Katea D. Stitt, as Personal Representative of the Estate of Pamela Wanga Stitt v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 09-653V

Filed: May 31, 2013

******************************************* TO BE PUBLISHED

KATEA D. STITT, as Personal Representative *

of the Estate of PAMELA WANGA STITT, * Special Master Zane

*

Petitioner, * Entitlement; trivalent

* influenza vaccine;

v. * Guillain-Barré

* Syndrome (GBS);

SECRETARY OF HEALTH * Campylobacter jejuni; death.

AND HUMAN SERVICES, *

*

Respondent. *

*

*******************************************

Franklin John Caldwell, Jr., Maglio, Christopher & Toale, Sarasota, FL, for Petitioner

Glenn A. MacLeod, United States Dep’t of Justice, Washington, DC, for Respondent

RULING ON ENTITLEMENT 1

This matter is before the undersigned on the issue of entitlement following a hearing.

Petitioner, Katea D. Stitt (“Petitioner”), as the personal representative of the estate of her mother,

Pamela Wanga Stitt (“Mrs. Stitt”), filed this petition alleging that the trivalent influenza (“flu”)

1

Because this decision contains a reasoned explanation for the Special Master’s action in this

case, the Special Master intends to post it on the website of the United States Court of Federal

Claims, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 113 Stat. 2899,

2913 (Dec. 17, 2002). All decisions of the Special Master will be made available to the public

unless they contain trade secret or commercial or financial information that is privileged and

confidential, or medical or similar information whose disclosure would clearly be an

unwarranted invasion of privacy. When such a decision or designated substantive order is filed,

a party has 14 days to identify and to move to redact such information before the document’s

disclosure. Absent a timely motion to redact, the decision will be made available to the public in

its entirety. If the Special Master, upon review of a timely-filed motion, agrees that the

identified material fits within the categories listed above, the Special Master shall redact such

material from the decision made available to the public. 42 U.S.C. § 300aa-12(d)(4); Vaccine

Rule 18(b).

1

vaccination Mrs. Stitt received on September 25, 2008, caused Mrs. Stitt to develop Guillain-

Barré syndrome (“GBS”), 2 which then caused her death. Petition ¶ 8. Petitioner seeks

compensation pursuant to the National Childhood Vaccine Injury Act (“Vaccine Act”), as

amended, 42 U.S.C. § 300aa-1, et seq. 3

Petitioner contends that the evidence shows that it is more probable than not that the flu

vaccine was a substantial factor in causing Mrs. Stitt’s GBS and subsequent death. Petitioner

relies on molecular mimicry as the medical theory that causally connects the flu vaccine to GBS.

Id. Petitioner argues that Mrs. Stitt’s clinical picture and the results of diagnostic tests

demonstrate a logical sequence of cause and effect showing the flu vaccine caused Mrs. Stitt’s

GBS. Id. Finally, Petitioner maintains that the 5-1/2 weeks between the vaccine and Mrs. Stitt’s

hospitalization are within the standard, medically acceptable time frame of six weeks between

infection and onset of symptoms. Id. Petitioner argues that she has satisfied her burden and

shown by preponderant evidence that the flu vaccine caused her GBS, which, in turn, caused her

death.

Respondent argues that Petitioner has not satisfied her burden of proof. Although

Respondent acknowledges that Mrs. Stitt’s GBS was one of the causes of her death, Respondent

claims that Petitioner has failed to satisfy her burden of showing the flu vaccine caused Mrs.

Stitt’s GBS. Respondent contends that Petitioner’s presentation of molecular mimicry as a

theory is inadequate because Petitioner has failed to identify a specific protein in the peripheral

myelin as being similar to the antigen in the flu vaccine as evidence that molecular mimicry

could occur. Respondent also contends that because Petitioner could not point to any direct

evidence that would specifically identify the vaccine as the cause, Petitioner did not present

sufficient evidence to show a logical sequence of cause and effect. Respondent further claims

that Petitioner also failed to show a logical sequence because epidemiological evidence indicates

that in a majority of GBS cases, the cause is an infection, most likely a Campylobacter jejuni, or

C. jejuni, infection. 4 As a result, Respondent claims that the cause of Mrs. Stitt’s GBS is more

likely to be something other than the vaccine. Thus, according to Respondent, Petitioner fails to

2

Guillain-Barré syndrome, or GBS is defined as a rapidly progressive ascending motor neuron

paralysis of unknown etiology, frequently seen after an enteric or respiratory infection. An

autoimmune mechanism following viral infection has been postulated. It begins with paresthesias

of the feet, followed by flaccid paralysis of the entire lower limbs, ascending to the trunk, upper

limbs, and face; other characteristics include slight fever, bulbar palsy, absent or lessened tendon

reflexes, and increased protein in the cerebrospinal fluid without a corresponding increase in

cells. Variant forms include acute autonomic neuropathy, Miller-Fisher syndrome, acute motor

axonal neuropathy, and acute motor-sensory axonal neuropathy. Dorland’s Illustrated Medical

Dictionary 1832 (32d ed. 2012).

3

The National Vaccine Injury Compensation Program is set forth in Part 2 of the National

Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended,

42 U.S.C. § 300aa-10 through § 300aa-34 (2006).

4

Campylobacter jejuni or C. jejuni has been defined as an acute diarrheal disease or infection

with clinical manifestations like those of other acute bacterial gut infections of the intestinal tract

such as salmonellosis or shigellosis. Blaser, et al., Clinical Aspects of Campylobacter jejuni and

Campylobacter coli Infections, Campylobacter 99 (3d ed. 2008). R’s Ex. G-1.

2

present sufficient evidence that the vaccine was a substantial factor in causing Mrs. Stitt’s GBS

and subsequent death.

For the reasons set forth below, upon review of the record as a whole, the undersigned

concludes that Petitioner has satisfied her burden. She has shown by preponderant evidence that

the vaccine was a substantial factor in bringing about Mrs. Stitt’s GBS. And Mrs. Stitt’s GBS

was a substantial factor in bringing about her death. Petitioner is entitled to compensation.

I. PROCEDURAL BACKGROUND

Petitioner, Katea D. Stitt, filed a petition for vaccine injury compensation on October 2,

2009. In her petition, Petitioner alleges that her mother, Mrs. Stitt, died on November 20, 2008,

from GBS, which was caused by the flu vaccine she received on September 25, 2008. Petition.

Following the submission of medical records and expert reports, an entitlement hearing

was held on July 26, 2011, in Washington, DC. 5 Petitioner, Ms. Katea Stitt, and Petitioner’s

expert witness, Dr. Thomas Morgan, testified for Petitioner. Respondent relied on one witness,

her expert witness, Dr. Winfried Raabe. Post-hearing briefing was conducted following the

hearing. This case is now ready for ruling.

II. FACTS

The facts as evidenced by the records and testimony are as follows: 6

Mrs. Stitt received an influenza (“flu”) vaccination on September 25, 2008, at her local

Safeway store. Petitioner’s Exhibit (“P’s Ex”) 10. She was 74. P’s Ex. 6. At that time, Mrs.

Stitt’s medical condition was generally healthy, although she did have hypertension. P’s Ex. 2 at

13-16, 19; Transcript of July 26, 2011 hearing (“Tr.”) at 16. Mrs. Stitt’s medical history

indicated that she had had gall bladder surgery and intermittent lower back pain over the last few

years. P’s Ex. 2 at 13-16, 19. Mrs. Stitt had also had some specific orthopedic issues, i.e.,

rotator cuff problems and a twisted ankle. P’s Ex. 2 at 7, 8-13.

Approximately a week after she received the flu vaccine, on October 2, 2008, Mrs. Stitt

went to her orthopedist, Dr. Moskovitz, for a follow-up on her right knee and left shoulder pain

(Rotator Cuff Syndrome). P’s Ex. 2 at 1. At that time, Mrs. Stitt mentioned a new complaint,

i.e., stiffness and pain in both her hands and in her fingers, with the symptoms being greater in

her right versus her left hand and fingers. Id.

5

This case was originally assigned to another Special Master, who presided over it while records

were submitted, expert reports prepared and settlement discussions occurred. It was transferred

to the undersigned in May 2011, approximately 60 days before the hearing.

6

The facts as set forth herein are derived from the medical records, Petitioner’s testimony and

the parties’ Joint Submission of Uncontested Facts (“Stip.”), all of which are consistent. There

were no identified disputes as to the material facts.

3

Approximately two weeks later, on October 17, 2008, Mrs. Stitt traveled to New York

City for an awards ceremony and concert. P’s Ex. 15 at 1; Tr. at 13. After returning from her

trip, Mrs. Stitt suffered a bout of gastroenteritis (non-diarrheal illness), i.e., she had a bit of a

“stomach upset.” P’s Ex. 6 at 6, 36, 39; Tr. at 14, 18. Petitioner, who spoke to her mother

nearly every other day, explained that this was nothing more than a passing stomach upset for

which Mrs. Stitt took some ginger ale to settle her stomach. Tr. at 18, 19, 23. Knowing her

mother, had it been more than some mild stomach upset, Mrs. Stitt would have described the

illness in great detail to Petitioner, her daughter. Tr. at 23.

On October 30, 2008, Mrs. Stitt visited her primary care physician/internist, Dr. George

Graves, for a follow-up on her hypertension. P’s Ex. 4 at 19. Mrs. Stitt reiterated the complaint

she had made to her orthopedist of tingling in her hand up to her elbow for the past month. Id.

She denied complaints of chest pain, shortness of breath, and cough. Id. There was no

indication of any complaints of stomach problems, nausea, diarrhea or vomiting. Id.

A few days later, on November 3, 2008, Mrs. Stitt telephoned her doctor complaining of

tingling in her hands and feet. P’s Ex. 4 at 19; P’s Ex. 6 at 16-17. Later that same day, Mrs. Stitt

was admitted to Sibley Hospital due to leg weakness. P’s Ex. 6 at 21. At the time of her

admission, Mrs. Stitt told the admitting personnel that she had had leg weakness since the

morning, that her knees buckled twice, and that she experienced shortness of breath and

polyuria. 7 P’s Ex. 6 at 21; Tr. at 26-27.

Upon admission, Dr. Mahgoub, a neurologist, provided a consult. P’s Ex. 6 at 36-38. He

specifically noted that Mrs. Stitt had received a flu vaccine four weeks before admission and that

the differential diagnosis, which included GBS, was well described. P’s Ex. 6 at 36-37. Having

noted the receipt of the flu vaccine and possible GBS diagnosis, Dr. Mahgoub noted that the

Centers for Disease Control (“CDC”) and Food and Drug Administration (“FDA”) had not

issued an alert in connection with the flu vaccine. Id. Nonetheless, Dr. Mahgoub made a note to

contact the CDC out of concern regarding the vaccine being a possible cause. P’s Ex. 6 at 36-38.

Dr. Mahgoub also noted Mrs. Stitt’s trip to New York and a possibility of West Nile Virus. Id.

Dr. Mahgoub eliminated that as a potential cause because Mrs. Stitt’s cerebral spinal fluid

(“CSF”) and serum loads were the same. P’s Ex. 6 at 37. Finally, he considered botulism but

rejected that as Mrs. Stitt had not consumed fish in New York. Id. Mrs. Stitt’s laboratory tests

showed an elevated glucose level and elevated liver enzymes with otherwise normal results. P’s

Ex. 6 at 23. 8 Her urinalysis was positive for erythrocytes, bilirubin, ketones and protein. Id.

After being admitted to Sibley Hospital, Mrs. Stitt continued to experience leg weakness,

as well as weakness in her arms. P’s Ex. 6 at 17. Tests on Mrs. Stitt’s blood, spinal fluid, and

stool samples were ordered for routine cultures as well as for C. jejuni. 9 P’s Ex. 6 at 144.

7

Polyuria is defined as the passage of a large volume of urine in a given period, as in diabetes

mellitus. Dorland’s Illustrated Medical Dictionary 1494 (32d ed. 2012).

8

Mrs. Stitt learned she had diabetes this same day. P’s Ex. 6 at 16-17; Tr. at 21-22.

9

Progress notes from other parts of the record seemed to indicate that there may have been other

laboratory tests performed although the laboratory test results were not in the record.

Undersigned raised this with the parties at the time this matter was transferred to the

4

Results from her CSF and fungal culture tests were normal. P’s Ex. 6 at 179, 181. On

November 9, 2008, the results of her culture noted there was no Campylobacter (C. jejuni),

Salmonella, Shigella or E. coli isolated. P’s Ex. 6 at 178.

On November 6, 2008, the results from an electrodiagnostic study confirmed that Mrs.

Stitt’s presentation was consistent with GBS. P’s Ex. 7 at 2. Mrs. Stitt was treated with a two-

day course of IVIG. P’s Ex. 6 at 52; P’s Ex. 5 at 2. Because she developed shallow breathing

and an increased respiratory rate on that day, Mrs. Stitt was intubated. P’s Ex. 6 at 53-54; Tr. at

32. Within a day, Mrs. Stitt developed what was diagnosed as staphylococcus pneumonia. Id.

She was treated with antibiotics. Id. Mrs. Stitt also developed a fever and an elevated white

blood cell count. P’s Ex. 6 at 67.

Beginning November 10, 2008, Mrs. Stitt’s strength in her extremities began to return

and her breathing improved. P’s Ex. 6 at 7. However, it was also determined that Mrs. Stitt had

developed hemolytic anemia due to her IVIG treatment. Id. As a result, her IVIG treatment was

stopped after just two courses. Id.

By November 12, 2008, Mrs. Stitt’s pneumonia had resolved. Id. Later that day, Mrs.

Stitt was removed from the ventilator. P’s Ex. 6 at 100. Mrs. Stitt was noted to be “doing quite

well” and to have a good voice. Id. On November 13, 2008, Mrs. Stitt was again noted to be

“doing well,” “breathing easily,” and “swallowing without difficulty,” and her pneumonia had

resolved. P’s Ex. 6 at 105-06. Plans were made to transfer Mrs. Stitt to the National

Rehabilitation Hospital. Id.

On November 14, 2008, Mrs. Stitt was discharged from Sibley Hospital to the National

Rehabilitation Hospital. P’s Ex. 6 at 6. The discharge summary indicated that Mrs. Stitt was

diagnosed with, inter alia, GBS. P’s Ex. 6 at 6. The doctors told Petitioner that Mrs. Stitt’s GBS

was caused either by the flu vaccine or some other unidentified infection. Tr. at 76.

On November 16, 2008, while at the National Rehabilitation Hospital, Mrs. Stitt

experienced severe respiratory distress and was transported to Washington Hospital Center. P’s

Ex. 5 at 2. Mrs. Stitt was intubated. P’s Ex. 5 at 8. Because her blood pressure dropped, Mrs.

Stitt was placed on medication to raise her blood pressure. Id. A chest X-ray revealed bibasal

infiltrates and an echocardiography demonstrated a nearly collapsed ventricle suggestive of

hypovolemia. 10 P’s Ex. 8 at 8, 13; Ex. 5 at 225. An evaluation for cardiac arrest revealed that

Ms. Stitt had a cardiomyopathy. 11 P’s Ex. 5 at 2; Tr. at 65.

undersigned. July 14, 2011 Order. After inquiry, Petitioner represented that she made inquiry to

the health care providers and verified that she had filed all the pertinent medical records. Tr. at

5-8. Respondent acquiesced in Petitioner’s representation that all pertinent records had been

filed. Tr. at 8.

10

Hypovolemia is defined as an abnormally decreased volume of circulating blood in the body;

the most common cause is hemorrhage. Dorland’s Illustrated Medical Dictionary 908 (32d ed.

2012).

11

Cardiomyopathy is a general diagnostic term designating primary noninflammatory disease of

the heart muscle, often of obscure or unknown etiology and not the result of ischemic,

5

On the following day, November 17, 2008, Mrs. Stitt’s EKG tests revealed changes in her

ST-elevation and increased enzymes. P’s Ex. 5 at 288. She received cardiac catherization,

which revealed non-obstructive coronary artery disease, elevated right heart filling pressures, and

takotsubo 12 with severe liver dysfunction. P’s Ex. 8 at 4. Mrs. Stitt’s lab results revealed no

abnormalities in her stool cultures. P’s Ex. 5 at 277.

Mrs. Stitt was placed on a ventilator, and on November 18, 2008, she suffered hypoxic

respiratory failure while on the ventilator. P’s Ex. 5 at 74. Mrs. Stitt was determined to have

takotsubo syndrome with functional obstruction of liver outflow. Id. There was no change in

Mrs. Stitt’s status the next day, November 19, 2008. P’s Ex. 5 at 84. Later on November 19,

2008, Mrs. Stitt began to experience worsening hypotension due to sepsis versus takotsubo

cardiomyopathy. P’s Ex. 5 at 85-86; Stip. ¶ 15. Mrs. Stitt’s mental status worsened and her

family decided that she should not be resuscitated. P’s Ex. 5 at 2-3.

Ms. Stitt died on November 20, 2008. P’s Ex. 11 at 1; P’s Ex. 5 at 3, 91. Her causes of

death were listed as: (A) Cardiogenic shock; (B) Cardiomyopathy; (C) GBS; and (D)

Pneumonia. P’s Ex. 11 at 1; P’s Ex. 5 at 3, 91; Stip. ¶ 16. An autopsy was performed on

January 12, 2009. P’s Ex. 5 at 292-96. The autopsy report listed the causes of death as, inter

alia, (1) Septic shock with respiratory failure (clinical) and (2) GBS (clinical). P’s Ex. 5 at 292;

Stip. ¶ 17.

The parties stipulated that Mrs. Stitt had been diagnosed with GBS at the time of her

discharge from Sibley Hospital to the National Rehabilitation Hospital. Stip. ¶ 10. The parties

also stipulated that the medical records listed GBS as a cause of her death. Stip. ¶ 16. Finally,

the parties stipulated that the autopsy report identified GBS as one of the causes of Mrs. Stitt’s

death. Stip. ¶ 17.

III. PETITIONER’S CASE

In support of her case, Petitioner relied on the expert report and testimony of Dr. Thomas

Morgan. Dr. Morgan is a neurologist. P’s Ex. 13. Since 1978, he has been an Assistant

Professor in the Department of Clinical Neuroscience at the School of Medicine of Brown

University. P’s Ex. 13. Prior to his appointment with Brown University, he was a Clinical

Instructor in Neurology at Boston University’s Medical School. Id. He is board certified in

neurology. P’s Ex. 12. During his training, as a result of electives taken, he developed a good

understanding of peripheral nervous system disorders. Tr. at 36. Additionally, in 1976, he

hypertensive, congenital, valvular, or pericardial disease. Dorland’s Illustrated Medical

Dictionary 294 (32d ed. 2012).

12

Takotsubo cardiomyopathy is defined as a syndrome characterized by transient apical and

midventricular akinesis that is typically precipitated by acute stress. Manzanal, et al., Inverted

Takotsubo Cardiomyopathy, Tex. Heart Inst. J. 2013; 40(1):56-9. It is also defined simply as a

weakening of the left ventricle, the heart's main pumping chamber, usually as the result of severe

emotional or physical stress, such as a sudden illness, the loss of a loved one, a serious accident,

or a natural disaster such as an earthquake. Harvard Women’s Health Watch, November 2010.

6

treated patients who had received the swine flu vaccine and then developed GBS, which was

determined to have a causal relationship. Tr. at 37. He is on the clinical track of the school,

where they work with patients and teach residents to extract information from patients to try to

formulate a diagnosis. Tr. at 39-40. The last patient he treated with GBS was a few years ago.

Tr. at 107.

Dr. Morgan opined that Mrs. Stitt had suffered from GBS, an acute inflammatory

demyelinative polyneuropathy, causally related to her vaccination. Tr. at 51. The mechanism

that he believes could have caused this injury is molecular mimicry. Tr. at 91-92; P’s Ex. 12 at

4. As to timing, Dr. Morgan explained that a medically appropriate temporal relation would be

between two and six weeks after vaccination so that the timing here, 5-1/2 weeks between

vaccination and hospitalization, was appropriate. P’s Ex. 14.

Dr. Morgan explained that to determine the actual cause, as a clinician, he would apply a

multi-step process as set forth in the neurology textbook, Adams & Victor’s Principles of

Neurology. Tr. at 46, 96; P’s Ex. 12 at 6. As a clinician, Dr. Morgan looked at the various

possible etiologies of Mrs. Stitt’s GBS and used the symptoms displayed and other information

to eliminate potential causes and to determine the cause of Mrs. Stitt’s GBS, in essence using a

differential diagnosis method. Tr. at 46, 96. Dr. Morgan testified that because GBS is an

inflammatory immune disorder, the possible causes would be bacterial, viral or vaccinal. Tr. at

84. Dr. Morgan testified that the records, in his view, excluded bacterial and viral causes

because the tests for bacterial and viral illnesses had been negative, and Mrs. Stitt did not have

any clinical signs of bacterial or viral illnesses. Tr. at 86-87. Based on the records excluding

other potential causes and her clinical symptoms (and lack thereof) as well as the temporal

relation, Dr. Morgan concluded, as a matter of medical probability, that Mrs. Stitt’s GBS was

caused by the influenza vaccine she had received. P’s Ex. 12; Tr. at 51.

IV. RESPONDENT’S CASE

Respondent relied on the expert report and testimony of Dr. Winfried Raabe. Dr. Raabe

is a board-certified neurologist who is a Clinical (Adjunct) Associate Professor of Neurology at

the University of Minnesota’s Medical School. R’s Ex. B; Tr. at 162. He is also a certified

member of the American Association of Neuromuscular Electro-diagnostic Medicine. Tr. at

162. His area of expertise is electro-diagnostics, and he was the director of the EMG

(electromyography) lab until 2007. Tr. at 163. He is semi-retired. Id.

Dr. Raabe opined that Mrs. Stitt’s influenza vaccination was coincidental to her

developing GBS. Tr. at 167. Dr. Raabe relied on the literature that indicated that there has been

no epidemiological evidence connecting the flu vaccine and GBS since 1976-77 to conclude that

there was no evidence of a causal connection between the flu vaccine and GBS. Tr. at 172, 175;

R’s Ex. A at 4. Again, relying on literature, Dr. Raabe noted that because 60% of the time where

the cause of GBS is identified as being infectious, half of the infections are C. jejuni. R’s Ex. D

at 4. Thus, he concluded that C. jejuni was the likely cause of Mrs. Stitt’s gastrointestinal illness,

which in turn was the likely cause of Mrs. Stitt’s GBS. R’s Ex. D at 3-4. In his expert report,

Dr. Raabe noted that one study reflected in the literature discussed the onset of GBS as generally

occurring two weeks after infection. R’s Ex. A at 4. Based on this, in his expert report, Dr.

7

Raabe stated that the timing between the vaccine and Mrs. Stitt’s hospitalization, some 5-1/2

weeks, tended to make it a less medically appropriate temporal relation. R’s Ex. A at 4.

Following the hearing, Dr. Raabe submitted a supplemental report. 13 R’s Ex. F. That

report consisted of the results of his further literature search on the following questions: (1) how

C. jejuni is diagnosed; and (2) whether the test results indicating that Mrs. Stitt’s stool sample

tested negative for C. jejuni are conclusive. R’s Ex. F. Dr. Raabe’s search of the literature

revealed that the definitive test for C. jejuni is a stool sample. Id. His search also revealed that

some percentage of individuals with GBS do not show signs of C. jejuni. Id. Dr. Raabe

concluded that the negative stool culture for C. jejuni is not dispositive as to whether Mrs. Stitt

actually had C. jejuni. Id.

V. APPLICABLE LEGAL STANDARDS

The Vaccine Act provides for two means of recovery: Table claims and off-Table

claims. 14 In an off-Table, or causation-in-fact case, such as this one, a petitioner must prove

actual causation by a preponderance of the evidence. Moberly v. Sec’y of Health & Human

Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010). To prove actual causation, a petitioner must “show

that the vaccine was ‘not only a but-for cause of the injury but also a substantial factor in

bringing about the injury.’ ” Moberly, 592 F.3d at 1321–22 (quoting Shyface v. Sec’y of Health

& Human Servs., 165 F.3d 1344, 1352–53 (Fed.Cir.1999)). Causation is determined on a case-

by-case basis. Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994).

A petitioner satisfies this burden if she provides: (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 proximate temporal

relationship between vaccination and injury. Althen v. Sec’y of Health & Human Servs., 418

F.3d 1274, 1278 (Fed. Cir. 2005). A petitioner must satisfy the three Althen prongs by

preponderant evidence. Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326

(Fed. Cir. 2006). This preponderant-evidence standard “simply requires the trier of fact to

believe that the existence of a fact is more probable than its nonexistence.” Moberly, 592 F.3d at

1322 n.2; Althen, 418 F.3d at 1279 (citing Hellebrand v. Sec’y of Health & Human Servs., 999

F.2d 1565, 1572–73 (Fed. Cir. 1993)) (noting the standard requires that a petitioner demonstrate

the existence of the element is “more probable than not.”). Evidence used to satisfy one of the

Althen prongs can overlap and be used to satisfy another prong. Capizzano, 440 F.3d at 1326.

There are no “hard and fast per se scientific or medical rules” for finding causation under

the Vaccine Act. Knudsen, 35 F.3d at 548. The Vaccine Act does provide that a claimant may

satisfy the preponderant evidence standard by producing “medical records or a medical opinion.”

13

The report submitted post-hearing was actually Dr. Raabe’s third report, or second

supplemental report. R’s Ex. F; see also R’s Ex. A and D.

14

In a Table case, a claimant who shows that he or she received a vaccination listed in the

Vaccine Injury 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 v. Sec’y of Health & Human

Servs., 569 F.3d 1367, 1374 (Fed. Cir. 2009).

8

42 U.S.C. § 300aa-13(a)(1). A petitioner must provide a reputable medical or scientific

explanation that pertains specifically to the petitioner's case. Moberly, 592 F.3d at 1322.

However, the explanation need only be “legally probable, not medically or scientifically certain.”

Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1345-46 (Fed. Cir. 2010);

Moberly, 592 F.3d at 1322 (quoting Knudsen, 35 F.3d at 548-49). Along these lines, a special

master may not require “epidemiologic studies. . .or general acceptance in the scientific or

medical communities. . . .” Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378

(Fed. Cir. 2009).

At the same time, special masters are “entitled to require some indicia of reliability to

support the assertion of the expert witness.” Moberly, 592 F.3d at 1324; Cedillo v. Sec’y of

Health & Human Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010). In determining reliability, a

special master may appropriately rely on the standards set forth in Daubert v. Merrell Dow

Pharmaceuticals, Inc., 509 U.S. 579, 593-94 (1993); see Terran v. Sec’y of Health & Human

Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999) (finding that special masters’ use of the Daubert

factors reasonable); Cedillo, 617 F.3d at 1338-39 (finding no legal error in the standards applied

by the special master in utilizing Daubert). When a party relies upon expert testimony, that

testimony must have a reliable scientific basis. Cedillo, 617 F.3d at 1339. Although a party

need not produce medical literature to establish causation, where such evidence is submitted, the

special master can consider it in reaching an informed judgment as to whether a particular

vaccination likely caused a particular injury. Andreu, 569 F.3d at 1379; Althen, 418 F.3d at

1281; see also Daubert, 509 U.S. at 593-94.

With regard to alternative causes, the respondent bears the burden of proving by

preponderant evidence that an alternative cause, or factor unrelated, was the sole cause of the

injury. 42 U.S.C. § 300aa-13; de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347,

1354 (Fed. Cir. 2008); Knudsen, 35 F.3d at 549. But, neither 42 U.S.C. § 300aa-13 nor the

decisions limit what evidence the special master may consider in deciding whether a prima facie

case has been established. Doe 11, 601 F.3d at 1358 (citing de Bazan, 539 F.3d at 1353); see

also Walther v. Sec’y of Health & Human Servs., 85 F.3d 1146, 1151 (Fed. Cir. 2007). As a

result, the government may also present and the special master may consider evidence of

alternative causes on the issue of the adequacy of the petitioner’s evidence regarding the

petitioner’s case-in-chief. Doe 11 v. Sec’y of Health & Human Servs., 601 F.3d 1349, 1358

(Fed. Cir. 2010) (quoting de Bazan, 539 F.3d at 1354).

In this regard, there are two particular points that the decisions make clear. First, a

special master may not require the petitioner to shoulder the burden of eliminating all possible

alternative causes in order to establish a prima facie case. Stone v. Sec’y of Health & Human

Servs., 676 F.3d 1373, 1379-80 (Fed. Cir. 2012). Second, a special master may find that a factor

other than a vaccine caused the injury in question only if that finding is supported by a

preponderance of the evidence. Stone, 676 F.3d at 1379-80 (citing Doe 11, 601 F.3d at 1356–

57); see Walther, 485 F.3d at 1151-52 (the petitioner does not bear the burden of eliminating

alternative independent potential causes, and the respondent has the burden of proving an

alternative cause as the sole, unrelated factor that caused the injury by a preponderance of

evidence).

9

It is established that a special master is entitled to, and should, consider the record as a

whole in determining causation. 42 U.S.C. § 300aa-13(a)(1)(A). This is especially true in a case

involving multiple potential causes acting in concert. Stone, 676 F.3d at 1379-80; see also Doe

11, 601 F.3d at 1356–58; de Bazan, 539 F.3d at 1353; Shyface, 165 F.3d at 1352. In considering

the record, the Vaccine Act does not contemplate full blown tort litigation. Knudsen, 35 F.3d at

548. A petitioner may use circumstantial evidence to prove the case, and “close calls” regarding

causation must be resolved in favor of the petitioner. Althen, 418 F.3d at 1280. Indeed, “the

purpose of the Vaccine Act’s preponderance standard is to allow the finding of causation in a

field bereft of complete and direct proof of how vaccines affect the human body.” Althen, 418

F.3d at 1280); Capizzano, 440 F.3d at 1324.

VI. DISCUSSION

The issue to resolve here is whether the influenza vaccine Mrs. Stitt received on

September 25, 2008 was a substantial factor in causing Mrs. Stitt’s GBS. The parties agree on

other material issues. Specifically, Petitioner and Respondent agree that Mrs. Stitt was

diagnosed with and had GBS. P’s Ex. 14; R’s Ex. A at 4. The parties also agree that Mrs. Stitt’s

GBS was one of the causes of her death. Stip. ¶ 17(2); Tr. at 66-67; Tr. at 149; Tr. at 167; Tr. at

231-32. 15 As explained below, Petitioner has satisfied her burden.

A. Petitioner Has Presented Sufficient Proof of a Medical Theory Causally

Connecting the Flu Vaccine to Mrs. Stitt’s GBS, Satisfying Althen’s Prong One.

To satisfy Althen’s prong one, Petitioner presented evidence that the flu vaccine could

cause GBS through the biological mechanism of molecular mimicry. P’s Ex. 12; Tr. at 92-94;

123. 16 As Dr. Morgan explained, molecular mimicry occurs when the immune system is

stimulated, such as when an individual receives a vaccine. Tr. at 92. With molecular mimicry,

antibodies stimulated to fight the flu, due to chemical similarity, mimic or cross react with

normal tissue of the nerve roots or of the peripheral nerves and attack normal myelin or swan

cells or axons. Tr. at 92-94. By the molecular mimicry process, the immune system “mistakes”

myelin in the peripheral nervous system for parts of the antigen it has been “taught” to recognize

15

By virtue of their stipulating that the cause of Mrs. Stitt’s death was GBS, the parties are in

agreement that Mrs. Stitt’s GBS was the cause and, thus, a substantial factor in bringing about

her death. Stip. ¶¶ 16, 17. See supra VI.B.

16

As recently recognized by the Federal Circuit, despite GBS not being listed on the Vaccine

Injury Table, there certainly are many flu vaccine causing GBS cases that have been

compensated under the Program. Figueroa v. Sec’y of Health & Human Servs., ____F.3d,

____, 2012 WL 1811018 *1 (Fed. Cir. May 1, 2013) (citing cases); see generally Isaac v. Sec’y

of Health & Human Servs., 2012 WL 3609993 *4 (Fed. Cl. Spec. Mstr. July 30, 2012) (in a case

in which the influenza vaccine is alleged to have caused GBS by a process of molecular

mimicry, there would be at least some indication from the swine flu experience that the influenza

vaccine can cause GBS). Although these cases certainly indicate outcomes of cases involving

the same or similar vaccines and the same alleged injury, as Congress recognized, rulings on

entitlement in the Vaccine Program are decided on the record as a whole in the particular case.

42 U.S.C. § 300aa-13(a)(1).

10

as the flu vaccine, and attacks the myelin, which can then cause GBS. Tr. at 94; P’s Ex. 18; see

also Court Exhibit 1005. Respondent’s expert, Dr. Raabe, agreed that the biological mechanism

for GBS was some form of immune-mediated molecular mimicry. Tr. at 199. In fact, literature

relied on by Respondent’s expert noted that molecular mimicry has emerged as the leading

hypothesis for the pathogenesis of GBS. R’s Ex. E-3 at 2 (p. 644 of actual article).

The record further contains evidence that the flu vaccine, a stimuli of the immune system,

could trigger molecular mimicry and lead to GBS. Respondent’s expert’s article, Lehmann, et

al., GBS after Exposure to Influenza Virus, Lancet Infect. Dis. 2010; 10:643-51, indicates that

there was epidemiological evidence of the swine flu vaccine in 1976-77 being causally

connected with GBS. R’s Ex. E-3 at 2. That article is evidence that there is a causal connection

between at least one type of flu vaccine and GBS. That article also acknowledges that molecular

mimicry is the mechanism that would likely cause GBS. R’s Ex. E-3 at 2. Finally, the article

summarizes the results of other studies and indicates that two of these studies suggest a causal

connection between the flu vaccine and GBS. R’s Ex. E-3 at 5 Table 2.

The articles regarding those two studies, also submitted in the record, provide further

evidence of a flu vaccine causal connection with GBS. The 2010 Juurlink study, GBS after

Influenza Vaccination in Adults, indicated a 1.7-fold adjusted relative risk for GBS associated

with vaccination. R’s Ex. C-4 at 3. The Laskey study also indicated a slightly greater risk of

GBS after receipt of the flu vaccine. R’s Ex. C-3 at 4; see also Court Exhibit 1008.

Respondent’s expert, Dr. Raabe, acknowledged that these studies did suggest a possible causal

connection between the flu vaccine and GBS. Tr. at 253.

In addition to these studies, the Vaccination Information Statement (“VIS”) provided by

the Centers for Disease Control (“CDC”) for the influenza vaccine also points to a causal

connection. Court Exhibit 1001. 17 Under the heading “severe problems,” the VIS states that in

1976 a type of influenza vaccine was associated with GBS. Id. That warning goes on to state

that if there is a risk of GBS from the current flu vaccine, it is very rare. Id. When asked about

this, Respondent’s expert, Dr. Raabe, acknowledged this statement and referenced the Laskey

and Juurlink studies as a possible reason for this warning. Tr. at 252.

Despite this evidence, Respondent argues that Petitioner has failed to satisfy prong one

because Petitioner’s expert has failed to prove that a particular protein in the human peripheral

myelin that gets attacked under the molecular mimicry theory is sufficiently similar to the

antigen found in the flu vaccine and that this is necessary to show that molecular mimicry has

taken place. R’s Post-Hearing Brief at 11-12. In essence, Respondent argues that Petitioner

must show the exact biologic mechanism that could have caused Petitioner’s injury.

Contrary to Respondent’s argument, Petitioner is not required to demonstrate the exact

biologic mechanism by which the flu vaccine could cause GBS. As the Federal Circuit observed

in Knudsen, “to require identification and proof of specific biological mechanisms would be

17

Court Exhibits were placed into the record in advance of the hearing. July 14, 2011 Hearing

Order. The parties were advised to provide their experts these exhibits for comment and

consideration and that inquiry might be made of their experts at hearing regarding these exhibits.

11

inconsistent with the purpose and nature of the vaccine compensation program.” Knudsen, 35

F.3d at 551 (quoting House Report 99-908 at 3, 1986 U.S. Code Cong. &. Admin. News at

6344). The Vaccine Program “is therefore not to be seen as a vehicle for ascertaining precisely

how and why vaccines sometimes destroy the health and lives of certain individuals while safely

immunizing most others.” Knudsen, 35 F.3d at 549. Indeed, “the purpose of the Vaccine Act’s

preponderance standard is to allow the finding of causation in a field bereft of complete and

direct proof of how vaccines affect the human body.” Althen, 418 F.3d at 1280. Thus, Petitioner

is only required to establish that the medical theory upon which she relies shows that it is more

likely than not that the flu vaccine could cause GBS.

Respondent also argues that Petitioner’s evidence is insufficient due to the lack of

epidemiological support for Petitioner’s position. R’s Post-Hearing Brief at 12. Again, contrary

to Respondent’s argument, it is well-recognized that Petitioner is not required to present

epidemiological evidence to satisfy her burden. Andreu, 569 F.3d at 1378.

The evidence presented here is sufficient to satisfy Petitioner’s burden as to Althen’s

prong one. Petitioner presented through her expert a medical theory for how the vaccine could

have caused Mrs. Stitt’s GBS. The medical literature provides evidence of the reliability of

Petitioner’s medical theory that there is a causal connection between the flu vaccine and GBS.

Indeed, the CDC’s warning on the Vaccine Information Statement for the flu vaccine also

supports this. Petitioner has shown by a preponderance of evidence a medical theory evidencing

a causal connection between the flu vaccine and GBS.

B. Petitioner Has Provided Sufficient Evidence Which Demonstrates a Logical

Sequence of Cause and Effect Showing the Vaccine Was a Substantial Factor

Leading to Mrs. Stitt’s GBS, Satisfying Althen’s Prong Two.

Petitioner’s expert, Dr. Morgan, opined that, to a reasonable degree of medical

probability, the flu vaccine was the cause of Mrs. Stitt’s GBS and subsequent death. P’s Ex. 12;

Tr.at 51, 71. He reached his conclusion by reviewing the various medical records evidencing

Mrs. Stitt’s symptoms and medical test results to conclude that it is more likely than not that the

influenza vaccine was a substantial factor in causing her GBS. Tr. at 35-74.

As explained by Dr. Morgan, to determine the cause of Mrs. Stitt’s GBS, he and, to a

degree, the treating physicians used a clinical diagnostic approach, which included a differential

diagnosis method. Differential diagnosis is an established scientific technique used to identify

the cause of a medical problem by eliminating the potential causes until the most probable cause

is identified. Westburry v. Gislaved Gummi AB, 178 F.3d 257, 262 (4th Cir. 1999). Differential

diagnosis “generally is accomplished by determining the possible causes for the patient’s

symptoms and then eliminating each of these potential causes until reaching one that cannot be

ruled out or determining which of those that cannot be excluded is most likely.” Id. While not

labeling it as such, the Federal Circuit has recognized that a petitioner may present “evidence

eliminating other potential causes to help carry the burden on causation and may find it

necessary to do so when the other evidence on causation is insufficient to make out a prima facie

case.” Walther, 485 F.3d at 1151. But, a simplistic elimination of other causes does not

necessarily mean that a remaining factor actually caused the condition. Moberly, 592 F.3d at

12

1323 (quoting Althen, 418 F.3d at 1278). On the other hand, it has been recognized that a

sufficiently rigorous differential diagnosis can support a finding of causation under the Vaccine

Act. See Hocraffer v. Sec’y of Health & Human Servs., 63 Fed. Cl. 765, 777, 779 (2005)

(finding that Petitioner was entitled to compensation based on the differential diagnosis

testimony presented by her expert witnesses); Ruggero v. Warner-Lambert Co., 424 F.3d 249,

254 (2d Cir. 2005) (stating that the district judge has broad discretion in determining whether in

a given case a differential diagnosis is enough by itself to support a causation opinion); see

generally Doe 93 v. Sec’y of Health & Human Servs., 98 Fed. Cl. 553, 570 (2011). The

foregoing suggests that where a differential diagnosis is part of the record, as part of the

consideration of the record as a whole, the special master should consider this process and any

resulting diagnosis and accord it weight in the same way other evidence is considered.

Here, the doctors treating Mrs. Stitt applied this method in looking for a cause for her

GBS. P’s Ex. 6 at 36-38. The treating physicians looked at various potential causes, including

the flu vaccine. Id. The doctors asked questions to establish clinical symptoms and performed

diagnostic tests in an effort to determine the particular cause of Mrs. Stitt’s GBS. Id.

Regarding potential bacterial and viral agents, they tested for a number of alternative

causes of GBS, including West Nile virus, various bacterial infections, Lyme disease, C. jejuni,

as well as Hepatitis B and C, acknowledging that these conditions “can cause” GBS. P’s Ex 6 at

37-38, 176-79. All these tests were negative. Id.

The doctors also explored the possibility of a causal link by considering the stomach

upset Mrs. Stitt had reported experiencing after returning from her New York trip. They did this

by asking her questions upon her admission related to the symptoms of gastroenteritis, i.e.,

whether she had had nausea, vomiting, or diarrhea. P’s Ex. 6 at 36-38. They also took a stool

sample and tested for, inter alia, C. jejuni, which was negative. P’s Ex. 6 at 178.

As is well established in the record, Mrs. Stitt did not have these symptoms at the time

she first came to the hospital and had only very minor symptoms beforehand. Id. The absence

of these symptoms coupled with the negative test results are evidence that those various bacterial

and viral infections were not the cause of Mrs. Stitt’s GBS. P’s Ex. 6 at 36-38.

The doctors also considered the flu vaccine as a potential cause. P’s Ex. 6 at 38. The

doctors acknowledged that, in a practice setting, the flu vaccine/GBS connection is one regularly

explored, that a flu shot can cause GBS. P’s Ex. 6 at 36-38. The treating neurologist’s

impression upon consultation states specifically that Petitioner developed ascending paralysis

four weeks after receiving a flu shot. P’s Ex. 6 at 37. Upon learning of Mrs. Stitt’s recent

vaccination, the treating neurologist made note to inquire with the CDC and FDA to learn

whether there were reports of concerns regarding the vaccine’s potential risks. Id.

The doctors did appear to eliminate or minimize certain potential causes based on results

of objective tests and lack of clinical symptoms. P’s Ex. 6 at 36-38. But, they were unable to

eliminate all of them. One which they did not eliminate was the flu vaccine. The neurologist’s

notes specifically discuss other potential causes, such as West Nile virus. P’s Ex. 6 at 36-38. In

some instances, after looking at symptoms, circumstances and test results, he eliminates or

13

discounts them. Id. He did not necessarily do that with regard to the flu vaccine.

That the doctors still considered the flu vaccine a potential cause is evidenced by the

discussion they had with Petitioner. When discussing the cause of Mrs. Stitt’s GBS, the treating

physicians advised Petitioner that it was either the flu vaccine or some other, unidentified

infection. Tr. at 76. They did not say it was either the flu vaccine or West Nile or C. jejuni.

Rather they limited it to the flu vaccine or some “other” infection. This is certainly some

evidence, albeit circumstantial, that the vaccine caused the injury. Capizzano, 440 F.3d at 1326

(treating physician’s opinions should be considered).

Dr. Morgan also used the clinical and diagnostic information to determine the likely

cause of Mrs. Stitt’s GBS. Tr. at 43. Dr. Morgan explained that because GBS is an acute

inflammatory demyelinating polyneuropathy, related to an inflammatory immune process, the

possible causes would break down as either post-infectious, post-viral or post-vaccinal. Tr. at

48, 108.

According to Dr. Morgan, in looking at the clinical time line, a crucial piece of

information was the fact that Mrs. Stitt had seen her primary care physician on October 30, 2008,

a little over four weeks after the vaccination. Tr. at 51-52, referencing P’s Ex. 18; see also P’s

Ex. 4 at 19. At that time, Mrs. Stitt mentions tingling in her hands and numbness. But there is

no mention of any fever, nausea, vomiting or diarrhea. Mrs. Stitt does not have a gastrointestinal

issue or a fever and does not mention her recent stomach upset. Tr. at 53.

Consistent with this, when first arriving at the hospital on November 3, 2008, although

Mrs. Stitt again mentions tingling, she does not mention fever, nausea or diarrhea. P’s Ex. 6 at 6,

To Dr. Morgan, the absence of symptoms of illness or even stomach upset is significant because

if there were a bacterial or viral condition, there would be some manifestation of those

conditions. Tr. at 51-52.

The negative results of diagnostic tests taken at the time of her hospital admission are

also evidence Mrs. Stitt was not and had not been suffering from a bacterial or viral infection.

The results of the tests conducted for a variety of bacterial and viral infections, such as Lyme

disease, were all negative. P’s Ex. 6 at 178. Mrs. Stitt’s stool culture test for C. jejuni was also

negative. Id. Additionally, Mrs. Stitt had no symptoms other than tingling and no fever at the

time of her admission and did not have a fever or an elevated white blood count. P’s Ex. 6 at 27,

31-32, 36-38. Based on these test results, Dr. Morgan, like the treating physicians, concluded

that Mrs. Stitt’s GBS was not due to a bacterial or viral infection. Tr. at 53. At the same time,

the tingling suggests some autoimmune process, which would operate without a fever or signs of

a gastroenteritis. The vaccine certainly stimulates the immune system. These facts provide

circumstantial evidence that a substantial factor that caused Mrs. Stitt’s GBS was the vaccine and

not a bacterial or viral infection or other process.

Respondent contends that Petitioner has failed to satisfy the second prong, arguing that “Dr.

Morgan points to no specific evidence, such as biological markers, tests, or clinical symptoms, which

implicate the flu vaccination as the likely cause of petitioner’s injury.” R’s Post-Hearing Brief at 14.

Respondent seems to suggest that there must be some specific, direct proof that the particular vaccine

14

at issue, here the influenza vaccine, caused a specific autoimmune response that led to Mrs. Stitt’s

GBS. Respondent’s suggested approach is inconsistent with governing principles. It “prevents the

use of circumstantial evidence envisioned by the preponderance standard and negates the system

created by Congress, in which close calls regarding causation are resolved in favor of injured

claimants.” Capizzano, 440 F.3d at 1324 (quoting Althen, 418 F.3d at 1280). Indeed, were the

standard such that a petitioner could only prevail if there were direct evidence, especially as to

Althen’s prong two, it would be unlikely that a petitioner would ever be found entitled to

compensation.

Reliance on circumstantial evidence to find that Petitioner has satisfied her burden is

consistent with the purpose of the Vaccine Act. Indeed, “the purpose of the Vaccine Act’s

preponderance standard is to allow the finding of causation in a field bereft of complete and direct

proof of how vaccines affect the human body.” Althen, 418 F.3d at 1280; see Knudsen, 35 F.3d at

549 (explaining that “to require identification and proof of specific biological mechanisms would be

inconsistent with the purpose and nature of the vaccine compensation program”). As explained

above, the circumstantial evidence points to the vaccine as being a substantial factor in causing Mrs.

Stitt’s GBS.

Respondent cites Moberly, 592 F.3d at 1323, and argues that Dr. Morgan has done nothing

more than show a proximate temporal relationship and eliminate other potential causes and that is

insufficient to prove vaccine causation. Certainly, evidence that satisfies prongs one and three, can

overlap and be used to satisfy Prong 2. Capizzano, 440 F.3d at 1326. Here, as discussed in VI.A,

supra, there is strong evidence to satisfy prong one. Similarly, with regard to temporal relationship,

there is not much question that it is satisfied. See infra VI.C. That evidence also overlaps and

supports the evidence in the record relating to prong two.

Rather than simply summarily eliminate other potential causes, the record shows that both

Dr. Morgan and the treating physicians applied a recognized diagnostic approach as a means to

establish the cause of Mrs. Stitt’s GBS. They methodically performed diagnostic tests and reviewed

clinical symptoms to determine the cause of Mrs. Stitt’s GBS. This is a logical manner to use to

identify the cause of Mrs. Stitt’s GBS. See Capizzano, 440 F.3d at 1327 (A logical sequence of

cause and effect means that a claimant’s theory of cause and effect must be logical).

Respondent also argues that Petitioner has failed to show that a potential alternative cause, C.

jejuni, was not a factor in causing Mrs. Stitt’s GBS. 18 To support this argument, Respondent’s

18

Although Respondent presented C. jejuni as an alternative cause, Respondent presented this

evidence only to show that Petitioner had not satisfied her burden and not to show that there was

a sole, unrelated cause of Mrs. Stitt’s GBS. 42 U.S.C. § 300aa-11. Indeed, 42 U.S.C. § 300aa-

11 provides that entitlement is not appropriate where Respondent shows that another unrelated

factor was the sole reason for Mrs. Stitt’s GBS. Here, Respondent’s expert, Dr. Raabe,

acknowledged that he could not unequivocally say that C. jejuni was the cause of Mrs. Stitt’s

GBS. Tr. at 253. Rather, he testified that he could not say whether C. jejuni or something else

was responsible for Mrs. Stitt’s GBS, including the vaccine. Tr. at 253. Also, the results of the

one test for C. jejuni were negative. P’s Ex. 6 at 178. This evidence is insufficient for

Respondent to show by preponderant evidence that a factor unrelated to the vaccine was the sole

cause of Mrs. Stitt’s GBS. de Bazan, 539 F.3d at 1353-54.

15

expert, Dr. Raabe, relied on literature that showed that C. jejuni is strongly associated with GBS. Tr.

at 170. Dr. Raabe points to the upset stomach Mrs. Stitt experienced after her return from New York

and concluded that this was likely C. jejuni, which is responsible for GBS in about 30% of cases. Tr.

at 170-71; R’s Ex. A. The actual evidence does not support the existence of a C. jejuni infection.

Mrs. Stitt did not have the classic symptoms of C. jejuni: diarrhea, vomiting and nausea. Tr. at 97-

98; 99-100. As Dr. Morgan explained, if Mrs. Stitt had gastroenteritis that was caused by C. jejuni,

that would certainly not have been something Mrs. Stitt would have forgotten or referred to as a mere

stomach ache. Tr. at 114-19. And the fact is that the results of the objective diagnostic evidence

from her stool sample test for C. jejuni were negative. P’s Ex. 6 at 178.

To counter this evidence, Dr. Raabe presents literature that indicates that C. jejuni could still

be the cause of Mrs. Stitt’s GBS even if she did not have symptoms. R’s Ex. F. Dr. Raabe has never

treated a patient with C. jejuni, and he based his opinion entirely on his research of medical literature.

P’s Ex. E, and F. Given the lack of any classic symptoms and a negative test result, Respondent’s

argument that C. jejuni could be the cause of Mrs. Stitt’s GBS is weak.

This case presents a close call, especially with regard to Althen’s prong two. In reviewing the

record, to reach a decision, the undersigned must also weigh the persuasiveness of the testimony. To

do this, one of the factors to be considered is the relative expertise of the witnesses. Locane v. Sec’y

of Health & Human Servs., 685 F.3d 1375, 1380 (Fed. Cir. 2012) (holding that the special master

was not arbitrary or capricious in finding that one of the parties’ expert’s testimony was more

persuasive in light of different backgrounds and specialties and because the literature supports that

expert’s theory); see also Moberly, 592 F.3d at 1325 (special master must be able to assess the

reliability of the expert testimony).

Both parties’ experts were very well qualified and certainly demonstrated expertise in their

fields. But, in weighing their testimony, the undersigned gives greater weight to Dr. Morgan’s

testimony. Dr. Morgan is a clinician who has treated patients with GBS, including those that

suffered from GBS that appeared to have been caused by vaccines. Tr. at 37. His most recent

contact with a patient suffering from GBS was approximately two years ago. Tr. at 106-07. In his

testimony, he logically explained how Mrs. Stitt’s symptoms did not suggest a bacterial or viral

illness in that she did not exhibit the classic symptoms. Tr. at 53. He also explained how the test

results precluded bacterial and viral causes. Tr. at 53.

Dr. Raabe, who is also a qualified neurologist, did not appear to base his testimony on any

clinical experience. He testified that he was semi-retired, and that his prior area of specialty had been

electromyography. Tr. at 162-63. He has never testified in the Vaccine Program before. Id. He

became involved in this case when a doctor approached him. Tr. at 163. He agreed to serve as

an expert as he is interested in neurological diseases and this related to GBS. Tr. at 163.

Agreeing to act as an expert forced him to read the literature and to perform research regarding

the case. Tr. at 163-64. There was no indication that he had treated patients with GBS. He did

not have experience with diagnosing or treating patients with C. jejuni. Tr. at 174. He did not

articulate reliance on clinical work but instead relied nearly entirely on his review of medical

literature as a basis for his opinions. Tr. at 163.

At times, Dr. Raabe’s opinions appeared to be unsupported by the record or literature. For

instance, with regard to his opinion that Mrs. Stitt’s GBS was more likely due to her having C. jejuni,

in his original report Dr. Raabe stated he was relying in part on the fact that Mrs. Stitt was never

16

evaluated for C. jejuni. R’s Ex. A. But, contrary to this assertion, the medical records clearly

indicate that a test was done for C. jejuni, the results of which were negative. Tr. at 224-25,

referencing P’s Ex. 6 at 178. And, although he postulated that it was likely that Mrs. Stitt’s GBS was

caused by C. jejuni, he admitted that he did not know the symptoms of C. jejuni and had never

treated anyone for it. Tr. at 174. Even during his testimony, Dr. Raabe did not rule out the flu

vaccine as a potential cause. When asked about his conclusion regarding cause, he

acknowledged that he could not conclude whether the cause was C. jejuni or the flu vaccine or

something else. Tr. at 253.

In addition, in his initial report, Dr. Raabe opined that an appropriate post-vaccinal temporal

relationship was approximately 10-14 days and that he believed that 5-1/2 weeks made it less likely

to have caused Mrs. Stitt’s GBS. Tr. at 168; R’s Ex. A. But, during his testimony, Dr. Raabe

acknowledged that based on studies, the accepted standard time frame was six weeks. Tr. at 237.

In sum, Dr. Morgan had more experience with treating patients with GBS including those

where the cause was post-vaccinal. He also appeared to have more familiarity with the literature

regarding vaccines and GBS. Dr. Morgan’s testimony is given more weight.

As to whether there is sufficient evidence to establish a logical sequence of cause and

effect between Mrs. Stitt’s GBS and her death, the parties have stipulated that one of the causes

of Mrs. Stitt’s death was GBS. Stip. ¶¶ 16 & 17. The parties’ respective experts acknowledged

this although they had slightly different views as to the connection. Petitioner’s view was that

the flu vaccine was a substantial factor in causing Mrs. Stitt’s GBS and that that brought about

her death. Tr. at 66-67. Respondent’s view was that Mrs. Stitt’s GBS led to her hospitalization

and weakened condition and that the treatment she received, including intubation, caused her to

contract pneumonia which, in turn, led to her death. Tr. at 231. Under either view, Mrs. Stitt’s

GBS was a substantial factor in bringing about her death.

Based on the record as a whole and giving appropriate weight to the evidence, undersigned

finds that Petitioner has provided sufficient evidence and has satisfied Althen prong two. She has

proven that it is more likely than not that the vaccine was a substantial factor in causing Mrs. Stitt’s

GBS, which in turn was a substantial factor in bringing about her death.

C. Petitioner Has Shown That Mrs. Stitt’s GBS Occurred Within a Medically

Acceptable Time Frame, Thereby, Satisfying Althen’s Prong Three.

With regard to Althen’s prong three, there is little, if any, dispute that this prong is

satisfied. Dr. Morgan said that six weeks was generally accepted as a medically appropriate time

period for the onset of GBS after infection. P’s Ex. 14; Tr. at 124. Given Mrs. Stitt’s

hospitalization occurred on November 3, 2008, 5-1/2 weeks after her vaccination on September

25, 2008, the temporal relationship prong is satisfied. The literature submitted in the record

indicates that six weeks is the standard, accepted time frame. R’s Ex. E-1at 8. n.26; R’s Ex. E-3

at 4 (p. 646); R’s Ex. E-4 at 1; R’s Ex. C-3 at 3. Although Dr. Raabe initially said that the 5-1/2

week lapse between vaccination and Mrs. Stitt’s hospitalization made it unlikely to be the cause,

see R’s Ex. A, at the hearing, he acknowledged that the studies all use up to six weeks as the

accepted time period. Tr. at 221-23, 236. Petitioner has produced sufficient evidence to show

that Mrs. Stitt’s hospitalization, within 5-1/2 weeks of the vaccination, occurred within a

17

medically acceptable time frame, thereby satisfying Althen’s prong three.

VII. CONCLUSION

For the reasons stated above, the evidence presented demonstrates that the flu vaccine Mrs.

Stitt received was a substantial factor in causing Mrs. Stitt’s GBS. And, her GBS was a substantial

factor in causing her death. Petitioner has established entitlement to compensation under the

Vaccine Act. This matter shall now proceed to consideration of damages.

IT IS SO ORDERED.

/s/ Daria J. Zane

Daria J. Zane

Special Master

18