist was informed in 2016 as part of Ms. Jennings’s history

that Ms. Jennings “[h]as been diagnosed w/ chronic fatigue syndrome” and

concluded that her “symptoms seem most consistent with chronic fatigue

syndrome.” Exhibit 6 at 10, 12.

However, crediting Dr. Baptist’s conclusion is not possible. Preliminarily,

the doctor who originally diagnosed Ms. Jennings as suffering from chronic fatigue

23

syndrome is not clear from Dr. Baptist’s record or Ms. Jennings’s brief. It seems

that Dr. Baptist may have carried forward a diagnosis without much analysis.

More significantly, Ms. Jennings did not complain about fatigue in many

appointments after the vaccination. See exhibit 27 (Dr. Santoro’s report) at 5

(describing instances in which Ms. Jennings did not complain of fatigue). Instead,

she complained that her breathing problems were interfering with her attempts to

compete in travel-level soccer. E.g., exhibit 25 at 61 (Dr. Hurwitz on May 14,

2013: Ms. Jennings “has experienced pressure sensation on the chest and

lightheadedness and almost near syncope after 10 minutes of hard running”);

exhibit 25 at 26 (reporting, at August 27, 2013 appointment, chest symptoms in

soccer practices and games after running); exhibit 15 at 19-34 (emergency room

visit on October 16, 2013 for collapsing while playing soccer); id. at 48 (Ms.

Jennings reporting at October 28, 2013 appointment that she plays competitive

soccer). Playing soccer is inconsistent with the fatigue associated with chronic

fatigue syndrome. See McCabe v. Sec’y of Health & Human Servs., No. 13-570V,

2018 WL 3029175, at *37-42 (Fed. Cl. Spec. Mstr. May 17, 2018) (discussing

diagnostic criteria for chronic fatigue syndrome).

Accordingly, Ms. Jennings has not demonstrated, by a preponderance of

evidence, that she suffers from chronic fatigue syndrome.

Gastrointestinal Disease. Compared with the allegations that Ms. Jennings

suffered allergies or chronic fatigue syndrome, her claim that she suffered from

gastrointestinal disease is even less developed. In the context of her Althen prong

1 argument concerning molecular mimicry, Ms. Jennings argues she “continues to

suffer gastric problems that developed after the second dosage.” Pet’r’s Br. at 25.

However, Ms. Jennings provided no citation to this assertion. Later, in the section

on Althen prong 2, Ms. Jennings adds more argument about molecular mimicry.

Id. at 33-37. Within this extended section, the only portion even loosely

suggesting Ms. Jennings suffered from gastrointestinal problems is on page 35.

There, Ms. Jennings asserts that she “also has developed gastrointestinal problems

post-July 2013 vaccination. These problems first developed within four weeks after

vaccination of July 2013.” Again, the absence of any citation to a medical record

is noticeable.

Dr. Santoro provides minimal support. In his August 21, 2018 report, Dr.

Santoro states that Ms. Jennings has gastrointestinal problems based upon food

allergies. Exhibit 27 at 6. The basis for this statement is Denise Jennings’s

affidavit, exhibit 7. Dr. Santoro’s June 4, 2019 report asserts that Ms. Jennings

“further developed gastrointestinal problems post-July 2013 vaccination. These

problems first developed within four weeks after vaccination of July 2013,” exhibit

24

40 at 3, but provides no citation for this assertion. Finally, Dr. Santoro’s August 3,

2019 report provides no information that Ms. Jennings suffered from

gastrointestinal problems. See exhibit 41.

Ms. Jennings has not identified any treating doctors who diagnosed her with

any gastrointestinal disease. It appears that none of the doctors who treated Ms.

Jennings referred her to a gastroenterologist and there are no records from a

gastroenterologist who treated her. To the extent that Dr. Santoro has reached this

diagnosis independently, Dr. Santoro seems to rely solely upon the affidavit of

Denise Jennings, which is not a reliable basis for a diagnosis. Thus, Ms. Jennings

has not established by preponderant evidence that she suffers from a

gastrointestinal disease.

In sum, Ms. Jennings has not established that she suffered from allergies,

chronic fatigue syndrome, or gastrointestinal disease. Absent this predicate, a full

Althen analysis is not required. Hibbard v. Sec’y of Health and Human Servs., 698

F.3d 1355, 1365 (Fed. Cir. 2012).

B. Breathing Difficulties

Ms. Jennings argues that she developed asthma and breathing problems after

the first HPV vaccination in March 2013. She bases this argument upon her

mother’s affidavit, exhibit 7. Pet’r’s Br. at 24, 26. As noted several times

throughout the section summarizing Ms. Jennings’s medical records, this

chronology is not factually correct. Ms. Jennings had breathing problems when

she came to Dr. Newcombe’s office for the appointment in which she was given

the first HPV vaccination. Exhibit 25 at 5. Thus, Ms. Jennings cannot prevail on a

theory that the HPV vaccination caused her breathing difficulties. See Locane v.

Sec'y of Health & Human Servs., 685 F.3d 1375, 1380-81 (Fed. Cir. 2012). 27

Ms. Jennings claim regarding breathing difficulties is being resolved based

upon the pre-existing nature of those problems as Ms. Jennings has not claimed

significant aggravation. In doing so, the undersigned is not determining how the

evidence preponderates for other elements, including the role of any factors other

27 Conceivably, Ms. Jennings could have argued that the second HPV vaccination

aggravated a pre-existing condition. However, although Denise Jennings states that her

daughter’s breathing problems were worse after the July 2013 HPV vaccination, Dr. Santoro has

failed to present a minimally persuasive opinion regarding significant aggravation. See Wittner

v. Sec’y of Health & Human Servs., 43 Fed. Cl. 199, 209 (1999) (“general statements that new

symptoms appeared or became more severe ‘following’ each immunization are too vague to

show on-Table onset or significant aggravation”).

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than a vaccine in causing her breathing difficulties. However, a preliminary view

is that a factor other than a vaccine could explain Ms. Jennings’s respiratory

problems. Ms. Jennings first sought treatment for breathing problems from Dr.

Newcombe approximately two weeks after the family brought a new dog into their

home. See exhibit 25 at 48 (Dr. Leo’s October 28, 2013 report). Dr. MacGinnitie

suggested an allergy to dogs was a better explanation for Ms. Jennings’s breathing

problems. Exhibit A at 5-6. If this opinion were credited, then a factor unrelated

to the vaccination would have caused her breathing problems.

C. Resolution on the Papers is Appropriate

The undersigned has reviewed the entire record.28 Ms. Jennings retained Dr.

Santoro, who presented opinions that Ms. Jennings suffered from various

conditions for which there was little, if any, support in the contemporaneously

created medical records. Instead, Dr. Santoro seems to have accepted the accuracy

of an affidavit created years later. When there is a disparity between information

in contemporaneously created medical records and affidavits, a special master is

not required to hold a hearing to receive testimony from an expert. Burns v. Sec’y

of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993).

Conclusion

Ms. Jennings has not established that she is entitled to compensation. The

Clerk’s Office is directed to enter judgment in accord with this decision unless a

motion for review is filed.

IT IS SO ORDERED.

s/Christian J. Moran

Christian J. Moran

Special Master

28While the collection of medical records appears to contain gaps in that Ms. Jennings

seems to not have filed records from the offices of all doctors who treated her, such as Dr.

Hurwitz, Dr. Leo, Dr. Pittaway, and Dr. Johnstone, the record is sufficient to evaluate her claim

for compensation.

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