VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-01417
Package ID: USCOURTS-cofc-1_15-vv-01417
Petitioner: Michael Bailey Jr., on behalf of the Estate of Michael Bailey, Sr.
Filed: 2015-11-23
Decided: 2020-04-24
Vaccine: influenza
Vaccination date: 2012-12-12
Condition: amyotrophic lateral sclerosis
Outcome: denied
Award amount USD: 

AI-assisted case summary:
On November 23, 2015, Michael Bailey Sr. filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that the flu vaccine Fluarix he received on December 12, 2012, caused him to develop Guillain-Barre Syndrome (GBS). He acknowledged that his doctors had diagnosed him with Amyotrophic Lateral Sclerosis (ALS) but contended he had all the symptoms of GBS. Mr. Bailey reported experiencing symptoms such as heart palpitations, dizziness, and headaches within days of vaccination, followed by progressive weakness in his extremities, loss of control, and eventual total disability. He died on July 28, 2017, and his son, Michael Bailey Jr., continued the claim on behalf of the estate. The Special Master, Katherine E. Oler, denied entitlement, finding that the evidence overwhelmingly supported an ALS diagnosis and not GBS. The Special Master's decision was reviewed by Senior Judge Nancy B. Firestone of the United States Court of Federal Claims, who upheld the denial, finding it was not arbitrary or capricious. Petitioner's counsel was Braden Andrew Blumenstiel, and respondent's counsel was Colleen Clemons Hartley. The Special Master did not conduct an evidentiary hearing, finding that the parties had ample opportunity to support their claims with written evidence and briefs. The court found that the Special Master's decision to first determine the injury before addressing causation was legally proper, citing precedent where the injury itself is in dispute. The court also found that the Special Master's conclusion that the record supported a finding of ALS and not GBS was not arbitrary or capricious. This conclusion was based on the opinions of Mr. Bailey's treating physicians, including three neurologists, and the respondent's expert, Dr. Vinay Chaudhry, a neurologist. The Special Master found Petitioner's experts, Dr. Phillip DeMio (a medical doctor) and Dr. James Lyons-Weiler (a Ph.D. in ecology, evolution, and conservation biology), were not qualified to opine on the issue of diagnosis and were not persuasive. The court noted that Dr. DeMio's expert opinions had been discredited in other program cases. The Special Master also noted that Mr. Bailey's treating physicians never diagnosed him with GBS or considered it a differential diagnosis. The court upheld the Special Master's decision, noting that Petitioner did not challenge the Special Master's conclusion that he failed to demonstrate that the flu vaccine caused Mr. Bailey's ALS or significantly aggravated his pre-existing ALS. The petition was dismissed, and no award was granted.

Theory of causation field:
Petitioner Michael Bailey Jr., on behalf of the Estate of Michael Bailey Sr., alleged that the influenza vaccine administered on December 12, 2012, caused Guillain-Barre Syndrome (GBS). The petitioner's experts, Dr. Phillip DeMio and Dr. James Lyons-Weiler (Ph.D.), opined that Mr. Bailey suffered from GBS. However, the Special Master found Dr. DeMio and Dr. Lyons-Weiler unqualified to diagnose neurological conditions, with Dr. Lyons-Weiler not being a medical doctor. The Special Master and the reviewing court found the evidence overwhelmingly supported a diagnosis of Amyotrophic Lateral Sclerosis (ALS), as diagnosed by Mr. Bailey's treating physicians (Drs. Hugh Miller, Melanie Taylor, and Erik Pioro) and the respondent's expert, Dr. Vinay Chaudhry (a neurologist). The petitioner explicitly confirmed he was not asserting that the flu vaccine caused ALS or significantly aggravated pre-existing ALS. The case was denied because the petitioner failed to prove GBS and did not pursue a theory that the vaccine caused ALS. The decision was issued by Special Master Katherine E. Oler on April 24, 2020, and upheld by Senior Judge Nancy B. Firestone on December 10, 2020. Attorneys involved were Braden Andrew Blumenstiel for the petitioner and Colleen Clemons Hartley for the respondent. No award was granted.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_15-vv-01417-1
Date issued/filed: 2020-12-10
Pages: 26
Docket text: JUDGE VACCINE REPORTED OPINION re: 135 Opinion 4/24/2020 REDACTED Denying Petitioner's Motion for Review. Signed by Senior Judge Nancy B. Firestone. (dpk) Service on parties made.
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Case 1:15-vv-01417-NBF Document 139 Filed 12/10/20 Page 1 of 26
In the United States Court of Federal Claims
No. 15-1417V
(Filed: December 10, 2020)*
*Opinion orgianlly issued under seal on November 10, 2020
)
MICHAEL BAILEY JR., on behalf )
of the Estate of Michael Bailey, Sr., )
)
Petitioner, )
)
v. ) Vaccine Act; Initial Injury; Off-Table;
) 42 U.S.C. 300aa-10, et seq.
Secretary of Health and Human )
Services, )
)
Respondent. )
)
Braden Andrew Blumenstiel, The Law Office of Dupont & Blumenstiel, Dublin, Ohio,
for petitioner.
Colleen Clemons Hartley, Torts Branch, Civil Division, United States Department of
Justice, Washington DC, with whom were Joseph H. Hunt, Assistant Attorney General,
C. Salvatore D’Alessio, Acting Director, and Alexis B. Babcock, Assistant Director, for
respondent.
OPINION1
FIRESTONE, Senior Judge.
Pending before the Court is Petitioner Michael Bailey Jr.’s Motion for Review of
Special Master Oler’s (the “Special Master”) April 24, 2020 Decision (the “April 24,
1 Pursuant to Rule 18(b) of Appendix B of the Rules of the United States Court of Federal
Claims (“RCFC, App. B”), this Opinion was initially filed under seal on November 10, 2020.
The parties had more than fourteen days from the date of filing of this Opinion to propose
redactions of any of the information herein. Neither party submitted any redactions.

Case 1:15-vv-01417-NBF Document 139 Filed 12/10/20 Page 2 of 26
2020 Decision”) denying a claim for compensation pursuant to the National Vaccine
Injury Compensation Program, codified at 42 U.S.C. 300aa-10, et seq. (the “Vaccine
Act”), which he is maintaining on behalf of his late father, Michael Bailey, Sr. (“Mr.
Bailey”).2 The court heard oral argument on this motion on November 3, 2020. For the
reasons stated below, the Court denies Petitioner’s motion and sustains the decision of the
Special Master.
I. BACKGROUND
On November 23, 2015, Mr. Bailey filed a petition seeking compensation under
the Vaccine Act based on his claim that a dosage of the flu vaccine Fluarix administered
on December 12, 2012 caused him to suffer “heart palpitations, dizziness, and
headaches” within days, and loss of control of his hands, arms and legs in the months and
years that followed, ultimately leaving Mr. Bailey “totally disabled and reliant on others
for total daily care.” Pet. at 1, 3, ECF No. 1 (the “Petition”). While Mr. Bailey
acknowledged in his petition that his doctors attributed these symptoms to amyotrophic
lateral sclerosis (“ALS”), he based his compensation claim on his contention that “he has
every symptom associated with Guillain-Barre Syndrome [(“GBS”)], which has been
recognized as an adverse reaction to the Fluarix Vaccination.” Id. at 3-4.
A. Procedural History
2 As noted below, Mr. Bailey died on July 28, 2017, nearly two years after filing the petition
currently before this court. Following his death, his son Michael Bailey, Jr., elected to continue
the prosecution of the estate’s claim. As did the Special Master in the April 24, 2020 Decision,
the court refers to Mr. Michael Bailey Sr. as “Mr. Bailey” and Mr. Michael Bailey, Jr. as
“Petitioner.” See April 24, 2020 Decision at 1, n.2.
2

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After Mr. Bailey had filed his medical records, the Secretary for Health and
Human Services (the “Secretary” or the “Respondent”) on April 5, 2016 filed a Rule
4(c)3 report, in which the Secretary argued that the Petition should be dismissed on the
ground that Mr. Bailey’s medical records indicated that he was suffering from ALS and
he had failed to establish that he suffered from GBS. In the alternative the Secretary
argued that Mr. Bailey had failed to establish that his flu vaccination had caused his
injury. Resp’t Report at 10-11, ECF No. 24. Specifically, the Secretary argued that Mr.
Bailey “ha[d] not established that any of the symptoms he reported . . . are symptoms of
GBS” and that “neither [his] medical records, his clinical presentation, nor his test results
support a diagnosis of GBS.” Id. Upon review of the Rule 4(c) Report, the Special
Master ordered Mr. Bailey to file an expert report by June 6, 2016. Scheduling Order
dated Apr. 6, 2020, ECF No. 25.
On June 28, 2016, Mr. Bailey filed an expert report authored by Dr. Philip DeMio,
a medical doctor, who opined that Mr. Bailey suffered from GBS, not ALS, based on his
examination of Mr. Bailey, review of Mr. Bailey’s medical records, and review of
statements authored by Mr. Bailey and his family. Expert Report of Dr. Philip DeMio at
1-3, ECF No. 31 (the “DeMio Report”). Mr. Bailey did not include Dr. DeMio’s
curriculum vitae with his expert report, but, in the report, Dr. DeMio describes himself as
“a medical doctor who has cared for patients since 1984” with a practice that “gives
3 Rule 4(c) of the Vaccine Rules of the United States Court of Federal Claims requires the
Secretary to file a report that sets forth “a full and complete statement of its position as to why an
award should or should not be granted” after a petitioner seeking compensation under the
Vaccine Act “has satisfied all required documentary submissions.” Rules of the U.S. Court of
Federal Claims, App. B, Vaccine Rule 4(c).
3

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detailed ongoing care, including diagnosis and treatment, to patients with chronic
sustained illnesses including those of neurologic and immunologic disorders.” Id. at 1.
Dr. DeMio is not a neurologist. Id.
On September 12, 2016, Mr. Bailey filed a transcript of the August 24, 2016
deposition of Dr. Erik Pioro, one of Mr. Bailey’s treating physicians and the director of
the Cleveland Clinic’s ALS clinic, to support his claim. Dep. of Erik Pioro, M.D., ECF
No. 38-1 (the “Pioro Dep.”). In his deposition, Dr. Pioro testified regarding his
professional background; the differences between GBS and ALS; and his treatment of
Mr. Bailey. Dr. Pioro testified that ALS is a “motor neuron disease” that affects both the
brain and spinal cord (as opposed to one or the other). Id. at 7:4-10. Dr. Pioro
distinguished ALS from other motor neuron diseases that affect “other parts of the brain
or spinal cord that are not purely motor,” offering the example of Parkinson’s disease. Id.
at 7:11-16, 8:3-13. When asked whether GBS could be classified as another “complex
neurodegenerative motor neuron disorder[],” Dr. Pioro explained in his deposition that
GBS is “a condition that affects just the peripheral nervous system and just the peripheral
nerves,” classifying it instead as a “neuromuscular condition” that is “really quite
different from ALS.” Id. at 8:20-9:6, 37:17-18. Later, Dr. Pioro re-emphasized this
distinction, testifying that GBS “is a peripheral nervous problem” whereas ALS is “a
condition that primarily is in the central nervous system” with “some peripheral
components.” Id. at 38:3-8.
With respect to his ALS diagnosis of Mr. Bailey, Dr. Pioro testified that there is
“no single definitive test for ALS,” and that ALS is “diagnosed by a combination of the
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symptoms . . . [and] the signs, what we find on the clinical examination as well as these
ancillary tests.” Id. at 22:8, 23:3-8. Dr. Pioro testified that because ALS is difficult to
diagnose and because of the severity of the diagnosis, “it’s extremely important that
we’re sure that it is ALS and nothing else.” Id. at 22:2-7. Dr. Pioro also testified that
certain clinical tests can distinguish ALS and GBS patients, despite their symptoms being
similar, as “[t]he spinal fluid is going to be abnormal for [GBS]” and “[t]he EMG is
going to be different in a totally different way in [GBS] than it is in ALS.” Id. at 51:15-
52:5. Dr. Pioro also testified that he could not state whether Mr. Bailey’s symptoms
began before or after his December 12, 2012 flu vaccine as Dr. Pioro began seeing him
on August 29, 2013, several months later. Id. at 13:7-11. Dr. Pioro did not dispute that
Mr. Bailey and his family had reported that “they had no evidence prior to the vaccine of
[Mr. Bailey] weakening in any fashion,” but noted that it is difficult to predict how long a
patient may have had ALS before symptoms developed. Id. at 12:9-19, 14:20-25. Dr.
Pioro acknowledged that certain of Mr. Bailey’s symptoms – lack of bladder function,
sexual function, headaches, heart palpitations, and dizziness – are not typical symptoms
of ALS and that “other conditions can mimic it,” making ALS difficult to diagnose. Id.
at 16:9-24, 17:17-20, 20:16-20, 21:24-25.
Counsel for the Secretary reviewed notes of the Cleveland Clinic’s treatment of
Mr. Bailey for ALS and provided Dr. Pioro the opportunity to explain how Mr. Bailey’s
symptoms and test results supported an ALS diagnosis. Id. at 57:20-66:8. When asked,
Dr. Pioro explained that he could not say whether Mr. Bailey’s flu vaccine caused or
aggravated Mr. Bailey’s ALS. Id. at 54:15-55:5, 66:10-16.
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On February 17, 2017, the Secretary filed his expert report authored by Dr. Vinay
Chaudhry, along with supporting medical literature. Expert Report of Dr. Vinay
Chaudhry, ECF No. 53-1 (the “Chaudhry Report”). As discussed in detail below, Dr.
Chaudhry confirmed the ALS diagnosis of Mr. Bailey’s treating physicians.
Petitioner requested the opportunity to obtain a rebuttal expert opinion to address
Dr. Chaudhry’s report. On January 29, 2018, nearly a year after this request, Petitioner
filed a report authored by Dr. James Lyons-Weiler, who holds his Ph.D. in ecology,
evolution, and conservation biology. Expert Report of James Lyons-Weiler dated Jan.
28, 2018, ECF No. 91 (the “First Lyons-Weiler Report”). Although not a medical doctor,
Dr. Lyons-Weiler prepared a table of symptoms typical of GBS and opined that Mr.
Bailey’s symptoms were “consistent with both the diagnosis of GBS and, to a lesser
extent, the diagnosis of ALS.” Id. at 3.
After reviewing all expert reports, on June 28, 2018, the Special Master held a
Rule 5 status conference.4 At the conference, the Special Master stated her tentative
opinion that Mr. Bailey had ALS and not GBS, which she based on the fact that no
treating physician had diagnosed Mr. Bailey with GBS (or had even raised it as a
differential diagnosis). Rule 5 Order dated July 18, 2018 at 2, ECF No. 102. Petitioner
requested an opportunity to address the Special Master’s concern.
4 Rule 5 of the Vaccine Rules of the United States Court of Federal Claims requires the special
master to hold a status conference within 30 days after the Secretary files its report called for
under Rule 4(c) (described above) in order to afford the parties an opportunity to address each
other’s positions, review the materials submitted and evaluate the parties’ respective positions,
and present tentative findings and conclusions. Rules of the U.S. Court of Federal Claims, App.
B, Vaccine Rule 5.
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On November 16, 2018, Petitioner submitted two supplemental expert reports
authored by Dr. Lyons-Weiler. In his first supplemental report, Dr. Lyons-Weiler walked
back his conclusion that Mr. Bailey’s symptoms were consistent with both GBS and
ALS, stating instead that Mr. Bailey’s symptoms “cannot support ALS” and that it was
his “medical opinion” that Mr. Bailey’s first expert, Dr. DeMio, had properly concluded
that Mr. Bailey suffered from GBS. Expert Report of Dr. James Lyons-Weiler dated
Nov. 14, 2018, ECF No. 108 (the “Second Lyons-Weiler Report”). In his second
supplemental report, Dr. Lyons-Weiler also provided a list of medical studies that he
claimed demonstrated that flu vaccines can cause chronic inflammatory demyelinating
polyneuropathy (“CIDP”), which, in his opinion, is similar enough to GBS and ALS to
evidence that the flu vaccine can cause those conditions. Expert Report of Dr. James
Lyons-Weiler dated Nov. 14, 2018, ECF No. 109 (the “Third Lyons-Weiler Report”).
On December 17, 2018, the Special Master held another status conference. At that
conference, the Special Master informed Petitioner that he had not yet provided evidence
that supported his contention he was suffering from GBS. See Order dated Dec. 18, 2018
at 1, ECF No. 112. Petitioner responded that he was searching for expert medical
opinions to support his cases. Id. Although the Special Master gave him over a year to
do so, Petitioner did not submit any additional expert reports from medical doctors to
support his Petition.
On December 18, 2018, the Special Master set a briefing schedule for the
Secretary’s requested motion to dismiss. Id. at 1-2. On February 28, 2019, the Special
Master ordered that the Secretary style his motion as a motion for a ruling on the record
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instead. On April 12, 2019, the Secretary filed his motion, arguing that Petitioner was
not entitled to compensation under the Vaccine Act because: (1) Petitioner failed to show
Mr. Bailey suffered from GBS; and (2) Petitioner failed to show that the flu vaccine
caused his injury. Mot. for Ruling on the Record, ECF. No. 115. On November 5, 2019,
the Special Master held another status conference and ordered Petitioner to file a
responsive brief by December 16, 2019 or his opportunity to respond would be
considered waived. Order dated Nov. 5, 2019, ECF No. 124. At the conference,
Petitioner represented that he had “retained” a neurologist to support his GBS diagnosis,
and planned to file his responsive brief after conferring with him. Id. at 1. On December
16, 2019, Petitioner filed his responsive brief, but did not include any new expert
evidence to support his claim that Mr. Bailey suffered from GBS. Opp’n to Mot. for
Ruling on the Record, ECF No. 125 (“Pet’r’s Opp.”).
On December 27, 2019, the Special Master held another status conference during
which Petitioner confirmed that he was alleging only that Mr. Bailey had GBS and that
the flu vaccine caused Mr. Bailey’s GBS. Mr. Bailey expressly confirmed to the Special
Master that he was not asserting that the flu vaccine had caused Mr. Bailey to develop
ALS or that Mr. Bailey’s ALS was “significantly aggravated” by the flu vaccine. Order
dated Dec. 27, 2019 at 1, ECF No. 126.
B. The April 24, 2020 Decision
On April 24, 2020, the Special Master issued her decision denying Petitioner’s
request for compensation under the Vaccine Act as the record evidence “best supported”
the conclusion that Mr. Bailey suffered from ALS, not GBS. April 24, 2020 Decision at
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17. The Special Master based her conclusion on a comprehensive overview of Mr.
Bailey’s treatment history and each of the proffered expert opinions, which the court will
summarize below.
1. Mr. Bailey’s Treatment History
On October 30, 2012, over a month before receiving a flu vaccine, Mr. Bailey
sought treatment from his orthopedist, Dr. Matthew Kay, for numbness, tingling, and loss
of grip strength in his right hand. April 24, 2020 Decision at 2. At that time, Mr. Bailey
reported that his symptoms “had been present for years, but had been slowly worsening
over the last several months.” Id. Dr. Kay diagnosed Mr. Bailey with right carpal tunnel
syndrome, and performed a right carpal tunnel release on November 12, 2012. Id.
On December 12, 2012, Mr. Bailey received a flu vaccine. Id. at 2. Less than a
month later, on January 8, 2013, Mr. Bailey visited the emergency room at the Robinson
Memorial Hospital for treatment of lacerations caused by him tripping and falling. Id.
At that time, Mr. Bailey denied experiencing headache, dizziness, and/or neck pain, and
did not report feeling any numbness or tingling in his extremities. Id. On April 16, 2013,
Mr. Bailey returned to the emergency room at the Robinson Memorial Hospital for
treatment of “stroke-like symptoms,” including weakness in his right upper extremity,
slurred speech, right facial drooping, and balance issues. Id. Mr. Bailey stated that these
symptoms began in January 2013. Id. The physician who treated Mr. Bailey that day
recommended that he see his primary care provider for follow up. Id. at 2-3.
On April 29, 2013, Mr. Bailey visited his primary care provider, William Raux,
D.O. Id. at 3. At that appointment, Mr. Bailey complained of weakness in his
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extremities and slow speech. Id. Dr. Raux ordered testing and referred Mr. Bailey to a
neurologist, Dr. Hugh Miller. Id. On May 15, 2013, Dr. Miller diagnosed Mr. Bailey
with ALS based on results of a nerve conduction study (“NCS”) that was “suspicious” for
early motor neuron disease, an EMG, and a physical examination. Id. Dr. Miller referred
Mr. Bailey to the Cleveland Clinic for a second opinion. Id.
On August 29, 2013, Mr. Bailey visited the Cleveland Clinic to seek a second
opinion of Dr. Miller’s ALS diagnosis. Id. Dr. Melanie Taylor examined him and
concluded that her findings were consistent with a probable motor neuron disease like
ALS. Id. Dr. Pioro, described above, agreed with Dr. Taylor’s assessment and, along
with Dr. Taylor, recommended Mr. Bailey for further evaluation to rule out other possible
diagnoses. Id. On September 23, 2013, Mr. Bailey returned to the Cleveland Clinic for
an appointment with Dr. Taylor. Id. at 3-4. Based on additional testing, Dr. Taylor
confirmed her diagnosis of “right upper extremity onset ALS” and set out treatment plan,
which included both physical therapy and Riluzole, a prescription medication
administered to treat the symptoms of ALS. Id. Dr. Pioro agreed with Dr. Taylor’s
diagnosis and her treatment plan. Id. at 4. In line with the recommendations of Drs.
Taylor and Pioro, Mr. Bailey attended physical therapy until January 2014, when he
could no longer continue in light of his worsening symptoms. Id.
By March 2014, Mr. Bailey required use of a power wheelchair for movement,
positioning, and pressure relief. Id. On July 23, 2014, Mr. Bailey returned to the
Cleveland Clinic and presented with trouble swallowing, no upper extremity function,
and breathing problems. Id. On December 17, 2014, Roswell Dorsett, D.O. examined
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Mr. Bailey and observed that his ALS had progressed to a quadriparesis. Id. On July 28,
2017, nearly four years after his initial diagnosis, Mr. Bailey died. Id.
2. Expert Reports
As stated above, Petitioner presented four reports from two experts – the report of
Dr. DeMio, a medical doctor, and the reports of Dr. Lyons-Weiler, a biologist who holds
a Ph.D. in ecology, evolution, and conservation biology. The Secretary presented one
expert – Dr. Vinay Chaudhry, a neurologist and professor at Johns Hopkins University–
in response. The court briefly summarizes each below.
As noted above, Dr. DeMio is a medical doctor – though not a neurologist – who
examined Mr. Bailey to prepare his expert report. In his report, Dr. DeMio observed that
Mr. Bailey “has a severe advance neuromuscular degeneration” and states that its
presentation “is quite consistent with Guillain-Barre’ [sic] Syndrome,” which was
“caused by his one & only influenza vaccine.” DeMio Report at 2. Dr. DeMio does not
reference how or why Mr. Bailey’s case is consistent with a GBS diagnosis (or,
alternatively why it is not consistent with an ALS diagnosis), instead resting on the
timing of Mr. Bailey’s symptoms, the connection between the flu vaccine and GBS, and
his observation that “the bulbar variant of ALS” (i.e., the type of ALS with which Mr.
Bailey was diagnosed) is “rare[]” and that “many physicians would never see a case in
their entire career.” Id. Dr. DeMio then concluded that “[m]any aspects of Mr. Bailey’s
case do not fit the more usual presentation of ALS,” that one of Mr. Bailey’s neurologists
“said his case is caused by the flu vaccine,” and that another of Mr. Bailey’s neurologists
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“has other cases of ALS caused by the flu vaccine,” but Dr. DeMio did not expand on
any of these statements or present support for them. Id.
Dr. Lyons-Weiler submitted three separate reports in support of Petitioner’s claim.
In the first, Dr. Lyons-Weiler, who holds no medical degree, prepared a table of
symptoms typical of GBS and opined that “all but one of Mr. Bailey’s symptoms support
the diagnosis of GBS” based on that table. First Lyons-Weiler Report at 1. Dr. Lyons-
Weiler also described a genetic test that he ordered to further assess Mr. Bailey’s
diagnosis. Id. While Dr. Lyons-Weiler considered the report received “to fall far short of
[his] professional expectations in terms of a full report,” he admitted that the limited
report received “seem[ed] to favor an ALS diagnosis for Mr. Bailey.” Id. at 2. Indeed,
Dr. Lyons-Weiler concluded that Mr. Bailey’s symptoms were “consistent with both the
diagnosis of GBS and, to a lesser extent, the diagnosis of ALS.” Id. at 4. In his second
report, Dr. Lyons-Weiler retracted his view that Mr. Bailey could be diagnosed with
either GBS or ALS, stating instead that Mr. Bailey’s symptoms “cannot support ALS”
and that it was his “medical opinion” that Dr. DeMio’s conclusion that Mr. Bailey
suffered from GBS was “medically correct” and that Dr. Pioro’s conclusion that Mr.
Bailey suffered from ALS was “medically incorrect.” Second Lyons-Weiler Report at 1,
6. In his third report, as noted above, Dr. Lyons-Weiler provided a list of medical studies
that allegedly demonstrate that flu vaccines can cause chronic inflammatory
demyelinating polyneuropathy (“CIDP”), which is similar enough to GBS and ALS to
evidence that the flu vaccine can cause these ailments. See generally Third Lyons-Weiler
Report.
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The Secretary’s expert, Dr. Chaudhry, is a neurologist who serves as the co-
director of the EMG Laboratory at Johns Hopkins Hospital and as a professor of
neurology at the Johns Hopkins University School of Medicine. During his career, Dr.
Chaudhry has published more than 200 articles, book chapters, and related publications
relevant to his field, and has received multiple grants related to the study of ALS and
neuropathy. Based on a review of Mr. Bailey’s medical records, along with Dr. DeMio’s
report and Dr. Pioro’s deposition transcript, Dr. Chaudhry concluded that Mr. Bailey’s
symptoms were “typical for the diagnosis of ALS.” ECF No. 53-1, the “Chaudhry
Report” at 4. In reaching that conclusion, Dr. Chaudhry reviewed Mr. Bailey’s
symptoms against the diagnostic criteria for both ALS and GBS and found that “[t]here is
no evidence that Mr. Bailey suffered from [GBS].” Id. at 5. Dr. Chaudhry also
countered the conclusions reached by Dr. DeMio, noting that Mr. Bailey’s heart
palpitations, diarrhea, and headache (i.e., symptoms not attributable to ALS) were not
documented in a number of Mr. Bailey’s medical records; that Mr. Bailey “wasn’t sure
when the symptoms precisely began” and that “it is possible that Mr. Bailey had
beginning of symptoms of ALS even prior to his carpal tunnel surgery” in November
2012; that “nothing about [Mr. Bailey’s] presentation is consistent with GBS”; that the
“bulbar variant” of ALS (i.e., Mr. Bailey’s presentation of ALS) is not at all rare. Id. at
6-7. Dr. Chaudhry also agreed with the “majority” of the testimony proffered by Dr.
Pioro at his deposition including Dr. Pioro’s conclusion that Mr. Bailey had ALS and not
GBS, and Dr. Pioro’s distinctions between the two conditions. Id. at 7. Indeed, Dr.
Chaudhry specifically states that “ALS and GBS are two different diseases with different
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clinical, physiological, and pathogenic features and have different treatment and
prognosis.” Id.
3. The Special Master’s Decision
The Special Master’s April 24, 2020 decision denying Petitioner’s request for
compensation under the Vaccine Act included a thorough review of the above-described
record evidence. Based on that review, the Special Master held that the evidence
supported the conclusion that Mr. Bailey suffered from ALS, not GBS. In reaching that
decision, the Special Master stated that neither of Petitioner’s experts were “qualified to
opine o[n] the issue of diagnosis” and were “not persuasive in contending that Mr. Bailey
suffered from GBS” and instead credited the diagnoses of Mr. Bailey’s treating
physicians, which included three neurologists, and the Secretary’s expert, Dr. Chaudhry,
another neurologist. April 24, 2020 Decision at 18-20. Having concluded that “the
preponderance of the evidence establishe[d] that Mr. Bailey’s injury is ALS rather than
GBS,” the Special Master explained why Petitioner had not established, by a
preponderance of the evidence, that the flu vaccination caused Mr. Bailey’s ALS. Id. at
22. The Special Master noted that Petitioner “has confirmed that he is not asserting Mr.
Bailey developed ALS from the vaccine or that his pre-existing ALS was significantly
aggravated by the vaccine.” Id. She then denied relief. Id.
II. LEGAL STANDARDS.
A. Standard of Review
The United States Court of Federal Claims has jurisdiction to review the decision
of a special master, upon a properly filed motion for review. 42 U.S.C. § 300aa-12(e)(1);
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Rules of the U.S. Court of Federal Claims, Appx. B, Vaccine Rule 23. Upon such
review, the Court of Federal Claims may: (A) uphold the findings of fact and
conclusions of law of the special master and sustain the special master’s decision; (B) set
aside any findings of fact or conclusions of law the special master found to be arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law and issue its
own findings of fact and conclusions of law; or (C) remand the petition to the special
master for further action in accordance with the court’s discretion. 42 U.S.C. § 300aa-
12(e)(2). Different standards of review apply to different aspects of a special master’s
decision: “the court reviews conclusions of law under the ‘not in accordance with law’
standard, findings of fact under the deferential arbitrary and capricious standard, and
discretionary rulings under the abuse of discretion standard.” Stillwell v. Sec’y of Health
& Human Servs., 118 Fed. Cl. 47, 54 (2014) (citing Masias v. Sec’y of Health & Human
Servs., 634 F.3d 1283, 1287-88 (Fed. Cir. 2011)). Here, it is undisputed that Petitioner’s
challenge centers on the Special Master’s conclusion that Mr. Bailey suffered from ALS
and not GBS, a finding of fact subject to review under the “arbitrary and capricious”
standard.
The arbitrary and capricious standard is “well understood to be the most
deferential possible.” Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 870 (Fed.
Cir. 1992). With that in mind, the court acknowledges that its role in reviewing a special
master decision is not to “reweigh the factual evidence, assess whether the special master
correctly evaluated the evidence, or examine the probative value of the evidence or the
credibility of the witnesses – these are all matters within the purview of the fact finder.”
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Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011) (quoting
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1349 (Fed Cir. 2010))
(internal quotation marks omitted); see also Milik v. Sec’y of Health & Human Servs.,
822 F.3d 1367, 1376 (Fed. Cir. 2016) (“The arbitrary and capricious standard is ‘difficult
for an appellant to satisfy with respect to any issue, but particularly with respect to an
issue that turns on the weighing of evidence by the trier of fact.’” (quoting Lampe v.
Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed Cir. 2000))). Indeed, given
the court’s limited role, “reversible error is ‘extremely difficult to demonstrate’ if the
special master has ‘considered the relevant evidence of record, drawn plausible
inferences and articulated a rational basis for the decision.” Wyatt v. Sec’y of Health &
Human Servs., 144 Fed. Cl. 531, 537 (2019), aff’d, 825 F. App’x 880 (Fed. Cir. 2020)
(internal citations omitted); see also Porter, 663 F.3d at 1249 (“[A]s long as a special
mater’s finding of fact is based on evidence in the record that [is] not wholly implausible,
we are compelled to uphold that finding as not being arbitrary or capricious.” (internal
citation and quotation marks omitted)).
B. Vaccine Act Standards
To qualify for relief under the Vaccine Act, a petitioner must show by a
preponderance of the evidence “that the injury or death at issue was caused by a vaccine.”
42 U.S.C. §§ 300aa-11(c)(1), 13(a)(1). The standard used to determine whether a
petitioner has satisfied this initial burden differs depending on whether the alleged
vaccine and injury is listed in the Vaccine Injury Table (i.e., a “Table” injury). See 42
U.S.C. §§ 300aa-11(c)(1)(C)(i), -14. Where a petitioner has suffered a “Table” injury,
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the vaccine is presumed to have caused the injury. Wyatt, 825 F. App’x at 885. But,
where a petitioner has suffered an “off-Table” injury, “a petitioner must prove causation-
in-fact, i.e., by showing by a preponderance of the evidence: (1) a medical theory
causally connecting the vaccination to the injury; (2) a logical sequence of cause and
effect demonstrating that the vaccination caused the injury; and (3) a proximate temporal
relationship between the vaccine and the injury.” Austin v. Sec’y of Health & Human
Servs., 818 F. App’x 1005, 1007 (Fed. Cir. 2020) (quoting Althen v. Sec’y of Health &
Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005)). These are referred to as the Althen
prongs.
GBS was added to the Vaccine Injury Table as of March 21, 2017. See Black v.
Sec’y of Health & Human Servs., No. 16-1189, 2018 WL 4390985, at *1 n.3 (Fed. Cl.
May 31, 2018) (“The final rule amending the Table to add GBS as a Table injury for the
flu vaccine was published on January 19, 2017 and took effect on March 21, 2017.”).
But the revised Vaccine Injury Table only governs petitions filed on or after the effective
date of the final rule. See 42 U.S.C. § 300aa-14(c)(4) (“Any modification . . . of the
Vaccine Injury Table shall apply only with respect to petitions for compensation under
the Program which are filed after the effective date of such regulation.”). As stated
above, Mr. Bailey filed the Petition on November 23, 2015, more than one year before
GBS was added to the Vaccine Injury Table. Accordingly, Petitioner bore the initial
burden to show by a preponderance of the evidence that his alleged GBS was caused by
the flu vaccine.
17

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As referenced above, the Special Master here concluded, however, that Mr. Bailey
suffered from ALS, not GBS, and that Petitioner failed to prove that his December 12,
2012 flu vaccination caused his ALS. In his Motion for Review before this court,
Petitioner challenges only the Special Master’s conclusion that Mr. Bailey had ALS and
not GBS. Mot. for Review of Decision of Special Master, ECF No. 128 (“Pet’r’s Mot.
for Review”). Petitioner then argues that he satisfied his burden of demonstrating that the
flu vaccine caused Mr. Bailey’s GBS.5 Id.
III. DISCUSSION
A. The Special Master’s Decision to Determine Mr. Bailey’s Injury before
Addressing Causation Was Legally Proper.
Although not challenged by Mr. Bailey, the court holds as an initial matter that the
Special Master’s decision to first determine whether or not Mr. Bailey suffered from GBS
5 During the November 3, 2020 oral argument, Petitioner argued for the first time that the Special
Master erred in neglecting to hold an evidentiary hearing before issuing the April 24, 2020
Decision. As an initial matter, because this argument was presented for the first time at oral
argument (i.e., after briefing was complete), it need not be addressed. See Novosteel SA v.
United States, 284 F.3d 1261, 1274 (Fed. Cir. 2002). Nonetheless, the court will briefly address
its merits. Under Vaccine Rule 8(d), “[a] special master’s decision to hold an evidentiary
hearing[] . . . is discretionary.” Kreizenbeck v. Sec’y of Health & Human Servs., 141 Fed. Cl.
138, 139 (2018), aff’d, 945 F.3d 1362 (Fed. Cir. 2020); Rules of the U.S. Court of Federal
Claims, Appendix B, Vaccine Rule 8 (d) (“The special master may decide a case on the basis of
written submissions without conducting an evidentiary hearing.” (emphasis added)). The Special
Master’s decision not to hold a hearing was upheld in Kreizenbeck because the Special Master
“gave [the parties] ample opportunity to support their claims with written evidence and briefs.”
Kreizenbeck, 141 Fed. Cl. at 140. In the pending matter the Special Master also provided the
Petitioner with ample opportunity to support his claims. She held four status conferences,
accepted all of the Petitioner’s expert submissions and granted Petitioner’s requests for time to
address her stated concerns about the strength of Petitioner’s GBS claim. Petitioner took
advantage of that time, using it to submit the expert reports authored by Dr. Lyons-Weiler
offered in support of Petitioner’s claims and to search for an additional expert report from a
medical doctor (which was ultimately not filed). In view of the foregoing, the court finds that
the Special Master did not abuse her discretion in electing not to hold a hearing before denying
Petitioner’s request for relief.
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was legally proper. See April 24, 2020 Decision at 17. While ordinarily “the function of
a special master is not to diagnose vaccine-related injuries, but instead to determine based
on the record evidence as a whole and the totality of the case whether it has been shown
by a preponderance of the evidence that a vaccine caused [petitioner’s] injury,” Andreu v.
Sec’y of Health & Human Servs., 569 F.3d 1367, 1382 (Fed. Cir. 2009) (internal
brackets, quotation marks, and citations omitted), the Federal Circuit has explained that,
under certain circumstances, “identifying the injury is a prerequisite to the [causation]
analysis.” Broekelschen, 618 F.3d at 1346. Similar to the petition here, the special
master in Broekelschen was presented with competing diagnoses: the petitioner asserted
that the flu vaccine had caused him to suffer transverse myelitis (“TM”) while the
Secretary contended that the petitioner suffered from anterior spinal artery syndrome. Id.
As the underlying injury was in dispute, the Special Master first considered which of the
two injuries – TM or anterior spinal artery syndrome – was best supported by the record.
Id. The Federal Circuit upheld this approach in this “atypical” circumstance where “the
injury itself is in dispute, the proposed injuries differ significantly in their pathology, and
the question of causation turns on which injury [petitioner] suffered.” Id. The Federal
Circuit has consistently upheld the standard set in Broekelschen when presented with
similar circumstances. See Wyatt, 825 F. App’x at 885 (affirming that “[i]dentification of
the petitioner’s injury is a prerequisite to causation analysis” where petitioner proffered
two possible injuries as a basis for his claim); Simanski v. Dep’t of Health & Human
Servs., 601 F. App’x 982, 986 (Fed. Cir. 2015) (affirming same where the petitioner
claimed that childhood vaccinations caused her child to suffer from GBS or CIPD and the
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Secretary countered that her child suffered from spinal muscular atrophy with respiratory
distress).
As in Broekelschen and its progeny, the threshold issue in this case is whether Mr.
Bailey suffered from GBS, as Mr. Bailey’s experts claimed, or ALS, as his treating
physicians concluded and as the Secretary’s expert neurologist confirmed. Petitioner
does not argue that the Special Master erred in addressing Mr. Bailey’s injury before
addressing causation. The court thus holds, under Broekelschen and the cases that follow
it, the Special Master properly addressed Mr. Bailey’s injury first.
B. The Special Master’s Conclusion That the Record Supported Finding
that Mr. Bailey Suffered from ALS and Not GBS was Not Arbitrary or
Capricious.
In his Motion for Review, Mr. Bailey contends that the Special Master’s
conclusion that the record supports finding that Mr. Bailey suffered from ALS and not
GBS was “unreasonable, arbitrary, and an abuse of discretion.” Pet’r’s Mot. for Review
at 8. As noted above, Petitioner’s arguments center on the Special Master’s decision to
rely on Mr. Bailey’s medical records and to credit the Secretary’s expert, Dr. Chaudhry,
over Petitioner’s experts, Dr. DeMio and Dr. Lyons-Weiler. However, this court cannot
“reweigh the factual evidence, assess whether the special master correctly evaluated the
evidence, or examine the probative value of the evidence or the credibility of the
witnesses – these are all matters within the purview of the fact finder.’” Austin, 818 F.
App’x at 1008 (quoting Porter, 663 F.3d at 1249). “[A]ssesssments as to the reliability
of expert testimony often turn on credibility determinations and finders of fact are
entitled – indeed, expected – to make determinations as to the reliability of the evidence
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presented to them and, if appropriate, as to the credibility of the persons presenting that
evidence.” Porter, 663 F.3d at 1250-51; see also Broekelschen, 618 F.3d at 1347 (“[T]he
special master’s decision often times is based on the credibility of the experts and the
relative persuasiveness of their competing theories,” and such credibility findings “are
virtually unchallengeable on appeal”); Chinea v. Sec’y of Health & Human Servs., No.
15-095, 2019 WL 1873322, at *28 (Fed. Cl. March 15, 2019) (“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.”). Indeed, this court is bound by “the deferential
arbitrary and capricious standard of review.” Porter, 663 F.3d at 1251. A petitioner’s
“mere disagreement” with a Special Master’s reasoned analysis will not render a decision
arbitrary and capricious. R.V. v. Sec’y of Health & Human Servs., 127 Fed. Cl. 136, 140
(2016). As discussed above, “as long as the special master’s conclusion is based on
evidence in the record that is not wholly implausible, we are compelled to uphold that
finding as not being arbitrary or capricious.” Austin, 818 F. App’x at 1008 (quoting
Milik, 822 F.3d at 1376).
As discussed below, it is clear to the court that both the Special Master’s
credibility assessments of the parties’ respective experts and her decision that the record
evidence supports the conclusion that Mr. Bailey suffered from ALS and not GBS satisfy
the deferential arbitrary and capricious standard.
1. The Special Master’s Rejection of Petitioner’s Experts Was Not
Arbitrary or Capricious.
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In rejecting the Petitioner’s experts’ opinions, the Special Master focused on their
respective credentials, and concluded that Dr. DeMio and Dr. Lyons-Weiler were “not
qualified to opine o[n] the issue of diagnosis and [were] not persuasive in contending that
Mr. Bailey suffered from GBS.” April 24, 2020 Decision at 20. With respect to Dr.
DeMio, the Special Master took issue with the fact that – unlike Mr. Bailey’s treating
physicians and the Secretary’s expert, Dr. Chaudhry – Dr. DeMio is not a neurologist and
has no specialized training in autoimmune or neurological disorders. Id. at 20. Indeed,
Dr. DeMio himself noted that, while he diagnoses and treats “patients with chronic
sustained illnesses including those of neurologic and immunologic disorders,” such
patients have seen him in tandem with “neurologists and immunologists.” DeMio Report
at 1. The Special Master also took issue with Dr. DeMio’s failure to provide any basis,
“factual or medical,” to support his conclusion that Mr. Bailey suffered from GBS rather
than ALS, criticizing his failure to “discuss the diagnostic criteria for GBS or compare
those criteria with Mr. Bailey’s medical history before diagnosing him with GBS. April
24, 2020 Decision at 20. The Special Master appropriately evaluated Dr. DeMio’s
credentials and ability to support his theory, and the Special Master’s reasoned decision
not to credit Dr. DeMio’s theory is not arbitrary or capricious.
Notably, other courts have criticized (and ultimately rejected) expert reports
submitted by Dr. DeMio for similar reasons, most recently in a case involving a nearly
identical “after-the-fact” GBS diagnosis. See Wyatt, 825 F. App’x at 886 (affirming the
special master’s finding that Dr. DeMio’s was “not reliable”); see also April 24, 2020
Decision at 20-21 (collecting cases). In affirming the Special Master in Wyatt, the
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Federal Circuit noted that Dr. DeMio was the only doctor to diagnose the petitioner with
GBS, despite none of the petitioner’s treating physicians ever diagnosing her with GBS
and contrary to their testimony that “they did not believe [the petitioner] ever suffered
from GBS.” 825 F. App’x at 886. In Wyatt, as here, Dr. DeMio based his diagnosis only
on the portions of the petitioner’s medical history he received, an examination of the
petitioner that took place “several years after her vaccination,” and his review of the
petitioner’s medical records, without conducting any of his own testing to verify his
diagnosis. Id.
With respect to Dr. Lyons-Weiler, the court similarly finds that the Special
Master’s conclusion that he was not qualified to diagnosis Mr. Bailey with GBS was not
arbitrary or capricious. The Special Master emphasized that she could not rely on Dr.
Lyons-Weiler’s GBS diagnosis of Mr. Bailey because Dr. Lyons-Weiler is not a medical
doctor and his “background in biology and genetic sequences does not qualify him to
opine, as an expert or otherwise, on the topic of medical diagnoses.” April 24, 2020
Decision at 21. While Petitioner notes that Dr. Lyons-Weiler has “extensive experience
with vaccine related issues and has published numerous peer-reviewed articles on matters
concerning vaccines and adverse reactions,” Pet’r’s Mot. for Review at 5, n.5, that
observation does not undermine the Special Master’s conclusion that Dr. Lyons-Weiler, a
non-medical doctor, is “inherently less qualified to opine on Mr. Bailey’s correct
neurologic diagnosis than a neurologist.” April 24, 2020 Decision at 21.
In addition, and contrary to Petitioner’s contentions, the April 24, 2020 Decision
makes clear that the Special Master also considered (and rejected) the merits of
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Petitioner’s experts’ reports in reaching her decision. The Special Master described the
Petitioner’s experts’ opinions extensively in her decision and explicitly stated that she
“considered” them, but did not find them persuasive, relevant, or useful in assessing the
merits of the Petition. See April 24, 2020 Decision at 8-10, 20-21. The Special Master
also explained – albeit implicitly – why Petitioner’s experts’ conclusions that Mr. Bailey
suffered from GBS (and not ALS) were not supported by the record by crediting the
Secretary’s expert’s overview of the criteria for GBS and his explanations of how Mr.
Bailey failed to display those “signs or symptoms.” Id. at 20. Accordingly, the Special
Master’s decision to reject Petitioner’s experts’ opinions was not based solely on her
finding that Petitioner’s experts did not have the necessary credentials to diagnose Mr.
Bailey with GBS; her decision was based on a thorough evaluation of the record evidence
presented by both Petitioner and the Secretary.
2. The Special Master’s Finding that the Record Best Supported
Concluding that Mr. Bailey Suffered from ALS, not GBS, Was
Not Arbitrary or Capricious.
The Special Master’s conclusion that the record best supported a finding that Mr.
Bailey suffered from ALS, not GBS, is also amply supported by record evidence and is
therefore not arbitrary or capricious. It is undisputed that all of Mr. Bailey’s treating
physicians – including neurologists from the Cleveland Clinic who specialize in ALS and
other motor neuron diseases – confirmed the ALS diagnosis after testing him for other
possible ailments. April 24, 2020 Decision at 3-4. The Federal Circuit has consistently
held that medical records prepared by treating physicians are “quite probative” or
“favored” when considering claims brought under the Vaccine Act. Wyatt, 825 F. App’x
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at 886 (“As this court has previously stated, testimony from treating physicians ‘is quite
probative’ since ‘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 Andreu v. Sec’y of Health & Human Servs., 569 F.3d
1367, 1375 (Fed. Cir. 2009)); see also Simanski, 601 F. App’x at 988 (“[T]o the extent
that the finding relied on medical records from treating physicians, we note that we have
held such records can be quote probative or favored when considering issues relating to
claims under the Vaccine Act.” (internal quotation omitted)).
The Special Master’s conclusion that Mr. Bailey suffered from ALS and not GBS
is also supported by the Secretary’s expert, Dr. Chaudhry, a neurologist who serves as the
co-director of the EMG Laboratory at Johns Hopkins Hospital and as a professor of
neurology at the Johns Hopkins University School of Medicine. Chaudhry Report at 1.
Dr. Chaudhry has extensive experience treating patients with ALS, evaluating over 2000
patients for neuromuscular disease (including ALS) each year. Id. In his report, Dr.
Chaudhry confirmed Mr. Bailey’s ALS diagnosis and explained why Mr. Bailey’s
symptoms do not support a diagnosis of GBS. See April 24, 2020 Decision at 20;
Chaudhry Report at 4-5. Petitioner presents no reason for this court to believe that Dr.
Chaudhry’s opinions were “wholly implausible.” Porter, 663 F.3d at 1249. Petitioner
simply disagrees with them. As indicated above, petitioner’s mere disagreement does not
provide grounds for this court to find the Special Master’s reliance on Dr. Chaudhry (and
dismissal of Drs. DeMio and Lyons-Weiler) is arbitrary or capricious. R.V., 127 Fed. Cl.
at 140.
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In view of the foregoing, the Special Master’s conclusion that the record evidence
“best supported” a finding that Mr. Bailey suffered from ALS and not GBS must be
upheld.6 Broekelschen, 618 F.3d at 1346.
IV. CONCLUSION
For the reasons stated above, the court DENIES Petitioner’s motion for review of
the Special Master’s April 24, 2020 Decision; and SUSTAINS the decision of the Special
Master. The Clerk shall enter judgment accordingly.
IT IS SO ORDERED.
s/Nancy B. Firestone
NANCY B. FIRESTONE
Senior Judge
6 The court notes that Petitioner does not challenge the Special Master’s conclusion that he failed
to demonstrate, by a preponderance of the evidence, that Mr. Bailey’s December 12, 2012 flu
vaccine caused his ALS. As such, the court has no occasion to opine on that issue.
26

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_15-vv-01417-2
Date issued/filed: 2021-07-21
Pages: 22
Docket text: PUBLIC DECISION (Originally filed: 04/24/2020) regarding 127 DECISION of Special Master. Signed by Special Master Katherine E. Oler. (sl) Service on parties made.
--------------------------------------------------------------------------------
Case 1:15-vv-01417-NBF Document 142 Filed 07/21/21 Page 1 of 22
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: April 24, 2020
To be published
* * * * * * * * * * * * * * * * * * * * * * * * *
*
MICHAEL BAILEY JR., Administrator of *
the Estate of MICHAEL BAILEY SR., * No. 15-1417V
*
Petitioner, *
*
v. * Dismissal; Influenza Vaccine; Amyotrophic
* Lateral Sclerosis (“ALS”); Insufficient Proof
SECRETARY OF HEALTH * of Causation.
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Braden A. Blumenstiel, Blumenstiel Falvo, LLP, Dublin, OH, for Petitioner.
Colleen C. Hartley, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION DENYING ENTITLEMENT1
Oler, Special Master:
On November 23, 2015, Michael Bailey Sr. (“Mr. Bailey”)2 filed a petition for
compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10,
1 This decision 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 Decision 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 decision’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 decision will be available to the public in its present form. Id.
2 Mr. Michael Bailey Sr., the original petitioner in this case, passed away. His son, Mr. Michael Bailey, Jr.
elected to continue the prosecution of the estate’s claim. For ease of reference, I will refer to Mr. Michael
Bailey Sr. as Mr. Bailey, and Mr. Michael Bailey, Jr. as Petitioner.
1

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et seq.3 (the “Vaccine Act” or “Program”). The petition alleges that Mr. Bailey’s “doctors have
diagnosed [him] with ALS” yet he “has every symptom associated with Guillain-Barre Syndrome”
which was proximately caused by his flu vaccine, administered on December 12, 2012. See
Petition (Pet.) at 2-3, ECF No. 1.
Upon review of the evidence submitted in this case, I find that Petitioner has failed to carry
his burden showing that he is entitled to compensation under the Vaccine Act. In particular,
Petitioner has failed to show that Mr. Bailey’s injury and subsequent death were caused by the
vaccination he received. The petition is accordingly dismissed.
I. Medical Records
Mr. Bailey was born in 1954. He was 58 years old on December 12, 2012, when he
received the allegedly causal flu vaccination. Petitioner’s Exhibit (“Ex.”) 16 at 1-3.
A. Mr. Bailey’s Medical History Prior to the Flu Vaccination
Mr. Bailey’s medical history is significant for a diagnosis of right carpal tunnel syndrome
in the months immediately prior to the vaccination. He reported numbness, tingling, and loss of
grip strength in his right hand to his orthopedist, Dr. Matthew Kay, on October 30, 2012. Ex. 12
at 4. He told Dr. Kay that the symptoms had been present for years but had been slowing worsening
over the last several months. Id. Bilateral wrist x-rays were normal and Dr. Kay’s clinical
impression was right carpel tunnel syndrome. Id. Dr. Kay performed a right carpal tunnel release
on Mr. Bailey on November 12, 2012. Ex. 10 at 11. Dr. Kay examined Mr. Bailey on November
20, 2012 and noted a stable appearance with little or no pain reported and improved sensation in
fingers. Ex. 12 at 8.
B. The Flu Vaccination and Mr. Bailey’s Subsequent Medical History
After receiving his flu vaccination on December 12, 2012, Mr. Bailey did not seek medical
care until January 8, 2013 when he presented to the Robinson Memorial Hospital emergency room
for lacerations from a tripping incident. Ex. 10 at 12. He reported that he was walking and tripped
over some wood, striking his right ear against the corner of a plastic piece. Id. According to the
ER report, Mr. Bailey denied headache, dizziness, and neck pain. Id. He reported no numbness
or tingling in his extremities. Id.
Mr. Bailey returned to the emergency room on April 16, 2013, almost four months after
the flu vaccination. He described stroke-like symptoms including right upper extremity weakness,
slurred speech, right facial drooping, and balance issues. Ex. 10 at 44. He reported the symptoms
occurring since at least January 2013. Id. at 45. An MRI of the brain showed an old hemorrhage
and his labs were mostly within normal limits. Id. The ER doctor attributed the symptoms to a
3 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).
2

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cerebrovascular accident and recommended follow up with a neurologist or his primary care
provider (“PCP”). Id.
On April 29, 2013, Mr. Bailey presented to his PCP, William Raux, D.O., with complaints
of weakness in his extremities and slow speech. Ex. 10 at 30. Dr. Raux ordered tests and arranged
for Mr. Bailey to see a neurologist, Hugh Miller, M.D. Id. at 35. Dr. Miller examined Mr. Bailey
on April 30, 2013 and noted that he had a flu vaccination in December and progressive right sided
weakness since February. Ex. 17 at 2. Dr. Miller recommended a follow up appointment after
further testing. Id. at 4.
Mr. Bailey tripped again on May 3, 2013, this time hitting his chin. He reported to the ER
for treatment of a laceration to his left upper lip. Ex. 10 at 55. Mr. Bailey was scheduled for a
cervical spine MRI and MRA of the head on the same day; the results were normal. Id. at 57-59.
On May 13, 2013, Mr. Bailey underwent a nerve conduction study (“NCS”) that was
suspicious for early motor neuron disease. Ex. 10 at 60-61. On May 15, 2013, Dr. Miller advised
Mr. Bailey that the NCS, EMG, and physical examination all suggested amyotrophic lateral
sclerosis (“ALS”). Id. at 8. Dr. Miller recommended Mr. Bailey get a second opinion and referred
him to the Cleveland Clinic. Id.; Ex. 8 at 1.
Mr. Bailey presented to the Neuromuscular Center at the Cleveland Clinic Neurological
Institute on August 29, 2013. Ex. 8 at 1. Melanie Taylor, M.D. took a history from Mr. Bailey
who stated his symptoms started in November 2012 after a flu shot. Id. at 2. He said he “felt ill”
for three weeks after the vaccination with heart palpitations, diarrhea, and headache. Id. Later he
noticed progressive right extremity weakness and by February 2013, he was experiencing frequent
falls. Id. Within the next few months, he had weakness in the left side with progressive muscle
atrophy of both shoulders, chest, and back. Id. Since February, his family noticed “muscle
twitches” in his arms and legs. Id. In March or April 2013, his speech worsened, becoming quieter
and more slurred. Id. He described dysphagia that was worse with solids. Id. at 3. He also
reported symptoms such as shortness of breath on exertion and while talking as well as minor
memory loss, depressed mood with “surges of emotions,” mild numbness/tingling in feet, and mild
low back pain. Id. Dr. Taylor noted that he had a history of right carpal tunnel syndrome (“CTS”)
and that he stated that he developed right hand weakness two years ago and was told it was CTS.
Id.
Dr. Taylor examined Mr. Bailey and determined that the findings were consistent with a
probable motor neuron disease (“MND”), including ALS. Ex. 8 at 6. Erik Pioro, M.D., Ph.D.,
FRCPC, is the ALS and Related Disorders Section Director and he agreed with Dr. Taylor’s
assessment and recommendation for further evaluation. Id. at 7.
After further testing to exclude other causes of motor neuron degeneration, Mr. Bailey
returned to Dr. Taylor on September 23, 2013. Dr. Taylor confirmed a final clinical diagnosis of
right upper extremity onset ALS. Ex. 8 at 38. Dr. Taylor wrote the following:
Now that all the additional investigations have been completed, the final clinical
diagnosis is right upper extremity-onset ALS. Because of the extent of upper motor
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neuron (UMN) and lower motor neuron (LMN) abnormalities at present, he meets
the World Federation of Neurology El Escorial diagnostic criteria of probable ALS.
There are combined upper motor neuron (UMN) and lower motor neuron (LMN)
abnormalities at cervical and lumbosacral levels, with evidence of UMN signs in
the bulbar region; by EMG here, LMN changes are not seen in thoracic myotomes.
The clinical diagnosis of ALS is certain.
Id. Dr. Pioro agreed with the diagnosis and the proposed treatment plan, which included
continuing Riluzole, the only FDA-approved prescription medication for the treatment of ALS.
Id. at 38-39.
On August 23, 2013, Mr. Bailey started physical therapy and continued attending once or
twice weekly until January 2014. Ex. 9 at 2. He discontinued physical therapy due to progressive
physical limitations. Id. By March 2014, Mr. Bailey required the use of a power wheelchair for
all mobility, positioning, and pressure relief needs. Ex. 8 at 50. He no longer had the ability to
communicate except through an eye gaze communication device. Id. at 55.
Mr. Bailey had significantly worsened by July 23, 2014 when he returned to the ALS Clinic
at Cleveland Clinic. Ex. 8 at 58. His swallowing was worse with choking, his upper extremity
function was non-existent, and he was having breathing problems. Id. at 59. He required the
placement of a PEG feeding tube on August 28, 2014 due to an inability to swallow. Ex. 10 at 66-
67.
On December 17, 2014, Roswell Dorsett, D.O. examined Mr. Bailey and noted that his
ALS had progressed to a quadriparesis. Ex. 14 at 3. He had a PEG tube in place and used a
BiPAP at night. He was unable to speak. Id. Dr. Dorsett saw Mr. Bailey again on March 18, 2015
and noted his MRI showed no change from the prior study. Id. at 1.
Mr. Bailey continued to decline and passed away on July 28, 2017.
II. Affidavits
A. Affidavit of Michael Bailey
Mr. Bailey’s wife signed his affidavit on his behalf on September 14, 2015. Ex. 1 at 8.
Mr. Bailey stated that he enjoyed good health throughout his life. Id. at 1. For the last 20 years
before the affidavit was drafted, Mr. Bailey worked as an operating room technician at Robinson
Memorial Hospital in Ravenna, Ohio. Id. at 2. During this time, he received the nickname of
“Forklift” because he could lift patients weighing up to 400 pounds. Id. Mr. Bailey did not believe
in vaccinations, and as a result, did not receive any the entire time he worked at Robinson. Id.
The year before his flu vaccination, Robinson changed their policy and required employees to
receive a flu vaccination. Id. at 3.
Within two or three days of the vaccination, Mr. Bailey stated that he began to experience
heart palpitations, headaches, and dizziness. Ex. 1 at 4. By early 2013, Mr. Bailey described that
he began to fall and slur his speech. Id. at 5. After visiting various doctors, he went to the
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Cleveland Clinic. Id. The doctors diagnosed him with ALS. Id. According to Mr. Bailey, one
doctor told him, “I won’t say this again, but I have had three patients of mine who got ALS after
receiving the flu vaccination.” Id.
Mr. Bailey described his continued deterioration. As of the date of the affidavit, he was
unable to walk, talk, move his arms or legs, or swallow. Ex. 1 at 5. He was confined to a
wheelchair and used a feeding tube to eat. Id.
Mr. Bailey stated that their attorney, Mr. James Blumenstiel came to the house and read a
list of approximately 20 symptoms and asked Mr. Bailey to nod if he had experienced them. Ex.
1 at 7. Mr. Bailey indicated that he had experienced every symptom on the list. Id. Mr.
Blumenstiel later informed them the list was from a Mayo Clinic article about Guillain-Barré
syndrome (“GBS”). Id.
B. Affidavit of Petitioner
Petitioner (Michael Bailey, Jr.) is the son of Michael Bailey. He filed an affidavit on
October 29, 2015. Ex. 3. Petitioner stated that his father’s physical health before the December
12, 2012 flu vaccination was excellent. Id. at 2. Petitioner stated that within a few days of
receiving the flu vaccination, his father began to complain of heart palpitations, dizziness,
headaches, and not feeling like himself. Id. at 3. According to Petitioner, his father began to fall
around that time. Id. Soon thereafter, his speech and facial features began to change and resembled
someone who suffered a stroke. Id. As of the date of his affidavit, Mr. Bailey was wheelchair
bound and incapable of caring for himself. Id.
Petitioner stated that their attorney, Mr. James Blumenstiel came to the house and read a
list of approximately 20 symptoms to Mr. Bailey and asked Mr. Bailey to nod if he had experienced
them. Id. Mr. Bailey indicated that he had experienced every symptom Mr. Blumenstiel read to
him. Id. Mr. Blumenstiel later informed them the list was from a Mayo Clinic article about GBS.
Id. at 4.
C. Affidavit of Mrs. Danette Bailey
Mrs. Danette Bailey stated that her husband had always been very healthy. Ex. 2 at 1. In
their 36 years of marriage, she could only remember one time that he was sick. Id. She stated that
he did not receive vaccinations because he was afraid of them, and specifically, was concerned
that something bad could happen to him. Id. at 3. Mr. Bailey was told that if he did not receive
the flu vaccination, he would be fired from his job at the hospital. Id.
Mrs. Bailey stated that immediately after he received the flu vaccination, Mr. Bailey began
to have heart flutterings and headaches. Ex. 2 at 4. After that he began to fall, and in January, his
face looked like he had suffered a stroke. Id. His hands also did not work well, and he could not
grip things. Id. As of August 2013, Mr. Bailey was in a wheelchair, and Mrs. Bailey had to do
everything for him. Id.
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Mrs. Bailey stated that their attorney, Mr. James Blumenstiel came to the house and read a
list of approximately 20 symptoms and asked Mr. Bailey to nod if he had experienced them. Ex.
2 at 7. Mr. Blumenstiel also asked Mrs. Bailey to indicate whether Mr. Bailey experienced these
symptoms. Id. Mr. Bailey indicated that he had experienced every symptom on the list. Id. Mrs.
Bailey also so indicated. Id. Mr. Blumenstiel later informed them the list was from a Mayo Clinic
article about GBS. Id. at 8.
III. Procedural History
On November 23, 2015, Mr. Bailey filed a petition alleging that the flu vaccine he received
on December 12, 2012 caused him to develop symptoms of GBS. Pet. at 3-4. He acknowledged
in his petition that his doctors diagnosed him with ALS rather than GBS. Id. Mr. Bailey submitted
treatment records from his medical providers over the following months. ECF Nos. 8, 9, 13, 17,
19.
Respondent filed a Rule 4(c) Report on April 5, 2016 requesting the petition be dismissed
for failure to demonstrate entitlement to compensation. ECF No. 24. Respondent asserted that
Petitioner failed to establish that Mr. Bailey suffered from GBS and, even if he did, Petitioner did
not provide evidence that the flu vaccination caused the injury. Mr. Bailey was ordered to file an
expert report by June 6, 2016. ECF No. 25.
On June 28, 2016, Mr. Bailey filed an expert report from Dr. Phillip DeMio. Ex. 20; ECF
No. 31. Mr. Bailey filed a transcript of a deposition of Dr. Erik Pioro on September 12, 2016 as
Exhibit 21. ECF No. 38. In response, Respondent filed the expert report of Dr. Vinay Chaudhry,
on February 17, 2017. Ex. A. Respondent also filed supporting medical literature, (Exs. A-1
through A-4), Dr. Chaudhry’s curriculum vitae (“CV”) (Ex. B), and Dr. Chaudhry’s updated CV
(Ex. C).
On March 1, 2017, Mr. Bailey filed a motion for permission to obtain a rebuttal opinion
which was granted on the same day. ECF Nos. 57, 58. Special Master Hastings ordered Petitioner
to file his rebuttal expert report by May 1, 2017. ECF No. 58. On May 15, 2017, Petitioner was
ordered to file his overdue report as soon as possible. Non-PDF Order dated May 15, 2017; ECF
No. 63. Mr. Bailey died on July 28, 2017 and was eventually succeeded as Petitioner by the
administrator of the estate, Michael Bailey, Jr. (“Petitioner”). ECF Nos. 71, 98. Petitioner’s
counsel changed from James Blumenstiel to Braden Blumenstiel on September 22, 2017. ECF
No. 77. This case was reassigned to Special Master Brian Corcoran on October 4, 2017.
On October 18, 2017, Special Master Corcoran set Petitioner’s expert report deadline for
October 31, 2017. ECF No. 81. Petitioner requested and was granted an extension until December
15, 2017. In his Non-PDF Order, Special Master Corcoran stated, “In light of Petitioner's
opportunity to file a rebuttal expert report since March of 2017, no further extensions of time shall
be permitted.” Non-PDF Order dated October 24, 2017.
This case was reassigned to my docket on December 1, 2017. ECF No. 86. On January 5,
2018, I ordered Petitioner to file his overdue supplemental expert report immediately. Non-PDF
Order dated January 5, 2018. ECF No. 89. On January 15, 2018, Petitioner filed a request for an
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extension of time. ECF No. 90. I granted that request. The rebuttal opinion, a report by Dr. James
Lyons-Weiler, was filed on January 29, 2018. ECF No. 91.
On June 28, 2018, I held a Rule 5 status conference with counsel for Petitioner and
Respondent. I reviewed and summarized the findings of the experts and articulated my belief that
Mr. Bailey had ALS and not GBS. My assessment was based on the fact that no treating physician
ever diagnosed Mr. Bailey with GBS or raised it as a differential diagnosis. Rule 5 Order, ECF
No. 102. Rather, the treating physicians diagnosed Mr. Bailey with ALS. Id. I informed Petitioner
of my belief that the medical records, medical literature, and medical opinions all supported and
confirmed the diagnosis of the treating physicians in this case. Id. Petitioner requested the
opportunity to address my concerns and I ordered him to file a status report by August 17, 2018
indicating how he would like to proceed. Id.
Petitioner twice requested additional time to respond, claiming he was searching for
additional medical opinions, and then missed the third deadline. ECF Nos. 103, 104. On October
26, 2018, I issued an order to show cause why this case should not be dismissed pursuant to
Vaccine Rule 21(b) for failure to prosecute and for failure to comply with prior orders in the action.
ECF No. 105. Petitioner filed a response to the order to show cause on November 15, 2018 (ECF
No. 107) and submitted two more reports from Dr. Lyons-Weiler on November 16, 2018. Exs.
26, 27; ECF Nos. 108, 109.
I held a status conference on December 17, 2018 with counsel on behalf of Petitioner and
Respondent. I informed Petitioner that he had yet to provide evidence in support of a GBS
diagnosis and Petitioner responded that he was still searching for expert medical opinions in
support of the case. See Scheduling Order on 12/12/18, ECF No. 112. Respondent expressed
concern that this case was “not progressing” given the numerous unfruitful attempts to obtain
evidence. Id. I agreed with Respondent’s concerns and directed Respondent to file a Motion to
Dismiss if he believed that was appropriate, and informed Petitioner that he would have the
opportunity to file a reply and include new evidence with the reply. Id.
On February 28, 2019, I issued a docket order instructing Respondent to file a Motion for
Ruling on the Record rather than a motion to dismiss. On April 12, 2019, Respondent filed a
motion for a ruling on the record, stating that Petitioner is not entitled to compensation because he
failed to show that Mr. Bailey suffered from GBS and failed to show that the flu vaccine caused
his injury. ECF No. 115. I ordered Petitioner to file a response and any new evidence he wished
to submit by June 11, 2019. See Non-PDF Scheduling Order on 4/14/19. Petitioner filed four
motions for extensions of time, stating that he was working with a neurologist; he then missed a
deadline. ECF Nos. 116, 118, 119, 120. On October 16, 2019, I ordered Petitioner to file his
overdue response immediately. Instead, Petitioner filed a motion for extension of time until
December 16, 2019. ECF No. 121.
I held another status conference on November 5, 2019 and informed Petitioner that I would
grant his request for more time but if he failed to file a responsive brief by December 16, 2019, I
would consider the brief to be waived. During the status conference, Petitioner stated that he had
retained a neurologist, Dr. Marcel Kinsbourne, and would file the brief after conferring with him.
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ECF No. 124. Petitioner filed a response to the motion for ruling on the record on December 16,
2019. ECF No. 125. No new evidence was attached to the response.
On December 27, 2019, I held a status conference with the parties to address Petitioner’s
response. I confirmed with Petitioner that he is alleging that Mr. Bailey had GBS and the vaccine
caused the GBS. Petitioner agreed that he is not asserting that Mr. Bailey developed ALS from
the vaccine or that Mr. Bailey’s pre-existing ALS was significantly aggravated by the vaccine.
I summarized this portion of the December 27, 2019 status conference as follows:
Mr. Blumenstiel stated that Petitioner is not asserting that Mr. Bailey Sr. developed
ALS from the vaccine or that Mr. Bailey Sr.’s pre-existing ALS was significantly
aggravated by the vaccine.
I made it clear to Mr. Blumenstiel that the only theory of causation I will be
addressing in my Ruling on the Record is whether the vaccination caused Mr.
Bailey Sr. to develop GBS. Mr. Blumenstiel indicated that he understood and
agreed with this approach.4
ECF No. 126 (Order, Dec. 27, 2019).
Because all the evidence has been filed in this case, I will decide whether Mr. Bailey’s
December 12, 2012 flu vaccination caused him to develop GBS. ECF No. 126.
IV. Expert Opinions
A. Dr. Phillip DeMio
Petitioner submitted an expert report by Phillip C. DeMio, M.D. on June 28, 2016. Ex. 20
(hereinafter “DeMio Rep.”). Dr. DeMio described his background as “a medical doctor who has
cared for patients since 1984, and [his] current practice gives detailed ongoing care, including
diagnosis and treatment, to patients with chronic sustained illnesses including those of neurologic
and immunologic disorders.” DeMio Rep. at 1. Petitioner did not submit Dr. DeMio’s CV
although he claimed it was attached to his response to Respondent’s motion for ruling on the
record. See ECF No. 125 at 6, fn 4. Dr. DeMio’s credentials have been evaluated in other program
cases.5 Notably, Dr. DeMio is not a neurologist.
Dr. DeMio examined Mr. Bailey and reviewed his medical records and affidavits. He
4 In accordance with this representation, I have not evaluated whether the flu vaccination Mr. Bailey
received caused him to develop ALS, or whether the flu vaccination significantly aggravated his pre-
existing ALS.
5 See Wyatt v. Sec’y of Health & Human Servs., 144 Fed. Cl. 531 (2019) “Dr. DeMio obtained his medical
degree from Case Western Reserve University in 1984, and completed residencies in pathology and
emergency medicine. Dr. DeMio treats patients with chronic tick-borne and other infections and Autism
Spectrum Disorder as well as ‘chronic pain and disease.’”
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provided an overview of Mr. Bailey’s medical history in his report and stated that Mr. Bailey “has
severe advance [sic] neuromuscular degeneration” that “is quite consistent with GBS” and “was
caused by his one [and] only influenza vaccine.” DeMio Rep. at 2. Dr. DeMio wrote that “[m]any
aspects of Mr. Bailey’s case do not fit the more usual presentation of ALS” but Dr. DeMio did not
elaborate on those aspects or explain the usual presentation of ALS. Id. Dr. DeMio concluded
that Mr. Bailey’s problems are permanent, but he is expected to live for many more years. Id.
B. Dr. Erik Pioro
Petitioner deposed Dr. Pioro, a neurologist at the Cleveland Clinic, on August 24, 2016
and filed the transcript on September 12, 2016. Ex. 21. Dr. Pioro testified that he arrived at the
Cleveland Clinic in 1993 and took over as the director of the ALS clinic in 2000. Id. at 5. Dr.
Pioro testified about ALS in general and about the evaluation and treatment that he and Dr. Taylor
provided to Mr. Bailey at the Cleveland Clinic.
Dr. Piero described ALS as a progressive neuromuscular disease that gets worse with time
with no typical or average progression of the disease. Ex. 21 at 10. He testified that he has seen
close to 2000 patients over the last 15 years, and “no two patients are necessarily alike in terms of
how the disease behaves in them.” Id. Dr. Pioro explained that the median survival of his patients
“is about two years” and the clock starts at the onset of symptoms. Id. at 10-12.
Dr. Pioro first saw Mr. Bailey on August 29, 2013 so he could not say whether the
symptoms started before or after the influenza vaccination. Ex. 21 at 13. He testified that it is
difficult to predict how long a patient might have ALS prior to the development of symptoms. Id.
at 14. He illustrated the point by describing a situation where a patient might fall and strike their
head and then develop symptoms of ALS. See id. at 15. He stated that,
when you think of it superficially it suggests that head trauma was responsible for
the development of ALS. But when you delve into it, you find the patient was
having problems with their walking and balance and that’s why they fell in the first
place. So it’s the chicken or egg phenomenon when it comes to things like that.
Id. at 15. Dr. Pioro agreed that Mr. Bailey’s reported symptoms of heart palpitations, diarrhea,
and headache are not manifestations of ALS. Id. at 16. He also agreed that other conditions can
mimic ALS. Id. at 21.
Later in the deposition, Dr. Pioro noted that “the diagnosis of ALS is primarily based on
the symptoms and signs the physician observes in the patient and a series of tests to rule out other
diseases.” Ex. 21 at 28. He distinguished GBS as a peripheral nervous system problem and ALS
as a condition primarily in the central nervous system with peripheral components. Id. at 38.
Although both conditions cause weakness in the extremities, GBS will often present with
numbness and tingling that begins in the feet and ascends which is unusual in ALS patients. Id. at
50-51. He said he uses clinical exams combined with medical tests to distinguish between ALS
and other diseases like GBS. As an example, he said the spinal fluid is going to be abnormal for
GBS and the EMG is going to be different in a GBS case than in an ALS case. Id. at 51.
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Upon questioning from Respondent, Dr. Pioro reviewed and explained Mr. Bailey’s
Cleveland Clinic treatment notes. According to Dr. Pioro, Mr. Bailey’s symptoms and test results
supported the diagnosis of ALS. Ex. 21 at 57-66. Dr. Pioro could not identify any medical
evidence to suggest that the flu vaccine caused or worsened Mr. Bailey’s condition. Id. at 55, 67-
68. Dr. Pioro testified that he recommends ALS patients receive flu vaccines to prevent further
chance of infection. Id. at 72.
C. Dr. James Lyons-Weiler
Petitioner submitted three reports from James Lyons-Weiler, Ph.D. Exs. 25-27. Dr. Lyons-
Weiler is not a medical doctor. He holds a Ph.D. in ecology, evolution, and conservation biology
from the University of Nevada, Reno. See Ex. 28 (“Lyons-Weiler CV”).
In the first report, Dr. Lyons-Weiler prepared a table of symptoms that he said showed Mr.
Bailey’s symptomology favored a GBS diagnosis over ALS. Ex. 25 at 1. Then he explained that
he had recommended a genetic test be performed but the report from the test was, in his opinion,
incomplete. Id. Although Dr. Lyons-Weiler indicated this incomplete report seemed to favor an
ALS diagnosis, he recommended that Mr. Bailey be considered to have a diagnosis of GBS and
ALS. Id. at 3.
In the second report, Dr. Lyons-Weiler wrote that he had “re-reviewed his files and now
present [sic] how clearly his symptoms cannot support ALS.” Ex. 26 at 1. He stated that it is his
“medical opinion” that Dr. DeMio’s conclusion that Mr. Bailey had GBS is correct and that Dr.
Pioro’s diagnosis of ALS is incorrect. Id. at 6.
In the third report, Dr. Lyons-Weiler provided a list of medical studies that purported to
show that flu vaccines can cause chronic inflammatory demyelinating polyneuropathy (“CIDP”).
Dr. Lyons-Weiler claimed that ALS is similar enough to GBS and CIDP for the purpose of these
studies. Ex. 27 at 1.
D. Dr. Vinay Chaudhry
On February 17, 2017, Respondent filed an expert report from Vinay Chaudhry, M.D. Ex.
A (hereinafter “Chaudhry Rep.”). Dr. Chaudhry is a professor of neurology at the Johns Hopkins
University School of Medicine and Co-Director of the EMG Laboratory at Johns Hopkins
Hospital. Exhibit C at 1 (“Chaudhry CV”). In this position, Dr. Chaudhry evaluates over 2000
patients per year with the majority related to neuromuscular diseases. Chaudhry Rep. at 1. Dr.
Chaudhry has published more than 200 articles, book chapters and other relevant publications in
his field. See Chaudhry CV at 3-17. He has received multiple grants related to ALS and
neuropathy during the course of his career. Id. at 17-23. Dr. Chaudhry serves as a reviewer on a
number of journals relating to neurology. Id. at 28. He is board certified in neurology with an
added qualification in clinical neurology. Id. at 29.
Dr. Chaudhry summarized Mr. Bailey’s medical records then concluded that his clinical
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features are typical for the diagnosis of ALS. He applied the ALS diagnostic criteria6 to Mr.
Bailey’s case in his report as follows:
1. Signs of lower motor neuron (LMN) degeneration.
Mr. Bailey had fasciculations, atrophy, and EMG evidence (denervation
potentials) of LMN degeneration.
2. Signs of upper motor neuron (UMN) degeneration
Mr. Bailey had spasticity, and hyperreflexia all consistent with UMN signs.
3. Progressive spread of signs within a region or to other regions.
Mr. Bailey had progression from the right side to the left side, from arm to
face to breathing and leg muscles.
4. Absence of other disease processes by electrophysiology and neuroimaging
studies.
Mr. Bailey had no evidence of sensory involvement of demyelination and
no features on neuroimaging to raise the possibilities of other disease
processes in the peripheral nerve or brain/spinal cord to explain his
progressive symptoms and signs.
Chaudhry Rep. at 4.
Next, Dr. Chaudhry applied the criteria for GBS7 and demonstrated that Mr. Bailey did not
show signs or symptoms of GBS:
1. Presence of progressive ascending weakness starting in the legs in a relatively
symmetrical fashion.
Mr. Bailey did not display an ascending pattern of weakness and his
weakness was not symmetrical.
2. Areflexia or absent reflexes.
Mr. Bailey rather than having absent reflexes, had brisk reflexes.
6 Dr. Chaudhry referenced a website for the El Escorial World Federation for Neurology criteria for
diagnosing ALS: http://www.alsa.org/als-care/resources/publications-videos/factsheets/criteria-for-
diagnosis.html. Ex. A-1.
7 Dr. Chaudhry cited to the following article for GBS’s diagnostic criteria: Willison et al., Guillain-Barré
syndrome, LANCET 2016; Vol. 388, pp. 717-27. (Hereinafter “Willison”). Filed as Ex. A-3 at 5.
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3. Progressive phase that lasts days to 4 weeks (often 2 weeks).
Mr. Bailey has continued to show progressive disease for over 4 years. GBS
is a monophasic illness that evolves rapidly reaching its zenith at < 4 weeks.
There is improvement over several months. Mr. Bailey’s illness didn’t peak
at < 4 weeks and didn’t show stabilization or improvement. On the contrary,
he has continued to progress for four years. This rules out any possibility
of the diagnosis of GBS or any other immune mediated neuropathy.
4. Sensory symptoms or signs including pain.
Mr. Bailey did not show pain or sensory involvement (beyond carpal tunnel
syndrome).
5. Nerve conduction studies show features of demyelination in the form of
decreased conduction velocities, prolonged distal motor latencies, increased F-
wave latencies, conduction block and temporal dispersion.
Mr. Bailey didn’t have any of the above noted features in his nerve
conduction studies.
6. GBS is treated with IVIG or plasma exchange. None of these treatments were
even considered since none of the physicians entertained this diagnosis.
Chaudhry Rep. at 5.
Dr. Chaudhry addressed and disputed Dr. DeMio’s various claims individually. For
example, Dr. DeMio claimed that “we physicians only rarely see bulbar variant of ALS and many
physicians will never see a case in their entire career,” but Dr. Chaudhry stated that he sees
approximately 50 patients per year with this diagnosis and with similar presentation to Mr. Bailey.
Chaudhry Rep. at 6-7. Contrary to Dr. DeMio’s claim, Dr. Chaudhry stated that all aspects of Mr.
Bailey’s presentation fit the usual presentation of ALS. Id. at 7. Finally, Dr. Chaudhry stated that
he agreed with the majority of Dr. Pioro’s deposition including when Dr. Pioro testified that Mr.
Bailey had ALS and not GBS. 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).
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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;
(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.
With respect to 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. Nov. 7, 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).
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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’
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
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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 proposition 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.
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).
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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 Opinion Evidence
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
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.”
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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
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
Petitioner alleges that Mr. Bailey’s flu vaccination caused him to develop GBS. The first
step in analyzing a claim is to “determine what injury, if any, was supported by the evidence
presented in the record.” Lombardi v. Sec’y of Health & Human Servs., 656 F.3d 1341,1353 (Fed.
Cir. 2011). The question of whether the vaccination caused Mr. Bailey’s injury turns on Mr.
Bailey’s correct diagnosis. Broekelschen v. Health & Human Servs., 618 F.3d at 1346. Therefore,
I must first determine which injury is best supported by the evidence presented in the record before
determining whether the vaccination caused the injury. After a careful review of the record, I find
the evidence supports that Mr. Bailey had ALS and not GBS.
A. GBS Generally
GBS is an acute paralytic neuropathy that affects approximately 100,000 people annually.
See Willison at 1. AIDP is the most common GBS variant seen within the United States. It is
characterized by focal demyelination of motor and sensory nerves. Id. at 3. Other recognized
GBS variants do not involve damage to the myelin coating the nerve fibers, but instead involve
damage to the axons themselves (the nerve fibers). Id. at 5. GBS generally follows some form of
stimulation to the immune system and is a rapidly progressing, monophasic illness characterized
by progressive weakness in the legs and arms along with decreased tendon reflexes. Id. at 2, 5.
Weakness is the key presenting symptom, and is typically described as ascending, beginning in
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the distal lower extremities. Id. at 5. The progressive phase of GBS, depicted in the below chart,
generally lasts up to four weeks.
Id. at 2. During the progressive phase of GBS, 20-30% of patients develop respiratory failure and
need the support of a ventilator. Id. at 5. GBS is effectively treated with IVIg or plasma exchange.
Id. at 7.
B. ALS Generally
ALS is a “rapidly progressive neurodegenerative disorder.” Morgan & Orrell,
Pathogenesis of amyotrophic lateral sclerosis, BRITISH MEDICAL BULLETIN, Vol. 119, pp. 87-97.
(Hereinafter “Morgan”). Filed as Ex. A-2 at 1. The rapid degeneration of motor neurons results
in weakness and muscle wasting. Id. at 2. The clinical symptoms of ALS include the loss of arm
and hand function, loss of the ability to walk, shortness of breath, and difficulty with speech and
swallowing. Id. Typical time from symptom onset to death is three to five years. Id. The
pathogenesis of ALS is largely unknown, although there are an increasing number of recognized
genetic factors. Id.
C. Mr. Bailey Was Correctly Diagnosed with ALS by his Treating Physicians
In weighing evidence, special masters are expected to consider the views of treating
doctors. Capizzano, 440 F.3d at 1326. The views of treating doctors about the appropriate
diagnosis are often persuasive because the doctors have direct experience with the patient whom
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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). During the course of his illness, Mr. Bailey
was evaluated and treated by three neurologists, Dr. Hugh Miller, Dr. Melanie Taylor, and Dr. Erik
Pioro. All three doctors agreed that Mr. Bailey’s correct diagnosis was ALS, and all documented
their examinations and conclusions in the contemporaneous medical records. Ex. 10 at 8, Ex. 8 at
38-39.
Dr. Miller performed initial testing including an NCS and EMG and noted on May 15,
2013 that the results suggested ALS. Ex. 10 at 8. Dr. Miller referred Mr. Bailey to the Cleveland
Clinic for a second opinion. Id.
Dr. Taylor examined Mr. Bailey on August 29, 2013 and determined that the findings were
consistent with a probable motor neuron disease including ALS. Ex. 8 at 6. Dr. Taylor noted the
following in Mr. Bailey’s medical records:
Now that all the additional investigations have been completed, the final clinical
diagnosis is right upper extremity-onset ALS. Because of the extent of upper motor
neuron (UMN) and lower motor neuron (LMN) abnormalities at present, he meets
the World Federation of Neurology El Escorial diagnostic criteria of probable ALS.
There are combined upper motor neuron (UMN) and lower motor neuron (LMN)
abnormalities at cervical and lumbosacral levels, with evidence of UMN signs in
the bulbar region; by EMG here, LMN changes are not seen in thoracic myotomes.
The clinical diagnosis of ALS is certain.
Id. (emphasis added). Dr. Pioro supervised Dr. Taylor and agreed with her assessment. Dr. Pioro
also agreed with the proposed treatment plan, which included continuing with Riluzole, the only
FDA-approved prescription medication for the treatment of ALS. Id. at 38-39.
Dr. Pioro testified in a deposition on August 24, 2016 wherein he described the nature of
ALS and how ALS is diagnosed. Ex. 21. He explained that Mr. Bailey’s symptoms and test
results supported the diagnosis of ALS rather than GBS. Dr. Pioro has been the director of the
ALS Clinic at the Cleveland Clinic for over 15 years and has seen close to 2000 patients during
that time. I find his opinion to be persuasive and fully supported by the contemporaneous treatment
records.
Ultimately, all of Mr. Bailey’s treating neurologists concluded that he suffered from ALS.
None of them considered GBS as a diagnosis or a differential diagnosis, or even noted it as a
possibility in the medical records.
D. Respondent’s Expert Agrees with Mr. Bailey’s Treating Physicians and is
Persuasive
Respondent’s expert, Dr. Vinay Chaudhry, is a professor of neurology at Johns Hopkins
University School of Medicine. Chaudhry CV at 1. He agreed with the treating physicians’
assessment that Mr. Bailey suffered from ALS rather than GBS. Dr. Chaudhry included in his
report the criteria for the diagnosis of ALS and described how Mr. Bailey met the criteria.
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Chaudhry Rep. at 4. He summarized by stating that “all aspects of Mr. Bailey’s presentation fit
the usual presentation of ALS.” Id. at 7.
Dr. Chaudhry also listed the criteria for GBS and explained how Mr. Bailey did not display
those signs or symptoms. Chaudhry Rep. at 5. In particular, Dr. Chaudhry noted that 1) Mr. Bailey
did not display an ascending pattern of weakness, and that his weakness was not symmetrical; 2)
Mr. Bailey had brisk as opposed to absent reflexes; 3) instead of a progressive phase that typically
lasts up to four weeks, Mr. Bailey continued to show deterioration for four years, until the time of
his death; 4) Mr. Bailey did not exhibit pain or sensory involvement; 5) Mr. Bailey’s nerve
conduction studies did not show features of demyelination in the form of “decreased conduction
velocities, prolonged distal motor latencies, increased F-wave latencies, conduction block and
temporal dispersion”; and 6) Mr. Bailey’s treating physicians did not consider treating with IVIg
or plasma exchange, standard therapies for GBS. Id. Dr. Chaudhry summarized his assessment
by stating, “nothing about [Mr. Bailey’s] presentation is consistent with GBS.” Id. at 6.
Importantly, Dr. Chaudhry is a neurologist who is qualified to opine on the question of
diagnosis. I find Dr. Chaudhry’s opinion to be persuasive and well supported by the medical
records.
E. Petitioner’s Experts Are Not Qualified to Opine of the Issue of Diagnosis and Are
Not Persuasive in Contending that Mr. Bailey Suffered from GBS
Petitioner presented two experts in support of the allegation that Mr. Bailey had GBS.
Neither expert treated Mr. Bailey, neither expert is a neurologist, and neither expert claims to have
specialized knowledge or experience in diagnosing or treating patients with ALS or GBS.
1. Dr. DeMio
Dr. DeMio is a medical doctor who treats patients with autism spectrum disorder, chronic
pain and disease. He is not a neurologist. Dr. DeMio concluded that Mr. Bailey suffered from
GBS rather than ALS but provided no basis, factual or medical, for this conclusion. See Ex. 20
(“DeMio Rep.). He did not discuss the diagnostic criteria for GBS or compare those criteria with
Mr. Bailey’s medical history. Id. While I considered Dr. DeMio’s report, I did not find it
persuasive.
Dr. DeMio’s expert opinion has been discredited by other special masters in the Vaccine
Program. In Wyatt, the special master stated “[o]nce again, Dr. DeMio has rendered an opinion in
a case in which he lacks the underlying requisite medical expertise. Dr. DeMio has neither
specialized training in either autoimmune or neurological disorders nor has he ever conducted
research or written papers in either of these fields”, mot. for review den'd, slip op. No. 14-706V
(Fed. Cl. June 5, 2019); See Wyatt v. Sec’y of Health & Human Servs., 144 Fed. Cl. 531 (2019)
(finding that the Special Master properly determined Dr. DeMio lacked the requisite medical
expertise to render an opinion on Petitioner’s injury, due to his lack of specialized training in the
fields of autoimmune or neurological disorders); McKown v. Sec’y of Health & Human Servs., No.
15-1451V, 2019 WL 4072113 (Fed. Cl. Spec. Mstr. July 15, 2019) (noting Dr. DeMio’s
“questionable medical credentials to offer a reliable opinion on this subject”); Wolf v. Sec’y of
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Health & Human Servs., No. 14-342V, 2015 WL 6518581, at *16 (Fed. Cl. Spec. Mstr. Sept. 15,
2016) (finding Dr. DeMio provided a conclusory opinion supported by scant scientific support).
In a different case, Dr. DeMio testified regarding the cause and treatment of autism in 2013 despite
having no formal specialized training in the area. Holt v. Sec’y of Dept. of Health and Human
Servs., No. 05-136V, 2015 WL 4381588 at *16 (Fed. Cl. Spec. Mstr. June 24, 2015). The former
Chief Special Master described his testimony in that case as “involving broad, general statements”
and stated that he “used medical terminology vaguely and indiscriminately.” Id. at 17. She did
not find his testimony reliable in general or useful in resolving the issues and gave little weight to
his opinion. Id. In another vaccine case, a special master took issue with the decision to retain Dr.
DeMio. Dia v. Sec’y of Health & Human Servs. No. 14-954V, 2017 WL 2644695 at *3 (Fed. Cl.
Spec. Mstr. May 25, 2017) (finding the “conclusory nature of Dr. DeMio’s report made it
practically valueless and forced the petitioner to seek the report from a second expert.”) Id.
In this case, I similarly find Dr. DeMio’s opinion to be unpersuasive. He is not a
neurologist and is inherently less qualified to render an opinion on Mr. Bailey’s correct diagnosis
than Dr. Chaudhry or Mr. Bailey’s treating neurologists.
2. Dr. Lyons-Weiler
Petitioner’s other expert, Dr. Lyons-Weiler, is not a medical doctor. Of the three
documents submitted by Dr. Lyons-Weiler, the first indicated that Mr. Bailey had ALS but should
be considered to have both GBS and ALS, the second included his “medical opinion” that Mr.
Bailey had GBS, and the third simply claimed that ALS was similar enough to GBS and CIDP for
purposes of claiming the flu vaccine can cause ALS. Dr. Lyon-Weiler’s background in biology
and genetic sequencing does not qualify him to opine, as an expert or otherwise, on the topic of
medical diagnoses. I considered the documents submitted by Dr. Lyons-Weiler but I did not find
them relevant or useful. I have reviewed Dr. Lyons-Weiler’s work in a prior case and determined
that his report did not advance any theory as to how the flu vaccine caused petitioner to develop
GBS 15 weeks and five days after the vaccination. Kamppi v. Sec’y of Health & Human Servs.,
No. 15-1013V, 2019 WL 5483161 (Fed. Cl. Spec. Mstr. July 24, 2019).
Dr. Lyons-Weiler, a Ph.D. in ecology, evolution, and conservation biology, and Dr. DeMio,
an emergency room doctor, are inherently less qualified to opine on Mr. Bailey’s correct
neurologic diagnosis than a neurologist. I consider the opinions of the four neurologists (three
treating physicians and Dr. Chaudhry) to be significantly more persuasive than the opinions of Dr.
DeMio and Dr. Lyons-Weiler. See Contreras v. Sec'y of Health & Human Servs., No. 05–626V,
2013 WL 6698382, at *33-34 (Fed. Cl. Spec. Mstr. Nov. 19, 2013) (discussing that a treating
neurologist's opinion is more credible in determining the cause of a neurological illness than the
opinions of a treating emergency medicine specialist and a treating pediatric specialist), vacated
and remanded on other grounds, 116 Fed. Cl. 472 (Fed.Cl.2014), on remand, 2014 WL 8098606
(Fed. Cl. Spec. Mstr. Oct. 24, 2014), aff'd, slip op. (Fed. Cl. Apr. 17, 2015).
Based on my review of all the evidence in this case, particularly the medical records and
the expert reports, the evidence overwhelming supports that Mr. Bailey’s correct diagnosis is ALS
rather than GBS.
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F. Causation of Injury
I have determined that the preponderance of the evidence establishes that Mr. Bailey’s
injury is ALS rather than GBS. Therefore, in order to prevail, Petitioner must establish by a
preponderance of the evidence that the flu vaccination caused Mr. Bailey’s ALS “by providing:
(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of
cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of
a proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278.
Petitioner has not provided evidence that a flu vaccine can cause ALS or that it did so in Mr.
Bailey’s case. In fact, he has confirmed that he is not asserting Mr. Bailey developed ALS from
the vaccine or that his pre-existing ALS was significantly aggravated by the vaccine. See ECF
No. 126. Accordingly, Petitioner cannot meet his burden of proof under any of the Althen prongs.
VII. Conclusion
I express my deep personal condolences to Mr. Bailey’s family for their loss. It is clear
that Mr. Bailey’s life was cut short by a terrible illness. However, the evidence in this case prevents
me from awarding compensation. Upon careful evaluation of all the evidence submitted in this
matter, including the medical records, the affidavits, the experts’ opinions, and medical literature,
I conclude that Petitioner has not shown by preponderant evidence that he is entitled to
compensation under the Vaccine Act. Petitioner has failed to offer preponderant evidence showing
that Mr. Bailey had GBS. Further, he has not offered evidence (or pursued a theory) that Mr.
Bailey’s ALS was either caused or significantly aggravated by vaccination. His petition is
therefore DISMISSED. The clerk shall enter judgment accordingly.8
IT IS SO ORDERED.
s/ Katherine E. Oler
Katherine E. Oler
Special Master
8 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by each filing (either jointly
or separately) a notice renouncing their right to seek review.
22