In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-748V
Filed: December 2, 2015
**************************** UNPUBLISHED
NICOLE SOLOMON, *
* Chief Special Master Nora Beth Dorsey
Petitioner, *
* Entitlement; Ruling on the Record;
v. * Decision Without a Hearing; Lack of a
* Medical Opinion; Insufficient Proof of
* Causation; Fibromyalgia;
SECRETARY OF HEALTH * Guillain-Barré Syndrome (“GBS”)
AND HUMAN SERVICES, * Special Processing Unit (“SPU”)
*
*
*
****************************
Amber Wilson, Maglio Christopher and Toale, PA, Washington, DC, for petitioner.
Julia McInerny, U.S. Department of Justice, Washington, DC, for respondent.
DECISION1
On August 19, 2014, Nicole Solomon (“petitioner”) filed a petition for
compensation under the National Vaccine Injury Compensation Program, 42 U.S.C.
§300aa-10, et seq.,2 [the “Vaccine Act” or “Program”]. Petitioner alleges she suffered
symptoms of dizziness, numbness, fatigue, tingling, and pain after receiving the
1 Because this unpublished decision contains a reasoned explanation for the action in
this case, the undersigned intends to post this decision on the website of the United
States Court of Federal Claims, in accordance with the E-Government Act of 2002 §
205, 44 U.S.C. § 3501 (2006). In accordance with the Vaccine Rules, each party has 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). Further,
consistent with the rule requirement, a motion for redaction must include a proposed
redacted ruling. If, upon review, the undersigned agrees that the identified material fits
within the requirements of that provision, such material will be deleted from public
access.
2National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755.
Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the
pertinent subparagraph of 42 U.S.C. § 300aa (2012).
influenza vaccine on September 20, 2011 and the tetanus, diphtheria, and pertussis
(“TDP”) vaccine on October 6, 2011. Petition at 1-2. Petitioner further alleges that her
symptoms are “believed to be consistent with Guillain-Barre Syndrome” (id., ¶ 6) and
that her injuries are “causally connected to an adverse reaction” to her vaccinations (id.,
¶ 8). The case was assigned to the Special Processing Unit of the Office of Special
Masters.
Under the Vaccine Act, compensation may not be awarded “based on the claims
of a petitioner alone, unsubstantiated by medical records or by medical opinion.”
§ 13(a)(1). Petitioner has failed to file the report of a medical expert, and the medical
records do not support petitioner’s claims. For the reasons discussed below, petitioner
has failed to demonstrate that she is entitled to compensation. The petition is dismissed
for insufficient proof.
I. Procedural History
Petitioner indicated she filed her petition on August 19, 2014, without all relevant
medical records due to the impending expiration of the Vaccine Act’s statute of
limitations. Petition, ¶ 2. The next day, she filed some medical records. See Exhibits
1-8 (ECF No. 5). She was allowed additional time to file the remaining records. See
Non-pdf Order, issued Sept. 4, 2014.
During the following month, petitioner continued to file medical records. See
Exhibits 9-14 (ECF Nos. 8, 10-11). The initial status conference was held telephonically
on September 30, 2014. During the call, the parties discussed the time needed for
petitioner to file her remaining medical records and for respondent to file a status report
providing her tentative position regarding petitioner’s claim. See Order at 1 (ECF No.
13). After the call, petitioner filed one more document (her affidavit) on November 3,
2014. See Exhibit 15 (ECF No. 14). On December 1, 2014, petitioner indicated she
had completed her filings. See Statement of Completion (ECF No. 17).
On December 21, 2014, respondent filed a status report indicating her belief that
“settlement discussions [were] not appropriate.” Status Report at 1 (ECF No. 19).
Respondent argued that “petitioner’s correct diagnosis is fibromyalgia syndrome and not
Guillain-Barre Syndrome.” Id.
On January 29, 2015, respondent filed her Rule 4(c) report asserting that
petitioner’s claim should not be compensated. Rule 4(c) Report at 1 (ECF No. 21).
Respondent again argued that petitioner has not established that she suffered from
Guillain-Barré Syndrome (“GBS”) adding that she had not proven her vaccinations
caused her alleged injury, whether categorized as “GBS, fibromyalgia or any other
condition.” Id. at 7. Petitioner was ordered to file the report of a medical expert. See
Order at 1 (ECF No. 22).
Over the next five months, petitioner filed three motions for additional time to file
an expert report. Shortly after the first and second motions, petitioner filed updated
2
medical records and a letter from one of her treating physicians.3 Petitioner did not file
an expert report as ordered.
Instead, on July 21, 2015, petitioner filed a motion for a decision on the record
pursuant to Vaccine Rule 8(d).4 In her motion, petitioner indicated she “has filed all
relevant medical records and affidavits pertaining to this Petition and considers the
evidentiary record closed.” Motion for a Decision on the Record at 1 (ECF No. 30). She
further indicated that she “will not proffer the opinion of a medical expert in support of
vaccine causation of the injury alleged, and consequently elects not to pursue a formal
causation hearing with expert witness testimony.” Id. at 2.
Respondent filed her response approximately one month later (on August 24,
2015). Respondent argued that petitioner’s claim should not be compensated and
instead, should be dismissed. Response at 6 (ECF No. 32).
The matter is now ripe for adjudication.
II. Medical History
The medical records from petitioner’s primary care physician, Dr. Karen
Wendowski, consist mainly of Dr. Wendowski’s copy of records from other providers.
See Exhibit 14. The only record discussing a visit to Dr. Wendowski describes a sick
visit for sinusitis on October 27, 2009. See id. at 20. Petitioner’s condition prior to the
vaccinations alleged as causal can be gleaned from the other medical records filed.
The medical records from petitioner’s allergist, Dr. Wise, show petitioner suffered
frequent upper respiratory infections (“URIs”) since childhood. See Exhibit 7 at 15. She
has undergone back and sinus surgeries,5 has experienced an adverse reaction (hives)
3 See Exhibits 16-17 (ECF Nos. 24, 28). Approximately one week after her first motion
for additional time (on April 8, 2015), petitioner filed updated medical records from her
allergist, Dr. Steven L. Wise. See Exhibit 16 (ECF No. 24). Approximately one month
after her second motion for additional time (on June 30, 2015), petitioner filed a letter
from a neurologist, Dr. Cynthia K. McGarvey, whom she first saw in November 2013
(two years after receiving the alleged causal vaccinations). See Exhibit 17 (ECF No.
28). Because these documents contain statements from petitioner’s treating physicians
regarding her injury, its cause, and the need to avoid future influenza vaccinations, the
undersigned will discuss their contents further in Sections II and IV.
4The Vaccine Rules, which can be found at Appendix B to the Rules of the Court of
Federal Claims (“RCFC”), govern all Vaccine Act proceedings. Vaccine Rule 1(a).
Under the Vaccine Rules, a special master may “decide a case on the basis of written
submissions without conducting an evidentiary hearing.” Vaccine Rule 8(d).
5See Exhibits 6 at 2; 7 at 10, 15; 13 at 86. The medical records indicate petitioner
underwent a tonsillectomy and adenoidectomy in 1983 (when 10 years old) and sinus
3
to sulfa drugs, and has “a history of Bell’s palsy on the right [side] with some slight
residual weakness.” Exhibit 7 at 15.
On May 4, 2010, approximately 18 months prior to the alleged causal
vaccinations (in May 2010), petitioner was seen by her gynecologist for excessive and
frequent menstruation. Exhibit 6 at 22. Around that same time, allergy testing revealed
petitioner suffered from a “significant mold allergy,” and she began receiving injections
for allergen immunotherapy. Exhibit 7 at 15. Approximately one year later (on April 18,
2011), petitioner was described as improving and “tolerating the immunotherapy” with
no intervening sinusitis. Exhibit 7 at 12.
On July 7, 2011, petitioner was treated by her ophthalmologist for a bump and
morning “goop” in her left eye. Exhibit 5 at 3. Although she suffered from itchy eyes
due to her allergies, she reported that the bump did not itch. She also reported that she
treated the same problem in May 2011 with warm compresses and eye drops. Id.
Petitioner’s ophthalmologist removed the bump6 and mentioned that petitioner may wish
to consider Botox therapy for “the aberrant regeneration of her right seventh nerve.”
Exhibit 5 at 5.
Medical records from petitioner’s allergist, Dr. Wise, indicate she suffered a sinus
infection in early September 2011 but was feeling better after ten days of an antibiotic.
Exhibit 7 at 11. Petitioner received the influenza vaccination on September 20, 2011
and the TDP vaccination on October 6, 2011. See Exhibits 1-2. She received an
immunotherapy injection on October 12, 2011 (exhibit 7 at 24) and a Botox injection on
October 14, 2011 (exhibit 5 at 4).
On October 30, 2011, petitioner visited the emergency room at St. Vincent’s
Indianapolis Hospital with complaints of right side numbness and frequent urination.
Exhibit 13 at 97. She indicated her symptoms began on Wednesday, October 26, 2011
after she returned from vacation. Id. at 106. She reported intermitted dizziness after
her airplane flight, numbness, and heaviness and but denied any tingling or weakness.
Id. at 97. She was told to follow-up with Dr. Caryn M. Vogel at Indiana Neuroscience
Associates the next day. Id. at 103.
Petitioner saw Dr. Vogel on October 31, 2011. According to Dr. Vogel’s records,
petitioner described a “vague sense of dizziness” after returning from her trip. Exhibit
surgery in 1991 (when 18 years old). Exhibit 7 at 15. Her back surgery (lumbar fusion)
occurred in 2007. Exhibit 7 at 10.
6 Petitioner’s ophthalmologist described the bump as a “pyogenic granuloma.” Exhibit 5
at 5. Pyogenic means “producing pus.” DORLAND’S at 1561. A pyogenic granuloma is
“a usually solitary polypoid type of capillary hemangioma (which is neither pyogenic nor
a true granuloma).” DORLAND’S at 804
.
4
10 at 4. A few days after that she felt heaviness, numbness, and tingling in her right
foot and calf but no pain. As this sensation continued, she “began to note a cold
sensation like an ice pack running up and down the leg [and] . . . felt as though she
[was] a little off balance” Id. These later symptoms prompted petitioner’s trip to the
emergency room where she received a normal screening evaluation. Id.
During the visit with Dr. Vogel, petitioner mentioned her recent injections (Botox,
influenza, and TDP) and reported some cognitive impairment and greater frequency in
urination over the last several months. Exhibit 10 at 4. Dr. Vogel reassured petitioner
that her “neurologic evaluation [was] normal but . . . agree[d] we need to rule out
secondary causes such as a demyelinating disease or less likely [a] mass or stroke.”
Id. at 5. Dr. Vogel ordered labs and a brain MRI.7 Exhibit 10 at 5.
Petitioner visited Dr. Vogel again on November 14, 2011. At that visit, petitioner
reported that her symptoms were worsening with the numbness moving to all four
extremities, her face, and her head and the addition of twitching and “waves of fatigue.”
Exhibit 10 at 6. She also reported a reoccurring sinus infection. Noting that all tests to
date had been normal, Dr. Vogel ordered an EMG,8 cervical MRI, and lumbar puncture.9
Exhibit 10 at 6. Before submitting to this testing, petitioner agreed to wait several weeks
to determine if the symptoms would resolve and to take another Z-pack for her sinus
infection in the meantime. Dr. Vogel instructed petitioner to “follow up closely with her
primary care physician.” Id. at 7. In addition to the possibility of multiple sclerosis
(“MS”)10 raised by petitioner, Dr. Vogel discussed “other etiologies including connective
tissue disease, Lyme disease, fibromyalgia syndrome, and even depression.” Exhibit
10 at 6. The results of the EMG performed on December 5, 2011 were normal. Id. at 8.
7MRI, or magnetic resonance imaging, is “a method of visualizing soft tissues of the
body.” DORLAND’S ILLUSTRATED MEDICAL DICTIONARY (32d ed. 2012) [“DORLAND’S”] at
916.
8EMG, or electromyogram is used to evaluate patients with muscle weakness. The test
monitors the electrical activity of a muscle. MOSBY’S MANUAL OF DIAGNOSTIC AND
LABORATORY TESTS (4th ed. 2010) [“MOSBY’S LABS”] at 577-78.
9 A lumbar puncture, also known as a spinal tap, involves placing a needle in the
subarachnoid space of the spinal column to measure pressure and to obtain
cerebrospinal fluid for laboratory examination. The presence of blood or bacteria and
the amount of glucose or protein present in the spinal fluid may assist in diagnosis of
autoimmune and demyelinating disorders and many other diseases. MOSBY’S LABS at
682-88.
10 Multiple sclerosis is “a disease in which there are foci of demyelination throughout the
white matter of the central nervous system, sometimes extending into the gray matter.”
Symptoms include “weakness, incoordination, paresthesias, speech disturbances, and
visual complaint.” DORLAND’S at 1680.
5
On January 6, 2012, petitioner visited her allergist, Dr. Wise, for a follow-up visit
regarding her reoccurring sinusitis, specifically mentioning an episode in early October
2011. Exhibit 7 at 10; see id at 11 (September 2011 record ordering follow-up in four
months). At that visit, she described her current symptoms as muscle twitching, fatigue,
and dizziness. She reported the symptoms began in October 2011 and were resolving.
She also reported that her neurological work-up was negative, that she had lumbar
fusion surgery in 2007, and that she had received a Botox injection two weeks prior to
onset. In notes that appear to have been added later (possibly as petitioner and Dr.
Wise discussed her condition), it was noted that petitioner had received the TDP
vaccine, had normal MRI and lab results, and was being treated by Dr. Vogel who had
prescribed Cymbalta.11 Dr. Wise questioned the etiology of petitioner’s symptoms,
speculating whether they were due to GBS or some other viral illness. This is the first
mention of GBS in petitioner’s records. Dr. Wise indicated petitioner should continue
immunotherapy for her mold allergy, questioned whether petitioner should avoid the flu
vaccine, and ordered a follow-up appointment in six months. Id.
Petitioner saw Dr. Vogel in March 12, 2012. At that visit, petitioner described her
symptoms as improving after she began taking Cymbalta but “not totally gone.” Exhibit
10 at 10. She indicated that she sometimes feels a random twitch and tingling all over,
that she sleeps poorly and fatigues easily, and that “her muscle pain is worse when the
weather is about to change.” Id. Dr. Vogel noted that petitioner’s December 5, 2011
EMG and all laboratory tests were normal. She indicated that she had discussed the
possibility of a lumbar puncture but petitioner “chose to hold off on this test.” Id. She
observed that petitioner was much calmer than at earlier visits. She noted that
petitioner “is accepting of the fact that we may not be able to find a definite etiology and
wants to focus more on symptoms management.” Id. Dr. Vogel proposed checking
petitioner’s ferritin levels to determine if “a trial of dopamine” may help her sleep better
and recommended that petitioner stay as active as possible. Id.
Petitioner saw Dr. Vogel again six months later on September 10, 2012.
Previously, Dr. Vogel had described petitioner’s symptoms as diffuse myalgia and
paresthesia and chronic dizziness. See, e.g., Exhibit 10 at 10. At this visit, she
attributed petitioner’s condition to “[p]resumed fibromyalgia syndrome.” Id. at 11. Dr.
Vogel recorded petitioner’s retrospective belief that her symptoms “started after she had
had a series of injections including Botox, a tetanus injection and a flu shot.”12
Characterizing petitioner’s belief as “interesting,” she agreed that “there may have been
some sort of autoimmune response” but noted that this was never proven and that
11 Cymbalta (manufactured by Eli Lilly) is a serotonin and norepinephrine reuptake
inhibitor used to treat chronic musculoskeletal pain. PHYSICIAN’S DESK REFERENCE (66th
ed. 2012) [“PDR”] at 1603. It has been shown to be effective in treating fibromyalgia.
Id. at 1610-11.
12Exhibit 10 at 11. Dr. Vogel also noted a personal tragedy petitioner experienced
eleven years prior but discounted any effect, noting that petitioner believed she had
adjusted and that the prior event did not play a role in her current condition.
6
petitioner’s “workup for secondary causes such as peripheral neuropathy, myopathy or
central causes ha[d] been negative.” Id. at 12. She indicated that she had explained to
petitioner “that to some degree, fibromyalgia is a bit of a ‘diagnosis of exclusion’.” Id.
Petitioner returned to Dr. Vogel approximately two months later on November 12,
2012. Indicating petitioner suffered from fibromyalgia, Dr. Vogel described her
symptoms as improving but “exacerbated by stress (and her menstrual cycle), sleep
deprivation, and weather changes.” Exhibit 10 at 13. Noting that petitioner regularly
exercised and practiced yoga, Dr. Vogel attributed petitioner’s improvement to her
medication, Cymbalta and Savella.13 Id. at 14. She again mentioned that petitioner’s
neurological workup for secondary causes such as MS and myopathy were negative.
Because petitioner wished to try a higher dose of Savella, Dr. Vogel instituted a gradual
increase in dosage. Id. At this visit, petitioner also complained about migraine
headaches she had been experiencing in a recurrent pattern for years but chose to
defer any preventive medication. Id. at 13-14.
Over the next six months, petitioner visited Dr. Vogel two more times regarding
her symptoms. On February 11, 2013, Dr. Vogel noted that petitioner was taking
melatonin to help her sleep and had experienced a definite improvement on the higher
dosage of Savella. Exhibit 10 at 15-16. Because of concerns regarding weight gain,
Dr. Vogel instructed petitioner to discontinue the Cymbalta. When petitioner returned
on May 20, 2013, Dr. Vogel indicated there was no change in her weight but a definite
improvement in her level of fatigue which petitioner attributed to an intensive vitamin
therapy she had begun. Id. at 18. She recommended petitioner continue her vitamin
therapy and Savella. Id. at 19. It appears the May 2013 visit was the last time
petitioner was seen by Dr. Vogel.
On July 24, 2013, petitioner began seeing a chiropractor. On her intake form,
she listed numbness and twitching as her primary complaint and fibromyalgia as her
secondary complaint. Exhibit 4 at 10. She attributed her condition to her flu and
tetanus vaccinations and Botox injections. Id. She continued to see the chiropractor
through March 2014. See id. at 9. In the records from these visits, petitioner’s condition
was initially described as bilateral neck pain, then as diffuse pain with an unknown
trigger, pain at a manageable level, and finally fibromyalgia pain beginning in February
2014. Id. at 1-9.
Petitioner sought treatment from a new neurologist, Dr. McGarvey, during the fall
of 2013, approximately two years after her symptoms began. At her first visit (on
November 4, 2013), petitioner listed her chief complaint as fibromyalgia and indicated
debilitating pain was her biggest concern. Exhibit 12 at 32. She reported that her pain
was triggered by her menstrual cycle and the weather.
When providing her history, petitioner reported that she received a flu and
tetanus vaccination on the same day, a Botox injection to treat her right eye Bell’s palsy,
13
Savella (manufactured by Forest Pharmaceuticals) is used to treat fibromyalgia. See
www.savella.com (last visited on Nov. 30, 2015).
7
weakness and numbness in the left calf and neck, and dizziness and difficulty with her
vision. “These symptoms slowly dissapated [sic] and she was left with diffuse muscle
pain in arms and legs, which has gotten better [but she still had] pain in [her] neck and
jaw.” Id. Petitioner also reported that she had an EMG in the spring of 2012 after her
dizziness, fasciculation,14 and numbness had gone. Id. A comparison of this
information to that found in the medical records created closer in time to the onset of
petitioner’s condition showed several inaccuracies in the information petitioner provided
to Dr. McGarvey.15
Based on this history, Dr. McGarvey concluded petitioner “[l]ikely had GB, now
with residual symptoms.” Exhibit 12 at 35. She ordered a second EMG and referred
petitioner to an ophthalmologist for her eye issues. Id.
When petitioner visited the ophthalmologist on November 20, 2013, she reported
a history of GBS and fibromyalgia. Exhibit 3 at 5. Her examination was normal with no
edema observed. Id. at 2.
The results of the second EMG performed on November 22, 2013 were normal
but Dr. McGarvey discounted this finding since the EMG was performed “far out” from
when her symptoms occurred. Exhibit 12 at 29; see id. at 31 (EMG results). Dr.
McGarvey again opined that petitioner was experiencing residual symptoms of GBS. Id.
at 30. Theorizing that petitioner’s snoring may be contributing to daytime insomnia and
fatigue, Dr. McGarvey recommended a sleep study. Id.
Petitioner underwent a sleep study on December 19, 2013. The study indicated
she suffered from moderate sleep apnea but concluded not all of petitioner’s symptoms
could be explained by this finding. Exhibit 12 at 27. When Dr. McGarvey saw her the
next day, she noted petitioner was sleeping better due to her medication. Id. at 22. At
this visit, Dr. McGarvey recommended that petitioner receive no more flu vaccinations
due to her history of GBS. Id. at 25.
In February 2014, petitioner visited her allergist, Dr. Wise. He reported that she
was doing well with no sinusitis since her last visit and would continue her
14 Fasciculation is “the formation of fasciculi” or “a small local contraction of muscles,
visible through the skin, representing a spontaneous discharge of a number of fibers
innervated by a single motor nerve filament.” DORLAND’S at 682.
15 First, petitioner did not receive the flu and tetanus vaccinations on the same day. See
Exhibits 1-2. Second, petitioner’s weakness and numbness occurred in her right not left
leg and foot. See Exhibit 13 at 97. Most importantly, petitioner’s earlier EMG (the
results of which were normal) occurred on December 5, 2011 approximately one month
after petitioner’s symptoms began and while she was experiencing them. See Exhibit
10 at 8, 10. Although Dr. McGarvey mentioned this earlier EMG, she did not discuss its
results. Thus, it is not clear whether Dr. McGarvey even knew that the results were
reported to be normal.
8
immunotherapy. Exhibit 7 at 6. Reporting that petitioner suffered an episode of GBS
after receiving the flu vaccine in 2009, he indicated “the influenza vaccine is
contraindicated in her case.” Id.
In December 2013, petitioner saw her gynecologist for abnormal bleeding
between periods. See Exhibit 6 at 13. The results of a January 8, 2014 pap smear and
March 20, 2014 endometrium biopsy were normal. Id. at 12, 17. At a March 20, 2014
appointment with her gynecologist, petitioner included a history of fibromyalgia with
onset in 2011. Id. at 13.
Petitioner saw Dr. McGarvey again in May and July 2014. At both visits,
petitioner reported improving pain but continued fatigue and some dizziness. Exhibit 12
at 5, 12. For the first time, she also reported an inability to sing. Id. At the July 15,
2014 visit, Dr. McGarvey prescribed a small dose of depokote.16 Id. at 8.
Updated medical records from petitioner’s allergist, Dr. Wise, show she
continued to receive immunotherapy injections in 2014 and early 2015. See, e.g.,
Exhibit 16 at 22. At an August 18, 2014 visit, Dr. Wise reported that petitioner continued
to get good results from her immunotherapy. Id. at 10. He added that petitioner had
Tamiflu on hand in case she got the flu. Notes from a February 16, 2015 visit mention
GBS, deep muscle pain, and fibromyalgia, describing petitioner as “tearful when
discussing GB issue.” Id. at 20. The record also contains a recommendation that
petitioner receive no further flu vaccinations and an entry indicating petitioner requested
such a note for her attorney. Id. Both original and updated records from Dr. Wise
include a “Problem List Sheet” which contains an entry regarding GBS resulting from a
flu vaccination. Exhibits 7 at 3; 16 at 5. The sheet, however, contains no further
information and is not dated. Id.
On June 30, 2015, petitioner filed a letter from Dr. McGarvey to petitioner’s
counsel (dated June 22, 2015). Citing the instance of GBS related to vaccinations
reported in medical literature, Dr. McGarvey opined “it sounds as if [petitioner] had a
neurologic complications secondary to [one] or more of the combination of vaccines that
she had.” Exhibit 17 at 1. She qualified her opinion by noting that she “was not
involved in [petitioner’s] initial care” and thus, her opinion was “based on [petitioner’s]
history and symptoms.” Id. Dr. McGarvey also opined that petitioner’s symptoms were
consistent with GBS but added that it was “unfortunate that we do not have a lumbar
puncture from her original presentation.” Id. at 2. In drawing these conclusions, Dr.
McGarvey relied on facts which are contradicted by the more contemporaneously
created medical records. For example, she again reported that petitioner’s first EMG
was performed in the spring of 2012 rather than on December 5, 2011 as the records
show. Id. at 1. Like Dr. Wise, Dr. McGarvey recommended petitioner receive no further
flu vaccinations. Id. at 2.
16 Depakote is a drug used to treat seizure disorders. DORLAND’S at 490, 558.
9
III. Applicable Legal Standards
Under the Vaccine Act, petitioner may prevail on her claim if she has “sustained,
or endured the significant aggravation of any illness, disability, injury, or condition” set
forth in the Vaccine Injury Table (the Table). § 11(c)(1)(C)(i). The most recent version
of the Table, which can be found at 42 C.F.R. § 100.3, identifies the vaccines covered
under the Program, the corresponding injuries, and the time period in which the
particular injuries must occur after vaccination. § 14(a). If petitioner establishes that
she has suffered a “Table Injury,” causation is presumed.
If, however, petitioner suffered an injury that either is not listed in the Table or did
not occur within the prescribed time frame, she must prove that the administered
vaccine caused injury to receive Program compensation. § 11(c)(1)(C)(ii) and (iii). In
such circumstances, petitioner asserts a “non-Table or [an] off-Table” claim and to
prevail, petitioner must prove her claim by preponderant evidence. § 13(a)(1)(A). This
standard is “one of . . . simple preponderance, or ‘more probable than not’ causation.”
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1279-80 (Fed. Cir. 2005)
(referencing Hellebrand v. Sec’y of Health & Human Servs., 999 F.2d 1565, 1572-73
(Fed. Cir. 1993). The Federal Circuit has held that to establish an off-Table injury,
petitioner must “prove . . . that the vaccine was not only a but-for cause of the injury but
also a substantial factor in bringing about the injury.” Shyface v. Sec’y of Health &
Human Servs., 165 F.3d 1344, 1351 (Fed. Cir 1999). Id. at 1352. The received
vaccine, however, need not be the predominant cause of the injury. Id. at 1351.
The Circuit Court has indicated that petitioner “must show ‘a medical theory
causally connecting the vaccination and the injury’” to establish that the vaccine was a
substantial factor in bringing about the injury. Shyface, 165 F.3d at 1352-53 (quoting
Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)). The
Circuit Court added that "[t]here must be a ‘logical sequence of cause and effect
showing that the vaccination was the reason for the injury.’” Id. The Federal Circuit
subsequently reiterated these requirements in its Althen decision. See 418 F.3d at
1278. Althen requires a petitioner
to show by preponderant evidence that the vaccination
brought about her injury by providing: (1) a medical theory
causally connecting the vaccination and the injury; (2) a
logical sequence of cause and effect showing that the
vaccination was the reason for the injury; and (3) a showing
of a proximate temporal relationship between vaccination
and injury.
Id. All three prongs of Althen must be satisfied. Id. Close calls regarding causation
must be resolved in favor of the petitioner. Id. at 1280.
Petitioner is not required to eliminate alternative causes when establishing his
prima facie case. Doe 11 v. Sec’y of Health & Human Servs., 601 F.3d 1349, 1357-58
(Fed. Cir. 2010); de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352
(Fed. Cir. 2008). To support an argument regarding causation, petitioner may,
10
however, introduce evidence of the lack of an alternative cause. Walther v. Sec’y of
Health & Human Servs., 485 F.3d 1146, 1149-50 (Fed. Cir. 2007). Respondent also
may introduce evidence of the prescence of an alternative cause to rebut evidence
regarding causation. Doe 11, 601 F.3d at 1358; de Bazan, 639 F.3d at 1353.
Once petitioner has established a prima facie case, the burden shifts to
respondent to show by preponderant evidence that petitioner’s injury was “due to
factors unrelated to the administration of the vaccine.” § 13(a)(1); see also DeBazan,
639 F.3d at 1352-54; Walther, 486 F.3d at 1150.
IV. Analysis of Petitioner’s Claim
Petitioner maintains that she suffered GBS causally related to the influenza
vaccination she received on September 20, 2011 and the TDP vaccination she received
on October 6, 2011. Motion for a Decision on the Record at 1. To support her claim,
petitioner relies solely on the medical records filed and the June 22, 2015 letter from Dr.
McGarvey.
Respondent opposes compensation in this case and maintains that the petition
should be dismissed. Response at 1. She argues that petitioner’s correct diagnosis is
fibromyalgia and that petitioner has not established that she suffered from GBS.
Response at 5. She further argues that petitioner has failed to prove “that her alleged
injury, whether it is GBS, fibromyalgia, or any other condition, was caused in fact by
either her flu or DTP vaccines.” Id. at 6.
1. The Alleged Injury
The Federal Circuit has held that, when the injury itself is in dispute, “it was
appropriate . . . for the special master to first determine which injury was best supported
by the evidence presented in the record before applying the Althen test so that the
special master could subsequently determine causation relative to injury.”
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1346 (Fed. Cir.
2010). “[U]nder Broekelschen, identification of a petitioner’s injury is a prerequisite to
an Althen analysis of causation. Lombardi v. Sec’y of Health & Human Servs., 656 F.3d
1343, 1352 (Fed. Cir. 2011).
In this case, the record does not support petitioner’s allegation that she suffered
from GBS. GBS is mentioned in only a few places in the medical records filed.
Petitioner’s allergist, Dr. Wise, first suggested that petitioner’s symptoms may be due to
GBS or some viral illness in early January 2012. Exhibit 7 at 10. He did not opine
further and did not mention the possibility again until more than two years later on
February 17, 2014 after petitioner began seeing Dr. McGarvey. See id. at 6. At that
visit, Dr. Wise prescribed Tamiflu for petitioner because “the influenza vaccine [was]
contraindicated in her case” due to an earlier episode of GBS after the flu vaccine in
2009. Id. There is no indication that Dr. Wise (an allergist) reached this conclusion
himself. Rather, it appears that he simply accepted the diagnosis and assertion
regarding causation provided to him by petitioner. See Exhibit 12 at 35. Furthermore,
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he erroneously indicates petitioner suffered GBS in 2009, rather than 2011. Exhibit 7 at
6.
On November 20, 2013, one of petitioner’s ophthalmologists, Dr. Brazus, also
recorded a history of GBS as well as fibromyalgia. Exhibit 3 at 5. Like Dr. Wise, Dr.
Brazus appears to be reciting a history provided to him by petitioner. It is important to
note that neither Dr. Wise nor Dr. Brazus are neurologists and likely would not diagnosis
a condition such as GBS but would refer petitioner to a neurologist to determine if such
a diagnosis was appropriate.
Dr. McGarvey is the only physician who actually opined that it is likely petitioner
suffered from GBS, and she did not begin treating petitioner until two years after her
symptoms began. See Exhibit 12 at 35. Although Dr. McGarvey is a neurologist, she
acknowledged that she “was not involved in [petitioner’s] initial care” and based her
opinion on the history and symptoms described to her by petitioner. See Exhibit 17 at 1.
According to Dr. McGarvey, petitioner was no longer suffering from GBS when Dr.
McGarvey first saw her but only the “residual symptoms” of GBS. Exhibit 12 at 35.
Furthermore, Dr. McGarvey based her opinion on the medical history provided to
her by petitioner. See note 15. There is no evidence indicating that Dr. McGarvey ever
reviewed Dr. Vogel’s medical records herself or saw the results of the December 5,
2011 EMG. Even Dr. McGarvey acknowledges the weak nature of the evidence,
indicating it is “unfortunate” a lumbar puncture was not performed. Exhibit 17 at 2.
On the other hand, petitioner’s initial neurologist, Dr. Vogel (who treated
petitioner at the time of her initial symptoms and for the following two years and ordered
the December 5, 2011 EMG) never mentioned the possibility that petitioner suffered
from GBS. In fact, she consistently noted that petitioner’s neurological work-up was
negative and there was no indication petitioner suffered from any neuropathy. See,
e.g., Exhibit 10 at 12. Dr. Vogel subsequently diagnosed petitioner with fibromyalgia
and treated her accordingly. Petitioner’s improvement was attributed to the medication
Dr. Vogel prescribed to treat her fibromyalgia. See, e.g., Exhibit 10 at 14.
The opinion of a treating physician is favored because “treating physicians are
likely to be in the best position to determine whether a logical sequence of cause and
effect shows that the vaccination was the reason for the injury.” Capizzano v. Sec’y,
Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (citations and internal
quotation marks omitted). In this case, however, Dr. Vogel is the neurologist who
treated petitioner during the time when Dr. McGarvey believes she suffered from GBS.
It was Dr. Vogel who observed petitioner’s symptoms, ordered the appropriate tests,
and determined petitioner’s treatment.
In forming her opinion, Dr. McGarvey relied upon information provided to her two
years later by petitioner which conflicts with the information found in the
contemporaneously created medical records. “It has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little
evidentiary weight.” Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733
(1991) aff'd, 968 F.2d 1226 (Fed.Cir.1992), cert. denied, 506 U.S. 974, 113 S.Ct. 463,
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121 L.Ed.2d 371 (1992) (citing United States v. United States Gypsum Co., 333 U.S.
364, 396 (1947)). Based on this later provided, erroneous information and occurring
after she believed petitioner’s condition had resolved, Dr. McGarvey’s diagnosis should
not be given the same weight.
In light of Dr. Vogel’s contemporaneous diagnosis, Dr. McGarvey’s opinion two
years after the fact is not sufficient to establish petitioner suffered from GBS. And Drs.
Wise and Brazus relied on representations by petitioner shortly after Dr. McGarvey
opined petitioner had suffered from GBS. As the neurologist treating petitioner during
onset and the following two years, Dr. Vogel provides the more trustworthy diagnosis.
2. Causation
In Lombardi, the Federal Circuit held that “[i]n the absence of a showing of the
very existence of any specific injury of which petitioner complains, the question of
causation is not reached.” 656 F.3d at 1353. The Circuit explained that “the statute
places the burden on the petitioner to make a showing of at least one defined and
recognized injury.” Id. Petitioner cannot prove that her injury was caused by the
vaccinations she received when she cannot establish that she suffered an injury in the
first place. In this case, petitioner has failed to establish that she suffered from GBS.
Thus, it follows that she cannot prove that she suffered GBS which was caused by the
vaccinations she received.
Even if she had established that she had GBS, petitioner would still have to
prove that her injury was vaccine caused by satisfying the three pronged Althen test.
She must establish by preponderant evidence that the vaccinations she received
caused her injury “by providing: (1) a medical theory causally connecting the vaccination
and the injury; (2) a logical sequence of cause and effect showing that the vaccination
was the reason for the injury; and (3) a showing of a proximate temporal relationship
between vaccination and injury.” Althen, 418 F.3d at 1278.
Petitioner has provided no expert report with a medical theory causally
connecting her injury to the vaccinations she received. Similarly, she has provided no
evidence of a proximate temporal relationship between the vaccinations she received
and the symptoms she suffered. She has failed to satisfy the first and third prongs of
the Althen test.
The only evidence petitioner has provided to show a logical sequence of cause
and effect connecting the vaccinations she received to the symptoms she suffered is
predicated on the assertion that she suffered from GBS. Thus, petitioner has failed to
satisfy the second Althen prong as well.
Petitioner has not provided preponderant evidence that her symptoms were
caused by the vaccinations she received. Therefore, she has failed to satisfy all three
Althen prongs.
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V. Conclusion
Petitioner has failed to offer the opinion of a medical expert, and the medical
records filed do not support her allegations. She has failed to demonstrate that she
suffered from GBS and that her condition was caused the vaccination she received.
Petitioner has failed to establish that she is entitled to compensation under the
Vaccine Act. This case is dismissed for insufficient proof.
The clerk of the court is directed to enter judgment in accordance with this
decision.17
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
17 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party
filing a notice renouncing the right to seek review.
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