Lasnetski v. Secretary of Health and Human Services , 2016 U.S. Claims LEXIS 1485 ( 2016 )

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