Mohamad v. Secretary of Health and Human Services

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

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

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

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

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.

5

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.

6

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

7

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.

8

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.

9

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).

10

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.

11

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.

12

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).

13

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.

14

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

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).

16

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

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

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

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.”

20

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

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

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

(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

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

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

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

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

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

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

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

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

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