VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_08-vv-00724
Package ID: USCOURTS-cofc-1_08-vv-00724
Petitioner: Ida Mosley
Filed: 2008-10-14
Decided: 2015-11-12
Vaccine: Td
Vaccination date: 2007-09-06
Condition: transverse myelitis
Outcome: compensated
Award amount USD: 247000

AI-assisted case summary:
Ida Mosley was a mental health counselor in Florida when, on the evening of September 6, 2007, she went to the emergency room after pricking her finger on a screw at work. While there, at approximately 11:10 p.m., she received a tetanus toxoid vaccine. The following day, September 7, she felt unwell and had urinary symptoms. On September 8, she returned to the emergency room in a wheelchair, complaining of body aches, joint aches, fever, and frequent urination, and told the ER staff she had begun feeling sick on September 7. The emergency room doctors diagnosed a urinary tract infection and prescribed antibiotics.

On September 9, Ms. Mosley returned to the emergency room again, this time complaining of aching all over with weak legs for three days, an inability to urinate, and suprapubic pain radiating down both legs. She was admitted to the hospital. On September 10, an infectious disease specialist, Dr. Luis Duharte, noted that her presentation was "highly suggestive of adverse reaction to the tetanus toxoid." On September 11, internist Dr. Miguel Beltre recorded his impression that her condition was "probably reaction to the tetanus toxoid." Her neurologist, Dr. Bridglal Ramkissoon, initially doubted Guillain-Barré syndrome based on normal reflexes, but after a lumbar puncture on September 12 showed elevated protein and pleocytosis — consistent with viral meningitis rather than GBS — and after he noted absent reflexes on September 14, he tentatively diagnosed GBS and transferred her to the intensive care unit. A second lumbar puncture showed normal protein with continued pleocytosis and a white blood cell count of 33. Tests for absent tibial and peroneal F waves were noted on September 15, and possible diagnoses included GBS, viral meningitis, and acute inflammatory demyelinating polyneuropathy (AIDP).

Ms. Mosley transferred to an inpatient rehabilitation center at Winter Haven Hospital on September 20, where neurologist Dr. Alain Delgado assessed her with AIDP "with onset dating back to September 7, 2007," and noted her elevated, 100% lymphocytic white blood cell count as "suggesting some sort of viral syndrome." After discharge, her primary care physician, Dr. Audwin Nelson, recorded that Ms. Mosley was "in the recovery phase of Guillain-Barré syndrome secondary to tetanus toxoid booster." Ms. Mosley never returned to her job as a mental health counselor; she began receiving social security disability benefits in March 2008 and settled a workers' compensation claim in December 2008. Dr. Ramkissoon later submitted a letter stating that in his opinion the tetanus vaccination had caused her neurological injury through molecular mimicry, "destroy[ing] segments of the myelin sheath around the nerves."

Ms. Mosley filed her petition on October 14, 2008, originally alleging GBS. Her expert, Dr. William Triggs, a neurologist with a subspecialty in demyelinating disorders, disagreed with the GBS diagnosis and testified that Ms. Mosley had instead suffered an inflammatory lesion of the spinal cord — a partial or mild myelitis — caused by the Td vaccination. He identified September 9 as the onset of the neurological condition, distinguishing the urinary frequency on September 7 and 8 as symptoms of the urinary tract infection rather than a neurological condition, and explaining that the neurological presentation was urinary retention (inability to empty the bladder), which first appeared on September 9. In a supplemental report, Dr. Triggs explained that while he had expressed uncertainty at the hearing about molecular mimicry, he did not reject it and considered it "the viable mechanism, more likely than not, at work." The government's expert, Dr. Thomas Leist, testified that the best diagnosis was viral meningoradiculitis — a process between GBS and transverse myelitis. He testified that Ms. Mosley's bladder symptoms on September 7 and September 8 were not separate events but parts of the same continuous neurological process, making the onset less than twenty-four hours after vaccination — a timeframe he testified was too short for a vaccine-mediated immune response. He identified the minimum time for a cross-reactive immune response to manifest neurological symptoms as approximately five days.

Former Special Master Daria Zane held hearings on July 11 and July 20, 2012, but the case was eventually transferred to Special Master Laura Millman, who issued the entitlement decision on June 23, 2014, denying compensation. The special master accepted that tetanus vaccine can cause transverse myelitis, satisfying Althen's first prong. However, she found that Ms. Mosley failed to establish a proximate temporal relationship under Althen's third prong. Relying on Dr. Leist's opinion, the special master found that Ms. Mosley's neurological symptoms began on September 7, less than twenty-four hours after vaccination. She noted that Dr. Triggs, while using urinary dysfunction as proof of transverse myelitis, had ignored that urinary dysfunction began on September 7 — the very symptom he identified as signaling a spinal cord lesion at the conus medullaris. Medical literature, including case reports submitted by petitioner herself, showed onset of transverse myelitis following vaccination ranging from two days to weeks; the Federal Circuit in De Bazan had found an eleven-hour onset interval for a demyelinating disease too short to support causation. The special master's analysis did not mention, address, or weigh the notations or opinions of any of Ms. Mosley's treating physicians — Drs. Duharte, Beltre, Ramkissoon, Delgado, and Nelson — all of whom had explicitly attributed her neurological condition to the tetanus vaccination.

Judge Kaplan, writing for the Court of Federal Claims, vacated the special master's decision and remanded the case on January 28, 2015. The court held that the special master committed legal error by failing to consider and discuss the opinions of Ms. Mosley's treating physicians in her causation analysis. The Federal Circuit in Capizzano and Andreu had made clear that treating physicians are typically in the best position to detect a link between vaccination and injury, that their opinions are "quite probative" of causation, and that failure to consider them constitutes reversible error. The court reasoned that a treating physician's conclusion that a vaccine caused the petitioner's illness implicitly embeds a finding that the onset was within a medically appropriate timeframe — it would be difficult to conceive of a treating physician reaching a causal conclusion while believing the onset interval was medically inappropriate. The government's argument that Capizzano and Andreu confined treating physicians' opinions to the prong-two analysis was rejected; the court found no principled basis for that limitation, and Capizzano itself noted that evidence can overlap to satisfy multiple Althen prongs. On the Broekelschen issue, the court held that the special master had made no finding that the question of causation turned on whether Ms. Mosley had GBS rather than transverse myelitis, and therefore could not assume that the treating physicians' opinions (which diagnosed GBS) were irrelevant. The case was remanded for 120 days for the special master to consider and explain the impact of those treating physicians' opinions.

Special Master Millman issued an attorneys' fees decision on October 22, 2015, awarding $247,000.00 in attorneys' fees and costs based on the parties' stipulation, payable jointly to Ms. Mosley and her attorneys at Maglio, Christopher & Toale, PA.

Theory of causation field:
Td vaccine Sept 6, 2007 → GBS (treating physicians) or partial myelitis/TM (Dr. Triggs). Onset dispute: Dr. Triggs: Sept 9 onset (Sept 7-8 = UTI, not neurological); Dr. Leist: Sept 7 onset (bladder symptoms continuous process; onset < 24 hours). Four treating physicians (Duharte, Beltre, Ramkissoon, Nelson) attributed neurological condition to Td vaccine. Dr. Ramkissoon letter: molecular mimicry destroyed myelin. SM Millman June 23, 2014: DISMISSED — Althen prong 1 satisfied (Td can cause TM); prong 3 failed (onset = Sept 7 = < 24 hours = too short; De Bazan; case reports support 2 days to weeks; Tezzon article); SM failed to address treating physicians' opinions. CFC Judge Kaplan Jan 28, 2015: VACATED AND REMANDED — legal error: treating physicians' opinions not considered (Capizzano; Andreu); implicit in causal opinions = onset within appropriate timeframe; relevant to prong 3 not just prong 2; remanded 120 days. Fees Oct 22, 2015: $247,000 awarded. NOTE: DB outcome='compensated'/award=247000 likely wrong (fees to attorneys, not petitioner compensation; remand outcome unknown).

Public staged source text:

================================================================================
DOCUMENT 1: USCOURTS-cofc-1_08-vv-00724-0
Date issued/filed: 2014-07-15
Pages: 20
Docket text: PUBLIC DECISION (Originally filed: 06/23/2014) regarding 114 DECISION of Special Master Signed by Special Master Laura D Millman. (tlj) Copy to parties.
--------------------------------------------------------------------------------
Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 1 of 20
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 08-724V
June 23, 2014
To be Published
***************************************
IDA MOSLEY, *
*
Petitioner, *
*
v. * Td vaccine; transverse myelitis;
* one-day onset
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
***************************************
Diana S. Sedar, Sarasota, FL, for petitioner.
Lisa A. Watts, Washington, DC, for respondent.
MILLMAN, Special Master
DECISION1
On October 14, 2008, petitioner filed a petition under the National Childhood Vaccine
Injury Act, 42 U.S.C. §§ 300aa-10–34 (2006), alleging that a tetanus toxoid (“Td”) vaccination
on September 6, 2007, caused her to suffer from Guillain-Barré syndrome (“GBS”).2 Former
Chief Special Master Gary Golkiewicz assigned the case to himself.
1 Vaccine Rule 18(b) states that all decisions of the special masters will be made available to the
public unless they contain trade secrets or commercial or financial information that is privileged
and confidential, or medical or similar information whose disclosure would constitute a clearly
unwarranted invasion of privacy. When such a decision is filed, petitioner has 14 days to
identify and move to redact such information prior to the document’s disclosure. If the special
master, upon review, agrees that the identified material fits within the categories listed above, the
special master shall redact such material from public access.
2 Petitioner filed an expert report on June 6, 2011, from Dr. William Triggs, a neurologist, in
which he opined that tetanus toxoid vaccine caused petitioner’s transverse myelitis (“TM”). The
undersigned interprets this as petitioner’s amended petition that Td vaccine caused her TM.

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 2 of 20
From February 2, 2009 to November 30, 2010, the parties attempted to reach a litigative
risk settlement, but failed to agree.
On June 23, 2011, the case was transferred to former Special Master Daria J. Zane.
On February 3, 2012, the parties stipulated to the following facts: petitioner received Td
vaccine at about 11:10 p.m. on Thursday, September 6, 2007. Med. recs. Ex. 5, at 11–12; Ex.
19, at 903. Petitioner visited the Emergency Room (“ER”) on September 8, 2007, complaining
of joint aches, generalized weakness, frequent urination, and the onset of fever on Thursday,
September 6, 2007. Med. recs. Ex. 5, at 141, 149–51. Because urinalysis revealed bacteria in
petitioner’s urine, the ER doctor diagnosed her with a urinary tract infection (“UTI”) and
prescribed Bactrim. Id. at 142, 145. On September 9, 2007, petitioner returned to the ER,
complaining of increased leg weakness, pain radiating into her legs, and difficulty voiding. Med.
recs. Ex. 5, at 20; Ex. 28, at 2. In the ER, petitioner had preserved deep tendon reflexes
(“DTRs”) and no sensory loss. Med. recs. Ex. 5, at 76. Petitioner’s white blood cell (“WBC”)
count was elevated at 11,100 with increased neutrophils, and her erythrocyte sedimentation rate
was elevated at 41. Med. recs. Ex. 19, at 210, 494, 495. Petitioner was admitted to Florida
Heartland Hospital where Dr. Ramkissoon, a neurologist, evaluated her on September 11, 2007.
Med. recs. Ex. 5, at 116. He found normal DTRs and slightly reduced strength. Id. at 121; Ex.
19, at 186. A lumbar puncture revealed elevated protein (at 87) in petitioner’s cerebrospinal
fluid (“CSF”), with a WBC of 60, and 100% lymphocytes (pleocytosis). Med. recs. Ex. 5, at 23,
113. Possible diagnoses at that time included viral meningitis, spinal cord lesion, and GBS.
Med. recs. Ex. 5, at 23; Ex. 28, at 2. MRIs of petitioner’s brain and spinal cord at that time
revealed no lesions. Med. recs. Ex. 5, at 51–53; Ex. 19, at 992–93, 997; Ex. 39, at 189–90. Dr.
Ramkissoon examined petitioner on September 14, 2007, and found she had loss of DTRs in her
knees and ankles and down-going toes, but she had normal reflexes in her upper extremities.
Med. recs. Ex. 5, at 77–79. A repeat lumbar puncture showed normal protein in her CSF, a
WBC of 33, and continued pleocytosis. Id. at 49, 52, 77–79, 81; Ex. 28, at 3. Dr. Ramkissoon
noted absent F waves on petitioner’s nerve conduction studies. Med. recs. at Ex. 5, at 45.
Differential diagnoses included viral meningitis and GBS. Id. Petitioner was transferred to the
ICU where she was treated for GBS with a five-day course of intravenous immunoglobulin
(“IVIG”). Id. at 77–79; Ex. 28, at 3. Petitioner’s symptoms stopped progressing, and her
reflexes, sensory changes, and strength showed some improvement. Med. recs. Ex. 4, at 21. On
September 20, 2007, petitioner was transferred to in-patient rehabilitation at Winter Haven
Hospital. Med. recs. Ex. 4, at 12–22. The doctor performing petitioner’s admission examination
noted that she had developed malaise, polyarthralgia, polymyalgias, weakness, and fevers one
day after receiving a tetanus shot. Id. at 12. The doctor diagnosed petitioner with “acute
inflammatory demyelinating polyneuropathy with onset dating back to September 7, 2007.” Id.
at 13.
On February 8, 2012, petitioner filed a Motion In Limine To Consolidate (De-Bifurcate)
Proceedings and to Exclude Evidence. In her motion, petitioner moved to combine both the
2

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 3 of 20
issues of entitlement and damages at the hearing. She also moved to exclude the expert report of
Dr. James McCluskey (filed by petitioner on October 26, 2009 as Exhibit 19), which was written
for petitioner’s disability claim against her employer. On February 21, 2012, respondent filed
her response opposing the motion. Former Special Master Zane heard argument on petitioner’s
motion on February 24, 2012, and denied the motion on March 3, 2012.
On July 11 and 20, 2012, former Special Master Zane held a hearing in this case.
Transcripts of the hearing were filed on August 8, 2012. Dr. William Triggs, a neurologist,
testified for petitioner. Dr. Thomas P. Leist, a neurologist, testified for respondent.
On January 14, 2013, the parties filed simultaneous post-hearing briefs. On April 15,
2013, the parties filed simultaneous responsive briefs.
On August 31, 2013, former Special Master Zane retired. On September 23, 2013, Chief
Special Master Denise K. Vowell assigned the case to herself to explore the possibility of
settlement. Settlement was not availing. On November 6, 2013, this case was transferred to the
undersigned.
On December 4, 2013, the undersigned held a telephonic status conference with counsel.
At the hearing, petitioner’s expert, Dr. Triggs, testified that petitioner had partial myelitis but no
demyelination, although in his expert report, he described petitioner as having a demyelinating
disease. The undersigned requested that Dr. Triggs explain how long it takes an autoimmune
reaction to cause partial myelitis and the basis for his opinion. The undersigned ordered
petitioner to file Dr. Triggs’ supplemental expert report by February 11, 2014.
On February 4, 2014, petitioner filed a motion for an extension of time of sixty days to
file Dr. Triggs’ supplemental expert report, which the undersigned granted that day, setting a
new deadline of April 4, 2014.
On April 4, 2014, petitioner filed a second motion for an extension of time, requesting
forty-five days to file Dr. Triggs’ supplemental expert report, which the undersigned granted on
April 7, 2014 in an Order, setting a new deadline of May 19, 2014.
On May 19, 2014, petitioner filed Dr. Triggs’ supplemental expert report as Exhibit 70.
On May 20, 2014, the court received a CD from petitioner containing the five medical articles to
which Dr. Triggs referred in his supplemental expert report.
On May 29, 2014, the undersigned held a telephonic status conference with counsel to
discuss Dr. Triggs’ supplemental expert report and the literature to which he referred in that
report.
The case is now ready for adjudication.
3

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 4 of 20
FACTS
I. Pre-vaccination records
Petitioner was born on February 18, 1962.
On May 29, 1973, July 14, 1981, and January 10, 1990, petitioner received Td vaccine.
Med. recs. Ex. 19, at 882, 897. She received the 1973 and 1981 Td vaccinations at the Hardee
County Health Department, and the 1990 Td vaccination at the Watson Clinic. Id. There is a
booster tetanus vaccination dated October 19, 1972 at the Hardee County Health Department, but
it is unclear if petitioner received it, because if she had, she would not have needed the booster
Td vaccination she received just seven months later on May 29, 1973. Id. at 897.
On January 10, 1990, petitioner visited the Watson Clinic after an automobile accident on
January 5, 1990. Id. at 882. She had first been to DeSoto Memorial Hospital ER, later Lakeland
Regional Medical Center ER, and lastly Hardee Memorial Hospital. Id. She was diagnosed with
contusions and viral syndrome. Id. All her x-rays were negative. Id. She complained of pain at
the base of her neck and in her left elbow and left knee. Id. During her examination at Watson
Clinic, she said she needed to make a telephone call, as she was late for an appointment with her
attorney. Id. Dr. Hoke H. Shirley, Jr., diagnosed petitioner with cervical strain, contusion and
abrasion of her left elbow, and contusion of her left knee. Id.
On January 30, 1990, Urgent Care referred petitioner to the Watson Clinic. Med. recs.
Ex. 19, at 879. Dr. Wallace W. Coyner wrote that petitioner was involved in an automobile
accident on January 5, 1990. Id. She was not wearing a seat belt when a camper struck her car.
Id. She went to DeSoto Memorial Hospital and later checked in at Lakeland Regional Medical
Center because of chest pain that night. Id. A few days later, she went to Hardee Memorial
Hospital for chest pain. Id. She complained of left knee pain and some pain in her left arm as
well as pain in her head. Id. She said her mother thought it was her nerves, but she thought
something was wrong with her knee. Id. Petitioner weighed 176 pounds and was five foot two
inches tall. Id. Dr. Coyner opined that petitioner probably sprained her knee. Id. He stated,
“Her clinical findings are not quite as impressive as is her dysfunction. I am unable to explain
this difference at this time.” Id. Dr. Coyner suggested petitioner continue with her anti-
inflammatory and analgesic agents and give the knee time to heal. Id. He expected petitioner
could return to work in two weeks. Id. He stated, “There is always some concern on the part of
the physician to learn that the attorneys were consulted before the physician was consulted, and
that tends to make one be concerned about the possibility of secondary gain motives.” Id. at 880.
On March 13, 1990, petitioner saw Dr. Eberto Pineiro at the Watson Clinic for a second
opinion regarding her knee. Id. at 871. During her motor vehicle accident on January 5, 1990, a
truck struck the left front of petitioner’s car, throwing her forward, and her left knee struck the
dashboard. Id. X-rays at DeSoto Memorial Emergency Room were negative. Id. One to two
days later, she complained of stiffness in her left knee and said she could not walk. Id. Her
4

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 5 of 20
mother took her to Lakeland Regional Medical Center. Id. Repeat x-rays were also negative.
Id. A few days later, petitioner complained of chest pain and was taken to Hardee Memorial
Hospital, where the doctors attributed her chest pains to muscle spasms. Id. She was seen at
Urgent Care three times, once by Dr. Shirley and twice by Dr. Coyner, who referred her to Dr.
Pineiro. Id. Petitioner complained of left foot pain and constant, dull headaches. Id. Petitioner
had frequent, severe headaches with spells of dizziness. Id. at 873. She had difficulty using her
legs. Id. She had difficulty with vision that year. Id. Dr. Pineiro diagnosed petitioner with post-
traumatic headaches without focal neurological deficits, external obesity, and left post-traumatic
knee pain. Id. at 872.
On March 5, 2000, petitioner was hit by a car while collecting shopping carts at her work.
Med. recs. Ex. 6, at 13. She went to the Emergency Room, where she was diagnosed with a right
hip contusion. Id. She initially benefitted from physical therapy, and, due to an exacerbation of
symptoms, went to Florida Hospital, Heartland Division, for physical therapy on January 29,
2001. Id. Petitioner reported occasional paresthesia down the posterolateral aspect of her right
leg to her knee. Id. She complained of difficulty with sustained standing and noted trembling in
the musculature of the right lower extremity, secondary to unexpected buckling from her right
knee. Id. She walked with a cane. Id.
II. Post-vaccination records
On Thursday, September 6, 2007, at 10:20 p.m., petitioner went to Florida Hospital,
Heartland Division, Sebring, ER. Med. recs. Ex. 5, at 3. She had punctured her right thumb on a
piece of metal. Id. at 12. Petitioner received Td vaccine at 11:10 p.m. Id. at 8.
On Saturday, September 8, 2007, at 6:17 p.m., petitioner returned to Florida Hospital ER
in a wheelchair, complaining of body aches, joint aches, and fever, which started on Thursday,
September 6, 2007. Id. at 149. She had generalized weakness and frequent urination. Id. at
141. Her temperature was 99.4 degrees. Id. at 149. Dr. Pigman’s clinical impression was
petitioner had a urinary tract infection. Id. at 142. Petitioner gave a history that she was at
Florida Hospital on Thursday night for a tetanus injection, and she started to feel unwell on
Friday, September 7, 2007. Id. at 149. She was given antibiotics and a prescription for an
antibiotic. Id. at 143.
On Sunday, September 9, 2007, at 3:31 p.m., petitioner returned to Florida Hospital ER,
complaining of aching all over with weak legs for three days. Id. at 15, 13. She was unable to
urinate. Id. at 15. She complained of suprapubic pain radiating down both legs. Id. at 20. She
complained of dull pain and pressure in her abdomen whose onset was gradual over four days.
Id. She was catheterized at 4:20 p.m. Id. Her initial urinary output was 1,000 mL. Id. She was
admitted to the hospital. Id. at 14. A progress note of September 10, 2007, states petitioner
received tetanus toxoid and, 24 hours later, had general malaise, weakness, tremor, and fever. Id.
at 127. A progress note of September 11, 2007 states petitioner received tetanus toxoid on
September 6, 2007 after suffering an injury. Id. at 68. She developed progressive lower
5

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 6 of 20
extremity weakness the next day. Id. She had a temperature of 102.1 degrees on September 10,
2007. Id. On September 14, 2007, petitioner had a lumbar puncture performed. Id. at 23. Dr.
Bridglal Ramkissoon interpreted the results as suggestive of viral meningitis. Id. The initial
spinal tap performed on September 11, 2007 showed elevated protein of 87. Id. It also showed
61 white blood cells with 100 percent lymphocytes, which was not consistent with GBS. Id.
On September 17, 2007, Dr. Luis A. Duharte wrote that he had examined petitioner and
reviewed her chart. Id. at 129. She had remained afebrile for two days and said she felt a little
bit stronger. Id. Dr. Duharte suspected petitioner had a viral infection, probably enterovirus 71
because of her symptoms. Id.
From September 20 to October 3, 2007, petitioner was at Winter Haven Hospital. Med.
recs. Ex. 4, at 15. On September 21, 2007, Dr. Alain Delgado did a neurological consultation at
Winter Haven Hospital. Id. Petitioner gave Dr. Delgado the history that she cut her finger, went
to the ER, had a tetanus shot and, the next day, developed malaise, polyarthralgia, polymyalgia,
weakness, and fevers. Id. at 12. Dr. Delgado’s impression was that petitioner had acute
inflammatory demyelinating polyneuropathy whose onset was September 7, 2007. Id. at 13. Dr.
Delgado noted that petitioner’s case was atypical because she had elevated white blood cells at
60, which appeared to be 100 percent lymphocytic, suggesting some kind of viral etiology. Id.
Also on September 21, 2007, petitioner saw Pablo H. Norona for a psychological
screening report. Id. at 23. She stated that she punctured her finger, went to the ER for a tetanus
toxoid shot, and, following the shot, began experiencing weakness, stiffness, and inability to
walk, followed by two falls at home. Id. She returned to the ER. Id.
Dr. William L. Earp, writing the discharge summary for Winter Haven Hospital on
October 3, 2007, noted petitioner’s history of transferring from Florida Hospital at Sebring, with
complaints of weakness, some sensory changes, and decreasing endurance. Id. at 15. Petitioner
described her current problems as possibly beginning with a cut on her finger. Id. She went to
the ER and received a tetanus shot. Id. The next day after her tetanus shot, she started
developing malaise, polymyalgia, polyarthralgia, weakness, and fever. Id. The doctor diagnosed
her with a urinary tract infection and treated her with an antibiotic. Id.
On October 9, 2007, petitioner saw Dr. Audwin B. Nelson, an internist, and gave him the
history that on September 6, 2007, she cut the first digit on her right hand at work, went to the
ER later that day, and received a tetanus booster. Med. recs. Ex. 1, at 8, 10. She developed
weakness in her legs the next day and was eventually hospitalized on September 9, 2007, after
the weakness and numbness of her legs worsened. Id.
On October 30, 2007, petitioner began physical therapy. Med. recs. Ex. 6, at 38.
Physical therapist Evelyn Ongsiako evaluated petitioner, noting that petitioner reported her
current condition started on September 7, 2007 after she received a tetanus shot. Id. Petitioner
stated that on that day, she started having difficulty moving around. Id. She then went to the
6

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 7 of 20
ER, which sent her home. Id. The following day, September 8, 2007, she continued to have
difficulty ambulating and went back to the hospital. Id. She was not admitted to the hospital
until September 9, 2007. Id. Two to three weeks after her hospital admission, the doctors finally
diagnosed her with GBS. Id. A week later, she was transferred to a rehabilitation facility in
Winter Haven, where she continued strengthening. Id. She was discharged home and was much
improved. Id. Upon a recent visit with her primary care physician, she was referred for
outpatient physical therapy for further evaluation and treatment. Id. Her medical history is
significant for dizziness. Id.
In March 2008, petitioner qualified for Social Security Disability Income (“SSDI”)
benefits. Med. recs. Ex. 23, at 1.
On September 9, 2008, petitioner saw Dr. James McCluskey for an independent medical
examination. Med. recs. Ex. 19, at 910–24. Dr. McCluskey wrote a detailed history based on his
conversation with petitioner. On Thursday, September 6, 2007, petitioner nicked her right thumb
on an exposed screw head while exiting a stairwell at work around 6:45 p.m. Id. at 911. She
went home, but at around 10:00 p.m., she went to Florida Hospital Heartland ER to get a tetanus
shot. Id. She felt fine the rest of the evening until her husband, who works the midnight shift,
prepared to leave for work. Id. At that time, she had a headache and took Excedrin. Id. She
also called the hospital, told the nurse she was having a headache, and asked if there were a
relationship between the tetanus shot and the headache. Id. At 4:00 a.m., September 7, 2007,
petitioner woke at her normal time and reported that her toes/feet were tingling, but she did not
have a headache. Id. She went to work at around 8:00 or 8:30 a.m. Id. Between 10:30 and
11:00 a.m. on September 7, 2007, petitioner noted tingling in her fingers but no pain in her arms
or legs. Id. She told her co-worker she did not feel well and asked to leave in the mid-afternoon.
Id. After leaving work, she stopped at a convenience store to buy a soda and went home. Id.
She lay down and woke several hours later feeling weak, particularly in her legs. Id. When she
walked into her kitchen, she suddenly felt heat, numbness, and tingling in her arms and legs. Id.
She also had a headache. Id. Later in the evening of Friday, September 7, 2007, she was
scheduled to work at her part-time job with South Florida Community College from 10:00 p.m.
to 2:00 a.m. Id. Shortly after 6:00 p.m. on September 8, 2007, petitioner went back to the
Florida Hospital Heartland ER, where they diagnosed her with a urinary tract infection, gave her
an antibiotic, and prescribed an antibiotic. Id. She did not fill the prescription. Id. Petitioner
went to work but left after about an hour because she did not feel well. Id. She had a strong urge
to urinate. Id. On the way home, petitioner bought gas, which she pumped into her car, and
went to bed when she arrived home. Id. At about 2:30 a.m. on September 9, 2007, petitioner got
up to use the toilet and her legs felt weak. Id. She sat on the bathroom floor until 5:00 a.m.
when her sons helped her back to bed . Id. She remained in bed until 7:30 or 8:00 a.m. Id. At
that time, she walked into her kitchen to get some champagne grapes for a snack and slid onto
the floor because her legs gave out. Id. Petitioner’s family took her to Florida Hospital ER
midday, where she was informed she had a UTI-URI. Id. She went home to bed. Id. Sometime
between 7:00 p.m. and 8:30 p.m., she called South Florida Community College and told them
7

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 8 of 20
she could not come to work because she felt unwell. Id. She returned to the ER that night, and
they admitted her to the hospital. Id. Subsequently, she was diagnosed with GBS. Id.
Dr. McCluskey in his September 9, 2008 examination notes that petitioner was receiving
Social Security disability payments. Med. recs. Ex. 19, at 913. She never returned to work after
her September 2007 hospitalization. Id. During his physical examination of petitioner, Dr.
McClusky noted petitioner was alert and oriented to person, place, and time, and that she
answered all questions without difficulty. Id. at 914. Petitioner had difficulty with movement.
Id. She walked with assistance and required help to get on the exam table. Id. She responded
appropriately to questioning, and her short-term memory appeared intact. Id. Her DTRs were
2/4 at the knee and biceps tendon bilaterally. Id. Sensation appeared intact throughout. Id. Dr.
McCluskey reviewed petitioner’s vaccination history and stated in his report that the Td
vaccination of September 6, 2007 was at least the fourth vaccine containing tetanus toxoid that
she has received. Id. at 921.
On December 19, 2008, petitioner entered into a worker’s compensation settlement with
her employer’s carrier. Med. recs. Ex. 20, at 11. Winter Haven Hospital agreed that petitioner
punctured her right thumb while in its employ. Id. at 2. The lump sum settlement included
$5,000.00 for the cost of petitioner’s future medical care and treatment, and $10,000.00 in full
satisfaction of the obligation to pay. Id. at 3.
Petitioner filed a statement from her treating neurologist, Dr. Bridglal Ramkissoon, dated
January 31, 2012, as Exhibit 65. Dr. Ramkissoon states that he first saw petitioner on September
9, 2007, at Florida Hospital Heartland. Ex. 65, at 1. She was unable to urinate and had lower
extremity weakness but preserved reflexes. Id. He gave her a presumed diagnosis of GBS. Id.
His opinion is that tetanus toxoid vaccine caused her GBS because there was no other cause for
her GBS. Id. Dr. Ramkissoon opines that petitioner’s vaccination triggered molecular mimicry
to destroy segments of the myelin sheath around her nerves. Id. at 1–2. He also relies on the fact
that tetanus vaccination was given just days prior to her symptoms. Id. at 2.
EXPERTS’ REPORTS
Petitioner filed the expert opinion of Dr. Triggs as Exhibit 28. Dr. Triggs states that,
although doctors diagnosed petitioner with GBS, her medical records and clinical presentation
point to an “immune-mediated demyelinating disorder more consistent with a central nervous
system process and the diagnosis of transverse myelitis.” Ex. 28, at 5. Dr. Triggs lists the basis
for his reasoning. First, petitioner’s CSF showed a level of pleocytosis that excludes the
diagnosis of an inflammatory demyelinating neuropathy such as GBS or chronic inflammatory
demyelinating polyneuropathy, but is consistent with transverse myelitis (“TM”). Id. Secondly,
petitioner retained her deep tendon reflexes, which is contrary to a diagnosis of GBS but is
consistent with TM. Id. Thirdly, petitioner’s neurologic disorder included “urinary bladder
dysfunction that was both an early clinical manifestation of her illness and was relatively
8

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 9 of 20
disproportional to her weakness.” Id. Dr. Triggs states that TM results in neuronal injury and
demyelination. Id. at 6.
Respondent filed the expert report of Dr. Leist as Exhibit B. Dr. Leist notes that the
presence of urinary tract symptoms on September 8, 2007 suggested the presence of a neurologic
process affecting her bladder control. Ex. B, at 7–8. (This is the same point Dr. Triggs made in
his expert report.) Dr. Leist notes the time petitioner signed the informed consent for Td vaccine
was 11:10 p.m. on September 6, 2007. Id. at 7. Relying on Dr. McCluskey’s extensive
interview and evaluation of petitioner on October 20, 2008, when petitioner told Dr. McCluskey
that she became aware of tingling in her toes when she rose at 4:00 a.m. on September 7, 2007,
Dr. Leist opines that there was an onset interval of five hours between petitioner’s Td
vaccination and the onset of her neurologic disorder. Id. at 8. Dr. Leist writes that the time
interval of five hours “between vaccination and onset of tingling in the toes is too short for
induction or re-stimulation of a self-reactive immune process against the constituents of the Td
vaccine,” regardless of whether petitioner had GBS or TM. Id.
Dr. Leist states that when petitioner came to the ER on September 9, 2007, complaining
of aching all over and leg weakness for three days, fever, chills, and difficulty voiding, the tests
results of her blood were consistent with an infection. Id. Her white blood cell count was
elevated at 11,100 with increased neutrophils. Id. Her erythrocyte sedimentation rate was
elevated at 41. Id. Dr. Leist states that bodily joint pain, fever, chills, increased white cell count
with a left shift, and an elevated erythrocyte sedimentation rate are consistent with an infection.
Id. at 8. Dr. Duharte, a treating doctor, noted on September 17, 2007, that petitioner still had a
viral infection, probably enterovirus 71. Id. at 9 (citing Ex. 5, at 129).
Dr. Leist concludes that petitioner did not have GBS and that she could not have had a
demyelinating process five hours after Td vaccination because the onset interval was too short.
Id. at 10. Dr. Leist opines that an infection prior to petitioner’s receipt of Td vaccine caused her
flu-like symptoms, fever, and neurologic presentation, which began on September 7, 2007. Id.
On May 19, 2014, after the hearing, petitioner filed a supplemental expert report of Dr.
Triggs in response to the undersigned’s Order, as Exhibit 70. Dr. Triggs states that TM includes
symptoms of bladder and bowel dysfunction. Ex. 70, at 1. He states that petitioner received
tetanus vaccine at 10:52 p.m. on September 6, 2007. Id. at 2. He also states that petitioner went
to the ER at 6:00 p.m. on September 8, 2007 with a urinary tract infection. Id. at 3. Dr. Triggs
believes that the onset interval between petitioner’s tetanus vaccination and her symptoms was
“a little over 48 hours” because he puts onset at 5:00 a.m. on September 9, 2007. Id. He
distinguishes between petitioner’s urological complaints (which began within a day after her
vaccination) and her neurological complaints. Id. at 4. Petitioner had bilateral lower extremity
weakness with intermittent loss of reflexes and significant bladder dysfunction. Id. at 5. Dr.
Triggs states he was reluctant at the hearing to commit to molecular mimicry as the mechanism
causing petitioner’s TM. Id. at 7. He states tetanus vaccine can stimulate a cross-reactivity of
immune cells from the initial challenge and cause an inadvertent response within “self-cells.” Id.
9

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 10 of 20
Dr. Triggs states we do not have clear diagnostic evidence of demyelination in petitioner, but she
had clinical signs of an inflammatory process. Id. at 8. He does not agree that five days (as Dr.
Leist testified) is required in order to produce an inflammatory and/or autoimmune response, and
he cites case reports in the medical literature filed as Exhibits 41–60.3 He refers to a TM Fact
Sheet from NIH/NINDS, which notes that the onset of symptoms can occur from within hours to
several days to the outer ranges of one to four weeks.4 Id.
MEDICAL LITERATURE
Filed together with Dr. Triggs’ initial expert report are Exhibits 30 through 36, comprised
of references Dr. Triggs made in his initial expert report.
Exhibit 30 is a case report entitled, “Acute transverse myelitis in a 7-month-old boy after
diphtheria-tetanus-pertussis immunization.” R.M.S. Riel-Romero, Acute transverse myelitis in a
7-month-old boy after diphtheria-tetanus-pertussis immunization, 44 Spinal Cord 688 (2006).
3 The onset intervals for TM after vaccination in Exhibits 41–60 do not support Dr. Triggs’
opinion that onset can happen two days after vaccination and be causal. All of the articles that
address onset have onsets longer than two days. For example, Exhibit 41 has a 17-day onset.
Exhibit 42 has a 21-day onset. Exhibit 43 has a 16-day onset. Exhibit 44 has a four-week onset.
Exhibit 45 has numerous onsets (ranging from two to nine days), and the authors caution against
assuming causation from coincidences. Exhibit 46 has a two-month onset. Exhibit 47 has a
three-week onset. Exhibit 48 has a 10-day onset. Exhibit 49 has a two-week onset. Exhibit 50
has a three-week onset. Exhibit 51 has a two-week onset. Exhibit 52 has a six-day onset.
Exhibit 53 has a five-day onset. Exhibit 57 has a 16-day onset. Exhibit 59 has a 6- to 7-day
onset. The other articles do not address onset specifically. Exhibit 54 is a chapter on acute
disseminated encephalomyelitis from a textbook on autoimmune neurological disease. Exhibit
55 is an article about neurological complications from swine flu vaccine. Exhibit 56 is an article
about mono- and poly-neuritis (both peripheral neuropathies) after tetanus vaccination. Exhibit
58 is an article about the signs and symptoms of TM. Exhibit 60 is a chapter on acute
disseminated encephalomyelitis from a textbook on clinical neuroimmunology. In sum, these
exhibits do not support Dr. Triggs’ statement that a brief (he would posit a little more than 48
hours) interval between tetanus vaccination and onset of TM is “well-established” in the case
reports he cited in his initial expert report. Ex. 70, at 8.
4 Dr. Triggs’ description of the National Institute of Neurological Disorders and Stroke TM Fact
Sheet (Ex. 75) misrepresents its contents. The TM Fact Sheet says that symptoms of TM can
occur over several hours to several weeks. Ex. 75, at 1. It does not say that several hours to
several weeks is the interval between a trigger, such as a vaccination, and the onset of the TM
itself. The TM Fact Sheet does not discuss onset intervals after vaccination or a trigger at all.
The description in the Fact Sheet of developing TM over hours to several days or from one to
four weeks indicates solely the difference between acute TM and subacute TM; it does not refer
to the interval between trigger and onset of TM. Id. at 2.
10

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 11 of 20
(Petitioner also filed this case report as Exhibit 41.) A seven-month-old male was hospitalized
with acute TM 17 days after he received DTaP vaccine. Ex. 30, at 1. He also had an upper
respiratory infection two weeks prior to admission. Id. The author does not conclude that the
vaccination caused the child’s TM, as the child also had an upper respiratory infection within a
similar time period (two weeks before hospitalization). Id. at 3. The author lists other case
reports of vaccinees with TM post-vaccination: (1) a baby with TM 17 days after DPT vaccine;
(2) a baby with paraplegia six days after DT and oral polio vaccines; (3) a toddler with acute TM
21 days after MMR vaccine; (4) a teenager with right-sided weakness and numbness one week
after hepatitis B vaccine; (5) a four-year-old with acute TM 14 days after Japanese B encephalitis
vaccine; (6) a nine-year-old with TM 16 days after measles and rubella vaccine; and (7) an adult
who developed fatal inflammatory polyradiculopathy/myelopathy nine days after hepatitis B
vaccine. Id.
Exhibit 31 is a case report in the form of a letter entitled, “Transverse myelitis after
vaccination.” G. Zanoni et al., Transverse myelitis after vaccination, 9 Eur. J. Neurology 696
(2002). (Petitioner also filed this case report as Exhibit 42.) A 15-month-old baby girl had acute
TM 21 days after her first MMR and fourth DTaP vaccinations. Ex. 31, at 3. The authors note
that the MRI failed to detect abnormalities or spinal cord swelling, but this is typical of 60
percent of myelitis cases. Id. The authors suggest further study to determine causality. Id. at 4.
Exhibit 32 is a case report entitled, “Transverse myelitis after measles and rubella
vaccination.” S. Lim et al., Transverse myelitis after measles and rubella vaccination, 40 J.
Pediatric Child Health 583 (2004). (Petitioner also filed this case report as Exhibit 43.) A nine-
year-old girl had urinary incontinence 16 days after receiving her first measles rubella
vaccination. Ex. 32, at 2. Four days later, she developed low back pain and lower limb
weakness and was hospitalized. Id. The authors recognize that TM is most frequently associated
with an antecedent upper respiratory illness but may also follow other viruses. Id. at 3. They do
not conclude the girl’s TM was due to her vaccination, but they could not find another cause. Id.
Exhibit 33 is a case report entitled, “Acute Transverse Myelitis After Influenza
Vaccination: Magnetic Resonance Imaging Findings.” R. Bakshi et al., Acute Transverse
Myelitis After Influenza Vaccination: Magnetic Resonance Imaging Findings, 6 J. Neuroimaging
248 (1996). (Petitioner also filed this case report as Exhibit 44.) A 36-year-old woman was
hospitalized with a one-week history of progressive leg weakness, numbness below the chest,
and urinary retention. Ex. 33, at 3. Her symptoms began four weeks after receiving influenza
vaccine. Id. She had not had any antecedent illnesses. Id. She was diagnosed with post-
vaccination syndrome by exclusion. Id. at 4.
Exhibit 34 is an article entitled, “Immunopathogenesis of acute transverse myelitis.” D.A.
Kerr et al., Immunopathogenesis of acute transverse myelitis, 15 Current Opinion Neurology 339
(2002). (Petitioner also filed this article as Exhibit 45.) The authors state that virtually all TM
patients have some degree of bladder dysfunction. Ex. 34, at 2. For those with idiopathic TM,
the time between onset of symptoms and nadir of symptomatology is four hours to 21 days. Id.
11

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 12 of 20
The authors state that case reports must be viewed with caution, as two events occurring closely
in time may be coincidental. Id. at 3. Possible biological causative mechanisms include
molecular mimicry, superantigens, autoantibodies, or high levels of normal circulating
antibodies. Id. at 4–5.
Exhibit 35 is a case report in the form of a letter entitled, “Acute transverse myelitis after
tetanus toxoid vaccination.” S.J. Read et al., Acute transverse myelitis after tetanus toxoid
vaccination, 339 Lancet 1111 (1992). (Petitioner also filed this case report as Exhibit 57.) A 50-
year-old man received tetanus toxoid vaccine. Ex. 35, at 3. Sixteen days later, he had
generalized myalgia, lethargy, fatigue, and mild bi-frontal headache. Id. Twelve days after his
initial presentation, he was admitted to the hospital with TM. Id.
Exhibit 36 is a case report entitled, “Transverse myelitis after diphtheria, tetanus, and
polio immunization.” E. Whittle et al., Transverse myelitis after diphtheria, tetanus, and polio
immunization, 1 Brit. Med. J. 1450 (1977). (Petitioner also filed this case report as Exhibit 59.)
A seven-month-old girl developed TM six to seven days after receiving her first diphtheria,
tetanus toxoid, and polio vaccinations. Ex. 36, at 1. She also had a history of a slight cough and
hoarse cry for four days. Id. The authors note that, although myelitis may have occurred by
chance, the onset of the baby’s symptoms occurred when reactions to vaccinations are most
frequently found. Id.
Subsequently, petitioner filed other medical literature. Exhibit 46 is a case report
entitled, “Acute Transverse Myelitis at the Conus Medullaris Level After Rabies Vaccination in
a Patient with Behҁet’s Disease.” L.S. Bir et al., Acute Transverse Myelitis at the Conus
Medullaris Level After Rabies Vaccination in a Patient with Behҁet’s Disease, 30 J. Spinal Cord
Med. 294 (2007). The onset interval of acute TM after rabies vaccination was two months. Ex.
46, at 1. The authors posit that the vaccine may have contributed to the acute TM. Id. at 3.
Exhibit 47 is a case report entitled, “Acute radiculomyelitis after antitetanus vaccination.”
F. Tezzon et al., Acute radiculomyelitis after antitetanus vaccination, 15 Italian J. Neurological
Sci. 191 (1994). A 40-year-old woman had right lumbar sciatica three weeks after tetanus toxoid
vaccination. Ex. 47, at 1. Her sciatica was soon followed by paresthesia and hypoesthesia of the
lower limbs, and severe hyposthenia, making standing difficult. Id. The authors refer to a 1937
case report that was the first report of neurological complications after tetanus toxoid. Id. at 2.
The case report referred to a case of fatal acute necrotic encephalomyelitis, whose onset was
eight days after vaccination. Id. The authors describe another case report of a woman who, five
days after antitetanus vaccine, had a serious neurologic illness that included both the central and
peripheral nervous systems. Id. at 3. The authors refer to two 1992 case reports, the first
reporting optic neuritis and acute myelitis three days after vaccination, and the second reporting
severe acute encephalomyelitis ten days after antitetanus vaccine. Id. The authors state, “In the
majority of the cases reported in the literature, the time interval between vaccination and the
development of neurological complications varies between 10 and 20 days. In our case, the first
signs of radiculomyelitis appeared 20 days after vaccination.” Id. They conclude that the time
12

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 13 of 20
interval between the vaccination and the neurological event suggests antibody movement or a
cell-mediated mechanism. Id.
Exhibit 48 is a case report entitled, “Early-Onset Acute Transverse Myelitis Following
Hepatitis B Vaccination and Respiratory Infection.” L.F. Fonseca et al., Early-Onset Acute
Transverse Myelitis Following Hepatitis B Vaccination and Respiratory Infection, 61 Arquivos
Neuro-Psiquiatria 265 (2003). A three-year-old boy had acute TM ten days after receiving a
hepatitis B vaccine while he had a mild upper airway respiratory illness manifested by rhinorrhea
and cough. Ex. 48, at 2. The authors state the mean interval from infection to onset of
neurological symptoms is reported as between nine days to three weeks. Id. at 3. The authors
could not determine whether the viral respiratory infection or the hepatitis B vaccination caused
the TM, but they posited it might be both antigens. Id. at 4.
Exhibit 49 is a case report entitled, “MR Imaging in a Case of Postvaccination Myelitis.”
L.M. Tartaglino et al., MR Imaging in a Case of Postvaccination Myelitis, 16 Am. J.
Neuroradiology 581 (1995). A 40-year-old male had TM two weeks after receiving his first
hepatitis B vaccination. Ex. 49, at 1. One month after he received his second vaccination, the
sensory disturbance ascended. Id. The authors state, “[T]he striking temporal relationship
between symptoms and the two doses of hepatitis B vaccine strongly suggests that the vaccine
was the cause.” Id.
Exhibit 50 is a case report entitled, “Acute myelitis following hepatitis B vaccination.” F.
Mahassin et al., Acute myelitis following hepatitis B vaccination, 22 La Presse Médicale 1997
(1993). The article is written in French with a one-paragraph abstract in English. The authors
describe a 56-year-old man who had TM three weeks after receiving hepatitis B vaccine. Ex. 50,
at 2.
Exhibit 51 is a case report entitled, “Acute Myelitis after Hepatitis B Vaccination.” H-K
Song et al., Acute Myelitis after Hepatitis B Vaccination, 12 J. Korean Med. Sci. 249 (1997). A
31-year-old man had acute TM two weeks after receiving his third dose of plasma-derived
hepatitis B vaccine. Ex. 51, at 1. The authors surmise the temporal relationship between the
symptoms and the vaccination “strongly suggests that the vaccine was the cause.” Id. The
authors write that a possible mechanism involves an autoimmune phenomenon associated with
T-cell mediated immune reaction. Id.
Exhibit 52 is a case report in the form of a Letter to the Editor, translated from French,
entitled, “Acute myelitis after hepatitis B immunization with a recombinant vaccine.” A.
Senejoux et al., Acute myelitis after hepatitis B immunization with a recombinant vaccine, 20
Gastroénterologie Clinique Biologique 401 (1996). A 65-year-old woman had acute TM six
days after receiving her second dose of hepatitis B vaccine. Ex. 52, at 1.
Exhibit 53 is a case report entitled, “Acute transverse myelitis following typhoid
vaccination.” R.N. Das et al., Acute transverse myelitis following typhoid vaccination, 76 Ulster
13

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 14 of 20
Med. J. 39 (2007). A 19-year-old man had acute TM five days after receiving typhoid vaccine.
Ex. 53, at 1.
Exhibit 72 is a case report entitled, “Myelopathy following influenza vaccination in
inflammatory CNS disorder treated with chronic immunosuppression.” A.J. Larner et al.,
Myelopathy following influenza vaccination in inflammatory CNS disorder treated with chronic
immunosuppression, 7 Eur. J. Neurology 731 (2000). A 42-year-old man with optic neuropathy
developed TM a few days after influenza vaccination. Ex. 72, at 1.
Exhibit 73 is an article entitled, “Vaccine-induced Autoimmunity.” A.D. Cohen et al.,
Vaccine-induced Autoimmunity, 9 J. Autoimmunity 699 (1996). The authors state that a number
of autoimmune disorders have occurred two to four weeks after vaccination. Ex. 73, at 1.
Exhibit 74 is a case report in the form of a letter entitled, “Optic neuritis and myelitis
after booster tetanus toxoid vaccination.” H. Topaloglu et al., Optic neuritis and myelitis after
booster tetanus toxoid vaccination, 339 Lancet 178 (1992). An 11-year-old girl had rapid onset
of visual deterioration and weakness three days after tetanus toxoid vaccination. Ex. 74, at 1.
Although the undersigned has not described all the submissions of medical literature, the
undersigned has reviewed them.
TESTIMONY
The first part of the hearing on July 11, 2012, began with Special Master Zane’s
summary of the issue in the case: whether or not petitioner had GBS or some other neurological
disease caused by her Td vaccination of September 6, 2007. Tr. at 5. The second part of the
hearing began on July 20, 2012. The transcript pagination is continuous from the first part
through the second part of the hearing.
Petitioner testified first. Tr. at 7. On September 6, 2007, while exiting her place of
employment, she pricked her finger on a screw, got a Band-Aid from a secretary, and went
home. Id. at 10. Later that night, she went to the hospital and received a tetanus shot. Id. This
was about 10:00 p.m., and it took about an hour to get home. Id. at 11. She woke up the next
day, Friday, at around 4:30 a.m. to go to work and had a slight headache. Id. She did not feel
well about mid-morning and left for home after lunch. Id. at 12. She went to her auditing job
that night but stayed only about an hour or an hour and one-half. Id. On Saturday, she did not
feel well, and her husband took her to the ER. Id. at 13. She felt fatigued and had a headache.
Id. The ER physician diagnosed her with a urinary tract infection and gave her two
prescriptions. Id. She went for an hour to her night job. Id. at 14. After she went to bed, she
got up at 2:30 or 3:00 a.m. on Sunday to use the bathroom and then went to the kitchen to get
some grapes, but she lost her balance and slid to the floor with the refrigerator door open. Id. at
15. She yelled for her husband and sons to help her, but they did not hear her. Id. Before 5:00
a.m., her daughter came downstairs to make a bottle for her baby girl and discovered her on the
14

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 15 of 20
kitchen floor. Id. at 16. Petitioner could not get up, and her daughter got her brothers to help
her. Id. She slept most of the day. Id. Her family took her back to the ER when her husband
came home. Id.
On cross-examination, petitioner denied she had tingling, lower extremity weakness,
body aches, or muscle aches during the first 24 hours after her Td vaccination. Id. at 30. When
shown the ER records of September 8, 2007, in which she gave a history of aching all over,
fever, and cough that started the day before (September 7, 2007), petitioner replied, “Well, it
states here that that’s what I said, but I don’t remember.” Id. at 32. When advised that the ER
document had circles for “Review of Symptoms” indicating fever, chills, generalized weakness,
problems urinating, and frequent urination, petitioner replied, “Like I said, I don’t remember, but
it’s here on this paperwork, so evidently.” Id. at 33. When shown under the category “Chief
Complaint” at the ER on September 8, 2007, “Body aches and joint aches, fever. Started
Thursday. PT [patient] was here Thursday night for TD shot, and Friday she started not feeling
good,” petitioner replied, “That’s what it says here. I don’t remember, but that’s what it says
here.” Id. at 35. Petitioner did not recall giving the ER staff all the information in their records,
e.g., that her legs had been weak, and she had been aching for three days. Id. at 38.
On September 9, 2008, petitioner saw Dr. McCluskey, the worker’s compensation doctor.
Id. at 60. The report states the interview lasted from 10:00 a.m. to 12:50 p.m. or almost three
hours. Id. Petitioner stated it was a lengthy visit, but she was not sure of the time. Id. She
recalled talking with Dr. McCluskey for several hours. Id. at 61. She denied that she had
tingling toes or fingers on Friday, September 7, 2007. Id. at 64. Her main complaint on Friday
was headache. Id. She said that she did not report tingling until Sunday, September 10, 2007.
Id. at 65.
Dr. William Triggs, a neurologist, testified for petitioner. Id. at 132. Demyelinating
disorders are his subspecialty, and he is also an electromyographer. Id. at 134. He opined that
petitioner received Td vaccine and, then, between 48 and 72 hours later, developed transverse
myelitis. Id. at 180. To explain the basis for his opinion that Td vaccine caused petitioner’s TM,
Dr. Triggs stated it was an autoimmune event and that this was his “educated speculation.” Id.
He said autoimmunity is not well understood: “I mean, we don’t know.” Id. Dr. Triggs stated no
one understands how or why the immune system goes awry. Id. at 181. He said there is still a
lot that remains to be understood about it. Id. He did not think petitioner had an infectious
etiology at the time, which would be an alternative cause, although if she had an infection, the
cause could be both the infection and the vaccine. Id. at 183. He could not testify that molecular
mimicry was definitely the mechanism here. Id. at 250. Molecular mimicry is a very popular
theory for autoimmunity, but autoimmunity is probably much more complicated than that. Id.
Molecular mimicry is an oversimplification for which we have some isolated examples in the
field of immunology. Id. Other than petitioner having an immune response that targeted a part
of her spinal cord, he could not be more specific. Id. at 260. Dr. Triggs would call it “just
myelitis as opposed to transverse [myelitis].” Id. at 310. Technically, petitioner did not have
transverse myelitis “because it didn’t affect completely every neurological function at a level.”
15

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 16 of 20
Id. at 316. She had an inflammatory lesion of her spinal cord. Id. She had a mild or partial
myelitis. Id. at 321. Giving “an educated speculation,” Dr. Triggs said the way the immune
system affects the cord produces a variable degree of swelling. Id. at 322. The immune system,
not swelling, destroys tissue. Id.
Dr. Triggs thought petitioner’s lesion was at the bottom part of the spinal cord in the
conus medullaris. Id. at 330. The neural structures that control bladder function are in the conus
medullaris, which is also the origin of nerve roots for the lower extremities. Id. Dr. Triggs said,
“I’m hanging up on demyelination. I’m not convinced that the injury to her cord was necessarily
demyelination. In fact, I think if it was demyelination, her outcome might have been better, and
it’s more likely an MRI would have been abnormal. So the immune system doesn’t attack the
cord necessarily by producing demyelination . . . although that’s certainly one mechanism.” Id.
at 339. He opined that the vaccine caused an immune-mediated injury to petitioner’s spinal cord.
Id. An onset of less than 24 hours would cause Dr. Triggs “to squirm a little . . . from [his]
limited knowledge of immunology.” Id. at 340. But as a clinician, he said he believes that if
there is no other immune stimulation occurring in his patient and his patient gets myelitis, if the
onset interval is 23 hours, he would not say it absolutely cannot be the vaccine. Id. He said he
could not give a specific immunological mechanism because he is not an immunologist or a
neuroimmunologist. Id. He said he thinks a two- or three-day onset is okay for causation. Id. at
341.
Dr. Triggs considered the onset of petitioner’s neurological condition to be September 9,
2007. Id. at 210. He agreed that pain radiating in the legs and inability to void can be
neurological signs. Id. at 211. Petitioner gave a history on September 9, 2007 that she had a
several-day history of aching all over, and weak legs for three days, which is consistent with
GBS or transverse myelitis. Id. at 213–14. Even if the onset of petitioner’s neurologic problems
occurred one day after her Td vaccination, Dr. Triggs said he would still opine that the vaccine
was the cause. Id. at 243. He explained causation as autoimmune, but he could not tell if it
involved molecular mimicry or some sort of super antigen phenomenon. Id. at 260. He said he
could not cite specific evidence that this immune process could occur within less than 24 hours.
Id. at 261. Dr. Triggs said that when petitioner went to the ER on September 8, 2007, her urinary
tract infection was not the correct primary diagnosis. Id. at 297. She was having a reaction to
the vaccine and was feeling muscle aches, joint aches, and low-grade fever. Id. He said he did
not know if this was a neurological reaction. Id. at 298. He could not separate out the urinary
tract infection from the vaccination as causal of petitioner’s neurological condition. Id. at 300.
Dr. Triggs said an onset on September 8 would not bother him, but an onset on September 7
would become a little more problematic based on his knowledge of animal immunology. Id. at
307. But if he had a patient asking about causation, and he had no other cause but the vaccine to
consider, he would probably say that a vaccine caused a one-day reaction. Id. He said less than
24 hours becomes more problematic if you look at animal data and immunology. Id. at 307–08.
Dr. Triggs would not attribute petitioner’s leg weakness and urinary retention to something other
than a neurological condition. Id. at 317.
16

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 17 of 20
Dr. Thomas P. Leist, a neurologist, testified for respondent. Id. at 350. When petitioner
was in the ER on September 8, 2007, she had a normal white cell count. Id. at 362. On
September 9, 2007, her white cell count had increased to 11,100, and she had an elevated
erythrocyte sedimentation rate. Id. Her significantly elevated white cell count had lymphocytic
predominance. Id. The elevated white cell count, lymphocytic predominance in the white cells,
and elevated erythrocyte sedimentation rate are all congruent with a possible viral infection. Id.
In transverse myelitis generally, the peripheral white cell count is not increased. Id. at 363.
Dr. Leist said he thinks petitioner had a viral meningoradiculitis. Id. at 369.
Meningoradiculitis is a process between transverse myelitis and Guillain-Barré syndrome. Id. at
365–66. Meningoradiculitis principally involves the nerve roots and the spinal cord. Id. at 366.
Dr. Leist said he does not believe tetanus vaccine could cause petitioner to develop a
demyelinating or neurologic condition within one day. Id. at 377. It would take days for the
immune process to begin. Id. at 378. Dr. Leist thought the shortest time period for a cross-
reactive immune response to manifest would be five days. Id. at 378. Petitioner’s medical
records show that her symptoms began on September 7, 2007. Id. She did not feel well, cut
short her work hours, contacted her supervisor, and reported the next day, September 8, 2007, to
the ER personnel that she had generalized malaise and urinary symptoms. Id. Dr. Leist said that
the urinary symptoms were an indication that she had bladder dysfunction, not a urinary tract
infection. Id. Dr. Leist disagreed with Dr. Triggs’ interpretation that petitioner had a separate
urinary tract infection with urinary retention following it. Id. at 378–79. Dr. Leist viewed the
bladder presentation on September 7 as the same as the bladder presentation on September 8. Id.
at 379. The process affecting the central or radicular nerve root was already established on
September 8. Id. Therefore, petitioner’s symptoms began on September 7, within the first 24
hours after petitioner’s vaccination. Id. Petitioner’s bladder symptoms on September 8 are
congruent with urinary retention and can be viewed as a neurological symptom. Id. at 380. This
is a single process, presenting to the ER on September 8 at about 6:00 p.m. and returning to the
ER on September 9 at around 3:00 p.m. Id.
Dr. Leist said that an autoimmune process takes time. Id. at 502. A cross-reactive
immune response needs to get into the central nervous system, where it encounters the cross-
reactive antigen and is restimulated. Id. Dr. Leist said he did not think it was possible for such
an onset after vaccination to occur within two days. Id. at 503. After the injection of the
vaccine, T-cells respond to this antigen. Id. Then the response has to be transported into the
central nervous system. Id. First, the cells go in, and then they need to attract additional
lymphocytes in order to cause a local tissue injury, which also takes time. Id. at 503–04. It is
highly unlikely to occur in two days. Id. at 504.
DISCUSSION
To satisfy her burden of proving causation in fact, petitioner must prove by preponderant
evidence: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical
sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a
17

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 18 of 20
showing of a proximate temporal relationship between vaccination and injury.” Althen v. Sec’y
of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). In Althen, the Federal Circuit quoted its opinion
in Grant v. Secretary of Health and Human Services, 956 F.2d 1144, 1148 (Fed. Cir. 1992):
A persuasive medical theory is demonstrated by “proof of a logical
sequence of cause and effect showing that the vaccination was the
reason for the injury[,]” the logical sequence being supported by
“reputable medical or scientific explanation[,]” i.e., “evidence in
the form of scientific studies or expert medical testimony[.]”
Without more, “evidence showing an absence of other causes does not meet petitioners’
affirmative duty to show actual or legal causation.” Grant, 956 F.2d at 1149. Mere temporal
association is not sufficient to prove causation in fact. Id. at 1148.
Petitioner must show not only that but for her Td vaccination, she would not have had
TM, but also that the vaccine was a substantial factor in causing her TM. Shyface v. Sec’y of
HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999).
The Vaccine Act does not permit the undersigned to rule in favor of petitioner based
solely on her allegations unsupported by medical records or credible medical opinion. 42 U.S.C.
§ 300aa-13(a)(1).
The undersigned has no difficulty accepting that tetanus vaccine can cause transverse
myelitis. Petitioners have prevailed in cases in which they alleged that tetanus vaccine caused
their TM. See, e.g., Roberts v. Sec’y of HHS, No. 09-427V, 2013 WL 5314698, at *1 (Fed. Cl.
Spec. Mstr. Aug. 29, 2013) (four-week onset); Helman v. Sec’y of HHS, No. 10-813V, 2012 WL
1607142, at *3 (Fed. Cl. Spec. Mstr. Apr. 5, 2012) (three-week onset; respondent elected not to
defend the case); Bowes v. Sec’y of HHS, No. 01-481V, 2006 WL 2849816, at *3 (Fed. Cl.
Spec. Mstr. Sept. 8, 2006) (two-week onset). Petitioner has satisfied prong one of Althen.
Before discussing prong two of Althen, it is essential to discuss prong three because this
case hinges on timing. Petitioner’s expert, Dr. Triggs, stated in his initial expert report that
petitioner had transverse myelitis, which he described as an “immune-mediated demyelinating
disorder.” Ex. 28, at 5. He later changed his opinion, testifying at the hearing that petitioner had
an inflammatory lesion of her spinal cord, a partial myelitis. Tr. at 316. He also testified he was
“hanging up on demyelination” because he was not convinced petitioner had demyelination. Tr.
at 339. He did not know what the medical theory was connecting Td vaccine to transverse
myelitis. Because of the difference between his expert report and his testimony, the undersigned
ordered petitioner to file a supplemental expert report from Dr. Triggs. In this supplemental
report, Dr. Triggs identifies the onset of petitioner’s TM as 54 hours after vaccination, or just
over two days. Ex. 70, at 4.
18

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 19 of 20
Interestingly, in Dr. Triggs’ initial expert report, he emphasizes that petitioner had early
manifestation of her TM with urinary bladder dysfunction as one of the bases for his opinion that
she had TM and not GBS. Ex. 28, at 5. But he ignores in his expert report that the onset of
petitioner’s urinary bladder dysfunction was on September 7, 2007, within one day of her receipt
of Td vaccine (which she received at 11:10 p.m. on September 6, 2007). Med. recs. Ex. 5, at
141. She gave a history on September 8, 2007 at the Florida Hospital ER of bodily aching,
generalized weakness, frequent urination, fever, and chills since September 7, 2007. Id. On the
one hand, Dr. Triggs focuses on petitioner’s urinary tract infection as proof in his expert report
that petitioner had TM, not GBS, but on the other hand, he ignores that this proof includes a one-
day onset from the Td vaccination. This September 8, 2007 history of onset of urinary
dysfunction starting on September 7, 2007 is petitioner’s earliest contemporaneous recounting of
her symptomatology and its onset. At hearing, Dr. Triggs pinpointed the location of petitioner’s
lesion as in her conus medullaris, which is at the bottom part of the spinal cord, where the neural
structures that control bladder function are and where the nerve roots for the lower extremities
originate. Tr. at 330. This very location indicates that the lesion led to petitioner’s urinary
dysfunction, the onset of her TM.
Respondent’s expert Dr. Leist testified that petitioner’s urinary dysfunction is basic to her
evolving neurologic disease that he opines is due to a viral infection. He terms her neurologic
disease as meningoradiculitis (involving both the spinal cord and the nerve roots). In focusing
on the bladder dysfunction, Dr. Leist’s opinion is consonant with Dr. Triggs’ opinion in his
initial report (before Dr. Triggs changed his opinion at the hearing to view the bladder
dysfunction as unrelated to petitioner’s TM).
Dr. Triggs’ testimony about onset is similarly discordant. Although he testified that he
would be unlikely to support a one-day onset based on his understanding of animal studies, he
then concluded that a one-day onset was acceptable because there was no other factor that could
have caused petitioner’s TM. He omitted the possibility of an alternative cause—a urinary tract
infection unrelated to her vaccination, which he had previously mentioned in his testimony. In
contrast to Dr. Triggs’ conclusion that there was no other factor that could have caused
petitioner’s TM, respondent’s expert Dr. Leist opined there was a factor unrelated to the tetanus
vaccine that caused petitioner’s illness. Dr. Leist noted that petitioner had a significantly
elevated white blood count consisting of lymphocytes and an elevated erythrocyte sedimentation
rate, which are not indicia of TM but are indicia of a viral infection. In fact, two of petitioner’s
treating physicians opined that she had a viral meningitis or enterovirus 71 infection. However,
the initial burden is on petitioner, not respondent. Because the undersigned does not hold that
petitioner has satisfied her burden of proving an appropriate causal interval between tetanus
vaccination and her neurologic illness, the burden does not shift to respondent to prove a known
factor unrelated to the vaccine caused petitioner’s illness.
The Federal Circuit has addressed the short onset of a demyelinating central nervous
system disease after tetanus vaccination as preventing a petitioner from satisfying her burden of
proof. De Bazan v. Sec’y of HHS, 539 F.3d 1347 (Fed. Cir. 2008). In De Bazan, petitioner
19

Case 1:08-vv-00724-EDK Document 115 Filed 07/15/14 Page 20 of 20
alleged her acute disseminated encephalomyelitis (“ADEM”) occurred eleven hours after her
tetanus vaccination. Id. at 1349–50. ADEM is an autoimmune disorder affecting the central
nervous system. Id. at 1350, n.1. Petitioner became a quadriplegic. Id. at 1350. The testimony
of respondent’s expert at the hearing concerned the brevity of the eleven-hour onset interval.
The special master held that petitioner’s onset was too soon to be appropriate for vaccine
causation. However, a judge on the Court of Federal Claims reversed the special master’s
dismissal, concluding that petitioner had established a prima facie case. The Federal Circuit
reversed, finding no error in the special master’s conclusion that an eleven-hour onset was too
soon to connote causation. The Federal Circuit stated that a petitioner must provide
“preponderant proof that the onset of symptoms occurred within a timeframe for which, given
the medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation-in-fact.” Id. at 1352. Since eleven hours was not sufficient time to produce molecules
responsible for myelin destruction, the onset interval in De Bazan was inappropriate for
causation. Id. at 1353, 1354.
Consonant with the recognition in the medical community that an autoimmune
mechanism takes time to manifest is the Tezzon article (Ex. 47), which describes a woman who
had TM three weeks after tetanus toxoid vaccine. Ex. 47, at 2. The authors state that the process
for the vaccine injury should take days to manifest in order to enable the antibody movement or
cell-mediated mechanism to result in the neurologic illness. They report cases involving
neurologic illness after vaccination ranging from three to twenty days. Id. at 3. The case reports
petitioner filed in the instant action list onset of TM from two days to weeks after vaccination.
Medical literature, even in the form of case reports, does not support a one-day onset of TM.
Petitioner has failed to satisfy the third prong of Althen because an onset of TM one day
after tetanus vaccination is too soon to support vaccine causation. Because petitioner has failed
to satisfy the third prong of Althen, she has also failed to satisfy the second prong of Althen, i.e.,
that tetanus vaccine did cause her TM in this case. This petition is hereby DISMISSED.
CONCLUSION
Petitioner’s petition is DISMISSED. In the absence of a motion for review filed
pursuant to RCFC Appendix B, the clerk of the court is directed to enter judgment herewith.5
IT IS SO ORDERED.
June 23, 2014 s/Laura D. Millman
DATE Laura D. Millman
Special Master
5 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either
separately or jointly, filing a notice renouncing the right to seek review.
20

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_08-vv-00724-1
Date issued/filed: 2015-02-12
Pages: 13
Docket text: PUBLIC DECISION (Originally filed: 01/28/2015 ) Keywords: re: 127 National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (2006); Tetanus Toxoid Vaccine; Guillain-Barr Syndrome; Transverse Myelitis; Causation; Althen v. Secy of HHS, 418 F.3d 1274 (Fed. Cir. 2005); Medically Acceptable Timeframe; Treating Physicians Opinions Signed by Judge Elaine D. Kaplan. (jh) Copy to parties. Modified on 2/18/2015 - corrected pdf (jt1).
--------------------------------------------------------------------------------
Case 1:08-vv-00724-EDK Document 127 Filed 02/12/15 Page 1 of 13
In the United States Court of Federal Claims
No. 08-724V
(Filed Under Seal: January 28, 2015)
(Reissued: February 12, 2015)1
)
IDA MOSLEY, ) National Childhood Vaccine Injury Act of
) 1986, 42 U.S.C. §§ 300aa-1 to -34 (2006);
Petitioner, ) Tetanus Toxoid Vaccine; Guillain-Barré
) Syndrome; Transverse Myelitis;
v. ) Causation; Althen v. Sec’y of HHS, 418
) F.3d 1274 (Fed. Cir. 2005); Medically
SECRETARY OF HEALTH AND HUMAN ) Acceptable Timeframe; Treating
SERVICES, ) Physicians’ Opinions.
)
Respondent. )
)
)
Jennifer Anne Gore Maglio, Maglio Christopher & Toale, PA, Sarasota, FL, for
plaintiff.
Lisa A. Watts, Torts Branch, Civil Division, United States Department of Justice,
Washington, DC, for defendant. With her on the briefs were Voris E. Johnson,
Jr., Assistant Director; Vincent J. Matanoski, Deputy Director; Rupa
Bhattacharyya., Director; and Stuart F. Delery, Assistant Attorney General.
OPINION AND ORDER
KAPLAN, Judge.
On October 14, 2008, petitioner Ida Mosley filed a petition for compensation under the
National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (2006) (“Vaccine
Act”), alleging that a tetanus toxoid (“Td”) vaccination had caused her to develop Guillain-Barré
Syndrome (“GBS”). On June 23, 2014, a special master issued a decision denying Ms. Mosley
compensation and holding that she had failed to establish causation between the vaccination and
her injuries. Currently before this Court is Ms. Mosley’s motion for review. For the reasons set
1 In accord with the Rules of the court of Federal Claims, App. B, Rule 18(b), this opinion was
initially filed under seal to afford the parties fourteen days to propose redactions. The parties did
not propose any redactions. Accordingly, the opinion is reissued publically in its original form.

Case 1:08-vv-00724-EDK Document 127 Filed 02/12/15 Page 2 of 13
forth below, this Court vacates the special master’s decision and remands the case for further
consideration in light of this opinion.
BACKGROUND2
I. Vaccination and Subsequent Treatment
On the evening of September 6, 2007, after having punctured her thumb with a piece of
metal at work earlier in the day, Ms. Mosley went to the Emergency Room (“ER”) at Florida
Hospital, Heartland Division, Sebring. Mosley v. Sec’y of HHS, No. 08-724V, 2014 WL
3503389 at *3 (Fed. Cl. Spec. Mstr. June 23, 2014); Pet’r’s Ex. 5 at 12. There, she received the
Td vaccine at 11:10 p.m. Mosley, 2014 WL 3503389 at *3.
Two days later, on September 8, at 6:17 p.m., Ms. Mosley returned to the ER in a
wheelchair, complaining of body aches, joint aches, fever, and frequent urination. Id. She gave
a history that she had received the Td vaccination on September 6 and had started to feel unwell
on September 7. Id. Because urinalysis revealed bacteria in Ms. Mosley’s urine, the ER doctor
diagnosed her with a urinary tract infection (“UTI”) and prescribed an antibiotic. Id. at *1.
The next day, on September 9 at 3:31 p.m., Ms. Mosley returned to the ER, complaining
of aching all over with weak legs for three days. Id. at *3. Ms. Mosley was unable to urinate.
Id. She complained of suprapubic pain radiating down both legs. Id. She also complained of
dull pain and pressure in her abdomen, whose onset had been gradual over four days. Id. The
ER doctor noted that the examination of Ms. Mosley resulted in “no objective neurological
findings”; her reflexes were normal, and there appeared to be “no sensory loss.” Pet’r’s Ex. 5 at
76; see also Mosley, 2014 WL 3503389 at *1. Ms. Mosley was admitted to the hospital for
further examination and treatment. Id. at *3.
During her hospital stay, several physicians examined Ms. Mosley. On September 10,
she was examined by Dr. Luis Duharte, an infectious disease specialist. Pet’r’s Ex. 5 at 127. His
notes from that examination are largely illegible, but according to Ms. Mosley, he noted that her
presentation was “highly suggestive of [an] adverse [reaction] to [the] tetanus toxoid”
vaccination. Pet’r’s Mem. 2 (citing Pet’r’s Ex. 5 at 127). But see Resp’t’s Mem. 5 n.4
(contending that the same notation reads “highly suspicious of [an] adverse reaction to tetanus
toxoid”). On September 11, she was examined by Dr. Miguel Beltre, an internist, who noted his
impression that her condition was “probably [a] reaction to [the] tetanus toxoid” vaccination.
Pet’r’s Ex. 19 at 197.
As it became clear that her symptoms were primarily neurological, the task of diagnosing
her illness fell mostly to her neurologist, Dr. Bridglal Ramkissoon. Early in Ms. Mosley’s
hospitalization, Dr. Ramkissoon tested Ms. Mosley’s reflexes, and because they appeared
normal, he indicated that he “doubt[ed that] she ha[d] GBS.” Pet’r’s Ex. 5 at 70. Nevertheless,
he ordered tests to rule out GBS as well as a spinal cord lesion. Id. Ms. Mosley underwent a
2 The Court recites the background facts as the special master found them, with some details
added from Ms. Mosley’s medical records.
2

Case 1:08-vv-00724-EDK Document 127 Filed 02/12/15 Page 3 of 13
lumbar puncture on September 12, and an analysis of her cerebrospinal fluid (“CSF”) revealed
an elevated protein level and pleocytosis. Id. at 60, 112-13. According to Dr. Ramkissoon, such
results were inconsistent with GBS and, instead, suggestive of viral meningitis. Id. at 59. On
September 14, however, Dr. Ramkissoon noted “absent reflexes in the lower extremities,” which
“can be seen with [GBS].” Id. at 78. Based on these symptoms, Dr. Ramkissoon tentatively
diagnosed Ms. Mosley with GBS and recommended that she be transferred to the intensive care
unit to receive treatment for that condition. Id. at 78-79. He also ordered a repeat lumbar
puncture. This time, the lumbar puncture “showed normal protein in her CSF, a [white blood
cell count] of 33, and continued pleocytosis.” Mosley, 2014 WL 3503389 at *1 (citing Pet’r’s
Ex. 5 at 49, 52, 77-79, 81).
Ms. Mosley also underwent MRIs of her brain, cervical spine, thoracic spine, and
lumbosacral spine. Mosley, 2014 WL 3503389 at *1; Pet’r’s Ex. 5 at 51-53. The images of Ms.
Mosley’s spine showed no spinal cord lesion or compression and thus, according to Dr.
Ramkissoon, “failed to show . . . any evidence of transverse myelitis.” Pet’r’s Ex. 5 at 78.
Additional MRI exams were ordered, but they were canceled because Ms. Mosley complained of
claustrophobia. Pet’r’s Ex. 5 at 30-31. On September 15, Dr. Ramkissoon noted absent tibial
and peroneal F waves and revised his possible diagnoses to include GBS, viral meningitis, and
acute inflammatory demyelinating polyneuropathy (“AIDP”). Pet’r’s Ex. 5 at 45.
On September 20, Ms. Mosley was transferred to an inpatient rehabilitation center at
Winter Haven Hospital. Mosley, 2014 WL 3503389 at *1 (citing Pet’r’s Ex. 4 at 12-22). There,
she was examined by Dr. Alain Delgado, a neurologist, who noted his impression that Ms.
Mosley suffered from AIDP “with onset dating back to September 7, 2007.” Pet’r’s Ex. 4 at 13.
“What was atypical about this case,” he noted, “was the elevation in white blood cells at 60
without any specific risk factors to suggest other underlying infectious etiologies. It was
improvement in white blood cell count which appeared to be 100% lymphocytic, suggesting
some sort of viral syndrome.” Id. He further noted that some of Ms. Mosley’s symptoms, such
as elevated protein, loss of ankle reflexes, and absent F waves, were “more typical of” GBS. Id.
After her discharge from Winter Haven on October 3, 2007, Pet’r’s Ex. 4 at 7, Ms.
Mosley continued to attend follow-up appointments with her doctors. In one such appointment,
her primary care physician, Dr. Audwin Nelson, noted that Ms. Mosley was “in the recovery
phase” of “Guillain Barre syndrome secondary to tetanus toxoid booster.” Pet’r’s Ex. 1 at 10.
On October 30, Ms. Mosley began outpatient physical therapy. Mosley, 2014 WL
3503389 at *4 (citing Pet’r’s Ex. 6 at 38). She never returned to her job as a mental health
counselor after her hospitalization. Mosley, 2014 WL 3503389 at *6; see also Pet’r’s Ex. 19 at
913. In March 2008, she began receiving social security disability benefits, Pet’r’s Ex. 23 at 1,
and in December 2008, she entered into a worker’s compensation settlement with her employer’s
carrier. Pet’r’s Ex. 20 at 11.
II. The Case Before the Special Master
Ms. Mosley filed her petition for compensation in the Office of Special Masters on
October 14, 2008. Former Chief Special Master Gary Golkiewicz assigned the case to himself.
3

Case 1:08-vv-00724-EDK Document 127 Filed 02/12/15 Page 4 of 13
Mosley, 2014 WL 3503389 at *1. Between February 2, 2009 and November 30, 2010, the
parties attempted to settle the case, but they ultimately failed to reach an agreement. Id.
On June 6, 2011, Ms. Mosley filed the expert report of Dr. William Triggs, a neurologist.
Pet’r’s Ex. 28. In the report, Dr. Triggs acknowledged that Ms. Mosley’s treating physicians had
diagnosed her with GBS. Id. at 5-6. He, however, disagreed. In his opinion, her symptoms
were more consistent with a diagnosis of transverse myelitis (“TM”), which he described as “an
immune-mediated spinal cord lesion.” Id. at 6. He further opined that “Ms. Mosley developed
transverse myelitis as a consequence of a tetanus vaccination received on September 6, 2007.”
Id. at 5. He identified the date of onset of Ms. Mosley’s TM as September 9, characterizing the
symptoms she complained that she had experienced on September 7 and 8 as “urological,” not
neurological. Pet’r’s Ex. 70 at 4. According to Dr. Triggs’s report, “[t]he occurrence of a
neurological disorder just days after receiving the tetanus vaccination is within a medically
appropriate time frame to implicate the vaccine,” and “[t]he medical records do not reveal any
alternative cause for her condition.” Pet’r’s Ex. 28 at 7.
On August 4, 2011, the government submitted a report from its expert, Dr. Thomas P.
Leist, also a neurologist. Resp’t’s Ex. B. As he explained in his report, Dr. Leist concluded that
Ms. Mosley’s neurological symptoms began to manifest on September 7, less than twenty-four
hours after she received the Td vaccination. Id. at 8. He opined that this time interval was “too
short” for her symptoms to have been caused by the vaccine, “irrespective [of] whether the
alleged injury is Guillain-Barre syndrome or meningitis as entertained by Dr. Ramkissoon, or
transverse myelitis as indicated in the opinion of Dr. Triggs.” Id. “It is furthermore my
opinion,” he wrote, “that the infection, which was present prior to administration of Td and
which caused flu-like symptoms and fever symptoms, has to be considered as a cause of Ms.
Mosley’s presentation.” Id. at 10.
Meanwhile, on June 23, 2011, the case was transferred to former Special Master Daria J.
Zane. Mosley, 2014 WL 3503389 at *1. Between October 2011 and February 2012, the parties
submitted additional medical records, medical literature, and other exhibits in preparation for
trial.
One such exhibit was a letter from Dr. Ramkissoon, which included “a summary of care
and treatment provided as well as [his] observations and opinions as a practicing clinical
neurologist as to the cause of Mrs. Mosley’s neurological injury.” Pet’r’s Ex. 65 at 1. He stated
that it was his “opinion that the neurological injury Mrs. Mosley suffered was caused by the
tetanus vaccination, further evidenced by the fact that other causes were not present.” Id.
Regarding the biological mechanism by which he believed the vaccine caused Ms. Mosley’s
injury, Dr. Ramkissoon explained that “[v]accination, by design, is intended to stimulate the
immune system. In the case of Mrs. Mosley, the tetanus vaccination triggered the immune
system, by a process known as molecular mimicry, to destroy segments of the myelin sheath
around the nerves, causing weakness, motor dysfunction and sensory issues.” Id. at 1-2. In
conclusion, he stated, “[t]he fact that Mrs. Mosley had no other precipitating events, coupled
with her clinical presentation, and the fact that a tetanus vaccination was given just days prior to
her symptoms, I believe it is more likely than not, that the tetanus vaccination was the proximate
cause of her injury.” Id. at 2.
4

Case 1:08-vv-00724-EDK Document 127 Filed 02/12/15 Page 5 of 13
On February 8, 2012, Ms. Mosley filed a motion to consolidate proceedings, asking that
the court consider the issues of both entitlement and damages at the same hearing. Mosley, 2014
WL 3503389 at *2. She also moved to exclude the expert report of Dr. James McCluskey, which
was written for her disability claim against her employer. Id. Special Master Zane denied the
motion to exclude Dr. McCluskey’s report. Id.
Special Master Zane held hearings on July 11 and 20, 2012. Id. Ms. Mosley, Dr. Triggs,
and Dr. Leist testified at the hearings. Id.
In his testimony, Dr. Triggs further explained his reasoning for rejecting the diagnosis of
GBS and instead adopting the diagnosis of TM. Tr. 169-178, Aug. 8, 2012, ECF No. 88. He
also testified regarding the date of the onset of Ms. Mosley’s neurological symptoms, which he
identified as September 9, 2007. Id. at 166. In his opinion, the symptoms that emerged on
September 7 and caused Ms. Mosley to go to the emergency room on September 8—notably,
frequent urination—were not neurological symptoms. Tr. 166-68, Aug. 8, 2012, ECF No. 88.
Instead, according to Dr. Triggs, they were symptoms of a urinary tract infection, as diagnosed
by the ER physicians. Tr. 168, Aug. 8, 2015, ECF No. 88. “[P]roblems urinating ha[ve] to be
refined further,” he said. Id. He explained that, in contrast to the urinary frequency that Ms.
Mosley reported experiencing on September 7 and 8, an “inability to empty the bladder . . . . [or]
to control the bladder is neurological. I don’t see evidence here that that’s the kind of problem
Mrs. Mosley was having,” he said, until her emergency room visit on September 9. Id.
When asked about the process by which a vaccine could cause TM, Dr. Triggs testified
that a vaccination is an “immunostimulatory event,” and that TM is an autoimmune disorder—in
other words, Ms. Mosley’s “immune system made a mistake and attacked part of [her] nervous
system.” Id. at 179-80. When asked to elaborate, however, he responded that autoimmunity is
not well understood. Id. at 180. He testified that it was his “educated speculation” that, “with
any robust immune response there is the potential for that immune response to go awry and
produce self-disease.” Id. “How or why that happens,” he said, “I don’t think anybody
understands.” Id. at 181. Dr. Triggs was pressed further about how the vaccine could cause TM,
and he responded that he was not an immunologist and could not offer an opinion about whether
it was molecular mimicry or some other mechanism at work in her case. Id. at 260.
On cross examination, counsel for the government asked Dr. Triggs to identify the
earliest medical interval that might occur between receipt of the vaccine and “injury to the spinal
cord resulting in demyelination,” regardless of the mechanism. Id. at 339. He responded that he
was “not convinced that the injury to her cord was necessarily demyelination” and stated that, “I
think if you’re dealing with less than 24 hours, then I’m going to start to squirm a little bit
because from my limited knowledge of immunology.” Id. at 340. “But as a clinician,” he
explained, “if I don’t have any other let’s call it immunostimulatory thing going on and my
patient gets that and asks me why do you think I had this, I mean, I would implicate what’s
available to me. If it’s 23 hours, I’m not necessarily going to say it absolutely cannot be the
vaccine.” Id.
When the government’s expert, Dr. Leist, took the stand, he testified that, in his opinion,
the best diagnosis for Ms. Mosley’s condition was viral meningoradiculitis. Tr. 369, Aug. 8,
5

Case 1:08-vv-00724-EDK Document 127 Filed 02/12/15 Page 6 of 13
2012, ECF No. 90. “Meningoradiculitis,” he explained, “is a process that is kind of in between
transverse myelitis and a Guillain-Barre syndrome” because, as in GBS, the nerve roots are
affected and, as in TM, the spinal cord is also affected. Id. at 365-66. He further testified that,
regardless of the particular diagnosis, id., the shortest period of time in which an immune
response could manifest as neurological symptoms “is probably somewhere around five days.”
Id. at 378.
On January 14, 2013, the parties filed simultaneous post-hearing briefs, and on April 15,
2013, they filed simultaneous responsive briefs. In her briefs, Ms. Mosley addressed the
difference in opinion between her treating physicians (who diagnosed her to be suffering from
GBS) and her testifying expert (who identified TM as her diagnosis). See Pet’r’s Post-Hearing
Mem. 9-12, ECF No. 94. Citing several decisions from the Court of Federal Claims and Office
of Special Masters, she argued that a petitioner has a limited duty to categorize, label, or prove a
particular diagnosis of her injury, and there is no duty to distinguish between diagnoses if the
distinction bears no significance in the causation analysis, such as when, as here, all proposed
diagnoses are autoimmune demyelinating disorders. Id. at 9-12 (citing Kelley v. Sec’y of HHS,
68 Fed. Cl. 84 (2005); Schmidt v. Sec’y of HHS, 2009 U.S. Claims LEXIS 709 (Fed. Cl. Spec.
Mstr. Dec. 17. 2009); Whitener v. Sec’y of HHS, 2009 WL 3007380 (Fed. Cl. Spec. Mstr. Sept.
2, 2009); Hawkins v. Sec’y of HHS, 2009 U.S. Claims LEXIS 169 (Fed. Cl. Spec. Mstr. Feb. 27,
2009)).
On August 31, 2013, Special Master Zane retired. Mosley, 2014 WL 3503389 at *2.
Chief Special Master Denise K. Vowell assigned the case to herself to explore the possibility of
settlement. Id. The parties again failed to settle, and on November 6, 2013, the case was
transferred to Special Master Laura Millman. Id. Special Master Millman held a status
conference and ordered Ms. Mosley to obtain a supplemental expert report from Dr. Triggs,
which Ms. Mosley filed on May 19, 2014.3
3 Special Master Millman requested a supplemental report from Dr. Triggs “[b]ecause of the
difference between his expert report and his testimony” at the hearing. Mosley, 2014 WL
3503389 at *14. In particular, Dr. Triggs had changed his opinion regarding whether Ms.
Mosley’s disorder involved demyelination, and “[h]e did not know what the medical theory was
connecting Td vaccine to transverse myelitis.” Id. In the supplemental report, Dr. Triggs
explained his equivocation at the hearing regarding demyelination and the mechanism by which
the vaccine could cause TM:
In my testimony, I was reluctant to commit to molecular mimicry as the actual
mechanism whereby vaccination resulted in Mrs. Mosley’s myelitis. This
reluctance was based on my knowledge, as a clinician, that the mechanism of
transverse myelitis is incompletely understood. I do not reject molecular mimicry
as an operant mechanism in this case. It is the viable mechanism, more likely
than not, at work. However, the practice of medicine is not in absolutes and
scientific certainty. I cannot say with absolute certainty the specific mechanism
(or mechanisms) or autoimmunity at work. We cannot always identify and
distinguish demyelination from axonal or cellular injury in an inflammatory
process like transverse myelitis, and without specific pathology, we do not know
if the neuronal targets are myelin, interneurons or axons. What we do know, is
6

Case 1:08-vv-00724-EDK Document 127 Filed 02/12/15 Page 7 of 13
III. The Special Master’s Decision
Special Master Millman issued her decision denying compensation on June 23, 2014.
While she had “no difficulty accepting that tetanus vaccine can cause transverse myelitis”
(thereby satisfying prong one of the standard set forth in Althen v. Secretary of Health and
Human Services, 418 F.3d 1274, 1278 (Fed. Cir. 2005)), she concluded that Ms. Mosley had
failed to demonstrate causation. Mosley, 2014 WL 3503389 at *14. Specifically, she concluded
that Ms. Mosley failed to establish by preponderant evidence “a proximate temporal relationship
between vaccination and injury,” as required by prong three of Althen. Mosley, 2014 WL
3503389 at *14.
First, the special master identified what she viewed as inconsistencies in Dr. Triggs’s
testimony. For instance, Special Master Millman observed, Dr. Triggs had focused on Ms.
Mosley’s urinary dysfunction as proof that she had TM and not GBS, but he had ignored that
Ms. Mosley began experiencing urinary dysfunction on September 7, 2007, less than twenty-four
hours after her Td vaccination. Id. Furthermore, “[a]lthough he testified that he would be
unlikely to support a one-day onset based on his understanding of animal studies, he then
concluded that a one-day onset was acceptable because there was no other factor that could have
caused petitioner’s TM.” Id. at *15.
After expressing a lack of confidence in Dr. Triggs’s opinion regarding the possibility of
a one-day onset between the vaccine and Ms. Mosley’s injuries, Special Master Millman cited de
Bazan v. Secretary of Health and Human Services, 539 F.3d 1347 (Fed. Cir. 2008). Mosley,
2014 WL 3503389 at *15. In that case, the Federal Circuit had affirmed a special master’s
finding that the alleged eleven-hour onset of a demyelinating central nervous system disease was
too short. Id. She further found that “[m]edical literature, even in the form of case reports, does
not support a one-day onset of TM.” Id. She cited one of the articles submitted by the petitioner
(Pet’r’s Ex. 47), which “describes a woman who had TM three weeks after tetanus toxoid
vaccine.” Mosley, 2014 WL 3503389 at *15. Special Master Millman noted that the authors of
the article “state that the process for the vaccine injury should take days to manifest in order to
enable the antibody movement or cell-mediated mechanism to result in the neurologic illness,”
and that “[t]hey report cases involving neurologic illness after vaccination ranging from three to
twenty days.” Id. at *15. Similarly, she noted, “[t]he case reports petitioner filed in the instant
action list onset of TM from two days to weeks after vaccination.” Id.
In short, Special Master Millman held that Ms. Mosley had “failed to satisfy the third
prong of Althen because an onset of TM one day after [a] tetanus vaccination is too soon to
support vaccine causation.” Id. at *16. Further, she stated, “because petitioner has failed to
satisfy the third prong of Althen, she has also failed to satisfy the second prong of Althen, i.e.,
the process of immunization, specifically the tetanus vaccination, can stimulate a
cross-reactivity of immune cells from the initial immune-stimulatory challenge
and transmute an inadvertent immune response against self-cells.
Pet’r’s Ex. 70.
7

Case 1:08-vv-00724-EDK Document 127 Filed 02/12/15 Page 8 of 13
that tetanus vaccine did cause her TM in this case.” Id. Accordingly, the special master
dismissed Ms. Mosley’s petition.
IV. Ms. Mosley’s Motion for Review
On July 23, 2014, Ms. Mosley filed a motion for review in this Court pursuant to
Appendix B of the Rules of the United States Court of Federal Claims, Vaccine Rule 23. She
grounds her motion on a single argument: that the special master committed error when she
failed to consider or discuss the opinions of Ms. Mosley’s treating physicians finding that the Td
vaccination caused her neurological disorder. Pet’r’s Mem. Supp. Mot. for Review (“Pet’r’s
Mem.”) 5. Ms. Mosley argues that the Federal Circuit has found error in decisions in which the
special master did not consider the opinions of the petitioner’s treating physicians when
analyzing causation. Pet’r’s Mem. 6-9 (citing, e.g., Capizzano v. Sec’y of HHS, 440 F.3d 1317,
1326 (Fed. Cir. 2006); Andreu v. Sec’y of HHS, 569 F.3d 1367, 1375-76 (Fed. Cir. 2009)).
Here, Ms. Mosley argues, “the Special Master’s Decision neglected to acknowledge, much less
weigh” the numerous notations of her treating physicians linking her injury to the vaccine or Dr.
Ramkissoon’s letter detailing his opinion, as Ms. Mosley’s neurologist, that her injury was
caused by the tetanus vaccination. Pet’r’s Mem. 6; see, e.g., Pet’r’s Ex. 1 at 10; Ex. 3 at 13; Ex.
19 at 197; Ex. 65 at 1.
For the reasons set forth below, the Court agrees with Ms. Mosley that the special master
committed legal error when she failed to consider and discuss the opinions of Ms. Mosley’s four
treating physicians as set forth in chart notations and/or written reports. While the Court
expresses no opinion regarding the weight that should be ascribed to this evidence and whether it
is sufficient to change the result the special master has reached, it agrees with Ms. Mosley that
those opinions were relevant to the determination of whether petitioner made out her prima facie
case under prong three of Althen. For that reason, the Court vacates the special master’s
decision and remands this case back to her, to allow her to apply her special expertise to these
issues. See 42 U.S.C. § 300aa-12(e)(2)(C) (providing that, upon review of a special master’s
decision, “the United States Court of Federal Claims . . . may . . . remand the petition to the
special master for further action in accordance with the court’s direction”); Doe 93 v. Sec’y of
HHS, 98 Fed. Cl. 553, 571 (2011) (finding that special master improperly elevated burden of
proving causation and remanding to special master for application of appropriate burden); Boley
v. Sec’y of HHS, 82 Fed. Cl. 407, 414-15 (2008) (finding multiple errors in special master’s
decision, including that special master failed to consider all relevant evidence in the record, and
remanding to the special master for reevaluation, while expressing no view on whether petitioner
was entitled to recover).
DISCUSSION
I. Legal Standards
A. Standard of Review
The Vaccine Act grants the Court of Federal Claims jurisdiction to review the record of
the proceedings before a special master and authority, upon such review, to:
8

Case 1:08-vv-00724-EDK Document 127 Filed 02/12/15 Page 9 of 13
(A) uphold the findings of fact and conclusions of law [of the special master]
and sustain the special master’s decision;
(B) set aside any findings of fact or conclusions of law found to be arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law
and issue a separate decision; or
(C) remand the case to the special master for further action [in accordance with
the court’s direction].
RCFC App. B, Rule 27; Flores v. Sec’y of HHS, 115 Fed. Cl. 157, 161 (2014) (citing 42 U.S.C.
§ 300aa-12(e)(2)). On review, the Court “do[es] not reweigh the factual evidence, assess
whether the special master correctly evaluated the evidence, or examine the probative value of
the evidence or the credibility of the witnesses,” which “are all matters within the purview of the
fact finder.” Porter v. Sec’y of HHS, 663 F.3d 1242, 1249 (Fed. Cir. 2011).
B. Causation
Under the Vaccine Act, a claim for compensation proceeds through one of two tracks. In
what is known as a “table claim,” “a claimant who shows that . . . she received a vaccination
listed in the Vaccine Injury Table (“table”), 42 U.S.C. § 300aa-14, and suffered an injury listed
in the table within a prescribed period is afforded a presumption of causation.” Andreu, 569
F.3d at 1374 (citing 42 U.S.C. § 300aa-11(c)(1)(C)(i)). On the other hand, in an off-table claim,
like Ms. Mosley’s, the petitioner must establish that her injury was “caused in fact” by the
vaccine; that is, she must establish “not only that but for her Td vaccination, she would not have
had TM, but also that the vaccine was a substantial factor in causing her TM.” Mosley, 2014
WL 3503389 at *14 (citing Shyface v. Sec’y of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999)).
In Althen, the Federal Circuit delineated three requirements for a prima facie case of
causation:
[The petitioner’s] burden is to show by preponderant evidence4 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.
418 F.3d at 1278. Regarding prong three, the main requirement at issue in this case, a petitioner
must provide “preponderant proof that the onset of symptoms occurred within a timeframe for
4 “The burden of showing something by a ‘preponderance of the evidence,’ the most common
standard in the civil law, simply requires 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 v. Sec’y of HHS, 592 F.3d
1315, 1322 n.2 (quoting Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers Pension Trust
for S. Cal., 508 U.S. 602, 622 (1993)).
9

Case 1:08-vv-00724-EDK Document 127 Filed 02/12/15 Page 10 of 13
which, given the medical understanding of the disorder’s etiology, it is medically acceptable to
infer causation-in-fact.” De Bazan, 539 F.3d at 1351.
II. Merits Analysis
A. The special master committed legal error when she failed to address the evidence
in the record showing that several of Ms. Mosley’s treating physicians ascribed
her injuries to the Td vaccination.
As described above, the special master found that the onset of Ms. Mosley’s neurological
disorder occurred less than twenty-four hours after she received her vaccination on September 6.
Thus, as the special master observed, the record shows that Ms. Mosley reported to her treating
physicians that she had started feeling sick on September 7, the day after her vaccination.
Mosley, 2014 WL 3503389 at *1, 3-7, 11-14. Furthermore, the special master relied on the
report and testimony of the government’s expert, Dr. Leist, who explained that Ms. Mosley’s
bladder presentation on September 7 and 8 and her bladder presentation on September 9 were not
separate events, but that rather, they were parts of the same complex of neurological symptoms.
Mosley, 2014 WL 3503389 at *13; Tr. 379-80, Aug. 8, 2012, ECF No. 90. Although Ms.
Mosley’s expert, Dr. Triggs, had distinguished between these two presentations and concluded
that only the urinary retention arising on September 9 was neurological, the special master acted
within her discretion when she found that Dr. Leist’s opinion in this regard was more credible
than Dr. Triggs’s. See Porter, 663 F.3d at 1250 (“[S]pecial masters are expected to consider the
credibility of expert witnesses in evaluating petitions for compensation under the Vaccine Act.”).
While Ms. Mosley continues to express disagreement with the special master’s
conclusion regarding the timing of the onset of her neurological symptoms, she does not argue
that the special master’s finding on this issue was arbitrary, capricious, or contrary to law.
Instead, her challenge to the special master’s decision focuses on the special master’s finding
that a one-day onset was not a medically appropriate timeframe for establishing causation and
that, accordingly, Ms. Mosley failed to make out her prima facie case under Althen prong three.
Pet’r’s Mem. 5-13.
In reaching this conclusion, as described above, the special master first noted that “[t]he
Federal Circuit has addressed the short onset of a demyelinating central nervous system disease
after tetanus vaccination”—specifically, an eleven-hour onset—“as preventing a petitioner from
satisfying her burden of proof,” Mosley, 2014 WL 3503389 at *15 (citing de Bazan, 539 F.3d at
1353-54).5 She also cited case reports that “list onset of TM from two days to weeks after
5 It is not clear from the special master’s decision whether she was citing de Bazan for the legal
principle that prong three of Althen is not met where the interval between the vaccine and injury
is too short, or whether she was using de Bazan to support a factual finding that a period of less
than twenty four hours (eleven hours in de Bazan) between the vaccination and the onset of the
injury “was not sufficient time to produce molecules responsible for myelin destruction.” 2014
WL 3503389 at *15. While it is, of course, perfectly appropriate (in fact, necessary) to consider
and follow de Bazan for purposes of the legal analysis, “[a]s a general rule, a special master
should not base his findings on causation-in-fact in one case on other Vaccine Act cases.”
10

Case 1:08-vv-00724-EDK Document 127 Filed 02/12/15 Page 11 of 13
vaccination,” as well as a 1994 article from the Italian Journal of Neurological Sciences, in
which “[t]he authors state that the process for the vaccine injury should take days to manifest in
order to enable the antibody movement or cell-mediated mechanism to result in the neurologic
illness.” Id. (citing Pet’r’s Ex. 47).
Notwithstanding the foregoing, as Ms. Mosley observes, her treating physicians
concluded that the Td vaccination caused her neurological disorder. Implicit in those
conclusions, Ms. Mosely argues, is their opinion that a one-day interval for the onset of
symptoms was a medically appropriate time period within which to infer causation. Pet’r’s
Mem. 11. She contends that the special master’s failure to even discuss their opinions in her
analysis of prong three constituted legal error. Id. at 5-12.
The Court agrees with Ms. Mosley. The Federal Circuit has underscored the value of
medical records as evidence in Vaccine Act cases, observing that “[m]edical records, in general,
warrant consideration as trustworthy evidence” because “[t]he records contain information
supplied to or by health professionals to facilitate diagnosis and treatment of medical
conditions.” Curcuras v. Sec’y of HHS, 993 F.2d 1525, 1528 (Fed. Cir. 1993). Furthermore, the
court of appeals has noted, “[w]ith proper treatment hanging in the balance, accuracy has an
extra premium.” Id. Such records have particular importance, the court observed, because they
are “generally contemporaneous to the medical events.” Id.
Similarly, the opinions of treating physicians are highly relevant in vaccine cases. As the
Federal Circuit observed in Capizzano and Andreu, because “treating physicians are likely to be
in the best position” to detect a link between a petitioner’s vaccination and her injury, the
opinions of a petitioner’s treating physicians are “quite probative” of causation. Andreu, 569
F.3d at 1375; Capizzano, 440 F.3d at 1326. Indeed, in Capizzano, the Federal Circuit held that
the special master committed legal error by failing to consider such evidence, warranting
vacation of the special master’s judgment. Capizzano, 440 F.3d at 1326.
In this case, it may well be that the special master concluded that the treating physicians’
general notations and opinions regarding the etiology of Ms. Mosley’s injuries should be
discounted in favor of the medical literature and/or other expert opinion (such as Dr. Leist’s) that
specifically addressed the time frame within which causation could be inferred. But the Court
has no way of knowing whether that was the conclusion that the special master reached and if so,
the basis for such conclusion, because the special master did not mention the treating physicians’
opinions that the vaccine caused Ms. Mosley’s injury at all in her analysis of causation. See
Mosley, 2014 WL 3503389 at *14-15. In fact, there is barely any citation of those opinions in
the special master’s recitation of the facts. See id. at *1-6.
Contreras v. Sec’y of HHS, 107 Fed. Cl. 280, 308 (2012) (citing Moberly, 592 F.3d at 1325;
Caves v. Sec’y of HHS, 100 Fed. Cl. 119, 129 n.11 (2011); Hanlon v. Sec’y of HHS, 40 Fed. Cl.
625, 630 (1998), aff’d, 191 F.3d 1344 (Fed. Cir. 1999)).
11

Case 1:08-vv-00724-EDK Document 127 Filed 02/12/15 Page 12 of 13
Of course, a “special master [is] not required to discuss every piece of evidence or
testimony in her decision.” Snyder v. Sec’y of HHS, 88 Fed. Cl. 706, 728 (2009) (citing Maza v.
Sec’y of HHS, 67 Fed. Cl. 36, 38 (2005)). But the opinions of treating physicians on the
ultimate issue of causation can hardly be characterized as mere “minutiae.” See Moreno v. Sec’y
of HHS, 65 Fed. Cl. 13, 26 (2005). To the contrary, they are highly relevant and warrant
thorough analysis and discussion. Capizzano, 440 F.3d at 1326. The special master’s failure to
engage in such analysis and discussion in this case, the Court concludes, constitutes reversible
error.
B. The government’s arguments are without merit.
The government does not dispute that the special master did not address the opinions of
Ms. Mosley’s treating physicians in her causation analysis. Instead, it points out that Capizzano
and Andreu addressed the relevance of treating physicians’ opinions in the context of Althen
prong two analysis. Resp’t’s Mem. 13-14. The government contends that, therefore, the Federal
Circuit’s statements regarding the probative value of these opinions are not relevant to Althen
prong three. Resp’t’s Mem. 13-14.
This argument is unpersuasive. The government has offered no reason why treating
physicians’ opinions regarding the cause of Ms. Mosley’s injuries would be considered relevant
in the context of a prong-two, but not a prong-three analysis. In fact, the court of appeals in
Capizzano noted that evidence used to satisfy one of the Althen prongs can “overlap to satisfy
another prong.” Capizzano, 440 F.3d at 1326. Here, a number of Ms. Mosley’s treating
physicians explicitly noted their impression that her injuries resulted from her Td vaccination.
See, e.g., Pet’r’s Ex. 1 at 10; Ex. 3 at 13; Ex. 19 at 197; Ex. 65 at 1. Each of these physicians
recorded Ms. Mosley’s medical history and had access to her medical records. Id. Arguably,
therefore, implicit in their opinions that the vaccine caused Ms. Mosley’s injury is a finding that
Ms. Mosley’s neurological symptoms appeared within a medically appropriate timeframe to
suggest a causal connection. Cf. Contreras, 107 Fed. Cl. at 299 (observing that “it is difficult to
conceive of a treating physician who would conclude that a vaccine caused the petitioner’s
illness without also concluding that the onset of the illness was within a medically-acceptable
time-frame”).
There is similarly no merit to the government’s arguments that the opinions of Ms.
Mosley’s treating physicians are irrelevant because they believed that Ms. Mosley suffered from
GBS while plaintiff’s expert, Dr. Triggs, testified that she suffered from TM. See Resp’t’s Mem.
1, 15-16. First, the Court finds unpersuasive the government’s argument that in her case in front
of the special master, Ms. Mosley “abandoned her GBS claim” by presenting Dr. Triggs as her
expert. Id. at 1. In fact, in her first post-hearing brief, Ms. Mosley acknowledged the
discrepancy between her treating physicians’ diagnosis and her expert’s, and she argued that,
under the circumstances of her case, it was irrelevant whether her condition was characterized as
GBS or TM. Pet’r’s Post-Hearing Mem. 9-12. Ms. Mosley’s position—that it is immaterial
whether her condition was classified as GBS or TM—has support in prior decisions in which the
two conditions are characterized as not materially different for purposes of determining
causation. See, e.g., Contreras, 107 Fed. Cl. at 293; Whitener, 2009 WL 3007380 at *19.
12

Case 1:08-vv-00724-EDK Document 127 Filed 02/12/15 Page 13 of 13
Further, in general, there is no requirement to ascribe a diagnosis to a petitioner’s injury
in a Vaccine Act case. See Porter, 663 F.3d at 1249; Lombardi v. Sec’y of HHS, 656 F.3d 1343,
1351 (Fed. Cir. 2011); Andreu, 569 F.3d at 1382. The government’s reliance upon Broekelschen
v. Secretary of Health and Human Services, 618 F.3d 1339 (Fed. Cir. 2010), for a contrary
proposition is misplaced. To be sure, in that case, the Federal Circuit confronted a record that
contained evidence supporting two different diagnoses and held that “it was appropriate for the
special master to first find which of [the petitioner’s] diagnoses was best supported by the
evidence presented in the record before applying the Althen test.” 618 F.3d at 1342-44, 1346.
But as the Federal Circuit noted in Broekelschen, the case before it was “atypical because the
injury itself [was] in dispute, the proposed injuries differ significantly in their pathology, and the
question of causation turns on which injury [petitioner] suffered.” Id. at 1346. Thus, the court
reasoned, Broekelschen differed from other, more typical cases where, for example, “competing
diagnoses were variants of the same disorder.” Id. (citing Kelley v. Sec’y of HHS, 68 Fed. Cl.
84, 100-01 (2005)).
In short, under Broekelschen, the opinions of Ms. Mosley’s treating physicians who
diagnosed her with GBS would become irrelevant to the analysis of causation only upon a
finding that “the question of causation turns on which injury [Ms. Mosley] suffered” and that the
injury she suffered was TM. Broekelschen, 618 F.3d at 1346. Here, the special master did not
make such a finding. Because the special master’s opinion is silent on the issue, the Court
cannot assume that the opinions of Ms. Mosley’s treating physicians were entitled to no weight
because they characterized her condition as GBS rather than TM.
CONCLUSION
Based on the foregoing, the Court concludes that it is necessary to remand this case back
to the special master to allow her to consider and explain the impact, if any, of the opinions of
Ms. Mosley’s treating physicians on her conclusion that Ms. Mosley failed to make out her
prima facie case under Althen. Accordingly, the special master’s decision denying compensation
to petitioner is VACATED and REMANDED for 120 days for further consideration in light of
this opinion.
Pursuant to Vaccine Rule 18(b), this opinion will be held for fourteen days to afford each
party an opportunity to object to the public disclosure of any financial or medical information
furnished by that party. An objecting party must provide the court with a proposed redacted
version of the decision. In the absence of an objection, the entire decision will be made public.
IT IS SO ORDERED.
s/ Elaine D. Kaplan
ELAINE D. KAPLAN
Judge
13

================================================================================
DOCUMENT 3: USCOURTS-cofc-1_08-vv-00724-3
Date issued/filed: 2015-11-12
Pages: 2
Docket text: PUBLIC DECISION (Originally filed: 10/22/2015) regarding 138 DECISION Fees Stipulation/Proffer Signed by Special Master Laura D Millman. (tlf) Copy to parties.
--------------------------------------------------------------------------------
Case 1:08-vv-00724-EDK Document 141 Filed 11/12/15 Page 1 of 2
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 08-724V
Filed: October 22, 2015
Not for Publication
*************************************
IDA MOSLEY, *
*
Petitioner, *
Attorneys’ fees and costs decision
*
based on stipulation of fact
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
*************************************
Diana L. Stadelnikas Sedar, Sarasota, FL, for petitioner.
Lisa A. Watts, Washington, DC, for respondent.
MILLMAN, Special Master
DECISION AWARDING ATTORNEYS’ FEES AND COSTS1
On October 22, 2015, the parties filed a stipulation of fact in which they agreed on an
appropriate amount for attorneys’ fees and costs in this case.
In accordance with the General Order #9 requirement, petitioner asserts that she did not
incur any costs in pursuit of her petition. Petitioner submitted a draft application for attorneys’
fees and costs to respondent. During informal discussions, respondent raised objections to
certain items in petitioner’s application. Based on these objections, petitioner amends her
1 Because this unpublished decision contains a reasoned explanation for the special master’s action in this
case, the special master intends to post this unpublished decision on the United States Court of Federal
Claims’s website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat.
2899, 2913 (Dec. 17, 2002). Vaccine Rule 18(b) states that all decisions of the special masters will be
made available to the public unless they contain trade secrets or commercial or financial information that
is privileged and confidential, or medical or similar information whose disclosure would constitute a
clearly unwarranted invasion of privacy. When such a decision is filed, petitioner has 14 days to identify
and move to redact such information prior to the document=s disclosure. If the special master, upon
review, agrees that the identified material fits within the banned categories listed above, the special
master shall redact such material from public access.

Case 1:08-vv-00724-EDK Document 141 Filed 11/12/15 Page 2 of 2
application for attorneys’ fees and costs to $247,000.00. Respondent does not object to this
amount. The undersigned finds this amount to be reasonable. Accordingly, the court awards
$247,000.00, representing reimbursement for attorneys’ fees and costs. The award shall be in the
form of a check payable jointly to petitioner and Maglio, Christopher & Toale, PA in the amount
of $247,000.00.
In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of
the court is directed to enter judgment herewith.2
IT IS SO ORDERED.
Dated: October 22, 2015 s/ Laura D. Millman
Laura D. Millman
Special Master
2 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either separately or
jointly, filing a notice renouncing the right to seek review.
2