Lasnetski v. Secretary of Health and Human Services

In the United States Court of Federal Claims

No. 14-580V

Filed: September 9, 2016

Reissued for Publication: October 5, 20161

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

HOLLY LASNETSKI, *

*

Petitioner, *

* National Vaccine Injury Act; HPV

v.

* Vaccine; Defined and Recognized

SECRETARY OF HEALTH * Injury; Application of Althen Test.

AND HUMAN SERVICES, *

*

Respondent. *

*

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

Randall Knutson, Knutson Casey Law Firm, Mankato, MN, for Petitioner. With him was

Peter Hemberger, Knutson Casey Law Firm.

Debra A. Filteau Begley, Trial Attorney, Torts Branch, Civil Division, United States

Department of Justice, Washington, D.C., for Respondent. With her was Benjamin

Mizer, Principal Deputy Assistant Attorney General, Rupa Bhattacharyya, Director,

Torts Branch, Civil Division, Catharine Reeves, Acting Deputy Director, Torts Branch,

Civil Division, and Gabrielle Fielding, Assistant Director, Torts Branch, Civil Division.

OPINION

HORN, J.

On July 9, 2014, Petitioner Holly Lasnetski filed a petition for compensation

under the National Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (2012) (the

Vaccine Act). Special Master Lisa D. Hamilton-Fieldman of the United States Court of

Federal Claims dismissed the petition for failure to state a claim upon which relief can

be granted and denied compensation in a decision issued on April 29, 2016. See

Lasnetski v. Sec’y Health & Human Servs., No. 14-580V, slip op. at 6 (Fed. Cl. Spec.

Mstr. April 29, 2016). Following the decision, on May 26, 2016, Petitioner filed a timely

Motion for Review of the Special Master’s decision pursuant to Rule 23 of the Rules of

1 This opinion was issued under seal on September 9, 2016. The parties did not

propose redactions to the September 9, 2016 opinion, and, thus, the court issues the

opinion for public distribution.

1

the United States Court of Federal Claims (RCFC), Appendix B (2016). This case

comes to the court upon that motion.

FINDINGS OF FACT

Holly Lasnetski was born on November 30, 1986. She claimed in her petition that

she was “a healthy adult female prior to receiving the Gardasil (HPV) vaccination,[2] with

the exception of the following conditions: neck sprain, migraine headaches, depression

and sinusitis.” She alleged that she subsequently

suffered sensory nervous system problems and sensory dysesthesia, as

well as typical symptoms associated with sensory dysesthesia, including

fatigue, fever, nausea, vomiting, constipation, heartburn, reflux, abdominal

pain and cramping, urine frequency issues, rash, memory impairment,

muscle weakness, alteration in menstrual pattern, ataxia[3], flushing, chills

and fever, and aggravated back problems; all caused-in-fact by the

Gardasil (HPV) vaccination administered on July 18, 2011.

In making her determination, Special Master Hamilton-Fieldman examined the

administrative record, including Ms. Lasnetski’s relevant medical history, both prior to

receiving the Gardasil vaccine and subsequent thereto. According to the Special

Master:

In 2008, Petitioner sought treatment for a history of headaches, tingling in

her left arm, and anxiety. In 2009, she again sought treatment for

headaches; numbness in her face, throat, arms, and hands; and anxiety-

related shortness of breath. In early 2011, she sought treatment for a viral

illness, as well as a cough, a sore throat, a fever, headaches, and

dizziness.

Lasnetski v. Sec’y Health & Human Servs., slip op. at 6 (citations omitted).

The record before the Special Master and the court demonstrates that,

throughout the pre-Gardasil-vaccine period, Ms. Lasnetski sought medical treatment for

various symptoms and illnesses and received a variety of diagnoses from various health

care professionals. In 2008, at a visit to a chiropractor, Dr. D.L. Duininck, in Willmar,

Minnesota, in which Petitioner mentioned symptoms of headache and tingling in her left

arm, she was diagnosed with a “[h]eadache of cervical origin.” In 2008, Dr. Raymond

2 “Gardasil is a vaccine that immunizes against four strands of human papillomavirus

(‘HPV’). The vaccine, administered in three doses, contains virus-like particles created

from an HPV protein, as well as an adjuvant, which assists in generating a robust

immune response to promote long-term immunity.” Koehn v. Sec’y of Health & Human

Servs., 773 F.3d 1239, 1241 (Fed. Cir. 2014).

3Ataxia is defined as: “failure of muscular coordination; irregularity of muscular action.”

Dorland’s Illustrated Medical Dictionary 170 (32nd ed. 2012).

2

Mellema, at an urgent care facility in Willmar, Minnesota, “advised Holly that she

probably belongs at the Crisis Center” for treatment of anxiety and insomnia. In April

2009, she was “diagnosed with aphthous ulcers[4] and was told it was the herpes virus”

by Dr. Kristin Wegner in Willmar, Minnesota. Again, in June 2009, she complained of “a

cold on and off” and was diagnosed by Dr. Steve Meister in Willmar, Minnesota with an

“[u]pper respiratory infection.” In July 2009, Ms. Lasnetski “thought she had a

miscarriage”; she was “worn down and tired,” and Dr. Michael Nicklawsky, in Willmar,

Minnesota, diagnosed sinusitis, depression and migraine headaches. At the end of July

2009, while starting and stopping the medications Topamax, Citalopram and Augmetin,

Ms. Lasnetski suddenly felt numb all over her body, had shortness of breath, and felt as

if she was going to have a panic attack. Dr. Wegner thought the numbness was

“probably secondary to anxiety or panic,” although, he added, it could have been a

reaction to starting and stopping medication. In February 2011, Petitioner presented at

an urgent care facility, in Willmar, Minnesota, “with urinary frequency and burning.” She

also complained of back pain. Dr. Mellema assessed a “[p]robable UTI.” On April 3,

2011, Dr. Mellema, in Willmar, Minnesota recorded a diagnosis of “[c]hronic rhinitis”

after noting:

She gives a history of having been ill a lot this winter and seems to be

describing more of [a] progression of viral illnesses rather than one

specific thing. . . . She has been on antibiotics multiple times without

benefit and this has been through other clinics. . . . [S]he thinks there is

some mold in her current living environment.

As noted above, the vaccine at issue was administered on July 18, 2011. On the

date of the vaccine, Ms. Lasnetski was seen by her primary care doctor at the St. Cloud

Medical Group in St. Cloud, Minnesota for “an annual preventive health examination.” At

this appointment, Lasnetski reported “new health concerns [of] sore throat, chronic

cough.” Additionally, she was diagnosed by the treating physician, Dr. Sara Jorgenson,

with genital warts. Petitioner had previously tested positive for HPV, and the doctor

recommended the Gardasil vaccination. Initially, Ms. Lasnetski declined the vaccine.

Following a discussion with Ms. Lasnetski about the risks and benefits of Gardasil, a

Human Papillomavirus (HPV) vaccine, Dr. Jorgenson administered the vaccine to Ms.

Lasnetski.

There are discrepancies both in Ms. Lasnetski’s filings in the present case and

elsewhere in the record as to when Ms. Lasnetski began suffering the symptoms she

alleges were caused by the July 18, 2011 vaccine. Ms. Lasnetski’s July 9, 2014 petition

for compensation and her May 26, 2016 motion for review present different

symptomatology. The petition reads: “Petitioner began to develop . . . pain . . . within a

few days after receiving the Gardasil (HPV) vaccination.” The motion to review,

however, reads: “Petitioner reported problems the day after receiving the Gardasil

vaccination. . . . Petitioner developed acute complications including but not limited to

4 Aphthous ulcer is defined as “the ulcerative on the oral mucosa seen in recurrent

aphthous stomatitis.” Dorland’s Illustrated Medical Dictionary 1997.

3

low back pain, tingling into the legs, tingling in the face, neck pain, migraines,

constipation, increased urination, rash, hair loss and abdominal pain.” (citations

omitted). Review of the record before the court does not clarify the inconsistencies. Dr.

Melissa Ensign’s report dated Aug. 17, 2011, states: “She [Ms. Lasnetski] first noticed

symptoms a few hours after her gardasil [sic] injection on 7/28/11 with the tingling in her

L lower leg and then into her right leg.” The Special Master found, however, based on

the record before her that almost a year after the vaccination, “[p]etitioner reiterated her

symptoms [to the Mayo Clinic doctors on May 22-24, 2012], adding that almost all of

them appeared within a month after her vaccination.”

In her petition, Ms. Lasnetski alleges that the vaccine resulted in a wide array of

health effects, including:

sensory nervous system problems and sensory dysesthesia, as well as

typical symptoms associated with sensory dysesthesia, including fatigue,

fever, nausea, vomiting, constipation, heartburn, reflux, abdominal pain

and cramping, urine frequency issues, rash, memory impairment, muscle

weakness, alteration in menstrual pattern, ataxia, flushing, chills and fever,

and aggravated back problems.

Ms. Lasnetski’s list of ailments are referred to by Petitioner’s own medical expert, Dr.

James Dahlgren and by treating physician Dr. Michael Severson as a “constellation of

symptoms.”

On July 26, 2011, eight days after the vaccine was administered to Petitioner,

Ms. Lasnetski visited a health care professional for the first time after receiving the

vaccine. She complained to a chiropractor, Dr. Lacie Mockros, at the Minser

Chiropractic Clinic, in St. Cloud, Minnesota, that “[s]he has had a migraine headache for

the last 3 days.” She also complained of pain in her neck, shoulders and lower back and

tingling in the left leg. The chiropractor indicated in his report, “[s]he [Ms. Lasnetski] has

a history of a mild strain to her neck about a year ago that was treated by a chiropractor

and resolved. She has no other health problems.” On a visit two days later her

headache had improved, but she had been having a sharp pain in her lower back the

previous night at her job at a liquor store, where she had “to lift heavy cases of bottles.”

On August, 10, 2011, Petitioner went to the emergency trauma center at the St.

Cloud Hospital suspecting she was pregnant because of “passed tissue.” The

pregnancy test was negative, and she was diagnosed with vaginal bleeding and

cramping. Her primary care doctor, Dr. Sara Jorgensen, saw Ms. Lasnetski the next day

and noted that she had been “diagnosed with nothing.” This is also the first time in the

record that the Petitioner spoke of her symptoms in the context of the Gardasil injection:

“She states she has had a multitude of symptoms since her annual on 7/26/11. She

states she started to experience nausea and a stiff neck after her Gardasil injection.

She then developed a migraine that lasted for 4 days.”

One day later, on August 12, 2011, Dr. Gary Kolle, at the St. Cloud Medical

Group, heard a recitation of Ms. Lasnetski’s symptoms: lower back pain, headaches,

4

numbness, urinary frequency, and “pain radiat[ing] in[] both legs.” He wrote in his report,

“Holly Lasnetski has a history of back problems in the past. [Her] neck was stepped on

in a mosh pit last year.” He further postulated a diagnosis of: “1. Paresthesia[5] of the

leg; . . . 2. Headaches with paresthesias of the face; . . . 3. Urinary frequency; . . . 4.

GERD [Gastroesophageal Reflux Disease] symptoms.”

On August 14, 2011, Petitioner visited the emergency room at St. Cloud Hospital,

“[d]ue to the fact [that] she has had an increase in progressive numbness.” The treating

doctor, Dr. Michael Severson, ordered an MRI and MRA, both of which were negative,

and diagnosed “[p]aresthesias, left side, migraine headaches.” Dr. Severson

recommended Lasnetski follow up with a neurologist. He noted, “[i]t could be complex

migraines but there is some correlation with timing with the vaccination she had last

month, but no evidence for Guillain-Barré at this point, stroke syndrome, aneurysm or

subarachnoid hemorrhage.”

On August 22, 2011, Ms. Lasnetski visited with a neurologist, Dr. Iris Brossard.

Dr. Brossard took a medical history, which recounts, in part:

Patient has had migraines since about the age of 6th or 7th grade. There

is a significant history of migraines in her mother as well as other family

members.

The patient says the migraines have come and gone. She has also had

chronic pain and tingling in all of her body. She has what she calls “organ

pain” around her upper torso especially on the left. She will have tingling

that goes from her legs to her feet up to her arm, neck and chest. Her

migraines have been much worse over the last several weeks. She says,

however, they are getting better over the last few days. She seems to

have pain virtually everyplace [sic] and filled out quite a few symptoms on

her history list.

...

With the headaches patient sees spots in her vision, has tearing of the

eyes, experiences light, noise and odor sensitivity. She becomes

nauseated and fatigued. She may have numbness before, during or after

on the face, arm and leg, mainly on the left. She has difficulty

understanding people and feels as though she is going to faint.

Of note, the patient had a Gardasil shot to which she attributes these

headaches and the other forms of pain. This was done on July 26,

5 Paresthesia is “an abnormal touch sensation, such as burning, prickling, or

formication, often in the absence of an external stimulus.” Dorland’s Illustrated Medical

Dictionary 1383.

5

2011[6]. . . . She thinks she might have had a miscarriage, although her

pregnancy tests were negative.

...

Patient suffers from anxiety and depression. . . . She says she has a poor

immune system, getting frequent viruses, sinus infections and sore throat.

She has had heartburn and she thinks she has had carpal tunnel

syndrome.

Dr. Brossard subsequently conducted a series of neurological tests, including an

antinuclear antibodies (“ANA”) test7 that was negative, and diagnosed Ms. Lasnetski

“with many, many, many symptoms,” “likely due to chronic migraines, a possible

fibromyalgia syndrome with chronic muscle pain and depression and anxiety.” Dr.

Brossard noted that he “tried to reassure the patient and her mother that I did not think

these symptoms were from her vaccine as this is fairly unusual.”

The following day, Ms. Lasnetski came into the emergency room at St. Cloud

Hospital for “severe numbness, tingling and shortness of breath.” Dr. Brett Stolzenberg,

the attending physician, determined that the “etiology [was] unclear,” and stated, “I [Dr.

Stolzenberg] do not have a clear etiology for her symptoms.”

On September 30, 2011, Ms. Lasnetski met with a new primary care physician,

Dr. Sam Camp, in Willmar, Minnesota, for a second opinion. Ms. Lasnetski related to

Dr. Camp that she may have miscarried because of the injection, and, that her

menstrual cycle had been different since the injection. She also reported a rash,

abdominal pains, and canker sores in her mouth. Dr. Camp stated:

6 This is a different date from the one specified in the petition and found in all other

medical reports in the record, which state that Ms. Lasnetski received the vaccine on

July 18, 2011.

7 As the Special Master explained:

An ANA test reveals the level of antinuclear antibodies in the blood, which

are antibodies that attack the body’s own tissues. Mayo Clinic Staff, ANA

test: Definition, http://www.mayoclinic.org/tests-procedures/ana-

test/basics/definition/prc-20014566 (last visited April 25, 2016). Typically,

a ‘positive ANA test indicates that [one’s] immune system has launched a

misdirected attack on [one’s] own tissue—in other words, an autoimmune

reaction.

Lasnetski v. Sec’y Health & Human Servs., slip op. at 3 n. 4. Respondent’s expert Dr.

Thomas Leist also added: “A positive ANA with a titer of <1:40 can be observed in about

30% of the normal population and by itself, a positive ANA test does not indicate the

presence of an autoimmune disease.”

6

I am truly not sure what is the cause of these symptoms. . . . Potentially

she may need to be sent to an immunologist at Mayo or another research

center to determine whether the Gardasil vaccine has caused some type

of autoimmune disorder. I told Holly that I think this is unlikely, but I cannot

say that with 100% confidence. . . . So far, diagnostics and exam have

been normal. At what point is she willing to stop testing and seek other

modalities for treatment of her symptoms. [sic] At this time she is not

interested in this consideration.

On December 9, 2011, Ms. Lasnetski saw a rheumatologist, Dr. Robert Tierney.

In addition to her previous symptoms, abdominal pain, myalgias, fatigue and migraines,

she now indicated that she “had some itching and sores on the head.” Dr. Tierney noted

that the “[e]tiology of her symptoms is unclear.” Dr. Tierney performed a battery of tests,

including a test for lupus or connective tissue disease. All of these tests were

“completely normal.”

On January 28, 2012, Ms. Lasnetski again arrived in the emergency trauma

center complaining of “[c]ramping in the abdomen, left upper quadrant abdominal

pain . . . and blood and mucus in the stools” along with “ongoing problems with her GI

tract.” The report of the admitting physician, Dr. Mark E. Hoffman, noted that Ms.

Lasnetski had seen a neurologist and a rheumatologist and that “[g]iven the

constellation of other symptoms, apparently she had a positive ANA and a positive

rheumatoid factor[8], but they have not pinpointed a specific autoimmune disorder.” Dr.

Hoffman ultimately diagnosed Ms. Lasnetski with a “[c]onstellation of multiple

symptoms, not otherwise specified.”

On February 2, 2012, Dr. Camp saw Ms. Lasnetski for an ER follow up. Dr.

Camp noted that Ms. Lasnetski “and her family have been quite convinced that her

Gardasil vaccine has caused a systemic autoimmune type disorder resulting in

neuralgias, paresthesias, headaches, fatigue, and pain.” Dr. Camp summarized the

medical findings and diagnoses up to this point:

She has been referred to Neurology and Rheumatology and no clear

answer for her symptoms have been found. Fibromyalgia has been

diagnosed at one time. Vitamin D deficiency has been another diagnosis.

Otherwise autoimmune testing has been negative, as have general lab

studies and evaluations. This has been very frustrating to Holly and she is

quite certain that she has some systemic illness.

In his summary assessment from the visit, Dr. Camp stated:

8The origin of this rheumatoid result is unclear. Dr. Camp’s screening in the record

does not note such a result.

7

Multiple unexplained symptoms. There is one paper that suggests a

POTS[9] syndrome resulted due to the Gardasil vaccine. Certainly this can

be associated with a strange myriad of symptoms with profoundly negative

serological testing. The patient has been evaluated by Neurology and

Rheumatology without a definitive explanation of her symptoms. We will

see if the patient is open to being evaluated for POTS syndrome, although

this will likely need to be evaluated at Mayo. I am skeptical that this is the

underlying source of her symptoms, but certainly lack the ability to do the

appropriate evaluation here.

On a follow up visit with Dr. Camp, on March 28, 2012, he similarly recorded, “[s]he [Ms.

Lasnetski] is still fixated on her symptoms because of her immunization for HPV.” At his

next appointment with Ms. Lasnetski, on April 26, 2012, Dr. Camp confirmed Ms.

Lasnetski as pregnant.

At approximately eight weeks pregnant, on May 22, 2012, Ms. Lasnetski began a

full workup under a POTS framework upon Dr. Camp’s referral at the Mayo Clinic, in

Rochester, Minnesota. Her first consult at the Clinic was with a cardiovascular

specialist, Dr. Kari Carter. Dr. Carter delivered the following diagnoses: dizziness,

dyspnea, vision disturbances, paresthesias, positive ANA and positive RF, sleep-

disordered breathing, colon polyp, migraines, and pregnancy. The ANA and RF result,

at one time apparently both positive, are referenced by multiple doctors at the Mayo

Clinic. Dr. Carter noted:

Ms. Lasnetski states, and her medical records bear this out, that she had

a rheumatologic workup completed. An ANA titer was drawn, and this was

positive as was her RF. She saw a rheumatologist who according to Ms.

Lasnetski checked her for two muscle diseases as well as lupus, these

came back negative. She is still concerned that her ANA and RF are

positive, and she is unsure the implications that this may have.

After seeing Ms. Lasnetski, on May 24, 2012, Dr. R.D. Fealey summarized Ms.

Lasnetski’s history with the following comments:

The patient states she was relatively stable and well without most of her

current symptoms until she received the HPV vaccination during a time

when she had active lesions present apparently. The Gardasil shot within

days seemed to produce a variety of symptoms. . . . The patient has had

continued symptoms since that time. . . .

...

9 “[P]ostural orthostatic tachycardia syndrome ABBR: POTS. Inability to tolerate a

standing position as a result of a sudden increase in heart rate when rising from a

seated or recumbent position. It is thought to be one of the dysautonomic syndromes.”

Taber’s Cyclopedic Medical Dictionary 1879 (22nd ed. 2013).

8

The patient’s menstrual cycles changed. . . . The patient’s bladder seemed

to develop an irritation. . . . The paresthesias do not produce a deficit of

sensation, and although she reports arm weakness, this is much better

now. The patient has had a comprehensive POTS evaluation, and she, for

instance, did not have POTS criteria on the tilt in Neurology at ten

minutes. . . . The patient’s 24-hour Holter BP monitor showed some

spontaneous variation in heart rate some of which occurred when she

would first get up in the morning and some of that exceeded 30 beats per

minute. Again, however, this is a nonspecific finding, and I suspect relates

more to her moderately-severe deconditioning [from pregnancy].

The patient has a possible immuno-inflammatory tendency. Apparently

she has a positive ANA and rheumatoid factor. She does not really have a

well-defined connective tissue disease, however. Still, the input of

Rheumatology on some of her symptoms will be welcome especially on

some of her blood test abnormalities.

Autonomic testing showed no evidence of an underlying autonomic

neuropathy. We were able to review the photographs of the developing

sweat test particularly the areas where she has some tingling, and there

was no hint of any superficial sensory neuropathy affecting the smaller

sudomotor nerves.

Dr. Fealey’s report also noted that Ms. Lasnetski’s “neurological examination also

is normal including tests of sensation in the lower extremities. There was no weakness

appreciated and no postural tachycardia of significance nor any drops in blood pressure

going from supine to upright.” Dr. Fealey diagnosed Ms. Lasnetski with a “[s]ensory

dysesthesias following HPV vaccination.” (emphasis in original). He elaborated, “I

suspect this is a benign syndrome related to activation of her immune system at worst

perhaps some inflammatory neuritis that I would expect to eventually settle down and

which will likely not have significant implications as far as any permanent neuropathy.”

On May 25, 2012, Dr. C.J. Michet, Jr., a rheumatologist at the Mayo Clinic,

followed upon this diagnosis with the further explication of “[i]diosyncratic severe

reaction to vaccination,” while concluding, “I have reassured her [Ms. Lasnetski] that

the extensive testing done at Mayo reveals that she has not suffered any type of

permanent autonomic injury.” (emphasis in original). Moreover, he clarified, “We can be

reassured with no evidence of additional autoantibodies appearing.”

Following her visit to the Mayo Clinic on May 22, 2012, Ms. Lasnetski,

apparently, did not seek medical attention again until a May 10, 2013 appointment with

Dr. Camp. At this follow up with Dr. Camp, Ms. Lasnetski expressed frustration with the

medical outcomes and findings: “Holly has had strange vague symptoms from the time I

first met her. She has long felt that her symptoms are due to a Gardasil vaccination that

9

she received in her teens.[10] She has been sent to Rheumatology, Mayo, and

Cardiology.” In his report, Camp emphasized, “No obvious source of her symptoms has

been determined.” Dr. Camp returned to this conclusion later in his report, stating: “The

patient and her family has [sic] long felt that her symptoms in her late teens to her early

20s are a complication of the Gardasil vaccine. I have my skepticism. She has been

seen by several specialists and there is truly no confirmation.”

Ms. Lasnetski was evaluated by a disease specialist, Dr. Minces in Willmar,

Minnesota on May 22, 2013. Dr. Minces reported, “She [Lasnetski] is very frustrated

because she was never given a definitive diagnosis.” Dr. Minces found that his inquiry

was non-conclusive: “26-year-old female with multiple diffuse complaints. I do not find

any clinical evidence for infection, or concerns that prompt me to any particular tests.

She was extensively evaluated by rheumatology, and no diagnosis was found.” Dr.

Minces further indicated a “concern for somatization.”11 His opinion was that “there is no

evidence of infection, and from my standpoint, no evidence of rheumatological

condition. . . . She does fit the profile for somatization, given her multiple complaints,

anxiety, and depression, and the fact that she gets upset to hear that she may not have

a clear physical diagnosis.” His recommendation was to refer Lasnetski to “psychiatry

and therapy to optimize her treatment for depression, and anxiety, and also for

somatization.”

In 2014, Ms. Lasnetski visited the emergency room a number of times for viral

infections, C. difficile colitis secondary to Augmentin medication, upper respiratory tract

infection, migraines, and abdominal pain, the last one in the record before the court on

May 18, 2014.

Petitioner filed her petition for compensation on July 9, 2014. The Petition for

Compensation alleged that the sensory dysesthesias and the idiosyncratic severe

reaction Ms. Lasnetski experienced following July 18, 2011 were caused by the

Gardasil vaccine. Her petition further alleged that her current health problems were “all

caused-in-fact by the Gardasil (HPV) vaccination,” and that Petitioner “will require

substantial future medical care and monitoring.”

In response to the petition, respondent’s Vaccine Rule 4(c) Report filed October

7, 2014 argued that Petitioner “[did] not allege that she suffered a table injury” and,

moreover, she had not met her burden of proof for entitlement to compensation under

the Vaccine Act for an injury not on the Table. Respondent argued that for a non-Table

injury, Petitioner must prove by the preponderance of the evidence that her injury was

caused-in-fact by the vaccine. Respondent further argued that no compensation should

be awarded because 1) it was not clear what injury Petitioner claimed was caused by

10 The record indicates that the Petitioner received the vaccination when she was

twenty-four, not as a teenager.

11 Somatization is defined as “in psychiatry, the conversion of mental experiences or

states into bodily symptoms.” Dorland’s Illustrated Medical Dictionary 1734.

10

the HPV vaccination; and 2) that “there [was] no medical literature or scientific evidence

that the HPV vaccine can cause the injuries alleged by petitioner.”

In the proceedings before the Special Master, Petitioner produced Dr. James

Dahlgren, a toxicologist and internist, as her medical expert. Dr. Dahlgren interpreted

“the doctors at the Mayo Clinic [as having] diagnosed adverse vaccination reactions.”

Dr. Dahlgren stated, “[t]hey diagnosed Ms. Lasnetski with an adverse vaccination event

with ongoing illness since that event.” In support, he noted the frequency of her visits to

doctors and that “[h]er health status is obviously changed radically as a result of the

vaccination based upon the objective medical records.” In reviewing her medical history

he found a “constellation of sensory nervous system abnormalities.” He further

concluded, “[t]he positive ANA is an indication of an abnormal autoimmune occurrence.

The clinical and laboratory picture is compatible with adverse autoimmune reactions on

Ms. Lasnetski’s nervous system. In this case it is predominantly the sensory nervous

system that has been impacted by the deranged immune system.” In Dr. Dahlgren’s

view, Petitioner’s symptoms were consistent with an autoimmune illness, for which “[a]

large study of Gardasil® exposed women found an elevated occurrence of autoimmune

diseases.” Although he observed that a specific auto-immune disease had not been

identified, stating that “[t]he Mayo clinic doctors noted a positive ANA (anti-nuclear

antibody) titer but other serological tests did not provide a more specific auto-immune

diagnosis,” he ultimately concluded that “[t]here is no other causative factor in this

patient/subject to have developed these objective and subjective abnormalities.”

During the proceedings, Special Master Hamilton-Fieldman asked Petitioner to

submit a supplemental expert report, due May 19, 2015, after articulating “concerns with

the potential pre-existing condition(s), the rapid onset of symptoms, and the lack of a

definitive diagnosis.” Petitioner never submitted such a report. Instead, on the date the

supplemental report was due, May 19, 2015, Petitioner filed for judgment on the

administrative record.

On October 28, 2015, the government submitted an expert report by Dr. Thomas

Leist, a neuroimmunologist and biochemist. Dr. Leist professed skepticism that a

diagnosis of a condition or illness could be made by mere conversation and consultation

alone with a patient and remarked: “As did Dr. Fealey, Dr. Michet did not render a

diagnosis but merely lists petitioner’s claim of a ‘severe reaction to the vaccine’. Neither

physician appears to have reviewed records of practitioners involved in Petitioner’s case

following the vaccination with Gardasil. Neither physician recommended additional

testing to reach a diagnosis.” Dr. Leist’s opinion further advised that the labels of

“sensory dysesthesia” and “idiosyncratic severe reaction” did not amount to medical

diagnoses. Rather, Dr. Leist indicated “these statements are a description of the

symptoms Ms. Lasnetski described to her doctors.” Additionally, he stated “sensory

dysesthesia could be a symptom consistent with many different diagnoses, none of her

treating doctors actually assessed her with any of those conditions” and “an

‘idiosyncratic severe reaction,’ is not a diagnosis and is really another way of saying that

petitioner may have suffered a reaction.” Finally, he indicated “the onset of those

symptoms, within a day of the administration of the vaccine would be too soon for the

vaccine to be a plausible immunological cause of those symptoms.” Ultimately, Dr. Leist

11

questioned the nature of the adverse event and argued that the method and studies

used by Dr. Dahlgren were “not designed to evaluate causality” and “not related to the

alleged condition in petitioner’s case.”

In a decision dated April 29, 2016, the Special Master dismissed the petitioner’s

claim. See Lasnetski v. Sec’y Health & Human Servs., slip. op at 6-7. In her decision,

the Special Master reviewed the record and made a number of factual findings. The

Special Master noted that Ms. Lasnetski had travelled to the Mayo Clinic on May 22,

2012 and that, while at the Mayo Clinic, she was seen by Drs. Fealey and Michet. See

id. at 3-4. With regard to Dr. Fealey, the Special Master found:

The treating neurologist, Dr. Fealey, concluded that Petitioner had neither

autoimmune neuropathy nor POTS, but that she could have an “immuno-

flammatory tendency.” And even though she had a positive ANA test, she

did not have a “really well-defined connective tissue disease.” Although

Dr. Fealey indicated that her sensory dysesthesias “follow[ed]” the HPV

vaccination, he made no finding as to whether it was caused by the

vaccination.

Id. at 3 (citations omitted and brackets in original). With regard to Dr. Michet, the Special

Master found: “[T]he treating rheumatologist, Dr. Michet, asserted that Petitioner had an

‘idiosyncratic severe reaction to vaccination,’ and thus, ‘it would probably be prudent in

the future’ for her to be ‘cautious about any further vaccinations.’” Id. at 3-4 (citation

omitted). The Special Master also summarized the findings in the reports of the

Petitioner’s and defendant’s experts, Drs. Dahlgren and Leist, respectively. See id. at 4-

6. The Special Master’s summary of the conclusions of Dr. Dahlgren included:

1. The subject, Ms. Lasnetski, developed an adverse and persisting illness

in the proper time frame after the vaccination to qualify for it being

recognized as consistent with the temporality requirement of a vaccine

injury.

2. The illness she developed is consistent with the known illnesses

cause[d] by vaccine adverse illness.

3. There is no other causative factor in this patient/subject to have

developed these objective and subjective abnormalities.

4. There are human and animal studies that illuminate the mechanism that

explains this young woman’s current state of poor health.

Id. at 5 (footnote omitted). With regard to the report of Dr. Leist, the Special Master

found:

Addressing the claimed “diagnoses” of “sensory dysesthesia” and

“idiosyncratic severe reaction to vaccination” Dr. Leist opined that these

are not diagnoses at all, but mere descriptions of her symptoms.

Moreover, he noted that Dr. Dahlgren and Petitioner’s doctors at the Mayo

12

Clinic reached these “diagnoses” seemingly without consulting Petitioner’s

medical history. As to Dr. Dahlgren’s expert report, Dr. Leist explained that

the data underlying the report suffers from limitations including

“underreporting, selective reporting, lack of a control group, inadequate

denominator data to calculate event rates, and diagnostic uncertainty of

events”; Dr. Leist also emphasized that Dr. Dahlgren “cites articles that

are not related to the alleged condition in [P]etitioner’s case.” Ultimately,

Dr. Leist argued that one could not say that the vaccine caused

Petitioner’s condition because (1) Petitioner had not actually received a

diagnosis; (2) Petitioner’s symptoms occurred too rapidly after the

vaccination to be causally linked to the vaccination; and (3) Dr. Dahlgren’s

expert report cited flawed data, referenced studies of autoimmune

conditions that Petitioner does not have, and failed to offer a “reputable

theory explaining how HPV vaccine could cause the numerous

symptoms.”

Id. at 5-6 (citations omitted and brackets in original).

After reviewing the administrative record, the Special Master concluded that

“Petitioner is not entitled to compensation under the Vaccine Act because she has failed

to identify the underlying injury from which all of her alleged symptoms arise,” and

dismissed the petition. Id. at 6. The Special Master’s decision states:

To receive compensation under the Vaccine Act, a petitioner must prove,

by a preponderance of the evidence, that she suffered an injury that was

caused by a vaccine. See 42 U.S.C. §§ 300a-11(c)(1), -13(a)(1)(A) (2012).

Where, as here, the petitioner alleges no “Table Injury,” see § 300a-

13(a)(1)(A), she must demonstrate, by a preponderance of the evidence,

“(1) a medical theory causally connecting the vaccination and the injury;

(2) a logical sequence of cause and effect showing that the vaccination

was the reason for the injury; and (3) a showing of a proximate temporal

relationship between vaccination and injury.” Althen, 418 F.3d at 1278.

That being said, “[i]n the absence of a showing of the very

existence of any specific injury of which the petitioner complains, the

question of causation is not reached.” Lombardi v. Sec’y Health & Human

Servs., 656 F.3d 1343, 1353 (Fed. Cir. 2011). Under the Vaccine Act, the

petitioner must show “at least one defined and recognized injury” and “not

merely a symptom or manifestation of an unknown injury.” Id. Stated

differently, the special master’s role “is not to diagnose vaccine-related

injuries, but instead to determine based on the record evidence as a whole

and the totality of the case,” if a vaccine caused Petitioner’s claimed injury.

Id. at 1351 (internal quotation marks omitted).

Here, after reviewing Petitioner’s medical records in conjunction

with Dr. Dahlgren’s expert report, the undersigned concludes that

Petitioner has failed to allege a “defined and recognized injury.” As an

13

alternative, Petitioner relies on the diagnoses of “sensory dysesthesias”

and “idiosyncratic severe reaction to vaccination,” but as Dr. Leist pointed

out, the former is “merely a symptom or manifestation of an unknown

injury” and the latter is an umbrella term which could be used to describe

any manifestation of symptoms that post-dates a vaccination. Finding that

either of these medical conditions actually constituted an injury under the

Vaccine Act would effectively eliminate the Act’s injury-requirement, as

petitioners would need only prove that they manifested a medical

symptom after receiving a vaccination to meet it. Because the

undersigned cannot countenance such a result, the petition must be

dismissed.

Id. at 6-7.

On May 26, 2016, Petitioner filed a motion for review of the Special Master’s

decision, and the case was assigned to the undersigned. In her motion, Petitioner

alleged that the Special Master had abused her discretion and had acted not in

accordance with the law. Ms. Lasnetski requested that her petition be remanded to the

Special Master with a “direction to apply the Althen[ v. Secretary of Health & Human

Services, 418 F.3d 1274 (Fed. Cir. 2005)] analysis to the facts presented.” In her

motion, Petitioner specifically asserted that the Special Master had erred: 1) by

requiring Petitioner to allege “a defined and recognized injury” as a threshold matter; 2)

by not concluding that the Petitioner had specified a “defined and recognized injury,” 3)

and by failing to conduct an Althen causation analysis.

The government’s response to the motion to the review, filed on June 27, 2016,

argued that the Special Master’s decision should be affirmed. The government argued

that this case indistinguishable from Lombardi v. Sec’y of Health & Human Servs.,

which required an allegation of “‘a defined and recognized injury’” and “‘not merely a

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

Servs., 656 F.3d 1343, 1353, 1356 (Fed. Cir.), reh’g en banc denied (Fed. Cir. 2011).

Respondent argued that the Special Master in Ms. Lasnetski’s case correctly and

logically decided that the causation question should not be reached.

DISCUSSION

As noted, Ms. Lasnetski alleges that the Special Master erred on three grounds.

First, Petitioner alleges that the Special Master erred by requiring Petitioner to allege a

“defined and recognized injury,” which petitioner alleges amounted to an “increased

burden” not supported by the Vaccine Act’s definition of “vaccine-related injury.”

Petitioner argues that this was an error “in the interpretation of the law and not

questions of fact” and, thus, subject to “complete and independent review” by this court.

Second, Petitioner alleges that, even if the Special Master did not err in requiring

Petitioner to allege a “defined and recognized injury,” Petitioner met this standard by

alleging that she had suffered sensory dysesthesia and an “idiosyncratic severe

reaction to vaccination.” According to Petitioner, the Special Master’s determination that

Petitioner had not alleged a “defined and recognized injury” amounted to an abuse of

14

discretion. Third, Petitioner alleges that the Special Master erred as a matter of law by

failing to conduct an Althen v. Secretary of Health and Human Services analysis to

allow her to prove that the vaccine caused her alleged injuries. Petitioner argues that,

had the Special Master analyzed the evidence in the record under the Althen standard,

Petitioner would have met her initial burden of showing causation and the burden would

have shifted to the government to show that her injury was caused by a factor unrelated

to the vaccine.

In its response to Petitioner’s motion for review, the government rejects each of

petitioner’s alleged grounds for alleged error. First, the government argues that the

Special Master’s decision applied the proper standard for alleging the existence of an

injury, correctly requiring that Petitioner prove the existence of an injury, rather than just

symptoms of an injury. In support of this argument, the government cites Broekelschen

v. Secretary of Health and Human Services, 618 F.3d 1339 (Fed. Cir. 2010), and

Lombardi v. Secretary of Health and Human Services, 656 F.3d 1343, the latter of

which was relied upon by the Special Master in her decision and which the government

argues is “indistinguishable” from the present case. Second, the government argues

that “[t]he Special Master carefully considered the evidence in the record . . . in an effort

to understand the nature of petitioner’s alleged injury” and ultimately concluded that

petitioner had “‘failed to identify the underlying injury from which her alleged symptoms

[arose].’” (quoting Lasnetski v. Sec’y Health & Human Servs., slip op. at 6) (alteration is

respondent’s). Finally, the government argues that the Special Master properly

determined that, in the absence of a showing of at least one defined and recognized

injury, the question of causation under the Althen analysis could not be reached.

According to the government, because Petitioner has failed to demonstrate that the

Special Master erred or that her actions were arbitrary, capricious, an abuse of

discretion or otherwise legally prohibited, the petition for review should be denied and

the Special Master’s decision should be affirmed.

When reviewing a Special Master's decision, the assigned Judge of the United

States Court of Federal Claims shall:

(A) uphold the findings of fact and conclusions of law of the special

master and sustain the special master's decision,

(B) set aside any findings of fact or conclusions of law of the special

master found to be arbitrary, capricious, an abuse of discretion, or

otherwise not in accordance with law and issue its own findings of fact and

conclusions of law, or

(C) remand the petition to the special master for further action in

accordance with the court's direction.

42 U.S.C. § 300aa-12(e)(2). The legislative history of the Vaccine Act states: “The

conferees have provided for a limited standard for appeal from the [special] master's

decision and do not intend that this procedure be used frequently, but rather in those

15

cases in which a truly arbitrary decision has been made." H.R. Rep. No. 101-386, at

517 (1989) (Conf. Rep.), reprinted in 1989 U.S.C.C.A.N. 3018, 3120.

In order to recover under the Vaccine Act, petitioners must prove that the vaccine

caused the purported injury. See W.C. v. Sec’y of Health & Human Servs., 704 F.3d

1352, 1355-56 (Fed. Cir. 2013) (“The Vaccine Act created the National Vaccine Injury

Compensation Program, which allows certain petitioners to be compensated upon

showing, among other things, that a person ‘sustained, or had significantly aggravated’

a vaccine-related ‘illness, disability, injury, or condition.’” (quoting 42 U.S.C. § 300aa–

11(c)(1)(C))); Lombardi v. Sec’y of Health & Human Servs., 656 F.3d at 1350 (“A

petitioner seeking compensation under the Vaccine Act must prove by a preponderance

of the evidence that the injury or death at issue was caused by a vaccine.”); see also

Shapiro v. Sec’y of Health & Human Servs., 105 Fed. Cl. 353, 358 (2012), aff’d, 503

Fed. App’x 952 (Fed. Cir. 2013); Jarvis v. Sec’y of Health & Human Servs., 99 Fed. Cl.

47, 54 (2011). Regarding the standard of review, articulated in Markovich v. Secretary

of Health and Human Services, the United States Court of Appeals for the Federal

Circuit wrote, “[u]nder the Vaccine Act, the Court of Federal Claims reviews the Chief

Special Master's decision to determine if it is ‘arbitrary, capricious, an abuse of

discretion, or otherwise not in accordance with the law.’ 42 U.S.C. § 300aa-12(e)(2)(B).”

Markovich v. Sec’y of Health & Human Servs., 477 F.3d 1353, 1355-56 (Fed. Cir.), cert.

denied, 552 U.S. 816 (2007); see also Deribeaux ex rel. Deribeaux v. Sec’y of Health &

Human Servs., 717 F.3d 1363, 1366 (Fed. Cir.) (The United States Court of Appeals for

the Federal Circuit stated that “we ‘perform[ ] the same task as the Court of Federal

Claims and determine[ ] anew whether the special master's findings were arbitrary or

capricious.’” (quoting Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1360

(Fed. Cir. 2000))) (brackets in original), reh’g and reh’g en banc denied (Fed. Cir. 2013);

W.C. v. Sec’y of Health & Human Servs., 704 F.3d at 1355; Hibbard v. Sec’y of Health

& Human Servs., 698 F.3d 1355, 1363 (Fed. Cir. 2012); Avera v. Sec’y of Health &

Human Servs., 515 F.3d 1343, 1347 (Fed. Cir.) (“Under the Vaccine Act, we review a

decision of the special master under the same standard as the Court of Federal Claims

and determine if it is ‘arbitrary, capricious, an abuse of discretion, or otherwise not in

accordance with law.’” (quoting 42 U.S.C. § 300aa-12(e)(2)(B))), reh’g and reh’g en

banc denied (Fed. Cir. 2008); de Bazan v. Sec’y of Health & Human Servs., 539 F.3d

1347, 1350 (Fed. Cir.), reh’g and reh’g en banc denied (Fed. Cir. 2008); Althen v. Sec’y

of Health & Human Servs., 418 F.3d at 1277; Dodd v. Sec’y of Health & Human Servs.,

114 Fed. Cl. 43, 47 (2013); Taylor v. Sec’y of Health & Human Servs., 108 Fed. Cl. 807,

817 (2013). The arbitrary and capricious standard is “well understood to be the most

deferential possible.” Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d at

870.

Therefore, this court may set aside a Special Master’s decision only if the court

determines that the “findings of fact or conclusion of law of the special master . . . [are]

arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with

law . . . .” 42 U.S.C. § 300aa-12(e)(2)(B); see also Lombardi v. Sec’y of Health &

Human Servs., 656 F.3d at 1350 (“We uphold the special master's findings of fact

unless they are arbitrary or capricious.”) (internal citations omitted); Moberly ex rel.

Moberly v. Sec’y of Health & Human Servs., 592 F.3d at 1321; Markovich v. Sec’y of

16

Health & Human Servs., 477 F.3d at 1356-57; Lampe v. Sec’y of Health & Human

Servs., 219 F.3d at 1360. The United States Court of Appeals for the Federal Circuit

has indicated that:

These standards vary in application as well as degree of deference. Each

standard applies to a different aspect of the judgment. Fact findings are

reviewed by us, as by the Claims Court judge, under the arbitrary and

capricious standard; legal questions under the “not in accordance with

law” standard . . . ; and discretionary rulings under the abuse of discretion

standard. The latter will rarely come into play except where the special

master excludes evidence.

Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d at 871 n.10; see also

Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d at 1366; W.C.

v. Sec’y of Health & Human Servs., 704 F.3d at 1355; Griglock v. Sec’y of Health &

Human Servs., 687 F.3d 1371, 1374 (Fed. Cir. 2012); Porter v. Sec'y of Health &

Human Servs., 663 F.3d at 1249 (citing Broekelschen v. Sec'y of Health & Human

Servs., 618 F.3d at 1345) (explaining that the reviewing court “do[es] not reweigh the

factual evidence, assess whether the special master correctly evaluated the evidence,

or examine the probative value of the evidence or the credibility of the witnesses—these

are all matters within the purview of the fact finder”); Dodd v. Sec’y of Health & Human

Servs., 114 Fed. Cl. at 43, 56.

“With regard to both fact-findings and fact-based conclusions, the key decision

maker in the first instance is the special master. The Claims Court owes these findings

and conclusions by the special master great deference – no change may be made

absent first a determination that the special master was ‘arbitrary and capricious.’”

Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d at 870; see also 42 U.S.C.

§ 300aa-12(e)(2)(B). Generally, “if the special master ‘has considered the relevant

evidence of record, drawn plausible inferences and articulated a rational basis for the

decision, reversible error will be extremely difficult to demonstrate.’” Hibbard v. Sec'y of

Health & Human Servs., 698 F.3d at 1363 (quoting Hines on Behalf of Sevier v. Sec’y of

Dep’t of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)); see also Porter

v. Sec'y of Health & Human Servs., 663 F.3d at 1253-54; Lampe v. Sec’y of Health &

Human Servs., 219 F.3d at 1360; Avila ex rel. Avila v. Sec’y of Health & Human Servs.,

90 Fed. Cl. 590, 594 (2009); Dixon v. Sec’y of Dep’t of Health & Human Servs., 61 Fed.

Cl. 1, 8 (2004) (“The court’s inquiry in this regard must therefore focus on whether the

Special Master examined the ‘relevant data’ and articulated a ‘satisfactory explanation

for its action including a “rational connection between the facts found and the choice

made.”’” (quoting Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S.

29, 43 (1983) (quoting Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168

(1962)))).

As noted by the United States Court of Appeals for the Federal Circuit:

“Congress assigned to a group of specialists, the Special Masters within

the Court of Federal Claims, the unenviable job of sorting through these

17

painful cases and, based upon their accumulated expertise in the field,

judging the merits of the individual claims. The statute makes clear that,

on review, the Court of Federal Claims is not to second guess the Special

Masters [sic] fact-intensive conclusions; the standard of review is uniquely

deferential for what is essentially a judicial process. Our cases make clear

that, on our review . . . we remain equally deferential. That level of

deference is especially apt in a case in which the medical evidence of

causation is in dispute.”

Deribeaux ex rel. Deribeaux v. Sec'y of Health & Human Servs., 717 F.3d at 1366

(quoting Hodges v. Sec'y of Dept. of Health & Human Servs., 9 F.3d at 961)

(modification in original); Hibbard v. Sec'y of Health & Human Servs., 698 F.3d at 1363;

Locane v. Sec'y of Health & Human Servs., 685 F.3d 1375, 1380 (Fed. Cir. 2012). The

Court of Appeals for the Federal Circuit has further explained that the reviewing courts

“‘do not sit to reweigh the evidence. [If] the special master's conclusion [is] based on

evidence in the record that [is] not wholly implausible, we are compelled to uphold that

finding as not being arbitrary and capricious.’” See Deribeaux ex rel. Deribeaux v. Sec'y

of Health & Human Servs., 717 F.3d at 1367 (quoting Lampe v. Sec'y of Health &

Human Servs., 219 F.3d at 1363) (modification in original); see also Hibbard v. Sec'y of

Health & Human Servs., 698 F.3d at 1363 (citing Cedillo v. Sec’y of Health & Human

Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010). “‘Clearly it is not then the role of this

court to reweigh the factual evidence, or to assess whether the special master correctly

evaluated the evidence. And of course we do not examine the probative value of the

evidence or the credibility of the witnesses. These are all matters within the purview of

the fact finder.’” Dodd v. Sec’y of Health & Human Servs., 114 Fed. Cl. at 56 (quoting

Munn v. Sec'y of Dept. of Health & Human Servs., 970 F.2d at 870 n.10); see also

Paluck v. Sec'y of Health & Human Servs., 113 Fed. Cl. 210, 224 (2013) (“A special

master's findings regarding the probative value of the evidence and the credibility of

witnesses will not be disturbed so long as they are ‘supported by substantial evidence.’”

(quoting Doe v. Sec'y of Health & Human Servs., 601 F.3d 1349, 1355 (Fed. Cir.), cert.

denied, 562 U.S. 1029 (2010))). Additionally, as instructed by the United States Court

of Appeals for the Federal Circuit, “[u]nder the Vaccine Act, Special Masters are

accorded great deference in determining the credibility and reliability of expert

witnesses. Indeed, we have held that a Special Master's ‘credibility determinations are

virtually unreviewable.’” Cedillo v. Sec’y of Health & Human Servs., 617 F.3d at 1347

(quoting Hanlon v. Sec’y of Health & Human Servs., 191 F.3d 1344, 1349 (Fed. Cir.

2010) (quotation omitted)).

Additionally, a Special Master is “not required to discuss every piece of evidence

or testimony in [his or] her decision.” Snyder ex rel. Snyder v. Sec’y of Health & Human

Servs., 88 Fed. Cl. 706, 728 (2009); see also Paluck ex rel. Paluck v. Sec’y of Health &

Human Servs., 104 Fed. Cl. 457, 467 (2012) (“[W]hile the special master need not

address every snippet of evidence adduced in the case, see id. [Doe v. Sec’y of Health

& Human Servs., 601 F.3d at 1355], he cannot dismiss so much contrary evidence that

it appears that he ‘simply failed to consider genuinely the evidentiary record before

him.’” (quoting Campbell v. Sec’y of Health & Human Servs., 97 Fed. Cl. 650, 668

(2011))).

18

Regarding the causation analysis, as indicated by the United States Court of

Appeals for the Federal Circuit in Althen v. Secretary of Health and Human Services:

The [Vaccine] Act provides for the establishment of causation in one of

two ways: through a statutorily-prescribed presumption of causation upon

a showing that the injury falls under the Vaccine Injury Table (“Table

injury”), see 42 U.S.C. § 300aa-14(a); or where the complained-of injury is

not listed in the Vaccine Injury Table (“off-Table injury”), by proving

causation in fact, see 42 U.S.C. §§ 300aa-13(a)(1), -11(c)(1)(C)(ii)(I).

Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278; W.C. v. Sec'y of Health &

Human Servs., 704 F.3d at 1356; Broekelschen v. Sec'y of Health & Human Servs., 618

F.3d at 1346; Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1356 (Fed.

Cir.), reh’g and reh’g en banc denied (Fed. Cir. 2006), cert. denied, 551 U.S. 1102

(2007); Dodd v. Sec’y of Health & Human Servs., 114 Fed. Cl. at 50; Paluck v. Sec'y of

Health & Human Servs., 113 Fed. Cl. at 212; Fesanco v. Sec’y of Health & Human

Servs., 99 Fed. Cl. 28, 31 (2011). The United States Supreme Court has explained

that:

Claimants who show that a listed injury first manifested itself at the

appropriate time are prima facie entitled to compensation. No showing of

causation is necessary; the Secretary bears the burden of disproving

causation. A claimant may also recover for unlisted side effects, and for

listed side effects that occur at times other than those specified in the

Table, but for those the claimant must prove causation.

Bruesewitz v. Wyeth LLC, 131 S. Ct. 1068, 1073-74 (2011) (footnotes omitted);

Kennedy v. Sec’y of Health & Human Servs., 99 Fed. Cl. 535, 539 (2011), aff’d, 485

Fed. App’x. 435 (Fed. Cir. 2012).

As both parties recognize, the injuries Petitioner alleges she suffered as a result

of the Gardasil vaccination are not included on the Vaccine Injury Table. See 42 U.S.C.

§ 300aa-14. Plaintiff, therefore, must proceed under an off-Table theory of recovery.

Under the off-Table theory of recovery, a petitioner is entitled to compensation if he or

she can demonstrate, by a preponderance of the evidence, see 42 U.S.C. § 300aa-

13(a)(1)(A), that the recipient of the vaccine sustained, or had significantly aggravated,

an illness, disability, injury, or condition not set forth in the Vaccine Injury Table, but

which was caused by a vaccine that is listed on the Vaccine Injury Table. See 42 U.S.C.

§ 300aa-11(c)(1)(C)(ii)(I); see also W.C. v. Sec’y of Health & Human Servs., 704 F.3d at

1356 (“Nonetheless, the petitioner must do more than demonstrate a ‘plausible’ or

‘possible’ causal link between the vaccination and the injury; he must prove his case by

a preponderance of the evidence.” (quoting Moberly ex rel. Moberly v. Sec’y of Health &

Human Servs., 592 F.3d at 1322)); Althen v. Sec’y of Health & Human Servs., 418 F.3d

at 1278; Hines on Behalf of Sevier v. Sec’y of Dep’t of Health & Human Servs., 940

F.2d at 1525.

Additionally, Petitioner must

19

prove causation-in-fact. Grant [v. Sec'y of Health & Human Servs.], 956

F.2d [1144,] 1147-48 [(Fed. Cir. 1992)]. [The United States Court of

Appeals for the Federal Circuit has] held that causation-in-fact in the

Vaccine Act context is the same as the “legal cause” in the general torts

context. Shyface v. Sec’y of Health and Human Servs., 165 F.3d 1344,

1352 (Fed. Cir. 1999). Therefore, drawing from the Restatement (Second)

of Torts, the vaccine is a cause-in-fact when it is “a substantial factor in

bringing about the harm.”

de Bazan v. Sec’y of Health & Human Servs., 539 F.3d at 1351 (quoting the

Restatement (Second) of Torts § 431(a)); see also Deribeaux ex rel. Deribeaux v. Sec’y

of Health & Human Servs., 717 F.3d at 1367 (“To prove causation, a petitioner must

show that the vaccine was ‘not only a but-for cause of the injury but also a substantial

factor in bringing about the injury.’” (quoting Shyface v. Sec’y of Health & Human

Servs., 165 F.3d at 1352–53)). A “‘substantial factor’ standard requires a greater

showing than ‘but for’ causation.” de Bazan v. Sec’y of Health & Human Servs., 539

F.3d at 1351 (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d at 1352).

“However, the petitioner need not show that the vaccine was the sole or predominant

cause of her injury, just that it was a substantial factor.” Id. (citing Walther v. Sec'y of

Health & Human Servs., 485 F.3d 1146, 1150 (Fed. Cir. 2007)). A judge of this court

has explained the relationship between “but-for” causation and “substantial factor”

causation in our court’s decision in Deribeaux ex rel. Deribeaux v. Secretary of Health

and Human Services:

The de Bazan court defined but-for causation as requiring that “the harm

be attributable to the vaccine to some nonnegligible degree,” and noted

that, although substantial is somewhere beyond the low threshold of but-

for causation, it does not mean that a certain factor must be found to have

definitively caused the injury. Id. [de Bazan v. Sec’y of Health & Human

Servs., 539 F.3d at 1351] Accordingly, a factor deemed to be substantial

is one that falls somewhere between causing the injury to a non-negligible

degree and being the “sole or predominant cause.” Id.

This definition of substantial—somewhere between non-negligible and

predominant—is applicable to respondent's burden to prove a sole

substantial factor unrelated to the vaccine. Accordingly, a respondent's

burden is to prove that a certain factor is the only substantial factor—one

somewhere between non-negligible and predominant—that caused the

injury.

Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 105 Fed. Cl. 583, 595

(2012), aff’d, 717 F.3d 1363 (Fed. Cir.), reh’g and reh’g en banc denied (Fed. Cir. 2013)

(emphasis in original).

A petitioner must prove his or her case by a preponderance of the evidence. See

42 U.S.C. § 300aa-13(a)(1)(A). According to the United States Court of Appeals for the

Federal Circuit, the preponderance of evidence standard is “one of proof by a simple

20

preponderance, of ‘more probable than not causation.’” Althen v. Sec’y of Health &

Human Servs., 418 F.3d at 1279-80 (citing concurrence in Hellebrand v. Sec’y of Dep’t

of Health & Human Servs., 999 F.2d 1565, 1572-73 (Fed. Cir. 1993)); see also W.C. v.

Sec’y of Health & Human Servs., 704 F.3d at 1356 (“In this off-table case, the petitioner

must show that it is ‘more probable than not’ that the vaccine caused the injury.”

(quoting Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1279-80)). Decisions of

the Federal Circuit permit the use of circumstantial evidence, which the court described

as “envisioned by the preponderance standard” and by the vaccine system created by

Congress, in which “close calls regarding causation are resolved in favor of injured

claimants” without the need for medical certainty. See Althen v. Sec’y of Health &

Human Servs., 418 F.3d at 1280; see also Cloer v. Sec’y of Health & Human Servs.,

654 F.3d 1322, 1332 n.4 (Fed. Cir. 2011), cert. denied, 132 S. Ct. 1908 (2012); Andreu

ex rel. Andreu v. Sec’y of Dept. of Health & Human Servs., 569 F.3d 1367, 1379 (Fed.

Cir. 2009) (“In Althen, however, we expressly rejected the Stevens test, concluding that

requiring ‘objective confirmation’ in the medical literature prevents ‘the use of

circumstantial evidence . . . and negates the system created by Congress’ through the

Vaccine Act.”) (modification in original); La Londe v. Sec’y of Health & Human Servs.,

110 Fed. Cl. 184, 198 (2013) (“Causation-in-fact can be established with circumstantial

evidence, i.e., medical records or medical opinion.”). The Althen court further noted that

“the purpose of the Vaccine Act’s preponderance standard is to allow the finding of

causation in a field bereft of complete and direct proof of how vaccines affect the human

body.” Id. (citing Knudsen by Knudsen v. Sec’y of Dep’t of Health & Human Servs., 35

F.3d 543, 549 (Fed. Cir. 1994)); see also W.C. v. Sec’y of Health & Human Servs., 704

F.3d at 1356. When proving eligibility for compensation for an off-Table injury under the

Vaccine Act, however, Petitioner may not rely on her testimony alone. According to the

Vaccine Act, “[t]he special master or court may not make such a finding based on the

claims of a petitioner alone, unsubstantiated by medical records or by medical opinion.”

See 42 U.S.C. § 300aa-13(a)(1).

The Federal Circuit in Althen defined a three-prong test which a petitioner must

meet to establish causation in an off-Table injury case:

To meet the preponderance standard, [Petitioner] must “show a medical

theory causally connecting the vaccination and the injury.” Grant v. Sec'y

of Health & Humans Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)

(citations omitted). A persuasive medical theory is demonstrated by “proof

of a logical sequence of cause and effect showing that the vaccination

was the reason for the injury[,]” the logical sequence being supported by

“reputable medical or scientific explanation[,]” i.e., “evidence in the form of

scientific studies or expert medical testimony[.]” Grant, 956 F.2d at 1148.

[Petitioner] may recover if she shows “that the vaccine was not only a but-

for cause of the injury but also a substantial factor in bringing about the

injury.” Shyface, 165 F.3d at 1352-53. Although probative, neither a mere

showing of a proximate temporal relationship between vaccination and

injury, nor a simplistic elimination of other potential causes of the injury

suffices, without more, to meet the burden of showing actual causation.

See Grant, 956 F.2d at 1149. Concisely stated, [Petitioner’s] burden is to

21

show by preponderant evidence that the vaccination brought about [the]

injury by providing: (1) a medical theory causally connecting the

vaccination and the injury; (2) a logical sequence of cause and effect

showing that the vaccination was the reason for the injury; and (3) a

showing of a proximate temporal relationship between vaccination and

injury.

Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278 (brackets in original); see

also Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d at 1367;

Porter v. Sec’y of Health & Human Servs., 663 F.3d at 1249; Moberly ex rel. Moberly v.

Sec’y of Health & Human Servs., 592 F.3d at 1322; Pafford v. Sec’y of Health & Human

Servs., 451 F.3d at 1355; Capizzano v. Sec’y of Health & Human Servs., 440 F.3d

1317, 1324 (Fed. Cir. 2006); C.K. v. Sec’y of Health & Human Servs., 113 Fed. Cl. 757,

766 (2013); Contreras v. Sec’y of Health & Human Servs., 107 Fed. Cl. 280, 291

(2012).

Ms. Lasnetski first alleges that the Special Master subjected Petitioner to an

increased burden not supported by the Vaccine Act by requiring her to allege a “defined

and recognized injury.” In this regard, Petitioner appears to be challenging the following

statement by the Special Master: “Under the Vaccine Act, the petitioner must show ‘at

least one defined and recognized injury’ and ‘not merely a symptom or manifestation of

an unknown injury.’” Lasnetski v. Sec’y Health & Human Servs., slip op. at 6 (quoting

Lombardi v. Sec’y of Health & Human Servs., 656 F.3d at 1353). Petitioner argues that

this standard involves a too “narrow interpretation” of the injury allegation and

demonstration required by the Vaccine Act. In support of her argument Petitioner,

argues that the Vaccine Act has a “broad and inclusive” definition of “vaccine-related

injury” and that the case from which the Special Master drew the her standard,

Lombardi v. Secretary of Health and Human Services, is distinguishable from the

present case.

If a petitioner’s diagnosis is not in dispute, the Special Master should proceed

directly to the Althen causation analysis. See W.C. v. Sec'y of Health & Human Servs.,

704 F.3d at 1357 (holding that, because the parties agreed on petitioner’s diagnosis, the

Special Master “should have expressly applied the analysis set forth in Althen” rather

than first resolving the “preliminary question of whether Petitioner had subclinical

multiple sclerosis before the vaccination” (internal quotation marks omitted)); see also

Contreras v. Sec'y of Health & Human Servs., 121 Fed. Cl. 230, 243 (2015) (“In a

typical Vaccine Act case adding this threshold inquiry [into the diagnosis of petitioner’s

injury] does not serve a useful purpose and may actually cause significant harm . . . .”).

However, “if the existence and nature of the [petioner’s] injury itself is in dispute, it is the

special master's duty to first determine which injury was best supported by the evidence

presented in the record before applying the Althen test to determine causation of that

injury.” Lombardi v. Sec'y of Health & Human Servs., 656 F.3d at 1352 (citing

Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d at 1346. In such a case, the

United States Court of Appeals for the Federal Circuit has held in Lombardi v. Secretary

of Health and Human Services that the Vaccine Act “places the burden on the petitioner

to make a showing of at least one defined and recognized injury.” Id. at 1353. Stated

22

another way, it is a petitioner’s “burden to show by a preponderance of the evidence

that she suffered from any medically recognized ‘injury,’ not merely a symptom or

manifestation of an unknown injury.” Id.

Initially, Ms. Lasnetski cites the Vaccine Act’s definition of “vaccine-related injury

or death” in 42 U.S.C. § 300aa-33(5) to argue that the term “vaccine-related injury,” as

used in the Vaccine Act, has a “broad and inclusive meaning.”12 Section 300aa-33(5)

defines the term “vaccine-related injury or death,” as used throughout the Vaccine Act,

as “an illness, injury, condition, or death associated with one or more of the vaccines set

forth in the Vaccine Injury Table.” 42 U.S.C. § 300aa-33(5). Petitioner’s argument

appears to be that this definition of “vaccine-related injury” is broader than the one

implied by the Special Master’s standard. As noted above, however, the Federal Circuit

has held that the Vaccine Act itself places the burden on Petitioner that the Special

Master required in the present case: “to make a showing of at least one defined and

recognized injury.” Lombardi v. Sec'y of Health & Human Servs., 656 F.3d at 1353.

Further, the Federal Circuit has explicitly rejected virtually the same argument made by

Petitioner based on § 300aa-33(5). In Broekelschen v. Secretary of Health and Human

Services, 618 F.3d 1339, the dissenting opinion argued that because § 300aa-33(5)

“broadly defines ‘vaccine-related injury or death,’” claimants could meet the Vaccine

Act’s criteria “even in the absence of a definitively diagnosed injury.” Id. at 1352 (Mayer,

J., dissenting). The majority, however, rejected this argument, holding that § 300aa-

33(5) “does not support [the dissent’s] argument that proof of an “illness, condition, or

disability” is something less than proof of an “injury” under the Vaccine Act.” Id. at 1349.

Instead, the Broekelschen court held that “[m]edical recognition of the injury claimed is

critical and by definition a ‘vaccine-related injury,’ i.e., illness, disability, injury or

condition, has to be more than just a symptom or manifestation of an unknown injury.”

Id.; see also Lombardi v. Sec'y of Health & Human Servs., 656 F.3d at 1353. This is the

same standard that the Special Master applied to Petitioner in the present case.13

12 Petitioner also cites 42 U.S.C. § 11(c)(1)(C)(i) (2012) in support of her argument. This

provision, however, is inapposite to Petitioner’s case as it applies only to petitioners

seeking compensation for Table injuries. See 42 U.S.C. § 300aa-11(c)(1)(C)(i) (“A

petition for compensation under the Program for a vaccine-related injury or death shall

contain . . . an affidavit, and supporting documentation, demonstrating that the person

who suffered such injury or who died . . . sustained, or had significantly aggravated, any

illness, disability, injury, or condition set forth in the Vaccine Injury Table . . . .”

(emphasis added)).

13 Petitioner also cites the use of the word “harm” in place of “injury” in the Federal

Circuit’s decision in Flores v. Secretary of Health and Human Services as evidence that

the term “vaccine-related injury” should be given and “broad and inclusive meaning.”

The Flores decision stated:

As noted above, the Federal Circuit, in Althen, distilled this prior precedent

into a three-part test, holding that to prove causation-in-fact, a petitioner

must provide “(1) a medical theory causally connecting the vaccination

23

As noted above, the “defined and recognized injury” standard utilized by the

Special Master was quoted directly from the Federal Circuit’s decision in Lombardi v.

Secretary of Health and Human Services. Petitioner argues, however, that the Special

Master’s reliance on Lombardi was “inappropriate,” because the facts and “resulting

legal analysis” in Lombardi “are distinguishable from the facts on the record in this

matter.” In particular, Petitioner argues that whereas “[t]he experts and physicians in

Lombardi could neither define nor recognize any one consistent injury,” in the present

case “physicians Dr. Fealey and Dr. Michet, as well as Dr. Dahlgren, agreed upon

defined and recognized injuries; specifically, the injuries of sensory dysesthesias

following HPV vaccination and idiosyncratic severe reaction to vaccination.” Further,

while the various diagnoses in Lombardi conflicted with one another, the two diagnoses

plaintiff received are “entirely consistent” with one another. According to Petitioner,

“[b]ecause of the competing and contradictory diagnoses, the Lombardi court concluded

that the petitioner failed to meet her burden of showing ‘at least one defined and

recognized injury.’” Plaintiff argues that this distinction from the present case is relevant

because “[t]he purpose of the requirement for a ‘defined and recognized injury’ in

Lombardi was not to create a new, narrower set of compensable injuries, but was

instead used to highlight the fact that the petitioner in Lombardi failed to provide

evidence of any one injury.”

In Lombardi, the petitioner’s experts offered three different diagnoses for her

injury, each of which was disputed by the government's experts, who offered five

different diagnoses of their own. Lombardi v. Sec’y of Health & Human Servs., 656 F.3d

at 1348-49. After examining the evidence in the record, as well as the opinions of the

and the injury; (2) a logical sequence of cause and effect showing that the

vaccination was the reason for the injury; and (3) a showing of a proximate

temporal relationship between vaccination and injury.” 418 F.3d at 1278.

All three prongs “must cumulatively show that the vaccination was a ‘but-

for’ cause of the harm, rather than just an insubstantial contributor in, or

one among several possible causes of, the harm.” Pafford v. Sec'y of

HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006).

Flores v. Sec'y of Health & Human Servs., 115 Fed. Cl. 157, 162, aff'd, 586 F. App'x

588 (Fed. Cir. 2014) (emphasis added by Petitioner). In Flores, there was no issue

regarding the sufficiency or nature of the alleged injury as “all three experts agreed that

petitioner had suffered a spinal cord stroke.” Id. at 160. Instead, the dispute centered on

causation, “whether the special master properly held that petitioner had not established

that the HPV vaccine caused [the Flores petitioner’s] spinal cord stroke.” Id. at 161. Nor

did the Flores court anywhere in its opinion discuss the Vaccine Act’s definition of

“vaccine-related injury” or otherwise elaborate on its use of the word “harm” in the

passage cited by petitioner. In the absence of any such indications, the Federal Circuit’s

use of the generic word “harm” in place of the word “injury” in a single sentence cannot

be interpreted as providing an additional interpretation of the Vaccine Act’s

requirements for alleging a “vaccine-related injury,” altering the standard the Federal

Circuit had set forth less than three years earlier in Lombardi.

24

various testifying experts, the Special Master concluded that the petitioner, Ms.

Lombardi, was not entitled to compensation because she had not established that she,

actually, had suffered from any of the three conditions proposed by her experts, a

decision which was affirmed, upon review, by the United States Court of Federal

Claims. See id. at 1349-50. Ms. Lombardi challenged the rulings of the Special Master

and the United States Court of Federal Claims on the grounds that the focus on whether

she suffered from one of her three claimed conditions “imposed on her an improper

burden of proving a diagnosis with scientific certainty even before she could prove

causation under Althen.” Id. at 1352.

In rejecting Ms. Lombardi’s arguments, the Federal Circuit turned to its decision

in Broekelschen v. Secretary of Health & Human Services, 618 F.3d 1339, which, it

found, “addressed the same issue as that presented” in Lombardi. Id. at 1352. The court

noted that, in Broekelschen, the petitioner “suffered from symptoms that were consistent

with two different conditions . . . which differ[red] significantly in their pathology,” and

that the Special Master denied the petition on the grounds that the condition the

petitioner “actually suffered from was not the one for which he had claimed or presented

causation evidence.” Id. at 1352 (citing Broekelschen v. Sec’y of Health & Human

Servs., 618 F.3d at 1344, 1346). The Broekelschen court upheld the Special Master’s

decision on the grounds that “the question of causation turned on which injury the

petitioner suffered” and thus, “if the existence and nature of the injury itself is in dispute,

it is the special master's duty to first determine which injury was best supported by the

evidence presented in the record before applying the Althen test to determine causation

of that injury.” Id. (citing Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d at

1346). Finding that Ms. Lombardi’s case was similar to the petitioner’s in Broekelschen,

the court held:

In the face of such extreme disagreement among well-qualified medical

experts, each of whom had evaluated the petitioner, it was appropriate for

the special master to first determine what injury, if any, was supported by

the evidence presented in the record before applying the Althen test to

determine causation. Broekelschen, 618 F.3d at 1346. In the absence of a

showing of the very existence of any specific injury of which the petitioner

complains, the question of causation is not reached.

Lombardi v. Sec'y of Health & Human Servs., 656 F.3d at 1352–53.

Petitioner is correct that in Lombardi, the petitioner offered “competing and

contradictory diagnoses.” Petitioner, however, is incorrect that this alone was the reason

why the Lombardi court “concluded that the petitioner failed to meet her burden of

showing ‘at least one defined and recognized injury.’” As the Federal Circuit recognized

in Broekelschen, the existence of competing diagnoses is not necessarily fatal to an off-

Table vaccine claim. See Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d at

1346 (distinguishing the finding in Kelley v. Sec'y of Health & Human Servs., 68 Fed. Cl.

84, 100–01 (2005) that “the petitioner was not required to categorize his injury” among

two possible diagnoses on the grounds that, in Kelley, “the competing diagnoses were

variants of the same disorder”). Instead, the problem with the competing diagnoses in

25

Lombardi (as in Broekelschen) was that, despite their common symptoms, the

competing diagnoses “differed significantly in their pathology.” Lombardi v. Sec’y of

Health & Human Servs., 656 F.3d at 1352 (citing Broekelschen v. Sec’y of Health &

Human Servs., 618 F.3d at 1346); see also Broekelschen v. Sec’y of Health & Human

Servs., 618 F.3d at 1346 (“Moreover, while the two conditions . . . have overlapping

symptoms, their underlying causes or etiology are completely different.”). The existence

of these potentially different potential pathologies meant that “nearly all of the evidence

on causation was dependent on the diagnosis of [the petitioner’s] injury.” Broekelschen

v. Sec’y of Health & Human Servs., 618 F.3d at 1346. Similarly, the reason both

Lombardi and Broekelschen held that a “vaccine-related injury” must “be more than just

a symptom or manifestation of an unknown injury,” was because such a symptom or

manifestation could indicate any number of different underlying injuries, each with its

own pathology, making it impossible for the court to accurately determine causation.

See Lombardi v. Sec'y of Health & Human Servs., 656 F.3d at 1352 (citing

Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339, 1349 (Fed. Cir.

2010)). The purpose of the “defined and recognized injury” standard in Lombardi was,

thus, not, as Petitioner argues, merely “to highlight the fact that the petitioner in

Lombardi failed to provide evidence of any one injury.” Instead the purpose of the

standard was to set the minimum standard of definitiveness for injuries required for a

court to be able to proceed to perform the Althen causation analysis. See Lombardi v.

Sec'y of Health & Human Servs., 656 F.3d at 1352 (“Thus, under Broekelschen,

identification of a petitioner's injury is a prerequisite to an Althen analysis of causation.”);

see also Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d at 1349 (“Medical

recognition of the injury claimed is critical . . . .”).

In the present case, the government’s expert, Dr. Leist, challenged the

arguments of Petitioner’s expert, Dr. Dahlgren, that plaintiff’s sensory dysesthesia or

idiosyncratic severe reaction to vaccination amount to defined and recognized injuries,

instead arguing that both amount to mere descriptions of symptoms. “[T]he existence

and nature of the [Petitioner’s] injury itself” was thus “in dispute.” Lombardi v. Sec'y of

Health & Human Servs., 656 F.3d at 1352. The Special Master, therefore, properly

“place[d] the burden on the petitioner to make a showing of at least one defined and

recognized injury.” Id. at 1353.

Petitioner alternatively argues that, even if the Special Master did not err in

requiring Petitioner to allege a “defined and recognized injury,” the Special Master

abused her discretion in finding that the petitioner had not done so. In particular,

Petitioner alleges that the evidence in the record demonstrates that the dysesthesia and

idiosyncratic severe reaction to vaccination she alleged she suffered amount to defined

and recognized injuries. The Special Master’s analysis and conclusions regarding

whether the Petitioner had alleged a “defined and recognized injury,” although

succinctly stated, were correct based on a review of the record before the court. See

Lasnetski v. Sec’y Health & Human Servs., slip op. at 6-7. The Special Master stated

that she had concluded that Petitioner had failed to allege a “defined and recognized

injury” “after reviewing Petitioner’s medical records in conjunction with Dr. Dahlgren’s

expert report.” Id. at 6. The Special Master specifically rejected Petitioner’s reliance on

her diagnosis of “sensory dyesthesias” and “idiosyncratic severe reaction to vaccination”

26

on the grounds that “as Dr. Leist pointed out, the former is ‘merely a symptom or

manifestation of an unknown injury’ and the latter is an umbrella term which could be

used to describe any manifestation of symptoms that post-dates a vaccination.” Id. The

Special Master then concluded: “[f]inding that either of these medical conditions actually

constituted an injury under the Vaccine Act would effectively eliminate the Act’s injury-

requirement, as petitioners would need only prove that they manifested a medical

symptom after receiving a vaccination to meet it.” Id. at 6-7.

Petitioner challenges the Special Master’s conclusions on the grounds that

dysesthesia is a “defined” injury and that both of the alleged injuries were “recognized”

through the diagnoses of two doctors. Petitioner first argues that dysesthesia is a

defined injury because it is included in Dorland’s Illustrated Medical Dictionary,

asserting that “[a]n injury that is defined by Dorland’s Medical Dictionary is a defined

injury.” Petitioner is correct that dysesthesia is defined in Dorland’s. See Dorland’s

Illustrated Medical Dictionary 577. The mere inclusion of an item in Dorland’s, however,

does not mean that the item is a defined injury for the purposes of the Vaccine Act.

Dorland’s contains, as noted in its preface, approximately 124,000 entries, id. at vii,

covering a wide range of topics, including medical procedures, medical instruments,

anatomy, symptoms, and chemical compounds. See, e.g., id. at 1808 (surgery), 1673

(scalpel), 728 (foot), 1665 (salt). Of particular note, the dictionary contains a number of

entries defining what are, indisputably, symptoms of injuries, rather than injuries. See,

e.g., id. at 1363 (pain), 1691 (sensation). Thus, the fact that dysesthesia is included in

Dorland’s Illustrated Medical Dictionary, is not evidence that the Special Master’s

conclusion that dysesthesia was “merely a symptom or manifestation of an unknown

injury” was arbitrary, capricious, or incorrect based on the record provided to his court.

See Lasnetski v. Sec’y Health & Human Servs., slip op. at 6.

Ms. Lasnetski next argues that Petitioner’s injuries amounted to recognized

injuries because they were diagnosed by Drs. Clement Michet and Dr. Robert Fealey at

the Mayo Clinic. Plaintiff argues that these facts “run[] counter” to the opinion of

defendant’s expert, Dr. Leist that Petitioner had not actually received a diagnosis, an

opinion which was relied upon by the Special Master. Dr. Fealey, did include “Sensory

dysesthesias following HPV vaccination” in the list of “DIAGNOSES” he noted in his

report after seeing Ms. Lasnetski on May 24, 2012. (capitalization and emphasis in

original). Similarly, Dr. Michet included “Idiosyncratic severe reaction to vaccination”

in the list of “DIAGNOSES” he noted in his report after seeing Ms. Lasnetski on May 25,

2012, although he also noted that he had “reassured her that the extensive testing done

at Mayo reveals that she has not suffered any type of permanent autonomic injury,”

suggesting that he doubted the impact or severity of this diagnosis. (capitalization and

emphasis in original). The conclusions of Drs. Michet and Fealey were both noted by

the Special Master in the factual background portion of her decision. See Lasnetski v.

Sec’y Health & Human Servs., slip op. at 3. The Special Master’s decision also

contained a summary of Dr. Leist’s opinion, including that the he believed “that

[plaintiff’s expert] Dr. Dahlgren and Petitioner’s doctors at the Mayo Clinic reached

these ‘diagnoses’ [of sensory dysesthesia and idiosyncratic severe reaction to

vaccination] seemingly without consulting Petitioner’s medical history,” a conclusion that

the Petitioner does not presently challenge. See id. at 5-6. The Special Master stated

27

that she came to her conclusion “after reviewing Petitioner’s medical records in

conjunction with Dr. Dahlgren’s expert report.” Id. at 6. But after reviewing the record,

including both expert reports, she chose to adopt Dr. Leist’s opinion that the petitioner’s

diagnoses of sensory dysesthesias and idiosyncratic severe reaction to vaccination

were “merely a symptom or manifestation of an unknown injury” and “an umbrella term

which could be used to describe any manifestation of symptoms that post-dates a

vaccination.” Id. The Special Master did what she was required to do, review the record,

including weighing the opinions of two treating physicians, Drs. Fealey and Michet, and

the two experts, Drs. Dahlgren and Leist. Ultimately, the Special Master found Dr.

Leist’s expert opinion to be more credible, when combined with the record before the

court. Petitioner essentially asks this court to second guess the Special Master’s

determination of how to assess the relative weight of the evidence before her, which

absent arbitrariness or capriciousness is not the appropriate role of this court.

Deribeaux ex rel. Deribeaux v. Sec'y of Health & Human Servs., 717 F.3d at 1366 (“‘The

statute makes clear that, on review, the Court of Federal Claims is not to second guess

the Special Masters [sic] fact-intensive conclusions; the standard of review is uniquely

deferential for what is essentially a judicial process.’” (quoting Hodges v. Sec'y of Dept.

of Health & Human Servs., 9 F.3d at 961) (modification in original)). Given Ms.

Lasnetski’s medical records included in the record before the Special Master, the issues

which Dr. Leist demonstrated regarding the diagnoses provided by Drs. Fealey and

Michet, and the credibility the Special Master afforded Dr. Leist’s expert opinion, the

decision of the Special Master was based on sufficient evidence and was not arbitrary

or capricious.

The third and final ground on which Petitioner objects to the Special Master’s

decision is that the Special Master allegedly erred as a matter of law by failing to apply

Althen v. Secretary of Health and Human Services to the evidence in the record. As the

Federal Circuit has noted:

“[A] careful reading of Althen, shows that each prong of the Althen test is

decided relative to the injury: (1) medical theory connecting the

vaccination to the injury; (2) cause and effect showing the vaccination was

the reason for the injury; and (3) proximate temporal relationship between

the vaccination and the injury.”

Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d at 1346 (citing Althen v.

Secretary of Health and Human Services, 418 F.3d at 1278 and Doe v. Sec'y of Health

& Human Servs., 601 F.3d at 1351) (emphasis in original). “Thus, . . . identification of a

petitioner's injury is a prerequisite to an Althen analysis of causation.” Lombardi v. Sec'y

of Health & Human Servs., 656 F.3d at 1352; see also Broekelschen v. Sec'y of Health

& Human Servs., 618 F.3d at 1346 (holding same). The logical extension of this

conclusion is that, “[i]f a special master can determine that a petitioner did not suffer the

injury that she claims was caused by the vaccine, there is no reason why the special

master should be required to undertake and answer the separate (and frequently more

difficult) question whether there is a medical theory, supported by ‘reputable medical or

scientific explanation,’ by which a vaccine can cause the kind of injury that the petitioner

claims to have suffered.” Hibbard v. Sec'y of Health & Human Servs., 698 F.3d at 1365

28

(quoting Althen, 418 F.3d at 1278)); see also Dillon v. Sec'y of Health & Human Servs.,

114 Fed. Cl. 236, 244 (2014) (“[I]n the event that the special master determines that the

petitioner cannot demonstrate that he or she actually suffers from the injury alleged,

compensation may be denied without reaching an Althen analysis.” (citing Lombardi v.

Sec'y of Health & Human Servs., 656 F.3d at 1353)). The Special Master stated

specifically, “‘[i]n the absence of a showing of the very existence of any specific injury of

which the petitioner complains, the question of causation is not reached.’” Lasnetski v.

Sec’y Health & Human Servs., slip op. at 6 (quoting Lombardi v. Sec'y of Health &

Human Servs., 656 F.3d at 1353). Because, as noted above, the Special Master

properly found that Petitioner had failed to sufficiently identify an “injury” to support her

claims, the Special Master’s decision to forego the application of Althen to Petitioner’s

case was not in error. See Lombardi v. Sec'y of Health & Human Servs., 656 F.3d at

1356 (affirming Special Master’s decision to deny compensation to an off-Table

petitioner without performing Althen analysis when the Special Master determined that

petitioner “had failed to prove by a preponderance of evidence that she suffered from

any of the three claimed medical conditions” was not arbitrary, capricious, an abuse of

discretion or contrary to law); see also Broekelschen v. Sec'y of Health & Human

Servs., 618 F.3d at 1346 (holding that, when the “injury itself” was in dispute, “it was

appropriate . . . for the special master to first determine which injury was best supported

by the evidence presented in the record before applying the Althen test”).

CONCLUSION

Petitioner has failed to persuade this court that the Special Master’s decision was

arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.

Accordingly, the Special Master’s decision that Petitioner is not entitled to compensation

under the Vaccine Act is AFFIRMED. The clerk’s office shall enter JUDGMENT

consistent with this opinion.

IT IS SO ORDERED.

s/Marian Blank Horn

MARIAN BLANK HORN

Judge

29