Pickens v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

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

DENNIS PICKENS, *

* No. 17-187V

* Special Master Christian J. Moran

Petitioner, *

v. *

* Filed: January 22, 2021

SECRETARY OF HEALTH *

AND HUMAN SERVICES, * Entitlement, MMR vaccine,

* SIDP, diagnosis, ruling on the

Respondent. * papers

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

Andrew D. Downing, Van Cott & Talamante, PLLC, Phoenix, AZ, for Petitioner;

Darryl R. Wishard, United States Dep’t of Justice, Washington, D.C., for

Respondent.

PUBLISHED DECISION DENYING COMPENSATION1

Mr. Pickens alleges that a measles-mumps-rubella (“MMR”) vaccination

caused him to suffer subacute inflammatory demyelinating polyneuropathy

(“SIDP”). The parties disputed when Mr. Pickens began to suffer various

problems and, after a hearing during which Mr. Pickens and other witnesses

testified, a ruling found facts about Mr. Pickens’s health.

Each party has a retained a neurologist. Mr. Pickens relies upon the

opinions of Dr. Robert Friedman. The Secretary relies upon the opinions of Dr.

Peter Donofrio. They have prepared multiple reports. After these doctors

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The E-Government Act, 44 U.S.C. § 3501 note (2012) (Federal Management and

Promotion of Electronic Government Services), requires that the Court post this decision on its

website. This posting will make the decision available to anyone with the internet. Pursuant to

Vaccine Rule 18(b), the parties have 14 days to file a motion proposing redaction of medical

information or other information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions

ordered by the special master will appear in the document posted on the website.

submitted their opinions, the parties submitted briefs in advance of a potential

adjudication.

The undersigned has considered the evidence as well as the arguments. Mr.

Pickens has not met his burden of establishing that he is entitled to compensation.

Mr. Pickens falls short in multiple respects. He has not presented preponderant

evidence that he suffers from SIDP. Even if he suffered from SIDP, Mr. Pickens

has not presented a persuasive medical theory explaining how an MMR vaccine

can cause SIDP. Next, Mr. Pickens has not shown that he began to suffer

symptoms of SIDP within a time for which an inference of causation is

appropriate. Finally, Mr. Pickens has not presented a logical sequence of cause

and effect, linking his MMR vaccine to his health problems. The relative lack of

persuasive evidence indicates that a hearing is not required. Consequently, this

decision finds that Mr. Pickens is not entitled to compensation.

I. Background

The discussion of the events in Mr. Pickens’s life is preceded by an

introduction to SIDP, which occurs relatively infrequently in the Vaccine Program.

This explanation of SIDP and its diagnostic criteria is intended to focus the

evaluation of the events in Mr. Pickens’s life.

A. SIDP

For Guillain-Barré syndrome, neuropathic problems progress for less than

four weeks. For chronic inflammatory demyelinating polyneuropathy, the

neuropathy progresses for more than eight weeks. Thus, cases with a progression

of neuropathy over four to eight weeks could fall into a diagnostic gap. In 2003, a

group of neurologists proposed an entity named “subacute inflammatory

demyelinating polyneuropathy.” S.J. Oh et al., Subacute inflammatory

demyelinating polyneuropathy, 61 Neurology 1507, 1507 (2003), filed as exhibit

26. In this article, the authors reported the “the clinical, electrophysiologic, and

histologic characteristics of SIDP and present[ed] the diagnostic criteria of this

disorder.” Id.

Oh and colleagues stated that a “definite SIDP” diagnosis was appropriate

when the person met four factors. These are:

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1) progressive motor and/or sensory dysfunction consistent with neuropathy

in more than one limb with time to nadir between 4 and 8 weeks,

2) electrophysiologic evidence of demyelination in at least two nerves,

3) no known etiology of neuropathy other than associated diseases, and

4) no relapse on adequate follow-up.

Exhibit 26 (Oh) at 1507. Oh also recognized that “[s]upportive criteria included

S1) high spinal fluid protein level of >55 mg/dL and S2) specific nerve biopsy

finding of inflammatory neuropathy.” Id.

In this case, both parties accepted the Oh criteria for SIDP. See Pet’r’s Br.

at 26; Resp’t’s Br. at 21. However, the parties disputed whether SIDP was an

appropriate diagnosis for Mr. Pickens based upon his medical history.

B. Facts

Mr. Pickens was born on March 3, 1951. Exhibit 1 ¶ 1. People born before

1957, the Secretary argued, “are usually considered to have been infected with

measles as children.” Resp’t’s Br. at 29 (citing Centers for Disease Control and

Prevention, Epidemiology and Prevention of Vaccine-Preventable Diseases:

Measles (2015) at 12, filed as exhibit K; Patricia L. Hibberd, Measles, mumps, and

rubella immunization in adults, UpToDate 1, 5, 8, 16-17 (2020), filed as exhibit

N). Although Mr. Pickens submitted a reply, he did not address this argument.

By 2015, Mr. Pickens had retired from his job as an engineer. He lived in

both Arizona and Mexico. He enjoyed activities such as motorcycling, snow

skiing, snorkeling, and boating. Exhibit 37 at 4; Tr. 12-14.

On February 9, 2015, Mr. Pickens was seen by a nurse practitioner for an

annual physical exam. He had no neurological or other complaints. His exam was

normal, including normal strength and sensation. Exhibit 4 at 26; see also Tr. 21.

He had a minimally elevated serum glucose, but his hemoglobin A1c was normal.

Exhibit 4 at 44-45. On this date, he received an MMR vaccination at a Walgreen’s

in Chandler, Arizona. Exhibit 3 at 1; Tr. 19.

While in Mexico, Mr. Pickens started having mild numbness in his hips and

buttocks on April 7, 2015. Ruling Finding Facts, issued Sept. 20, 2019, ¶ 1 (citing

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evidence); see also Tr. 19, 76. The progression of numbness to weakness and pain

was relatively slow. Similarly, the expansion of the problems from Mr. Pickens’s

hips and buttocks to his legs was also relatively slow. Ruling Finding Facts ¶ 2

(citing evidence).

On April 29, 2015, Mr. Pickens started to experience weakness (as distinct

from numbness) in his lower extremities. Ruling Finding Facts ¶ 3 (citing

evidence). On May 10, 2015, the pain in Mr. Pickens’s hips, buttocks, and legs

increased in severity. Id. ¶ 4 (citing evidence).

Mr. Pickens saw the doctor whom he usually saw on the rare occasions that

he needed a doctor in Mexico, Dr. Jacobo, on or about May 12, 2015. Tr. 22, 34-

35, 88. On May 14, 2015, Mr. Pickens had lab testing performed in Mexico. The

results showed a normal CBC, urinalysis, metabolic panel, rheumatoid factor, C-

reactive protein, and erythrocyte sedimentation rate. Exhibit 44 at 2.2

Mr. Pickens returned to his other home in Arizona on May 29, 2015. Tr.

38, 99, 136, 159-61. Once in Arizona, Mr. Pickens went to an urgent care in

Chandler, Arizona. Exhibit 12 at 1. The intake comments state: “bilateral thigh

pain/weakness, resulting in fall yesterday” and “symptoms began 4 weeks ago with

hip pain.” Id.; accord Tr. 100, 220. The examination revealed weak hip muscles.

Exhibit 12 at 4. X-rays of the spine and hips were normal. Id. at 8.

Mr. Pickens next sought care at the Sonoran Spine Center on June 3, 2015.

He reported a 20-year problem with back pain, which had worsened over the past

“3-4 weeks.” Exhibit 10 at 1. Mr. Pickens checked a box indicating that his

symptoms were “[g]etting somewhat worse.” Id. at 4. Mr. Pickens stated that the

pain was severe and radiated into the buttocks and thighs. He reported the pain as

burning and unlike anything he had experienced before. Due to difficulty with

walking, he was using a four-wheel walker. Id.; see also Tr. 43-44, 104-08, 221.

2

Mr. Pickens obtained results from lab testing performed in Mexico.

However, according to Dr. Jacobo, physicians do not retain copies of medical

records. Tr. 174, 181, 185. In any event, Mr. Pickens did not produce records

from any examination in Mexico.

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At the Sonoran Spine Center, Dr. Chang saw him. On exam, Dr. Chang

found that Mr. Pickens was in severe distress. His leg strength was normal with

the exceptions of 4+/5 left quadriceps weakness and 4/5 bilateral hamstring

weakness. His deep tendon reflexes (“DTRs”) were absent at the knees and ankles

bilaterally. Dr. Chang diagnosed Mr. Pickens with low back pain, and bilateral

lower extremity pain and weakness. Dr. Chang started Mr. Pickens on oral

corticosteroids and sent him for an MRI scan. Exhibit 10 at 12. A lumbar MRI

that same day showed grade 1 spondylolisthesis (forward movement) of L3 on L4

with very mild narrowing of the neural foramina. There was no canal stenosis and

no cord lesions. Id. at 6.

Two days later, on June 5, 2015, Mr. Pickens sought assistance from an

orthopedist at the Hedley Orthopaedic Institute, Dr. Chow. Mr. Pickens reported

that he had bilateral hip pain which had been present for two months and was

getting worse. He also had pain in his thighs and calves. On exam, he had 5/5

strength in his hips, legs, and arms. Dr. Chow diagnosed bilateral hip pain, and

stated that he could not rule out spinal stenosis. Exhibit 15 at 6.

Mr. Pickens returned to Sonoran Spine on June 8, 2015, and was again seen

by Dr. Chang. Mr. Pickens reported no benefit from the steroids and was still

walking with a four-wheeled walker. On exam, he had normal lower extremity

strength with the exception of 4/5 bilateral hamstrings weakness. His upper

extremity strength was normal. Dr. Chang stated that the MRI findings did not

explain all symptoms, and recommended a cervical MRI, lumbar epidural

injections, and physical therapy. Exhibit 10 at 10. Mr. Pickens declined the

epidural. Tr. 44.

On June 10, 2015, Mr. Pickens’s partner returned from their home in Mexico

and saw him in distress. She brought him to the Banner University Medical Center

emergency room. Tr. 163. There, Mr. Pickens complained of bilateral buttock

pain radiating down both legs and lower extremity weakness, with an onset of

symptoms of five weeks ago. His symptoms were worsening. Exhibit 14 at 20.

A doctor examined him in the emergency room and determined Mr. Pickens

had bilateral leg weakness and diminished DTRs in his legs. The doctor admitted

Mr. Pickens to the hospital. Exhibit 14 at 380.

During the hospitalization, Mr. Pickens was seen by a series of doctors,

including neurologists. A neurologist, Dr. Donlon, recorded that Mr. Pickens had

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4/5 weakness of his deltoids and triceps as well as 4/5 weakness of hip and knee

flexion. DTRs were absent in the legs and normal in the arms. Exhibit 14 at 363

(June 11, 2015). A first-year neurology resident, Dr. Ruggle, created a list of

potential diagnoses, which included Guillain-Barré syndrome (“GBS”). Id. at 359-

62.

The doctors ordered multiple tests. The cerebrospinal fluid (“CSF”) analysis

showed an elevated protein of 218 with 24 white cells. Id. at 289. Negative (or

normal) lab results included vitamin B12, creatine kinase, Lyme serology, serum

protein electrophoresis, and an autoimmune panel. Id. at 283-93. Another set of

normal results were MRI scans of the cervical and thoracic spine. Id. at 295 (June

12, 2015).

Based upon the test results and examination, Dr. Donlon determined that

“this likely represents CIDP (versus atypical GBS presentation).” Exhibit 14 at

314. Dr. Donlon ordered plasmapheresis for five days as well as five days of IV

corticosteroids. Id. On June 13, 2015, after two courses of plasmapheresis and

one dose of steroids, Dr. Donlon noted 5/5 bilateral upper extremity strength and

4+/5 hip/knee flexion weakness with absent DTRs. Id. at 326.

Another neurologist, Dr. Kumar, examined Mr. Pickens on June 15, 2015.

Dr. Kumar diagnosed a polyradiculoneuropathy and noted that Mr. Pickens did not

meet the “8 weeks criteria of CIDP yet” but noted it was a likely possibility.

Exhibit 14 at 343. Dr. Kumar again questioned whether Mr. Pickens had GBS or

CIDP. Id. at 357 (June 17, 2015).

The discharge summary from June 17, 2015, reflects some uncertainty in the

diagnosis. It states that Mr. Pickens’s “lower extremity weakness,” “pain,” and

“parathesias” were due to a new diagnosis of “CIDP, although atypical GBS can’t

be excluded.” Exhibit 14 at 6. For oral testimony about Mr. Pickens’s

hospitalization, see Tr. 45-56, 110-19. Mr. Pickens was expected to follow up with

a neurologist and physical therapist.3

3

Beginning in June 2015, Mr. Pickens often attended physical therapy.

Although these notes have been reviewed, they are generally not relevant to

resolving whether the MMR vaccine caused Mr. Pickens to suffer SIDP.

6

The neurologist, Dr. Levine, first saw Mr. Pickens on June 30, 2015. After

Mr. Pickens provided Dr. Levine a history, Mr. Pickens informed Dr. Levine that

he had upper and lower extremity weakness, tingling in his arms and legs, and poor

coordination. In Dr. Levine’s exam, Mr. Pickens had lower extremity weakness

ranging from 3/5 to 4/5 proximally. His DTRs were absent in the upper and lower

extremities. Dr. Levine stated that onset and progression of symptoms was

consistent with GBS. Dr. Levine disagreed with Mr. Pickens’s earlier diagnosis of

CIDP, stating that there was no indication of recurrence or progression beyond

eight weeks. Dr. Levine planned to taper Mr. Pickens’s use of steroids. Dr.

Levine noted that Mr. Pickens had not received the influenza vaccine in association

with onset of his symptoms. Exhibit 7 at 8; see also Tr. 57-60 (Mr. Pickens’s

testimony about the June 30, 2015 appointment with Dr. Levine), 123-24 (same).

Dr. Levine also conducted an EMG / nerve conduction study. The EMG

showed evidence of a severe motor neuropathy. Exhibit 22 at 5.

Mr. Pickens had an appointment with Dr. Andrews, who was his primary

care doctor. Exhibit 4 at 23 (July 20, 2015); Tr. 69 (Mr. Pickens describing Dr.

Andrews as his primary care doctor), 150 (Mr. Pickens stating that he liked Dr.

Andrews). After a history and an examination, Dr. Andrews assessed Mr. Pickens

as suffering from CIDP and hyperglycemia. Exhibit 4 at 24. Dr. Andrews carried

forward the CIDP assessment following an appointment on August 21, 2015. Id. at

20.4

Yet, Dr. Levine, the neurologist, disagreed. Dr. Levine, on September 29,

2015, stated that Mr. Pickens “returns for follow up of his GBS.” Exhibit 7 at 6.

Dr. Levine’s examination revealed “[a]reflexic” reflexes. Id. at 7. In the

assessment, Dr. Levine stated “[Mr. Pickens] is recovering quite nicely from GBS.

I see no evidence of ongoing disease activity to suggest CIDP.” Id.

The next day, Mr. Pickens had an appointment with Dr. Andrews. Exhibit 4

at 17. In the history of present illness, Dr. Andrews recorded: “[n]europathy

4

Because the question to resolve after the June 11, 2019 hearing was Mr.

Pickens’s health between the February 2015 vaccination and the June 2015

hospitalization, Mr. Pickens was not asked questions about medical records created

after July 2015.

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remaining stable and better than in past.” Dr. Andrews’s assessment included

CIDP. Id. at 18. Following this September 30, 2015 appointment with Dr.

Andrews, Mr. Pickens did not seek care from a medical doctor for neurologic

problems for several months. He continued to participate in formal physical

therapy through March 15, 2016, when he was discharged. Exhibit 8 at 24. He

noted some ongoing weakness in his right hip at discharge.

However, approximately just two weeks later, Mr. Pickens returned to

physical therapy and reported that “lately” he felt weaker in his upper extremities.

On exam, he was found to have 3+ to 4/5 upper extremity weakness and 3/5 right

hip flexor weakness. Exhibit 8 at 20 (March 28, 2016).

On March 29, 2016, Mr. Pickens had an appointment at Phoenix

Neurological. Exhibit 7 at 4. The history states that Mr. Pickens “returned to the

office for followup evaluation of his Guillain-Barré syndrome.” Id. Mr. Pickens

complained of weakness throughout the day, but he could perform his activities of

daily living. Mr. Pickens was assessed with continued weakness and the plan

states: “I do not see any evidence of an active neuropathic process. I think his

fatigue is most likely from his poorly treated sleep apnea . . . .” Id. at 5.

On July 11, 2016, Mr. Pickens saw Dr. Levine, reporting that his right foot

still felt weak. The neurological exam was normal, and GBS was the diagnosis

with no signs of recurrence. Exhibit 7 at 2.

About six months later, Mr. Pickens returned to Dr. Levine’s office where he

saw a nurse practitioner. NP Bland diagnosed Mr. Pickens with GBS, but stated

that “based on exam I am not convinced that he is having new peripheral

symptoms.” Exhibit 20 at 6 (January 5, 2017). NP Bland indicated that Mr.

Pickens’s deficits were “most likely residual from previous illness” but scheduled

an EMG to look for new signs of acute peripheral inflammation. Id.

On January 24, 2017, Mr. Pickens’s bilateral lower extremity EMG was

interpreted as normal, although F wave responses were noted to be absent in both

peroneal nerves. Exhibit 22 at 1.

More than one year after the EMG, Mr. Pickens returned to the office of Dr.

Andrews, where he saw a certified physician’s assistant, Anne Sopeland, for a

prescription refill. Mr. Pickens told Ms. Sopeland that he “has neuropathy that he

deals with regularly and is controlled with gabapentin prescription.” Exhibit 36 at

8

1 (January 26, 2018). He also reported “[t]ingling/[n]umbness, bilateral lower

extremities, that is moderate, which is constant.” Id. at 2. Under the CIDP

diagnosis it is noted that “[p]atient cannot have influenza vaccine.” Id. at 3.

About one month later, Mr. Pickens saw Dr. Andrews for a six-month follow

up appointment. Dr. Andrews wrote that Mr. Pickens’s CIDP was “fairly stable.”

Exhibit 36 at 6.

In anticipation of an operation to remove a squamous cell carcinoma, an

anesthesiologist from the Mayo Clinic Hospital in Arizona, Dr. Frances Hu,

evaluated Mr. Pickens on June 19, 2018. Mr. Pickens informed Dr. Hu that “[h]e

is limited by residual peripheral neuropathy following an MMR vaccination-related

[GBS] in 2015, but walks about once a week, completing approximately a mile in

20 minutes on level terrain. Intermittently uses a cane or walking stick on uneven

surfaces.” Exhibit 39 at 1. Dr. Hu’s assessment repeats “Postvaccination [GBS].”

Id. at 3.

On July 11, 2018, Mr. Pickens went to the emergency department of the

Mayo Clinic Hospital in Arizona for gluteal pain. Mr. Pickens recounted that “the

symptoms are similar in nature compared to when he had Guillain-Barré

syndrome.” Id. at 8. The emergency department doctor consulted a neurologist,

Erika Driver-Dunckley.

Dr. Driver-Dunckley obtained a history going back to 2015 when Mr.

Pickens had “back pain extending into the frontal thighs which [was] his

presenting symptom that he had when he had his CIDP three years ago.” Id. at 12.

As part of this history, Mr. Pickens stated that the doctors at “Barrow’s

Neurological Institute” felt his condition “could be GBS, but also CIDP given the

time course.” Id. at 12-13. Mr. Pickens recounted that he “felt weak on his feet . .

. He did try to call his primary neurologist, Dr. Levine, . . . but [he] did not have

anything available for a month and a half. He then decided to come to the

Emergency Department for progression of his pain and concern for return of

CIDP.” Id. at 13. Dr. Driver-Dunckley’s summary of Mr. Pickens’s past medical

history included: “GBS versus CIDP in 2015, attributed to an MMR vaccination

six months prior.” Id. The examination revealed diminished reflexes in the

bilateral Achilles. Id. at 14.

For an impression and plan, Dr. Driver-Dunckley stated, “It is interesting

that the patient has the same pain presentation that he had prior to him being

9

diagnosed with CIDP in the past. Because he is not experiencing any weakness or

progression of neurologic symptoms, we believe it is safe for the patient to be

discharged home.” Id. While Dr. Driver-Dunckley released Mr. Pickens from the

hospital, she also encouraged a relatively quick follow up: “I did contact his

primary neurologist’s office and asked that he have an expedited appointment with

an EMG prior to his appointment with the physician.” Id.

The next day, Mr. Pickens sought assistance from staff at the Banner

University Medical Center because of worsening bilateral leg pain and paresthesias

over the course of two days. Exhibit 40 at 23 (July 12, 2018). Mr. Pickens

informed the ER staff of his history of GBS and told the doctor “‘it starts like

this.’” Id. A lumbar puncture in the emergency department revealed that Mr.

Pickens’s CSF protein level was elevated at 122.8. Id. at 22. The admitting

physician diagnosed him with radiculopathy vs. CIDP. Id. at 22-23.

While in the hospital, a neurologist consulted on Mr. Pickens’s case. The

neurologist diagnosed Mr. Pickens with leg paresthesias with evidence of bilateral

lower extremity radiculopathy on exam as well as residual length-dependent

neuropathic pain from his 2015 GBS/CIDP. The neurologist stated that CIDP was

possible based on the reported urinary retention and elevated CSF protein, but

noted that the presentation was atypical with preserved strength and reflexes. The

consulting neurologist recommended that Mr. Pickens follow up with his regular

neurologist, Dr. Levine, and obtain a repeat EMG/NCS. Id. at 207-13; see also id.

at 3 (discharge summary).

Mr. Pickens returned to the Mayo Clinic for the EMG/NCS.5 The

interpreting doctor stated, “The EMG shows electrophysiologic evidence of an old

neurogenic process which could reflect residue of Guillain-Barré Syndrome or less

likely, a lower lumbosacral radiculopathy.” Exhibit 39 at 56.

A neurologist from the Mayo Clinic saw Mr. Pickens on August 2, 2018.

Mr. Pickens reported his history of GBS or CIDP and complained of “back pain.”

Exhibit 49 at 517, pdf 127. Mr. Pickens was found to be weak in the right hip

flexor and gluteus maximus. Id. at 518. The neurologist diagnosed him with

5

A nurse stated that Dr. Levine was out of the country. Exhibit 40 at 213.

10

“possible CIDP with recent exacerbation.” Id. at 519. For the possible CIDP, the

neurologist ordered IVIG therapy. Id. at 524.

After his last course of IVIG, Mr. Pickens returned to the Mayo Clinic and

reported that he had a severe diffuse rash with blisters. Mr. Pickens thought that he

had no improvement in his neurological symptoms with IVIG. His reflexes were

“diffusely absent,” and “sensory testing showed decreased pin sensation in the left

foot and right thigh.” Id. at 428. He was diagnosed with a history of GBS with a

stable exam, and further IVIG was not recommended. Id. at 426-29.

In March 2019, Mr. Pickens cancelled his neurology visit and did not

reschedule it. Id. at 266.

This background is the foundation for the analysis of the elements of Mr.

Pickens’s claim, which is set out below. In addition, the qualifications of the

parties’ retained experts are also relevant to the analysis of Mr. Pickens’s claim.

C. Qualifications

Special masters may consider the relative expertise of testifying experts

when weighing the value of their opinion. See Depena v. Sec’y of Health &

Human Servs., No. 13-675V, 2017 WL 1075101 (Fed. Cl. Spec. Mstr. Feb. 22,

2017), mot. for rev. denied, 133 Fed. Cl. 535, 547-48 (2017), aff’d without op.,

730 Fed. App’x 938 (Fed. Cir. 2018); Copenhaver v. Sec’y of Health & Human

Servs., No. 13-1002V, 2016 WL 3456436 (Fed. Cl. Spec. Mstr. May 31, 2016),

mot. for rev. denied, 129 Fed. Cl. 176 (2016).

1. Dr. Friedman

Robert J. Friedman graduated from the University of Pittsburgh medical

school in 1986. In 1987-1990, he was chief resident in neurology at the

Dartmouth-Hitchcock Medical Center. In 1996, he was a clinical fellow within the

department of neurology at Johns Hopkins University where he specialized in pain

management. He is board-certified in neurology, pain medicine, and

neuromuscular medicine. He is also certified by the American Board of

Independent Medical Examiners. Exhibit 46 (curriculum vitae) at 1-2.

11

Since 1998, Dr. Friedman has worked in a private practice that appears to

specialize in the treatment of headaches. The research studies in which he

participated as a subinvestigator from 1996-1998 involved migraines. Id. at 3-4.

Dr. Friedman’s curriculum vitae does not list any academic positions. He

has one publication, although, as he acknowledges, he has not written “any articles

published in peer-reviewed journals that inform the issues in this case.” Exhibit 23

(Dr. Friedman’s Dec. 20, 2017 report) at 1.

Dr. Friedman appears not to have any specialized knowledge in

immunology. This apparent deficit contributes to how his opinion regarding the

theory and the timing is weighed. See sections IV and V below.

2. Dr. Donofrio

Peter Donofrio received a medical degree from the Ohio State University

School of Medicine in 1975. He had a residency in neurology from 1978 to 1991

at the University of Michigan Medical Center followed by a fellowship in

neuromuscular medicine at the same institution. Dr. Donofrio holds board-

certifications in internal medicine, neurology, electrodiagnostic medicine, and

neuromuscular medicine. Exhibit B (curriculum vitae) at 1-2.

Beginning in 1981, Dr. Donofrio held various academic positions at various

medical institutions. When his curriculum vitae was prepared, he was a professor

of neurology and director of the neuromuscular division at the Vanderbilt

University School of Medicine. Id. at 3-4. He has participated in more than 25

research programs, including some in which he was the principal investigator.

Three research programs tested treatments in patients with CIDP. Id. at 9-12.

In response to an instruction asking about relevant publications, Dr.

Donofrio stated that he is the author of a textbook, The Textbook of Peripheral

Neuropathy, published in 2012. Exhibit A (Dr. Donofrio’s April 30, 2018 report)

at 1. In addition, Dr. Donofrio has written dozens of articles published in peer-

reviewed journals and book chapters. His topics have included GBS and CIDP.

His work on demyelinating diseases, such as GBS and CIDP, suggests that

Dr. Donofrio has some advanced knowledge in immunology because those

diseases are widely considered to have an autoimmune etiology. Cf. exhibit A at

16 (listing one publication titled “Clinical Pearls from An Expert: Redefining the

12

Limits of Immunotherapy and Its role in Autoimmune Disease”). However, Dr.

Donofrio has not stated that he is board-certified in immunology.

3. Evaluation

Dr. Friedman appears to be a competent neurologist and the undersigned

does not hesitate to recognize him as an expert in the field of neurology. However,

his subspecialty appears to be headaches and pain management.

Dr. Donofrio also appears to be a competent neurologist. But, his

background in studying and writing about disorders of the peripheral nervous

system, including GBS and CIDP, make him a better fit to opine on the issues in

Mr. Pickens’s case. Thus, simply by the question of qualifications, the Secretary

has presented stronger evidence.

In concluding that Dr. Donofrio possesses a deeper background in the

relevant topics, the undersigned has also noted a credibility issue in each of the

series of reports from Dr. Friedman and Dr. Donofrio. For Dr. Friedman, there

appears to be a variation in his opinion regarding the appropriate temporal

relationship. Initially, Dr. Friedman stated that 6 weeks “is the approximate onset

time course that has been employed to assess a link between GBS and

vaccination.” Exhibit 23 at 8. Later, after the Ruling Finding Facts was issued,

Dr. Friedman added that because the MMR vaccine contains a live attenuated

virus, “the immune response would take longer than in an inactivated vaccine

(which is the type most utilized in the study of the association of GBS with

seasonal influenza vaccine).” Exhibit 45 at 2. The omission of this explanation

from Dr. Friedman’s first report suggests that his opinion changed after the

Findings of Fact.

The Findings of Fact also appear to complicate Dr. Donofrio’s presentation

of an opinion. After the Ruling Finding Facts was issued, the parties were directed

to present the Findings of Fact with an instruction that these findings are the facts

in Mr. Pickens’s case. In the ensuing report, Dr. Donofrio stated, “Although I

accept the facts found in this case, I would like to take the liberty to further

comment on the Facts entered by Special Master Moran when compared with the

facts contained in the contemporaneous medical records.” Exhibit H at 1. In

commenting on how he thinks the evidence preponderates after the special master

has already ruled, Dr. Donofrio appears to be moving away from the perspective of

a dispassionate provider of information and slipping into the role of an advocate.

13

The credibility issue regarding Dr. Friedman and Dr. Donofrio plays, at

most, a meager role in the outcome of Mr. Pickens’s case. Because the case is

being adjudicated on the papers, neither Dr. Friedman nor Dr. Donofrio have been

questioned about these aspects of their reports. Nonetheless, because Dr. Friedman

and Dr. Donofrio appear to be qualified experts who may write reports in the

future, these concerns are noted here with the hope that they will not be repeated.

II. Standards for Adjudication

A petitioner is required to establish his case by a preponderance of the

evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence

standard requires a “trier of fact to believe that the existence of a fact is more

probable than its nonexistence before [he] may find in favor of the party who has

the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of

Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations

omitted). Proof of medical certainty is not required. Bunting v. Sec’y of Health &

Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).

Distinguishing between “preponderant evidence” and “medical certainty” is

important because a special master should not impose an evidentiary burden that is

too high. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379-80

(Fed. Cir. 2009) (reversing special master’s decision that petitioners were not

entitled to compensation); see also Lampe v. Sec’y of Health & Human Servs., 219

F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec’y of Health & Human Servs., 9 F.3d

958, 961 (Fed. Cir. 1993) (disagreeing with dissenting judge's contention that the

special master confused preponderance of the evidence with medical certainty).

III. Diagnosis

In Broekelschen v. Sec’y of Health and Human Servs., 618 F.3d 1339, 1346

(Fed. Cir. 2010), the Federal Circuit recognized that in some circumstances, the

special master may “first determine which injury was best supported by the

evidence presented in the record before applying the Althen test.” Citing

Broekelschen, the Federal Circuit has also explained that “[i]n the absence of a

showing of the very existence of any specific injury of which the petitioner

complains, the question of causation is not reached.” Lombardi v. Sec’y of Health

& Human Servs., 656 F.3d 1343, 1353 (Fed. Cir. 2011).

14

Here, the parties disagree about the appropriate diagnosis. Mr. Pickens’s

expert, Dr. Friedman, states that Mr. Pickens suffered from subacute inflammatory

demyelinating polyneuropathy (“SIDP”). Exhibit 23 at 8; accord exhibit 45 at 2.

In contrast, the Secretary’s expert in neurology, Dr. Donofrio, disagrees. He

stated that Mr. Pickens does not suffer from SIDP. (Dr. Donofrio also states that

Mr. Pickens does not suffer from GBS or CIDP.) Exhibit A at 8.

As mentioned earlier, the parties agree that the Oh article sets forth the

relevant diagnostic criteria for SIDP. See exhibit 26. The parties agree that of the

four criteria, Mr. Pickens satisfies one criterion---no other etiology for his

neurologic problems. The remaining three criteria are discussed below. These are:

a progressive motor and/or sensory dysfunction in more than one limb with time to

nadir 4-8 weeks, electrophysiologic evidence of demyelination in at least two

nerves, and no relapse on adequate follow up.

a progressive motor and/or sensory dysfunction in more than one limb with

time to nadir 4-8 weeks

Mr. Pickens started having mild numbness in his hips and buttocks on April

7, 2015. Ruling Finding Facts ¶ 1. The parties accept this development as the

beginning of Mr. Pickens’s neurologic problems. The question becomes did Mr.

Pickens reach his nadir four to eight weeks later?

In Mr. Pickens’s brief, he argues that “May 29, 2015 is a strong contender

for the date of nadir.” Pet’r’s Br. at 36. Dr. Friedman more generally opines that

“the progression of Mr. Pickens’ peripheral nerve condition was compatible with

an approximately 4-8 week time period of progression.” Exhibit 45 at 2. Dr.

Friedman, however, did not identify May 29, 2015 as the nadir. May 29, 2015 is

52 days (or nearly eight weeks) after April 7, 2015.

Counsel’s selection of May 29, 2015 as the nadir is unpersuasive. While

Mr. Pickens did seek medical attention at an urgent care center, see exhibit 12 at 1,

his symptoms progressed after that date. Just a few days later, Mr. Pickens

checked a box saying his symptoms were “[g]etting somewhat worse.” Exhibit 10

at 1 (June 3, 2015). Two more days later, Mr. Pickens told Dr. Chow, an

orthopedist at the Hedley Orthopaedic Institute, that he was getting worse. Exhibit

15 at 6, cited in Resp’t’s Br. at 5. It appears that Mr. Pickens continued to decline

until his partner returned from Mexico on June 10, 2015. When she saw his degree

15

of distress, she brought him to the emergency room. In the emergency room, Mr.

Pickens again said that he was worsening. Exhibit 14 at 20. Neither Mr. Pickens’s

attorney nor Dr. Friedman specifically discuss these medical records after May 29,

2015.

This series of medical records pushes Mr. Pickens’s nadir to June 10, 2015.

A progression of symptoms from April 7, 2015, to June 10, 2015, amounts to a

course that is 64 days, approximately nine weeks. Thus, this duration does not fit

the diagnostic criteria for SIDP.

electrophysiologic evidence of demyelination in at least two nerves

The parties dispute whether Mr. Pickens fulfills this criterion with any of the

three EMG/NCS tests he underwent. These tests were performed on June 30, 2015

(exhibit 22 at 5), January 24, 2017 (exhibit 22 at 1-4), and July 28, 2018 (exhibit

39 at 56-58).6 Mr. Pickens relies most heavily on the June 30, 2015 test. See

Pet’r’s Br. at 22.

The results of June 30, 2015 test, which Dr. Levine ordered, show various

measurements without any notation as to whether the results were expected or

abnormal. Exhibit 22 at 5. But, the entirety of the “summary/interpretation” is

“[t]his study found evidence for a severe motor neuropathy.” Id.

Dr. Donofrio stated that this study showed “minimal changes . . . not severe

enough to classify as demyelinating.” Exhibit P at 1. However, Dr. Donofrio does

not explain the basis for his reasoning that the changes were minimal.

The evidence on this narrow point is relatively close. Dr. Donofrio is correct

that Dr. Levine’s interpretation of the June 30, 2015 test does not literally say

“demyelinating.” On the other hand, the interpretation does say a “severe motor

neuropathy,” leaving open the possibility that Mr. Pickens’s injury was

demyelinating. The results of the third EMG/NCS, which was administered on

6

The earliest of these tests was performed 20 days after Mr. Pickens reached

nadir. The next two tests were performed approximately 18 months and

approximately two years later. Neither expert discussed how the passage of time

affects the value of the diagnostic tests, if at all.

16

July 24, 2018, elevates this possibility to a probability. The interpretation of this

study was that the results showed “evidence of an old neurogenic process which

could reflect residua of Guillain-Barré Syndrome.” As Mr. Pickens argued, GBS is

a demyelinating disease. See Pet’r’s Reply at 4. Thus, taken as a whole, the

evidence preponderates, even if slightly, in favor of finding that Mr. Pickens met

this criterion.

no relapse on adequate follow up

The remaining criterion concerns any relapse. This criterion helps

distinguish SIDP from chronic inflammatory demyelinating polyneuropathy. See

Pet’r’s Br. at 27 n.3 (suggesting that if Mr. Pickens did have a relapse, then CIDP

was an appropriate diagnosis).

Mr. Pickens may have suffered a relapse in symptoms in January 2017 and

July 2018. First, on January 5, 2017, Mr. Pickens was seen by nurse practitioner

Bland in the office of Dr. Levine. Mr. Pickens complained about “increased

LE/LBP and numbness in thighs for the last couple of weeks.” Exhibit 20 at 5.

However, NP Bland concluded that the deficits were “most likely residual from

previous illness.” Id. at 6. Moreover, the January 24, 2017 EMG/NCS was

normal. See exhibit 22 at 1-4; exhibit P (Dr. Donofrio’s report describing the

results as “normal”).

Second, and more importantly, Mr. Pickens’s treatment at the Mayo Clinic

in July-October 2018 constitutes a relapse according to Dr. Donofrio. Exhibit P at

1. Mr. Pickens told both the emergency room doctor and Dr. Driver-Dunckley, a

neurologist, that his symptoms were similar to the symptoms he experienced in

2015. Exhibit 39 at 8, 12. Mr. Pickens communicated similar information to a

doctor at the Banner University Medical Center. Exhibit 40 at 23 (reporting “it

starts like this”). A neurologist who examined Mr. Pickens on August 2, 2018,

diagnosed him with “possible CIDP with recent exacerbation.” Exhibit 49 at 519.

Against these reports, Mr. Pickens argues that he did not relapse because he did not

respond to IVIG. Pet’r’s Reply at 3 (citing exhibit 49 at 428-29). However,

people with CIDP or other demyelinating diseases do not always respond to IVIG.

Thus, the lack of response does not undermine Dr. Donofrio’s opinion that Mr.

Pickens suffered a relapse in 2018.

In sum, of the four diagnostic criteria, Mr. Pickens definitely meets one (no

other etiology). He probably meets another criterion, electrophysiologic evidence

17

of demyelination. But, he does not meet the other two criteria, a progression to

nadir in four to eight weeks and no relapse.

In addition to considering how Dr. Friedman and Dr. Donofrio have

evaluated Mr. Pickens in light of the criteria, the undersigned has also considered

the views of treating doctors. The diagnoses of treating doctors can be valuable

because they have first-hand experience in examining their patients and they are

usually presenting opinions outside the context of litigation. Capizzano v. Sec’y of

Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). Here, the

Secretary argued that no treating doctor diagnosed Mr. Pickens as suffering from

SIDP. Resp’t’s Br. at 23. Although Mr. Pickens filed a reply, he did not rebut this

argument and the undersigned has not located any treaters who diagnosed Mr.

Pickens with SIDP.

For these reasons, Mr. Pickens has failed to establish that he suffers from

SIDP.

IV. Theory

Assuming that Mr. Pickens had established that he suffered from SIDP, his

burden includes presenting evidence regarding “a medical theory causally

connecting the vaccination and the injury.” Althen, 418 F.3d at 1278. The theory

must be probable, not just possible. Boatmon v. Sec’y of Health & Human Servs.,

941 F.3d 1351, 1360 (Fed. Cir. 2019).

Here, in his brief, Mr. Pickens has advanced “molecular mimicry.” Pet’r’s

Br. at 27. This assertion, in turn, rests upon Dr. Friedman’s opinions. In his first

report, Dr. Friedman maintains that “[v]accines that contain antigens from

infectious agents may induce autoimmune events by several mechanisms such as

molecular mimicry, epitope spreading, bystander activation, and polyclonal

activation.” Exhibit 23 at 7 (citing Nancy Agmon-Levin et al., Vaccines and

autoimmunity, 5 Nat. Rev. Rheumatol. 648, 648-52 (2009), filed as exhibit 28).

Other than this sentence, the term “molecular mimicry” does not appear in Dr.

Friedman’s first report. The term also does not appear in Dr. Friedman’s second

report.

By citing cases, Mr. Pickens argues that special masters have accepted

molecular mimicry. Pet’r’s Br. at 27-28 n.4. However, the Secretary countered

“merely chanting the magic words ‘molecular mimicry’ in a Vaccine Act case does

18

not render a causation theory scientifically reliable, absent additional evidence

specifically tying the mechanism to the injury and/or vaccine in question.”

Resp’t’s Br. at 23-24 (quoting McKown v. Sec’y of Health & Human Servs., No.

15-1451V, 2019 WL 4072113, at *50 (Fed. Cl. Spec. Mstr. July 15, 2019)).

McKown’s description of the burden seems to fit the appellate guidance. See

Caves v. Sec’y of Health & Human Servs., 100 Fed. Cl. 119, 135 (2011), aff’d

without op., 463 F. App’x 932 (Fed. Cir. 2012).

Here, the evidence does not support a finding that molecular mimicry can

explain how an MMR vaccine can cause SIDP. The primary evidence, Dr.

Friedman’s report, is conclusory. It does not propose any homologies between

components of the MMR vaccine and any human tissue involved in the

pathogenesis of SIDP. As such, Dr. Friedman’s report is one of the thinnest

opinions regarding molecular mimicry.

Admittedly, Dr. Friedman cites some literature that he contends supports his

hypothesis that the MMR vaccine can cause SIDP via molecular mimicry.7

Preliminarily, none of the articles address SIDP specifically. Instead, the articles

discuss a more common demyelinating condition, GBS. Because Dr. Friedman has

explained that SIDP represents a condition between GBS and CIDP, an

extrapolation from articles about GBS to SIDP seems reasonable, at least when the

Secretary has not objected. However, these articles do not show that the MMR

vaccine can cause GBS.

The strongest evidence weighing against the finding that the MMR vaccine

can cause GBS is a set of epidemiological studies. For a lengthy discussion of how

epidemiologic studies contribute to an analysis of causation in the Vaccine

Program, see Tullio v. Sec’y of Health & Human Servs., No. 15-51V, 2019 WL

7580149, at *5-11 (Fed. Cl. Spec. Mstr. Dec. 19, 2019), mot. for rev. denied, 149

Fed. Cl. 448 (2020). In the first study, researchers compared the incidence of GBS

among approximately 73 million children living in Argentina, Brazil, Chile, and

Colombia between 1990 and 1994, who received a measles vaccine during a mass

vaccination campaign. The authors concluded, “We found no evidence of a

relation between measles vaccination and GBS.” Claudio da Silveria et al.,

7

The Secretary skipped any discussion of the articles on which Dr.

Friedman relied. See Resp’t’s Br. at 24.

19

Measles vaccination and Guillain-Barré syndrome, 349 Lancet 14, 16 (1997), filed

as exhibit 33.

The second study considered people hospitalized for GBS in Finland from

1982 to 1986, during which more than a half-million people received an MMR

vaccine. The researchers detected no increase in the cases of GBS. Thus, they

concluded that their study “provides further evidence against the postulated causal

relation between MMR vaccination and GBS.” Annamari Patja et al., Risk of

Guillain-Barré syndrome after measles-mumps-rubella vaccination, 138 J.

Pediatrics 250, 253 (2001), filed as exhibit 34.

To Dr. Friedman’s credit, he cited these population-based studies. However,

Dr. Friedman does not persuasively argue against them. See exhibit 23 at 8.

The presence of two large epidemiologic studies weighs against the finding

of causation. However, epidemiology is not the only factor that contributes to an

evaluation of prong 1. Thus, the remaining articles Dr. Friedman cites are

considered as well.

Dr. Friedman cited the package insert for the vaccine. Exhibit 23 at 7. The

manufacturer listed “adverse reactions . . . without regard to causality . . . [that]

have been reported during clinical trials.” Exhibit 30 at 6. One of those conditions

was “Guillain-Barré syndrome.” Id. at 7. Guillain-Barré syndrome is not listed in

the sections of the product insert listing “contraindications,” “warnings,” and

“precautions.” Id. at 3-7.

When the manufacturer’s statements about potential vaccine causation do

not stem from a scientific exploration of causation, special masters have not given

manufacturers’ package inserts much weight. In a leading case, one special master

went so far as to declare that “federal regulations specifically preclude the contents

of drug product labels, as reproduced in the [Physician’s Desk Reference], from

serving as admissions regarding causation.” Werderitsch v. Sec’y of Health &

Human Servs., No. 99-319V, 2005 WL 3320041, at *8 (Fed. Cl. Spec. Mstr. Nov.

10, 2005). Relying upon regulations found at 21 C.F.R. § 600.80, Werderitsch

reasoned that because the Food and Drug Administration requires manufacturers to

list adverse occurrences regardless of causality, the listing of an event on a product

insert does not support a finding of causation. Other cases declining to rely upon

package inserts to support a finding of causation include: Salerno v. Sec’y of

Health & Human Servs., No. 16-1280, 2020 WL 344163, at *13 (Fed. Cl. Spec.

20

Mstr. May 29, 2020); Bender v. Sec’y of Health & Human Servs., No. 11-693V,

2018 WL 3679637, at *31 (Fed. Cl. Spec. Mstr. July 2, 2018) (noting that “vaccine

package inserts do not constitute causation evidence meriting significant weight”),

mot. for rev. denied, 141 Fed. Cl. 262 (2019); Tompkins v. Sec’y of Health &

Human Servs., No. 10-261V, 2013 WL 3498652, at *14 (Fed. Cl. Spec. Mstr. June

21, 2013) (citing the testimony of petitioner’s expert who acknowledged that

reports in package inserts “may reflect a temporal relationship between vaccine

and illness”), mot. for rev. denied, 117 Fed. Cl. 713 (2014); Coppola v. Sec’y of

Health & Human Servs., No. 09-631V, 2012 WL 1118849, at *26 (Fed. Cl. Spec.

Mstr. Mar. 7, 2012) (rejecting a petitioner’s reliance on vaccine package insert

information as indicative of alleged vaccine causation); Doe v. Sec’y of Health &

Human Servs., No. 99-670V, 2004 WL 3321302, at *14 (Fed. Cl. Spec. Mstr. Oct.

5, 2004) (finding that petitioner failed to establish that hepatitis B vaccine can

cause chronic fatigue syndrome although the package insert listed several

symptoms petitioner experienced). But see Russell v. Sec’y of Health & Human

Servs., No. 11-0282V, 2014 WL 4922194, at *7 (Fed. Cl. Spec. Mstr. Sept. 9,

2014) (giving some weight to a manufacturer’s report of an adverse event “judged

to be vaccine related by the study investigator” but still finding that petitioner

failed to meet the burden regarding prong 1). Here, the manufacturer’s report that

Guillain-Barré syndrome has occurred during clinical trials was stated “without

regard to causality.” Exhibit 30 at 6. In accord with these non-binding precedents,

the undersigned declines to give the manufacturer’s insert more weight than the

epidemiologic studies.

So, too, the epidemiologic studies carry more weight than the two case

reports Dr. Friedman cites. These case reports are exhibit 31 (Morris) and exhibit

32 (Atkins). In general, case reports provide little, if any, information helpful to

determining causation because they present only a temporal sequence of events in

which the vaccination preceded an adverse health event. See K.O. v. Sec’y of

Health & Human Servs., No. 13-472V, 2016 WL 7634491, at *11-12 (Fed. Cl.

Spec. Mstr. July 7, 2016) (discussing appellate precedent on case reports).

Finally, Dr. Friedman also cites a study based upon the Vaccine Adverse

Events Reporting System (“VAERS”) database. Nizar Souayah et al., Guillain-

Barré syndrome after vaccination in the United States A report from the CDC/FDA

Vaccine Adverse Event Reporting System, 25 Vaccine 5253 (2007), filed as exhibit

25. One special master declined to rely upon this article because it lacked an

unvaccinated population who can serve as a comparison group. See Tompkins,

21

2013 WL 3498652, at *26 n.66. Moreover, even if the methodology of the

Souayah researchers could be set aside, the findings of the Souayah group with

respect to the MMR vaccine are ambiguous. The entirety of their discussion of the

MMR vaccine is contained in a single sentence: “Although no report of GBS

following measles–mumps–rubella vaccine (MMR) was observed in our study, it

was the most frequent vaccine associated with GBS when administrated with other

vaccines (6 patients).” Exhibit 25 (Souayah) at 5255. The presence of another

vaccine confounds any attempt to draw a meaningful conclusion about the MMR

vaccine.

For these reasons, Mr. Pickens has not established that molecular mimicry is

a persuasive medical theory to explain how the MMR vaccine can cause GBS. It,

therefore, follows that this theory cannot be extended as a basis for finding that the

MMR vaccine can cause SIDP, the condition from which Dr. Friedman asserts that

Mr. Pickens suffers. Consequently, Mr. Pickens has not met his burden regarding

prong 1.

V. Timing

Assuming that Mr. Pickens had established the condition for which he

sought compensation and further assuming that Mr. Pickens had established that

molecular mimicry persuasively explained how the MMR vaccine can cause SIDP,

Mr. Pickens would also be required to present preponderant evidence regarding

timing. As discussed above, Mr. Pickens has not met his burden regarding

diagnosis or theory. Nevertheless, for sake of completeness, the timing prong is

discussed as well.

“[T]he proximate temporal relationship prong requires preponderant proof

that the onset of symptoms occurred within a timeframe for which, given the

medical understanding of the disorder’s etiology, it is medically acceptable to infer

causation-in-fact.” Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347,

1352 (Fed. Cir. 2008). The timing prong actually contains two parts. A petitioner

must show the “timeframe for which it is medically acceptable to infer causation”

and 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). Because the onset of Mr. Pickens’s alleged SIDP is less controversial,

the analysis begins with that issue.

22

A. Onset of Neurologic Problems

Mr. Pickens started having mild numbness in his hips and buttocks on April

7, 2015. Ruling Finding Facts ¶ 1 (citing evidence). The spread of his problems to

his legs was relatively slow. Id. (citing evidence). On April 29, 2015, Mr. Pickens

started to experience weakness (as distinct from numbness) in his lower

extremities. Id. ¶ 3 (citing evidence).

Which of these problems constituted a manifestation of SIDP is not entirely

clear. As noted in the Order for Submissions in Advance of Potential

Adjudication, “the experts’ responses to the Ruling were cursory. Dr. Friedman

did not identify what problem was the initial manifestation of SIDP, although he

stated the time course was still consistent. Exhibit 45 at 2. Dr. Donofrio,

similarly, did not state what symptom was an initial manifestation of SIDP

perhaps, because Dr. Donofrio does not agree with the SIDP diagnosis. Dr.

Donofrio did note that the earliest symptom, mild numbness in the hips and back,

began 57 days after the vaccination.” Order, issued Apr. 27, 2020, at 6.

Mr. Pickens argues that April 7, 2015, marks the onset of Mr. Pickens’s

SIDP. Pet’r’s Br. at 35. As an attorney’s argument, the selection of this date is

fair. While Mr. Pickens’s case would be stronger if Dr. Friedman directly offered

an opinion as to what problem marked a manifestation of SIDP, the Secretary did

not forcibly challenge April 7, 2015, as the starting point for the alleged SIDP. See

Resp’t’s Br. at 26-27. Thus, for the sake of argument, the undersigned assumes

that April 7, 2015, is the beginning of Mr. Pickens’s neurologic condition. April 7,

2015, is 57 days (approximately eight weeks) after the February 9, 2015

vaccination. The ensuing and more controverted point is whether 57 days is an

amount of time for which an inference of causation is appropriate.

B. Appropriate Temporal Relationship

Analogizing to GBS, Dr. Friedman proposed that an acceptable interval is

six weeks. Exhibit 23 at 8; see also 42 C.F.R. § 100.3 ¶ XIV.D (associating flu

vaccine with GBS that develops within 3-42 days). Six weeks was used in the

epidemiologic studies. See exhibit 33 (da Silveria) at 14; exhibit 34 (Patja) at 250.

Later, Dr. Friedman stated that the latency after an MMR vaccine would be longer

because the MMR vaccine contains a live attenuated virus. Exhibit 45 at 2. The

entirety of Dr. Friedman’s report on this point is:

23

Given the nature of the MMR vaccine (a live attenuated vaccine), the

immune response would take longer than in an inactivated vaccine (which is

the type most utilized in the study of the association of GBS with seasonal

influenza vaccine). Additionally, the latency between immune exposure and

a more subacute onset condition such as SIDP would be longer than that

expected with GBS. For these reasons additionally, the time course of the

onset of Mr. Pickens’ SIDP condition was still consistent with the immune

response to the MMR vaccine being a significant contributing factor to Mr.

Pickens’ SIDP condition.

Id. This discussion from an expert is unusually brief.

As Dr. Friedman suggested, the MMR vaccine contains a live attenuated

virus. Mr. Pickens builds on this statement, adding that “the MMR vaccination

takes time to replicate in the body before it induces an immune response.” Pet’r’s

Br. at 34. One basis is a statement from the CDC. Centers for Disease Control and

Prevention, Principles of Vaccination (last reviewed Nov. 15, 2016) at 6, filed as

exhibit 29 (“To produce an immune response, live attenuated vaccines must

replicate (grow) in the vaccinated person. A relatively small dose of virus or

bacteria is administered, which replicates in the body and creates enough of the

organism to stimulate an immune response.”). Another basis is Ahlum v. Sec’y of

Health & Human Servs., No. 12-763V, 2018 WL 4323623 (Fed. Cl. Spec. Mstr.

Aug. 16, 2018).

In response, the Secretary challenges the extension beyond 42 days.

Relying upon an article published by the Centers for Disease Control and

Prevention covering the epidemiological aspects of the measles virus, the Secretary

asserts that the immune response to the measles vaccination develops within 7-9

days. Resp’t’s Br. at 28 (citing exhibit K at 1-2, 14). The Secretary further notes

that the Vaccine Injury Table lists certain injuries as associated with an MMR

vaccine, but the timeframes are 42 days or less. For thrombocytopenic purpura

after measles vaccine (included as part of the MMR vaccine), see 42 C.F.R.

§ 100.3 ¶ V.A (5-30 days). For encephalopathy after MMR, see 42 C.F.R. § 100.3

¶ III.B (5-15 days). For chronic arthritis after rubella vaccine (included as part of

the MMR vaccine), see 42 C.F.R. § 100.3 ¶ IV.A (7-42 days). Finally, the

Secretary contends that because Mr. Pickens suffered a measles infection as a

child, his exposure to the MMR vaccine should have generated a more rapid

response due to memory cells. Resp’t’s Br. at 29.

24

Overall, the experts’ reports on this issue were limp. As noted in the

discussion of Dr. Friedman’s and Dr. Donofrio’s qualifications, neither doctor

appears to have any particular knowledge of the immune system. The consequence

of this relative weakness in the expert’s background falls more heavily on Mr.

Pickens because he, as the petitioner, bears the burden of presenting a persuasive

case. Dean v. Sec’y of Health & Human Servs., No. 13-808V, 2017 WL 2926605,

at *18 n.12 (Fed. Cl. Spec. Mstr. June 9, 2017). And, this persuasive case must be

made through “medical records or medical opinion.” 42 U.S.C. § 300aa–13(a)(1).

However, the record includes medical literature and the attorneys have

constructed arguments based upon those exhibits. While attorney argument does

not constitute evidence, the undersigned has considered the medical literature and

arguments from both Mr. Pickens and the Secretary.

Tentatively, the undersigned is inclined to find that Mr. Pickens has not met

his burden of establishing that 57 days is within an appropriate period to establish

causation. First, when researchers explored whether the MMR vaccine increased

the incidence of GBS after vaccination, the researchers used 42 days as their

period. Exhibit 33 (da Silveria) at 14. This selection suggests that 42 days remains

an outside limit for an MMR vaccine-induced demyelinating injury.

Second, while Dr. Friedman states that an immune response to a vaccine

containing a live yet attenuated virus “would take longer” than the immune

response to a vaccine containing an inactivated pathogen, Dr. Friedman did not

quantify how much longer. This vagueness in Dr. Friedman’s opinion is a

deficiency. Dr. Friedman did not address or account for information suggesting

that the immune response to the MMR vaccine happens within 7-9 days. If, simply

for sake of argument, 9 days is added to 42 days, then the result is 51 days.

Third, the Secretary’s point about a memory response predicting a quicker

response could be valid. But, the Secretary’s response itself has holes. The

Secretary relies upon Mr. Pickens’s exposure to the measles virus in childhood.

But, what about mumps and rubella? If either the mumps portion or the rubella

portion of the MMR vaccine were responsible for the molecular mimicry (for

which there is no evidence), then Mr. Pickens’s encounter with these pathogens

through the vaccination might be his first.

The undersigned could conduct a hearing to receive oral testimony from Dr.

Friedman and Dr. Donofrio on these questions. However, in an exercise of

25

discretion, the undersigned declines to hold a hearing. Both parties were informed

that the expert reports could constitute direct testimony and that a hearing might

not be held. Order Regarding Expert Reports, issued Oct. 13, 2017, at 1-2. With

this awareness, the parties produced these reports. It seems reasonable to infer that

if Dr. Friedman and/or Dr. Donofrio were capable of saying more, they would have

expressed those opinions in writing. See Sphan v. Sec’y of Health & Human

Servs., 133 Fed. Cl. 588, 601 (2017) (noting that special master reasonably

determined that a hearing was not required after parties developed an extensive

evidentiary record).

More importantly, the outcome on timing does not affect the outcome of this

case. Even if Mr. Pickens had established that his problem began within a time for

which an inference of causation is appropriate, this showing would not carry the

day for him. See Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148

(Fed. Cir. 1992). Mr. Pickens is also required to show (1) that he suffers from

SIDP and (2) that molecular mimicry is a persuasive theory to connect the MMR

vaccine and SIDP. Mr. Pickens has not met his burden on either aspect. Thus, a

hearing and a finding on prong 3 favorable to Mr. Pickens would be academic.

VI. Logical Sequence

Mr. Pickens’s final element to establish is “a logical sequence of cause and

effect showing that the vaccination was the reason for the injury.” Althen, 418

F.3d at 1278. Given that Mr. Pickens did not establish that he suffers from the

condition for which he seeks compensation and did not present a persuasive

medical theory explaining how the MMR vaccine can cause SIDP, it also follows

as a matter of logic that Mr. Pickens has not presented a logical sequence of cause

and effect. See Caves v. Sec’y of Health & Human Servs., 100 Fed. Cl. 119, 145

(2011), aff’d without op., 463 F. App’x 932 (Fed. Cir. 2012). However, this

element is summarily discussed further for the sake of completeness.

With respect to this prong, the Federal Circuit has instructed special masters

to consider carefully the views of a treating doctor. Capizzano v. Sec’y of Health

& Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). In this case, although

directed to present any helpful statements from treating doctors, Order for

Submissions in Advance of Potential Adjudication, issued Apr. 27, 2020, at 5, Mr.

Pickens has not. See Pet’r’s Br. at 30; see also Resp’t’s Br. at 26 (asserting “SIDP

26

was never diagnosed by any of [Mr. Pickens’s] medical providers”). This lack of

support from treaters does not assist Mr. Pickens in meeting his burden.

Rather, Mr. Pickens asserts that no other cause for his problem has been

identified. However, the Federal Circuit has disagreed with the proposition that

the lack of alternative cause means that the vaccination was the cause. See

Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1320-21 (Fed. Cir.

2010).

In this context, the views of the doctors who suggested that Mr. Pickens

suffered from either GBS or CIDP have been considered. As discussed in the

summary of events in Mr. Pickens’s life, doctors who treated him did not diagnose

Mr. Pickens with the same disease consistently. Some suggested that he might

have GBS. E.g., exhibit 14 at 359-62, 6 (discharge report), exhibit 7 at 6, exhibit

39 at 12, 56. Others stated that he might have CIDP. E.g., exhibit 14 at 314, 6

(discharge report), exhibit 4 at 24, exhibit 39 at 12. However, none of the doctors

stated that Mr. Pickens suffered from SIDP and none of the doctors persuasively

linked Mr. Pickens’s health problems to the MMR vaccination.8 In any event, Mr.

Pickens has not asserted a claim based upon him suffering from GBS or CIDP.

See Pet’r’s Br. at 25 (“Mr. Pickens suffers from Subacute Inflammatory

Demyelinating Polyneuropathy.”). Likewise, Dr. Friedman has not presented an

opinion that the MMR vaccine caused Mr. Pickens to suffer GBS or CIDP. See

exhibit 23 at 8 (“SIDP best explains the apparent progression of the neurological

deficits from the disease over 4 to 8 weeks.”); exhibit 45. Special masters are not

required to evaluate claims that the parties have not advanced. See Vaccine Rule

8(f).

Consequently, Mr. Pickens has not met his burden of proof regarding

prong 2.

8

Perhaps the most supportive statement is a line from an anesthesiologist,

Dr. Hu, who seems to have adopted the history that Mr. Pickens gave him. Exhibit

39 at 1 (report, dated June 19, 2018). But, Dr. Hu does not explain the basis for his

assessment about Mr. Pickens’s condition three years earlier.

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VII. A Hearing is Not Required

Special masters possess discretion to decide whether an evidentiary hearing

will be held. 42 U.S.C. § 300aa-12(d)(3)(B)(v) (promulgated as Vaccine Rule 8(c)

& (d)), which was cited by the Federal Circuit in Kreizenbeck v. Sec’y of Health &

Human Servs., 945 F.3d 1362, 1365 (Fed. Cir. 2018). Here, after considering the

entire record as well as the parties’ arguments, the undersigned has determined that

a hearing is not required.

First, Mr. Pickens has enjoyed an opportunity to present his case fairly and

fully. After the parties disputed the onset of Mr. Pickens’s problems, the

undersigned conducted a hearing to receive testimony from Mr. Pickens and any

others whom he wanted to call as witnesses. After the undersigned issued the

Ruling Finding Facts, the parties were permitted to submit additional expert

reports. Then, the undersigned issued an order, scheduling the submission of briefs

in advance of potential adjudication. This order allowed the parties yet another

opportunity to present reports from experts. Thus, the undersigned finds that Mr.

Pickens has had a reasonable opportunity to present his case.

Second, the evidence that Mr. Pickens has presented is not persuasive. The

lack of persuasiveness is particularly apparent with respect to Mr. Pickens’s

diagnosis and medical theory. On diagnosis, little credible evidence suggests that

Mr. Pickens suffers from SIDP according to the diagnostic criteria. Dr. Friedman

could have addressed Mr. Pickens’s nadir, including his medical records created

after May 29, 2015, in his written reports. Similarly, Dr. Friedman could have

addressed Mr. Pickens’s health in 2018, when he apparently suffered a relapse in

his neurologic problems in a report filed in conjunction with Mr. Pickens’s brief.

Most importantly, any testimony from Dr. Friedman would not change the fact that

no treating doctor diagnosed Mr. Pickens as suffering from SIDP. As for

molecular mimicry, Mr. Pickens falls well short of presenting what could amount

to a persuasive showing. These independent reasons are sufficient to find, without

a hearing, that Mr. Pickens is not entitled to compensation.

As explained above, Mr. Pickens has a slightly stronger claim that he meets

the third prong concerning timing. But, on this point, Mr. Pickens’s evidence

seems not to rise to the level of more-likely-than-not. And, even if Mr. Pickens

were to prevail on timing, he would remain not eligible for compensation due to

the deficiencies on diagnosis and prong 1.

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VIII. Conclusion

Mr. Pickens has not established that he suffered from SIDP and has not

established that the MMR vaccine can cause SIDP via molecular mimicry. Due to

Mr. Pickens’s failure to meet his burden, he is not entitled to compensation.

The Clerk’s Office is instructed to enter judgment in accord with this

decision unless a motion for review is filed.

IT IS SO ORDERD.

S/ Christian J. Moran

Christian J. Moran

Special Master

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