VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_16-vv-01075
Package ID: USCOURTS-cofc-1_16-vv-01075
Petitioner: Ala Mohamad
Filed: 2016-08-29
Decided: 2024-06-21
Vaccine: Tdap
Vaccination date: 2015-09-18
Condition: Guillain-Barré syndrome
Outcome: compensated
Award amount USD: 919494

AI-assisted case summary:
Ala Mohamad, a 45-year-old man born in 1970, filed a petition on August 29, 2016, alleging that a Tdap vaccine administered on September 18, 2015, caused him to develop Guillain-Barré Syndrome (GBS). Mr. Mohamad, who immigrated to the United States in 1999, had worked in various jobs before his illness. He reported being in good health prior to the vaccination. Within two weeks of receiving the Tdap vaccine during a routine physical, he experienced numbness in his hands, feet, and lower back, which began around September 28, 2015. This led to falls and a diagnosis of GBS. His treating physicians at the Medical Center of Aurora, including Drs. Dennis Keselman, Kenneth Tompkins Jr., Janice Brenneman, Heather Katz, and Jeffrey Zamarripa, noted in his medical records that his GBS was likely triggered by the tetanus injection or was secondary to the tetanus vaccination. He was hospitalized from October 2 to October 30, 2015, receiving treatments including IVIG and plasmapheresis. His condition also involved kidney issues, with doctors considering nephritis and glomerulonephritis. Throughout his hospitalization, he was not tested for C. jejuni or cytomegalovirus, which are associated with GBS. The public decision does not detail the specific onset of symptoms beyond the reported numbness, nor does it describe all diagnostic tests performed or the specific mechanism of GBS causation. 

The Secretary of Health and Human Services contested entitlement, arguing that persuasive evidence did not show a Tdap vaccination can cause GBS, questioning the onset of symptoms, and raising CIDP as an alternative diagnosis. The case proceeded through extensive briefing and expert reports. Petitioner's expert, neurologist Dr. Yuval Shafrir, opined that the Tdap vaccine can cause GBS and did cause Mr. Mohamad's GBS, relying on case reports, temporal association, and treating physician statements. Respondent's expert, neuro-immunologist Dr. Thomas Leist, disagreed, citing the 2012 Institute of Medicine (IOM) report and suggesting a possible strep infection as an alternative cause. Dr. Neal Halsey also testified for the respondent. 

Special Master Christian J. Moran issued a Ruling on Entitlement on January 27, 2022, finding that Mr. Mohamad was entitled to compensation. The Special Master found that government publications, including the 2019 ACIP Best Practices, constituted strong evidence that a tetanus vaccine can cause GBS in rare cases, satisfying the first prong of the Althen test for off-Table injuries. He found a proximate temporal relationship between the vaccination and the onset of GBS on September 28, 2015 (ten days post-vaccination), satisfying the third prong. He also found a logical sequence of cause and effect, supported by the treating physicians' statements, satisfying the second prong. The Special Master concluded that the Secretary had not established an alternative cause for Mr. Mohamad's GBS. 

Following the entitlement ruling, the parties engaged in settlement discussions for damages. On May 24, 2024, respondent filed a Proffer on Award of Compensation, which petitioner accepted. On June 21, 2024, Special Master Moran issued a decision awarding Mr. Mohamad a total of $919,494.53. This award included $561,869.00 for past and future lost earnings, $225,000.00 for pain and suffering (reduced to present value), funds to satisfy a Colorado Medicaid lien of $92,602.13, and compensation for life care items detailed in a life care plan, to be paid via a lump sum and an annuity. The lump sum payment was $794,823.40, covering the first year of life care items, lost earnings, and pain and suffering. The Medicaid lien was paid jointly. Future life care items were to be funded through an annuity with a 4% annual growth rate, paid to Mr. Mohamad for his lifetime. 

The Secretary sought review of the entitlement ruling. On December 2, 2024, Judge Philip S. Hadji of the U.S. Court of Federal Claims denied the motion for review, sustaining the Special Master's decision. The court found that the Special Master properly considered the evidence, including government publications and treating physician statements, and did not improperly shift the burden of proof. The court affirmed that the Special Master's findings were not arbitrary or capricious.

Theory of causation field:
Ala Mohamad, age 45, received a Tdap vaccine on September 18, 2015. He developed Guillain-Barré Syndrome (GBS) with onset of numbness on September 28, 2015, ten days post-vaccination. This case was litigated as an off-Table claim. Petitioner's expert, Dr. Yuval Shafrir, opined that the Tdap vaccine caused Mr. Mohamad's GBS, relying on case reports, temporal association, and treating physician statements. Respondent's experts, Dr. Thomas Leist and Dr. Neal Halsey, disagreed, citing the 2012 IOM report and suggesting alternative causes like strep infection. Special Master Christian J. Moran found entitlement, determining that government publications, including the 2019 ACIP Best Practices, provided strong evidence that tetanus vaccines can cause GBS in rare cases (Althen prong 1). He found a proximate temporal relationship (Althen prong 3) and a logical sequence of cause and effect supported by treating physicians' statements (Althen prong 2). The Secretary did not establish an alternative cause. The Special Master awarded $919,494.53, comprising $561,869.00 for lost earnings, $225,000.00 for pain and suffering, $92,602.13 for a Medicaid lien, and life care items via lump sum and annuity. The Court of Federal Claims denied the Secretary's motion for review, sustaining the Special Master's decision.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_16-vv-01075-1
Date issued/filed: 2022-03-10
Pages: 33
Docket text: PUBLIC ORDER/RULING (Originally filed: 1/27/2022) regarding 150 Ruling on Entitlement Signed by Special Master Christian J. Moran. (jmw) Service on parties made.
--------------------------------------------------------------------------------
Case 1:16-vv-01075-PSH Document 153 Filed 03/10/22 Page 1 of 33
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * * * * * *
ALA MOHAMAD, *
* No. 16-1075V
Petitioner, * Special Master Christian J.
* Moran
v. *
* Filed: January 27, 2022
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * * * * *
Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner;
Voris Johnson, United States Dep’t of Justice, Washington, DC, for respondent.
RULING FINDING ENTITLEMENT TO COMPENSATION
Ala Mohamad alleges that a tetanus-diphtheria-acellular pertussis (“Tdap”)
vaccine caused him to develop a neurological problem known as Guillain-Barré
syndrome (“GBS”). After development of written evidence, the case proceeded to
a hearing. During the hearing, the parties presented testimony from experts whom
they retained on various topics, including a series of publications from the
Secretary about tetanus vaccines. The parties advocated for their positions in
briefs submitted after the hearing.
Mr. Mohamad has carried his burden of proof. The Secretary’s documents
show that a tetanus vaccine can cause GBS. This evidence plus the reports from
doctors who treated Mr. Mohamad constitute preponderant evidence. Moreover,
the Secretary has not established any alternative cause for Mr. Mohamad’s GBS.
Accordingly, Mr. Mohamad is entitled to compensation.
I. Facts
Mr. Mohamad was born in Iraq in 1970. He was educated until the 9th
grade. Tr. 16. He also received training as a machinist. Tr. 17. He immigrated to

Case 1:16-vv-01075-PSH Document 153 Filed 03/10/22 Page 2 of 33
the United States in 1999, and arrived in Colorado in 2000. Id. His wife, Salwa
Asada, was born in Lebanon and came to the United States in 1997. Tr. 26.
To support his family and himself, Mr. Mohamad worked at a Winchell’s
Donut House, which he sold in 2012. Tr. 18. He started a grocery store called Bus
Stop Groceries, which was located on Colfax Street in Denver. But, he closed the
store in 2015 because business was slow. Tr. 19.
In 2015, Mr. Mohamad and his wife owned a townhouse located at Fulton
Circle in Denver. Tr. 21. He testified that before the vaccination, he was in good
health. Tr. 12.1
Mr. Mohamad had an appointment with his primary care doctor, affiliated
with Kaiser Permanente, to obtain a routine physical on September 18, 2015. Tr.
11; exhibit 6 at 15. During this appointment, Mr. Mohamad received the Tdap
vaccination.
Mr. Mohamad returned to Kaiser on Wednesday, September 30, 2015.
Exhibit 6 at 20. Kaiser provided an official interpreter to assist Mr. Mohamad.
Presumably through the interpreter, Mr. Mohamad told the doctor that he had
“numbness sensation in both hands and feet and lower back x 2 days.” Id.2 The
report of any exam is not included in the medical record. The doctor diagnosed
Mr. Mohamad with hyperventilation syndrome. Id.
During the morning of the next day, Mr. Mohamad fell in his house. Exhibit
3 at 4. Mr. Mohamad was taken to the emergency department at the University of
Colorado hospital. Tr. 13; exhibit 3. Mr. Mohamad informed the medical staff
that he felt numbness all over his body, stating “‘I feel paralyzed, like I cannot feel
my body.’” Exhibit 3 at 7.3 During this appointment, Mr. Mohamad had the
benefit of an official interpreter. Id. at 12.
1 While the Secretary identified some medical conditions affecting Mr. Mohamad before
the vaccination, the Secretary has not argued that any of these problems contributed to Mr.
Mohamad's GBS. See Resp’t’s Br. at 2.
2 This September 30, 2015 medical record was the primary basis for finding Mr.
Mohamad developed numbness and tingling on September 28, 2015, which is 10 days after his
vaccination.
3 This October 1, 2015 record states that Mr. Mohamad said his symptoms “began 4 days
ago.” Four days before October 1, 2015 was September 27, 2015, making this history relatively
consistent with the history from September 30, 2015.
2

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The emergency room doctor examined Mr. Mohamad and determined that
his heel-toe walk had some instability. The doctor also found Mr. Mohamad’s
strength and sensation were normal. Exhibit 3 at 5. The doctor diagnosed Mr.
Mohamad with paresthesias of both his hands and feet. Mr. Mohamad was advised
to follow-up with a neurologist and his primary care doctor. Id. at 4; Tr. 13.
The following morning, Mr. Mohamad again fell and could not get up.
Exhibit 16 (affidavit) at 1. An ambulance transported Mr. Mohamad to the
Medical Center of Aurora Hospital, where he remained from October 2, 2015 to
October 30, 2015. Exhibit 5.2 at 601. Mr. Mohamad stated that he could not walk.
Exhibit 5.1 at 254.4 A spinal tap revealed that Mr. Mohamad’s total protein
concentration in CSF was elevated, a result consistent with GBS. Id. at 258-59.
After being admitted to the hospital from the emergency room, Mr.
Mohamad underwent MRIs of his spine. The MRI for his lumbar spine showed
“findings [that] are compatible with GBS with smooth enhancement of the cauda
equina.” Exhibit 5.2 at 613. Based upon the result of the MRIs, the lumbar
puncture, and the history, the doctor diagnosed Mr. Mohamad with GBS. The
doctor continued: “This was likely triggered by [a] recent tetanus injection on
9/19.” Id. at 614.
One of the first treatments for Mr. Mohamad’s GBS was a course of IVIG
given on five consecutive days from October 2 to October 6. Exhibit 5 at 614.
During the IVIG treatments, Mr. Mohamad had problems breathing and was
intubated from October 3 to October 9. Exhibit 5.2 at 619, 627; exhibit 5.4 at
2008.
On October 3, 2015, Dr. Heather Katz stated that Mr. Mohamad suffered
from GBS “likely triggered by vaccination.” Exhibit 5.3 at 830, 823.
A urine test showed that Mr. Mohamad had blood in his urine, a condition
known as hematuria. He was sent for a CT scan, which showed enlargement and
enhancement of both kidneys. Exhibit 5.2 at 619, 621. The internist for Mr.
Mohamad, Dr. Jiang, commented that Mr. Mohamad could possibly have nephritis.
Exhibit 5.3 at 808. Dr. Jiang indicated that his review of literature showed that
4 The history Mr. Mohamad provided about his health after the vaccination suggests that
the onset of neurologic problems was earlier than September 28, 2015. See, e.g., exhibit 5.1 at
254; exhibit 5.2 at 607.
3

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glomerulonephritis has been associated with GBS. Id. Dr. Jiang sought assistance
from a nephrologist.
The nephrology service attended to Mr. Mohamad from October 17, 2015
through October 23, 2015. Exhibit 5.3 at 831-63. At the beginning of this period,
one nephrologist, Dr. Villar, stated that Mr. Mohamad had “gross hematuria and
mild proteinuria of unclear etiology.” Exhibit 5.3 at 862. Dr. Vallarta suggested
that Mr. Mohamad might require a biopsy to reach a definitive diagnosis.
As it turns out, Mr. Mohamad did not undergo a kidney biopsy. On October
18, 2015, Dr. Vallarta assessed Mr. Mohamad’s kidney function as stable. Exhibit
5.3 at 860. In addition, Mr. Mohamad needed an additional treatment for his GBS,
plasmapheresis. Thus, Dr. Vincent delayed the biopsy. Id.
Mr. Mohamad’s blood was tested for anti-streptolysin O (“ASO”)
antibodies. The result was 1:1200. Exhibit 5.3 at 860/PDF 58. This result
exceeded the upper limit of normal by a factor of at least 10. Tr. 138; see also Tr.
253. Based, in part, on the ASO result, Dr. Vincent stated that Mr. Mohamad’s
kidney problem “could potentially be an acute post strep GN
[glomerulonephritis].” Exhibit 5.3 at 860.
This note is one basis for Dr. Leist’s opinion that Mr. Mohamad suffered
from a strep throat. Tr. 99-100. However, none of the doctors treating Mr.
Mohamad diagnosed him as being infected with Streptococcus bacteria.
Throughout Mr. Mohamad’s stay at the Medical Center of Aurora, he was
not tested for two infectious organisms that are associated with GBS, C. jejuni and
cytomegalovirus. Tr. 98 (Dr. Leist), 278 (Dr. Halsey); see also Tr. 59 (Dr.
Shafrir).
Dr. Jill Castro discharged Mr. Mohamad from the Medical Center of Aurora
to a rehabilitation facility on October 30, 2015. In the discharge report, Dr. Castro
stated that Mr. Mohamad had an allergy to tetanus toxoids and that the allergic
reaction produced GBS. Exhibit 5.3 at 947.5 Dr. Castro’s linking of the tetanus
vaccine to Mr. Mohamad’s GBS is consistent with an October 26, 2015 statement
5 The record from the Medical Center of Aurora contains multiple other notes about Mr.
Mohamad's allergic reaction to the tetanus vaccine. See Exhibit 5.2 at 655, 695, 747, 752, 756,
771, 776, 781; exhibit 5.3 at 839. In addition, multiple records show that medical personnel
were aware that Mr. Mohamad developed GBS “following tetanus shot.” See Exhibit 5.2 at 666,
679, 684, 691, 695-96, 701, 704, 707, 749, 753, 757, 762, 765, 769, 772, 777, 783, 791, 796,
801, Exhibit 5.3 at 809, 813, 817.
4

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from Dr. Jeffrey Zamarripa. Dr. Zamarripa described Mr. Mohamad’s chief
complaint as “GBS 2/2 [secondary to] Tetanus vaccination.” Exhibit 5 at 764.
After Mr. Mohamad left the Medical Center of Aurora, he had a lengthy
rehabilitation and recovery. See Resp’t’s Br. at 5-8. But, this convalescence
contributes very little, if at all, to determining whether the vaccination caused Mr.
Mohamad’s GBS. Tr. 74 (Dr. Shafrir), 124 (Dr. Leist); but see Tr. 272-73 (Dr.
Shafrir’s rebuttal testimony identifying a medical record from March 2018
indicating that Mr. Mohamad had an allergy to tetanus toxoid).
In July 2020, a neurologist (Dr. Daniel Koontz) evaluated Mr. Mohamad,
who was applying for disability. Dr. Koontz determined that Mr. Mohamad’s gait
was slow and mildly unsteady. Dr. Koontz recommended that Mr. Mohamad
should continue to take gabapentin and to increase his dose of duloxetine. Exhibit
83 at 1.
During the May 2021 hearing, Mr. Mohamad stated that he can walk, get
dressed, and feed himself. His current problems include lethargy and numbness.
Tr. 23; see also Tr 14. He is able to work for a friend, making donuts in a
convenience store, for at least a few hours. Tr. 20. Mr. Mohamad and his wife
moved from their townhouse in Denver to a house in Aurora, Colorado, which they
own subject to a mortgage from a bank. Tr. 21, 28.
II. Procedural History
Mr. Mohamad initiated this action by filing a petition on August 29, 2016.
Over the next six months, he filed medical records.
Mr. Mohamad disclosed some information about the extent of his possible
compensation by filing a damages affidavit on February 17, 2017. Mr. Mohamad
stated that before and after the vaccination his state’s Medicaid program provided
health care coverage. He estimated that before the vaccination he was earning
approximately $9,000 per year in income while working at Winchell’s Donut
House and he was starting part-time work in January 2017. Exhibit 8 (filed
February 17, 2017).
After reviewing this material, the Secretary found that the record was
substantially complete and invited Mr. Mohamad to consider an informal
resolution. Resp’t’s Status Rep., filed March 14, 2017. Mr. Mohamad responded
that to present a demand, his counsel would need to retain a vocational expert, an
economist, and a life care planner. Pet’r’s Status Rep., filed April 12, 2017.
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Rather than explore settlement on these terms, the Secretary opted to defend the
case. See order issued April 28, 2017.
The Secretary argued that Mr. Mohamad was not entitled to compensation
for three reasons. First, the Secretary maintained that persuasive evidence did not
show that a Tdap vaccination can cause GBS. For this proposition the Secretary
relied upon the 2012 report from the Institute of Medicine (“IOM”), which the
Secretary later submitted as exhibit B, tab 2. Second, the Secretary questioned
when Mr. Mohamad began to display neurologic symptoms that were
manifestations of his GBS. Third, respondent raised CIDP as a different diagnosis.
Resp’t’s Report, filed June 6, 2017.
In the status conference following the submission of the Secretary’s report,
Mr. Mohamad proposed that previous decisions from special masters had resolved
the question that the Tdap vaccination can cause GBS or CIDP in petitioners’
favor. Accordingly, the parties were directed to file briefs on this topic. Order,
issued June 21, 2017. In the status conference, Mr. Mohamad additionally
announced an intention to submit a demand supported by a life care plan.
Both parties submitted briefs about precedent for Tdap vaccinations causing
GBS. After reviewing these, the undersigned determined that the lack of
uniformity in outcome prevented a finding in petitioner’s favor on this point before
the parties had developed evidence. Order, issued August 15, 2017. The
undersigned also indicated that the parties could explore settlement if they wished.
Id.
Uncertainty about when Mr. Mohamad began to suffer neurologic problems
appeared to be an obstacle for meaningful progress on settlement. Accordingly,
the undersigned directed Mr. Mohamad to submit evidence relevant to the question
of onset in advance of a hearing at which percipient witnesses could testify. Order,
issued Dec. 13, 2017. During the next four months, Mr. Mohamad did not present
affidavits from percipient witnesses. See order, issued March 13, 2018.
Due in part to this delay and in part to a surge in case filings, the
undersigned shifted course. Instead of proceeding to an onset hearing, the
undersigned directed the parties to obtain reports from experts. Order, issued May
7, 2018. Through an Order on Expert Instructions, the parties were directed to
have their experts assume different dates of onset. Order, issued May 24, 2018,
¶ 6.b.ii.
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Mr. Mohamad submitted his Social Security Earnings Statement on July 6,
2018. This government report showed that in the three years before vaccination,
Mr. Mohamad earned $9,175, $13,505, and $15,181. In 2015, the year in which
Mr. Mohamad received a vaccination in September, his earnings were $9,286. In
the next year, Mr. Mohamad earned $10,814. Exhibit 15.
Mr. Mohamad requested additional time to file a report from his expert twice
and both motions were granted. Mr. Mohamad filed a third motion for
enlargement of time on November 1, 2018, requesting that the report from his
expert be due 45 days after a finding regarding onset. Pet’r’s Mot. filed Nov. 1,
2018. This request was granted in part and denied in part. The undersigned stated
that Mr. Mohamad did not require a finding regarding onset because the expert
instructions presented hypothetical questions based upon different starting dates.
Accordingly, Mr. Mohamad was ordered to file his expert report 45 days later.
Order, issued Nov. 2, 2018.
After receiving a fourth extension of time, Mr. Mohamad submitted a report
from Dr. Yuval Shafrir on February 28, 2019. Exhibit 20. Dr. Shafrir opined that
a Tdap vaccination can cause GBS and that the Tdap vaccination did cause Mr.
Mohamad’s GBS. Id.
The Secretary responded with a report from Dr. Thomas Leist. Dr. Leist
disagreed with the proposition that the Tdap vaccination can cause GBS and cited
the 2012 IOM report in support. Exhibit B. Dr. Leist also maintained that a Strep
infection could have caused Mr. Mohamad’s GBS. Id.
Mr. Mohamad obtained a supplemental report from Dr. Shafrir. Exhibit 52,
filed Sep. 10, 2019.
In the ensuing status conference, the undersigned explained that the case
would not necessarily proceed to a hearing. To make sure that both parties had an
opportunity to present their evidence, the undersigned scheduled another report
from Dr. Leist as well as a report from Dr. Shafrir. Order, issued Oct. 15, 2019.
Without seeking any additional time, the Secretary filed a second report
from Dr. Leist on November 25, 2019. Exhibit C.
Mr. Mohamad twice requested additional time to file a response from Dr.
Shafrir and both requests were granted. Then, Mr. Mohamad explained that he
wanted Dr. Shafrir to respond at a hearing, but not present another report. Pet’r’s
Status Rep., filed Feb. 26, 2020. Mr. Mohamad was reminded that a hearing was
not guaranteed and given a deadline of March 12, 2020. Order, issued February
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27, 2020. On the same day as this order was issued, Mr. Mohamad filed the third
report from Dr. Shafrir. Exhibit 58.
It appeared that the report from Dr. Shafrir completed the submission of
opinions from experts. Order, issued March 11, 2020. A comprehensive
scheduling order was issued on March 25, 2020. Mr. Mohamad was directed to
file updated medical records and any information regarding an application for
disability benefits through the Social Security Administration by April 30, 2020.
Mr. Mohamad was further instructed to file a brief regarding entitlement on May
29, 2020. The Secretary was ordered to file a response 60 days later, to which Mr.
Mohamad might reply 30 days later.
To discuss the expected content of the entitlement briefs, a status conference
was held on April 14, 2020. During this conference, Mr. Mohamad sought and
received additional time to file his medical records, Social Security records, and
employment records. The undersigned also suggested, due in part to Mr.
Mohamad’s relatively modest claim for lost earnings, that the parties might explore
settlement. Order, issued April 14, 2020.
Later on April 14, 2020, the undersigned submitted materials from the
government about the Tdap vaccine and GBS. Court exhibit 10016, court exhibit
1002.7 The parties were offered an opportunity to obtain opinions from Dr. Shafrir
and Dr. Leist about the Court exhibits. Order, issued April 14, 2020.
The Secretary sought to amend the schedule because the Secretary wished to
retain a person other than Dr. Leist to address the Court exhibits. Resp’t’s Mot.,
filed April 28, 2020. Despite an objection from Mr. Mohamad, this motion was
granted. Order, issued May 4, 2020. This order also set a deadline for Mr.
Mohamad to file a status report regarding his presentation of a demand for
settlement by June 15, 2020.
Mr. Mohamad filed exhibits on a range of topics. He submitted another
report from Dr. Shafrir on May 5, 2020. Exhibit 63. He submitted updated
medical records on May 20, 2020. Exhibits 72-73. He submitted his tax returns as
exhibits 74-80 on May 28, 2020. Also, on May 28, 2020, Mr. Mohamad submitted
a life care plan and a report from an economist. Exhibits 81-82. Mr. Mohamad
6 See infra note 22.
7 See infra note 23.
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represented that he was still putting together a demand. Pet’r’s Status Rep., filed
June 15, 2020. He filed his initial brief regarding entitlement on June 23, 2020.
Mr. Mohamad indicated that he had not presented a demand in his July 22,
2020 status report. This deadline was then extended, sua sponte, to September 4,
2020. Order, issued August 25, 2020. However, on September 4, 2020, Mr.
Mohamad did not file any status report.
The Secretary also presented evidence and argument regarding Mr.
Mohamad’s entitlement to compensation. On September 24, 2020, the Secretary
filed another report from Dr. Leist (exhibit D), a report from Neal Halsey (exhibit
E), and his initial brief.
Mr. Mohamad filed his reply brief on October 26, 2020. After reviewing the
parties’ evidence and their arguments, the undersigned determined that a hearing
was appropriate. Order, issued January 5, 2021. The undersigned also explained
that the parties may wish to explore settlement.
In conjunction with any potential efforts to resolve the case informally, Mr.
Mohamad documented that the Social Security Administration found that he was
disabled per the SSA rules on February 27, 2020. This document also reported that
Mr. Mohamad had not reported any earnings to the SSA after 2016. Exhibit 86.
This indication that Mr. Mohamad’s reported earnings stopped after 2016 was
consistent with the information Mr. Mohamad had filed as exhibit 15.
Mr. Mohamad indicated that he anticipated his life care plan would be
finished in “mid-April.” Pet’r’s Status Rep., filed March 25, 2021. He filed this
life care plan on April 16, 2021. Exhibit 87. With that submission, Mr. Mohamad
stated that he had communicated a demand. Pet’r’s Status Rep., filed April 16,
2021.
Before Mr. Mohamad filed his life care plan, the undersigned tentatively
found that Mr. Mohamad’s neurologic problem began on September 28, 2015.
Order, issued April 12, 2021. The undersigned permitted commentary on the
tentative finding of fact. Order, issued April 21, 2021. Following the pretrial
conference on April 22, 2021, the tentative finding of fact became official. Ruling,
issued April 23, 2021.
As for settlement, the Secretary offered a proposal on April 21, 2021. Mr.
Mohamad, however, preferred to proceed to a hearing. Pet’r’s Status Rep., filed
April 30, 2021.
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A hearing was held via videoconferencing on May 6-7, 2021. Mr. Mohamad
and his wife, Salwa Asada, testified about Mr. Mohamad and his health. Mr.
Mohamad called Dr. Shafrir to testify and the Secretary called Dr. Leist and Dr.
Halsey as witnesses.
At the end of the hearing, Mr. Mohamad requested an opportunity to file a
short brief. The undersigned outlined the significant issues, although the parties
were free to address any issue that they wished. Order, issued May 12, 2021. The
Secretary filed his brief on July 6, 2021, and Mr. Mohamad responded on July 27,
2021. Because the time for any reply has lapsed, Mr. Mohamad’s case is ready for
adjudication.
III. Standards for Adjudication
A petitioner is required to establish his case by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact's existence.” Moberly v. Sec'y of
Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
omitted). Proof of medical certainty is not required. Bunting v. Sec'y of Health &
Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec'y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed.
Cir. 2009) (reversing special master's decision that petitioners were not entitled to
compensation); see also Lampe v. Sec'y of Health & Hum. Servs., 219 F.3d 1357
(Fed. Cir. 2000); Hodges v. Sec'y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed.
Cir. 1993) (disagreeing with dissenting judge's contention that the special master
confused preponderance of the evidence with medical certainty).
When pursuing an off-Table injury, a petitioner bears a burden “to show by
preponderant evidence that the vaccination brought about [the vaccinee’s] 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.” Althen v. Sec’y of Health & Hum. Servs., 418
F.3d 1274, 1278 (Fed. Cir. 2005).
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IV. Analysis
The analysis consists of five parts. First, the analysis begins with an
assessment of the credibility of the two original experts, Dr. Shafrir and Dr. Leist.
In short, their credibility was poor. Thus, the remainder of the analysis relies upon
their opinions for relatively uncontroverted topics. The second part addresses the
most contested issue, whether a tetanus vaccine can cause GBS. The third part
finds that Mr. Mohamad’s GBS arose within a time for which an inference of
causation is appropriate. The fourth part finds that a logical sequence of cause and
effect connects the tetanus vaccine to Mr. Mohamad’s GBS. The fifth and final
part finds that no alternative factor caused Mr. Mohamad’s GBS.
A. Evaluation of Expert’s Credibility
Special masters may consider the credibility of experts who testify before
them. See Moberly, 592 F.3d at 1325-26. The analysis begins with this point
because the (lack of) credibility is a foundation for assessing the expert’s
persuasiveness. Contreras v. Sec’y of Health & Hum. Servs., 121 Fed. Cl. 230,
238 (2015) (“an expert witness who is not credible does not, as a general rule,
provide reliable expert testimony”), vacated on other grounds, 844 F.3d 1363 (Fed.
Cir. 2017).
To start, Dr. Shafrir’s testimony revealed he has relatively little recent
experience with GBS. This lack of experience tends to reduce the value of his
testimony. See Copenhaver v. Sec’y of Health & Hum. Servs., 129 Fed. Cl. 176
(2016). To be sure, Dr. Shafrir is a board-certified neurologist. Tr. 31. But on the
specific question about causes of GBS, his current experience is relatively slender.
For a time, Dr. Shafrir taught as an attending child neurologist at Oklahoma
University. However, Dr. Shafrir stopped his academic work in 2000. Exhibit 21
(curriculum vitae). More recently, he worked at Sinai Hospital, but that hospital
work stopped in 2019. Tr. 31. Since his retirement from the hospital, Dr. Shafrir
works at a private practice. Id. Most of Dr. Shafrir’s patients are children
suffering from PANDAS. Tr. 67.8 Dr. Shafrir most recently saw a person with
GBS approximately 3-4 years ago. Tr. 68.
Apart from his relative lack of experience with GBS, portions of Dr.
Shafrir’s testimony reduced his credibility. On cross-examination, he sometimes
evaded answering the question by providing rambling and non-responsive answers.
8 PANDAS is an acronym for pediatric autoimmune neuropsychiatric disorder associated
with strep. Tr. 68.
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See, e.g., Tr. 46, 49, 51; see also Vaughan v. Sec’y of Health & Hum. Servs., 107
Fed. Cl. 212 (2012) (special master may consider an expert’s evasiveness in
weighing an expert’s testimony).
Much like Dr. Shafrir, Dr. Leist’s demeanor undermined his credibility.9 On
cross-examination, Dr. Leist attempted to parry off entirely appropriate questions.
These defensive efforts left the impression that Dr. Leist either was unprepared to
testify or did not want to answer questions about relevant topics. Tr. 105-15; but
see Tr. 138. Special masters may consider the expert’s demeanor when evaluating
the strength of the testimony. See Moberly, 592 F.3d at 1325-26; Yalacki v. Sec’y
of Health & Hum. Servs., 146 Fed. Cl. 80, 89 (2019) (noting special master found
petitioner’s expert combative and evasive); Fadelalla v. United States, 45 Fed. Cl.
196 (1999).
Dr. Leist’s opinion on the role of a possible Strep infection was inconsistent.
Initially, Dr. Leist’s opinion was quite strong and direct: “It is my opinion that Mr.
Mohamad had a streptococcal infection in late September 2015 and that this
infection is the proximal cause of Mr. Mohamad’s Guillaine-Barre [sic]
syndrome.” Exhibit B at 8. But, in his oral testimony, Dr. Leist said something
different. He testified: “I’m not suggesting . . . that he had GBS because of the
streptococcal infection.” Tr. 133. This change in opinion was not adequately
explained.
To the extent Dr. Leist even raised the possibility of a Strep infection as a
possible cause of Mr. Mohamad’s GBS, this position was necessarily based upon
two premises. First, Mr. Mohamad was infected with Strep. Second, a Strep
infection can cause GBS.
As to whether Mr. Mohamad was infected with Strep, the experts might
reasonably dispute this question.10 Dr. Leist pointed to a test result showing a titer
well above a normal range and the presence of protein in Mr. Mohamad’s urine, a
condition associated with Strep. Tr. 138-39; see also Tr. 100. Dr. Leist also relied
upon the fact that some people infected with Strep do not display any symptoms.
9 Dr. Leist's qualifications did not raise any concerns. He is board-certified in neurology.
Tr. 91-92. Dr. Leist continues working in a tertiary-level hospital where he sees patients with
GBS. Tr. 91-92. Thus, strictly measured by experience with GBS, Dr. Leist was stronger than
Dr. Shafrir.
10 As neurologists, neither Dr. Shafrir nor Dr. Leist carry any special qualifications in
infectious diseases.
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Tr. 99-101; see also exhibit D, tab 1 (Johnson et al.).11 In contrast, Dr. Shafrir
countered that the single positive test for anti-streptolysin O antibodies was
valueless because Mr. Mohamad received IVIG before his ASO test. As such, the
IVIG could have been the source of the antibodies detected on that one test. Tr.
253-55. In short, although the experts differed, they offered opinions in good faith.
However, the basis for the other supposition – that Strep can cause GBS – is
questionable. To support the idea that Strep can cause GBS, Dr. Leist relies upon a
case report. Exhibit B, tab 3 (Yuki).12
But, case reports generally offer little, if any, value in determining causation.
Tr. 278 (Dr. Halsey); see also Tr. 133 (Dr. Leist). When pressed to explain why
this case report was meaningful, Dr. Leist’s answers were not satisfactory. Tr.
133-35. Dr. Leist’s reliance upon a single case report to construct an obstacle to
Mr. Mohamad’s receipt of compensation is inconsistent with Dr. Leist’s typical
reluctance to accept case reports as evidence favoring a finding that a vaccine
caused an adverse event. See Koller v. Sec’y of Health & Hum. Servs., No. 16-
493V, 2021 WL 5027947, at *15 (Fed. Cl. Spec. Mstr. Oct. 8, 2021) (quoting Dr.
Leist’s expert report as stating “the few case reports in the literature do not provide
information beyond temporality”); Harmon v. Sec’y of Health & Hum. Servs., No.
12-298V, 2017 WL 2872293, at *17 (Fed. Cl. Spec. Mstr. June 6, 2017) (quoting
Dr. Leist’s expert report as stating “case reports are not sufficient to establish
causation”). This inconsistency, in turn, reduced Dr. Leist’s overall
persuasiveness. See Moberly v. Sec’y of Health & Hum. Servs., 85 Fed. Cl. 571,
606 (2009) (expert’s lack of persuasiveness on one point reduced the value of the
expert’s testimony on other points), aff’d, 592 F.3d 1315 (Fed. Cir. 2010).
The undersigned is aware that Dr. Leist presented his opinion regarding a
possible Strep infection as a possible cause for Mr. Mohamad’s GBS as a
secondary opinion. Exhibit C at 1; Tr. 100, 126. Dr. Leist’s primary opinion is
that there is a lack of persuasive evidence to support the proposition that tetanus
toxoid can cause GBS. Exhibit B (report) at 4; Tr. 93-94, 104; see also Resp’t’s
11 Dwight R. Johnson, et al., The Human Immune Response to Streptococcal
Extracellular Antigens: Clinical, Diagnostic, and Potential Pathogenetic Implications, 50
CLINICAL INFECTIOUS DISEASES 481 (2010).
12 Nobuhiro Yuki & Koichi Hirata, Fisher’s syndrome and group A streptococcal
infection, 160 J. NEUROLOGICAL SCI. 64 (1998).
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Br. at 14-20. The primary basis for Dr. Leist’s opinion on this point is the 2012
IOM report. See exhibit C at 2.
Dr. Leist’s reliance on the 2012 IOM report makes his opinion both sensible
and limited. It is sensible in the sense that the IOM is comprised of knowledgeable
people whose work is generally respected. Consequently, Dr. Leist’s deferral to
the IOM’s expertise cannot really be faulted. Yet, in simply restating what the
IOM said, Dr. Leist seems to be adding relatively little. See Contreras v. Sec’y of
Health & Hum. Servs., 121 Fed. Cl. 230 (2015), vacated on other grounds, 844
F.3d 1363 (Fed. Cir. 2017).
Dr. Leist, for example, did not offer any testimony about how the IOM
forms its conclusions or how the IOM’s conclusions inform positions taken by the
Secretary on these topics. The Secretary presented testimony from Dr. Halsey,
whose opinions are reviewed in the following section.
B. Althen Prong 1
The first prong of Althen is equivalent to asking whether the evidence shows
the vaccine can cause the injury. Pafford v. Sec’y of Health & Hum. Servs., 451
F.3d 1352, 1355-56 (Fed. Cir. 2006). The present case is unusual in that the most
probative evidence that a tetanus-containing vaccine can cause GBS comes from
statements from the Secretary. The evidence shows that the Secretary of Health
and Human Services has accepted, and not rescinded, the proposition that a DTaP
vaccination can cause GBS.
Acting through the Centers for Disease Control and Prevention (“CDC”), the
Secretary of Health and Human Services (“HHS”) has issued a series of
publications that discuss, in part, a connection between a vaccine containing
tetanus toxoid and GBS. An independent part of the federal government, the
Institute of Medicine, has also contributed publications to this topic. These
publications are reviewed in chronological order, starting with the earliest. Dr.
Halsey’s testimony clarified some aspects of the process through which the reports
are prepared. Dr. Halsey was qualified to opine about the Secretary’s process
because, in part, of his earlier work as a member of the Advisory Committee on
Immunization Practices (“ACIP”). The summary of the relevant government
documents begins with the charter for the ACIP.
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1. Charter of the Advisory Committee on Immunization
Practices13
The Public Health Service Act, the Federal Advisory Committee Act, and
the Social Security Act authorize the Secretary of Health and Human Services to
appoint members to an advisory committee on immunization practices. The ACIP
consists of fifteen special government employees. Exhibit E, tab 1 at 4. The
Secretary of HHS selects them from authorities knowledgeable in the fields of
immunization practices and public health, who have experience with the use of
vaccines and other immunobiologic agents. Id. ACIP also has six non-voting ex-
officio members (a detailed list is included on Exhibit E, tab 1 at 4).
The ACIP’s specific duties include advising the Director of the CDC on (1)
the control of diseases for which a vaccine is licensed in the United States, (2) both
use of vaccines and the administration of immune globulin preparations and
antimicrobial therapy, (3) vaccine administration to specific groups and
populations, (4) precautions and contraindications for use of vaccines, and (5) the
list of vaccines for administration to children under the Vaccines for Children
Program. Id. at 2. ACIP also considers questions about disease epidemiology and
burden, as they relate to vaccine efficacy and safety. Id. at 1-2. As new
information about disease epidemiology and vaccine effects is published, ACIP
may withdraw their recommendations regarding particular vaccines. Id. at 2.
The Director of the CDC reviews ACIP recommendations and publishes
some of them as official CDC/HHS recommendations to the general public through
the Morbidity and Mortality Weekly Reports (“MMWRs”). Id. at 1; Tr. 227. Dr.
Halsey explained when the CDC director approves the guidance, the CDC also
sends the recommendation to the Assistant Secretary of Health, who also has the
authority to review the recommendations. Tr. 225-27 (discussing rescinded
recommendations for health care workers to receive a vaccine against small pox).
2. 1994 ACIP General Recommendations on Immunization14
In 1994, the Secretary revised her “general recommendations” concerning
vaccine practices from the previous version issued in 1989. The 1994 General
13 Exhibit E, tab 1: CENTER FOR DISEASE CONTROL & PREVENTION, CHARTER OF THE
ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (Mar. 22, 2020),
https://www.cdc.gov/vaccines/acip/committee/acip-charter.pdf.
14 Exhibit E, tab 4: Center for Disease Control & Prevention, General Recommendations
on Immunization: Recommendations of the Advisory Committee on Immunization Practices, 43
15

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Recommendations provide general information about vaccines, such as vaccine
storage and distribution.
The 1994 General Recommendations discussed contraindications and
precautions for vaccinations. Exhibit E, tab 4 at 32. Some true contraindications
and precautions include intense allergic responses and encephalopathy within
seven days of receiving a vaccine.
Tetanus-toxoid vaccination is recommended for “all persons,” with the
exception of individuals afflicted by serious allergic responses to previous tetanus
toxoid doses. Id. at 11-12. After a serious adverse reaction to tetanus toxoid, the
patient should be assessed before the administration of further doses -- generally
via a dermal test for reactivity. The 1994 General Recommendations did not
specifically discuss tetanus toxoid and any association with GBS.
3. 1994 IOM Publication: Adverse Events Associated with
Childhood Vaccines - Evidence Bearing on Causality15
In 1994, the IOM issued a lengthy study about whether childhood vaccines
can cause adverse events.
This study conducted an overview of the available medical research, as of
1994, on GBS’s relationship to receipt of tetanus toxoid-containing vaccines.
Exhibit 89 at 86-89. The IOM determined the “evidence favors a causal relation
between tetanus toxoid and GBS.” Id. at 89. Due to a lack of research that
included a “good age-specific background rate for [GBS]”, “aggressive
surveillance,” or a controlled observational study of a (preferably large) sample of
participants, the IOM could not assess either the prevalence or risk of GBS-onset
following tetanus toxoid-containing vaccination. Id. at 89.
The IOM concluded that tetanus toxoid-containing vaccines can cause GBS
based on a single case study, known as the Pollard-Selby case report. Id. at 87-89.
Pollard and Selby reported that a 42-year-old male laborer was found to have three
episodes of GBS-onset over thirteen years, each following receipt of a tetanus-
toxoid containing vaccine. The first GBS episode occurred twenty-one days after
CDC MORBIDITY & MORTALITY WKLY. REP. 1 (Jan. 28, 1994),
https://www.cdc.gov/mmwr/PDF/rr/rr4301.pdf.
15 Exhibit 89: INSTITUTE OF MEDICINE, ADVERSE EVENTS ASSOCIATED WITH CHILDHOOD
VACCINES: EVIDENCE BEARING ON CAUSALITY 86-89 (Kathleen R. Stratton, Cynthia J. Howe &
Richard B. Johnston, Jr., eds., 1994).
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vaccination, the second occurred fourteen days after, and the third occurred ten
days after. Id. at 87. A nerve biopsy following his third episode demonstrated
neuropathy consistent with GBS symptomatology: demyelination, onion bulb
formation, and incipient hypertrophic neuropathy. Id. at 88. Notably, this man
continued to experience multiple recurrences of demyelinating polyneuropathy
following his last GBS episode, and as of 1994, was still struggling with sensory
symptoms. Id. Based on the recurrent and proximate onset of GBS following the
receipt of tetanus toxoid-containing vaccines, his doctors concluded that his GBS
was caused by receipt of tetanus toxoid. Id. at 88-89.
The other studies that the IOM analyzed in 1994 were not so determinative.
All of them were uncontrolled case studies or reports that included varying levels
of detail. Id. at 87. Ultimately, the IOM found that only three of twenty-nine
“GBS-diagnosis” labeled cases were detailed enough to denote GBS-onset
following receipt of tetanus toxoid, and the rest either misdiagnosed GBS or were
too vague. Id. For DT and Td vaccinations (which contain tetanus toxoid)
specifically, the research was limited to passive reporting studies. Id. Following
DT vaccination, medical reports in “the former East Germany” indicated three
instances of symptomatology common to GBS from 1950-76, and the Monitoring
System for Adverse Events Following Immunization listed four cases between
1979 and 1990. Id. at 88. For the Td vaccine, VAERS indicated only two
“temporally associated” GBS-diagnoses. Id. It is unclear whether these reported
cases for DT and Td were accurate GBS diagnoses.
Thus, the IOM concluded that GBS can be caused by tetanus toxoid
vaccination, but that there is not enough reliable research to determine either
prevalence or likelihood. Id. at 89.
4. 1996 Update: Vaccine Side Effects, Adverse Reactions,
Contraindications, and Precautions Recommendations of the Advisory
Committee on Immunization Practices (ACIP)16
This report acted as an update (as of 1996) to the previously published ACIP
recommendations pertaining to precautions, contraindications, side effects, and
16 Exhibit E, tab 3: Center for Disease Control & Prevention, Update: Vaccine Side
Effects, Adverse Reactions, Contraindications, and Precautions Recommendations of the
Advisory Committee on Immunization Practices (ACIP), 45 CDC MORBIDITY & MORTALITY
WKLY. REP. 1 (Sept. 6, 1996), https://www.cdc.gov/mmwr/preview/mmwrhtml/00046738.htm.
17

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adverse reactions associated with vaccinations. Exhibit E, tab 3 at 1. The 1996
update compiled data from IOM findings and two ACIP MMWRs from 1993 and
1994 and highlighted major changes to the previous ACIP recommendations,
particularly concerning the hepatitis B, measles, DTP, and tetanus toxoid-
containing vaccines. Id. at 1. This summary focuses on the section of the report
discussing tetanus toxoid-containing vaccines.
The only contraindication to tetanus (and diphtheria) toxoids is a history of a
neurologic or severe hypersensitivity reaction to a previous dose. Id. at 14. Even
if an anaphylactic response occurs in response to a tetanus toxoid-containing
vaccination, skin testing with appropriately diluted tetanus toxoid should be used
before completely discontinuing tetanus toxoid vaccination. Id. A study has
shown that 94 of 95 people with a history of anaphylactic symptoms following a
previous dose of tetanus toxoid were nonreactive to intradermal testing and
tolerated further tetanus toxoid without incident. Id.
The 1996 Update recognized that the IOM had concluded that tetanus toxoid
can trigger GBS onset, based on (1) the case study of a 42-year-old man who had
GBS on three separate occasions, each following receipt of tetanus toxoid, and (2)
evidence that a vaccine-induced immunologic response can cause GBS. Id. at 14.
However, this 1996 Update discussed potentially contrary evidence found in
two studies. First, in a study in which over one million doses of tetanus-containing
toxoid were administered to people over 18 years old, two cases of GBS were
expected to appear by chance alone, and only one case was reported. Id. This
indicated that risk for GBS after administration of tetanus toxoid was extremely
low. Second, in a study of 0.7 million children, three cases of GBS were expected
by chance alone and only two cases were reported. Id. at 13-14. Because of how
rarely tetanus vaccination is associated with GBS recurrence, the decision to
administer an additional tetanus toxoid-containing vaccine to a person diagnosed
with GBS within six weeks should be based on the benefits of subsequent
vaccination versus risk of GBS recurrence. Id. at 14.
Ultimately, in the 1996 Update, the ACIP concluded these findings
suggested that the risk for GBS following administration of tetanus toxoid was
“extremely low.” Id. at 14.
5. Vaccine Program Litigation
After the 1994 IOM report and the ACIP’s 1996 Update, special masters
considered whether petitioners established that a tetanus-containing vaccine can
18

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cause GBS. During this era, special masters generally found that petitioners were
entitled to compensation for GBS caused by tetanus toxoid-containing vaccination.
See Garcia v. Sec’y of Health and Hum. Servs., No. 05-720V, 2008 WL 5068934
(Fed. Cl. Spec. Mstr. Nov. 12, 2008) (finding entitlement for petitioner’s claim that
Td vaccination caused his GBS); Watson v. Sec’y of Health and Hum. Servs., No.
96-539V, 2001 U.S. Claims LEXIS 268, 2001 WL 1682537 (Fed. Cl. Spec. Mstr.
Dec. 18, 2001) (ruling petitioner’s GBS was caused by tetanus vaccine); Domeny
v. Sec’y of Health and Hum. Servs., No. 94-1086V, 1999 U.S. Claims LEXIS 66,
1999 WL 199059, at *41 (stating “the possibility that tetanus vaccine can cause
GBS is not an issue here because the court accepts that it can”). For one exception
to this trend, see Tyson v. Sec’y of Health and Hum. Servs., No. 90-3379, 1997
U.S. Claims LEXIS 225, 1999 WL 702562 (Fed. Cl. Spec. Mstr. Sept. 30, 1997)
(finding against entitlement because preponderant evidence did not support
petitioner’s claim that a tetanus toxoid-containing vaccine caused his GBS).
6. 2011 ACIP General Recommendations on Immunization17
The ACIP provided updates to its 2006 general recommendations on
vaccines. As relevant for this case, the 2011 General Recommendations for the
first time formally defined two terms, which had appeared in its earlier
publications: “contraindication” and “precaution.” A contraindication is “a
condition in a recipient that increases the risk for a serious adverse reaction.”
Exhibit E, tab 5 at 3. A precaution is “a condition in a recipient that might increase
the risk for a serious adverse reaction or that might compromise the ability of the
vaccine to produce immunity.” Id. at 11.
The ACIP notes the only contraindication applicable for all vaccines
(including those containing tetanus toxoid) is if the potential recipient of a vaccine
suffered a severe allergic reaction, such as anaphylaxis, to a previous dose of
vaccine or to a vaccine component. Id. at 11.
In the 2011 General Recommendations, the ACIP identified the following
events constituted a precaution regarding a potential vaccination with tetanus
toxoid: a history of Arthus-type hypersensitivity reactions after a previous dose of
17 Exhibit E, tab 5: Andrew Kroger: Center for Disease Control & Prevention, General
Recommendations on Immunization: Recommendations of the Advisory Committee on
Immunization Practices, 60 CDC MORBIDITY & MORTALITY WKLY. REP. 3 (Jan. 28, 2011),
https://www.cdc.gov/mmwr/pdf/rr/rr6002.pdf.
19

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tetanus toxoid-containing vaccine, moderate or severe acute illness with or without
fever, and GBS less than six weeks after a previous dose of tetanus toxoid-
containing vaccine. Id. at 40.
7. 2012 IOM Publication: Adverse Effects of Vaccines: Evidence
and Causality18
The IOM published another report about vaccines and potential harmful
consequences in 2012. Exhibit B, tab 2.19 This report underlies the position of the
Secretary as well as the experts whom he retained. Resp’t’s Rep. at 9, exhibit B
(Dr. Leist’s report) at 4-5, exhibit E (Dr. Halsey’s report) at 4-5.
The IOM reexamined the Pollard and Selby case report. Exhibit B, tab 2 at
559-60. After recounting the patient’s three episodes, the report notes that the
authors did not rule out other possible causes (such as viral illness) and that they
did not provide evidence beyond a temporal relationship to vaccine administration.
Id. at 559-60. As such, the report concludes that the “evidence is inadequate to
accept or reject a causal relationship between diphtheria toxoid–, tetanus toxoid–,
or acellular pertussis–containing vaccine and CIDP.” Id. at 560.
8. Litigation in the Vaccine Program after 2012 IOM
To some extent, the 2012 IOM report affected the outcome of cases in the
Vaccine Program in which the Secretary appears as the respondent. See 42 U.S.C.
§ 300aa–12(b)(1). As noted above, previously, special masters often ruled in favor
of petitioners. But, the 2012 IOM report changed the trend. For example, the
special master relied heavily on the 2012 IOM report in finding that a petitioner
did not establish that a tetanus-diphtheria vaccination caused her GBS. Isaac v.
Sec’y of Health & Hum. Servs., No. 08-601V, 2012 WL 3609993 (Fed. Cl. Spec.
Mstr. July 30, 2012), mot. for rev. denied, 108 Fed. Cl. 743, aff’d per curiam, 540
18 Exhibit B, tab 2: INSTITUTE OF MEDICINE, ADVERSE EFFECTS OF VACCINES: EVIDENCE
AND CAUSALITY 556-62 (Kathleen Stratton, Andrew Ford, Erin Rusch & Ellen W. Clayton, eds.,
2012).
19 The IOM made available a pre-publication version of this report in 2011 and published
the report in 2012. See Isaac v. Sec’y of Health & Hum. Servs., 108 Fed. Cl. 743, 754 (2013),
aff’d without op., 540 Fed. App’x 999 (Fed. Cir. 2013); Raymo v. Sec’y of Health & Hum.
Servs., No. 11-0654V, 2014 WL 1092274, at *3 n.11 (Fed. Cl. Spec. Mstr. Feb. 24, 2014). This
ruling refers to the report as the “2012 IOM report.”
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Fed. App’x 999 (Fed. Cir. 2013).20 Other examples include Tompkins v. Sec’y of
Health and Hum. Servs., No. 10-261V, 2013 WL 3498652, *24 (Fed. Cl. Spec.
Mstr. June 21, 2013) (concluding that “the evidence that tetanus vaccine can cause
GBS is lacking.”), mot. for rev. denied, 117 Fed. Cl. 713 (2014) and Rupert v.
Sec’y of Health and Hum. Servs., No. 10-160V, 2014 WL 785256 (Fed. Cl. Spec.
Mstr. Feb. 3, 2014) (finding petitioner failed to establish by preponderant evidence
that Tdap vaccine caused his GBS, and respondent proved upper respiratory tract
infection as sole cause of the GBS).
While the special masters found Ms. Isaac, Mr. Tompkins, and Mr. Rupert
were not entitled to compensation, other petitioners asserting that a vaccine with
tetanus toxoid caused their GBS did receive compensation. Mr. Mohamad listed
multiple cases in which the Secretary resolved a case in which a petitioner alleged
a vaccine containing tetanus toxoid caused GBS. In these cases, the Secretary
compensated the petitioner without admitting that the vaccine caused the GBS.
Pet’r’s Br., filed June 23, 2020, appendix III.21
9. 2018 ACIP Publication: Prevention of Pertussis, Tetanus, and
Diphtheria with Vaccines in the United States: Recommendations of
the Advisory Committee on Immunization Practices22
Jennifer Liang et al. compiled the recommendations from ACIP “regarding
prevention and control of tetanus, diphtheria, and pertussis” in the United States, in
order to provide clinicians and public health providers with a comprehensive and
up-to-date “resource.” Court Exhibit 1001 at 4. The review discusses the DTaP,
Tdap, and Td vaccinations, as well as their component parts -- acellular pertussis,
and diphtheria and tetanus toxoids.
DTaP contains diphtheria and tetanus toxoids with acellular pertussis; Tdap,
as a booster, contains tetanus toxoid, reduced diphtheria toxoid, and acellular
pertussis; and Td, also a booster, contains reduced tetanus toxoid and reduced
20 The Secretary cited Isaac and other cases in his July 21, 2017 memorandum and in his
September 24, 2020 memorandum.
21 The Secretary did not address these settled cases in his September 24, 2020
memorandum. An expanded version of this list is attached to this ruling as an appendix.
22 Exhibit 1001: Center for Disease Control & Prevention, Prevention of Pertussis,
Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory
Committee on Immunization Practices (ACIP), 67 CDC MORBIDITY & MORTALITY WKLY. REP.
1 (Apr. 27, 2018), https://www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6702a1-H.pdf.
21

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diphtheria toxoid. DTaP administration typically occurs in five rounds between six
weeks and six years old; Tdap is administered once during adolescence (and to
adult women during pregnancy); and Td is administered every ten years throughout
life.
DTaP, Tdap, and Td, like many vaccinations, have certain contraindications
and precautions. The ACIP explains that a contraindication is a “condition in a
recipient that increases the risk for a serious adverse reaction,” and medical
professionals should not administer vaccinations when one (or more) is present.
Id. at 33. Precautions, by contrast, do not always justify vaccine deferral -- these
conditions are often mistaken for contraindications, but are not as serious. Thus,
their negative effects can sometimes be outweighed by the benefits of a vaccine.
Id. Because DTaP, Tdap, and Td consist of two to three components, the
contraindications and precautions associated with each specific component also
apply to DTaP, Tdap, and Td administration. Id. at 22, 33.
ACIP recommends that GBS occurring less than six weeks after receipt of a
tetanus toxoid-containing vaccine is a precaution for subsequent administration of
tetanus toxoid-containing vaccines. Notably, however, reports of GBS (and other
severe neurologic reactions) following receipt of a tetanus toxoid-containing
vaccine (TT, DTaP, Tdap, Td) are very rare. Id. at 22-23. The ACIP also cites the
2012 IOM publication, that “the evidence was inadequate to accept or reject a
causal relation between receipt of diphtheria toxoid- and tetanus toxoid-containing
vaccines and . . . Guillain Barré syndrome, . . . .” Id. at 23.
10. General Best Practice Guidelines for Immunization - Best
Practices Guidance of the Advisory Committee on Immunization
Practices (ACIP) (2019)23
This report is separated into ten documents, which outline updates accepted
by ACIP as of October 2014. Court Exhibit 1002 at 6. These updates regard
recommendations for seventeen vaccine-preventable diseases, and they are based
on studies and reviews conducted by medical professionals belonging to the
General Recommendations Working Group (“GRWG”) and Immunization Action
Coalition. Id. at 3, 6. Ezeanolue et al. compiled these updates to provide a
guideline for clinicians who vaccinate patients in various healthcare settings. Id. at
23 Exhibit 1002: Echezona Ezeanolue, et al., General Best Practice Guidelines for
Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices
(2019).
22

Case 1:16-vv-01075-PSH Document 153 Filed 03/10/22 Page 23 of 33
3. One major general update was made to the term “precaution” -- its definition
has been “enhanced” to include any condition that might confuse diagnostic
accuracy. Id. at 4. The report also specifically addresses updates made to
recommendations for tetanus toxoid-containing vaccines, which will be the rest of
this summary’s focus.
After monthly meetings in 2013, the GRWG revised the “Preventing and
Managing Adverse Reactions'' recommendations to explain that certain
vaccinations, like Td (adult tetanus and diphtheria toxoids) and DT (pediatric
diphtheria and tetanus toxoids), produce increased rates of local or systemic
reactions in certain recipients when administered more frequently than
recommended. Id. at 14. It stressed the importance of “careful record keeping,
maintenance of patient histories, and use of immunization information” to prevent
such unnecessary reactions. Id. at 14-15.
Additionally, Table 4.1 explicitly details the updated list of contraindications
and precautions for the DT, Td, Tdap, and DTaP vaccinations. Id. at 53. For Td
and DT, there is only one contraindication: severe allergic reaction, e.g.
anaphylaxis, after a previous dose or to a vaccine component, e.g. tetanus toxoid.
The precautions include: GBS less than six weeks after a previous dose of tetanus
toxoid-containing vaccine, history of hypersensitivity reactions after a previous
dose of diphtheria toxoid- or tetanus toxoid-containing vaccines, and/or moderate
or severe acute illness following a previous dose or component (with or without
fever). Id. For individuals with an Arthus-type hypersensitivity history, clinicians
should defer vaccination until at least ten years post-initial tetanus toxoid-
containing vaccine receipt. Id.
For both DTaP and Tdap, the contraindications are: severe allergic reactions
and encephalopathy, not attributable to some other cause, within seven days of
previous dose of DTP or DTaP. Id. at 53, 57. The precautions are the same as for
DT and Td, with the addition of “progressive neurologic disorders,” like epilepsy
and progressive encephalopathy. Prior to administration, neurologic disorders of
these kinds should first be evaluated by a physician. Id.
11. Testimony about these Documents
Of the three testifying doctors, Dr. Halsey provided the most useful
testimony about how the Secretary communicates information about vaccinations,
including any concerns for adverse consequences, to the public. While Dr. Shafrir
and Dr. Leist talked about some of the documents, their knowledge seemed to
extend only to reading the documents. See Tr. 35-39, 51-52 (Dr. Shafrir), 93-95
23

Case 1:16-vv-01075-PSH Document 153 Filed 03/10/22 Page 24 of 33
(Dr. Leist), 259-66 (Dr. Shafrir’s rebuttal testimony). Dr. Halsey, on the other
hand, had insights into the process leading to the production of the documents.
But, even Dr. Halsey’s knowledge was limited once he stopped participating in
working groups and Dr. Halsey filled some of the gaps in his first-hand knowledge
by speculating. See Tr. 174-76.24
The thrust of Dr. Halsey’s opinion is that the Pollard & Selby case report
was misunderstood originally, the IOM corrected that misunderstanding in 2012,
and the Secretary has overlooked the 2012 IOM change. Tr. 156-61. Thus, to Dr.
Halsey, the recommendations found in the ACIP’s 2019 Best Practice Guidelines
are misguided. However, Dr. Halsey’s opinion is not persuasive.
To start, the IOM’s 2012 report did change its previous assessment, but not
as drastically as sometimes suggested. In its 1994 report, the IOM found a vaccine
containing tetanus-toxoid can cause GBS. This finding was based upon an
understanding that the subject of the Pollard & Selby case report experienced
neurologic symptoms attributable to GBS when he first received the tetanus
vaccine and experienced neurologic symptoms when he again received the tetanus
vaccine. This pattern of recurrence is known as “challenge-rechallenge” and
evidence of “challenge-rechallenge” can demonstrate that an exposure is causing
an adverse reaction. See Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d
1317, 1322 (Fed. Cir. 2006) (defining rechallenge).
However, by 2011, additional information about the subject of the Pollard &
Selby report was learned. He experienced neurologic problems at times not in
association with a tetanus vaccine. His doctors, therefore, determined that he
suffered from a different disease, chronic inflammatory demyelinating
polyneuropathy. Tr. 94-95. With this information in hand, the IOM retreated from
its previous conclusion that a tetanus vaccine can cause GBS. Tr. 157. In 2012,
the IOM determined that the evidence “is inadequate to accept or reject a causal
relationship between diphtheria toxoid–, tetanus toxoid–, or acellular pertussis-
containing vaccines and GBS.” Exhibit B, tab 2 at 558. As Dr. Halsey explained,
this conclusion was “neutral,” and the IOM did not go the extra step of saying that
the evidence “favors rejection.” Tr. 238-39. In Dr. Halsey’s view, this shift did
not attract much attention. Tr. 222.
24 The Secretary might have avoided presenting speculation if the Secretary had called an
employee within the Department of Health and Human Services who actually participated in the
meetings.
24

Case 1:16-vv-01075-PSH Document 153 Filed 03/10/22 Page 25 of 33
To Dr. Halsey, the critical step is what happened (or more precisely, what
failed to happen) after the 2012 IOM report. Dr. Halsey maintains that people on
the ACIP did not consider modifying the recommendation regarding GBS. Tr.
161, 240.
Dr. Halsey’s assertion is difficult to accept for three reasons. First, the ACIP
divides tasks among working groups and the meetings of working groups are
closed to the public. Tr. 243. Thus, it appears that Dr. Halsey did not participate
in the working group that led to the 2019 Best Practice Guidance. So, an assertion
that the ACIP did not consider the 2012 IOM shift is more an assumption than a
preponderantly supported fact.
Next, the 2018 ACIP recommendations refers to the 2012 IOM report. See
Tr. 170. Thus, Dr. Halsey cannot say and has not suggested that the members of
the ACIP were entirely ignorant of the 2012 IOM report. Instead, Dr. Halsey
surmises that the ACIP failed to appreciate the significance of the 2012 IOM
change.
These points lead to the third point making Dr. Halsey’s position
unpersuasive. Dr. Halsey seems to be calling into question the professionalism of
the members of the ACIP, essentially saying that the members were asleep at the
switch. Tr. 174-75. However, members of the ACIP are selected for their
knowledge in the field of vaccines, vaccine effectiveness, and vaccine safety. Tr.
239. For example, one member of the ACIP is the director of the Health Resources
and Services Administration (“HRSA”). Tr. 228. In that capacity, Dr. Nair signed
stipulations in which the Secretary of HHS agreed to pay people who alleged a
tetanus vaccine caused their GBS. See Vaccine Rule 11(b) (“Any stipulation for a
money judgment must be signed by authorized representatives of the Secretary of
Health and Human Services and the Attorney General”). Dr. Nair’s personal
participation in the settlement of these cases strongly suggests that he was aware
that tetanus-GBS cases are litigated in the Vaccine Program.25 As a member of the
25 Each stipulation duly notes that the Secretary has not admitted that the tetanus vaccine
causes GBS. See e.g., Woodward v. Sec’y of Health & Hum. Servs., No. 15-1130V, 2017 WL
1239864 (Fed. Cl. Spec. Mstr. Mar. 9, 2017). As such, the stipulations do not serve as
admissions. See Woods v. Sec’y of Health & Hum. Servs., 105 Fed. Cl. 148, 152-53 (2012)
(noting Federal Rules of Evidence policy regarding settlement offers not reflecting admission of
liability). However, stipulations / settlements can constitute notice of a problem. See Spell v.
McDaniel, 824 F.2d 1380 (4th Cir. 1987) (finding prior settlement by the city of a brutality claim
was properly admitted to prove that the city was on notice of problem of aggressive police
officers in a subsequent civil rights case alleging excessive force by an officer); Abundis v.
United States, 15 Cl. Ct. 619, 621 (1988) (“There is an exception to application of [Federal] Rule
25

Case 1:16-vv-01075-PSH Document 153 Filed 03/10/22 Page 26 of 33
Department of Health and Human Services on the ACIP, Dr. Nair had an
opportunity to change the Secretary’s communications about any causal
relationship between tetanus vaccine and GBS.
12. Interpretation of the Secretary’s Most Recent Statement
In 2019, the Secretary offered guidance to the American public, including
practicing doctors, about the best practices for vaccines. The Secretary maintained
that a previous occurrence of GBS within six weeks of a tetanus vaccine warranted
a “precaution.” Tr. 174, 242. A precaution, in turn, means “a condition in a
recipient that might increase the risk for a serious adverse reaction or that might
compromise the ability of the vaccine to produce immunity.” Exhibit E, tab 5 at
11. To borrow from the 1996 General Recommendations, there is a “low risk” that
a tetanus vaccine can cause GBS. See Tr. 232.
Dr. Halsey wished that the Secretary had used different words. Tr. 232-34.
But, the Secretary is responsible for the words appearing in documents for which
he is responsible. The process by which the Secretary released the 2019 Best
Practices involves multiple steps in which many talented people participate. The
undersigned sees no persuasive reason to edit the 2019 Best Practices.
The 2019 Best Practices, which comes from the Secretary, constitutes strong
evidence that a tetanus vaccine can cause GBS in rare cases. This evidence is
sufficiently robust that it carries petitioner’s burden with respect to general
causation.
The 2019 Best Practices outweighs the value of the opinions from Dr. Leist
and Dr. Halsey. Dr. Leist’s opinion carries relatively less weight because Dr.
Leist’s analysis of the issue seems to start and to stop with the 2012 IOM report.
See exhibit B at 4-6; Tr. 93-95. While Dr. Leist is correct that the 2012 IOM
report did not accept the theory that a tetanus vaccine can cause GBS, the IOM
report also did not reject the proposition entirely.26
Dr. Halsey’s experience on the safety of vaccines is greater than Dr. Leist’s
experience. Thus, the undersigned does not dismiss Dr. Halsey’s opinion as
readily. Dr. Halsey indicated that there is no persuasive evidence that a tetanus
[of Evidence] 408, however, when the evidence of settlement is not offered to prove liability or
damages, but for some other purpose.”).
26 See INSTITUTE OF MEDICINE, supra note 18, at 558.
26

Case 1:16-vv-01075-PSH Document 153 Filed 03/10/22 Page 27 of 33
vaccine can cause GBS. Tr. 153-55. Part of Dr. Halsey’s assessment of the
evidence, however, included a conclusion that the 2019 Best Practices document
reflects an “oversight.” Tr. 174-75. For the reasons explained above, the
undersigned does not share Dr. Halsey’s conclusion on this point.
Special masters are not required to deny compensation when the IOM takes
a neutral stance. See Estep v. Sec’y of Health & Hum. Servs., 28 Fed. Cl. 664, 668
(1993) (“The [Vaccine] Act does not require [a special master] to accept the IOM
Report as dispositive”), app. dismissed, No. 93-5192 (Fed. Cir. Oct. 29, 1993);
Raymo v. Sec’y of Health & Hum. Servs., No. 11-0654V, 2014 WL 1092274, at
*21 (Fed. Cl. Feb. 24, 2014) (“it is apparent that the IOM requires a very high
standard before concluding that there is a causal relationship between vaccines and
an injury”).
Because the Secretary acknowledged the low risk that in rare cases a tetanus
vaccine can cause GBS by making a prior occurrence of GBS in temporal
relationship with a tetanus vaccine a precaution, Mr. Mohamad is not required to
establish, with preponderant evidence, the precise theory by which a tetanus
vaccine can cause GBS. See Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d
543, 549 (Fed. Cir. 1994) (“to require identification and proof of specific biologic
mechanisms would be inconsistent with the purpose and nature of the vaccine
compensation program”). The Secretary did not require elucidation of a scientific
theory in 1996 when the ACIP concluded that there was some (albeit “extremely
low”) risk for GBS following administration of tetanus toxoid.
Mr. Mohamad cannot be expected to bear a higher burden than the Secretary
in his public pronouncements. Accordingly, the evidence preponderates in favor of
finding that Mr. Mohamad has met his Althen prong one burden.27
C. Althen prong 3
Having found that a tetanus vaccine can cause GBS, the undersigned next
turns to the question of when GBS would typically manifest after the vaccine if the
vaccine caused the GBS. Dr. Shafrir analogized the process by which a tetanus
vaccine can cause GBS to the process by which flu vaccine can cause GBS. Tr.
27 If Dr. Halsey’s prediction that the ACIP revises the Secretary’s guidance comes true,
then the evidence will be different. The parties might also present different evidence in the form
of testimony from immunologists, epidemiologists, and/or people with first-hand knowledge of
the creation of the 2019 Best Practices. Different evidence in any hypothetical future case might
produce a different result.
27

Case 1:16-vv-01075-PSH Document 153 Filed 03/10/22 Page 28 of 33
40. Because the Secretary’s Vaccine Injury Table establishes a presumption that
causation is appropriate when GBS develops 3-42 days after the flu vaccine, 42
C.F.R. § 100.3(a) ¶ XIV.D., Dr. Shafrir maintained that an onset of GBS within
this period would be appropriate. Id.
Based upon the medical records, as well as the expert’s commentary on that
evidence, the undersigned found that Mr. Mohamad’s numbness started on
September 28, 2015, ten days after vaccination. Ruling Finding Fact, issued Apr.
23, 2021. The experts recognized that Mr. Mohamad’s numbness marked the
beginning of his GBS. Tr. 40 (Dr. Shafrir), 104 (Dr. Leist acknowledging a
temporal relationship).
Accordingly, Mr. Mohamad has established that his GBS was manifest
within a time for which an inference of causation is appropriate. He has satisfied
Althen prong 3.
D. Althen prong 2
In determining whether petitioners have met the second prong of Althen, the
Federal Circuit has emphasized the value of statements of treating doctors.
If a claimant satisfies the first and third prongs of the
Althen standard, the second prong can be met through
medical opinion testimony. Such testimony 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.”
Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1375 (Fed. Cir. 2009)
(quoting Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1326 (Fed.
Cir. 2006)).
Here, as Dr. Shafrir and Dr. Leist recognized, different doctors treating Mr.
Mohamad linked the preceding tetanus vaccine to his GBS. Some examples from
the Medical Center of Aurora Hospital follow.
On October 2, 2015, Dr. Dennis Keselman assessed Mr. Mohamad’s injury
“was likely triggered by recent tetanus injection,” and Dr. Kenneth Tompkins, Jr.
listed “Tetanus Vaccines & Toxoid” as coded allergies. Exhibit 5.2 at 614. The
record from Mr. Mohamad’s assessment by Dr. Janice Brenneman and Dr. Heather
Katz on October 3, 2015 notes his GBS was “[l]ikely triggered by vaccination.”
28

Case 1:16-vv-01075-PSH Document 153 Filed 03/10/22 Page 29 of 33
Exhibit 5.3 at 830. This conclusion was repeated on October 4, 2015. Id. at 823.
On October 26, 2015, Dr. Jeffrey Zamarripa noted the subjective chief complaint
as “GBS 2/2 Tetanus vaccination.” Exhibit 5.2 at 764. The same notation was
repeated the following day by Dr. Zamarripa. Id. at 759.
These statements implicate the vaccine directly and explicitly. They are,
therefore, more probative than various statements in which medical personnel
mentioned a temporal sequence in which the vaccine preceded the disease. For a
list of examples, see Pet’r’s Br., filed June 23, 2020, at 3-5. Mr. Mohamad’s
treating doctors’ statements that a tetanus vaccine caused his GBS also imply that a
tetanus vaccine can cause GBS generally. As such, these statements from treating
doctors are also relevant to the prong 1 discussion above. See Caves v. Sec’y of
Health & Hum. Servs., 100 Fed. Cl. 119, 136-37 (2011), aff’d without opinion, 463
F. App’x 932 (Fed. Cir. 2012).
Dr. Shafrir relied, in part, on the treating doctor’s statements to support his
opinion that the tetanus vaccine did cause Mr. Mohamad’s GBS. Tr. 41, 64.
Although Dr. Leist recognized these statements, he disagreed with them because,
in part, the treating doctors did not explain their reasoning. Tr. 97-98. Dr. Leist
also noted that the doctors did not explore whether Mr. Mohamad had any
conditions commonly suspected as causes for GBS, such as C. jejuni. Tr. 107. Dr.
Halsey shared this concern as well. Tr. 244, 278.
The lack of testing does not prevent Mr. Mohamad from meeting his burden
of proof, which is merely preponderant evidence, not evidence beyond a
reasonable doubt. The evidence from the treating doctors carries Mr. Mohamad’s
burden regarding Althen prong 2.
E. Alternative Cause
Because Mr. Mohamad has met his burden of establishing that the vaccine
was the cause-in-fact of his GBS, the burden shifts to the Secretary to present an
alternative cause. See LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d 1334,
1340 (Fed. Cir. 2014). Here, it appears that the Secretary may have offered a
possible Strep infection as a cause for Mr. Mohamad’s GBS. However, for the
reasons discussed in section IV.A above, Dr. Leist’s opinion on this topic was not
credible. Accordingly, a preponderance of the evidence does not support a finding
that any Strep infection was an alternative cause.
29

Case 1:16-vv-01075-PSH Document 153 Filed 03/10/22 Page 30 of 33
V. Conclusion
Mr. Mohamad has established that he is entitled to compensation. An order
to guide the parties in their assessment of damages will follow.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
30

Case 1:16-vv-01075-PSH Document 153 Filed 03/10/22 Page 31 of 33
List of Tdap – GBS Cases Settled by HHS
HHS Primary Medicaid Medical
Docket # Westlaw Citation Date SM Official Amount Liens Expenses Other
Caserta, $13,500.00
12-246V 2012 WL 6176760 11/16/2012 Moran Vito $135,000.00 (AF&C)
Caserta,
11-864V 2013 WL 474300 1/16/2013 Vowell Vito $150,000.00
Caserta,
12-141V 2013 WL 4476837 7/18/2013 Zane Vito $305,000.00
Caserta,
11-437V 2013 WL 4479852 7/24/2013 Zane Vito $237,500.00
Hamilton- Caserta,
12-277V 2014 WL 1689953 4/8/2014 Fieldman Vito $125,000.00 $66,633.55
Hamilton- Houston,
13-351V 2014 WL 3884448 7/14/2014 Fieldman Melissa $125,000.00
Houston,
13-589V 2015 WL 324651 1/5/2015 Millman Melissa $218,000.00
Houston,
14-209V 2015 WL 477204 1/13/2015 Millman Melissa $100,000.00
Houston,
12-276V 2015 WL 1805515 3/26/2015 Corcoran Melissa $290,000.00 $2,907.67
Houston,
14-99V 2015 WL 1932239 4/6/2015 Gowen Melissa $105,000.00
Houston,
13-1019V 2015 WL 2195111 4/15/2015 Moran Melissa $100,000.00
Houston,
14-882V 2015 WL 2453389 4/29/2015 Vowell Melissa $110,000.00
Houston,
10-522V 2015 WL 4734740 7/17/2015 Millman Melissa $60,000.00
Hamilton- Houston,
14-840V 2015 WL 5499318 8/21/2015 Fieldman Melissa $129,385.20 $443.69
Houston,
13-104V 2015 WL 6395694 9/11/2015 Gowen Melissa $280,015.62 Annuity
Houston,
14-363V 2015 WL 8521058 11/12/2015 Gowen Melissa $525,000.00
2015 WL Houston,
14-1188V 10434887 12/1/2015 Corcoran Melissa $200,000.00
Houston,
15-567V 2015 WL 9700586 12/10/2015 Gowen Melissa $137,500.00
Hamilton- Houston,
13-628V 2015 WL 9595427 12/11/2015 Fieldman Melissa $290,000.00
15-509V 2016 WL 943839 2/19/2016 Moran NA $145,000.00
Nair,
14-127V 2016 WL 1560074 3/24/2016 Moran Narayan $165,000.00
Nair,
15-001V 2016 WL 1567116 3/25/2016 Moran Narayan $140,000.00
Hamilton-
13-944V 2016 WL 2641400 4/14/2016 Fieldman NA $750,000.00
Nair,
13-337V 2016 WL 8114125 6/17/2016 Gowen Narayan $400,000.00
Nair,
15-1164V 2016 WL 5867277 8/5/2016 Dorsey Narayan $132,500.00
Hamilton- Nair,
14-336V 2016 WL 6839549 10/12/2016 Fieldman Narayan $215,006.21 $121,210.21
Nair,
16-156V 2016 WL 6806275 10/13/2016 Corcoran Narayan $190,000.00
1

Case 1:16-vv-01075-PSH Document 153 Filed 03/10/22 Page 32 of 33
List of Tdap – GBS Cases Settled by HHS
Nair,
15-568V 2016 WL 7488354 11/10/2016 Corcoran Narayan $155,000.00
Nair,
16-169V 2017 WL 436105 1/3/2017 Corcoran Narayan $84,464.00
Nair,
16-274V 2017 WL 514247 1/12/2017 Gowen Narayan $160,000.00
Nair,
15-1130V 2017 WL 1239864 3/9/2017 Gowen Narayan $345,000.00
Nair,
16-74V 2017 WL 4324984 3/10/2017 Dorsey Narayan $150,000.00
Nair,
16-894V 2017 WL 1424051 3/27/2017 Roth Narayan $132,718.94
Nair,
16-846V 2017 WL 1737714 4/5/2017 Corcoran Narayan $150,000.00
Nair,
16-1069V 2017 WL 1737716 4/6/2017 Gowen Narayan $140,000.00
Nair,
14-1224V 2017 WL 2116705 4/20/2017 Roth Narayan $90,000.00
Nair,
16-562V 2017 WL 2418308 5/11/2017 Roth Narayan $140,000.00
Nair,
16-822V 2017 WL 2812933 5/22/2017 Gowen Narayan $200,000.00
Nair,
16-1005V 2017 WL 3574915 6/28/2017 Corcoran Narayan $150,000.00
Nair,
16-06V 2017 WL 3445253 7/17/2017 Roth Narayan $150,000.00
Nair,
15-1099V 2017 WL 3623558 7/27/2017 Gowen Narayan $120,000.00
Nair,
12-124V 2017 WL 4174072 8/23/2017 Gowen Narayan $850,000.00
Nair,
16-725V 2018 WL 615074 1/2/2018 Moran Narayan $235,000.00
Nair,
16-375V 2018 WL 818262 1/16/2018 Roth Narayan $440,000.00 $2,809.18
Nair,
17-648V 2018 WL 2225991 3/29/2018 Corcoran Narayan $142,000.00
Nair,
16-15V 2018 WL 3030970 5/17/2018 Moran Narayan $130,000.00
Nair,
16-868V 2018 WL 3991064 6/27/2018 Moran Narayan $80,000.00
Nair,
14-880V 2018 WL 3989449 7/13/2018 Moran Narayan $118,000.00
Nair,
16-641V 2018 WL 4042363 7/30/2018 Roth Narayan $132,500.00
Nair,
16-1228V 2018 WL 6975188 11/15/2018 Corcoran Narayan $80,000.00
Nair,
17-1135V 2018 WL 6582356 11/19/2018 Roth Narayan $81,650.77
Nair,
17-883V 2019 WL 1451311 2/11/2019 Corcoran Narayan $115,000.00
Nair,
17-1963V 2019 WL 1283779 2/22/2019 Roth Narayan $82,500.00
Overby,
17-819V 2019 WL 6358958 9/27/2019 Corcoran Tamara $150,000.00 $1,870.41
2

Case 1:16-vv-01075-PSH Document 153 Filed 03/10/22 Page 33 of 33
List of Tdap – GBS Cases Settled by HHS
Overby,
16-598V 2019 WL 5889230 10/18/2019 Gowen Tamara $25,000.00
Overby,
17-1184V 2020 WL 995975 2/6/2020 Roth Tamara $147,500.00 $12,459.65
Overby,
18-622V 2020 WL 1429238 2/27/2020 Gowen Tamara $155,000.00
Overby,
18-1372V 2020 WL 3839891 6/3/2020 Oler Tamara $77,500.00
Overby,
19-523V 2020 WL 6303764 9/11/2020 Roth Tamara $200,000.00
Overby,
18-1317V 2020 WL 6146045 9/23/2020 Moran Tamara $107,000.00
Overby,
15-713V 2020 WL 6043838 9/23/2020 Gowen Tamara $170,000.00
Overby,
18-1067V 2020 WL 6636353 10/16/2020 Roth Tamara $93,322.98
Overby,
19-267V 2020 WL 7093975 10/28/2020 Oler Tamara $117,500.00
Overby,
17-1063V 2020 WL 6940012 10/29/2020 Moran Tamara $22,500.00
Overby,
19-223V 2021 WL 619683 1/26/2021 Gowen Tamara $60,000.00
Overby,
18-1420V 2021 WL 1352262 2/23/2021 Oler Tamara $132,265.99 $14,713.53
Overby,
19-546V 2021 WL 1120974 3/2/2021 Moran Tamara $40,400.00
Overby,
18-1796V 2021 WL 1346043 3/16/2021 Roth Tamara $105,000.00
Overby,
17-174V 2021 WL 2795423 3/23/2021 Moran Tamara $654,253.29 $86,235.24 Annuity
Overby,
16-521V 2021 WL 2206519 5/4/2021 Moran Tamara $32,120.59 $7,879.41
Overby,
20-392V 2021 WL 2310429 5/12/2021 Roth Tamara $60,000.00
Overby,
19-980V 2021 WL 2805297 6/8/2021 Roth Tamara $120,000.00
Overby,
20-767V 2021 WL 3206105 6/15/2021 Oler Tamara $105,000.00
Overby,
20-915V 2021 WL 4305860 8/24/2021 Horner Tamara $103,315.74
Overby,
18-1211V 2021 WL 5851062 9/22/2021 Oler Tamara $20,000.00
Overby,
20-1036V 2021 WL 4955867 10/5/2021 Gowen Tamara $47,500.00 $10,000.00
Overby,
19-1283V 2021 WL 5567538 11/2/2021 Horner Tamara $135,181.05
3

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_16-vv-01075-3
Date issued/filed: 2024-06-21
Pages: 10
Docket text: PUBLIC DECISION (Originally filed: 05/30/2024) regarding 256 DECISION Stipulation/Proffer, Signed by Special Master Christian J. Moran. (ceo) Service on parties made.
--------------------------------------------------------------------------------
Case 1:16-vv-01075-PSH Document 257 Filed 06/21/24 Page 1 of 10
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * * * * * *
ALA MOHAMAD, *
* No. 16-1075V
Petitioner, * Special Master Christian J.
* Moran
v. *
* Filed: May 30, 2024
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * * * * *
Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner;
Voris Johnson, United States Dep’t of Justice, Washington, DC, for respondent.
UNPUBLISHED DECISION AWARDING DAMAGES1
On August 29, 2016, Ala Mohamad filed a petition seeking compensation
under the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-1
et seq., alleging that a tetanus-diphtheria-acellular pertussis vaccine he received on
September 21, 2015 caused him to develop a neurological problem known as
Guillain-Barré syndrome. After development of written evidence, the case
proceeded to a hearing, and the parties submitted post-hearing briefs. On January
1 Because this Decision contains a reasoned explanation for the action taken
in this case, it must be made publicly accessible and will be posted on the United
States Court of Federal Claims’ website, and/or at
https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with
the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal
Management and Promotion of Electronic Government Services). This means the
Decision will be available to anyone with access to the internet. In accordance with
Vaccine Rule 18(b), the parties have 14 days to identify and move to redact
medical or other information, the disclosure of which would constitute an
unwarranted invasion of privacy. Any changes will appear in the document posted
on the website.

Case 1:16-vv-01075-PSH Document 257 Filed 06/21/24 Page 2 of 10
27, 2022, the undersigned determined that Mr. Mohamad is entitled to
compensation.
On May 24, 2024, respondent filed a Proffer on Award of Compensation, to
which petitioner agrees. Based upon the record as a whole, the special master
finds the Proffer reasonable and that petitioner is entitled to an award as stated in
the Proffer. Pursuant to the attached Proffer, with Tab A, the court awards
petitioner the following:
A. All items of compensation set forth in the life care plan and
illustrated by the chart attached at Tab A.
B. $561,869.00 in past and future lost earnings under 42 U.S.C. § 300aa-
15(a)(3)(A).
C. $225,000.00 in actual and projected pain and suffering. This amount
reflects that any award for projected pain and suffering has been
reduced to net present value. See 42 U.S.C. § 300aa-15(a)(4).
D. Funds to satisfy a State of Colorado Department of Health Care
Policy & Financing Medicaid lien in the amount of $92,602.13, which
represents full satisfaction of any right of subrogation, assignment,
claim, lien, or cause of action the Colorado Department of Health Care
Policy & Financing may have against any individual as a result of any
Medicaid payments the Colorado Department of Health Care Policy &
Financing has made to or on behalf of petitioner from the date of his
eligibility for benefits through the date of judgment in this case as a
result of his vaccine-related injury suffered on or about September 21,
2015, under Title XIX of the Social Security Act.
In the absence of a motion for review filed pursuant to RCFC, Appendix
B, the clerk is directed to enter judgment in case 16-1075V according to this
decision and the attached proffer.2
2 Pursuant to Vaccine Rule 11(a), the parties can expedite entry of judgment
by each party filing a notice renouncing the right to seek review by a United States
Court of Federal Claims judge.
2

Case 1:16-vv-01075-PSH Document 257 Filed 06/21/24 Page 3 of 10
Any questions regarding this order may be directed to my law clerk,
Christine Olson, at (202) 357-6360.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
3

Case 1:16-vv-01075-PSH Document 257 Filed 06/21/24 Page 4 of 10
IN THE UNITED STATES COURT OF FEDERAL CLAIMS
OFFICE OF SPECIAL MASTERS
ALA MOHAMAD,
Petitioner,
No. 16-1075V
v. Special Master Moran
ECF
SECRETARY OF HEALTH
AND HUMAN SERVICES,
Respondent.
RESPONDENT’S PROFFER ON AWARD OF COMPENSATION
On August 29, 2016, Ala Mohamad (“petitioner”) filed a petition for compensation under
the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (“Vaccine Act”
or “Act”), alleging that as a result of receiving a tetanus-diphtheria-acellular pertussis (“Tdap”)
vaccination on September 21, 2015, he suffered from Guillain-Barré syndrome (“GBS”). ECF
No. 1. On January 27, 2022, Special Master Moran issued a Ruling on Entitlement in favor of
petitioner. ECF No. 150. Respondent now proffers the following regarding the amount of
compensation to be awarded.1
I. Items of Compensation
A. Life Care Items
Respondent engaged Linda Curtis RN, MS, CCM, CNLCP, and petitioner engaged Liz
Kattman, MS and Helen M. Woodard, M.A., of ReEntry Rehabilitation Services, Inc., to provide
1 The parties have no objection to the amount of the proffered award of damages. However,
respondent reserves his right, pursuant to 42 U.S.C. § 300aa-12(f), to seek review of the Special
Master’s January 27, 2022 Ruling on Entitlement, finding petitioner entitled to an award under the
Vaccine Act. This right accrues following the issuance of the damages decision.

Case 1:16-vv-01075-PSH Document 257 Filed 06/21/24 Page 5 of 10
an estimation of petitioner’s future vaccine injury-related needs. For the purposes of this proffer,
the term “vaccine injury” is as described in the Special Master’s January 27, 2022 Ruling on
Entitlement. All items of compensation identified in the life care plan are supported by the
evidence, and are illustrated by the chart entitled Appendix A: Items of Compensation for Ala
Mohamad, attached hereto as Tab A.2 Respondent proffers that petitioner should be awarded all
items of compensation set forth in the life care plan and illustrated by the chart attached at Tab
A. Petitioner agrees.
B. Lost Earnings
The parties agree that based upon the evidence of record, Ala Mohamad has suffered past
loss of earnings and will suffer future loss of earnings as a result of his vaccine-related injury.
Therefore, respondent proffers that petitioner should be awarded lost earnings as provided under
the Vaccine Act, 42 U.S.C. § 300aa-15(a)(3)(A). Respondent proffers that the appropriate award
for Ala Mohamad’s past and future lost earnings is $561,869.00. Petitioner agrees.
C. Pain and Suffering
Respondent proffers that petitioner should be awarded $225,000.00 in actual and
projected pain and suffering. This amount reflects that any award for projected pain and
suffering has been reduced to net present value. See 42 U.S.C. § 300aa-15(a)(4). Petitioner
agrees.
D. Medicaid Lien
Respondent proffers that Ala Mohamad should be awarded funds to satisfy a State of
Colorado Department of Health Care Policy & Financing Medicaid lien in the amount of
2 The chart at Tab A illustrates the annual benefits provided by the life care plan. The annual
benefit years run from the date of judgment up to the first anniversary of the date of judgment,
and every year thereafter up to the anniversary of the date of judgment.
2

Case 1:16-vv-01075-PSH Document 257 Filed 06/21/24 Page 6 of 10
$92,602.13, which represents full satisfaction of any right of subrogation, assignment, claim,
lien, or cause of action the Colorado Department of Health Care Policy & Financing may have
against any individual as a result of any Medicaid payments the Colorado Department of Health
Care Policy & Financing has made to or on behalf of petitioner from the date of his eligibility for
benefits through the date of judgment in this case as a result of his vaccine-related injury suffered
on or about September 21, 2015, under Title XIX of the Social Security Act.
II. Form of the Award
The parties recommend that the compensation provided to petitioner should be made
through a combination of lump sum payments and future annuity payments as described below,
and request that the Special Master’s decision and the Court’s judgment award the following:3
A. A lump sum payment of $794,823.40, representing compensation for life care
expenses expected to be incurred during the first year after judgment ($7,954.40), lost earnings
($561,869.00), and pain and suffering ($225,000.00), in the form of a check payable to
petitioner, Ala Mohamad.
B. A lump sum payment of $92,602.13, representing compensation for satisfaction of the
Colorado Department of Health Care Policy & Financing Medicaid lien, payable jointly to
petitioner and:
Colorado Department of Health Care Policy & Financing
Attn: Erika Herrera
Tort & Casualty Specialist
Third Party Liability & Recoveries Section
303 E. 17th Avenue
Denver, CO 80203
State I.D. No. Y566782
Case No. 1002405
3 Should petitioner die prior to entry of judgment, the parties reserve the right to move the Court
for appropriate relief. In particular, respondent would oppose any award for future medical
expenses, future lost earnings, and future pain and suffering.
3

Case 1:16-vv-01075-PSH Document 257 Filed 06/21/24 Page 7 of 10
Petitioner agrees to endorse this payment to the Colorado Department of Health Care Policy &
Financing.
C. An amount sufficient to purchase an annuity contract,4 subject to the conditions
described below, that will provide payments for the life care items contained in the life care plan,
as illustrated by the chart at Tab A, attached hereto, paid to the life insurance company5 from
which the annuity will be purchased.6 Compensation for Year Two (beginning on the first
anniversary of the date of judgment) and all subsequent years shall be provided through
respondent’s purchase of an annuity, which annuity shall make payments directly to petitioner,
Ala Mohamad, only so long as petitioner is alive at the time a particular payment is due. At the
Secretary’s sole discretion, the periodic payments may be provided to petitioner in monthly,
quarterly, annual, or other installments. The “annual amounts” set forth in the chart at Tab A
4 In respondent’s discretion, respondent may purchase one or more annuity contracts from one
or more life insurance companies.
5 The Life Insurance Company must have a minimum of $250,000,000 capital and surplus,
exclusive of any mandatory security valuation reserve. The Life Insurance Company must have
one of the following ratings from two of the following rating organizations:
a. A.M. Best Company: A++, A+, A+g, A+p, A+r, or A+s;
b. Moody's Investor Service Claims Paying Rating: Aa3, Aa2, Aa1, or Aaa;
c. Standard and Poor's Corporation Insurer Claims-Paying Ability Rating: AA-,
AA, AA+, or AAA;
d. Fitch Credit Rating Company, Insurance Company Claims Paying Ability
Rating: AA-, AA, AA+, or AAA.
6 Petitioner authorizes the disclosure of certain documents filed by the petitioner in this case
consistent with the Privacy Act and the routine uses described in the National Vaccine Injury
Compensation Program System of Records, No. 09-15-0056.
4

Case 1:16-vv-01075-PSH Document 257 Filed 06/21/24 Page 8 of 10
describe only the total yearly sum to be paid to petitioner and do not require that the payment be
made in one annual installment.
1. Growth Rate
Respondent proffers that a four percent (4%) growth rate should be applied to all life care
items. Thus, the benefits illustrated in the chart at Tab A that are to be paid through annuity
payments should grow as follows: four percent (4%) compounded annually from the date of
judgment for all items. Petitioner agrees.
2. Life-contingent annuity
Petitioner will continue to receive the annuity payments from the Life Insurance
Company only so long as he, Ala Mohamad, is alive at the time that a particular payment is due.
Written notice shall be provided to the Secretary of Health and Human Services and the Life
Insurance Company within twenty (20) days of Ala Mohamad’s death.
3. Guardianship
Petitioner is a competent adult. Evidence of guardianship is not required in this case.
III. Summary of Recommended Payments Following Judgment
A. Lump Sum paid to petitioner, Ala Mohamad: $794,823.40
B. Medicaid lien: $ 92,602.13
C. An amount sufficient to purchase the annuity contract described
above in section II.C.
5

Case 1:16-vv-01075-PSH Document 257 Filed 06/21/24 Page 9 of 10
Respectfully submitted,
BRIAN M. BOYNTON
Principal Deputy Assistant Attorney General
C.SALVATORE D’ALESSIO
Director
Torts Branch, Civil Division
HEATHER L. PEARLMAN
Deputy Director
Torts Branch, Civil Division
JULIA M. COLLISON
Assistant Director
Torts Branch, Civil Division
/s/Voris E. Johnson, Jr.
VORIS E. JOHNSON, JR.
Assistant Director
Torts Branch, Civil Division
U.S. Department of Justice
P.O. Box 146
Benjamin Franklin Station
Washington, D.C. 20044-0146
Tel: (202) 616-4136
Dated: May 24, 2024
6

Case 1:16-vv-01075-PSH Document 257 Filed 06/21/24 Page 10 of 10
Appendix A: Items of Compensation for Ala Mohamad Page 1 of 1
Lump Sum
Compensation Compensation Compensation Compensation
ITEMS OF COMPENSATION G.R. * M Year 1 Years 2-11 Years 12-19 Years 20-Life
2024 2025-2034 2035-2042 2043-Life
Medicare Part B Premium 4% M 2,096.40 2,096.40
Medicare Part B Deductible 4% 240.00 240.00 240.00 240.00
Neurology 4% * 100.00 100.00 100.00 100.00
Gabapentin 4% *
Duloxetine 4% *
Sertraline 4% *
Ibuprofen 4% 16.00 16.00 16.00 16.00
Case Mngt 4% 780.00 780.00 780.00 780.00
Assistance 4% M 4,056.00 4,056.00 4,056.00 8,112.00
Pill Box 4% 6.00 1.20 1.20 1.20
Interpreting Services 4% 660.00 660.00 660.00 660.00
Lost Earnings 561,869.00
Pain and Suffering 225,000.00
Medicaid Lien 92,602.13
Annual Totals 887,425.53 7,949.60 5,853.20 9,909.20
Note: Compensation Year 1 consists of the 12 month period following the date of judgment.
Compensation Year 2 consists of the 12 month period commencing on the first anniversary of the date of judgment.
As soon as practicable after entry of judgment, respondent shall make the following payment to petitioner for Yr 1 life care
expenses ($7,954.40), lost earnings ($561,869.00), and pain and suffering ($225,000.00): $794,823.40.
As soon as practicable after entry of judgment, respondent shall make the following payment jointly to
petitioner and the State of Colorado, as reimbursement of the state's Medicaid lien: $92,602.13.
Annual amounts payable through an annuity for future Compensation Years follow the anniversary of the date of judgment.
Annual amounts shall increase at the rates indicated above in column G.R., compounded annually from the date of judgment.
Items denoted with an asterisk (*) covered by health insurance and/or Medicare.
Items denoted with an "M" payable in twelve monthly installments totaling the annual amount indicated.

================================================================================
DOCUMENT 3: USCOURTS-cofc-1_16-vv-01075-4
Date issued/filed: 2024-12-02
Pages: 15
Docket text: JUDGE VACCINE UNREPORTED OPINION (PUBLIC VERSION) of 266 Opinion and Order Denying Motion for Review and Sustaining Decision of Special Master. Signed by Judge Philip S. Hadji. (lrf) Service on parties made.
--------------------------------------------------------------------------------
Case 1:16-vv-01075-PSH Document 269 Filed 12/02/24 Page 1 of 15
In the United States Court of Federal Claims
ALA MOHAMAD,
Petitioner,
No. 16-1075
v.
(Filed Under Seal: November 12, 2024)
(Reissued Publicly: December 2, 2024)
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Richard Gage, Richard Gage, P.C., Cheyenne, Wyoming, for Petitioner.
Voris E. Johnson, Jr., Assistant Director, Julia M. Collison, Assistant Director, Heather L.
Pearlman, Deputy Director, C. Salvatore D’Alessio, Director, Torts Branch, Brian M.
Boynton, Principal Deputy Assistant Attorney General, Civil Division, United States
Department of Justice, Washington, D.C., for Respondent.
OPINION AND ORDER1
HADJI, Judge.
Respondent, the Secretary of Health and Human Services, seeks review of Special
Master Christian J. Moran’s entitlement ruling and award of compensation in favor of
Petitioner, who began suffering from Guillain-Barré Syndrome (GBS) shortly after
receiving a tetanus-diphtheria-acellular pertussis (Tdap) vaccine in September 2015. ECF
258. For the reasons stated below, Respondent’s Motion for Review is DENIED, and the
Special Master’s Decision is SUSTAINED.
BACKGROUND
I. Petitioner’s Medical History
As the underlying facts set forth in Petitioner’s medical records are not in dispute,
the Court’s recitation of facts draws largely from the Special Master’s entitlement ruling.
See ECF 259 at 2; ECF 261 at 8.
1 This Opinion was issued under seal on November 12, 2024. The parties were directed to propose
redactions by November 26, 2024. No proposed redactions were received. The Court hereby publicly
releases the Opinion and Order in full.

Case 1:16-vv-01075-PSH Document 269 Filed 12/02/24 Page 2 of 15
On September 18, 2015, Petitioner received a Tdap vaccine during a routine
physical. ECF 150 at 2. Less than two weeks later, he visited a medical facility complaining
of numbness in his hands, feet, and lower back. Id. The treating physician diagnosed
Petitioner with hyperventilation syndrome. Id.
The next morning, Petitioner fell in his home and was taken to the emergency room
where he again complained of numbness. Id. The emergency room doctor diagnosed him
with paresthesias of both hands and feet. Id. at 3. Petitioner fell again the next morning. Id.
Following tests, including MRIs and a lumbar puncture, Petitioner was diagnosed with
GBS and hospitalized for almost the entirety of October 2015. Id. at 3-4. During his stay,
two doctors concluded that Petitioner’s GBS was “likely triggered” by his Tdap
vaccination. Id. at 3. Petitioner’s internist theorized that Petitioner could have nephritis and
noted that his review of literature indicated that glomerulonephritis has been associated
with GBS. Id. at 3-4. Petitioner’s internist sought a consult from the nephrology service,
which suggested that a kidney biopsy might be needed to reach a definitive diagnosis. Id.
at 4. Due to a necessary GBS treatment and the state of Petitioner’s kidney function,
Petitioner did not undergo a kidney biopsy. Id. Instead, after reviewing Petitioner’s blood
results, one of Petitioner’s doctors theorized that Petitioner’s kidney problem “could
potentially be an acute post strep GN [glomerulonephritis].” Id. Despite this speculation,
none of Petitioner’s treating physicians diagnosed him with a streptococcus infection. Id.
Near the end of his hospital stay, a different doctor described Petitioner’s chief
complaint as “GBS 2/2 [secondary to] Tetanus vaccination.” Id. at 5. Petitioner was
discharged from the hospital to a rehabilitation facility on October 30, 2015. Id. at 4-5. In
the discharge report, the discharging physician noted that Petitioner “had an allergy to
tetanus toxoids and that the allergic reaction produced GBS.”2 Id. at 4.
II. The Petition and Procedural History
On August 29, 2016, Petitioner filed a petition seeking compensation under the
National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa–10-34,3 alleging that
his September 2015 Tdap vaccine caused him to develop GBS. ECF 1. In support of his
Vaccine Act claim, Petitioner submitted medical records as well as expert reports from
neurologist Yuval Shafrir to show that a Tdap vaccine can cause GBS and actually did so
in this case. ECF 150 at 5, 7-8 (citing Pet. Ex. 20, ECF 66-1; Pet. Ex. 52, ECF 78-1; Pet.
Ex. 58, ECF 90-1; Pet. Ex. 63, ECF 101-1, and Pet. Ex. 64, ECF 101-2). Specifically, in
2 The Special Master noted that Petitioner’s medical record from the Medical Center of Aurora contains
several notes about Petitioner’s allergic reaction to the tetanus vaccine. ECF 150 at 4 n.5. He also noted
that multiple medical providers recognized that Petitioner developed GBS “following tetanus shot.” Id.
3 The National Vaccine Injury Compensation Program was established by the National Childhood Vaccine
Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (the Vaccine Act).
2

Case 1:16-vv-01075-PSH Document 269 Filed 12/02/24 Page 3 of 15
his initial expert report, Dr. Shafrir noted that the “[t]etanus vaccine is a known trigger for
GBS,” and set forth potential pathophysiological mechanisms by which tetanus toxoid
could cause GBS. Pet. Ex. 20 at 14-17, ECF 66-1. In concluding that the Tdap vaccine
caused Petitioner’s GBS, Dr. Shafrir primarily relied on case reports of GBS following
tetanus-containing vaccines, the temporal association between Petitioner’s Tdap
vaccination and the onset of his symptoms, and statements from Petitioner’s treating
physicians. See ECF 66-1.
Disputing causation, Respondent offered responsive reports from neuro-
immunologist Thomas Leist. Resp’t Ex. B, ECF 76-2; Resp’t Ex. C, ECF 82-1; Resp’t Ex.
D, ECF 112-1. In his initial report, Dr. Leist disagreed with the proposition that the Tdap
vaccine can cause GBS and in support relied on the 2012 report from the Institute of
Medicine (IOM), which concluded that there is insufficient scientific evidence to accept or
reject that tetanus-containing vaccines can cause GBS. See Resp’t Ex. B at 4-5, ECF 76-2.
Dr. Leist opined that Petitioner’s GBS was not caused by Tdap and theorized that a group
A streptococcal infection possibly caused Petitioner’s GBS. Id. at 4, 6-7.
In April 2020, the Special Master introduced two exhibits (the Court Exhibits) into
the record. See Court Ex. 1001, ECF 96-1; Court Ex. 1002, ECF 96-2. Both addressed
recommendations by the Advisory Committee on Immunization Practices (ACIP), a
federal advisory committee chartered to “provide expert external advice and guidance to
the Director of [the Centers for Disease Control and Prevention (CDC)] on use of vaccines
and related agents for the control of vaccine-preventable diseases.” ECF 96-1 at 3. Court
Exhibit 1001 is a CDC weekly report that compiled and summarized the recommendations
from ACIP “regarding prevention and control of tetanus, diphtheria, and pertussis in the
United States” in order to provide clinicians and public health providers with a
comprehensive and up-to-date “resource.”4 Id. at 3-4. This April 2018 publication reflects
the ACIP’s recommendation that GBS occurring less than six weeks after receipt of a
tetanus toxoid-containing vaccine warrants a precaution for subsequent administration of
tetanus toxoid-containing vaccines. Id. at 6. Court Exhibit 1002,5 a 2019 ACIP publication
which outlines the ACIP’s best practice guidelines for several vaccine-preventable
diseases, likewise listed GBS less than six weeks after a previous dose of tetanus toxoid-
containing vaccine as a precaution for the DT, Td, Tdap, and DTaP vaccinations. ECF 96-
2 at 53, 57. The Special Master directed the parties to share the Court Exhibits with their
4 Court Ex. 1001: Centers for Disease Control and Prevention, Prevention of Pertussis, Tetanus, and
Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on
Immunization Practices (ACIP), 67 CDC MORBIDITY & MORTALITY WKLY. REP. 1 (Apr. 27, 2018),
https://www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6702a1-H.pdf.
5 Court Ex. 1002: EZEANOLUE E, ET AL., General Best Practice Guidelines for Immunization: Best
Practices Guidance of the Advisory Committee on Immunization Practices (2019).
3

Case 1:16-vv-01075-PSH Document 269 Filed 12/02/24 Page 4 of 15
respective experts and, if desired, to submit supplemental expert reports addressing them.
ECF 96. The Special Master also ordered the parties to submit briefs addressing the merits
of Petitioner’s claim to aid him in his determination of whether to hold an evidentiary
hearing. ECF 93 at 1.
In May 2020, Petitioner submitted a supplemental report from Dr. Shafrir
addressing the Court Exhibits. See ECF 101-1 (Ex. 63). He opined: “Court [E]xhibits 1001
and 1002 further support [Petitioner’s] petition, as they reiterate the recognition of the
relationship between Tdap vaccination that he received on September 21 [sic], 2015 and
his [GBS].” Id. at 7. In June 2020, Petitioner filed his brief on entitlement. ECF 106.
In September 2020, Respondent filed his brief on entitlement, along with additional
expert reports from Dr. Leist and Dr. Neal Halsey,6 specifically addressing the Court
Exhibits. ECF 112-114. Dr. Leist deemed the Court Exhibits consistent with a finding that
evidence for a causal relationship between tetanus toxoid-containing vaccines and GBS is
lacking and again opined that Petitioner did not suffer GBS as a result of his vaccination.
ECF 112-1 (Ex. D) at 1-2, 4. Dr. Halsey likewise concluded that the inclusion of a
precaution “is not evidence that CDC or the scientific or medical community has concluded
that [tetanus toxoid-containing] vaccines can cause GBS.” ECF 113-1 (Ex. E) at 5.
In October 2020, Petitioner filed a reply brief. ECF 116. After reviewing the parties’
submissions, the Special Master scheduled an entitlement hearing. ECF 125 at 1. Two
weeks before the scheduled hearing, the Special Master issued Findings of Fact to resolve
inconsistencies in the medical records regarding the onset of Petitioner’s GBS. ECF 132.
The Special Master determined that onset occurred on September 28, 2015, ten days post-
vaccination. Id. at 3.
During the May 2021 entitlement hearing, Petitioner and his wife testified about his
health. See, e.g., Hearing Tr. 11:6-16:3, 26:16-29:25, ECF 144. Dr. Shafrir testified for
Petitioner, and Drs. Leist and Halsey testified for Respondent. Id. at 30:10-65:4, 90:25-
139:16. Following the hearing, the Special Master issued an order directing the parties to
brief whether the Court Exhibits constituted an admission by Respondent that tetanus-
containing vaccines can cause GBS, and whether, as a matter of policy, Respondent should
be allowed to offer expert testimony from Drs. Leist and Halsey to the contrary. ECF 139
at 1-2. In July 2021, Respondent filed his response to the order and argued that: (1) the
CDC/ACIP guidelines reflected in the Court Exhibits do not represent an admission by the
Secretary that tetanus toxoid-containing vaccines can cause GBS; and (2) it would be
arbitrary and capricious for the Special Master to find that they are sufficient on their own
to meet Petitioner’s burden under the first prong of the causation test established in Althen
6 Dr. Halsey is a pediatrician with subspecialty training in pediatric infectious diseases, epidemiology,
preventive medicine, vaccines, and vaccine safety. ECF 113-1 (Ex. E) at 1.
4

Case 1:16-vv-01075-PSH Document 269 Filed 12/02/24 Page 5 of 15
v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). ECF 146 at 10.
Petitioner filed his response three weeks later. ECF 147.
On January 27, 2022, the Special Master determined that Petitioner is entitled to
compensation. Mohamad v. Sec’y of Health & Hum. Servs., No. 16-1075V, 2022 WL
711604, at *1 (Fed. Cl. Spec. Mstr. Jan. 27, 2022), ECF 150. As discussed in relevant part
infra, the analysis section of the Special Master’s 30-page entitlement ruling included: (1)
an assessment of the credibility of the two original experts, Dr. Shafrir and Dr. Leist; (2) a
discussion of each of the three Althen causation prongs; and (3) an analysis of whether an
alternative factor caused Petitioner’s GBS. Id. at 11-29.
As is relevant here, on the issue of general causation, the Special Master engaged in
a chronological recitation of government publications that discuss, in part, a connection
between a vaccine containing tetanus toxoid and GBS. Id. at 15-23. Specifically, the
Special Master noted that, in 1994, the IOM published a comprehensive report addressing
“whether childhood vaccines can cause adverse events,” which found that “tetanus toxoid-
containing vaccines can cause GBS based on a single case study, known as the Pollard-
Selby case report.”7 Id. at 16. The Special Master went on to recognize that in 1996, the
ACIP issued an update to its previously published recommendations pertaining to
precautions, contraindications, side effects, and adverse reactions associated with
vaccinations in which the ACIP found that the risk for GBS following administration of a
tetanus vaccine was “extremely low.” Id. at 18. The Special Master noted that, fifteen years
later, in 2011, the ACIP again issued updated recommendations, and identified GBS less
than six weeks after a previous dose of a tetanus toxoid-containing vaccine as a precaution
against future tetanus vaccines. Id. at 19-20. The Special Master then noted how, in the
following year, the IOM published a new report on vaccine safety in which it revisited the
Pollard-Selby case report, retreated from its previous stance, and issued a neutral
conclusion that neither favored nor rejected causation. Id. at 20, 24. Specifically, the IOM
concluded that the “‘evidence is inadequate to accept or reject a causal relationship between
diphtheria toxoid-, tetanus toxoid-, or acellular pertussis-containing vaccine and CIDP.’”
Id. at 20. Finally, the Special Master described how, despite the IOM’s updated position in
2012, the ACIP issued publications (i.e. the Court Exhibits) in 2018 and 2019 that
continued to recognize a precaution against future tetanus vaccines for those who
experienced GBS less than six weeks after receipt of a tetanus toxoid-containing vaccine.
Id. at 21-23. After interpreting the meaning of the ongoing precaution, the Special Master
found that the latest Court Exhibit “constitutes strong evidence that a tetanus vaccine can
cause GBS in rare cases.” Id. at 26.
7 The Pollard-Selby case report followed a 42-year-old male laborer who had GBS on three separate
occasions, each following receipt of a tetanus-toxoid containing vaccine. ECF 150 at 16.
5

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In reaching this conclusion, the Special Master weighed expert testimony regarding
the ACIP’s recommendations and activities. Id. at 23-27. For example, Dr. Halsey testified
that the ACIP likely failed to appreciate the significance of the 2012 IOM shift and that the
ACIP’s failure to update the recommendation regarding GBS and tetanus vaccines in the
Court Exhibits represented an oversight. Id. at 24-25. He predicted that the ACIP would
likely revise the recommendation in a future publication.8 Id. at 27 n.27. Ultimately,
because Dr. Halsey did not participate in the working group that led to the latest Court
Exhibit and because evidence suggested the ACIP was aware of the 2012 IOM report, the
Special Master declined to find Dr. Halsey’s opinions on this point persuasive. Id. at 25.
After the parties spent nearly two years resolving Petitioner’s damages, the Special
Master awarded compensation in May 2024. ECF 256. On June 28, 2024, Respondent
sought review of the Special Master’s decision. ECF 258.
STANDARD OF REVIEW
Under the Vaccine Act, this Court has jurisdiction to review a special master’s
decision. 42 U.S.C. § 300aa–12(e)(2). In reviewing a special master’s decision, this Court
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 of the findings of fact or conclusions of law of 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 direction.
42 U.S.C. § 300aa–12(e)(2)(A)-(C). The standards set forth in 42 U.S.C. § 300aa–
12(e)(2)(B) “vary in application as well as degree of deference” as each “standard applies
to a different aspect of the judgment.” Munn v. Sec'y of Health & Hum. Servs., 970 F.2d
863, 870 n.10 (Fed. Cir. 1992). Findings of fact receive deferential review under the
“arbitrary and capricious” standard; legal conclusions are reviewed under the “not in
accordance with law” standard; and discretionary rulings are reviewed for “abuse of
discretion.” Turner v. Sec’y of Health & Hum. Servs., 268 F.3d 1334, 1337 (Fed. Cir. 2001).
With respect to the arbitrary and capricious standard, “no uniform definition . . . has
emerged,” but it is “a highly deferential standard of review” such that “[i]f the special
master has considered the relevant evidence of record, drawn plausible inferences and
8 Respondent concedes that, despite Dr. Halsey’s prediction, the ACIP has not updated its recommendations
regarding tetanus-containing vaccines since its 2019 publication. ECF 259 at 12 n.7.
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articulated a rational basis for the decision, reversible error will be extremely difficult to
demonstrate.” Hines v. Sec’y of Health & Hum. Servs., 940 F.2d 1518, 1527-28 (Fed. Cir.
1991); see also Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto Ins. Co.,
463 U.S. 29, 43 (1983) (a decision is arbitrary and capricious only if it is “so implausible
that it could not be ascribed to a difference in view”). “The arbitrary and capricious
standard of review 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.” Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000). That
is because it is not for the courts 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.” Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011)
(citing Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1349 (Fed. Cir.
2010)).
The “not in accordance with law” standard, on the other hand, is applied without
deference to legal determinations, such as “[w]hether the special master applied the
appropriate standard of causation . . . .” Deribeaux v. Sec’y of Health & Hum. Servs., 717
F.3d 1363, 1366 (Fed. Cir. 2013). Lastly, the abuse of discretion standard applies to the
special master’s discretionary rulings, such as evidentiary determinations regarding the
qualification of experts and the admissibility of their testimony. Piscopo v. Sec’y of Health
& Hum. Servs., 66 Fed. Cl. 49, 53 (2005). Determinations subject to review for abuse of
discretion must be sustained unless “manifestly erroneous.” Id.; see also Milmark Servs.,
Inc. v. United States, 731 F.2d 855, 860 (Fed. Cir. 1984).
DISCUSSION
Respondent raises two objections to the Special Master’s finding of entitlement and
subsequent compensation award. First, he argues that the Special Master impermissibly
shifted the burden of proof to the Secretary to prove he had not conceded prong 1 of the
Althen causation test, rather than properly placing the burden on Petitioner to affirmatively
prove a medical theory. ECF 258 at 1; ECF 259 at 6. Second, Respondent argues that the
Special Master erred in finding that Respondent conceded Althen prong 1 and “ignored
other important record evidence.” ECF 258 at 1; ECF 259 at 6, 17. Respondent raises no
objection to the Special Master’s application of the remaining Althen prongs.
I. Legal Framework
Under the Vaccine Act, petitioners bear the burden of proving that a vaccine caused
an injury or death. 42 U.S.C. § 300aa–13(a)(1). There are two methods by which a
petitioner may establish causation and thus eligibility for an award of compensation. Munn,
970 F.2d at 865. Through the first method, a petitioner may demonstrate causation through
a statutorily prescribed presumption by showing that the alleged injury meets the criteria
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listed on the Vaccine Injury Table, as set forth in 42 U.S.C. § 300aa–14 and 42 C.F.R.
§ 100.3. Id. The Table identifies the covered vaccines, the corresponding injuries, and the
time period after vaccination in which the particular injuries must occur. 42 C.F.R. § 100.3.
“[I]f a petitioner can establish that [he] received a listed vaccine and experienced such
symptoms or injuries within the specified timeframes, [he] has met [his] prima facie burden
to prove that the vaccine caused [his] injuries.” de Bazan v. Sec’y of Health & Hum. Servs.,
539 F.3d 1347, 1351 (Fed. Cir. 2008). Alternatively, and most relevant here, if a petitioner
suffered an “off-Table injury,” he must prove “causation-in-fact” by a preponderance of
the evidence. See 42 U.S.C. §§ 300aa–11(c)(1)(C)(ii), 13(a)(1); see also Broekelschen, 618
F.3d at 1341-42. The Federal Circuit has “interpreted the ‘preponderance of the evidence’
standard referred to in the Vaccine Act as one of proof by a simple preponderance, of ‘more
probable than not’ causation.” Althen, 418 F.3d at 1279. Proof of medical certainty is not
required. Bunting v. Sec'y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).
“Once causation is established, the petitioner is entitled to compensation unless the
Government can show by a preponderance of the evidence that the injury is due to factors
unrelated to the vaccine, i.e., an alternative cause.” Porter, 663 F.3d at 1249.
In this case, Petitioner alleged that a Tdap vaccination caused him to suffer GBS.
ECF 1 at 1. GBS is not a Table injury for the Tdap vaccine. See 42 C.F.R. § 100.3(a).
Petitioner therefore could not claim a presumption of causation, and instead was required
to affirmatively prove causation-in-fact. Under the test articulated by the Federal Circuit in
Althen, the test for proving causation-in-fact requires a showing of: (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 proximate
temporal relationship between vaccination and injury. 418 F.3d at 1278.
II. The Special Master Did Not Improperly Shift the Burden of Proof on
Althen Prong 1 nor Exceed His Legal Authority.
Respondent argues that the Special Master acted contrary to law by shifting the
burden to the Secretary of Health and Human Services to prove that he had not conceded
prong 1 of the Althen causation test, rather than properly placing the burden on Petitioner
to affirmatively prove a medical theory causally connecting the vaccination and injury.
ECF 258 at 1; ECF 259 at 15-16. Specifically, Respondent takes issue with the Special
Master’s introduction of the Court Exhibits and argues he impermissibly “placed the
burden on respondent to disprove [his] own interpretation of that evidence,” effectively
granting petitioners a legal presumption of causation. ECF 259 at 15-16. When faced with
such a contention, the Court of Federal Claims reviews the Special Master’s application of
the law de novo. Rodriguez v. Sec’y of Health & Hum. Servs., 632 F.3d 1381, 1384 (Fed.
Cir. 2011) (“‘Not in accordance with the law’ refers to the application of the wrong legal
standard, and the application of the law is reviewed de novo.”).
In this case, the Special Master repeatedly cited the correct burden of proof. See,
e.g., ECF 150 at 10. He acknowledged that petitioners are generally required to establish
their cases by a preponderance of the evidence, and he specifically recognized that
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petitioners pursuing an off-Table injury bear the burden of demonstrating each of the
Althen prongs by preponderant evidence. Id. With respect to Petitioner specifically, he
repeatedly emphasized that Petitioner bore (and carried) the initial burden of proof. For
example, he noted that “[Petitioner] carried his burden of proof,” id. at 1, that the evidence
before him was “sufficiently robust that it carries [P]etitioner’s burden with respect to
general causation,” id. at 26, and that “[t]he lack of testing does not prevent [Petitioner]
from meeting his burden of proof . . . .” Id. at 29. Indeed, even in the language Respondent
cites for the proposition that it is “clear on which party the Special Master placed the
burden,” ECF 259 at 16 (“Mr. Mohamad cannot be expected to bear a higher burden than
the Secretary . . . .”), the Special Master made clear that, regardless of how high or low the
evidentiary burden, the onus was on Petitioner to meet it.
Respondent next takes issue with the fact that the relevant evidence was submitted
by the Special Master, not the Petitioner. According to Respondent, the Special Master
“relied solely on evidence he filed into the record,” id. at 15 (first emphasis added), which
happens to be written materials created and distributed by the Government. But this
challenge ignores the unique inquisitorial role special masters play in Vaccine Act cases,
in which the “permissible scope of the special master’s inquiry is virtually unlimited.”
Whitecotton v. Sec’y of Health & Hum. Servs., 81 F.3d 1099, 1108 (Fed. Cir. 1996)
(“Congress desired the special masters to have very wide discretion with respect to the
evidence they would consider and the weight to be assigned that evidence.”). Notably,
Respondent does not challenge the admissibility of the Court Exhibits, see ECF 146 at 4-
5, and he offers no authority contesting the Special Master’s ability to consider material
not introduced by the parties. See Hines, 940 F.2d at 1526 (finding no error where the
special master took judicial notice of a medical textbook that was not part of the record at
hearing); see also Massachusetts v. Westcott, 431 U.S. 322, 323 n.2 (1977) (public records
“may be judicially noticed”). Nor does Respondent cite any authority for the proposition
that evidence introduced into the record cannot be used for any purpose. Instead, without
invoking any prohibiting authority, Respondent complains that the Special Master relied
on evidence that he himself introduced to find that Petitioner met his burden on Althen
prong 1. The trouble with this approach is that it ignores the Vaccine Act’s statutory
instruction for the Special Master to consider “the record as a whole,” which in this case
includes “the Court Exhibits [the Special Master] himself filed.” See 42 U.S.C. § 300aa–
13(a)(1) (requiring fact findings to be based “on the record as a whole”).
Concerned by the prospect of special masters finding petitioners met their burden
of proof by relying on record evidence not supplied by petitioners themselves, Respondent
argues that, by relying on the Court Exhibits, the Special Master improperly granted “a
legal presumption of causation” linking tetanus toxoid-containing vaccines with GBS. See
ECF 259 at 16. According to Respondent:
If the Special Master’s entitlement ruling in this case is upheld,
then no petitioner in any future case alleging GBS due to a
tetanus-containing vaccine would need to produce any
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evidence addressing Althen prong one, which is tantamount to
petitioners being granted a legal presumption of causation in
such cases. In other words, the Special Master effectively made
GBS a presumptive injury for the Tdap vaccine – i.e., a Table
injury.
Id. This argument fails. It does not follow that just because the Special Master considered
evidence he himself filed in the record of this case (which again, Respondent did not
challenge on admission), petitioners in all future Tdap-GBS cases are granted a
presumption of causation. Instead, any findings of causation in those cases will turn on the
evidence on record in those cases. Such records may or may not include evidence of the
Court Exhibits along with any other evidence filed by the parties. The Special Master
recognized as much, and noted that if the evidence differs a different result might follow:
If Dr. Halsey’s prediction that the ACIP revises the Secretary’s
guidance comes true, then the evidence will be different. The
parties might also present different evidence in the form of
testimony from immunologists, epidemiologists, and/or people
with first-hand knowledge of the creation of the 2019 Best
Practices. Different evidence in any hypothetical future case
might yield a different result.
ECF 150 at 27 n.27. Such acknowledgment is hardly indicative of the grant of a legal
presumption of causation; instead, it demonstrates an expectation that, as required by
statute, special masters consider “the record as a whole.” See 42 U.S.C. § 300aa–13(a)(1).
Notably, since the Special Master issued the entitlement ruling in this case,
Respondent’s fear of special masters applying a legal presumption has not come to pass.
Other special masters have considered petitions alleging a Tdap-GBS association and
decided them based on the evidence before them. See, e.g., K.A. v. Sec’y Health & Hum.
Servs., No. 16-969V, 2022 WL 20213037, at *23, 25 (Fed. Cl. Spec. Mstr. Apr. 18, 2022),
review denied, decision aff’d, 164 Fed. Cl. 98 (2022), aff’d, No. 2023-1315, 2024 WL
2012526 (Fed. Cir. May 7, 2024) (distinguishing Mohamad in part because almost all of
the publications it evaluated were not offered as evidence in that case and recognizing that
“the outcome in such cases is mostly a function of the evidence before the special master,
with no clear trend one way or the other”); see also Harris v Sec’y of Health & Hum. Servs.,
No. 18-944V, 2023 WL 2583393, at *22-27 (Fed. Cl. Feb. 21, 2023) (noting the Court
Exhibits were not filed in that case and finding other adequate evidence to demonstrate that
Tdap vaccines can cause GBS).
Finally, in resolving this issue, the Court notes that Respondent’s argument is
predicated on a faulty premise, specifically that in finding Petitioner satisfied Althen prong
1, “the Special Master . . . relied solely on evidence he filed into the record.” ECF 259 at
15 (first emphasis added). This statement mischaracterizes the Special Master’s actions. It
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is true that the Special Master’s analysis on the first Althen prong afforded great weight to
his interpretation of the Court Exhibits. However, as described in more detail below, the
Special Master also considered the whole history of reports and actions taken under the
authority of the Secretary, and emphasized evidence of prior post-vaccination
demyelination, suggesting proof of “rechallenge,” a pattern of recurrence that can
demonstrate that an exposure is causing an adverse reaction. See Capizzano v. Sec’y of
Health & Hum. Servs., 440 F.3d 1317, 1322 (Fed. Cir. 2006) (defining rechallenge).
Further, in reaching his ultimate conclusion that Petitioner carried his burden of proof, the
Special Master wrote: “[t]he Secretary’s documents show that a tetanus vaccine can cause
GBS. This evidence plus the reports from doctors who treated Mr. Mohamad constitute
preponderant evidence.” ECF 150 at 1 (emphasis added). The Special Master went on to
specifically note that, in resolving Althen prong 1, he relied on statements from Petitioner’s
doctors: “[Petitioner]’s treating doctors’ statements that a tetanus vaccine caused his GBS
also imply that a tetanus vaccine can cause GBS generally. As such, these statements from
treating doctors are also relevant to the prong 1 discussion above.” ECF 150 at 29 (citing
Caves v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 119, 136-37 (2011), aff’d without
opinion, 463 F. App’x 932 (Fed. Cir. 2012)). In light of this other evidence, it is simply not
accurate to say that “the Special Master relied solely on evidence he filed into the record”
or that he “arbitrarily began and ended his analysis with the Court Exhibits.” ECF 259 at
15, 18. As such, the Court cannot conclude that the Special Master improperly shifted the
burden of proof nor that he exceeded his legal authority.
III. The Special Master’s Evaluation of the Evidence Was Not Arbitrary and
Capricious.
Next, Respondent argues that the Special Master’s finding that Respondent
conceded Althen prong 1 was based on an arbitrary and capricious evaluation of the
evidence and that, in reaching that finding, he “ignored other important record evidence
and gave undue weight to his own unsupported interpretation of Court [E]xhibits.” Id. at
17.
The crux of this challenge is that the Special Master improperly weighed the
evidence before him. But it is not for this Court 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.” Porter, 663 F.3d at 1249. It is simply “not our role to ‘second guess the
Special Master[’]s fact-intensive conclusions’ particularly in cases ‘in which the medical
evidence of causation is in dispute.’” Id. (quoting Hodges v. Sec’y of Health & Hum. Servs.,
9 F.3d 958, 961 (Fed. Cir. 1993)). Instead, special masters are entitled to “the special
statutory deference in fact-finding normally reserved for specialized agencies.” Munn, 970
F.2d at 871. This is because “Congress assigned to a group of specialists, the Special
Masters within the Court of Federal Claims, the unenviable job of sorting through these
painful cases and, based upon their accumulated expertise in the field, judging the merits
of the individual claims.” Hodges, 9 F.3d at 961. Accordingly, if the Special Master’s
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findings of fact are “based on evidence in the record that [is] not wholly implausible,” the
Court is compelled to uphold that finding. Cedillo v. Sec’y of Health and Hum. Servs., 617
F.3d. 1328, 1338 (Fed. Cir. 2010).
Under Althen prong 1, Petitioner was required to demonstrate by a preponderance
of the evidence a medical theory causally connecting the Tdap vaccine and GBS. Althen,
418 F.3d at 1278. Put differently, Petitioner was required to show that the vaccine can
cause the type of injury alleged. See Capizzano, 440 F.3d 1326 (finding the first prong of
Althen satisfied by the finding that the hepatitis B vaccine can cause rheumatoid arthritis).
While “[a] petitioner must provide a reputable medical or scientific explanation that
pertains specifically to petitioner’s case … the explanation need only be ‘legally probable,
not medically or scientifically certain.’” Moberly v. Sec’y of Health & Hum. Servs., 592
F.3d 1315, 1322 (Fed. Cir. 2010). Petitioners may satisfy this prong without resort to
medical literature, epidemiological studies, demonstration of a specific mechanism, or a
generally accepted medical theory. Capizzano, 440 F.3d at 1325-26.
In this case, the Special Master devoted thirteen full pages of his analysis to the first
Althen prong. See ECF 150 at 14-27. His ruling reveals a thorough and careful evaluation
of the evidence. Id. After discounting the opinions of Drs. Shafrir and Leist, the two
original experts, due to credibility concerns, he: (1) discussed at length the demonstrated
evolution of the Government’s published scientific/medical conclusions about tetanus-
GBS causality, as well as some of the underlying studies it relied upon; (2) noted the
Vaccine Program’s historical treatment of the issue; and (3) weighed expert testimony
regarding the ACIP’s recommendations and activities. Id. at 15-26. Ultimately, he
concluded that the Government’s most recent publication “constitutes strong evidence that
a tetanus vaccine can cause GBS in rare cases” and is “sufficiently robust [such] that it
carries Petitioner’s burden with respect to general causation.” Id. at 26.
This finding was not arbitrary and capricious. As discussed at length by the Special
Master, the Court Exhibits contain evidence that as late as 2019 the ACIP offered as a
“precaution” that Tdap was to be carefully considered for individuals who previously had
experienced GBS within six weeks of a tetanus toxoid-containing vaccine.9 ECF 150 at 26.
Although a “precaution” is not as strong as a “contraindication,” it is still evidence of an
association between GBS, tetanus toxoid-containing vaccines, and the possibility of a
serious adverse reaction. See ECF 96-2 at 51 (defining “precaution” as “a condition in a
9 The parties agree that the ACIP has not updated its recommendations concerning tetanus toxoid-containing
vaccines since its 2019 publication. See ECF 259 at 12 n.7; ECF 261 at 28.
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recipient that might increase the risk for a serious adverse reaction, might cause diagnostic
confusion, or might compromise the ability of the vaccine to produce immunity”).10
To be sure, the Court Exhibits do not themselves specify that one possible adverse
reaction is a recurrence of GBS. However, support for this finding is in the record.
Specifically, in a 1996 update to previously published ACIP recommendations pertaining
to precautions, contraindications, side effects, and adverse reactions associated with
vaccinations, the ACIP noted that “[p]ersons who have a history of GBS associated with a
particular vaccine may be at increased risk for recurrent GBS after subsequent doses of that
vaccine.” Resp’t Ex. E, Tab 3 at 14, ECF 113-4. After finding that “the risk for GBS after
administration of tetanus toxoid is very low,” the ACIP identified GBS as a precaution in
all but name for tetanus vaccination due to the possibility of recurrence. Id. It did so,
“[b]ecause tetanus vaccination has been associated rarely with recurrence of GBS, [and]
the decision to administer additional doses of tetanus-toxoid-containing vaccine to persons
who have had GBS within 6 weeks after receiving tetanus toxoid should be based on the
benefits of subsequent vaccination and the risk for recurrence of GBS.”11 Id. The Special
Master discussed the 1996 update at length in his entitlement ruling, ECF 150 at 17-18,
and read it alongside Court Exhibit 1002 to interpret the significance of—and rationale
for—the ongoing precaution. Id. at 26. Given the lack of a stated explanation for the
precaution in the Court Exhibits, the Court will not fault the Special Master for considering
the 1996 update in conjunction with the Court Exhibits as it provides context for why the
ACIP continues to identify GBS less than six weeks after a previous dose of tetanus vaccine
as a precaution against future tetanus vaccines. Accordingly, because the Court finds that
the Special Master’s finding that “a tetanus vaccine can cause GBS in rare cases” is
supported by evidence in the record that is “not wholly implausible,” the Court will not
disturb the Special Master’s finding. Cedillo, 617 F.3d. at 1338.
The Court recognizes that much of Respondent’s concern is with the fact the Special
Master allegedly found the Secretary conceded the first Althen prong. It is true that the
Special Master’s analysis primarily rested on finding that “the Secretary acknowledged the
low risk that in rare cases a tetanus vaccine can cause GBS by making a prior occurrence
10 On September 11, 2024, the Court ordered supplemental briefing regarding the significance of the fact
Petitioner did not previously develop GBS within six weeks of a prior tetanus vaccine, as required for the
precaution to apply to him at the time of his September 2015 Tdap vaccination. ECF 263 at 1. Upon
consideration of the parties’ briefs (ECF 264, ECF 265) as well as further review of the “challenge-
rechallenge” paradigm, the Court is satisfied that evidence of “rechallenge” in other injectees can constitute
proof of general causality under Althen prong 1. See Capizzano, 440 F.3d at 1326 (Fed. Cir. 2006)
(affirming decision in Capizzano v. Sec’y of Health & Hum. Servs., No. 00-759, 2004 WL 1399178, at *
16 (Jun. 8, 2004), which concluded that the “[C]ourt need not determine an exact mechanism for which
Hepatitis B occurs in rechallenge cases or in any other cases where a hepatitis B vaccination allegedly
caused [rheumatoid arthritis]” given the IOM’s position that “rechallenge is tantamount to causation”)).
11 Although the 1996 update did not expressly characterize the ACIP’s recommendation as a precaution,
Dr. Halsey testified that the ACIP “listed it as a precaution” in his testimony regarding the 1996 update.
Hearing Tr. 232:20-25, ECF 145.
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of GBS in temporal relationship with a tetanus vaccine a precaution.” ECF 150 at 27.
However, the Court finds no fault with the Special Master recognizing the source of the
evidence before him. The Court Exhibits, which acknowledge a continuing concern over
administering doses of a tetanus toxoid-containing vaccine to persons who previously
suffered GBS within six weeks of receiving a prior dose, were created under the authority
of the Secretary.12 Recognizing this fact is not improper. Nor does such acknowledgment
serve as an indication that the Special Master’s decision turned solely on whether the Court
Exhibits constituted an admission. Although the Special Master once ordered briefing on
the issue of whether the Court Exhibits constituted an admission by a party-opponent
pursuant to Rule 801(d)(2) of the Federal Rules of Evidence, ECF 139, he “apparently
abandoned any reliance on Rule 801(d)(2) since it was not addressed in the Decision,” as
conceded by Respondent, and he at no point referred to the Court Exhibits as an admission
or concession. ECF 259 at 15-16 n.10; see generally ECF 150. Accordingly, the Court
interprets the Special Master’s language for what it is—recognition of publications written
under the authority of the Secretary that the Special Master interpreted as demonstrating
some association between a tetanus vaccine and GBS.
Respondent also contends that the Special Master “ignored other important record
evidence.” ECF 259 at 17. Specifically, Respondent argues that the Special Master’s
analysis included no discussion of the available epidemiological studies, some of which
were discussed in the IOM’s 2012 report and that served as the basis of subsequent special
master decisions rejecting a causal association between tetanus-containing vaccines and
GBS. Id. at 17-18. Respondent argues that “at a minimum, [the Special Master] should
have explained why that evidence was not deserving of more weight in his causation
analysis.” Id. at 18. Respondent also argues that, in evaluating the persuasiveness of Dr.
Halsey’s testimony, the Special Master failed to mention evidence of correspondence and
discussions between Dr. Halsey and ACIP members pertaining to ACIP’s recommendation
regarding GBS and Tdap. Id. at 18. In Respondent’s view, these communications show that
Dr. Halsey was not engaging in “rank speculation” as to ACIP’s intentions. Id.
This argument fails for a simple reason: the Court “generally presume[s] that a
special master considered the relevant record evidence even though he does not explicitly
reference such evidence in his decision.” Moriarty v. Sec’y of Health & Hum. Servs., 844
F.3d 1322, 1328 (Fed. Cir. 2016). Respondent cites no authority—and the Court is aware
of none—for the proposition that a special master is required to explicitly address every
piece of record evidence. Indeed, this Court has previously recognized that a special master
is “not required to discuss every piece of evidence or testimony in [his or] her decision.”
12 The Court Exhibits involve discussion of recommendations by ACIP, which was established by the
Secretary under Section 222 of the Public Health Service Act, 42 U.S.C. § 217a. ACIP’s members are
selected by the Secretary to advise the Director of the CDC. See 96-1 at 3;
https://www.cdc.gov/acip/about/acip-charter.html (last accessed Oct. 16, 2024). Once ACIP’s
recommendations are reviewed and approved by the CDC Director, recommendations are published in the
CDC’s Morbidity and Mortality Weekly Report, which represents the official CDC recommendations for
immunizations of the U.S. population. Id.
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Simanski v. Sec’y of Health and Hum. Servs., 115 Fed. Cl. 407, 436 (2014), aff’d, 601 F.
App’x 982 (Fed. Cir. 2015) (alteration in original).
Moreover, in this case, the supposedly “ignored” evidence is of little consequence.
First, with respect to the Special Master’s silence as to epidemiological studies that were
discussed in the IOM’s 2012 report and served as the basis for subsequent special master
decisions, the Court fails to understand why the Special Master would need to address such
studies when he discussed at length the IOM report that drew from those studies. Put
another way, why would the Special Master need to discuss the underlying studies when
he scrutinized the conclusion that flowed from those studies?
Second, with respect to the Special Master’s supposed failure to mention Dr.
Halsey’s correspondence and discussions with ACIP members when evaluating the
persuasiveness of Dr. Halsey’s testimony, the Court notes that the Special Master
acknowledged Dr. Halsey’s “first-hand knowledge” and “insights into the process leading
to the production of the documents.” ECF 150 at 24. He explicitly noted that he did not
readily dismiss Dr. Halsey’s opinion. Id. at 26. Nevertheless, the Special Master still
articulated multiple reasons for deeming unpersuasive Dr. Halsey’s assertion that the ACIP
did not consider modifying the recommendation for GBS. Id. at 25-26. As such, even if the
Special Master had fully credited Dr. Halsey’s email correspondence and other
communications with ACIP members in the manner Respondent wishes he had, the Special
Master still would have had other reasons for finding Dr. Halsey’s opinions unpersuasive.
For the foregoing reasons, the Court finds the Special Master did not engage in an
arbitrary and capricious evaluation of the evidence. Instead, he thoughtfully “considered
the relevant evidence of record, dr[ew] plausible inferences and articulated a rational basis
for the decision.” Hines, 940 F.2d at 1527-28.
CONCLUSION
In this case, the Special Master applied the appropriate standard, engaged in a
lengthy review of Government publications that discuss, in part, a connection between a
vaccine containing tetanus toxoid and GBS, and articulated a rational basis for finding that
Petitioner met his burden in demonstrating Althen prong 1. Accordingly, Respondent’s
Motion for Review (ECF 258) is DENIED and the Special Master’s Decision is
SUSTAINED. The Clerk of the Court is directed to enter judgment accordingly.
IT IS SO ORDERED.
PHILIP S. HADJI
Judge
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