Mosley v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 08-724V

April 27, 2015

To be Published

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IDA MOSLEY, *

*

Petitioner, *

*

v. * Remand Decision; tetanus

* toxoid (Td) vaccine; transverse

SECRETARY OF HEALTH * myelitis; one-day onset

AND HUMAN SERVICES, *

*

Respondent. *

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Diana Stadelnikas Sedar, Sarasota, FL, for petitioner.

Lisa A. Watts, Washington, DC, for respondent.

MILLMAN, Special Master

REMAND 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 On June

23, 2014, the undersigned issued a decision denying petitioner compensation, holding that she

failed to establish that the vaccine caused her injuries. On January 28, 2014, the Honorable

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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.

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Petitioner filed an expert report on June 6, 2011, from Dr. William Triggs, a neurologist, in which he

opined that Td vaccine caused petitioner’s transverse myelitis (“TM”). The undersigned interpreted this

as petitioner’s amended petition that Td vaccine caused her TM.

Elaine D. Kaplan vacated that decision and remanded to the undersigned for further

consideration. Judge Kaplan held that the undersigned committed legal error when she failed to

consider and explain the impact of petitioner’s treating physicians’ opinions. In this remand

decision, after consideration of the treating physicians’ opinions, the undersigned again

concludes that petitioner has failed to prove that the vaccine caused her injuries.

PROCEDURAL HISTORY

Petitioner filed her petition on October 14, 2008. Former Chief Special Master Gary

Golkiewicz assigned the case to himself. 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

July 11 and 20, 2012, former Special Master Zane held a hearing in this case. Dr. William

Triggs, a neurologist, testified for petitioner. Dr. Thomas P. Leist, a neurologist, testified for

respondent.

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 June 23, 2014, the undersigned issued a published decision denying compensation to

petitioner on the ground that petitioner’s TM occurred one day after her Td vaccination, an onset

interval too brief to permit a finding of causation. Mosley v. Sec’y of HHS, 2014 WL 3503389

(Fed. Cl. Spec. Mstr. June 23, 2014). Consequently, since the onset was too short for a finding

of causation, petitioner failed to show that Td vaccine caused in fact her TM. Id.

On July 23, 2014, petitioner filed a motion for review, arguing that the undersigned

committed error by failing to consider or to discuss the opinions of petitioner’s treating

physicians, who found that Td vaccine caused her neurological disorder.

On January 28, 2015, Judge Kaplan issued a decision vacating and remanding the

undersigned’s decision, holding that the undersigned erred when she failed to discuss the

opinions of petitioner’s four treating physicians as recorded in the medical records. Slip op. at 8.

Judge Kaplan referenced petitioner’s argument that the treating doctors’ conclusions imply “that

a one-day interval for the onset of symptoms was a medically appropriate time period within

which to infer causation.” Slip op. at 11.

The undersigned held a status conference on February 4, 2015, in which the parties stated

they wished to file briefs to be considered for the remand decision.

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Petitioner filed a memorandum regarding the treating physicians’ opinions on March 11,

2015. Petitioner discusses records from infectious disease specialist Dr. Duharte, internal

medicine physician Dr. Beltre, petitioner’s treating neurologist Dr. Ramkissoon, and petitioner’s

treating physician Dr. Nelson, all of whom state petitioner likely developed GBS as a result of

her tetanus vaccination. Pet’r’s Mem. at 2–3, Mar. 11, 2015, ECF No. 129 (citing Med. recs. Ex.

5, at 127; Ex. 19, at 197; Ex. 3, at 5–7, 11, 13, 17; Ex. 8, at 5–6; Ex. 65; Ex. 1, at 10, 14, 17, 26;

Ex. 9, at 4, 8, 12, 16, 20; Ex. 39, at 23–24, 26, 29–30, 34, 206, 209, 212, 221; Ex. 40, at 16).

Petitioner discusses that a special master is required to “consider the entire record and the

course of the injury, disability, illness or condition” when determining whether to award

compensation. Pet’r’s Mem. at 4 (citing 42 U.S.C. §§ 300aa-13(b)(1)(B) (emphasis added)).

She cites the Federal Circuit’s statement that Congress envisioned “close calls regarding

causation would be resolved in favor of injured claimants.” Id. at 5 (quoting Althen, 418 F.3d

1274, 1280 (Fed. Cir. 2005)). She also states a petitioner “need not necessarily supply evidence

from medical literature” to support his or her causation theory, “so long as the petitioner supplies

the medical opinion of a qualified expert.” Id. Petitioner argues that the treating physicians’

opinions should be given significant weight, discussing Capizzano v. Sec’y of HHS, 440 F.3d

1317 (Fed. Cir. 2006), Andreu v. Sec’y of HHS, 569 F.3d 1367 (Fed. Cir. 2009), and Zatuchni v.

Sec’y of HHS, 69 Fed. Cl. 612, 624 (Fed. Cl. 2006), aff’d, 516 F.3d 1312 (Fed. Cir. 2008).

Petitioner argues that the treating doctors’ opinions in favor of vaccine causation

“necessarily include[] the temporal association,” since “[o]ne can not [sic] conclude a causative

event within the context of a medical diagnosis without determining that the timing was

medically appropriate.” Pet’r’s Mem. at 8, 10 (citing Capizzano, 440 F.3d at 1326, and

Dobrydnev v. Sec’y of HHS, 566 Fed. Appx. 976 (Fed. Cir. 014)).

Petitioner asserts that the onset of her TM was 54 hours after the shot, not 24 hours after

the shot. Pet’r’s Mem. at 11. She distinguishes between her urinary frequency on the evening of

September 8, 2007, which she states is due to her diagnosed urinary tract infection (“UTI”), and

her inability to urinate/neurogenic bladder during the afternoon of September 9, 2007, which she

states was the onset of her neurological illness. Id. at 11–13.

Petitioner also argues that the testimony of respondent’s expert, Dr. Leist, that petitioner

suffered from viral meningoradiculitis is not supported by her UTI diagnosis, the treating

doctors’ opinions, the standard of care followed during her hospitalization, or her residual

disability. Id. at 13–14. She further argues against respondent’s theory by asserting that no

reliable evidence was presented to support Dr. Leist’s identification of five days as a medically

acceptable onset. Id. at 14.

Respondent filed a responsive memorandum on April 8, 2015. Respondent argues that

none of the treating physicians in this case “actually considered, reflected upon, commented, or

opined that the onset of petitioner’s claimed injury occurred within a ‘medically appropriate’

timeframe to ascribe causation to the Td vaccine.” Resp’t’s Post-Remand Submission 3, Apr. 8,

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2015, ECF No. 130. She addresses each of the treating physicians’ opinions that petitioner

argues the undersigned failed to consider (Dr. Duharte’s, Dr. Beltre’s, Dr. Ramkissoon’s, and Dr.

Nelson’s) in turn.

In conformance with Judge Kaplan’s direction, the undersigned has evaluated the opinion

of each treating doctor who offered a statement about causation including, particularly,

petitioner’s treating neurologist, Dr. Ramkissoon. The undersigned finds these statements

deficient because the doctors either do not specify an onset interval, specify the onset interval as

more than one day (Dr. Ramkissoon), or state the onset interval was one day but give no basis for

their opinion. This topic is discussed more fully later in this opinion.

FACTS

The Parties’ Factual Stipulations

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, down-going toes, and 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

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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.

Facts from the Medical Records

Petitioner was born on February 18, 1962.

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 Td vaccine 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

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

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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

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

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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.3 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

3

On February 8, 2012, petitioner moved to exclude the expert report of Dr. McCluskey, 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.

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between 7:00 p.m. and 8:30 p.m., she called South Florida Community College and told them

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, noted 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.

INITIAL 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

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. 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. 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. To reach this conclusion, Dr. Leist

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relies 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. Id. 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 test

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.

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).

(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.

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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 an 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.

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.

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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

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.

11

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

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.

12

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

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

13

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.”

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.

14

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.

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

15

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.

SUPPLEMENTAL EXPERT REPORT

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.

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

16

he cites case reports in the medical literature filed as Exhibits 41–60.4 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.5 Id.

TREATING DOCTORS’ OPINIONS

In accordance with Judge Kaplan’s remand instructions, the undersigned now considers

and discusses petitioner’s treating doctors’ opinions as expressed in the medical records and in

Dr. Bridglal Ramkissoon’s opinion letter dated January 31, 2012.

On September 9, 2007, petitioner went to the Emergency Department (“ED”) of Winter

Haven Hospital, where she saw Dr. Miguel Beltre, an internal medicine physician. Med. recs.

Ex. 19, at 196. Petitioner told Dr. Beltre that she went to the ED four days earlier with a cut on

her finger. Id. (Petitioner’s history was incorrect. She went to the ED less than three days

earlier on September 6, 2007.) She said she received a tetanus toxoid injection but returned to

the ED, complaining of weakness and back pain. Id. Medical personnel prescribed Bactrim for

infection. Id. She returned once more to the ED because of inability to void and inability to

walk. Id. Petitioner appeared before Dr. Beltre with fever and chills, and he admitted her to the

hospital with a working diagnosis of urinary tract infection. Id. Dr. Beltre’s impression was that

petitioner had acute febrile illness and “probably [sic] reaction to tetanus toxoid.” Id. at 197. It

4

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.

5

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.

17

is difficult from these brief notes to determine when Dr. Beltre thought her reaction to Td

vaccine began. While he knew petitioner had a Td vaccination, because of her inaccurate

history, he thought it was four days earlier instead of less than three days earlier. The

undersigned therefore cannot determine whether Dr. Beltre assumed petitioner had a one-, two-,

three-, or four-day onset of a neurologic reaction to tetanus toxoid. Moreover, Dr. Beltre did not

opine that petitioner had a demyelinating disease, and thus did not address whether a one-day

onset was a medically appropriate timeframe for Td vaccine to cause a demyelinating disease,

such as GBS or TM.

On September 10, 2007, petitioner saw an infectious disease specialist, Dr. Luis Duharte,

and gave a history that she had general malaise, weakness, tremor, and fever 24 hours after

receiving Td vaccine. Med. recs. Ex. 5, at 127. Dr. Duharte opined in his assessment: “Highly

suspicious6 of adverse rx [reaction] to tetanus toxoid.” Id. Dr. Duharte, who is not a neurologist,

does not give a reason for his suspicion. His plan was to have a neurologist evaluate petitioner.

Id. If Dr. Duharte, an infectious disease specialist, believed that Td vaccine can cause an adverse

reaction 24 hours later, he does not specify what that reaction was, or give the basis for his

opinion.

On September 11, 2007, Dr. Audwin Nelson, petitioner’s primary care physician,

reviewed petitioner’s chart and discussed her case with Dr. Ramkissoon. Med. recs. Ex. 5, at 68.

Petitioner had a tetanus vaccination on September 6, 2007, after suffering an injury. Id. She

developed progressive lower extremity weakness “the next day.” Id. She was admitted to

Winter Haven Hospital on September 9, 2007, after she was unable to walk. Id. She had some

tightness in her abdomen but no shortness of breath. Id. She did not have an increase in

weakness over the prior 24 hours. Id. She saw Dr. Ramkissoon and Dr. Wong as neurologic

consultants for probable GBS. Id. Dr. Ramkissoon detected that petitioner had 2+ deep tendon

reflexes bilaterally on neurologic examination. Id. Of note, petitioner had a temperature of

102.1 degrees on September 10, 2007. Id. Dr. Nelson’s impressions included a “possible tetanus

toxoid reaction.” Id. It is hard to determine from Dr. Nelson’s notes when he considered

petitioner’s neurologic reaction to have begun. If he did consider petitioner to have a possible

Td reaction with a one-day onset, he does not give a reason for his opinion.

On September 11, 2007, Dr. Duharte, the infectious disease specialist, wrote a progress

note, saying, “Guillain-barre [sic] syndrome has being [sic] described in patient after tetanus

toxoid, neurology evaluation will be very helpfull [sic] to rule it out.” Med. recs. Ex. 5, at 83.

This note is difficult to parse, in that the undersigned cannot determine if Dr. Duharte is referring

to other doctors describing petitioner as having GBS or medical literature generally describing

patients having GBS after tetanus toxoid vaccination. Nor can the undersigned determine if Dr.

6

Dr. Duharte’s handwriting is very difficult to read. Petitioner asserts he noted “highly suggestive,”

Pet’r’s Mem., ECF No. 119, at 2, while respondent asserts he noted “highly suspicious.” Resp’t’s Mem.,

ECF No. 121, at 5. The undersigned concludes that the word appears to be “suspicious.”

18

Duharte thought a neurologist could rule out petitioner’s GBS diagnosis or a causal relationship

to the Td vaccine. When Dr. Duharte followed up with petitioner on September 17, 2007, he

suspected that petitioner suffered from a viral infection, probably enterovirus 71, because of her

symptoms. Id. at 129.

On October 9, 2007, petitioner’s personal care physician, Dr. Nelson, saw petitioner and

wrote that petitioner received Td vaccine after cutting her finger on September 6, 2007, followed

by weakness in her legs a day later. Med. recs. Ex. 1, at 8. His impression was that she had GBS

“secondary to tetanus toxoid booster.” Id. at 10.7 Dr. Nelson noted in his subsequent records

that petitioner had an allergy to tetanus toxoid.8 Med. recs. Ex. 39, at 34. On October 26, 2009,

he again noted petitioner had an allergy to tetanus toxoid and recommended that she not receive

further vaccinations. Med. recs. Ex. 40, at 16. Dr. Nelson is an internist, not a neurologist. He

does not give a basis for his impression that petitioner had GBS secondary to tetanus toxoid

booster, although he appears to believe that petitioner’s onset was one day after her vaccination.

In addition, he does not give a basis for his recommendation that petitioner not receive vaccines.

On October 18, 2007, petitioner saw Dr. Ramkissoon, who recounted petitioner’s history

and noted, “[A] precipitating cause was a tetanus toxoid injection.” Med. recs. Ex. 3, at 13. He

also noted that a lumbar puncture (spinal tap) showed evidence for viral meningitis as well. Id.

Under the “Impression” section, Dr. Ramkissoon wrote that petitioner’s GBS began “soon after”

her tetanus toxoid injection. Id. at 17. He concluded, “The Patient most likely developed

Guillian [sic]-Barre Syndrome as a result of the tetanus toxoid injection.” Id. Although clearly

attributing petitioner’s neurologic condition to Td vaccine, Dr. Ramkissoon does not specify

what amount of hours or days “soon after” is. Therefore, it is hard to state that his opinion

encompasses a one-day onset.

Petitioner filed a statement from her treating neurologist, Dr. 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. He writes,

“On the basis of the clinical findings and observations and my expertise and knowledge as a

practicing neurologist, it is my opinion that the neurological injury Mrs. Mosley suffered was

caused by the tetanus vaccination, further evidenced by the fact that other causes were not

7

Dr. Nelson wrote petitioner had GBS secondary to tetanus toxoid booster in his notes for follow-up

visits on November 12, 2007 (Med. recs. Ex. 1 at 14), December 12, 2007 (Id. at 17), February 26, 2008

(Id. at 26), August 12, 2008 (Med. recs. Ex. 9, at 4), November 18, 2008 (Id. at 8), December 31, 2008

(Id. at 12), January 7, 2009 (Id. at 16), and February 18, 2009 (Id. at 20).

8

See also Med. recs. Ex. 39, at 34 (February 2, 2010 visit); Id. at 30 (May 19, 2010 visit); Id. at 28–29

(July 12, 2010 visit); Id. at 25–26 (August 24, 2010 visit); Id. at 23–24, 205–206 (September 28, 2010

visit); Id. at 209 (November 24, 2010 visit); Id. at 212 (January 13, 2011 visit); Id. at 215 (January 28,

2011 visit); Id. at 218 (February 21, 2011 visit); Id. at 221 (March 30, 2011 visit).

19

present.” 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 (emphasis

added). He does not specify how many days he thinks there were between vaccination and the

onset of petitioner’s neurological condition, but his use of “days” in the plural conveys his belief

that petitioner did not have a one-day onset.

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

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[.]”

In addition, 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). Nor is mere temporal association sufficient to prove causation in fact. Grant,

956 F.2d at 1148. Without more, “evidence showing an absence of other causes does not meet

petitioners’ affirmative duty to show actual or legal causation.” Id. at 1149.

With regard to Althen prong one, 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). The medical

literature filed in this case also supports a finding that tetanus vaccine can cause TM. Petitioner

has satisfied prong one of Althen.

20

Before discussing prong two of Althen, it is essential to discuss prong three because this

case hinges on timing. Petitioner’s expert, Dr. Triggs, states in his initial expert report that

petitioner had transverse myelitis, which he describes 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.

However, numerous records, including contemporaneous records, show that petitioner

experienced urinary dysfunction, leg weakness, difficulty ambulating, and numbness and tingling

in her legs within one day of receiving her tetanus vaccination. Petitioner received the tetanus

vaccination on Thursday, September 6, 2007, at around 11:10 p.m. Med. recs. Ex. 5, at 11–12;

Ex. 19, at 903. When she presented to the emergency room on Saturday, September 8, 2007, at

6:17 p.m., she reported fever, urinary frequency, problems urinating, body aches, joint aches, and

generalized weakness. Med. recs. Ex. 5, at 141, 148–49. She reported that she started not

feeling well on Friday, September 7, 2007. Id. at 149. On September 9, 2007, she gave a history

that she had been aching all over and had weak legs for the past three days. Id. at 15. Numerous

other histories within the next month document that her onset of symptoms, including

progressive lower extremity weakness, malaise, polyarthralgia, polymyalgia, fever, tremor, and

difficulty moving around, occurred the day after her vaccination. Id. at 15, 68, 127; Med. recs.

Ex. 1, at 8; Ex. 4, at 12; Ex. 6, at 38. Dr. Delgado, a neurologist who saw petitioner on October

3, 2007, opined that her onset of acute inflammatory demyelinating polyneuropathy was on

September 7, 2007. Med. recs. Ex. 4, at 13. Additionally, petitioner gave an extremely detailed

history to Dr. McCluskey, in which she reported tingling in her toes and feet beginning at 4:00

a.m. on September 7, 2007. Med. recs. Ex. 19, at 911.

In her brief regarding the treating doctors’ opinions, petitioner distinguishes between

petitioner’s urinary frequency on September 8, 2007, and her inability to urinate on September 9,

2007. Pet’r’s Memo. at 11. Petitioner 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. Med. recs. Ex. 5, at 141, 148–49. This September 8, 2007 history of urinary

dysfunction starting on September 7, 2007 is petitioner’s earliest contemporaneous recounting of

her symptomatology and its onset. 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. Med. recs. Ex. 5, at 141. Dr. Triggs then

testified at the hearing that petitioner was having a vaccine reaction on September 8, 2007, when

she complained of urinary frequency for the past day. Tr. at 297. His rationale for this was that

21

although she may have had a urinary tract infection based on the evidence of a bacterial

infection, she was also having a vaccine reaction at the time because her primary complaints

were pain and fever, which is not typical of a UTI. Id. at 298. He later changed his position in

his supplemental expert report, stating that petitioner’s urological complaints (as opposed to

neurological complaints) and diagnostic tests on September 7, 2007, indicated she had a urinary

tract infection, and her onset of TM was not until September 9, 2007. Ex. 70, at 4. On the one

hand, Dr. Triggs focuses on petitioner’s urinary dysfunction as proof in his initial 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. Furthermore, at the 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 was basic to

her evolving neurologic disease, which 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 to view the bladder dysfunction as

unrelated to petitioner’s TM).

Like Dr. Triggs’ testimony about petitioner’s urinary dysfunction, 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.

This opinion is legally insufficient, as the absence of other causes does not meet petitioner’s

affirmative duty to prove vaccine causation. Grant, 956 F.2d at 1148–49. Furthermore, Dr.

Triggs 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.

Consonant with this view 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

22

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.

In the remand instructions of the Opinion and Order, Judge Kaplan instructed the

undersigned to evaluate and consider the opinions of the treating doctors as to whether or not

petitioner proved her allegations.

Petitioner’s treating neurologist, Dr. Ramkissoon, did not indicate in any of his records or

his 2012 opinion letter that he considered petitioner’s onset to be one day. He specifically wrote

“days” in his opinion letter, showing that he apparently believed petitioner’s onset was greater

than 24 hours. This factual assertion that petitioner’s onset was “days” is not borne out after a

full review of the medical records, expert reports, and hearing testimony. Petitioner’s urinary

dysfunction, which Dr. Leist testified is related to her neurological disease, began on September

7, 2007, within one day of her vaccination. Moreover, Dr. Ramkissoon cites as one of the bases

for his opinion a lack of other precipitating events. As previously stated, however, the absence

of other causes does not meet petitioner’s affirmative duty to prove vaccine causation. Grant,

956 F.2d at 1148–49. The fact that Dr. Ramkissoon could not find another reason for

petitioner’s supposed GBS days after her Td vaccination except the vaccine is not legally

sufficient to establish causation.

The other treating doctors had various specialties, including infectious diseases, and are

thus less qualified to opine on causation of a neurologic injury than a neurologist would be. The

undersigned considers the opinion of a neurologist to be significantly more important than that of

an internist in evaluating what is the appropriate time interval between Td vaccination and onset

of neurologic disease. See Contreras v. Sec’y of HHS, No. 05-626V, 2013 WL 6698382, at *33–

34 (Fed. Cl. Spec. Mstr. Nov. 19, 2013) (discussing that a treating neurologist’s opinion is more

credible in determining the cause of a neurological illness than the opinions of a treating

emergency medicine specialist and a treating pediatric specialist), vacated and remanded on

other grounds, 116 Fed. Cl. 472 (Fed. Cl. 2014), on remand, 2014 WL 8098606 (Fed. Cl. Spec.

Mstr. Oct. 24, 2014), aff’d, slip op. (Fed. Cl. Apr. 17, 2015). Moreover, those who petitioner

argues opine in favor of vaccine causation (Dr. Nelson, Dr. Beltre, and Dr. Duharte) either do not

give a specific onset or do not explain the basis for their opinion. For example, Dr. Nelson, an

internist, opined that petitioner’s neurologic condition occurred one day after her vaccination and

was caused by the vaccination. However, Dr. Nelson did not explain his reasoning for his

diagnosis and did not address whether a one-day onset was a medically appropriate timeframe

for Td vaccination to cause a demyelinating disorder. Dr. Beltre, another internist, noted that

petitioner had acute febrile illness and a probable reaction to tetanus toxoid. He did not opine

that petitioner had a demyelinating disease, did not clarify in his note when he thought

23

petitioner’s onset was, and relied on an inaccurate history from petitioner.9 The notes of Dr.

Duharte (an infectious disease specialist arguably more qualified than an internist to opine on

vaccine causation) are unclear as to whether he believed petitioner had GBS caused by Td

vaccination. His notes suggest he was suspicious of such a causal relationship since he ordered a

neurology consultation to “rule it out.” But Dr. Duharte did not specifically discuss the temporal

relationship between petitioner’s vaccination and the onset of her demyelinating illness.

Dr. Nelson also recommended that petitioner not receive further vaccines. He did not,

however, give an explanation or a basis for this recommendation. The Federal Circuit noted in

Andreu v. Secretary of Health and Human Services, 569 F.3d 1367, 1376 (Fed. Cir. 2009), that,

“[a] treating doctor’s recommendation to withhold a particular vaccination can provide probative

evidence of a causal link between the vaccination and an injury a claimant has sustained.”

However, “there is nothing in Andreu that mandates that the testimony of a treating physician is

sacrosanct—that it must be accepted in its entirety and cannot be rebutted.” Snyder ex rel.

Snyder v. Sec’y of HHS, 88 Fed. Cl. 706, 745 n.67 (Fed. Cl. 2009). In Andreu, the petitioner’s

admitting neurologist testified that he “thought it would be ‘safer’ for [the petitioner] not to

receive additional pertussis inoculations because there was ‘some evidence’ to indicate that [the

petitioner’s] initial seizure was a ‘reaction’” to the vaccine. 569 F.3d at 1376, 1377 n.3. In

contrast to Andreu, Dr. Nelson offers no explanation for his recommendation, and his specialty

(internal medicine) is not apposite to the disease at issue. As an internist, Dr. Nelson would not

be as informed about the risk from and the type of reactions to tetanus toxoid vaccines as a

neurologist. Dr. Nelson’s opinion is therefore less probative of causation than the opinion of an

expert witness in the appropriate specialty (neurology).

In drafting the Vaccine Act, Congress directed that the special masters consider the

“entire record” in concluding whether or not to compensate a petitioner, but also specified that

“[a]ny . . . diagnosis, conclusion, judgment, test result, report, or summary shall not be binding

on the special master.” 42 U.S.C. § 300aa-13(b)(1) (emphasis added). The undersigned has had

the benefit of reading the expert reports, the transcripts of the expert testimony in this case, and

numerous medical articles written that discuss the very subject matter concerning this case. The

treating doctors have not. The undersigned relies, therefore, on the testimony of Dr. Leist rather

than the testimony of Dr. Triggs or the opinions of petitioner’s treating doctors. The undersigned

also relies on conclusions and information in the medical literature filed into evidence in this

case to conclude that one day is too soon for a vaccine to cause transverse myelitis.

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. The Federal Circuit has

addressed the failure of a petitioner to satisfy prong three of Althen in De Bazan v. Sec’y of

9

As the Federal Circuit has noted, a factfinder may properly reject an expert’s opinion when the expert

“assumes facts that are not supported by a preponderance of the evidence.” Dobrydnev v. Sec’y of HHS,

566 Fed. Appx. at 982–83 (quoting Dobrydnev, 2010 WL 816881, at *9, n.12 (Fed. Cl. Spec. Mstr. Oct.

27, 2010)).

24

HHS, 539 F.3d 1347 (Fed. Cir. 2008) (11-hour onset of acute disseminated encephalomyelitis

after tetanus vaccination). 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. If any petitioner fails to satisfy the third prong of Althen, i.e.,

prove appropriate timing for credible causation from the vaccine, that petitioner will similarly

fail to prevail on entitlement.

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.10

IT IS SO ORDERED.

April 27, 2015 s/Laura D. Millman

DATE Laura D. Millman

Special Master

10

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.

25