In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 12-673V
(not to be published)
*************************
* Special Master Corcoran
KATHLEEN J. AUCH, *
* Filed: January 13, 2017
Petitioner, *
*
v. * Decision; Influenza (“Flu”)
* Vaccine; Polyneuropathic Injury;
SECRETARY OF HEALTH AND * Onset of Symptoms; EMG
HUMAN SERVICES, * Testing.
*
Respondent. *
*
*************************
Richard Gage, Richard Gage P.C., Cheyenne, WY, for Petitioner.
Alexis B. Babcock, U.S. Dep’t of Justice, Washington, DC, for Respondent.
DECISION DENYING ENTITLEMENT1
On October 4, 2012, Kathleen Auch filed a petition seeking compensation under the
National Vaccine Injury Compensation Program (the “Vaccine Program”),2 alleging that she
experienced a generalized polyneuropathic injury after receiving the influenza (“flu”) vaccine on
October 6, 2009. Petition (“Pet.”) (ECF No. 1) at 2.
An entitlement hearing was held in this matter on August 24, 2016, in Omaha, Nebraska.
After considering the record as a whole, and for the reasons explained below, I find that Petitioner
1
Although I am not designating this as a decision “to be published,” because it contains a reasoned explanation for my
action in this case it will nevertheless be posted on the United States Court of Federal Claims’ website, in accordance
with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). As provided by 42 U.S.C § 300aa-12(d)(4)(B), however,
the parties may object to the decision’s inclusion of certain kinds of confidential information. To do so, Vaccine Rule
18(b) permits each party fourteen (14) days within which to request redaction “of any information furnished by that
party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes
medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.”
Vaccine Rule 18(b). Otherwise, the entire decision will be available to the public. Id.
2
The National Vaccine Injury Compensation Program comprises Part 2 of the National Childhood Vaccine Injury Act
of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (codified as amended at 42 U.S.C. § 300aa-10 through 34 (2012)).
has failed to carry her burden establishing causation, and therefore has not demonstrated
entitlement to compensation under the Vaccine Program.
I. FACTUAL BACKGROUND
The record in this case consists of Ms. Auch’s medical records, the testimony of two
experts and three fact witnesses, and medical or scientific literature submitted by the parties in
support of their respective positions. I have reviewed the entire record as required by the Vaccine
Act.
A. October 2009 Flu Vaccine and Initial Alleged Reactions
Ms. Auch was 50 years old at the time of vaccination and had a medical history significant
for fibromyalgia, depression, and anxiety. Petitioner’s Exhibit (“Pet’r’s Ex.”) 1 at 7. Petitioner
received the flu vaccine on October 6, 2009. At that time, she worked at a credit card call center
in Yankton, South Dakota. Tr. at 26-27. Ms. Auch recounted that her employer had encouraged
employees to receive the flu vaccine, so she did sometime that afternoon. Id. at 26, 56. She had
not eaten much that day leading up to the vaccination. Id. at 56.
Petitioner reported that she experienced an immediate reaction to the vaccine, with her
vision becoming blurry. Pet’r’s Ex. 2 pt. 2 at 49. She went that same day to the emergency room
in Yankton at the Avera McKennan Hospital. Id. The EMS notes from this visit state that Ms.
Auch had collapsed at work after receiving the flu vaccine. Pet’r’s Ex. 4 at 7. At the emergency
room, Petitioner testified, her limbs were functioning but she felt very weak. Tr. at 29. The
contemporaneous records confirm that she informed treaters at the time that she felt dizzy, weak,
and generally “weird,” although they provide no medical diagnosis for her reported symptoms.
Pet’r’s Ex. 2 pt. 2 at 47; Pet’r’s Ex. 4 at 7.
Ms. Auch was thereafter referred to Dr. Susan Fanta at Avera McKennan with the aim of
obtaining a diagnosis for her symptoms. Pet’r’s Ex. 2 pt. 2 at 49. Dr. Fanta’s records reflect
Petitioner’s complaints of feeling “funny” in the head and Petitioner’s descriptions of having
“spells.” Id. Petitioner specifically reported that for the few months before the flu vaccination, she
had been experiencing an “inside tremulousness sensation lasting several minutes, several times a
day.” Id. The notes also state that Ms. Auch reported that her daughter had at the time been
experiencing flu-like symptoms, prompting Dr. Fanta to suggest that Petitioner’s reaction might
be a type of “prodromal symptomatology.” Id. at 50. Ultimately, Ms. Auch declined hospital
admission and was instead given a liter of saline before being discharged, with no proposed
medical explanation for her post-vaccination symptoms. Id.
Three days later, on October 9, 2009, Ms. Auch saw Dr. Fanta for a follow-up examination.
Pet’r’s Ex. 3 at 12. Petitioner reported that she felt better but was still experiencing weakness. Id.
2
Petitioner also told Dr. Fanta that she had experienced similar dizziness to a lesser degree after
receiving flu vaccines in the past, and Dr. Fanta therefore speculated that the sudden weakness
could be related to the flu vaccine. Id. However, a systems review and limited testing again
revealed no identifiable problems with Petitioner, and the cause of her symptoms remained
unspecified. Id.
Petitioner returned to the emergency room on October 13, 2009 – a week after receiving
the flu vaccine. Pet’r’s Ex. 2 pt. 2 at 42. At hearing, Petitioner testified that in the time between
this visit and her immediate post-vaccination ER visit, she had stayed home to rest but finally opted
to go to work on the 13th. Tr. at 32. Upon arrival at her job, however, she began feeling ill and
was shaking and trembling, so she asked a friend to take her to the emergency room. Id. at 32-33.
Ms. Auch reported feeling as if she could not walk and specifically described her symptoms as
similar to what she had experienced on her October 6th ER visit (although she is also recorded as
having told initial treaters that her trembling symptoms had been recurring for a month, which
would place their onset before receipt of the flu vaccine). Pet’r’s Ex. 3 at 11; Pet’r’s Ex. 2 pt. 2 at
37. An initial examination (consistent with prior exams) again revealed no identifiable problems,
and in particular noted no focal neurologic findings. Pet’r’s Ex. 3 at 11. However, the intake
impressions noted (consistent with Dr. Fanta’s prior speculation) that Ms. Auch may have been
experiencing an allergic reaction to the flu vaccine. Pet’r’s Ex. 2 pt. 2 at 42, 44; Pet’r’s Ex. 3 at
11. Her potassium was also deemed low. Pet’r’s Ex. 2 pt. 2 at 37.
Ms. Auch was subsequently admitted to the hospital overnight for treatment of her claimed
symptoms and observation. Pet’r’s Ex. 2 pt. 2 at 44. Upon admission, she was given Solu-Medrol,3
an anti-inflammatory glucocorticoid used to treat pain and swelling that occurs with arthritis and
other joint disorders.4 Id. The next day, the attending physician, Dr. Dori Bigner, performed a
thorough review of symptoms aimed at finding an explanation for Petitioner’s ongoing symptoms.
See generally Pet’r’s Ex. 2 pt. 2 at 38-41. Her neurologic examination again revealed nothing
notable that could explain her symptoms, although no imaging diagnostics were performed. Id. at
39. Dr. Fanta (who also saw Petitioner on October 14th) observed that Petitioner displayed focal
weakness primarily in the lower, rather than upper, extremities and that she had weakness in her
quadriceps and lower legs bilaterally. Id. at 45. The differential diagnosis included Guillain-Barré
syndrome (“GBS”) versus an unspecified myositis (which was deemed possibly linked to a prior
viral infection Petitioner reported from August), and it was proposed that Ms. Auch obtain a
3
Solu-Medrol is a trademark name for a preparation of methylprednisolone sodium succinate. Dorland’s Medical
Dictionary 1731 (32nd ed. 2012) (hereinafter Dorland’s). Methylprednisolone sodium succinate is a synthetic
glucocorticoid, administered by intramuscular or intravenous injection, and is used in replacement therapy for
adrenocortical insufficiency and as an anti-inflammatory and immunosupressant. Id. at 1154. It is chiefly used for the
rapid achievement of high blood levels of methylprednisolone in short-term emergency treatment. Id.
4
It does not appear from the filed medical records (particularly those specifically recording medications that Ms. Auch
received while hospitalized) that Ms. Auch continued to receive Solu-Medrol, or any other corticosteroid, after the
first day of her admission to the hospital following her October 13, 2009, ER visit. See Pet’r’s Ex. 2 pt. 1 at 49-55.
3
consultation with the neurology department to evaluate whether a lumbar puncture or
electromyography (“EMG”) test5 was necessary. Id. at 40.
Petitioner remained an in-patient for the next five days at Avera McKennan Hospital while
she obtained her neurology evaluation. See generally Pet’r’s Ex. 2 pt. 1 at 1-5. During this time,
she underwent a number of tests, including a brain MRI that revealed no evidence of demyelinating
disease, a cervical spine MRI which showed a congenitally small cervical spinal canal, and an
echocardiogram, which was normal. Id. at 1. She also underwent a neurologic diagnostic lab test
which suggested possible postural orthostatic tachycardia syndrome (“POTS”),6 though it was
noted that Petitioner did not exhibit the typical findings often seen with this disorder. Id. Petitioner
was started on Florinef7 to help any symptoms that might be due to autonomic dysfunction. Id. at
2. Dr. Todd Zimprich, the neurologist who reviewed the test results suggestive of a possible POTS
diagnosis, noted that there was no convincing evidence of a “more diffuse autonomic disorder.”
Id. at 9.
The contemporaneous records also reveal that on October 15, 2009, during Petitioner’s
five-day in-patient evaluation at Avera, an EMG was performed. The medical records and notes
regarding the EMG test reinforced Dr. Zimprich’s original opinion that the test results were
“unremarkable,” in that they showed “no convincing evidence of
polyradiculopathy/polyradiculoneuropathy.” Pet’r’s Ex. 2 pt. 1 at 2; Pet’r’s Ex. 60 at 1. Dr.
Zimprich’s records interpreted these first EMG results as somewhat unreliable due to Petitioner’s
poor tolerance for the testing itself. Pet’r’s Ex. 60 at 1. Nevertheless, he found no convincing
evidence of any polyradiculoneuropathies, plexopathies, or mononeuropathies affecting the upper
and lower extremities, as well as no evidence of any other myogenic disorder. Id.
A handwritten addendum to the original medical record from this visit, prepared in
December 2016 by one of Ms. Auch’s former treaters and only recently filed in this action,8
5
EMG is a diagnostic procedure to assess the health of muscles and the nerve cells that control them (motor neurons).
See Dorland’s at 602.
6
POTS is made up of symptoms that sometimes occur when a person assumes an upright position, including
tachycardia, tremulousness, light-headedness, sweating, and hyperventilation. Dorland’s at 1844. The etiology is
uncertain. Id.
7
Florinef is the trademark name for fludrocortisone acetate, which is the acetate salt of a synthetic steroid with potent
mineralocorticoid and high glucocorticoid activity, used in replacement therapy for primary or secondary
adrenocortical insufficiency in different treatments and is administered orally. Dorland’s at 718-19.
8
At hearing, it was revealed that Petitioner had never obtained a copy of the actual EMG results, and thus the doctor’s
notes referencing the fact that an EMG had been performed and characterizing its results as unremarkable were the
only evidence of its findings. Pet’r’s Ex. 2 pt. 1 at 2; Tr. at 131. After trial, I asked Petitioner to produce a copy of the
actual EMG results if possible. Tr. at 226-27. Initially, Petitioner represented that she still could not obtain the EMG
results. See Status Report, dated October 13, 2016 (ECF No. 84). Then, on December 29, 2016, Petitioner
unexpectedly filed two documents: a handwritten addendum to Dr. Bigner’s record from Petitioner’s October 2009
4
explains that while Petitioner’s EMG test results showing mild neuropathy in the wrist would
normally suggest carpal tunnel syndrome, Dr. Zimprich found it more likely to be a false result
due to technical factors, rather than evidence of an actual underlying neuromuscular disease.
Pet’r’s Ex. 59 at 5. The addendum also states that the EMG test was done in conjunction with other
testing that revealed some evidence of POTS, leading to the ultimate POTS diagnosis on discharge.
Id.
During this stay, Petitioner also received non-steroidal anti-inflammatory drugs, but was
not given additional doses of Solu-Medrol or any other steroids. Pet’r’s Ex. 2 pt. 1 at 47-55. A
Lyrica trial was recommended (Pet’r’s Ex. 2 pt. 1 at 45, 54), in addition to the Cymbalta she was
already prescribed for depression. Pet’r’s Ex. 2 pt. 1 at 46.
Upon discharge, Ms. Auch’s treaters still could not identify the etiology of her symptoms.
POTS was identified as the most likely diagnosis, however. Pet’r’s Ex. 2 pt. 1 at 2. It was
recommended that Ms. Auch continue treatment with Dr. Fanta, but also that she possibly obtain
a POTS evaluation at the Mayo Clinic in Rochester, Minnesota. Id. at 4. Petitioner again repeated
her concerns that her illness might be related to her October 6th flu vaccination, and although her
treaters did not put much stock in the assertion, they encouraged her to report her symptoms to the
CDC Vaccine Adverse Events Reporting System9 website. Id. at 3. They also allowed for the
possibility that Petitioner’s autonomic instability might have been exacerbated by her anxiety. Id.
Two days after discharge, on October 21, 2009, an ambulance took Petitioner from her
home to Avera Sacred Heart Emergency Room in Yankton for her third ER visit that month. Pet’r’s
Ex. 4 at 2. At hearing, Petitioner recalled feeling funny again and that she was now unable to move.
Tr. at 40. She also testified that she “had all this pain and numbness and stuff in [her] legs and
[her] hands were numb.” Id. Petitioner specifically noted at hearing that she was in pain at this
time – although the contemporaneous record reflects that Petitioner denied such pain when asked
by the emergency responders. Pet’r’s Ex. 4 at 2. Petitioner relayed to the EMS responders that she
had been diagnosed with POTS and that a treater had suggested that her symptoms might be linked
to GBS. Id. at 1-2. The responder’s notes stated that Petitioner might be experiencing a “debatable”
flu shot reaction. Id. at 4.
evaluation at Avera McKennan and dated December 22, 2016, and the actual EMG results along with Dr. Zimprich’s
impressions. ECF No. 89 (Pet’r’s Exs. 59 and 60).
9
VAERS is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and
Prevention and the Food and Drug Administration, and allows individuals who believe they may have experienced a
vaccine reaction to make a report of the incident. See https://vaers.hhs.gov/index (last visited Dec. 28, 2016). Because
it is a passive reporting system, VAERS database findings that a number of individuals have complained of a supposed
adverse effect from a particular vaccine does not imply causation, but such evidence can still be used as a means to
find potential signals of causation.
5
Once Petitioner reached the ER, she characterized the incident as “another spell,” repeating
her claim that she could not walk or feel her legs, which felt numb and tingly. Pet’r’s Ex. 18 at 1-
3. However, she noted that she felt a bit better by the time she reached the hospital, and in fact was
able to walk after being seen by a treater. Id. at 1-2. The doctor’s impression was that she had
“transient” syndrome, which included numbness, tingling, and partial paralysis of her lower
extremities. Id. The ER treater proposed that the symptoms could be stress-related, but he lacked
the expertise to rule out a more ominous type of autonomic nerve dysfunction or demyelinating
disorder and felt that he could not further assist her since her reported symptoms had dissipated.
Id. Dr. Robert Neumayr (who also served as an expert in this case) noted in an October 22, 2009,
treatment record that the source of Ms. Auch’s problems was largely unclear (and specifically that
there were no focal neurologic findings), but that they dated from her receipt of the flu vaccine.
Pet’r’s Ex. 3 at 9.
B. Subsequent Treatment through the End of 2009
Petitioner obtained at-home treatment with Avera Sacred Heart Home Care from October
24, 2009, to November 4, 2009. During this time period, Ms. Auch utilized a walker and still
experienced “spells” after walking for extending periods of time. Pet’r’s Ex. 5 at 1. The Home
Care specialist’s notes specifically reveal that Petitioner had coordination difficulty, as well as a
slow and unsteady gait pattern. Id. at 1, 37. However, by the end of the treatment, Petitioner stated
that she was feeling “improved” every day and did not want to use her walker anymore. Id. at 14.
Petitioner was seen for follow-up visits at Yankton Medical Clinic on October 22, 2009,
and October 30, 2009. Pet’r’s Ex. 3 at 8-9. Dr. Fanta noted that Petitioner had received an apparent
diagnosis of POTS, but admitted that she lacked the expertise with autonomic disorders to confirm
the accuracy of the diagnosis, again stressing the need to seek POTS-specific treatment at a proper
care center (by this point, the Mayo Clinic had reportedly declined to see Ms. Auch, despite the
recommendation at her prior hospitalization discharge that she obtain a POTS evaluation there).
Id. at 8. Dr. Fanta’s notes also stated that Dr. Zimprich, who had performed the neurological testing
on Petitioner during her hospital admission earlier that month, did not ask to see Petitioner for any
follow-up. Id. Petitioner continued to report periods of weakness to the point of hardly functioning,
however. Id.
Petitioner was seen again by Dr. Fanta on November 16, 2009. Pet’r’s Ex. 3 at 3. Dr. Fanta
now stated that Ms. Auch (who remained “functionally limited” in light of her persistent
symptoms) had “probable” POTS, given that Petitioner’s symptoms were fairly consistent with
that condition. Id. at 3-4. Dr. Fanta also stated that Petitioner’s dyspnea10 was concerning, and she
wanted a cardiologist to examine Petitioner. Id. at 4. On November 17, 2009, Petitioner was seen
for a cardiac consultation at Yankton Medical Clinic. Id. at 1. A dobutamine stress echo test was
10
Dyspnea is defined as breathlessness or shortness of breath. Dorland’s at 582.
6
performed, and the notes discussing the results reveal that Petitioner experienced hyperventilation,
which “caused reproduction of symptoms of numbness and tingling in her feet and arms” along
with weakness. Id. at 1-2. The treater responsible for this testing proposed that these symptoms
were likely “induced” by the hyperventilation. Id.
Later that same month, Petitioner was seen at the CentraCare Health Center in St. Cloud,
Minnesota, for an assessment relating to POTS and/or other autonomic problems. Pet’r’s Ex. 8 at
3. Dr. David Benditt, the treater who performed the assessment, noted his suspicion that the prior
POTS diagnosis was a false positive, especially because additional attempts to reproduce the
earlier results supportive of the diagnosis from her October hospitalization had failed, and because
Petitioner was in an unstable state at the time of diagnosis due to her concomitant sickness. Id. at
4, 6. Dr. Benditt’s notes further reflect that by this point, Ms. Auch’s parasthesias were declining,
and Petitioner was becoming less limited by the severity of her reported symptoms. Id. at 4. His
examination also revealed no evidence of any ongoing inflammatory disease. Id. at 6. Dr. Benditt
proposed that Petitioner might have suffered from a hypersensitivity reaction to the flu vaccine,
which might have in turn triggered a sensory neuropathy resulting in parasthesias in the periphery.
Id. Regardless, he predicted that Ms. Auch would soon be able to again live a productive life.
C. Treatment of Other Illnesses in 2010
Petitioner continued to be seen for various complaints over the next year – although the
records reveal a cessation, for several months, in complaints of neuropathic symptoms of the sort
she alleges to have experienced in October and November 2009. Thus, in March 2010, she was
seen at Yankton Medical Clinic for abdominal pain and a CT scan was ordered. Pet’r’s Ex. 12 pt.
2 at 44. These records make no reference to either Ms. Auch’s October and November 2009
symptoms or vaccination, and her presenting symptoms were otherwise treated as if unconnected.
She was next seen for a follow-up on April 29, 2010, regarding possible diverticulitis. Pet’r’s Ex.
12 pt. 2 at 40. The records from this visit referenced her visits to the doctor earlier in 2010, but
otherwise pertained only to her then-stated reason for seeking medical intervention, and thus did
not reference her fall 2009 symptoms. Id. (Petitioner “offers no other concerns or complaints at
this time”).
Two months passed without Ms. Auch seeking any medical treatment. Then, in June 2010,
Petitioner went back to the Yankton Clinic for treatment of her ongoing depression. Pet’r’s Ex. 12
pt. 2 at 34-35. At this time, Petitioner discussed her antidepressant regime and the fact that she
often experienced a variety of emotional symptoms connected with her depression. Id. As with her
doctor’s visits for treatment of her diverticulitis, however, Ms. Auch made no mention at all of her
prior, allegedly vaccine-related, symptoms. By this point, Ms. Auch was again working – now as
a home care service provider to handicapped individuals. Tr. at 76-77.
7
D. Polyneuropathy Diagnosis in 2010
Toward the end of the summer of 2010, Ms. Auch experienced neuropathic symptoms
severe enough to compel her to seek treatment. Thus, on August 2, 2010, she returned again to the
Yankton Medical Clinic, where she was seen by Dr. Terrance Pederson. Pet’r’s Ex. 12 pt. 2 at 32.
Petitioner reported that she had a lot of burning pain in both of her feet and described these
symptoms as “something new here in the last few days.” Id. She did not link these to her symptoms
that she had been seen for previously in October 2009, nor did she even make mention of them;
by contrast, she compared the symptoms she was experiencing to her fibromyalgia. Id. Ms. Auch
was prescribed medication for her pain, and it was recommended that she pursue a neurologic
consultation to evaluate if she was suffering from some kind of peripheral neuropathy. Id.
On August 4, 2010, Petitioner was seen by a neurologist, Dr. Jugal Raval, to whom she
now reported (and contrary to the August 2nd record) that the burning pain in her feet had been
occurring for the last couple of months. Pet’r’s Ex. 12 pt. 2 at 28. She also informed Dr. Raval that
she had received a flu shot “three years ago,” and that she was unable to walk for almost three
months after the vaccination. Id. Her history of depression and fibromyalgia were also recounted.
Id.
Dr. Raval conducted an examination of Ms. Auch. The neurologic component of the
examination (including tests of motor function and reflexes) was normal, with the exception of the
sensory examination, which revealed decreased sensation in glove and stocking distribution.
Pet’r’s Ex. 12 pt. 2 at 29. Dr. Raval diagnosed Petitioner with polyneuropathy, etiology unknown.
Id. He recommended that Petitioner undergo an EMG nerve conduction study (although he made
no reference to the October 2009 EMG).11 Id.
The EMG recommended by Dr. Raval was performed on August 5, 2010, and confirmed
that Petitioner had evidence of both motor and sensory polyneuropathy that was axonal in nature.
Pet’r’s Ex. 12 pt. 2 at 11. Ms. Auch was seen again by Dr. Raval at the end of August 2010, at
which time she reported intermittent fatigue that she felt might have been a function of the
gabapentin she was taking. Id. at 10. Dr. Raval conducted another physical examination which,
again, was largely inconclusive, and he proposed that she had some kind of polyneuropathy, the
etiology of which remained unknown. Id. He recommended that she stop taking the gabapentin to
see if that alleviated her reported fatigue. Id.
Petitioner’s follow-up visits to doctors relating to her 2010 polyneuropathy diagnosis
continued throughout the rest of 2010 and into the ensuing years. She continued to report pain all
11
Dr. Raval’s treatment notes do reference the fact that a different EMG was performed at some unspecified time in
the past to evaluate pain in Ms. Auch’s left ankle. Pet’r’s Ex. 12 pt. 2 at 28. They do not mention the October 2009
EMG.
8
over her body and tingling and numbness in her hands. See, e.g., Pet’r’s Ex. 12 pt. 1 at 38 (June
30, 2011, treatment record prepared by Dr. Raval). She also reported symptoms of being unable to
walk distances due to her peripheral neuropathy and the pain sensation that developed in her feet.
Id. at 34. The etiology for her symptoms remained unidentified, however, and the records do not
reflect any speculation as to what caused her polyneuropathy from any of the doctors. Petitioner
for her part speculated to her doctors that certain events in the past might have caused her current
condition, including a chemical spill she cleaned up when she worked at a hospital. Pet’r’s Ex. 14
at 2. Petitioner’s lab results during this time were unremarkable and showed no signs of other
issues. See, e.g., Pet’r’s Ex. 12 pt. 1 at 24.
Ms. Auch was placed on methadone to help manage her pain levels, followed by a switch
to hydrocodone. Pet’r’s Ex. 10 at 6. Her medicines continued to be monitored, as she reported at
the Siouxland Surgery Center that she felt dizzy from the drugs she was taking. Id. at 3. Petitioner
was placed on disability leave beginning in March 2012 (Pet’r’s Ex. 15), and continued to follow
up with doctors for her symptoms from polyneuropathy through 2012. Pet’r’s Ex. 12 pt. 1 at 20.
There are no subsequent records identifying a proposed cause for her symptoms.
II. Fact Witness Testimony
Petitioner presented five witness affidavits: one from Brittany Arens,12 Petitioner’s
daughter; one from Julie Broders, Petitioner’s sister; one from Rhonda K. Surface, another of
Petitioner’s sisters; one from Leo Hallan, an individual for whom Petitioner provided in-home
care; and one from Robert Foxhoven, an employee at Petitioner’s place of employment, First
National Bank of Omaha. ECF No. 37 (Pet’r’s Exs. 21-24). At hearing, however, only Ms. Arens
and Ms. Surface testified as fact witnesses, along with Petitioner herself. Pet’r’s Ex. 25; Tr. at 4,
14, 25.
Ms. Auch largely testified about her receipt of the vaccine itself and her symptoms in the
days and weeks immediately following, as well as the difference in her abilities before and after
the vaccination.13 Tr. at 26-27. She generally stressed the debilitating nature of the symptoms, and
persuasively explained how disconcerting it had been to experience them and the toll they had
taken on her life. Id. at 34-35, 45-47. She also attempted generally to distinguish the symptoms
she experienced after receipt of the flu vaccine from those she had previously associated with her
fibromyalgia, characterizing the latter as less severe and alarming. Tr. at 38.
12
Brittany Arens’s Affidavit is signed by Brittany Auch, her maiden name. By the time of the hearing, her name had
changed to Brittany Arens, because she married in the intervening period. Tr. at 4.
13
Petitioner’s testimony was for the most part consistent with the filed medical records, although not all of the events
that occurred were addressed. She also did not discuss the gaps from the end of 2009 and the summer of 2010, when
her polyneuropathy was formally confirmed.
9
The other fact witnesses recounted the changes they had witnessed in Petitioner after her
receipt of the flu vaccine. All testified that prior to the vaccination, Petitioner was active and
enjoyed several activities, such as long shopping trips (Tr. at 6, 8), riding several miles on her
bicycle (Tr. at 18), and gardening (Tr. at 18). Ms. Auch had also been very active in her community
and with her children. Tr. at 6, 16, 34. Petitioner also testified that she was involved in the church,
and she spent a lot of time gardening and canning vegetables, which she enjoyed. Tr. at 34.
Though Ms. Auch acknowledged that she had suffered from fibromyalgia prior to the
vaccination, the witnesses averred that Petitioner was able to cope with its effects well. Tr. at 11,
20. But there was a “dramatic change” after the vaccination, and Petitioner was very limited in
what she could do going forward given the pain. Id. at 17. Thus, Ms. Arens recalled a visit home
while in college during which she noticed that Petitioner was unable to stand for long periods and
spent much of the time using a walker to get around the house. Id. at 8. Ms. Surface noted that
Petitioner was unable to ride her bicycle anymore, could not walk more than a block or two without
struggling, and had issues controlling her weight due to her inability to exercise. Id at 17-18.
Petitioner herself admitted that she had to use a motorized cart while shopping because she could
not walk around an entire store without pain. Id. at 46. Additionally, she previously acted as a
caregiver to a paraplegic from 2006-2009, which she was eventually unable to continue doing
because of her weakness and numbness. Pet’r’s Ex. 23 at 2. Overall, Petitioner testified that her
constant pain and numbness had taken away her ability to participate in activities she once enjoyed
and worsened over time. Tr. at 47.
III. Expert Testimony
A. Dr. Robert Neumayr
Petitioner’s initial expert report filed in the action came in the form of a one-page letter
from Dr. Neumayr, one of her treaters14 at Yankton Medical Clinic from October 2009 (although
the record does not suggest that his care of Petitioner, or direction of treatment, predominated
over other caregivers from this same period, such as Drs. Fanta or Zimprich). See Letter, dated
May 21, 2014, filed as Pet’r’s Ex. 28 (ECF No. 52-2) on June 4, 2014 (“First Neumayr Rep.”).
Dr. Neumayr’s initial opinion letter was perfunctory and conclusory; beyond setting forth an
opinion as to the causal role of the flu vaccine in Ms. Auch’s polyneuropathy, the letter provided
no explanation or scientific support for its statements.
14
Dr. Neumayr is a practicing doctor in the Internal Medicine Department at Yankton Medical Clinic, P.C., in
Yankton, South Dakota, where he treats Ms. Auch as a patient. Dr. Neumayr received his B.S. in Pharmacy and M.S.
in Pharmacology from South Dakota State University, followed by a PhD in Pharmacology from the University of
Utah in 1974. Pet’r’s Ex. 29 at 1. He received his M.D. from the University of Utah in 1975, and completed a residency
in internal medicine at the University of Utah Affiliated Hospitals from 1975-1978. Id. He is board certified in internal
medicine, a member of the American Medical Association, and holds an active license to practice medicine in South
Dakota. Id. Dr. Neumayr has also conducted research in various areas of neuropharmacology, specifically in the study
of the central control of the autonomic nervous system. Id. at 2.
10
At a subsequent status conference held in June 2014, I noted to Petitioner that Dr.
Neumayr’s report was substantively thin, and Petitioner agreed, stating that Dr. Neumayr
intended to file a follow-up report. See June 18, 2014 Scheduling Order (ECF No. 53). I therefore
ordered her to do so – and after receiving two extensions of time in which to act, Petitioner filed
a second report from Dr. Neumayr on October 20, 2014. See Report, dated October 16, 2014,
filed as Pet’r’s Ex. 30 (ECF No. 57-1) (“Second Neumayr Rep.”).
The second report from Dr. Neumayr is still in letter form, but is now three pages in length
rather than one. In it, Dr. Neumayr recounts Ms. Auch’s October 2009 symptoms and related
treatment. Second Neumayr Rep. at 1. He sets forth the opinion that a polyneuropathy is an
autoimmune condition, and that it is “well established” that the flu vaccine can cause such a
condition – although his second report included no medical citations or references in support of
this contention. Id. at 2. He went on to propose that Ms. Auch’s immune system appeared to be
“hypersensitive” to the flu vaccine, as evidenced by her initial immediate reaction, noting that he
had (when treating Ms. Auch in October 2009) proposed that she had experienced an allergic
reaction to the vaccine. Id. at 3. He also stated that the seven-day period that elapsed from the
time of her vaccination to her second round of symptoms was medically appropriate for an
autoimmune reaction – again without offering medical or scientific support for the point. Id.
Dr. Neumayr was not called as a witness at the August 2016 hearing.
B. Dr. Lawrence Steinman
Petitioner offered Dr. Steinman’s expert report in reaction to Dr. Lancaster’s report
(discussed in more detail below) filed by Respondent. The core of Dr. Steinman’s opinion is
reflected in his written report, although he provided some additional detail in his testimony at
hearing as well. See Report, dated July 5, 2015, filed as Pet’r’s Ex. 31 (ECF No. 65-1) (“Steinman
Rep.”).
Dr. Steinman is a professor in Stanford University’s Departments of Neurology, Pediatrics,
and Genetics, and the chair of Stanford’s Immunology Program. Steinman Rep. at 2-3; see also
Pet’r’s Ex. 32 (Dr. Steinman’s curriculum vitae). He has been elected to the Institute of Medicine
(“IOM”) in neurology, and he has published more than 400 articles, including articles related to
his research on autoimmune disease and molecular mimicry. Pet’r’s Ex. 32 at 2. He is also board
certified by the American Board of Psychiatry and Neurology. Id. Dr. Steinman’s research appears
to focus more on the central nervous system and related neuropathies, as opposed to peripheral
neuropathies.
11
Dr. Steinman’s report proposes a theory that he has advanced in many other Vaccine
Program cases: that the flu vaccine can prompt an autoimmune response, causing individuals to
experience a demyelinating injury to the central or peripheral nervous system (here, an
inflammatory polyneuropathy affecting the limbs).15 Given his overall experience studying not just
central nervous system illnesses, like multiple sclerosis, but the autoimmune character of those
conditions, he was qualified to testify on the issues in dispute in this case.
Thus, Dr. Steinman opined that the version of flu vaccine that Ms. Auch received (Fluzone)
contained wild flu virus strains that have protein components that are capable of cross-reacting
with the structures of myelin basic protein – a primary component of human nerves. Steinman
Rep. at 3-5, 13-16. As a result, an autoimmune process begins, encouraging the production of
antibodies that erroneously attack self-cells and structures. Tr. at 89-90. For a polyneuropathy such
as that Ms. Auch alleges to have experienced, Dr. Steinman proposed that the nerve axon, rather
than its sheath, was the primary target (via nerve gangliosides on the axon surface), making the
disease in this case a bit different from a more acute form of neuropathy, such as GBS, which is
characterized by an autoimmune attack on the nerve myelin sheath and is associated with greater
amounts of inflammation and demyelination. Steinman Rep. at 10-13, 17; Tr. at 93-94.
Dr. Steinman offered the mechanism of molecular mimicry to explain how the flu vaccine
could prompt an autoimmune reaction. Steinman Rep. at 9-17; Tr. at 90. In essence, molecular
mimicry is defined as a “sequence and/or conformational homology between an exogenous agent
(foreign antigen) and self-antigen leading to the development of tissue damage and clinical disease
from antibodies and T cells directed initially against the exogenous agent that also react against
self-antigen.” Institute of Medicine, Adverse Effects of Vaccines: Evidence and Causality at 70 (K.
Stratton et al., eds. 2012) [hereinafter “Adverse Effects of Vaccines”]; see also L. Steinman,
Autoimmune Disease, 269 Scientific American 106-14 (Sept. 1993) (Pet’r’s Ex. 55). Dr.
Steinman’s expert report provided a highly detailed walkthrough of possible mimics between
protein sequences contained in components of the flu vaccine and of the myelin basic protein,
offering substantial research involving other demyelinating illnesses or the wild flu virus to
corroborate his opinion.16
15
See, e.g., Dillon v. Sec’y of Health & Human Servs., No. 10-850V, 2013 WL 3745900, at *9 (Fed. Cl. Spec. Mstr.
June 25, 2013) (denying entitlement to a petitioner who alleged the influenza vaccine caused her demyelinating
transverse myelitis), mot. for review den’d, 114 Fed. Cl. 236 (2014); Brown v. Sec’y of Health & Human Servs., No.
09-426V, 2011 WL 5029865, at *21 (Fed. Cl. Spec. Mstr. Sept. 30, 2011) (finding the influenza vaccine more likely
than not caused a petitioner’s demyelinating injury of acute disseminated encephalomyelitis).
16
Thus, Dr. Steinman’s report attempts to identify the specific protein peptide sequence found in components of the
flu vaccine that would be homologous (meaning corresponding in structure, position, origin, etc. (see Dorland’s at
868)) to like sequences found in the myelin basic protein. See, e.g., Steinman Rep. at 14-15. I note, however, that
Vaccine Program petitioners are not required to establish a specific biological mechanism. Knudsen v. Sec’y of Health
& Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). More importantly, my decision does not turn on Petitioner’s
success in establishing a plausible causation theory (and in any event, the causation theory espoused herein has found
12
Dr. Steinman next engaged in an overview of Ms. Auch’s medical history, linking it to his
theory. Steinman Rep. at 5-8. He largely accepted the factual summary and conclusions about her
history as set forth in Dr. Neumayr’s letter, however, without any separate analysis of his own.
Significantly, he differentiated Ms. Auch’s reported initial reaction to the flu vaccine as probably
the product of an allergic reaction to it (akin to Dr. Neumayr’s “hypersensitivity” hypothesis) from
the symptoms she reported the following week (and that Petitioner alleges were the true start of
her polyneuropathy). Steinman Rep. at 7-8; Tr. at 96-98, 145-46.
As support for the claimed injury, Dr. Steinman made special reference to the “nerve
conduction study done 10 months after the FluZone vaccination,” or on August 5, 2010 – despite
the fact that the first such study (performed in the same month as the vaccination at issue) had not
at the time been considered convincing evidence of any neuropathy at all. Pet’r’s Ex. 2 pt. 1 at 2;
Pet’r’s Ex. 60 at 1; Steinman Rep. at 6. His report later attempted to rebut the negative findings
from the first EMG test results, as pointed out by Dr. Lancaster, by arguing that the steroid
treatment that Ms. Auch received just before (Solu-Medrol) might explain the negative result.
Steinman Rep. at 19. At trial, he expanded on this point:
It’s a very potent drug that does a lot of things to the immune
system, the endocrine system. Water metabolism, swelling – swelling in
nerves. There’s just – the good news about the drug, it’s often very powerful
and does a lot of things. The bad news about the drug, it has what we call
pleiotropic effects, many different effects on physiology. So, that could have
been a confound, the fact that she got the Depo-Medrol.17 Not a confound in the
treatment, but a confound in why this test was deemed unremarkable.
It’s something that’s seen with drugs that are used for, let’s say, the chronic version
of inflammatory demyelinating polyneuropathy, . . . you see improvement so rapidly
that it can’t be simply explained as – on the basis of immunologic phenomenon.
Tr. at 135-36.
Dr. Steinman also took issue with Dr. Lancaster’s proposal that the possible cause of Ms.
Auch’s polyneuropathy was diabetes, noting that (a) no treater had ever so proposed, (b) the record
did not include any corroborative proof supporting this possibility, and (c) if in fact Ms. Auch was
diabetic, he reasonably would have expected her treaters to have caught the condition (and so the
fact that they never proposed it was significant). Tr. at 125-28. He also disagreed that her
symptoms reflected a diabetic neuropathy, reasoning in part that onset would be more gradual,
success repeatedly in other Program cases as reliable and persuasive), so this decision will not contain a detailed
recitation of the science and other proof offered in its support.
17
Both in his expert report and trial testimony, Dr. Steinman referred to the steroid Ms. Auch received as “Depo-
Medrol,” but the record reveals that she actually received Solu-Medrol. However, these are both trademarked names
of similar versions of methylprednisolone.
13
rather than the acute symptoms Ms. Auch first displayed in the weeks immediately after she
received the flu vaccine. Id. at 129-30.
C. Dr. Eric Lancaster
Dr. Lancaster testified on behalf of Respondent at hearing and also offered two reports in
this matter. The first was filed on January 30, 2015, and responded to both of Dr. Neumayr’s letter-
reports. See Report, dated January 25, 2015, filed as Resp’t’s Ex. A (ECF No. 59-1) (“First
Lancaster Rep.”). The second, filed on September 14, 2015, responded to Dr. Steinman’s sole
report. See Report, dated September 10, 2015, filed as Resp’t’s Ex. G (ECF No. 69-1) (“Second
Lancaster Rep.”). Dr. Lancaster’s testimony at hearing was in most respects consistent with his
reports, although (as noted below) it leaned more in the direction of his second report on certain
topics.18
Dr. Lancaster is a clinical doctor at the Center for Autoimmune Neurology at the University
of Pennsylvania, as well as an assistant professor of neurology at the University of Pennsylvania.
Resp’t’s Ex. B at 1. He received his M.D. from the University of Maryland in 2003, followed by
a neurology residency at the University of Pennsylvania from 2004-2007. Id. Dr. Lancaster’s
research focuses on antibody-mediated neurological disorders, and he sees patients with complex
autoantibody disorders on a regular basis. Resp’t’s Ex. B at 1.
Dr. Lancaster challenged Petitioner’s contention that she had experienced a
polyneuropathy due to the October 2009 vaccination. And although he did not dispute that she had
been properly diagnosed with a form of peripheral polyneuropathy in 2010 (which his second
report specifically characterized as a “mild, chronic, distal symmetrical polyneuropathy”), he
disagreed that it was in any way linked to her receipt of the flu vaccine in the year before. Tr. at
173-76, 178-79; Second Lancaster Rep. at 2. His testimony also differed from Dr. Steinman’s in
how he evaluated Ms. Auch’s immediate symptoms versus those she experienced in the weeks
after she received the flu vaccine – and how he compared the 2009 symptoms with those from
2010.
Dr. Steinman testified that Petitioner’s symptoms beginning a week after her October 6,
2009, vaccination revealed the onset of her neuropathy, but Dr. Lancaster felt these symptoms
were equally consistent with Ms. Auch’s preexisting conditions such as fibromyalgia. Tr. at 173.
Based on his review of the medical records, Dr. Lancaster felt that immediate treaters appropriately
included peripheral neuropathy in the differential diagnosis, but the extremely acute and
18
Thus, Dr. Lancaster’s first expert report reacted to Dr. Neumayr’s two fairly bare-bones letter-reports, while the
second addressed Dr. Steinman’s lengthier and more substantive opinion. In addition, at trial Dr. Lancaster was more
emphatic in agreeing with Petitioner’s 2010 diagnosis of a polyneuropathy; at the time of his first report, by contrast,
he was skeptical of the diagnosis. See First Lancaster Rep. at 15.
14
reportedly-debilitating nature of the symptoms (“very rapid development of the weakness over a
period of seconds”) made a demyelinating injury unlikely (which would take longer to manifest in
his experience). Id. at 174-75. He also noted that these reported symptoms were not corroborated
by any other signs of a peripheral neuropathy, such as reflex function or sensory function, or test
results. Id. at 175, 203-04. And he questioned whether an individual suffering from a severe
neuropathic injury characterized by sudden limb malfunction could have the symptoms improve
so quickly as well. Id. at 175 (“[a] patient with Guillain-Barré will worsen over hours, but they
can’t suddenly get all better and then suddenly get all sick and then suddenly get all better again
over just the course of hours to days.”); Second Lancaster Rep. at 4.
In addition to the above, Dr. Lancaster found persuasive the results of the neurologic work-
up Ms. Auch received in October 2009 from treaters like Dr. Zimprich. Tr. at 177; Second
Lancaster Rep. at 2. Her treaters had specifically sought input from specialists to evaluate if a
neuropathy such as GBS were present, and then after a series of tests (including the October 2009
EMG), determined it was not. Pet’r’s Ex. 2 pt. 1 at 9. And treatments that would have been
considered if in fact Ms. Auch’s neuropathy was acute enough to affect her limb function, such as
plasmapheresis or IVIG, were neither proposed nor provided. Tr. at 192.
Dr. Lancaster also, however, considered Ms. Auch’s reported immediate symptoms to be
more significant than Dr. Steinman, deeming them as likely related to the symptoms she reported
later that month. Thus, while Dr. Steinman proposed that the blurry vision and sudden symptoms
that Petitioner reported were evidence of an underlying allergic reaction to the flu vaccine, Dr.
Lancaster felt the first-day symptoms were related to the more reportedly-severe symptoms
occurring later that month – all of which he opined were probably attributable to her preexisting
conditions, such as her depression or fibromyalgia. Tr. at 176; First Lancaster Rep. at 15, 22. He
did not accept Dr. Neumayr’s assertion that the flu vaccine might have aggravated some underlying
intolerance, and/or that Ms. Auch even possessed such an intolerance at all based on her claimed
immediate symptoms. Tr. at 189-91; First Lancaster Rep. at 18, 22.
Dr. Lancaster largely accepted the 2010 polyneuropathy diagnosis, observing that the EMG
results corroborated it, along with Dr. Raval’s interpretation of the EMG. Tr. at 184, 199; Pet’r’s
Ex. 12 pt. 2 at 11. But he denied that Petitioner’s illness could possibly be linked to a vaccination
Petitioner had received 10 months before. Tr. at 194-95.19 Simply too much time had passed – with
19
Dr. Lancaster’s reports and hearing testimony also discuss his views as to the likelihood that the flu vaccine could
cause a neuropathy at all, and/or do so via the proposed mechanism of molecular mimicry, questioning whether the
science and related hypotheses included in Dr. Steinman’s expert report and testimony applied herein. Tr. at 192-94;
Second Lancaster Rep. at 5-6. As I informed the parties at the start of Dr. Steinman’s testimony, however, I did not
deem these Althen prong one issues to be central to disposition of this case, and urged both experts to tailor their
testimony accordingly. See, e.g., Tr. at 84-85. In fact, there are numerous Vaccine Program decisions in which the flu
vaccine has been persuasively demonstrated to be causally associated with a variety of central and peripheral
neuropathies. See, e.g., Barone v. Sec’y of Health & Human Servs., No. 11-707V, 2014 WL 6834557 (Fed. Cl. Spec.
Mstr. Nov. 12, 2014); Stewart v. Sec’y of Health & Human Servs., No. 06-777V, 2011 WL 3241585 (Fed. Cl. Spec.
15
a demonstrated cessation of symptoms for most of 2010 – for him to accept that her subsequent
diagnosis was connected to a vaccination received almost a year before.
In rejecting the record evidence about Ms. Auch’s claimed October 2009 post-vaccination
symptoms, while embracing evidence of similar symptoms from 2010 as supportive of a
polyneuropathy diagnosis, Dr. Lancaster placed great stock in the result of the EMG tests
performed at those two points in time. Thus, he noted that if in fact Ms. Auch’s reported symptoms
in the first half of October had been as severe as she claimed (an inability to walk or move coupled
with profound weakness) such that they reflected an acute demyelinating incident or similar nerve
damage, then the EMG test performed in October 2009 should have corroborated that damage –
when in fact the results did not show any convincing evidence of a neuropathy. Tr. at 203-205;
Pet’r’s Ex. 2 pt. 1 at 2; Pet’r’s Ex. 60 at 1.20
Dr. Lancaster was particularly critical of Dr. Steinman’s assertion that Ms. Auch’s normal
EMG results from October 2009 could be explained by the fact that she had recently been treated
with a steroid that may have thrown off the test results. Tr. at 181-83. At trial, he explained in
detail the process of performing an EMG, noting that he had just performed several within a week
of his testimony. Id. at 210. Dr. Lancaster has considerable experience with EMGs, having
performed (and reviewed the results of) around 2,000 in his entire career, while performing 12 to
18 in any given month. Id. at 171. He explained in detail the process of testing – and particularly
the sensitivity of that testing in measuring severity and age of injury to different parts of the nerve.
Id. at 211-13.
In his supplemental report, Dr. Lancaster observed that damage to nerves sufficient to be
diagnosed as a severe polyneuropathy of the kind alleged herein could not be reversed so quickly
merely through receiving a steroidal treatment, such that a subsequent EMG would show nothing
abnormal. Lancaster Supp. Rep. at 6 (“[b]asically, it is completely impossible for a neuropathy to
cause severe numbness or weakness and recover over a few days to such a degree that the
EMG/NCS is normal. Even if steroids completely stopped an inflammatory process, the deficits
would remain visible on a [nerve conduction study] for weeks thereafter as the nerves repaired
themselves”); Tr. at 215. He also noted that if Dr. Steinman’s assertions were correct, then steroids
would in effect function as a cure for severe neuropathies like GBS, when in fact treaters
understood that they did not serve that function (even if they could be ameliorative over time). Tr.
at 216 (“if [steroid treatments] could suddenly normalize your nerve conduction studies, that would
Mstr. July 8, 2011); Daily v. Sec’y of Health & Human Servs., No. 07-173V, 2011 WL 2174535 (Fed. Cl. Spec. Mstr.
May 11, 2011). I therefore do not address herein the portions of the reports or testimony that related to such matters,
which for present purposes are tertiary to the real issues in dispute.
20
Although Dr. Lancaster did not have the benefit of reviewing the October 2009 EMG results at the time he prepared
his reports or testified, they are in fact consistent with his supposition, which was based on the references to the tests
contained in the contemporaneous records. Pet’r’s Ex. 60 at 1.
16
go hand-in-hand with the drug being a miracle cure, . . . and everybody with [GBS], we would
load them up with [the treatment], they’d pop right out of bed and they’d be fantastic.”).21
Finally, Dr. Lancaster proposed an alternative explanation for Ms. Auch’s 2009 symptoms
– diabetes – as more consistent with the record. Tr. at 179-80, 195-96; First Lancaster Rep. at 16-
17. He was not able to point to any such diagnosis in the record, however, admitting that based
upon what records he had reviewed of glucose level testing from blood work, “it is not clear
whether [Petitioner] is diabetic or prediabetic.” First Lancaster Rep. at 16. Dr. Steinman for his
part disputed that Ms. Auch suffered from some form of diabetic neuropathy, noting that he would
have expected some of her treaters to have considered the possibility. The fact that they never
proposed it as a diagnosis in any of the treatment records, despite many opportunities to do so (and
to perform the sorts of tests that would easily confirm existence of the condition) was evidence to
him that it was not deemed an applicable diagnosis to Ms. Auch. Tr. at 129-30. Dr. Steinman also
questioned whether her form of neuropathy had the characteristics of a diabetic form (Tr. at 128-
29).
21
At the very end of the August 2016 hearing, Petitioner recalled Dr. Steinman to the stand for a rebuttal point relevant
to this particular issue. See Tr. at 222-25. Dr. Steinman referenced Respondent’s Exhibit E (M. Dalakas, Pathogenesis
of Immune-Mediated Neuropathies, 1852 Biochimica et Biophysica Acta 4:658-66 (May 2014) (“Dalakas”)) and read
directly from a portion of it. His intent was to show that polyneuropathic symptoms could in fact fluctuate rapidly –
and this would explain both why (a) Ms. Auch’s symptoms appeared to swing so dramatically in October 2009 and
(b) the steroidal treatment that Dr. Lancaster discounted as masking EMG results might in fact have performed as Dr.
Steinman proposed. Id. at 223-24.
The section of the Dalakas article from which Dr. Steinman read, however, does not really support the main
proposition for which it was cited (i.e., that steroidal treatment could cause a sufficiently sudden improvement in Ms.
Auch’s condition to confuse the EMG test results). Entitled “emerging target antigens in the nodal regions: an
explanation for conduction block and rapid recovery,” the section’s focus is the search for the antigen targets that
cause CIDP or other peripheral neuropathies. Dalakas’s authors proposed that one place to look for them was in the
“nodal or paranodal regions” of nerves rather than in the compact myelin. This was based on the fact that two known
effective treatments for peripheral neuropathies – plasmapheresis or IVIG – could produce rapid recovery as reflected
in a patient’s reported pain level or feeling of health, despite the fact that the remyelination process would itself take
much longer. Dalakas at 5. This fact led the Dalakas authors to propose that the treatments were likely inducing a
“‘minute-to-minute’ blockade” at the nodal points that had a salutary effect independent of the remyelination process
– and therefore these nodes might be the location of the antibodies that were at the core of the autoimmune process,
making them a favorable place in which to search. Id.
But the treatments specified in this article are distinguishable from the steroid treatments Ms. Auch received (and
which, as noted above, were administered prior to her first EMG tests). More significantly, the fact that steroidal
treatments might have ameliorated Ms. Auch’s pain, and thus been rapidly effective in making her feel better, does
not mean that they would have thrown off tests that exist to measure underlying nerve function or deterioration. Tr. at
215-16. Dalakas itself notes a difference between the speed at which the treatments it discusses would “work” and the
slower, ongoing remyelination process – a process the EMG is designed explicitly to test, rather than whether a patient
feels better.
Petitioner otherwise offered no literature in support of this rebuttal contention, such as an article discussing what
kinds of factors could skew or impact EMG test results.
17
IV. Procedural History
Ms. Auch filed her Petition on October 4, 2012. ECF No. 1. In it, she alleged that she
suffered significant fatigue, headache, flushing, tingling, nausea, loss of muscle control, lower
extremity weakness, and shortness of breath as a result of her receipt of the influenza vaccination
on October 6, 2009. Pet. at 1-2. After several motions for extensions of time, Petitioner filed
medical records in April of 2013, followed by a statement of completion on May 13, 2013. ECF
No. 23. Petitioner thereafter filed additional medical records. ECF No. 28.
Respondent filed her Rule 4(c) Report on September 30, 2013, asserting that Ms. Auch was
not entitled to compensation because she could not carry her burden of proof under Althen.
Respondent’s Rule 4(c) Report (ECF No. 31). Specifically, Respondent alleged that Petitioner’s
existing significant health issues could account for most, if not all, of the symptoms she attributes
to the flu vaccine. ECF No. 31 at 14. Additionally, Respondent notes that Petitioner told at least
three different providers that the majority of her symptoms preceded vaccination. Id.
The case was re-assigned to me on April 7, 2014. ECF No. 46. After additional extensions
of time, Petitioner finally filed the first opinion letter from Dr. Neumayr on June 4, 2014. ECF No.
52-2 (Pet’r’s Ex. 28). In a subsequent status conference, Petitioner acknowledged that the expert
opinion was only “partially-complete,” and after again requesting several extensions of time,
Petitioner filed a somewhat longer report from Dr. Neumayr. ECF No. 57 (Pet’r’s Ex. 30).
On January 30, 2015, Respondent filed Dr. Lancaster’s first report. ECF No. 59 (Resp’t’s
Ex. A). Petitioner was given the opportunity to file a supplemental expert report in response, and
after an extremely protracted amount of time and admonishments for failing to comply with my
orders, Petitioner filed Dr. Steinman’s report on July 8, 2015. ECF No. 65 (Pet’r’s Ex. 31).
Respondent then filed a supplemental report of Dr. Lancaster in response on September 14, 2015.
ECF No. 69 (Resp’t’s Ex. G).
Thereafter, an entitlement hearing was scheduled for August 24-25, 2016 in Omaha,
Nebraska. ECF No. 70. Petitioner filed her prehearing submissions on June 6, 2016 (ECF No. 76),
and Respondent filed her prehearing submissions on July 1, 2016. ECF No. 78. The parties elected
not to file post-hearing briefs. Tr. at 228-29. After the hearing, Petitioner was directed to file the
medical literature cited by Dr. Steinman in his expert report, which she filed on November 23,
2016. ECF Nos. 86-88 (Pet’r’s Exs. 36-58).
Though it originally had been determined that a copy of Petitioner’s first EMG performed
on October 15, 2009, could not be produced (ECF No. 84), Petitioner was ultimately able to file
those EMG results, as well as Dr. Zimprich’s interpretation of them, on December 29, 2016. ECF
No. 89 (Pet’r’s Exs. 59-60). I have incorporated discussion of these recently-filed record materials
into my decision.
18
V. Applicable Legal Standards
A. Petitioner’s Overall Burden in Vaccine Program Cases
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
she suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table –
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that her illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).22
In this case, Petitioner does not assert a Table claim.
For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d
867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not
only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344,
1352-53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on her assertions;
rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen: “(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.
22
Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings
concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121,
124 (2003), aff’d, 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-
159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
19
Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen, 35 F.3d at 548. Such a theory must only be “legally probable, not medically or
scientifically certain.” Id. at 549.
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325-26). Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of
Health & Human Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility . . . in many cases may be
enough to satisfy Althen prong one” (emphasis in original)), rev’d on other grounds, No. 2015-
5097 (Fed. Cir. Jan. 3, 2017). But this does not negate or reduce a petitioner’s ultimate burden to
establish her overall entitlement to damages by preponderant evidence. W.C. v. Sec’y of Health &
Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted).23
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
23
There is ample contrary authority for the more straightforward proposition that the first Althen prong, like the overall
test itself, simply applies a preponderance standard when evaluating if a reliable and plausible causal theory has been
established. Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1350 (Fed. Cir. 2010). For purposes of
the present analysis, I am stressing those cases focusing on the plausibility of the causal theory proposed, as opposed
to whether preponderant evidence supports it, in order to avoid imposing on Petitioner a greater evidentiary burden
than the law requires. This does not, however, change the fact that any theory’s plausibility, for purposes of satisfying
the Althen test, is properly analyzed by subjecting its components to the Daubert tests for scientific reliability. Terran
v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999). In any event, my decision herein does not
turn on Petitioner’s success in establishing a medical causation theory.
20
However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is
nothing . . . that mandates that the testimony of a treating physician is sacrosanct – that it must be
accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a
theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the
reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence also present in the record – including conflicting opinions
among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742, 749 (2011)
(not arbitrary or capricious for special master to weigh competing treating physicians’ conclusions
against each other), aff'd, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Dep't of Health &
Human Servs., 100 Fed. Cl. 119, 136 (2011), aff'd, 463 F. App'x 932 (Fed. Cir. 2012); Veryzer v.
Sec’y of Health & Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr.
Apr. 29, 2011), mot. for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475
Fed. App’x 765 (Fed. Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” Bazan v.
Sec'y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine
can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health &
Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012),
aff’d mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec'y of Health & Human Servs., No.
11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den’d (Fed. Cl.
Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Law Governing Analysis of Fact Testimony and Evidence
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [] relevant medical and scientific evidence contained in the record,” including “any
diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the
record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury,
condition, or death,” as well as “the results of any diagnostic or evaluative test which are contained
in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then
21
required to weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is
within the special master’s discretion to determine whether to afford greater weight to
contemporaneous medical records than to other evidence, such as oral testimony surrounding the
events in question that was given at a later date, provided that such a determination is evidenced
by a rational determination).
Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s
health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed.
Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his
contemporaneous medical records, the special master’s decision to rely on petitioner’s medical
records was rational and consistent with applicable law”), aff’d, Rickett v. Sec’y of Health &
Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is
based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people
honestly report their health problems to those professionals; and (iii) medical professionals record
what they are told or observe when examining their patients in as accurate a manner as possible,
so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez
v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr.
Apr. 10, 2013); Cucuras v. Sec'y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993
F.2d 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to accurately
report the onset of their daughter’s symptoms. It is equally unlikely that pediatric neurologists,
who are trained in taking medical histories concerning the onset of neurologically significant
symptoms, would consistently but erroneously report the onset of seizures a week after they in fact
occurred”).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneously medical
records are generally found to be deserving of greater evidentiary weight than oral testimony –
especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;
see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd, 968 F.2d
1226 (Fed. Cir.), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v.
United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).
However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon
22
common sense and experience, this rule should not be treated as an absolute and must yield where
the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19
(“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than
those which are internally consistent”) (quoting Murphy v. Sec’y of Health & Human Servs., 23
Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed. Cir. 1992)). Ultimately, a
determination regarding a witness’s credibility is needed when determining the weight that such
testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Human
Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Human
Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In
determining the accuracy and completeness of medical records, the Court of Federal Claims has
listed four possible explanations for inconsistencies between contemporaneously created medical
records and later testimony: (1) a person’s failure to recount to the medical professional everything
that happened during the relevant time period; (2) the medical professional’s failure to document
everything reported to her or him; (3) a person’s faulty recollection of the events when presenting
testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. La Londe v.
Sec’y Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir.
2014). In making a determination regarding whether to afford greater weight to contemporaneous
medical records or other evidence, such as testimony at hearing, there must be evidence that this
decision was the result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory often requires a petitioner to present
expert testimony in support of his claim. Lampe v. Sec’y of Health & Human Servs., 219 F.3d
1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to
the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1339
(Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir.
1999)). “The Daubert factors for analyzing the reliability of testimony are: (1) whether a theory or
technique can be (and has been) tested; (2) whether the theory or technique has been subjected to
peer review and publication; (3) whether there is a known or potential rate of error and whether
there are standards for controlling the error; and (4) whether the theory or technique enjoys general
acceptance within a relevant scientific community.” Terran, 195 F.3d at 1316 n.2 (citing Daubert,
509 U.S. at 592-95).
The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial fora (such as the district courts). Daubert factors are usually
23
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors
are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health
& Human Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742-45. In this matter (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.
Respondent frequently offers one or more experts of her own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d at 1347 (citing Lampe, 219 F.3d at
1362). However, nothing requires the acceptance of an expert’s conclusion “connected to existing
data only by the ipse dixit of the expert,” especially if “there is simply too great an analytical gap
between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v.
Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec’y of Health & Human Servs., No. 08-601V,
2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for review den’d, 108 Fed.
Cl. 743 (2013), aff’d, 540 Fed. App’x 999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339).
Weighing the relative persuasiveness of competing expert testimony, based on a particular expert’s
credibility, is part of the overall reliability analysis to which special masters must subject expert
testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325-26 (“[a]ssessments as to the
reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec’y
of Health & Human Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously
explained that special masters are expected to consider the credibility of expert witnesses in
evaluating petitions for compensation under the Vaccine Act”).
In determining whether a particular expert’s testimony was reliable or credible, I may
consider whether the expert offers an opinion that exceeds his training or competence, whether
across the board or with respect to any particular element of testimony. Walton v. Sec’y of Health
& Human Servs., No. 04-503V, 2007 WL 1467307, at *17-18 (Fed. Cl. Spec. Mstr. Apr. 30, 2007)
(otolaryngologist not well suited to testify about disciplines other than her own specialty). While
(in keeping with the liberality with which evidence offered in Vaccine Program cases is treated) I
heard and have considered all of the testimony of the experts offered at the entitlement hearing, I
may properly evaluate, and give appropriate weight to, whether certain testimony is beyond a
particular expert’s purview. See, e.g., King v. Sec’y of Health & Human Servs., No. 03-584V, 2010
WL 892296, at *78-79 (Fed. Cl. Spec. Mstr. Mar. 12, 2010) (petitioner’s expert far less qualified
24
to offer opinion on general causation issues pertaining to autism than specific issues pertaining to
the petitioner’s actual medical history, given the nature of the expert’s qualifications).
D. Consideration of Medical Literature
Both parties filed medical and scientific literature in this case, including some articles (such
as those discussing molecular mimicry and protein sequences in vaccines) that do not factor into
the outcome of this decision. I have reviewed all of the medical literature submitted in this case,
but I discuss only those articles that are most relevant to my determination and/or are central to
Petitioner’s case – just as I have not exhaustively discussed every individual medical record filed.
Moriarty v. Sec’y of Health & Human Servs., No. 2015-5072, 2016 WL 1358616, at *5 (Fed. Cir.
Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record
evidence even though he does not explicitly reference such evidence in his decision”) (citation
omitted); see also Paterek v. v. Sec’y of Health & Human Servs., 527 F. App'x 875, 884 (Fed. Cir.
2013) (“[f]inding certain information not relevant does not lead to — and likely undermines —
the conclusion that it was not considered”).
ANALYSIS
This case does not turn on Petitioner’s success in establishing the first Althen prong –
although she has satisfied this element of her overall burden of proof. Many other petitioners have
demonstrated that the flu vaccine can cause a variety of neuropathies. See, e.g., Stewart v. Sec’y
of Health & Human Servs., No. 06-777V, 2011 WL 3241585 (Fed. Cl. Spec. Mstr. July 8, 2011)
(petitioner was entitled to compensation in a flu/GBS case); Daily v. Sec’y of Health & Human
Servs., No. 07-173V, 2011 WL 2174535 (Fed. Cl. Spec. Mstr. May 11, 2011) (entitlement proven
on a claim that the flu vaccine more likely than not caused the petitioner to develop chronic
inflammatory demyelinating polyneuropathy); Doe/06 v. Sec’y of Health & Human Servs., 2007
WL 3120297 (Fed. Cl. Spec. Mstr. Oct. 18, 2007) (granting entitlement in a flu/small fiber
neuropathy case). Based on the expert testimony and reports, as well as the submitted literature,
preponderant evidence supports Petitioner’s theory that the flu vaccine could plausibly cause
some kind of neuropathy, whether severe or mild, and also that the proposed mechanism,
molecular mimicry, is a reliable explanation for how the flu vaccine would induce an autoimmune
reaction that would damage an individual’s myelin or nerves.
There are other factual matters that are largely undisputed, or readily resolved in
Petitioner’s favor. For example, the parties agree that Ms. Auch was correctly diagnosed with
some form of polyneuropathy in 2010. Also, I do not find persuasive Respondent’s arguments
that diabetes was a plausible alternative cause for her condition, given that none of her treaters
ever considered the possibility that she even suffered from diabetes, as Dr. Steinman suggested
25
would be expected for a person of Petitioner’s age, and Respondent has not pointed to record
evidence that would support her contention.
The above does not, however, end the analysis. The question before me, based on the record
as interpreted by both side’s experts, is whether in this particular case the flu vaccine Ms. Auch
received in October 2009 caused severe neuropathic symptoms in the ensuing two months,
followed by a lengthy lull, ultimately resulting in a formal diagnosis of polyneuropathy nearly a
year later attributable to the vaccine. This raises a question as to Althen prongs two and three. I
find that it is more likely than not that the flu vaccine did not cause Ms. Auch’s 2010-diagnosed
polyneuropathy.
A. Ms. Auch’s Immediate Symptoms Do not Bear on Her Claim.
The parties dispute somewhat the nature of Ms. Auch’s immediate reaction to the flu
vaccine received on October 6, 2009. As noted above, Petitioner alleges that on the same day she
received the vaccine, she experienced blurry vision and felt a strange and disorienting sensation
that alarmed her enough to cause her to visit the ER. Petitioner distinguishes that reaction from
the symptoms that began either on October 9th or 13th, viewing her initial reaction as an allergic
response to the vaccine not linked to her ultimate polyneuropathy, which she argues began a week
later. Respondent, by contrast, believes all of the October 2009 symptoms are of a piece, and
reflect ongoing fibromyalgia (or perhaps a psychosomatic reaction at the same time). Overall, the
evidence is somewhat confused as to the etiology of Petitioner’s immediate symptoms, making
it difficult to say not only what they really were, but whether they were vaccine-caused, as
Petitioner alleges.24 But I need not resolve those questions, given that Petitioner’s own theory
argues for onset of her claimed injury beginning around a week after vaccination.
B. Petitioner Has Not Demonstrated that Her October 2009
Symptoms Were Neuropathic or Vaccine-Related.
The medical record does not permit the conclusion that Ms. Auch was experiencing a
vaccine-induced neuropathy in October 2009. Beginning with her second ER visit on October 13,
2009, and subsequent hospitalization, Petitioner had the benefit of a fairly comprehensive
evaluation in which a number of possible explanations for her symptoms were explored –
including the flu vaccine. But immediate treaters ultimately rejected the concept that she was
24
Thus, Petitioner alleged, without much evidentiary support beyond Dr. Steinman’s proposal and Ms. Auch’s own
testimony, that Ms. Auch had previously experienced similar reactions to the flu vaccine that could be deemed allergic.
At the same time, however, Respondent proposed the inference (based on some record evidence but not firmly
established) that Ms. Auch may simply have been reacting fearfully to the vaccine, given her past history of anxiety
and the fact that the symptoms she initially reported were not corroborated by treaters.
26
suffering from any kind of acute neuropathy. Not only did no test results corroborate the existence
of a neuropathy, but Ms. Auch’s sudden recoveries from her symptoms (whereby she was able to
ambulate not long after ER trips inspired by her immediately-prior reported inability to do so)
rebut the conclusion that she was, at that time, experiencing a severe neuropathic vaccine
reaction. At most, treaters proposed that Petitioner might be suffering from POTS – yet even that
tentative diagnosis was later abandoned. Pet’r’s Ex. 2 pt. 1 at 1; Pet’r’s Ex. 8 at 4, 6.
Thus, although neuropathy was included in the immediate treaters’ differential diagnoses,
it was never confirmed by any test results or other evidence. Dr. Lancaster also persuasively
established that a true, acute vaccine reaction rising to the level of a neuropathy (like GBS) would
more likely than not have been far more debilitating than what Petitioner actually experienced.
Whatever Ms. Auch’s illness was, it was not deemed a neuropathy – and ultimately no
explanation was offered for its cause. Petitioner has therefore offered insufficient preponderant
evidence to support her proposed explanation for her symptoms.
The October 2009 EMG is an important piece of evidence undermining Petitioner’s
assertion that she was suffering from a neuropathy. Had Ms. Auch been experiencing the kind of
nerve damage from demyelination sufficient to produce total limb malfunction or the degree of
weakness and parasthesias she alleged, an EMG would reasonably be expected to detect it. Tr. at
203-05. Indeed, Respondent’s expert Dr. Lancaster credited the August 2010 EMG as confirming
Ms. Auch’s subsequent polyneuropathy. By contrast, the October 2009 EMG suggested to
contemporaneous treaters that Ms. Auch did not have a demyelinating condition, and therefore
they never so diagnosed her. The now-produced results from that test are consistent with the
treatment record’s references to it. Pet’r’s Exs. 59-60.
Dr. Steinman dismissed the value of the 2009 EMG results, noting that by the time it was
performed Ms. Auch had already received steroid treatments, which in his opinion would likely
mute the results of such a test. But Petitioner did not bulwark that assertion with reliable evidence,
such as literature or medical studies confirming the effect proposed by Dr. Steinman.25 The
medical history also casts some doubt on his assertion. Notably, Petitioner received the Solu-
Medrol the night she was first admitted to the Yankton hospital on October 13, 2009, after going
to the ER for a second time – but the record is devoid of any mention of the drug being administered
again. It thus cannot be assumed that the drug’s potency would persist at the same level when the
EMG was performed two days later, on October 15th.
Moreover, even if the EMG had been performed close enough in time for the drug to
potentially affect the test results, Dr. Steinman did not persuasively establish that a corticosteroid
would inherently do so. On this topic, the specific experience and qualifications of the parties’ two
25
As noted above, the sole piece of literature Dr. Steinman referenced in rebuttal (Tr. at 223-25) did not persuasively
support his argument.
27
testifying experts impacted the weight I give to their counter-assertions. While Dr. Steinman was
a very qualified expert overall for the matters in dispute, and was highly persuasive on matters that
go directly to his prime areas of expertise (such as autoimmune diseases generally or the
mechanisms by which they may occur), I deem him somewhat less qualified on the topic of EMGs
than Dr. Lancaster, who more regularly performs and interprets them in his day-to-day medical
practice. Tr. at 171, 210-13. Dr. Lancaster persuasively explained that receipt of steroids prior to
the administration of an EMG would not, in his experience, result in a “clean” test, as it could not
obliterate all evidence of preexisting demyelination or nerve damage that the test would otherwise
detect – and if it could actually do so in a few days’ time after being administered, it would
constitute an unheralded, miraculous cure for peripheral neuropathies. Rather, it is more likely that
nerve damage beginning not long after Ms. Auch’s October 6th vaccination (as consistent with
Petitioner’s allegations in this case), and severe enough to cause the degree of symptoms she
claims, would be too extensive by more than a week later (especially given her reported symptoms
of total limb dysfunction and numbness) to be masked by a one-time steroidal treatment.
C. Petitioner Has Not Demonstrated that the Flu Vaccine Caused Her
2010 Polyneuropathy.
Petitioner was never diagnosed with any form of neuropathy until August 2010 – ten
months after the vaccination at issue. But no treaters at that time considered the flu vaccine to have
played a role in Ms. Auch’s condition. The medical record also reveals that Ms. Auch’s complaints
about her condition subsided for much of 2010, suggesting that (whatever their cause) the previous
symptoms were no longer an issue – and thus does not help explain how her pain and related severe
symptoms could have subsided from November 2009 until spontaneously flaring up long after.
Nor did Dr. Steinman explain in a persuasive manner how Ms. Auch’s medical history was
consistent with the process he outlined, wherein the flu vaccine might cause a neuropathy, then
become subacute for months on end before reappearing. The evidence does not preponderate in
favor of the conclusion that Ms. Auch’s 2010 diagnosed polyneuropathy is related to her reported
October 2009 reactions.
My conclusion would be the same even if I found that Petitioner’s October 2009 symptoms
were vaccine-caused. As the medical record establishes, those symptoms largely abated less than
two months from the date of vaccination. Several months thereafter passed without any complaint
of pain or symptoms similar in character to those of October 2009. And by the time Ms. Auch was
diagnosed with a polyneuropathy in August 2010, she did not relate the pain and symptoms to her
earlier complaints – and the record also does not suggest they were so related by her treaters.
Petitioner’s experts did not otherwise persuasively link the October 2009 symptoms to those
prompting Ms. Auch to seek treatment in August 2010.26
26
Indeed, given the record in this case, even if I had found that Ms. Auch’s October 2009 symptoms were vaccine-
related, I would not be able to find as well that Petitioner has met the Vaccine Act’s requirement of an injury lasting
more than six months, since there is no evidence that her condition and complaints still existed as of April or May of
28
D. Petitioner’s Proposed Timeframe for Development of Her Alleged Disease
Was Dependent on the Finding that She had Experienced a Vaccine-Caused
Neuropathy in 2009.
Had I found that Ms. Auch’s symptoms beginning around a week after her October 6,
2009, vaccination constituted the onset of a polyneuropathy, then I would also be able to find that
the timeframe in which it began was medically appropriate. Certainly a one-week timeframe for
an autoimmune process of the kind proposed by Dr. Steinman is scientifically reasonable and
reliable. See, e.g., D.S. v. Sec’y of Health & Human Servs., No. 10-077V, 2015 WL 8409472, at
*25 (Fed. Cl. Spec. Mstr. May 19, 2015) (accepting the experts’ opinions that an appropriate
temporal period for the autoimmune process causing GBS to occur is one to six weeks); Salmins
v. Sec’y of Health & Human Servs., No. 11-140V, 2014 WL 1569478, at *18 (Fed. Cl. Spec. Mstr.
Mar. 31, 2014) (one week after the triggering event for an autoimmune condition like GBS to
occur was acceptable).
However, Ms. Auch’s polyneuropathy was not diagnosed until almost a year later – and
Petitioner did not successfully establish that her earlier symptoms were related to those she
experienced the following summer. Nor did she establish that the flu vaccine could otherwise cause
a neuropathic injury that would wax, wane, and then manifest acutely ten months after vaccination.
She also failed to establish that her October 2009 symptoms were neuropathic, as alleged. As a
result (and in particular due to Ms. Auch’s inability to prove by preponderant evidence that the flu
vaccine caused her to experience any neuropathy – as diagnosed in 2010, or as claimed without
diagnosis in 2009), the reasonableness of the timeframe from a theoretical standpoint does not aid
Petitioner given the facts of this case.
CONCLUSION
Petitioner and her family have unquestionably experienced tremendous difficulties in
coping with her symptoms, and she persuasively established at trial the toll they have taken on her
quality of life. But my sympathies for her suffering are an insufficient basis for an entitlement
award. The Vaccine Act permits me to award compensation only if a petitioner alleging a “non-
Table Injury,” as here, can show by medical records or competent medical opinion that the claimed
injury was more likely than not vaccine-caused. Petitioner’s causation theory depends upon my
2010. See Section 11(c)(1)(D)(i); Song v. Sec’y of Health & Human Servs., No. 92-279, 1993 WL 534746, at *3 (Fed.
Cl. Spec. Mstr. Dec. 15, 1993) (a petitioner bears the burden of proving by preponderant evidence that he suffered the
residual effects or complications of a vaccine-related injury for longer than six months), mot. for review den’d, 31
Fed. Cl. 61 (1994), aff’d, 4 F.3d 1520 (Fed. Cir. 1994). The record better supports the conclusion that Petitioner’s
August 2010 diagnosis was unrelated to her earlier reported symptoms, whatever their initial cause; there is too much
of a break in the records between the first set of symptoms from the fall of 2009 and those related to the polyneuropathy
diagnosis to link the two.
29
finding that she experienced onset of a vaccine-induced neuropathy in 2009 that waned before
being diagnosed almost a year later – but the weight of the evidence does not support that
conclusion. Rather, the record facts suggest that any reaction she experienced after receipt of the
flu vaccine was unrelated to her later diagnosis, and I do not find it more likely than not that her
initial reactions and symptoms were the result of a vaccine. There is therefore insufficient evidence
to support an award of compensation, leaving me no choice but to hereby DISMISS this claim.
In the absence of a timely-filed motion for review (see Appendix B to the Rules of the
Court), the Clerk shall enter judgment in accord with this decision.27
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Special Master
27
Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing
their right to seek review.
30