Bryan v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 14-898V

Filed: October 9, 2020

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*

THEODORE A. BRYAN, *

* TO BE PUBLISHED

Petitioner, *

*

v. * Special Master Katherine E. Oler

*

SECRETARY OF HEALTH AND *

HUMAN SERVICES, * Chronic Fatigue Syndrome (CFS);

* Influenza vaccine; Th2 immunity

Respondent. *

*

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Richard Gage, Richard Gage, P.C., Cheyenne, WY, for Petitioner

Camille Collett, U.S. Department of Justice, Washington, DC, for Respondent

RULING ON ENTITLEMENT1

Oler, Special Master:

On September 23, 2014, Theodore Bryan (“Mr. Bryan” or “Petitioner”) filed a petition for

compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10,

et seq.2 (the “Vaccine Act” or “Program”). The petition alleges that Mr. Bryan developed chronic

fatigue syndrome (“CFS”) as a result of the influenza (“flu”) vaccination he received on October

10, 2011. Amended Pet. at 1-2.

1

This Ruling will be posted on the United States Court of Federal Claims’ website, in accordance with the

E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Ruling will be available to anyone

with access to the internet. As provided in 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may

object to the Ruling’s inclusion of certain kinds of confidential information. To do so, each party may,

within 14 days, request redaction “of any information furnished by that party: (1) that is a trade secret or

commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or

similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine

Rule 18(b). Otherwise, this Ruling will be available to the public in its present form. Id.

2

National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease

of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa

(2012).

Upon review of the evidence in this case, I find that Petitioner has met his burden in

showing that the flu vaccination he received on October 11, 2011 caused him to develop CFS. He

is therefore entitled to compensation under the Vaccine Act.

I. Procedural History

Petitioner filed his petition on September 23, 2014 and filed an amended petition on

January 9, 2015. ECF Nos. 1, 15. On February 26, 2015, Respondent filed a Rule 4(c) Report

stating that compensation was not appropriate in this case and the petition should be dismissed.

Resp’t’s Rep. at 15., ECF No. 18.

Petitioner filed several affidavits on April 20 and 28, 2015. Exs. 21-24. On June 15, 2015,

Petitioner filed an updated medical report from his treating physician, Regina Smith, D.O. Ex. 27.

Dr. Smith filed a supplemental report on September 9, 2015 that answered additional questions

about Petitioner’s CFS diagnosis. Ex. 28.

On May 17, 2017, Petitioner filed an expert report from Dr. Susan Levine. Ex. 36, ECF

No. 78. On September 21, 2017, Respondent filed an expert report from Dr. Kenneth Fife, along

with his curriculum vitae. Exs. A, B, ECF No. 87. On July 9, 2018, Petitioner filed an expert

report from Dr. Charles Lapp. Ex. 52, ECF No. 97.

I held an entitlement hearing on January 9 and 10, 2019. See Minute Entry on 1/23/19. On

January 30, 2019, this case was referred to Special Master Dorsey for Alternative Dispute

Resolution (ADR). ECF No. 116. This case was removed from ADR on March 6, 2019. ECF

No. 121. Petitioner filed a post-hearing brief on August 13, 2019. ECF No. 124. Respondent

filed his post-hearing brief on December 18, 2019, and Petitioner filed a post-hearing brief reply

on February 18, 2020. ECF Nos. 127, 128. Petitioner filed Dr. Smith’s CV on September 23,

2020. Ex. 60, ECF 131. The parties have indicated that the record is complete. Accordingly, this

matter is ripe for adjudication.

II. Medical Records

A. Petitioner’s Health Prior to the Allegedly Causal Vaccination

Mr. Bryan had a history of depression, hyperlipidemia, and fatigue prior to vaccination.

Petitioner had numerous visits with his primary care physician (PCP), Dr. William Albright at

Pinnacle Health in 2009 regarding these health issues; the medical records are unclear as to the

precise onset of these symptoms.3

B. Petitioner’s Health after the Allegedly Causal Vaccination

3

With the medical records provided, Petitioner’s symptoms of depression, sleeping difficulties, and

concentration difficulties date back to July 2, 2009, the earliest medical record provided. Ex. 16 at 5.

Respondent does not assert that Petitioner had CFS prior to his vaccination. I agree and have not analyzed

this issue.

2

Petitioner was 42-years old when he presented to Dr. Albright at Pinnacle Health on

October 10, 2011. Ex. 2 at 2. Mr. Bryan had left and right elbow lateral epicondylitis release

procedures performed in 2011 and had a history of neck, back, and forearm pain. See id. at 25-28.

As of October 10, 2011, Petitioner was on the following medication: promethazine, sertraline,

Wellbutrin, simvastatin, Zithromax, zolpidem, AndroGel, and Abilify. Id. at 3.

Petitioner received the flu vaccine at his appointment with Dr. Albright on October 10,

2011. Ex. 2 at 3. On October 20, 2011, Petitioner returned to Dr. Albright with joint pain. Id. at

5. Dr. Albright prescribed Medrol and noted “medrol is helping most likely rxn to flue [sic]

injection.” Id. Petitioner returned to Dr. Albright on October 24, 2011 presenting with fatigue

and depression. Id. at 8. Dr. Albright noted that Petitioner “feels much better most likley [sic] a

reaction to the flue [sic] injection. abilify is working well at this point.” Id.

On November 14, 2011, Petitioner presented to Dr. Natalie Dubchek for a rheumatology

consultation. Ex. 3 at 1. Dr. Dubchek noted that Petitioner “was in a good general state of health

until October 12th of this year when he developed diffuse arthralgias and joint swelling two days

after he received his flu shot….. Also he noticed early onset fatigue.” Id. She also noted that “he

may have had a reaction to the flu vaccine that presented with arthralgias and now is greatly

improved. Another possibility could be underlying psoriatic arthritis with enthesitis with the onset

of his symptoms after the flu shot may be coincidental.” Id. at 2.

Petitioner returned to Dr. Dubchek on November 29, 2011. Ex. 3 at 3. The doctor noted

that “[h]e continues to experience the same symptoms of generalized fatigue, generalized pain,

now mostly localized to the lower legs, knees, and calves.” Id. Dr. Dubchek noted that Petitioner

denied worsening depression but continued to have significant trouble with insomnia. Id. at 4.

On December 5, 2011, Petitioner returned to Dr. Albright. The reason for this visit was

noted to be depression. Ex. 2 at 14. More specifically, Dr. Albright noted:

The patient presents with difficulty concentrating, fatigue and muscle weakness.

The fatigue is associated with generalized weakness. The patient denies any change

in appetite, chills, change in sleep cycle, constipation, diaphoresis, diarrhea,

dyspnea, flank pain, heartburn, hematemesis, hematochezia, hoarseness, increased

abdominal girth, jaundice, lightheadedness, loss of interest, malaise, melena,

myalgia, pallor, pruitus [sic] and weight gain; Additional information: saw

reumatologist [sic], most likley [sic] rxn to TVF [sic], had extensive work up.

Id. Petitioner was prescribed tryprednisone to treat his fatigue. Id. at 16.

Petitioner returned to Dr. Albright on December 19, 2011 for depression and fatigue. Id.

at 18. Under depression, Dr. Albright noted “still does not feel right? rxn to flue [sic] shot. ? rxn

to zocor.? ms saw rheumatologist. No dx.” Id. Petitioner was taken off Zocor and was directed to

follow up in two weeks. Id. at 19.

3

On January 5, 2012, Mr. Bryan returned to Dr. Albright. Ex. 2 at 21. Dr. Albright noted

that Petitioner’s depression and fatigue had not improved after stopping Zocor. Id. Dr. Albright

assessed Petitioner with chronic fatigue syndrome and referred him to a neurologist. Id. at 22.

On February 6, 2012, Petitioner saw Dr. Salim Qazizadeh at the Pennsylvania

Neurosurgery & Neuroscience Institute, Inc. (hereinafter “PNNI”). Ex. 4 at 13, 17. Petitioner

presented with memory loss. Id. at 13. Dr. Qazizadeh noted:

43-year old man who has been having a variety of complaints since October of last

year when he had a flu shot. These include difficulty focusing, unable to multitask,

blurriness of vision, extreme fatigue, muscle weakness, tremor, numbness, tingling,

cramps in the legs, joint pain, interrupted sleep, memory problems, low back pain,

stiffness, and vertigo. The patient also does have a history of depression and is

being treated for that. He has seen different physicians, including his primary care

physician as well as a rheumatologist. The thought is that probably it is a serum

sickness reaction to the flu shot that he had. Due to persistence of his symptoms he

is being referred to me for further evaluation and management.

Id. Dr. Qazizadeh ordered MRIs with and without contrast of Mr. Bryan’s brain, an EEG, a full-

night sleep study, and a wide assortment of lab tests. Id. Dr. Qazizadeh also noted that he is “not

sure if indeed his problems are neurological.” Id.

On March 8, 2012, Mr. Bryan returned to Dr. Qazizadeh for follow-up. Ex. 4 at 18. Dr.

Qazizadeh noted that Petitioner’s MRI and EEG were “unremarkable” and other lab tests were

also unremarkable, but his vitamin D level was low and that he should continue a multi-week

course of high-dose vitamin D. Id. The summary for the visit noted that “[t]he possibility of serum

sickness is being entertained.” Id. Petitioner’s wife stated they were interested in getting a second

opinion at Johns Hopkins and were encouraged to do so by Dr. Qazizadeh. Id.

On January 15, 2014, Petitioner saw Dr. Maria Michalek at Pinnacle Health Sleep Center

for a comprehensive polysomnography. Ex. 17 at 4. The results of the polysomnography state

that Petitioner was in bed for 428 minutes but slept 115 minutes, achieving a sleep efficiency of

26%. Id. Petitioner underwent another polysomnography on January 23, 2014. Id. at 6. The

results of the January 23, 2014 polysomnography show that Petitioner was in bed for 463 minutes

and asleep for 1824 minutes, achieving a sleep efficiency of 39%. Id. Petitioner returned on

February 3, 2014 for another comprehensive polysomnography, with a CPAP. Id. at 9. Petitioner

was in bed for 382 minutes, slept for 243 minutes and had a sleep efficiency of 67%. Id.

On May 1, 2014, Petitioner visited PA Amanda Renninger (under the supervision of Dr.

Stephen Ross, a neurologist) at the Penn State Hershey Medical Center. Ex. 7 at 1. The notes

from this visit summarize Petitioner’s clinical course after the flu shot: “He progressively got better

over a year, did not reach 100%, was able to function. Approximately 6-8 months ago, he began

to get progressively worse in his symptoms both mentally and physically. He suffers from chronic

fatigue and pain.” Id. The record notes that “[i]t is also possible that he may have had some

4

Exhibit 17 was scanned poorly and at times is illegible. The numbers of 463 and 182 are not clear.

4

neurologic episode from the flu shot…” Id. at 3.

On July 30, 2014, Petitioner began seeing Regina Smith, D.O. Ex. 17 at 20. In a letter

dated August 6, 2014, Dr. Smith wrote that she performed a physical exam and reviewed

Petitioner’s extensive medical records; she stated that it was her opinion Petitioner’s “medical and

cognitive issues are a direct result of the flu vaccination that he received on 10/11/2011.” Ex. 11.

On September 8, 2014, Dr. Smith saw Petitioner again and noted fatigue or malaise, as the

primary concern, but also muscle weakness, constipation, insomnia, memory loss, abnormality of

gait, depressive disorder, tremor, joint pain, and low testosterone. Ex. 14 at 2. Dr. Smith sent a

referral to Dr. Jon Vickery to analyze Mr. Bryan’s fatigue, muscle weakness, memory loss,

abnormality of gait, and tremors. Id. at 2-3.

On September 9, 2014, Petitioner saw Dr. Christopher Royer, Psy.D., for a

neuropsychological evaluation. Ex. 15 at 1. Dr. Royer’s impression was that Petitioner’s

symptoms were indicative of a mixed neurocognitive profile. Id. at 6. Dr. Royer summarized

Petitioner’s past diagnostic history as “serum sickness, sleep disorder, and depressive disorder,”

and further noted that “these problems are likely sufficient to account for the cognitive difficulties

seen here.” Id.

On January 9, 2015, Mr. Bryan saw Dr. Jon Vickery at Vickery Neurodiagnostics Group,

Ltd. Ex. 17 at 1. The medical records from this visit state:

46 year old male presents with c/o memory loss fatigue & cognitive troubles

“started 3 years ago after getting a flu shot.” Developed pain in R knee. In bed for

a week… with pain more or less everywhere. “Couldn’t move”. Then got better

& got back to work in his field of HVAC in ~ 2 weeks. Then, symptom

constellation gradually got worse again, states that in 2013 things went downhill

with pain all over.

Id. Dr. Vickery assessed Petitioner with cognitive deficits along with chronic fatigue syndrome,

REM sleep behavior disorder, and depressive disorder. Id. at 2. Dr. Vickery informed Petitioner

and his wife that he found no evidence of a neurological disease. Id. at 3.

Dr. Smith saw Petitioner again on June 15, 2015. Ex. 27 at 1. Dr. Smith noted chronic

fatigue syndrome along with anxiety, low back pain, myalgia and myositis, jaw pain, other

cerebellar ataxia, and motion sickness. Id. at 2.

III. Affidavits/Statements and Fact Testimony

A. Affidavits/Statements

1. Self-Written Statement of Theodore Bryan

Petitioner filed a self-written statement on November 11, 2014. Ex. 8. Petitioner provided

a personal history of his health, his relationship with his wife, and his hobbies prior to the allegedly

5

causal vaccination. Id. at 1. Following the vaccination, “Within a week [Petitioner]… was

basically paralyzed in bed for 4 days.” Id. at 2. He received a steroid prescription which enabled

him to walk, but he still experienced pain. Id. He required assistance performing everyday tasks

such as tying his shoes and getting dress for “approximately 16 weeks.” Id. Petitioner stated,

“things seemed to be a little better for about one year”. Id. After that, Petitioner’s symptoms

grew worse and included pain and a strange sensation in his feet and lower legs, weak legs, blurred

vision, feeling like he was going in slow motion, experiencing excessive fatigue after doing normal

activities, a tremor while doing simple but intricate tasks he could previously do, red/green/brown

color blindness, irritability, short temperedness, and anger. Id. Petitioner’s boss noticed some of

these symptoms. Id. at 3. Petitioner began using a CPAP machine which reduced his movement

during sleep but did not help his sleep quality or reduce his fatigue upon waking. Id.

2. Affidavit of Jackie Bryan

Jackie Bryan, Petitioner’s wife, signed her affidavit on April 16, 2015. Ex. 20. Ms. Bryan

stated her husband was an active person prior to the October 2011 vaccination and that he was an

avid hunter, fisherman, outdoorsman, and golfer. Id. at 1. Ms. Bryan also stated that Petitioner

loved his job as a plumber and HVAC technician and was in the process of remodeling their home

after work as well. Id. at 1-2.

After the vaccination, Ms. Bryan stated her husband developed excessive fatigue and

sometimes slept for 36 hours straight and as a result began to miss work because of the extreme

fatigue and pain. Ex. 20 at 2. Ms. Bryan noticed that Petitioner’s symptoms included body pain,

joint pain, weak legs, memory loss, blurry vision, migraine headaches, dizziness, loss of balance,

numbness/clumsiness in both hands and feet, abnormal gait, agitation, irritation, anxiety, and lack

of sexual interest and romance. Id. at 3.

Ms. Bryan added Petitioner’s quality of life was greatly diminished. Ex. 20 at 4. Petitioner

has gained weight, cannot lift objects over 20-25 pounds, and cannot drive long distances. Id.

3. Affidavit of Doug Vaughan

Doug Vaughan, Petitioner’s co-worker, signed his affidavit on April 20, 2015. Ex. 21. Mr.

Vaughan worked with Petitioner for several years. Id. at 1. Both Mr. Vaughan and Petitioner were

responsible for a 15-story office business and a separate 12-story garage, where Petitioner

performed plumbing, electrical, and general building maintenance work. Id. Mr. Vaughan stated,

“Ted got sick at some point. He was unable to do a fraction of the things he did before and his

rate of decline was pretty fast.” Id. Mr. Vaughan also indicated that Petitioner’s decline was

noticed by building tenants. Id. By the end of his work tenure, Mr. Vaughan stated that “Ted

could not do much at all.” Id.

4. Affidavit of Bruce Kageorge

Bruce Kageorge, Petitioner’s employer, signed his affidavit on April 16, 2015. Ex. 22.

Mr. Kageorge has known Petitioner since June 2008 and found Petitioner to be a dependable and

dedicated employee. Id. at 1. Petitioner received positive performance reviews and interacted

6

well with co-workers, contractors, and tenants. Id. Mr. Kageorge and Petitioner were partners in

a weekly golf league and became good friends. Id.

After the October 2011 vaccination, Mr. Kageorge stated that Petitioner “was out for over

a week immediately following the vaccine due to the paralyzing effect it had on him.” Ex. 22 at

2. According to Mr. Kageorge, when Mr. Bryan returned to work, he had many issues doing

anything physical, including walking, standing, or kneeling. Id. In 2013, Mr. Kageorge noticed

that Mr. Bryan’s pain and discomfort was “getting worse on a more regular basis along with very

noticeable neurological difficulties like trouble remembering things, stressing out and getting very

emotional over the smallest of things.” Id. Petitioner had tremors that made him unable to handle

a drill and balance issues that made him unable to safely climb a ladder. Id. Petitioner also suffered

from muscle weakness and cramps that hindered his ability to do his job. Id. Because of the

physical nature of his job, Petitioner would need additional sleep to recover and would miss at

least two days of work a week. Id.

5. Affidavit of Dennis Corbett

Dennis Corbett, a friend of Petitioner, signed his affidavit on April 17, 2015. Ex. 23. Mr.

Corbett has known Petitioner since May 2012 through social activities and regular golf outings.

Id. at 1. Mr. Corbett noticed shaking in Petitioner’s leg while he was sitting for breakfast and/or

lunch. Id. Mr. Corbett stated that eventually, Petitioner’s leg tremors would shake the table they

shared for meals. Id. According to Mr. Corbett, Petitioner stopped golfing because he could not

handle the physicality. Id. Mr. Corbett noticed that Petitioner’s speech was slower and that he

would depend on Ms. Bryan to “fill in some of his thoughts.” Id. Mr. Corbett stated that

Petitioner’s personality and mood would fluctuate based on how he was doing physically. Id.

6. Affidavit of Cortney Hartnett

Cortney Hartnett, Petitioner’s neighbor, signed her affidavit on April 20, 2015. Ex. 24.

Ms. Hartnett has known Petitioner since 2008. Id. at 1. Ms. Hartnett noticed that Petitioner “has

been struck down by severe illness over the last two years… and his health has declined

significantly.” Id. Ms. Harnett stated Petitioner “was a thriving, busy, hardworking, golfing,

fishing kind of a man” when she first met him but is now unproductive, homebound, and in pain.

Id. Ms. Hartnett has observed a drastic physical change in Petitioner and stated that his illness has

taken a heavy toll on him and his family. Id.

B. Fact Testimony

Petitioner Theodore Bryan, Mr. Dennis Corbett, Mr. Bruce Kageorge, Ms. Jackie Bryan,

and Mr. David Timme testified as fact witnesses at the January 9 and 10, 2019 entitlement hearing.

1. Petitioner Theodore Bryan

Petitioner provided a history of his work prior to the 2011 vaccination. Tr. at 6-14.

Petitioner also stated he led a very active lifestyle, participating in competitive bass fishing, golf,

volleyball, and roller hockey. He testified that he also was an active runner until 2000. Id. at 14.

7

Petitioner addressed his history of depression. Id. at 16-17. He stated that he had received the

diagnosis when he was around 22 or 23 and started taking Prozac but stopped treatment when he

began feeling better. Id. at 17.

Prior to the October 2011 vaccination, Petitioner suffered from fatigue due to the physical

nature of his work but “never missed working because of it” and certainly “didn’t miss [any of his]

hobbies because of it.” Tr. at 18. In comparison to his current symptoms, Petitioner stated, “it

seems almost laughable that I called that fatigue.” Id. Prior to 2011, Petitioner stated that his

fatigue would be cured when he had a good night sleep or slept in. Id.

Regarding the October 2011 vaccination, Petitioner testified that he experienced knee pain

two days after vaccination, along with swollen and stiff knees three days after vaccination. Tr. at

24. He described that “[o]n the fourth day I couldn't move. I couldn't get out of bed. And all my

-- I was like a board. My joints -- my hands were double the size, my legs were double the size.

All my joints were just kind of like locked in place.” Id. Petitioner said his doctor gave him

Medrol, a steroid, to treat his symptoms. Id. at 24-25. Petitioner also remembered that Dr. Albright

said it “was most likely something called serum sickness.” Id. at 25. During this time, Petitioner

needed help going to the bathroom and tying his shoelaces and was still experiencing pain. Id. at

26. Petitioner took time off work; when he returned, he performed light duties, which included

paperwork and phones calls. Id. at 28, 31.

Two months post-vaccination, Petitioner’s swelling had largely dissipated but he still

experienced pain from the hips down and numbness in his feet, particularly his left foot. Tr. at 30.

Petitioner testified that he sometimes experienced pain that felt like sharp jabs along with

cramping. Id. at 31.

Four months post-vaccination, Petitioner testified that he saw Dr. Qazizadeh, a neurologist.

Tr. at 34. It was then that Petitioner’s vitamin D deficiency was discovered and thought to have

been the cause of his fatigue. Id. at 33. Petitioner began seeing Dr. Smith because he believed Dr.

Albright was unable to answer questions that were not specific to the appointment purpose. Id. at

82.

2. Dennis Corbett

Mr. Corbett met Petitioner through Mr. Corbett’s brother in 2012. Tr. at 144. Mr. Corbett

and Petitioner played golf almost weekly. Id. at 144, 146-47. Mr. Corbett also shared meals with

Petitioner and Ms. Bryan on a near weekly basis in 2012. Id. at 148. Mr. Corbett testified that he

began noticing Petitioner’s leg shaking in early 2013 during meals. The leg shaking increased to

the point that silverware would rattle on the table. Id. at 149. Mr. Corbett testified that he does

not remember Petitioner golfing with him after July 2013 because Petitioner did not have the

energy to complete a hole. Id. at 152. In the years since he stopped golfing, Mr. Corbett noticed

that Petitioner started to walk slower, he had much less energy, he needed assistance walking up

and down stairs, he had issues speaking, and he had lost a noticeable amount of weight. Id. at 154-

55.

3. Bruce Kageorge

8

Mr. Kageorge hired Petitioner in 2008 for Penn National Insurance. Tr. at 161-62.

Petitioner was a licensed plumber with a certification for HVAC. Id. at 162. Mr. Kageorge

testified that Petitioner was well-liked by the building’s customers and did his job well. Id. at 165.

Petitioner was very dependable and would sometimes travel with Mr. Kageorge to other sites

managed by Penn National to assist him. Id. at 163. Mr. Kageorge stated that their occupation

was extremely physical and involved different types of work, not just plumbing. Id. at 166-67.

Mr. Kageorge also formed a friendship with Petitioner outside of work that included playing golf

together. Id. at 168. Mr. Kageorge testified that Petitioner had no issues with playing 36 holes of

golf on their golf trips prior to the vaccination. Id.

Mr. Kageoge testified that he received a call from Petitioner or Ms. Bryan in October 2011

saying Petitioner had “blown up” and he could not bend his arms and legs and was experiencing

pain. Tr. at 169. Petitioner returned to work performing light duties and eventually resumed his

full duties, however, not at full speed. Id. at 170. Mr. Kageorge stated it was noticeable that

Petitioner did not have the same stamina as prior to the vaccination because he would be exhausted

at the end of the day. Id. at 170, 172. Eventually, Petitioner’s tremors became progressively worse

and he also experienced memory issues. Id. at 170. Mr. Kageorge made accommodations for

Petitioner; for example, he allowed Petitioner to take naps and gave him lighter duties, but these

accommodations did not solve the underlying problem. Id. at 173. Mr. Kageorge testified that

Petitioner finally left his position in 2014 because he would often have to miss three to four days

of work a week. Id. at 171-72.

4. Jackie Bryan

Ms. Bryan has been married to Petitioner for 24 years. Tr. at 182. Ms. Bryan testified that

Petitioner received his plumbing license through a union apprenticeship program and had worked

as a plumber for multiple years prior to his position with Penn National. Id. at 183-84. He enjoyed

his work immensely. Id. at 184. Ms. Bryan also testified that before the vaccination, Petitioner

began renovation projects in their home and would work on them on the weekdays after dinner.

Id. at 185.

Ms. Bryan testified that Petitioner had swelling for over two weeks after the October 2011

vaccination. Tr. at 189. Petitioner would need her assistance getting dressed because he was

unable to move. Id. Petitioner was also unable to work eight to ten hours days at Penn National

and could not work on the renovation projects in their home, as he did prior to vaccination. Id. at

190. Ms. Bryan observed that when Petitioner spoke, he would often pause and lose his train of

thought. Id.

Ms. Bryan testified that Petitioner was a competitive fisher and golfer prior to the October

2011 vaccination. Tr. at 186, 192. Petitioner was unable to compete or participate in his hobbies

post-vaccination. Id. at 192. Petitioner now naps every day and can still sleep for 36 hours straight.

Id. at 195. He is unable to see his children and grandchildren due to his inability to drive long

distances. He does not have the same quality of life that he once did. Id.

5. David Timme

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Mr. Timme has worked as a physician assistant for over 25 years. Tr. at 320. Petitioner

began seeing Mr. Timme in 1993 for depression. Id. at 322. He treated Petitioner for a number of

years, stopped for a few years, and then resumed seeing Petitioner again in 2012. Id. at 322-23.

The practice where Mr. Timme originally saw Petitioner in 1993 has since closed and no medical

records of Mr. Timme’s treatment of Petitioner prior to 2012 exist. Id. at 321, 324. Mr. Timme

testified that he saw Petitioner for depression and provided him with medication to treat the

depression. Id. at 324-25. When Mr. Timme saw Petitioner again in 2012, he noticed a very

different man than the person he had come to know. He described the difficulty Petitioner

experienced just trying to get out of his car to come into the office. Petitioner needed help from

Ms. Bryan, and then used a walker to enter the building. Id. at 326-27. This was markedly different

from the man he knew previously, who was an avid golfer and fisherman. Id. at 325.

IV. Expert Opinions

A. Dr. Charles Lapp

Petitioner filed one expert report from Dr. Charles Lapp. See Expert Report, filed as Ex.

52 (hereinafter “Lapp Rep.”). Dr. Lapp also testified at hearing.

1. Qualifications

Dr. Lapp received his medical degree from Albany Medical College in 1974. Ex. 53 at 1

(hereinafter “Lapp Brief Resumé”); Ex. 54 at 1 (hereinafter “Lapp CV”). Dr. Lapp completed two

residencies in internal medicine and pediatrics at the North Carolina Memorial Hospital and began

his practice in internal medicine and pediatrics in 1978. Lapp Brief Resumé at 1; Lapp CV at 1.

Dr. Lapp is board certified in internal medicine, pediatrics, and independent medical examination.

Lapp CV at 1. Dr. Lapp has also conducted clinical research for companies including (but not

limited to) Pfizer, Eli Lilly, Cephalon, and Hemispherx Biopharma. Id. at 2.

Dr. Lapp began his work in CFS in 1983 when there was what he described as “an epidemic

of chronic fatigue syndrome” in Raleigh, North Carolina, where he started his medical practice.

Tr. at 220-21. He contacted the CDC around 1985 to report the epidemic. Id. at 222. After this

initial work, Dr. Lapp continued his involvement with CFS, as a consultant/medical advisor for

CFIDS (Chronic Fatigue Immune Dysfunction Syndrome) Association from 1992-2013, which

published what is known as the CDC criteria or the International Case Definition Criteria for

chronic fatigue syndrome. Id. at 224, 235. From 2003-2007, Dr. Lapp developed a training

program to teach other medical professionals about the diagnosis and medical treatment of CFS

patients. Id. at 235-36. That transitioned to webinars in 2008. Id. at 236.

Dr. Lapp also worked and performed research for a pharmaceutical company, Hemispheryx

Biopharma, from 1988, which identified Ampligen as an effective treatment of CFS. Tr. at 237.

He is one of two medical providers allowed to administer the drug in the United States. Id. at 237-

38. Over the years, Dr. Lapp has published approximately 35 papers about CFS. Id. at 238; see

also Lapp CV at 3-5. Dr. Lapp was also involved with the more recently developed IOM criteria.

Tr. at 226.

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Dr. Lapp treats CFS patients from all 50 states and 20 foreign countries. Tr. at 242. He

has treated approximately 28,000 CFS patients during the course of his career. Id. at 447. Dr.

Lapp has spoken in foreign countries about CFS and was contracted by the Norwegian government

to help set up a treatment clinic in Oslo when a burst water line caused a Giardia outbreak, which

in turn led to over 300 people developing CFS. Id. at 242-43. Dr. Lapp is currently the Director

of the Hunter-Hopkins Center, which specializes in treatment of CFS, FM, and other related

disorders. Lapp CV at 1. I recognized Dr. Lapp as a medical expert with special expertise in CFS.

Tr. at 238.

2. Dr. Lapp’s Opinion

In Dr. Lapp’s report, he summarized Petitioner’s symptoms and opined that Petitioner met

the 1994 CDC Case Definition of CFS. Lapp Rep. at 2. Regarding causation, Dr. Lapp stated that

the physiologic cause of CFS has never been determined but the disorder “is frequently triggered

by infections and various adverse reactions, including vaccinations.” Id.

3. Dr. Lapp’s Expert Testimony

a. History and Development of CFS Diagnostic Criteria

Dr. Lapp testified regarding his involvement with the Fukuda paper and the IOM criteria.

Tr. at 222-32. With respect to the differences between the Fukuda and IOM criteria, Dr. Lapp

testified that the Fukuda paper was targeted for broad additional research on CFS thus “[w]e

wanted to find the patients that were most alike … for the purposes of research.” Id. at 239.

Regarding the IOM criteria, Dr. Lapp opined it was “developed more for the clinician, the provider,

and they were not for research purposes. They were made to be simple to follow.” Id. at 240.

Dr. Lapp used the Fukuda criteria in analyzing Petitioner’s symptoms because they were

the only criteria available when Petitioner fell ill and Medicare uses it to assess Social Security

determinations. Dr. Lapp testified that he believes Petitioner satisfies the IOM criteria as well. Tr.

at 241-42.

Dr. Lapp testified that there is not one well-defined cause of CFS and there are many

proposed theories of pathophysiology. Tr. at 244. Dr. Lapp testified that 85% of CFS cases have

sudden onset and within those cases, 75% are attributed to bacterial or viral infections. Id.

Remaining triggers include trauma in childbirth, allergic reaction, stress, and immunizations. Id.

at 244-45.

Dr. Lapp testified about the Kerr paper and that it demonstrates that patients with CFS have

a Th2 profile. Tr. at 245. The Th2 profile involves the increased secretion of interleukin-6 (“IL-

6”) and interleukin-4 (“IL-4”) by T lymphocytes. Id. at 245-46. The Th2 profile also involves

elevated interferon-gamma, decreased IgG and TGF-beta. Id. at 246.

Dr. Lapp discussed how CFS is diagnosed. Tr. at 249. He stated that CFS cannot be

diagnosed through a single blood test, urine test, or x-ray but is diagnosed through symptomology.

11

See id. at 249-50. However, certain tests can be used to eliminate other possible diseases and help

confirm CFS.

In discussing how the flu vaccine can cause CFS, Dr. Lapp testified about a paper from Dr.

Brenu at Griffith University (filed as Ex. 59) which involved a small sample size of CFS patients

who received the flu vaccine. Id. at 253. Based on the observed cytokine response discussed in

the paper, Dr. Lapp testified that the CFS patients had a proclivity toward Th2 immunity after they

received the flu vaccine. Id. at 253-54.

b. General Observations regarding Patients with CFS

Dr. Lapp testified that he has seen many patients with CFS who present after the flu as well

as two or three cases where the flu vaccine was the trigger. Tr. at 256-57. According to Dr. Lapp,

the Hepatitis B vaccine is a more common trigger. Id. at 257. Dr. Lapp also opined that CFS

presents abruptly, “like a flu-like illness or a mono-like illness or some sort of an illness and then

the symptoms develop over time.” Id. at 280. CFS symptoms can “change from hour to hour, day

to day, week to week, and month to month,” and it was Dr. Lapp’s personal opinion that symptoms

come in cycles and a relapse or flare is when all of the symptoms occur at the same time. Id. at

281.

Dr. Lapp testified that Petitioner’s sleeping issues prior to vaccination were later diagnosed

as obstructive sleep apnea, for which he was given a CPAP machine. Tr. at 258. Petitioner’s non-

restorative sleep issues were not cured by the CPAP machine, which is further evidence that his

prior sleep issues were not related to CFS. Id. at 258-59. Furthermore, Petitioner’s pre-vaccination

medical records identify that his sleeping issues include “trouble falling asleep and staying asleep,”

which is not the unrefreshing sleep that is seen in CFS patients. Id. at 260. Dr. Lapp defined the

fatigue seen in CFS patients as “exertional intolerance with post exertional malaise.” Id. at 261.

Dr. Lapp then opined that Petitioner’s long-lasting depression could not have caused his CFS

because “the only depression that could plausibly explain symptoms severe enough would be a

psychotic depression, that is out of touch with reality.” Id. at 265-66. Petitioner never showed

signs of this. Id. at 266.

c. Symptomology and Progression of CFS

Dr. Lapp testified that the joint pain Petitioner experienced two days after vaccination was

a result of an immune reaction to the influenza vaccine. See Tr. at 268-69. According to Dr. Lapp,

Dr. Dubchek noted that Petitioner had “early onset fatigue” at the same time he was experiencing

joint pain. Id. at 272. Based on those medical records, Dr. Lapp testified the flu vaccination was

the triggering event for Petitioner’s CFS, and that onset took place two days later. Id. Dr. Lapp

stated that Dr. Albright’s observations of muscle weakness in December 2011 were also consistent

with the progression of CFS. Id. at 278. Dr. Lapp testified that Dr. Albright’s notes of difficulty

focusing, inability to multitask, vision blurriness, joint pain, stiffness, and vertigo four months

post-vaccination, is also consistent with CFS. Id. at 289.

According to Dr. Lapp, Petitioner’s improvement from 2012-2013 is also consistent with

CFS. Tr. at 292-93. With regards to CFS progression, Dr. Lapp testified it is typical for there to

12

be good periods and bad periods and there is no way to predict when they will occur. Id. at 293.

However, Dr. Lapp added, “The only thing you can say about the bad periods is that they can be

brought on by exertion, by stress, by illness. Those are probably the major things that can bring on

a bad period, and those can be very prolonged as a matter of fact.” Id. at 294. Dr. Lapp testified

that about 40 percent of CFS patients report modest improvement over time and fewer than 5%

recover. Id. at 295.

Treatment for CFS involves treating the symptoms and more importantly, learning to pace

oneself and set limits. Id. at 296. Regarding Petitioner’s case specifically, Dr. Lapp observed ,

I think what I saw in Ted yesterday was typical of the patients that we see and that

is they go through a chaotic period for the first couple of years where they push

very hard. They go to multiple doctors trying to find a solution to this problem…

they’ve learned from the past that if they push, things are going to get better; if they

try harder things are going to try to get better and unfortunately, it works adversely.

Id. at 296-97.

In 2014, Petitioner’s symptoms began worsening again. Dr. Lapp opined that Dr.

Albright’s notes of “arthralgia, back pain, difficulty concentrating, fatigue, headache, muscle

weakness, somnolence, and weight loss” are consistent with CFS. Tr. at 308-09. Petitioner’s

neuropsychological evaluation by Dr. Royer was also consistent with CFS. Id. at 310. More

specifically, Dr. Royer’s notes of impairments in motor speed and coordination, cognitive

flexibility (the ability to multitask), and processing speed are symptoms of CFS. Id. at 311.

d. Serum Sickness

Dr. Lapp also addressed the multiple references to serum sickness in Petitioner’s medical

records. Dr. Lapp defined serum sickness as,

basically an allergic reaction to an injection…. It’s an IgE reaction that will last as

long… as the offending agent is in the body, and the body attempts to clear that

reaction, and the reaction will cause the kind of symptoms that we have seen here.

In the case of an injection like this, it’s usually characterized by swelling, a reaction

that goes to the joints. So you get joint swelling and pain and overall edema, which

is fluid building up in the body, can cause feverishness and a number of different

systemic symptoms that … usually last days to a couple weeks.

Tr. at 288-89. Regarding the possibility that serum sickness could last multiple months, Dr. Lapp

testified, “It’s not likely. Not from what I’ve seen in my personal experience…. It seems the body

should have cleared it by then.” Id. at 289-90.

e. Sleep Studies

Dr. Lapp opined that Petitioner’s first sleep study was likely the result of the “first night

effect,” where the new bed, environment, and discomfort from the attached wiring probably caused

13

Petitioner’s lack of sleep. Tr. at 301. In Dr. Lapp’s opinion, the second and third sleep studies

were a better reflection of Petitioner’s sleep issues. Id. Dr. Lapp pointed out that in the second

and third sleep studies Petitioner had difficulty reaching REM sleep and had a low sleep efficiency.

These features are consistent with patients suffering from CFS. Id. at 302-03.

f. Lyme Disease

Dr. Lapp testified that Petitioner did not have Lyme disease. See Tr. at 314. Petitioner

tested negative numerous times for Lyme disease and had no history of a tick bite or rash. Id. at

314-15. Furthermore, Dr. Smith attempted to treat Petitioner for Lyme disease to no avail. Id. at

317-18.

g. Dr. Lapp’s Causation Theory

Dr. Lapp’s theory of causation is summarized as follows: “[Petitioner] had an allergic

reaction to [the] vaccine and that allergic reaction stirred up the immune system, which in this

particular case, because he’s susceptible, has turned his immune system toward a Th2 immune

response, which is typical of chronic fatigue syndrome.” Tr. at 434. Dr. Lapp elaborated stating,

when a foreign substance gets into the body, it stimulates macrophages and it

stimulates the immune system and sets off alarms which are – they’re cytokines,

the alarms that get set off. And that stimulates lymphocytes to – it stimulates the

lymphocytes to generate more cytokines and that drives the immune system in to a

Th2 type pattern. . . . And it’s totally conceivable that something like that happened

in this case and drove Ted’s body toward a Th2 response, which is typical of chronic

fatigue syndrome. And in chronic fatigue syndrome what happens in susceptible

individuals is that that response is not shut off. NK cells, which are supposed to

shut off part of the reaction, don’t work properly and suppressor cells, which are

supposed to shut off the reaction, don’t work properly. And so you get a perpetual,

abnormal, activated immune system.

Id. at 435-36.

Dr. Lapp testified that a 48-hour onset was an appropriate window of time for the onset of

symptoms after flu vaccine. Tr. at 440.

B. Dr. Susan Levine

Petitioner filed one expert report from Dr. Levine. See Expert Report, filed as Ex. 36

(hereinafter “Levine Rep.”). Dr. Levine did not testify at the entitlement hearing.

1. Qualifications

Dr. Levine received her medical degree from Albert Einstein College of Medicine in 1981.

Ex. 37 at 1 (hereinafter “Levine CV”). Dr. Levine is board certified in internal medicine and

infectious diseases. Id. Dr. Levine serves as the Chairman of the U.S. Chronic Fatigue Syndrome

14

Advisory Committee, Principal Investigator at the Chronic Fatigue Initiative, Co-Medical Director

of the New Jersey Chronic Fatigue Syndrome Association, Inc., and was a former member of the

Name Change Working Group of the U.S. Chronic Fatigue Syndrome Coordinating Committee.

Id. at 1-2. Dr. Levine has published over 40 articles regarding CFS. See id. at 2-7.

2. Expert Opinion

Dr. Levine noted that the following symptoms reported by Petitioner are consistent with

CFS: knee, wrist and back pain; thigh spasms and stiffness; severe fatigue; weight loss of nine

pounds; ringing in his ears; irregular heart beat; getting up at night to pass urine; headaches;

dizziness; night sweats; anxiety; depression and difficulty falling asleep. Levine Rep. at 2.

As a proposed mechanism for how Petitioner developed CFS from the flu vaccine, Dr.

Levine stated it has been established that vaccines have led to the development of Gulf War

Syndrome, another fatiguing illness, “and likely reflects a shift in the immune response towards a

TH2 profile.” Levine Rep. at 2. In patients who meet the clinical criteria for CFS, levels of

cytokine activity are linked to the severity of CFS and “[s]hifts in cytokine levels lead to alterations

in the cardiovascular and cognitive systems. Id. at 2-3. Dr. Levine stated:

the onset of [Petitioner’s] arthralgias two days following receipt of influenza

vaccine, is one consequence of the overproduction of pro-inflammatory cytokines

in response to a foreign antigen. The persistence over time (over a three year period

following the administration of the influenza vaccine) of this patient’s arthralgias,

sleep disturbances, cognitive issues and dizziness reflects a permanent shift in the

immune milieu...

Id. at 3.

Dr. Levine further posited that the pathogenesis of CFS could be a result of the “kindling

theory,” which is the theory that “repeated exposure to an initially sub-threshold stimulus can

eventually exceed threshold limits, resulting in persistent hypersensitivity to the stimulus and

ultimately, full blown illness.” Levine Rep. at 2. Dr. Levine stated that Petitioner suffered from

psoriasis, an autoimmune disorder, and following vaccination, a release of IL-1 beta occurred

“which led to an alteration in the electrical activity of his brain, resulting in permanent cognitive

dysfunction.” Id.

Live viruses, such as the Epstein Barr virus and herpesviruses, contain genomic sequences

that can influence the secretion of adenocorticotrophic hormone (“ACTH”) in the brain. Levine

Rep. at 2. This immune response interacts with the hypothalamic pituitary axis (“HPA”), which

results in lower cortisol levels, which is observed in patients with profound fatigue, insomnia,

adverse responses to stress and sensitivity to noise and light in CFS patients. Id.

Dr. Levine additionally stated that Petitioner’s symptoms of blurred vision and irregular

heartbeat are consistent with autonomic dysfunction. Levine Rep. at 3. To explain these

symptoms, Dr. Levine noted that 71 patients who were administered a routine flu vaccine

displayed a reduction in heart rate variability, and CFS patients with disrupted sleep have also been

15

shown to have reduced heart rate variability. Id. Alternatively, Petitioner’s autonomic dysfunction

symptoms of palpitations and dizziness might be related to pain or analgesia. Id. at 3. Dr. Levine

concluded that because Petitioner suffered symptoms of arthralgia two days after his October 10,

2011 vaccination and suffered numerous symptoms consistent with CFS, it is her opinion “to a

reasonable degree of medical certainly [sic] that the flu vaccine was the cause of Mr. Bryan’s

subsequent Chronic Fatigue Syndrome.” Id.

C. Dr. Marcel Kinsbourne

Petitioner filed one expert report from Dr. Kinsbourne. See Expert Report, filed as Ex. 34,5

(hereinafter “Kinsbourne Rep.”). Dr. Kinsbourne did not testify at the entitlement hearing.

1. Qualifications

Dr. Kinsbourne received his medical degree from Oxford University in 1955. Ex. 32 at 1

(hereinafter “Kinsbourne CV”). Dr. Kinsbourne did post-doctoral training in neurology and

pediatrics and is Board Certified in Pediatrics. Kinsbourne CV at 1. Dr. Kinsbourne has had a

number of hospital and academic appointments but has been a research professor at the Center for

Cognitive Studies at Tufts University since 1992 and a Professor of Psychology at New School

University since 1995. Id. at 2. Dr. Kinsbourne serves on numerous editorial boards, including

Brain Research, Cognitive Neuropsychiatry, Journal of Psycholinguistic Research, and many

others. Id. at 3. Dr. Kinsbourne has published over 400 articles regarding pediatrics and

psychology. See id. at 5-32.

2. Expert Opinion

After review of Petitioner’s medical records, Dr. Kinsbourne states that although Petitioner

was never diagnosed with chronic fatigue syndrome, he fits the diagnostic criteria provided by the

CDC. Kinsbourne Rep. at 3. The CDC criteria includes:

Clinically evaluated, unexplained, persistent or relapsing chronic fatigue that is *

of new or definite onset (has not been lifelong), * is not the result of ongoing

exertion * is not substantially alleviated by rest and * results in substantial reduction

in previous levels of occupational, educational, social or personal activities.

Id. The CDC also requires four or more of the following symptoms to have persisted or recurred

for six or more months and predated the fatigue:

1. Self-reported impairment in short-term memory or concentration severe enough

to cause substantial reduction in previous levels of occupational, education, social

or personal activities

2. Sore throat

5

This expert report was originally filed as Ex. 31 however, Petitioner discovered a typographical error and

moved to strike the report (ECF No. 68). Special Master Hastings denied the motion and instructed

Petitioner to re-file the report with a new exhibit number (ECF No. 69).

16

3. Tender cervical or axillary lymph nodes

4. Muscle pain

5. Multi-joint pain without joint swelling or redness

6. Headaches of a new type, pattern or severity

7. Unrefreshing sleep

8. Post-exertional malaise lasting more than 24 hours

Id. Dr. Kinsbourne cited medical records in which he identified what he believed were

manifestations of the above-mentioned symptoms. See id. at 3-4. Dr. Kinsbourne stated that

despite Petitioner’s attempts to find a diagnosis for his condition, “no one else has diagnosed him

with CFS,6 or any other underlying systemic illness. Nor have providers accepted that his fatigue

is an adverse effect of the influenza vaccination.”7 Id. at 4. Dr. Kinsbourne further indicated that

he cannot propose a “brain-based mechanism of injury.” Id. at 5.

D. Dr. Regina Smith

Regina Smith, D.O., provided testimony regarding Petitioner’s medical treatment since

2014. Tr. at 44. Dr. Smith received a degree in osteopathic medicine (D.O.) from Ohio University,

College of Osteopathic Medicine. Id. at 40. She completed a residency in internal medicine at St.

Joseph’s Hospital and is board certified in internal medicine. Id. I recognized Dr. Smith as an

expert in internal medicine. See id. at 43-44.

Dr. Smith began treating Petitioner in July 2014; her treatment continued as of the day of

trial. Tr. at 45, 47. It was her medical opinion that Petitioner suffers from CFS. Id. Petitioner

presented to Dr. Smith in July 2014 with fatigue, sleep disorder, cognitive trouble, and pain. Id.

at 47. Dr. Smith opined that Petitioner met the Institute of Medicine’s diagnostic criteria for CFS.

Id. at 48. Based on his history of symptoms and how they progressed, Dr. Smith testified the flu

vaccine was the triggering event “because prior to the flu shot he was not having difficulties with

any of these symptoms on a severity level that he has after the flu shot.” Id. at 67. Regarding how

the flu vaccine could cause CFS, Dr. Smith stated, “The influenza vaccine can definitely trigger

the immune system which can, in a predisposed individual, can lead to this condition.” Id. at 68.

Dr. Smith added,

6

This is incorrect. On January 5, 2012, Dr. Albright assessed Petitioner with chronic fatigue syndrome.

See Ex. 2 at 22. Dr. Vickery also assessed him with chronic fatigue syndrome on January 9, 2015. See Ex.

17 at 2.

7

This is also incorrect. In a letter dated August 6, 2014, Dr. Smith wrote that it was her opinion Petitioner’s

“medical and cognitive issues are a direct result of the flu vaccination that he received on 10/11/2011.” Ex.

11.

17

when someone has an immune activation of some sort from a flu shot or an

infection, it can trigger an underlying condition or trigger a new syndrome which

can cause chronic fatigue syndrome. So with the timing of the event and the

severity of Ted’s symptoms after the flu shot, it would appear that that was when

his chronic fatigue symptoms really began. So by looking at that as the time when

things went downhill, the most likely etiology was the flu vaccination.

Id. at 69-70.

Dr. Smith testified that she did treat Petitioner for Lyme disease with several weeks of

Doxycycline but the drug did not resolve any of his symptoms. Tr. at 72-73. Dr. Smith testified

that there is an overlap of symptoms between Lyme disease and CFS, however she is more

confident in the diagnosis of CFS because of Petitioner’s fatigue and cognitive issues. Id. at 64,

75-77.

E. Dr. Kenneth Fife

Respondent filed two expert reports from Kenneth Fife, M.D., Ph.D. See Expert Reports,

filed as Ex. A (hereinafter “First Fife Rep.”) and Ex. C (hereinafter “Second Fife Rep.”). Dr. Fife

also testified at the entitlement hearing.

1. Qualifications

Dr. Fife received his medical degree from Johns Hopkins University. Ex. B at 1

(hereinafter “Fife CV”). Dr. Fife also received a Ph.D. in microbiology from Johns Hopkins

University. Id. He completed a fellowship at the University of Washington Division of Infectious

Diseases. Id. Dr. Fife is currently a professor of microbiology and pathology at the Indiana

University School of Medicine and has been since 1995. Id. at 2. Dr. Fife has written over 140

articles and is board certified in internal medicine. First Fife Rep. at 1; Fife CV at 4, 8-22. I

recognized Dr. Fife as an expert in the field of infectious disease. Tr. at 383.

2. Expert Opinion in Expert Reports

Dr. Fife noted that Petitioner had complained of fatigue to a “sufficient severity that his

primary care provider (Dr. Albright) listed it as one of his diagnoses and included it as an active

problem” on the day Petitioner received his allegedly causal vaccination. First Fife Rep. at 2. Dr.

Fife acknowledged Dr. Levine as a CFS expert but points out that Dr. Levine postulated that

changes in cytokines are “associated with CFS and states that such changes occurred in

[Petitioner’s] case.” Id. However, Dr. Fife opined that there is no record of any cytokine level

measurement in Petitioner’s medical record and “Dr. Levine can only speculate about cytokine

levels because there are no objective measurements of any cytokines to support her theory.” Id.

Dr. Fife also noted that Dr. Levine identifies Petitioner’s palpitations as a sign of autonomic

instability, a feature of CFS, however indicates that Petitioner was evaluated on June 30, 2013 for

palpitations, which is prior to the allegedly causal vaccination. Id. Dr. Fife stated that “Dr.

Levine’s conclusion of a causal relationship between [Petitioner’s] diagnosis of CFS and the

18

influenza vaccine is completely without objection support”. He further stated that none of the

references cited by Dr. Levine provide any support for her hypothesis. Id. at 2-3.

Dr. Fife concluded that Petitioner’s arthralgias following vaccination may have been

related to the vaccine but were improved with treatment. First Fife Rep. at 3. But more

importantly, Petitioner’s underlying symptoms of idiopathic chronic fatigue were present prior to

the receipt of the vaccine and waxed and waned in the subsequent years. Id.

Dr. Fife’s second report was written after reviewing additional medical records and Dr.

Lapp’s expert report. See Second Fife Rep. at 1. Dr. Fife disagreed with Dr. Lapp’s analysis of

Petitioner’s health prior to the October 2011 vaccination, and again identified fatigue as one of

Petitioner’s symptoms prior to vaccination. Id. Dr. Fife additionally questioned Dr. Lapp’s use

of the 1994 diagnostic criteria for CFS when the Institute of Medicine published revised criteria in

2015. Id. Applying the 2015 IOM criteria, Dr. Fife indicated that Petitioner does not meet the

diagnostic criteria because he has experienced prolonged episodes of normal activity, and further,

his fatigue symptoms were not new and could have been a result of Petitioner’s depression. Id.

Dr. Fife additionally stated that Dr. Lapp had not provided medical literature to support a

theory of causation as to how the influenza vaccine can cause CFS. Second Fife Rep. at 2. Dr.

Fife reiterated his medical opinion that Petitioner’s fatigue “antedated the receipt of the vaccine”

and has waxed and waned in the subsequent years. Id.

3. Testimony

During the entitlement hearing, Dr. Fife testified that upon hearing the testimony of

Petitioner and other fact witnesses, “it’s pretty clear that prior to [the October 2011 vaccination]

[Petitioner] did not meet the criteria for chronic fatigue syndrome.” Tr. at 385-86. Thus,

Petitioner’s fatigue prior to October 2011 “probably should not disqualify the current diagnosis of

chronic fatigue syndrome.” Id. at 386. Dr. Fife testified that he believes that Petitioner now meets

the IOM diagnostic criteria for CFS and the CDC criteria from the Fukuda article. Id. Dr. Fife

testified that Petitioner had not identified a plausible mechanism of causation by which the

influenza vaccine could cause CFS. Id. at 386, 394.

Additionally, Dr. Fife stated an onset date was unclear and difficult to determine because

of Petitioner’s period of improvement after his initial reaction to the vaccine. Id. at 388.

Petitioner’s symptom of joint pain post-vaccination improved after treatment and serum sickness

is “a well-described complication of [the] influenza vaccination.” Id. at 388-89, 391. Dr. Fife

stated that Petitioner’s visits with Dr. Qazizadeh showed that Petitioner had no identifiable

neurological problem post-vaccination. Id. at 392. Furthermore, Petitioner reported to Dr.

Qazizadeh that he was feeling better after a few months. Id. Dr. Fife did admit that serum sickness

lasting five or six months would not be typical. Id. at 423.

Despite Dr. Lapp’s testimony, Dr. Fife stated that the causal mechanism for CFS remains

unknown. Tr. at 394. In her expert report, Dr. Levine proffered a theory that an increase in

cytokines from the influenza vaccination could have caused Petitioner to develop CFS. Dr. Fife

19

concurred with Dr. Lapp that cytokine assays are not readily available to most practitioners. He

testified:

the other problem with all of the cytokine theories is that it continues to be an

evolving field…. It becomes very difficult to attribute things to these cytokines

because, again, new cytokines continue to be identified. And it may be that they

haven’t found the right one or it may be the cytokines aren’t involved at all. It’s

difficult to tell but, again, we have no evidence in this case of any cytokine

disturbances because they were never tested and cannot really be tested easily.

Id. at 395. Regarding Dr. Levine’s kindling theory, Dr. Fife stated that it is merely a theory and

there is no evidence to support the theory. Id. at 396. Dr. Fife testified that to his knowledge, no

subsequent studies have taken place regarding either of Dr. Levine’s theories. Id.

V. Applicable Law

A. Petitioner’s Overall Burden in Vaccine Program Cases

Under the Vaccine Act, a petitioner may prevail in one of two ways. First, a petitioner may

demonstrate that she suffered a “Table” injury—i.e., an injury listed on the Vaccine Injury Table

that occurred within the time period provided in the Table. § 11(c)(1)(C)(i). “In such a case,

causation is presumed.” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed.

Cir. 2006); see § 13(a)(1)(B). Second, where the alleged injury is not listed in the Vaccine Injury

Table, a petitioner may demonstrate that he suffered an “off-Table” injury. § 11(c)(1)(C)(ii).

For both Table and non-Table claims, Vaccine Program petitioners bear a “preponderance

of the evidence” burden of proof. § 13(1)(a). That is, a petitioner must offer evidence that leads

the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before

[she] may find in favor of the party who has the burden to persuade the judge of the fact’s

existence.” Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1324 (Fed. Cir. 2010);

see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or

speculation is insufficient under a preponderance standard). Proof of medical certainty is not

required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In

particular, a petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the

injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321

(quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999));

Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner

may not receive a Vaccine Program award based solely on her assertions; rather, the petition must

be supported by either medical records or by the opinion of a competent physician. Section

13(a)(1).

In attempting to establish entitlement to a Vaccine Program award of compensation for a

non-Table claim, a petitioner must satisfy all three of the elements established by the Federal

Circuit in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). Althen

requires that petitioner establish by preponderant evidence that the vaccination he received caused

his injury “by providing: (1) a medical theory causally connecting the vaccination and the injury;

20

(2) a logical sequence of cause and effect showing that the vaccination was the reason for the

injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.”

Id. at 1278.

Under Althen prong one, petitioners must provide a “reputable medical theory,”

demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at

1355-56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound

and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Human Servs., 35

F.3d 543, 548 (Fed. Cir. 1994). Proof that a vaccine likely caused an injury or that the proffered

medical theory is reasonable, plausible, or possible does not satisfy a petitioner’s burden. Boatmon

v. Sec’y of Health & Human Servs., 941 F.3d 1351, 1359-60 (Fed. Cir. 2019).

Petitioners may satisfy the first Althen prong without resort to medical literature,

epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical

theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009)

(citing Capizzano, 440 F.3d at 1325-26). However, special masters are “entitled to require some

indicia of reliability to support the assertion of the expert witness.” Boatmon, 941 F.3d at 1360,

quoting Moberly, 592 F.3d at 1324. Special Masters, despite their expertise, are not empowered

by statute to conclusively resolve what are complex scientific and medical questions, and thus

scientific evidence offered to establish Althen prong one is viewed “not through the lens of the

laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence

standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden

placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y

of Health & Human Servs., 121 Fed. Cl. 230, 245 (2015).

The second Althen prong requires proof of a logical sequence of cause and effect, usually

supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,

569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion

testimony are favored in vaccine cases, as treating physicians are likely to be in the best position

to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the

reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed

as particularly trustworthy evidence, since they are created contemporaneously with the treatment

of the patient. Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

However, medical records and/or statements of a treating physician’s views do not per se

bind the special master to adopt the conclusions of such an individual, even if they must be

considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,

conclusion, judgment, test result, report, or summary shall not be binding on the special master or

court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is

nothing … that mandates that the testimony of a treating physician is sacrosanct -- that it must be

accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a

theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the

reasonableness of their suppositions or bases. The views of treating physicians should also be

weighed against other, contrary evidence also present in the record -- including conflicting

opinions among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742,

749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians’

21

conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Health &

Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot.

for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed.

Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between

the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to

the phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer

“preponderant proof that the onset of symptoms occurred within a timeframe which, given the

medical understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de

Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation

for what is a medically acceptable timeframe must also coincide with the theory of how the relevant

vaccine can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of

Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl.

353 (2012), aff’d mem., 503 F. App’x 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human

Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review

den’d (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Law Governing Analysis of Fact Evidence

The process for making factual determinations in Vaccine Program cases begins with

analyzing the medical records, which are required to be filed with the petition. Section 11(c)(2).

The special master is required to consider “all [] relevant medical and scientific evidence contained

in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s

report which is contained in the record regarding the nature, causation, and aggravation of the

petitioner’s illness, disability, injury, condition, or death,” as well as the “results of any diagnostic

or evaluative test which are contained in the record and the summaries and conclusions.” Section

13(b)(1)(A). The special master is then required to weigh the evidence presented, including

contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Human Servs.,

3 F.3d 413, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether

to afford greater weight to contemporaneous medical records than to other evidence, such as oral

testimony surrounding the events in question that was given at a later date, provided that such

determination is evidenced by a rational determination).

Medical records created contemporaneously with the events they describe are presumed to

be accurate and “complete” such that they present all relevant information on a patient’s health

problems. Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed. Cl.

598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his

contemporaneous medical records, the special master’s decision to rely on petitioner’s medical

records was rational and consistent with applicable law”), aff’d, Rickett v. Sec’y of Health &

Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption

is based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people

honestly report their health problems to those professionals; and (iii) medical professionals record

what they are told or observe when examining their patients in as accurate a manner as possible,

so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez

v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr.

22

Apr. 10, 2013), mot. for review den’d (Fed. Cl. Feb. 11, 2019), appeal docketed, No. 19-1753 (Fed.

Cir. 2019); Cucuras v. Sec’y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993

F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to

accurately report the onset of their daughter’s symptoms.”).

Accordingly, if the medical records are clear, consistent, and complete, then they should

be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005

WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical

records are generally found to be deserving of greater evidentiary weight than oral testimony --

especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;

see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam,

968 F.2d 1226 (Fed. Cir. 1992), (citing United States v. U.S. Gypsum Co., 333 U.S. 364, 396

(1947) (“[i]t has generally been held that oral testimony which is in conflict with contemporaneous

documents is entitled to little evidentiary weight.”)).

However, there are situations in which compelling oral testimony may be more persuasive

than written records, such as where records are deemed to be incomplete or inaccurate. Campbell

v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon

common sense and experience, this rule should not be treated as an absolute and must yield where

the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19

(“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than

those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a

determination regarding a witness’s credibility is needed when determining the weight that such

testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Human

Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

When witness testimony is offered to overcome the presumption of accuracy afforded to

contemporaneous medical records, such testimony must be “consistent, clear, cogent and

compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Human

Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In

determining the accuracy and completeness of medical records, the Court of Federal Claims has

listed four possible explanations for inconsistencies between contemporaneously created medical

records and later testimony: (1) a person’s failure to recount to the medical professional everything

that happened during the relevant time period; (2) the medical professional’s failure to document

everything reported to her or him; (3) a person’s faulty recollection of the events when presenting

testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. LaLonde v.

Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir.

2014). In making a determination regarding whether to afford greater weight to contemporaneous

medical records or other evidence, such as testimony at hearing, there must be evidence that this

decision was the result of a rational determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory connecting the vaccine to the injury often

requires a petitioner to present expert testimony in support of her claim. Lampe v. Sec’y of Health

& Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is

23

usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert

v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health &

Human Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human

Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999). “The Daubert factors for analyzing the reliability

of testimony are: (1) whether a theory or technique can be (and has been) tested; (2) whether the

theory or technique has been subjected to peer review and publication; (3) whether there is a known

or potential rate of error and whether there are standards for controlling the error; and (4) whether

the theory or technique enjoys general acceptance within a relevant scientific community.”

Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-95).

The Daubert factors play a slightly different role in Vaccine Program cases than they do

when applied in other federal judicial fora. Daubert factors are employed by judges to exclude

evidence that is unreliable and potentially confusing to a jury. In Vaccine Program cases, these

factors are used in the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health

& Human Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have

been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of

expert testimony already admitted”). The flexible use of the Daubert factors to evaluate

persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88

Fed. Cl. at 743. In this matter, (as in numerous other Vaccine Program cases), Daubert has not

been employed at the threshold to determine what evidence should be admitted, but instead to

determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s

case. Where both sides offer expert testimony, a special master’s decision may be “based on the

credibility of the experts and the relative persuasiveness of their competing theories.”

Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing

Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion

“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too

great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743

(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A “special master is entitled to

require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592

F.3d at 1324. Weighing the relative persuasiveness of competing expert testimony, based on a

particular expert’s credibility, is part of the overall reliability analysis to which special masters

must subject expert testimony in Vaccine Program cases. Id. at 1325-26 (“[a]ssessments as to the

reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec’y

of Health & Human Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously

explained that special masters are expected to consider the credibility of expert witnesses in

evaluating petitions for compensation under the Vaccine Act”).

D. Consideration of Medical Literature

Although this decision discusses some but not all of the medical literature in detail, I

reviewed and considered all of the medical records and literature submitted in this matter. See

Moriarty v. Sec’y of Health & Human Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We generally

presume that a special master considered the relevant record evidence even though [s]he does not

explicitly reference such evidence in h[er] decision.”); Simanski v. Sec’y of Health & Human

24

Servs., 115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is ‘not required to discuss every piece

of evidence or testimony in her decision.’” (citation omitted)), aff’d, 601 F. App’x 982 (Fed. Cir.

2015).

VI. Analysis

Because Petitioner does not allege an injury listed on the Vaccine Injury Table, Petitioner’s

claim is classified as “off-Table.” As noted above, to prevail on an “off-Table” claim, Petitioner

must prove by preponderant evidence that he suffered an injury and that this injury was caused by

the vaccination at issue. See Capizzano, 440 F.3d at 1320.

A. CFS Generally

CFS is a disease of unknown etiology that involves “profound dysregulation of the central

nervous system and immune system…” Carruthers et al., Myalgic encephalomyelitis:

International Consensus Criteria, 270 JOURNAL OF INTERNAL MEDICINE at 328 (2011) (filed at Ex.

39) (hereinafter “Carruthers”). It is characterized by “profound fatigue, cognitive dysfunction,

sleep abnormalities, autonomic manifestations, pain, and other symptoms that are made worse by

exertion of any sort.” Institute of Medicine of the National Academies, Beyond Myalgic

Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness, NAT’L ACAD. PRESS, p. 9

(2015) (filed as Ex. 40) (hereinafter “IOM Rep.”). CFS is thought to have a prevalence of .4-1%

worldwide. Devanur & Kerr, Chronic fatigue syndrome, JOURNAL OF CLINICAL VIROLOGY, p. 2

(2006) (filed as Ex. 41) (hereinafter “Devanur & Kerr”).

As its name suggests, fatigue is the disease’s central symptom. While in other conditions,

fatigue is generally proportional to an individual’s level or duration of effort, “[t]he pathological

low threshold of fatiguability of [CFS] … often occurs with minimal physical or mental exertion

and with reduced ability to undertake the same activity within the same or several days.”

Carruthers at 328. “Another distinguishing feature of the illness, in comparison with other ‘fatigue

states’, is its prolonged relapsing and remitting course over months or years.” See Ex. C1 at 46;

A REPORT OF THE CFS/ME WORKING GROUP, 1-82, January 2002 (filed as Ex. C1) (hereinafter

“Working Group Rep.”).

While the cause of CFS is unknown, Carruthers states that “[m]ost patients have an acute

infectious onset with flu-like and/or respiratory symptoms.” Carruthers at 332. This is consistent

with Dr. Lapp’s testimony at hearing where he indicated that 75% of CFS cases are attributable to

viral or bacterial infection. Tr. at 244. Researchers believe that the immune system plays a key

role in the pathogenesis of CFS. Devanur & Kerr at 2.

B. Petitioner has Demonstrated that CFS is his Correct Diagnosis

Dr. Smith diagnosed Petitioner with CFS and Dr. Lapp confirmed this diagnosis during his

testimony. See Tr. at 241-42. Although Respondent contested Petitioner’s CFS diagnosis during

the initial portion of the entitlement hearing, it is no longer in dispute. Dr. Fife testified at hearing

that after listening to Petitioner’s testimony, he was convinced Petitioner was correctly diagnosed

with CFS. Tr. at 386-87. Respondent has conceded the issue in his post-hearing brief: “there

25

remains no dispute between the parties that petitioner’s appropriate diagnosis is CFS.” Resp’t’s

Post-Hr’g Br. at 7, ECF No. 127. Accordingly, I find there is preponderant evidence to support

the preliminary point that CFS is Petitioner’s correct diagnosis.

C. Petitioner has Carried his Burden of Proof

1. Althen Prong 1

a. General Evidence that Vaccination Can Cause CFS

Petitioner has filed medical literature which articulates a link between vaccination

generally, and CFS. I would categorize this literature as providing general support for Petitioner’s

theory, although these articles do not articulate a causal mechanism. For instance, Devanur & Kerr

write that “immunisation with various vaccines have [sic] been reported to trigger CFS. These

vaccines include MMR, pneumovax, influenza, hepatitis B, tetanus, typhoid and poliovirus.”

Devanur & Kerr at 7. Additionally, the Working Group Report, a report prepared to advise the

U.K.’s National Health Service, states as follows:

A few case reports have suggested that CFS/ME has occurred after immunisations,

though intercurrent events, including infection, might have played a part in the

disease process. It is biologically plausible that some processes seen after

infections could also occur after immunisations, but this has yet to be confirmed by

a good quality cohort study in the case of CFS/ME. Current advice to avoid

immunisations during infections is designed to avoid such triggering.

Working Group Rep. at 32. Of course, Petitioners are not required to produce “good quality cohort

studies” in order to prevail in the Vaccine Program. Later in their report, the Working Group

further notes that “other factors have been associated with onset of CFS/ME in individual cases,

including some immunisations…” Id. at 48.

Dr. Lapp also testified about his extensive work in treating CFS patients. Dr. Lapp has

dedicated the majority of his career to working in the field of CFS, and in so doing has treated

approximately 28,000 patients with CFS. See Tr. at 447. In his experience, Dr. Lapp described

personally treating two or three patients who developed CFS after flu vaccine. Id. at 257.

While these above-mentioned references and Dr. Lapp’s treatment experience do not

articulate a specific theory as to how vaccination can cause CFS, they do provide some support for

Petitioner’s theory that vaccinations can cause CFS.

b. Petitioner’s Theory

At the entitlement hearing, Dr. Lapp proffered a theory of causation by which CFS can

develop following vaccination. Dr. Lapp posited that Petitioner’s flu vaccination caused immune

dysregulation and this dysregulation resulted in CFS. Dr. Lapp testified:

What we're saying is that in his case, he had an allergic reaction to that vaccine and

26

that allergic reaction stirred up the immune system, which in this particular case,

because he's susceptible, has turned his immune system toward a Th2 immune

response, which is typical of chronic fatigue syndrome. And I think that that

perhaps has just perpetuated. It's continued.

Tr. at 434.

Dr. Fife testified at hearing about the difference between Th1 and Th2 immunity.

[T]hey're two responses to an immunologic challenge and typically Th1 response

triggers B-cell activation, which is B-cells producing antibodies. And Th2

responses trigger other T-cells which triggers a cellular immune response.

Both are normal responses and where problems arise is when one becomes more

dominant than it should be. There's a lot of back and forth regulation within the

immune system to try to balance those responses.

And, again, a theory of autoimmune disease and a number of other conditions is

that in some cases that balance gets off and one reaction gets -- becomes more

responsive than it should be and causes harm.

Tr. at 404-05.

Dr. Lapp’s theory that there is a shift in CFS patients from a Th1 to a Th2 immune response

generally finds support in the medical literature. See Hardcastle et al., Serum Immune Proteins in

Moderate and Severe Chronic Fatigue Syndrome, 12 INT J MED SCI., p. 4 (2015) (filed as Ex. 42)

(hereinafter “Hardcastle”). The Hardcastle article states that “CFS/ME patients have shown

evidence of a bias towards a Th2 immune response as IFN-γ and IL-4 were increased in CFS/ME

patients compared with healthy controls.” Hardcastle at 4. The Carruthers article also describes

“a shift towards a Th2 profile.” Carruthers at 6. The Devanur & Kerr article notes that “[v]arious

studies suggest that CFS exhibits a Th2 profile of CD4 helper T lymphocyte responsiveness.”

Devanur & Kerr at 3.

Dr. Levine’s expert report also provides support for this theory. Dr. Levine stated, “The

development of a fatiguing illness following inoculation with vaccines of many types has best been

established in the case of Gulf War Syndrome (GWS) and likely reflects a shift in the immune

response towards a TH2 profile.” Levine Rep. at 2.

According to Dr. Lapp, CFS is characterized by a shift to a Th2 dominant immune

response. This response is never turned off, and results in chronic immune activation. Dr. Lapp’s

theory that CFS can occur following flu vaccination has three main steps. First, the flu vaccination

causes an inflammatory response. Second, this inflammatory response causes immune

dysregulation in susceptible individuals. Third, immune dysregulation leads to CFS.

27

c. Step 1: Flu Vaccination Can Cause an Inflammatory Reaction

It is well accepted that flu vaccination causes a mild inflammatory response. See Perring

& Jones, Assessment of changes in cardiac autonomic tone resulting from inflammatory response

to the influenza vaccination, 32 CLIN. PHYSIOL FUNCT IMAGING, 437-44 (2012) (filed as Ex. 46)

(hereinafter “Perring”) (“Our findings indicate that influenza vaccination … can be used as a model

to study the response of mild stimulation of the inflammatory system.”). Vaccination triggers

activation of the innate immune system, as this is necessary for the vaccinee to develop a robust

immune response.

An example of an inflammatory response that can occur after vaccination is serum

sickness. The IOM has defined serum sickness as “[a]n immune complex disease appearing some

days (usually 1-2 weeks) after injection of a foreign serum or serum protein, with local and

systemic reactions such as urticaria, fever, general lymphadenopathy, edema, arthritis, and

occasionally albuminuria or severe nephritis.” Institute of Medicine, 2012, Adverse Effects of

Vaccines: Evidence and Causality, THE NATIONAL ACADEMIES PRESS, at 644. Dr. Lapp also

discussed serum sickness and defined it as,

“an allergic reaction to an injection…. It’s an IgE reaction that will last as long…

as the offending agent is in the body, and the body attempts to clear that reaction,

and the reaction will cause the kind of symptoms that we have seen here. In the

case of an injection like this, it’s usually characterized by swelling, a reaction that

goes to the joints. So you get joint swelling and pain and overall edema, which is

fluid building up in the body, can cause feverishness and a number of different

systemic symptoms that … usually last days to a couple weeks.”

Tr. at 288-89. Dr. Fife testified that serum sickness is “a well-described complication of [the]

influenza vaccination.” Tr. at 391.

Petitioner has demonstrated that the flu vaccine generally causes a mild inflammatory

response and can also cause a more robust response (as is the case when a vaccinee develops serum

sickness).

d. Step 2: The Inflammatory Reaction from Flu Vaccination Can

Lead to Immune Dysregulation

The second step in Petitioner’s theory is that flu vaccination can cause immune

dysregulation. Specifically, Dr. Lapp testified that vaccination can cause a shift toward a Th2

immune response. Dr. Lapp cited one primary medical article in support of this proposition. See

Brenu et al., The Effects of Influenza Vaccination on Immune Function in Patients with Chronic

Fatigue Syndrome/ Myalgic Encephalomyelitis, 3 INTERNATIONAL JOURNAL OF CLINICAL

MEDICINE 2012, pp. 554-51 (filed as Ex. 59) (hereinafter “Brenu”). The Brenu article studied

seven patients meeting the CDC criteria for CFS as well as eight healthy controls. Bloodwork

from each participant was collected before receipt of the flu vaccine, and at both 14 and 28 days

after vaccination. The study described a number of findings with respect to different levels of

cytokines pre and post vaccination. The study found that “NK activity was significantly decreased

28

at baseline and at 28 days, while at 14 days it significantly increased in the CFS/ME patients

compared to the healthy controls.” Brenu at 544. The authors also observed that IL-4 (a Th2

cytokine) was increased in the CFS patients when compared to controls. Id. at 548. The following

graph depicts a statistically significant increase in IL-4 at 14 and 28 days post vaccination:

Id. at 547.

Additionally, although there were no statistically significant differences in general

wellbeing between the CFS patients and the healthy controls at baseline, “at day 14 and particularly

day 28 post vaccination, the CFS/ME patients recorded a significantly lower general wellbeing

compared to the controls.” Brenu at 547. Ultimately, the study concluded that “immunization

with influenza vaccine is accompanied by a degree of immune dysregulation8 in CFS/ME patients

compared with controls, and further, the study “suggests that vaccination with seasonal influenza

vaccine, Influvac may affect cellular immune function in CFS/ME patients…” Id.

Dr. Lapp testified about the significance of Brenu at the entitlement hearing. He stated:

“At 28 days, the proinflammatory cytokines were increased and natural killer cell was decreased

in the patients. So clearly patients that have a proclivity toward this Th2 activity, Th2 immunity,

have a change when they're exposed to the vaccine.” Tr. at 253-54.

In analyzing the Brenu article, it is important to note that the study did not address

individuals who developed CFS after receiving the flu vaccine, but instead studied patients who

were already diagnosed with CFS and how they responded to vaccination.9 Still, this study did

demonstrate that vaccination can trigger immune dysfunction in some susceptible individuals.

Further, the study demonstrates that in susceptible individuals, the cytokine response generated by

8

The study did find several Th1 cytokines were also increased post vaccination.

9

I will note that the Federal Circuit in W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1361 (Fed.

Cir. 2013) affirmed the special master’s decision, finding that his reliance on a series of studies which

showed that MS patients did not experience disease flares after flu vaccination was not arbitrary and

capricious. The same reasoning employed by the special master in W.C. -- that studies involving how

individuals who already have a disease respond to vaccination are relevant to the Petitioner’s prong one

theory -- is applicable in this case as well.

29

the flu vaccine appears to go beyond the short-lived cytokine up-regulation that is known to occur

after vaccination.

Although Petitioner’s evidence in support of this component of his theory is not robust, I

find that it is sufficient to preponderantly establish that the inflammatory reaction from the flu

vaccination can lead to immune dysregulation in a small percentage of susceptible individuals.

e. Step 3: Immune Dysregulation is Linked to CFS

There is evidence in the medical literature that immune dysregulation is a feature of CFS.

Petitioner submitted the 2015 Institute of Medicine (IOM) report on CFS, Beyond Myalgic

Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness, Nat’l Acad. Press (2015)

(filed as Ex. 40) (hereinafter “IOM Rep.”). In its report, the IOM found that there is sufficient

evidence to support the finding of immune dysfunction in CFS. IOM Rep. at 17. The IOM further

concluded that there is data demonstrating “poor NK cell cytotoxicity (NK cell function, not

number) that correlates with illness severity in ME/CFS patients and could serve as a biomarker

for the severity of the disease….” Id.

Several other articles filed by Petitioner also make this point. For example, the Hardcastle

article states “immunological dysregulation consistently occurs in the illness.” Hardcastle at 1.

The Carruthers article describes CFS as “a complex disease involving profound dysregulation of

the central nervous system and immune system.” Carruthers at 1.

Dr. Lapp testified at hearing about this third step in his theory, that a shift in the immune

system towards Th2 immunity can cause CFS.

NK cells, which are supposed to shut off part of the reaction, don't work properly

and suppressor cells, which are supposed to shut off the reaction, don't work

properly. And so you get a perpetual, abnormal, activated immune system.

Tr. at 435-36.

I also note that Special Master Moran has conducted a reasoned analysis of this precise

issue. While not binding on me10, he concluded that although it is not medically accepted that

immune dysregulation can cause CFS, it is a viable and reputable theory under Althen prong one.

See McCabe v. Sec’y of Health & Human Servs., 2018 WL 3029175, at *47-48 (Fed. Cl. Spec.

Mstr. May 17, 2018). I agree with his analysis with respect to this issue and arrive at the same

conclusion in the present case.11

10

See Boatmon, 941 F.3d at 1358-59 (finding that “special masters are not required to distinguish non-

binding decisions of other special masters” in part because each case has a different evidentiary record).

11

The decision in McCabe ultimately concluded that Petitioner did not establish the first Althen prong

because she did not present evidence that the inflammatory reaction from the flu vaccination can lead to

immune dysregulation. I will note that this case is distinguishable from McCabe in several respects. Unlike

the case at bar, Petitioner in McCabe did not file any medical literature in support of the proposition that an

inflammatory reaction to the flu vaccine can lead to immune dysregulation. Additionally, Respondent’s

30

I find that Petitioner has presented preponderant evidence that the flu vaccine can cause

CFS in a small percentage of susceptible individuals.

2. Althen Prong 2

Under the second Althen prong, Petitioner must demonstrate by a preponderance of the

evidence that there is a “logical sequence of cause and effect showing that the vaccination was the

reason for the injury.” Capizzano, 440 F.3d at 1324 (quoting Althen, 418 F.3d at 1278).

a. Petitioner’s Treating Physicians

In weighing evidence, special masters are expected to consider the views of treating

doctors. Cappizano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006).

The views of treating doctors about the appropriate diagnosis are often persuasive because the

doctors have direct experience with the patient whom they are diagnosing. See McCulloch v. Sec’y

of Health & Human Servs., No. 09-293V, 2015 WL 3640610, at *20 (Fed. Cl. Spec. Mstr. May

22, 2015).

Petitioner’s treating physician, Dr. Smith, has opined that Petitioner’s flu vaccination

caused him to develop CFS. In medical records from June 4, 2015 Dr. Smith stated, “[b]ased on

these symptoms, he fits the CDC criteria for chronic fatigue syndrome, and his symptoms

definitely were triggered by the flu shot he had in 2011.” Ex. 27 at 2. She further discussed her

opinion during the entitlement hearing. Dr. Smith testified that “[t]he influenza vaccine can

definitely trigger the immune system which can, in a predisposed individual, can lead to this

condition.” Id. at 68. Dr. Smith added,

when someone has an immune activation of some sort from a flu shot or an

infection, it can trigger an underlying condition or trigger a new syndrome which

can cause chronic fatigue syndrome. So with the timing of the event and the severity

of Ted’s symptoms after the flu shot, it would appear that that was when his chronic

fatigue symptoms really began. So by looking at that as the time when things went

downhill, the most likely etiology was the flu vaccination.

Id. at 69-70.

Dr. Smith’s opinion is persuasive in this case, as she has been Petitioner’s treating

physician since 2014 and had direct interaction with him for four-and-one-half years, as of the date

she testified at the January 9-10, 2019 hearing. Id. at 45. I have given her opinion substantial

weight.

expert in this case only relied upon two pieces of medical literature (A Report of the CFS/ME Working

Group (Ex. C1), and the IOM Article, Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Redefining an Illness (Ex. A1)) and did not discuss the epidemiological study related to flu vaccine and

CFS that was filed in McCabe. Further, Petitioner’s expert, Dr. Lapp is a CFS expert, whereas one of the

experts in McCabe (Dr. Mikovits) is not and has been repeatedly discredited in the Vaccine Program.

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b. Petitioner Experienced an Abnormal Response to the Flu Vaccine

In order to establish a logical sequence of cause and effect between the vaccination and the

illness, Petitioner should present evidence which suggests that the vaccinee responded to the

vaccine in a manner which is consistent with the causal theory. In this case, Petitioner experienced

an abnormal response to the flu vaccine that began two days after vaccination. This response is

well-documented in Petitioner’s medical records and is consistent with his Althen prong one

theory.

The first medical visit post-vaccination took place on October 20, 2011, ten days after

Petitioner received his flu shot. Petitioner visited Dr. Albright and complained of joint pain. Ex.

2 at 5. Dr. Albright noted that Petitioner was most likely experiencing a reaction to the flu vaccine.

He had previously prescribed Medrol (a steroid) and noted in the records, “getting better, medrol

is helping.” Id. The records do not contain any information about the circumstances that led

Petitioner to receive a Medrol prescription. Petitioner’s testimony at hearing helps fill in the gaps.

When asked to describe his symptoms after vaccination, Petitioner testified as follows:

The first effect -- the first effect was the, was knee pain, just on one knee and that

was on the second day. On the third day both knees were swelled and very, very

stiff. On the fourth day I couldn't move. I couldn't get out of bed. And all my -- I

was like a board. My joints -- my hands were double the size, my legs were double

the size. All my joints were just kind of like locked in place. And called -- my wife

called the doctor and told him that, you know, I was not being able to move. And

he said -- he called in a steroid.

Tr. at 23-24.

On November 14, 2011, Petitioner saw Dr. Natalie Dubchek (a rheumatologist). Ex. 3 at

1. Dr. Dubchek noted that Petitioner “was in a good general state of health until October 12th of

this year when he developed diffuse arthralgias and joint swelling two days after he received his

flu shot…. Also he noticed early onset fatigue.” Id. (emphasis added).

Petitioner returned to Dr. Dubchek on November 29, 2011. Ex. 3 at 3. The doctor noted

that “[h]e continues to experience the same symptoms of generalized fatigue, generalized pain,

now mostly localized to the lower legs, knees, and calves.” Id.

Petitioner visited Dr. Albright twice in December 2011 and once in January 2012. He

presented with difficulty concentrating, fatigue and muscle weakness. Ex. 2 at 14, 18, 21. Dr.

Albright again questioned whether these symptoms were in connection with Petitioner’s flu

vaccine. Id. at 18. On January 5, 2012, Dr. Albright assessed Petitioner with chronic fatigue

syndrome.12 Id. at 22.

12

780.71 is the diagnostic code for chronic fatigue syndrome. See Centers for Disease Control and

Prevention, International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM)

(2011), https://www.cdc.gov/nchs/icd/icd9cm.htm (last accessed Sept. 18, 2020).

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On February 6, 2012, Petitioner saw Dr. Salim Qazizadeh (a neurologist). Ex. 4 at 13-17.

During this visit, Dr. Qazizadeh noted that since his flu shot, Petitioner had experienced “difficulty

focusing, [an inability] to multitask, blurriness of vision, extreme fatigue, muscle weakness,

tremor, numbness, tingling, cramps in the legs, joint pain, interrupted sleep, memory problems,

low back pain, stiffness, and vertigo.” Id. at 13.

On March 8, 2012, Petitioner returned to Dr. Qazizadeh for follow-up regarding memory

loss. Ex. 4 at 18. During this visit, Petitioner described his symptoms as fatigue, tiredness, and

joint pain. Id. at 20. The summary for the visit noted that “[t]he possibility of serum sickness is

being entertained.” Id. Dr. Qazizadeh described him as “slightly better, but … not back to

baseline.” Id. at 18.

In examining the medical records and in evaluating Petitioner’s testimony, it appears that

Petitioner experienced improvement in his symptoms starting in mid-2012 and continuing through

part of 2013. While the worst of these symptoms subsided sometime in 2012, Petitioner did not

return to baseline. Establishing when and the extent to which Petitioner’s health improved is

somewhat challenging. Petitioner was unwell in March of 2012, but when he returned to Dr.

Qazizadeh for follow-up on May 8, 2012, the records indicate that Petitioner was having serum

sickness since the flu vaccine, but also indicate that he was improving. Ex. 4 at 23. Petitioner’s

medical records and testimony when taken together, paint the picture of someone trying to hold on

to a sense of normalcy in terms of work, hobbies, and other activities while still experiencing some

symptomology. Petitioner discussed this during the hearing.

Q. But generally speaking, what do you remember about your abilities in 2012?

A. They were diminished but not, not to the -- I don't know what percentage point

-- I was -- I knew something was wrong, yet I didn't want to admit it and I wanted

to just be myself. I wanted to be normal, go to work, not be tired and come home

and be able to work on my house and not have to sleep all weekend to recover.

Tr. at 84.

During the hearing, Petitioner discussed the fact that he had to give up his hobbies due to

his health limitations. He stopped playing volleyball in 2011. Tr. at 87. He quit competitive

fishing in 2012 because standing on the boat for hours at a time would result in him being in bed

and feeling sick for the next two days. Id. at 86. With respect to golf, Petitioner testified that he

“struggled” through 2012.

At that point I could physically play. Now, I'm not -- my flexibility wasn't there so

I wasn't as good as I once was, but it would just cause me to sleep the next day. So

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I could physically play and still have fun; just not as good as I once was, which is

fine by me; it was just being out there.

But then I would end up the next day or the day after it sleeping for over 20 to 24

hours just to recover from that. That's driving in a cart and not trying to walk.

Id. at 85. Petitioner had to give up the sport entirely in 2013. Id.

Petitioner testified about his work performance during the 2013 timeframe.

Q. So we're in 2013 now. How was your work performance at that time?

A. Going downhill. Tasks were taken away from me due to safety precautions for

myself and anybody around me. Ladder work was taken away. Unfortunately, a

lot of my job was standing on top of a ladder and it was -- I was still working on

the water heater project and it was to the -- it was getting to where I could only cut

maybe three or four pieces of pipe and my arms would cramp so bad that I had to

stop for the day and I'd go down to my desk to talk to my boss and tell him, You

know, I don't know what's going on. Something is just not -- I said, you can look

at my arms; they're cramped up and shaking. And he said, Well, what did you do?

I said, I cut three pieces of pipe.

Tr. at 87-88.

Petitioner did have a reduced number of medical visits related to fatigue in 2013. This

absence of records suggests that he was feeling better. However, Petitioner’s medical records do

indicate that he experienced some symptoms in 2013. On July 15, 2013, Petitioner visited Dr.

Albright to review recent lab work and to discuss his hyperlipidemia. During this visit, Petitioner

indicated that he was experiencing fatigue. Ex. 2 at 42.

Further, on May 1, 2014, Petitioner visited the neurology clinic at Penn State Hershey

Medical Center. The notes from this visit summarize Petitioner’s clinical course after the flu shot:

“He progressively got better over a year, did not reach 100%, was able to function. Approximately

6-8 months ago, he began to get progressively worse in his symptoms both mentally and

physically. He suffers from chronic fatigue and pain.” Ex. 7 at 1. Six to eight months before this

May 1 appointment places the worsening of Petitioner’s condition during the September 1-

November 1, 2013 timeframe.

In all, the medical records and testimony taken together make it clear that Petitioner

experienced a severe reaction to the flu vaccine for at least five months. Petitioner’s symptoms

included joint pain, swelling, fatigue, muscle weakness, memory and cognitive issues. Although

Petitioner’s severe symptoms dissipated sometime in the April/May 2012 timeframe, he still

continued to experience symptoms of fatigue that did not exist pre-vaccination. These reduced

symptoms occurred from April/May 2012 through September/November 2013. After that time,

Petitioner’s symptoms worsened again.

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c. The Onset of Petitioner’s CFS

Petitioner’s theory is that his well-documented severe response to the flu vaccine was not

serum sickness, but instead constituted the beginning of his CFS. In refuting the theory that

Petitioner’s adverse reaction to his vaccination was due to serum sickness, Dr. Lapp explained that

serum sickness will generally resolve when the body has a chance to clear the foreign antigen. Tr.

at 289. He further testified that serum sickness typically lasts for days to a couple of weeks. Id.

Regarding the possibility that serum sickness could last multiple months, Dr. Lapp stated, “It’s not

likely. Not from what I’ve seen in my personal experience…. It seems the body should have

cleared it by then. I think something else is going on there. I think the immune reaction and – my

personal opinion is that the immune reaction has been triggered here and is continuing on, is what's

happening.” Id. at 289-90.

Dr. Fife also acknowledged that Petitioner’s response to the flu vaccine exceeded the time

he would expect for serum sickness to continue after vaccination. Dr Fife testified as follows:

Q. So you would expect, at least in most cases, serum sickness would last a matter

of weeks, maybe a month, something like that? It would be unusual for it to last

four months or five months or six months, something like that, wouldn't it?

A. That would not be typical, correct.

Tr. at 423.

Respondent’s position is that Petitioner’s improvement during the 2012-2013 timeframe is

inconsistent with CFS which began two days after vaccination. In their post-hearing brief,

Respondent stated,

[P]etitioner’s fatigue symptoms waxed and waned in intensity the year following

his vaccination, which is inconsistent with the Institute of Medicine’s (“IOM”)

diagnostic criteria for CFS13, and ceased completely for nine months following an

adjustment made to petitioner’s depression medications. This brings into question

when the onset of petitioner’s CFS occurred.

Resp’t’s Post-Hr’g Br. at 3.

13

The IOM’s diagnostic criteria for CFS indicate that “Frequency and severity of symptoms should be

assessed. The diagnosis of ME/CFS (SEID) should be questioned if patients do not have these symptoms

at least half of the time with moderate, substantial, or severe intensity.” IOM Rep. at 11. I do not find

Petitioner’s symptoms, documented in his medical records and discussed in his testimony at hearing make

his CFS diagnosis inconsistent with this statement from the IOM. Petitioner consistently testified that he

had reduced capacity during the 2012-2013 timeframe, and that although he was improved from his severe

post-vaccine reaction, he never returned to baseline. Further, the IOM indicates the diagnosis should be

“questioned if patients do not have these symptoms”, not that the diagnosis is ruled out. Ultimately, I credit

Petitioner’s treating physician, Dr. Smith as well as Dr. Lapp on this issue.

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It is clear that a unique feature of CFS is the waxing and waning course of the disease. The

Working Group Report addressed this very issue. They stated that “[a]nother distinguishing

feature of the illness, in comparison with other ‘fatigue states’, is its prolonged relapsing and

remitting course over months or years.” Working Group Rep. at 48. This report (filed by

Respondent) specifically states that CFS can wax and/or wane over the course of years. Dr. Lapp

also testified about the waxing and waning of CFS symptoms and how this is characteristic of the

disease.

SPECIAL MASTER: Could you explain generally, not in relation to this case, but

generally how chronic fatigue syndrome, is it sort of something that is a steady state

or do patients change over time, get better, get worse?

…

THE WITNESS: That's typical of chronic fatigue syndrome, is good periods and

bad periods and there's no way to predict them unfortunately. The only thing you

can say about the bad periods is that they can be brought on by exertion, by stress,

by illness. Those are probably the major things that can bring on a bad period, and

those can be very prolonged as a matter of fact.

Id. at 293-94.

The medical record evidence and the expert testimony establish that Petitioner experienced

a severe reaction to the flu vaccine. This severe reaction lasted for at least five months, which is

not consistent with a serum sickness. I find, in accordance with the testimony of Petitioner’s

treating physician, Dr. Smith, and with the expert opinions of Dr. Lapp and Dr. Levine, that

Petitioner’s severe reaction to the flu vaccine constituted the beginning of his CFS. Petitioner has

presented preponderant evidence in support of Althen prong 2.

3. Althen Prong 3

The timing prong contains two parts. First, a petitioner must establish the “timeframe for

which it is medically acceptable to infer causation” and second, he must demonstrate that the onset

of the disease occurred in this period. Shapiro v. Secʼy of Health & Human Servs., 101 Fed. Cl.

532, 542-43 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012), aff’d

without op., 503 F. App’x 952 (Fed. Cir. 2013).

a. Petitioner Developed CFS Two Days after Vaccination

Dr. Lapp testified at hearing that Petitioner’s CFS began two days after his flu vaccine.

See Tr. at. 252. Dr. Smith also testified at the entitlement hearing that the onset of Petitioner’s

CFS was two days after his vaccination. See id. at 69-70.

Dr. Fife testified that the onset of Petitioner’s CFS is unclear.

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Well, that's why I said I think the timing of the chronic fatigue syndrome, when that

actually happens, is a little unclear, at least in my mind, because of the period -- a

long period of time when there did not appear to be that level of symptoms. As I

said, I believe he meets the criteria now, but I think because of the long period

where there weren't those symptoms present, that's why I have trouble timing it

specifically associated with the vaccine.

Id. at 407. As discussed earlier in this ruling, I am convinced by preponderant evidence, based on

the testimony of Petitioner, Dr. Lapp, and Dr. Smith, that Petitioner developed CFS two days after

his flu vaccine.

b. Two Days Is a Temporally-Appropriate Onset Interval

Dr. Lapp testified at hearing that Petitioner’s severe reaction to the flu vaccine constituted

the beginning of his CFS, and that onset 48 hours after vaccination is an appropriate temporal

interval. See Tr. at 434-40. He stated that “85% of cases of [CFS] are acute in origin….” Id. at

253. Dr. Lapp further opined that the “abrupt onset is usually like a flu-like illness or a mono-like

illness or some sort of an illness and then the symptoms develop over time.” Tr. at 280. Lapp’s

opinion that the onset of Petitioner’s CFS is medically appropriate is rooted in substantial

experience treating patients with CFS.

Dr. Lapp’s testimony on this point is supported by several of the medical articles filed in

this case. For example, Devanur & Kerr state: “When a cohort of patients suffering from acute

infection with a particular infectious agent are followed in time, a subset of these have been shown

to develop CFS with an onset contemporaneous with the onset of the particular microbial

infection.” Devanur & Kerr at 5. This reference suggests that an infection can trigger CFS, and

that onset of CFS occurs at the same time as the trigger. Although Petitioner did not suffer from

an infection, he did experience a documented reaction to his flu vaccination which included the

contemporaneous onset of fatigue.

The Working Group also discussed onset of CFS, indicating that it can be “sudden”.

Working Group Rep. at 48. The Working Group further stated that “[a]n insidious and gradually

progressive course is uncommon.” Id.

For the reasons discussed above, I find that Petitioner developed CFS two days after his

flu vaccination, and that this period of time constitutes a medically appropriate onset interval.

Petitioner has presented preponderant evidence in support of the third Althen prong.

VII. Conclusion

Upon careful evaluation of all the evidence submitted in this matter, including the medical

records, testimonies, as well as the experts’ opinions and medical literature, I conclude that

Petitioner has met his burden of proof under Althen. Petitioner is entitled to compensation. An

order regarding damages will issue shortly.

IT IS SO ORDERED.

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s/ Katherine E. Oler

Katherine E. Oler

Special Master

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