In the United States Court of Federal Claims 

OFFICE OF SPECIAL MASTERS

No. 19-969V

UNPUBLISHED

COLLEEN BLOCK,

 Petitioner,

v.

SECRETARY OF HEALTH AND 

HUMAN SERVICES,

 Respondent.

Chief Special Master Corcoran 

Filed: October 29, 2021

Special Processing Unit (SPU); OffTable Dismissal; Influenza (Flu); 

Guillain-Barré syndrome (GBS); 

Althen Prong Three; One-Day Onset; 

Adaptive Immune Response.

Lia Obata Dowd, Dowd & Dowd, P.C., St. Louis, MO, for Petitioner.

Jeremy Fugate, U.S. Department of Justice, Washington, DC, for Respondent.

ENTITLEMENT DECISION1

On July 3, 2019, Colleen Block filed a petition for compensation under the National 

Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.

2

(the “Vaccine 

Act”). Petitioner alleged that she suffered Guillain-Barré syndrome (“GBS”) as a result of 

an influenza (“flu”) vaccine administered on November 10, 2017. Petition at 1-2. The case 

was assigned to the Special Processing Unit of the Office of Special Masters (the “SPU”).

On April 26, 2021, after consideration of the medical record and other filed 

evidence, I concluded that Petitioner had experienced the onset of her alleged GBS 

1 Because this unpublished opinion contains a reasoned explanation for the action in this case, I am 

required to post it on the United States Court of Federal Claims' website in accordance with the EGovernment Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic 

Government Services). This means the opinion will be available to anyone with access to the internet.

In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or 

other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon 

review, I agree that the identified material fits within this definition, I will redact such material from public 

access. 

2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease 

of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 

300aa (2012).
2

symptoms within approximately 24 hours of vaccination – outside of the 3 to 42-day period 

prescribed for a Table flu/GBS injury – thus, constituting grounds for dismissal of that 

claim. See generally Findings of Fact and Conclusions of Law (ECF No. 25) (“Table Claim 

Dismissal”). In so doing, I also observed that Petitioner’s submission of an expert report 

from a neurologist, Dr. David Simpson, barely supported even a causation-in-fact version 

of the claim. But I noted that I would permit both sides to submit additional evidence on 

the medical acceptability of onset for a non-Table version of the claim. Table Claim 

Dismissal at 11-13.

3

Both parties have offered legal responses

4 and expert materials5 on this issue.

Having reviewed these materials in light of my prior opinion, I hereby conclude that 

Petitioner has not established by a preponderance of the evidence that the onset of GBS 

within 24 hours of receipt of the flu vaccine is medically acceptable. Therefore, she cannot

establish causation-in-fact and her non-Table claim is hereby dismissed.6

I. Evidentiary and Expert Submissions

A. Respondent’s Experts

On June 10, 2021, Respondent filed reports from two experts. The first, Norman 

Werdiger, M.D., has been employed at the Yale University School of Medicine since 1982 

and specifically as a clinical associate professor of neurology since 2006. See Werdiger 

3 My prior summary of the relevant procedural history, underlying facts, Petitioner’s expert’s first report, 

parties’ arguments, applicable legal standards, and my initial analysis concerning the feasibility of 

Petitioner’s off-Table flu/GBS claim are set forth at length in the Table Claim Dismissal, and fully 

incorporated and relied upon herein. 

4 Petitioner’s Brief filed September 1, 2020 (ECF No. 20); Respondent’s Brief filed October 30, 2020 (ECF 

No. 24). While the briefs were filed prior to the Table Claim Dismissal (and are cited therein), those briefs

address whether Petitioner has established an off-Table claim.

5 See Expert Report of David Simpson, M.D. dated September 1, 2020, filed as Ex. 13 (ECF No. 21)

(“Simpson Rep.”); Expert Report of Norman Werdiger, M.D., dated June 4, 2021, filed as Ex. A (ECF No. 

27-1) (“Werdiger Rep.”); Expert Report of Neil Romberg, M.D., dated June 10, 2021, filed as Ex. N (ECF 

No. 28-1) (“Romberg Rep.”); Supplemental Report of David Simpson, M.D., dated August 29, 2021, filed 

as Ex. 26 (ECF No. 30) (“Simpson Supp. Rep.”).

6 While this opinion discusses the elements of the record that were emphasized by the parties and that I 

found most relevant to the outcome, I have reviewed and considered the entire record, including all of the 

literature submitted by both parties. Section 13(a)(1); see also Moriarty v. Sec’y of Health & Human 

Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“we generally presume that a special master considered 

the relevant record evidence even though he does not explicitly reference such evidence in his decision”);

Simanski v. Sec’y of Health & Human Servs., 115 Fed. Cl. 407, 436 (2014) (“a special master is not 

required to discuss every piece of evidence in [his] decision”) (internal citation omitted), aff’d, 601 Fed. 

Appx. 982 (Fed. Cir. 2015). 
3

Rep. at 2. Dr. Werdiger retired his private neurology practice in August 2019 but continues 

to provide outpatient general neurological care through his affiliation at Yale. Id. In the 

past five years, he has seen or participated in the treatment of approximately ten patients 

with GBS. Id. He has not authored any publications that inform this case but based his 

opinion on a review of the relevant literature.

Respondent’s second expert, Neil Romberg, M.D., joined Yale University as a 

fellow in allergy and clinical immunology from 2008 to 2011, then served as an associate 

professor and the director of Yale’s Pediatric Immune Deficiency Clinic from 2011 to 2015.

See Romberg Rep. at 1. Since 2015, he has served as an assistant professor of pediatrics 

at the University of Pennsylvania School of Medicine and an attending physician at the 

Children’s Hospital of Philadelphia. Id. at 1-2. Dr. Romberg has focused his career on 

researching the molecular mechanisms, as well as providing appropriate treatment, for 

immunological disorders. Id. He asserted that he is aware of the classic findings as well 

as the immunological basis of GBS. Id. at 1, 5.

Respondent’s experts both take issue with an item of literature that was offered in 

connection with the submission of Petitioner’s earlier expert report (and discussed at 

length in the Table Claim Dismissal), Park. See Table Claim Dismissal at 7-8, 11-12. Drs. 

Werdiger and Romberg both note that although Park describes the South Korean 

government’s compensation of claims for post-vaccination GBS, including instances in 

which the illness purportedly manifested within two days, approximately one-third of the

total cases were not confirmed diagnostically. Additionally, approximately one-tenth of the 

cases at issue may have been caused by unrelated infections. Werdiger Rep. at 14; 

Romberg Rep. at 8. Otherwise, these experts argue, the South Korean government’s 

decision to compensate certain cases of purported GBS manifesting less than two days 

of vaccination does not establish anything with regard to causation. Werdiger Rep. at 14; 

Romberg Rep. at 8.

Respondent’s experts further discussed the pathophysiology of GBS and how that

relates to its clinical onset after a triggering event. As they explained, GBS occurs when 

a genetically susceptible individual encounters an environmental agent which causes an 

adaptive immune response, including T cells and antibodies, misdirected against specific 

targets in the peripheral nervous system. The misdirection occurs due to molecular 

mimicry between amino acid sequences on the proteins of the pathologic/presenting 

antigens and the similar sequences in the protein components of nerve structures. 

Romberg Rep. at 6; Werdiger Rep. at 12 (citing K. Sheikh, Review: Guillain-Barré 

Syndrome, 26 Continuum – Peripheral Nerve and Motor Neuron Disorders 1184 (2020), 

filed as Exhibit D (ECF No. 27-4) (“Sheikh”)).
4

Dr. Romberg opined that the time it would take for this process to result in the 

onset of GBS could not occur within one day of exposure to the precipitating 

environmental agent. Rather, the adaptive immune response is “more deliberate,” and 

will involve “a delay between exposure and onset of symptoms,” in contrast to the more 

rapid, but nonspecific, innate immune response. Romberg Rep. at 8, citing C.A. Janeway 

et al., Principles of Innate and Adaptive Immunity, in Immunobiology: The Immune 

System in Health and Disease (5th ed. 2001), filed as Exhibit X (ECF No. 28-11).

Dr. Romberg acknowledged that certain epidemiologic evidence seemed facially 

to allow for the possibility of a short onset, but he opined that this evidence was ultimately 

thin and quite limited. One such article, long cited in favor of the flu vaccine-GBS 

association, reported that a small number of GBS cases observed – 10 out of 532, or

1.8% - manif within two days of vaccination. Romberg Rep. at 7-8, citing L. Schonberger 

et al., Guillain-Barré Syndrome Following Vaccination in the National Influenza 

Immunization Program, United States, 1976 – 1977, 100 Am. J. Epidem. 105 (1979), filed 

as Ex. 19 (ECF No. 21-6) (“Schonberger”). A later meta-analysis of 23 million adverse 

events reported after flu vaccines, found only 54 instances of GBS - with 51 of them (95%) 

showing onset within two days. Romberg Rep. at 9, citing D.A. Salmon et al., Association 

Between Guillain- Barré Syndrome and Influenza A (H1N1) 2009 Monovalent Inactivated 

Vaccines in the USA: A Meta-Analysis, 381 Lancet 1461 (2013), filed as Ex. Y (ECF No. 

28-12 (“Salmon”). Importantly, neither Schonberger nor Salmon address whether the 

timing for this small minority of cases is even medically acceptable. Thus, Dr. Romberg 

maintained that these findings were inconsistent with what was well understood about 

GBS’s pathologic timeframe, as well as too minimal to be meaningful.

Dr. Werdiger agreed with the above, adding that the timeframe issue could be 

better grasped by analogizing GBS to another neurological injury also understood to be 

mediated by an adaptive immune response - acute disseminated encephalomyelitis 

(“ADEM”). Werdiger Rep. at 12, citing A. Rowhani-Rahbar et al., Review: Biologically 

Plausible and Evidence-Based Risk Intervals in Immunization Safety Research, 31 

Vaccine 271 (2012), filed as Exhibit K (ECF No. 27-11) (“Rowhani-Rahbar”). In discussing 

ADEM, Rowhani-Rahbar writes that “Some neurologic events are immune-mediated in 

which an immune response involving self-directed antibodies are autoreactive T-cells 

generated against neuronal epitopes may occur. Consideration of biologic plausibility of 

an AEFI [adverse event following immunization] would require a certain period between 

immunization and onset of symptoms.” Id. at 274 (emphasis added). While there is limited 

data existing about the shortest possible timeframe between introduction of an antigen, 

mounting of a subsequent immune response, and the onset of clinical disease, “an

interval of less than 48 h[ours] would seem to be biologically implausible.” Id. (emphasis 

added). As a result, the Centers for Disease Control and Prevention (“CDC”), upon 
5

reviewing an individual case of vaccination and ADEM, only considers a potential causal 

association when onset is beyond 48 hours. Id. Indeed, more robust epidemiological 

studies only consider causation potentially present when the onset exceeds five days. Id.

Dr. Werdiger opined that the same limitations on the timeframe between vaccination and 

GBS should apply, because of the diseases’ similar pathophysiology.

B. Dr. Simpson’s Supplemental Report

In his supplemental report,

7 Dr. Simpson discussed some of the limitations on Park 

raised by Respondent. He acknowledged that over one-third of the GBS diagnoses

discussed by Park were uncertain. Simpson Supp. Rep. at 6. But he maintained that these 

cases were nevertheless “reviewed thoroughly and concluded as having GBS by experts 

meeting.” Id. In so arguing, however, he did not address the other concern that I raised, 

and Respondent’s experts echoed – that pre-vaccination infection could not be excluded 

as a causative factor in approximately one-tenth of the total compensated flu-GBS cases

considered in Park. Dr. Simpson also suggested that South Korea’s vaccine 

compensation program “appears to have notable similarities to that employed by the US 

National Vaccine Compensation Program.” Id. However, the only discernable similarity is 

that South Korea’s program involves some degree of participation by medical experts.

Dr. Simpson went on to address issues relevant to the timeframe for an aberrant 

immune response leading to GBS. He acknowledged that the “early onset of neurological 

symptoms” following vaccination is “atypical,” but has nevertheless been reported by

other authors such as Schonberger and Salmon. Simpson Supp. Rep. at 5. He further 

opined that there is precedent for his proposed one-day timeframe, as reflected by the 

CDC’s defined risk interval of 0 – 48 hours between receipt of inactivated flu vaccine and 

febrile seizures. Simpson Supp. Rep. at 6 (citing Rowhani-Rahbar at 273). However, Dr. 

Simpson did not explain why febrile seizures, rather than ADEM, are a more useful 

analogue for GBS. And he did not dispute that GBS involves an adaptive immune 

response, in which it would take time both for the adaptive response to mount and then 

for the autoimmune attack to cause symptoms.

7 Dr. Simpson devoted several pages to addressing other points raised by Respondent’s experts, including 

whether GBS is the correct diagnosis for Petitioner’s injury and whether her injury was more likely caused 

by a preceding diarrheal illness. Simpson Supp. Rep. at 2-5. I have reviewed both parties’ positions on 

those issues, but find them unnecessary to resolve, in light of the dispositive onset issue which is discussed 

above.
6

II. Legal Standard for Althen Prong Three 

As previously noted, a temporal association alone between vaccination and 

disease onset “does not suffice to show a causal link” between the two. Table Claim 

Dismissal at 11 (quoting Grant v. Sec'y of Health & Human Servs., 956 F.2d 1144, 1148 

(Fed. Cir. 1992)). Rather, under the third prong set by the Federal Circuit in Althen v. 

Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005), a petitioner is required 

to establish a “proximate temporal relationship” between the vaccination and the injury

alleged. Althen, 418 F.3d at 1281 (emphasis added). That relationship must ultimately be

“medically acceptable.” Id.

To establish this prong, a petitioner must offer “preponderant proof that the onset 

of symptoms occurred within a timeframe which, given the medical understanding of the 

disorder's etiology, it is medically acceptable to infer causation.” De Bazan v. Sec’y of 

Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what 

is a medically acceptable timeframe must align with the theory of how the relevant vaccine 

can cause an injury (Althen prong one's requirement). Id. at 1352; Shapiro v. Sec’y of 

Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 

Fed. Cl. 353 (2012), aff'd mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of 

Health & Human Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 

2013, mot. for rev. denied (Fed. Cl. Dec. 3, 2013), aff'd, 773 F.3d 1329 (Fed. Cir. 2014).

III. Analysis

Over a year ago, I warned Petitioner that (even despite the fact that within the 

Vaccine Program, GBS is widely understood to be associated with flu vaccine), a GBS 

onset within 24 hours of receipt of flu vaccine would likely thwart even an off-Table claim. 

Order to Show Cause (ECF No. 18) (citing Rowan v. Sec’y of Health & Human Servs., 

No. 17-760V, 2020 WL 2954954 (Fed. Cl. Spec. Mstr. April 28, 2020) (finding that GBS 

is known to be mediated by autoantibodies produced via the adaptive immune system, 

and this process, if vaccine-induced, likely takes longer than three days to result in 

symptoms). Then, in dismissing Petitioner’s Table claim, I noted that her expert’s first

report and supporting literature (chiefly the Park article) “would, if unrebutted, barely 

support entitlement,” but that the short timing was still an area of significant risk that would 

likely prove to be dispositive. Table Claim Dismissal at 12-13. Respondent has now filed 

rebuttal evidence on this point, which Petitioner has not overcome.

Petitioner’s argument continues to rely solely on one item of evidence - the Park 

article – to support a one-day onset for GBS after the flu vaccine. But as Respondent’s 

experts have established, Park is not entitled to great weight for the reliability of its 
7

medical findings. Over one-third of the cases (18/48, or 37.5%) considered by Park met 

only the “lowest level” of diagnostic certainty for GBS, because of incompatible or 

insufficient testing. Park at 1158. Thus, it cannot be presumed that all cases at issue, 

whatever the onset, were in fact GBS. Park does not explain why the South Korean 

government decided to accept the claimed diagnosis in those cases, and Park in fact 

emphasizes that “complete treatment and testing results need to be obtained” to properly 

evaluate the incidence of GBS following vaccination. Id. at 1158-59. Dr. Simpson has only 

added that South Korea’s program appears to include some degree of medical review, 

but he has not addressed the standard for compensation8 or who makes the final 

determination.

9

Most importantly, Petitioner has not preponderantly established that from an 

immunologic standpoint, GBS could acceptably begin in so short a timeframe. On this 

subject, Dr. Simpson was not persuasive. Notwithstanding his general medical education 

and expertise treating neurological disorders including GBS,10 Dr. Simpson lacks the 

requisite immunological background to credibly support the short timeframe. It is 

reasonable for me to give less weight to his opinion, given his reduced expertise regarding 

this critical question. See Rowan, 2020 WL 2954954 at *18 ( “despite his overall 

testimonial qualifications, [the petitioner’s expert] cannot point to any personal research 

or direct expertise on the question of the timeframe for vaccine-induced GBS onset”).

Dr. Simpson demonstrated his lack of immunological expertise upon attempting to 

analogize the onset of post-vaccine GBS to that of post-vaccine febrile seizures. Simpson 

Supp. Rep. at 6 (citing Rowhani-Rahbar at 273). The two simply are not comparable, for 

(as discussed in many prior decisions) the theory of vaccine-induced seizure involves an 

aberrant innate immune response, generating fever and (subsequently) seizure. See 

Caredio v. Sec’y of Health & Human Servs., No., 2021 WL 4100294, at *30 (Fed. Cl. 

Spec. Mstr. July 30, 2021) (citing Ginn v. Sec’y of Health & Human Servs., No. 16-1466V, 

2021 WL 1558342 (Fed. Cl. Spec. Mstr. Mar. 26, 2021)); Tembenis v. Sec’y of Health & 

8 Y. Choe and G. Bae, Review: Management of Vaccine Safety in Korea, 2 Clin. Exp. Vaccine Res. 40, 44 

(2013), available at https://pubmed.ncbi.nlm.nih.gov/23596589/ (providing that South Korea provides for 

compensation in cases where vaccine causation is “definite, probable, or possible,” as defined by the World 

Health Organization) (emphasis added).

9 R. Mungwira et al., Research Article: Global Landscape Analysis of No-Fault Compensation Programmes 

for Vaccine Injuries: A Review and Survey of Implementing Countries, 15 PLOS ONE e0233334, 7 (2020), 

available at https://doi.org./10/1371/journalpone.02333334 (discussing that some countries have “purely 

administrative programs” overseen by medical experts, compared to other countries, such as the United 

States, in which “the final decision on compensation is made by legal experts.”).

10 See also Q.P. v. Sec’y of Health & Human Servs., No. 15-449V, 2019 WL 4013436 (Fed. Cl. Spec. Mstr. 

July 29, 2019) (finding that Dr. Simpson’s limited experience in the Vaccine Program, his work as an expert 

neurologist merited $500.00 per hour).
8

Human Servs., No. 03-820V, 2010 WL 5164324, at *15-16 (Fed. Cl. Spec. Mstr. Nov. 29, 

2010). This can in fact occur rapidly (since the innate response begins occurring closein-time to a vaccine’s administration) - and thus is inapposite to GBS, which (despite its 

acute and monophasic course once it becomes clinically evident) “involves the more 

deliberate adaptive immune system rather than just the rapid actions of innate immune 

cells.” Romberg Rep. at 8.

Respondent’s experts, by contrast, more persuasively opined that the 

understanding of immunologic processes that mediate and drive GBS likely do not occur 

so quickly after a triggering event. Upon introduction of the foreign pathogen (or vaccine 

antigen), it takes several days for the activation of the adaptive immune response and the 

production of antibodies, followed by any autoimmune attack on the peripheral nervous 

system and resulting clinical manifestations. Romberg Rep. at 6; Werdiger Rep. at 12; 

see also Rowan, 2020 WL 2954954, at *17 (citing Forrest v. Sec’y of Health & Human 

Servs., No. 14-1016V, 2019 WL 925495, at *6 (Fed. Cl. Spec. Mstr. Jan. 28, 2019) 

(explaining that these lag and “log” phases are sequential)).

As a final point, I am resolving Petitioner's claim on the papers rather than via 

hearing. The Vaccine Act and Rules not only contemplate but encourage special masters 

to decide petitions on the papers where (in the exercise of their discretion) they conclude 

that doing so will properly and fairly resolve the case. Section 12(d)(2)(D); Vaccine Rule 

8(d). The decision to rule on the record in lieu of hearing has been affirmed on appeal. 

Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020); 

see also v. Hooker Sec’y of Health & Human Servs., No. 02-472V, 2016 WL 3456435, at 

*21 n. 19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special 

masters decided case on the papers in lieu of hearing and that decision was upheld). I 

am simply not required to hold a hearing in every matter, no matter the preferences of the 

parties. Hovey v. Sec'y of Health & Hum. Servs., 38 Fed. Cl. 3 97, 402-03 (1997) 

(determining that special master acted within his discretion in denying evidentiary 

hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health & Human Servs., No. 90-882V, 

1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991).

Here, Ms. Block has long been made aware that the issue of the timing in her case 

was likely to be dispositive, directed to my prior rulings on this point, and given several 

opportunities to provide evidence to support a different result (such as unique 

circumstances, a more qualified expert, or medical literature supporting an evolving 

understanding of the immune response that manifests in GBS). She has not done so.
9

Conclusion

Petitioner has not established that the onset of GBS within one day of a flu vaccine 

is medically acceptable under Althen prong three. Therefore, she cannot establish 

causation-in-fact, and her off-Table claim must be dismissed. In the absence of a timelyfiled motion for review (see Appendix B to the Rules of the Court), the Clerk shall enter 

judgment in accordance with this decision.11

IT IS SO ORDERED.

s/Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

11 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice 

renouncing their right to seek review.