In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

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

MERDENA MONTGOMERY, *

* No. 15-1037V

Petitioner, * Special Master Christian J. Moran

*

v. *

* Filed: May 21, 2019

SECRETARY OF HEALTH *

AND HUMAN SERVICES, * Entitlement, Tdap vaccine, HPV vaccine, 

* Guillain-Barré syndrome, B12 deficiency, 

Respondent. * bench ruling

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

Michael G. McLaren & Christopher J. Webb, Black McLaren, et al., PC, Memphis, TN, for 

petitioner;

Robert P. Coleman, III, United States Dep’t of Justice, Washington, DC, for respondent. 

PUBLISHED DECISION DENYING COMPENSATION1

A hearing was held on May 14-15, 2019. After the parties submitted all their evidence, 

the undersigned issued a bench decision, finding that Ms. Montgomery had failed to establish 

that she was entitled to compensation. See Doe/17 v. Secʼy of Health & Human Servs., 84 Fed. 

Cl. 691, 704 n.18 (2008) (noting “[e]ven a special master’s ruling on entitlement may be 

delivered from the bench, with no written opinion”). 

The undersigned is issuing this document for two reasons. First, if only a bench decision 

was issued, the public would not have access to the transcript containing the bench decision and, 

thereby, the reasoning underlying the decision. To allow public access to the reasoning 

underlying the decision, this document will become available to the public pursuant to 42 U.S.C. 

§ 300aa-12(d)(4). 

Second, this document provides an abbreviated recitation of the basis for decision. See

Hebern v. United States, 54 Fed. Cl. 548 (2002) (example of a judge from the United States 

 

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

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

website (https://www.uscfc.uscourts.gov/aggregator/sources/7). This posting means that the 

decision will be available to anyone with the internet. Pursuant to Vaccine Rule 18(b), the 

parties have 14 days to file a motion proposing redaction of medical information or other 

information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by the special 

master will appear in the document posted on the website.
2

Court of Federal Claims formalizing a bench ruling denying a motion for review). The 

undersigned’s consideration of the evidence began when the evidence was received. See

Vaccine Rule 5. As explained in the decision from the bench, the undersigned considered all the 

evidence, including the medical records, expert reports, medical articles, and oral testimony. 

Facts

The parties agreed that medical records created contemporaneously with the events 

described in the records mostly set forth events in Ms. Montgomery’s life accurately. Moreover, 

because the parties’ briefs are generally in agreement on the facts, only a succinct recitation of 

facts is presented here. The bench decision contained a more detailed presentation of the 

relevant facts. 

Prior to the vaccinations, Ms. Montgomery did not enjoy perfect health. She had chronic 

lower back pain from a car accident in 2001 and also suffered from neck pain, depression 

anxiety, obesity, gastroesophageal reflux disease, irritable bowel syndrome, hypertension, and 

B12 deficiency. Exhibit 2 at 24; exhibit 4 at 130.

On January 28, 2013, Ms. Montgomery received the tetanus-diphtheria-acellular pertussis 

(“Tdap”) and human papillomavirus (“HPV”) vaccinations. Exhibit 2 at 4, exhibit 3 at 5. 

According to Ms. Montgomery’s testimony, on approximately February 7, 2013, she began to 

experience numbness. This numbness began in her right arm, near her forearm. On February 25, 

2013, Ms. Montgomery saw her primary care physician, Dr. Zulueta, complaining of the preexisting conditions noted above and left arm pain. Exhibit 4 at 130. In his assessment, Dr. 

Zulueta noted “numb tongue/arms/feet ?neuropathy” and ordered B12 testing. Id. at 132, 200 

(B12 test results). At a March 4, 2013 appointment with Dr. Zulueta, Ms. Montgomery 

complained of numbness all over her body for one week and falling the previous day due to an 

unsteady gait. Id. at 127. Dr. Zulueta reiterated his assessment of “numb tongue/arms/feet

?neuropathy” and also stated “B12 low end of normal.” Id. at 128. Dr. Zulueta planned to refer

Ms. Montgomery to a neurologist. Id. at 129. 

From a later notation during physical therapy, it appears that Ms. Montgomery started 

using a walker on March 16, 2013. Exhibit 5c at 23. In the morning of March 20, 2013, Ms. 

Montgomery saw her neurologist, Dr. Krishnaswamy, for the first time after vaccination. Ms. 

Montgomery complained of numbness of her entire body for one month and an unsteady gait. 

Exhibit 14 at 6.

2

 Dr. Krishnaswamy diagnosed Ms. Montgomery with Guillain-Barré syndrome 

(“GBS”) and directed her to go to the hospital. Id. at 7. On the same day, Ms. Montgomery was 

admitted to the hospital and treated for the GBS diagnosis with IVIG but a B12 deficiency was 

also noted and treated. Exhibit 5 at 112. During her five-day hospitalization, Ms. Montgomery 

was seen by other medical professionals who continued treating her with IVIG for GBS and also 

 

2 The parties disputed Dr. Krishnaswamy’s notation regarding Ms. Montgomery’s 

reflexes. Ms. Montgomery, supported by an explanatory letter from Dr. Krishnaswamy (exhibit

51), argued that the circle notation over the 2+ for Ms. Montgomery’s reflexes indicated a zero, 

meaning no reflexes. The Secretary argued that the circle notation was actually an emphasis of 

the 2+ indicating that Ms. Montgomery had normal reflexes. 
3

treating a B12 deficiency. Id. at 69, 114, 116, 118, 127. Ms. Montgomery’s discharge summary 

noted she “had improvement in overall symptoms” and included diagnoses for GBS and B12 

deficiency. Id. at 110.

Throughout the medical records created in February and March 2013, there are 

inconsistencies and sometimes contradictions within the same entries about what symptoms, 

notably weakness and numbness, Ms. Montgomery was experiencing. These inconsistences and 

contradictions within the medical records have made it difficult to come to conclusions on 

different factual issues.3

Following her hospitalization, Ms. Montgomery has made a partial recovery but still has 

limitations on her activities requiring help from others. The parties agree that the medical 

records after this key hospitalization in 2013 do not bear on the issue of establishing causation.

Procedural History

Ms. Montgomery alleged that the Tdap and HPV vaccines caused her to develop GBS. 

Pet., filed Sept. 17, 2015. Ms. Montgomery finished the submission of her medical records and 

filed a statement of completion on October 26, 2015. 

The Secretary filed his Rule 4 report on February 16, 2016. In the report, he disputed 

Ms. Montgomery’s GBS diagnosis and, even if he accepted the diagnosis, he argued that no 

treating physicians had connected the vaccinations to Ms. Montgomery’s injuries nor had Ms. 

Montgomery offered a medical theory to explain how the vaccines caused her injuries. The case 

then proceeded to the expert report phase with instructions regarding expert reports issuing on 

November 21, 2016. The instructions advised the parties that the expert reports may constitute 

direct testimony and, accordingly, any direct testimony by the experts at a hearing would be 

limited.

On February 15, 2017, Ms. Montgomery filed her first expert report from Dr. Lawrence 

Steinman. Dr. Steinman accepted the GBS diagnosis from Dr. Kishnaswamy and offered a 

medical theory that the HPV vaccination caused Ms. Montgomery’s GBS via molecular mimicry 

and the alum adjuvant in both vaccinations caused her GBS. Exhibit 17 at 7-18.

On November 17, 2017, the Secretary filed expert reports from Dr. Lindsay Whitton and 

Dr. Peter Donofrio. Dr. Whitton’s report argued against Dr. Steinman’s medical theories 

(exhibit A) and Dr. Donofrio disputed Ms. Montgomery’s GBS diagnosis (exhibit Z). Dr. 

 

3 Because the ultimate outcome does not depend on whether Ms. Montgomery 

established, by preponderant evidence, that she suffered from GBS, further evidentiary 

development is not required. In particular, the undersigned’s decision did not need to wait for 

Ms. Montgomery to obtain transcriptions of notes a neurologist (most likely, Dr. Krishnaswamy)

made during her hospitalization. While the handwriting is difficult to understand, during the 

hearing, Dr. Steinman and Dr. Donofrio could interpret most of the entries. Regardless of some 

limitations on the legibility of the notes, the entries clearly show that the author was assessing 

Ms. Montgomery as suffering from GBS. See exhibit 5b at, inter alia, 117, 124, 126, 135. 
4

Donofrio offered the alternative diagnoses of hypothyroidism and B12 deficiency. Exhibit Z at 

6.

On February 21, 2018, Ms. Montgomery filed a second report from Dr. Steinman (exhibit 

43). The Secretary then filed responsive reports from Dr. Whitton (exhibit FF) and Dr. Donofrio 

(exhibit JJ). After the close of the expert reports phase, an entitlement hearing was set for May 

2019.

On November 20, 2018, the undersigned issued an order setting a briefing schedule and 

outlining the requirements for the briefs. After four months, Ms. Montgomery filed her brief on 

March 9, 2019, and the Secretary filed his on April 9, 2019. The undersigned found the briefs, 

particularly Ms. Montgomery’s brief, to lack substance and a full articulation of the parties’ 

positions. A revised set of briefs were ordered and the parties were warned that deficient 

briefing could endanger the entitlement hearing from being held. Order, issued Apr. 15, 2019. 

Ms. Montgomery then filed an improved revised brief on April 29, 2019, and the Secretary filed 

a revised brief on May 8, 2019.

The entitlement hearing was held on May 14-15, 2019. The witnesses were Ms. 

Montgomery, Dr. Steinman, Dr. Whitton, and Dr. Donofrio. At the close of evidence, the 

undersigned issued a bench decision denying compensation for Ms. Montgomery.

Analysis

Ms. Montgomery bears the burden to establish her case on a more-likely-than-not basis. 

42 U.S.C. § 300aa-13(a); Bunting v. Secʼy of Health & Human Servs., 931 F.2d 867, 873 (Fed. 

Cir. 1991). The elements are set out in Althen v. Secʼy of Health & Human Servs., 418 F.3d 

1274, 1278 (Fed. Cir. 2005). 

While establishing a diagnosis is also required, see Broekelschen v. Sec'y of Health and 

Human Servs., 618 F.3d 1339 (Fed. Cir. 2010), the undersigned does not make a finding on 

diagnosis for the reasons that follow. The Secretary opposed Ms. Montgomery’s GBS diagnosis. 

Dr. Donofrio described the typical presentation of GBS as “numbness and tingling in the toes 

that ascends to the legs over a few days, moves to the hands and arms, and later, or at the same 

time, weakness begins in the arms and legs.” Exhibit Z at 5. At the hearing, Dr. Donofrio also 

emphasized that the typical progression of GBS was bilateral and symmetrical. Ms. 

Montgomery did not present as expected. Ms. Montgomery testified that she first felt numbness 

in one arm and then her tongue. Dr. Steinman did not necessarily dispute the diagnostic criteria 

proposed by Dr. Donofrio but instead maintained that the facts from the medical history could 

satisfy the diagnostic criteria for GBS. 

In his discussion of the diagnostic criteria for GBS, Dr. Donofrio went into more detail 

than Dr. Steinman and added the expected nadir of GBS symptoms. Resp’t’s Rev. Post-H’rg Br., 

filed May 8, 2019, at 9. One of the Secretary’s proposed diagnostic criteria for GBS was a 

“monophasic illness pattern AND interval between onset and nadir of weakness between 12h and 
5

28 days AND subsequent clinical plateau.” Id. (citing exhibit BB4at 1). Dr. Donofrio testified 

that 90% of GBS cases reach a nadir within 28 days after onset. Exhibit Z at 5. At the hearing, 

Dr. Steinman agreed that the nadir for most cases of GBS occur by 28 days. The parties do not 

dispute that Ms. Montgomery’s March 20, 2013 hospitalization was the nadir of her neurologic 

symptoms. As noted above, Ms. Montgomery’s medical records are not wholly clear on when 

her relevant neurologic symptoms began. If Ms. Montgomery started having neurologic 

problems on approximately February 7, 2013, which is the date she proposed in her testimony, 

then the progression of symptoms until the nadir on March 20, 2013 took much longer than 

expected. Her progression of symptoms calls into question the accuracy of the GBS diagnosis.

In addition to challenging Dr. Krishnaswamy’s diagnosis of GBS, Dr. Donofrio proffered 

a B12 deficiency diagnosis due to Ms. Montgomery’s low-normal levels of B12 during the key 

events and to her neurologic symptoms, including total body numbness. Exhibit Z at 6. 

However, Dr. Donofrio noted that a critical diagnostic test for B12 deficiency was not conducted 

to confirm a B12 deficiency diagnosis. Id. While looking at medical records for another reason 

during the hearing, Dr. Donofrio noted for the first time that Ms. Montgomery had been taking 

omeprazole for her irritable bowel syndrome. Ex. 2 at 24. Dr. Donofrio testified that B12 

deficiency is a possible side effect of omeprazole. Dr. Steinman agreed that omeprazole can 

cause B12 deficiency.

As noted above, the inconsistent and incongruent notations in the medical records 

regarding Ms. Montgomery’s weakness make her diagnosis uncertain. The records seem to 

frustrate a clear understanding of when Ms. Montgomery was experiencing weakness and what 

the overall pattern of that weakness was. However, at this time, it is not necessary to determine 

diagnosis because this case can be resolved without determining a diagnosis. For the sake of 

evaluating the Althen prongs, a diagnosis of GBS is presumed.

Althen prong 1 – Medical Theory

Ms. Montgomery has failed to establish a persuasive medical theory by a preponderance 

of the evidence. Dr. Steinman presented two medical theories: (1) a molecular mimicry theory 

connecting GBS to the HPV vaccination; and (2) an alum adjuvant theory connecting GBS to the 

Tdap and HPV vaccinations. The majority of Dr. Steinman’s reports and testimony at the 

hearing was devoted to the molecular mimicry theory.

While Ms. Montgomery does not need to present epidemiological evidence to prevail, the 

undersigned may consider epidemiological evidence. Grant v. Sec’y of Health & Human Servs., 

956 F.2d 1144, 1149 (Fed. Cir. 1992) (“epidemiological studies are probative medical evidence 

relevant to causation”); D'Tiole v. Sec'y of Health & Human Servs., 726 F. App'x 809, 811 (Fed. 

Cir. 2018) (special masters are not required to “ignore probative epidemiological evidence that 

undermines petitioner’s theory”). 

Here, regardless of the theory, epidemiological evidence did not support a finding that the 

HPV vaccine increases the incidence of GBS. Dr. Whitton presented three epidemiological 

 

4 Exhibit BB: Asbury et al., Assessment of Current Diagnostic Criteria for Guillain-Barré 

Syndrome, 27 (supp.) Ann. Neurol. S21-S24 (1990).
6

studies on the HPV vaccine and GBS. Exhibit A at 5. In the Gee study, the authors evaluated

over 600,000 doses of the HPV vaccine and did not find a statistically significant increase in 

GBS.5 In the Chao study, the authors followed almost 190,000 people for 180 days following 

the HPV vaccination and did not find any cases of GBS.6 In the recent Vichnin study, the 

authors again did not find an increased incidence of GBS following HPV vaccination.7 These 

studies all examined the HPV vaccine and GBS specifically and did not find a connection 

between the HPV vaccine and GBS. While these studies are not dispositive, the undersigned 

views the epidemiological evidence as weighing against Ms. Montgomery’s theory that the HPV 

vaccine can cause GBS. Although the epidemiological evidence undermines much of Ms. 

Montgomery’s evidence on prong one, Ms. Montgomery’s theories suffered from other 

deficiencies as well. 

Dr. Steinman opined that the HPV vaccine and the body’s myelin basic protein (“MBP”) 

share a homology, a similar sequence, that deceives the immune system into attacking MBP and 

causing GBS. Dr. Steinman used BLAST, a program that compares nucleotide and protein 

sequences, to search for a homology between the HPV vaccine and MBP. Dr. Whitton 

persuasively critiqued Dr. Steinman’s overreaching conclusions from BLAST searches and his 

choice of MBP as the appropriate molecule related to GBS for comparison with the HPV 

vaccine. Dr. Whitton explained that BLAST searches are appropriate for determining homology 

between molecules but not for determining cross-reactivity, which is necessary to generate an 

immune response. Beyond the limitations of BLAST searches, Dr. Whitton also argued that 

neurologists currently think gangliosides, not MBP, are the target in GBS. While Dr. Steinman 

admitted the current thought had turned toward gangliosides, he contended that the older 

literature promoting a connection between MBP and GBS has not been refuted. Because 

gangliosides are carbohydrates, Dr. Steinman could not conduct a BLAST search on them to 

determine their homology with the HPV vaccine. The uncertainty on the relevancy of MBP for 

the development of GBS does not help support Dr. Steinman’s theory. Moreover, because 

BLAST searches do not provide any insight into cross-reactivity, they do little to substantiate Dr. 

Steinman’s theory.

Dr. Steinman presented a second, less-developed theory that the alum adjuvant in the 

Tdap and HPV vaccines triggered an immune reaction in Ms. Montgomery that caused her to 

develop GBS. Dr. Steinman argued that the alum adjuvant could induce a cytokine response in 

the body and that these cytokines are related to the development of GBS. Dr. Whitton 

persuasively disputed this theory by pointing out that (1) Dr. Steinman did not support how large 

of a cytokine response is triggered by alum and (2) he did not explain how long the cytokine 

response lasts. Dr. Whitton explained that duration is especially important here because a release 

of cytokines is part of the innate immune system’s response, i.e., the body’s short-term immune 

 

5 Exhibit N: Gee et al., Monitoring the Safety of Quadrivalent Human Papillomavirus 

Vaccine: Findings from the Vaccine Safety Datalink, 29 Vaccine 8279-84 (2011).

6 Exhibit O: Chao et al., Surveillance of Autoimmune Conditions Following Routine Use 

of Quadrivalent Human Papillomavirus Vaccine, 271 J. Intern. Med. 193-203 (2012).

7 Exhibit Q: Vichnin et al., An Overview of Quadrivalent Human Papillomavirus Vaccine 

Safety: 2006 to 2015, 34 Pediatr. Infect. Dis. J. 983-91 (2015).
7

response. If a cytokine surge caused GBS, then it would be expected that the onset of GBS 

would be short-term, within one or two days from vaccination. However, in this case, even 

assuming the earliest onset of numbness on February 7, 2013, that onset is still 10 days after the 

vaccinations, too long after the vaccinations to implicate the innate immune system and 

cytokines. Thus, Dr. Steinman’s alum adjuvant theory does not fit with Ms. Montgomery’s 

onset. In addition, Dr. Steinman does not provide support for how the cytokine surge in his alum 

adjuvant theory would be substantial enough to trigger an immune response. See Zumwalt v. 

Sec'y of Health & Human Servs., No. 16-994V, 2019 WL 1953739, at *18 (Fed. Cl. Spec. Mstr. 

Mar. 21, 2019) (critiquing Dr. Steinman’s overly general alum adjuvant theory). 

After considering all the evidence, the undersigned finds that Ms. Montgomery has not 

established the first prong of Althen by a preponderance of the evidence. 

Althen Prong 2 - Logical Sequence of Cause and Effect

As a matter of logic, when a petitioner fails to establish that a vaccine can cause a disease 

(prong one), it follows that the petitioner cannot establish that the vaccine did cause the disease 

in this specific case (prong two). Nevertheless, the undersigned reviewed the medical records to 

see if they supported a logical sequence of cause and effect. At the May 9, 2019 pre-hearing 

status conference, the parties agreed that none of the treating doctors made any statements 

causally connecting either of the vaccinations to Ms. Montgomery’s GBS. Thus, Ms. 

Montgomery has not met her burden of proof on the second prong of Althen. 

Althen Prong 3 - Timing

For the timing prong of Althen, Ms. Montgomery is required to establish the timeframe 

for which it is medically acceptable to infer causation and when the petitioner’s onset of 

symptoms actually occurred. Shapiro v. Sec'y of Health & Human Servs., No. 99-552V, 2011 

WL 1897650, at *13 (Fed. Cl. Spec. Mstr. Apr. 27, 2011) (presenting this two-component 

articulation of the timing prong), review granted in non-relevant part, decision vacated in part, 

101 Fed. Cl. 532 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012), 

aff'd per curiam, 503 Fed. Appx. 952 (Fed. Cir. 2013). Dr. Steinman posited that GBS can 

develop in 42 days following vaccination. Exhibit 17 at 18-19. Dr. Donofrio argued for a 

shorter timeline for GBS to develop, 28 days. Exhibit Z at 5. As noted by the Secretary in his 

revised brief, Dr. Donofrio did not address onset because he was disputing the GBS diagnosis. 

Resp’t’s Rev. Br. at 16. Without a clear diagnosis, the Secretary did not believe he could address 

timing. Id. Thus, the Secretary did not dispute that the actual onset of Ms. Montgomery’s 

symptoms were within a viable time frame. 

Accordingly, if it is assumed that Ms. Montgomery suffered from GBS and if it is further 

assumed that her GBS was manifest on February 7, 2013, then Ms. Montgomery satisfied the 

timing prong. However, an appropriate temporal interval does not mean that Ms. Montgomery is 

entitled to compensation. See Grant, 956 F.2d at 1148. 

* * * * *

Even assuming that Ms. Montgomery established GBS as a diagnosis, Ms. Montgomery 

failed to meet her burden of showing that the HPV and/or Tdap vaccines can cause GBS. The
8

undersigned directs the Clerk’s Office to enter judgment based upon the decision in this case if a 

motion for review is not filed. When the time for filing a motion for review (see Vaccine Rule 

23) begins to run is for an appellate tribunal to decide. 

IT IS SO ORDERED.

s/Christian J. Moran

Christian J. Moran

Special Master