In the United States Court of Federal Claims 

OFFICE OF SPECIAL MASTERS

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

MARIE BROWN, *

* No. 18-786V

Petitioner, * Special Master Christian J. Moran

*

v. *

* Filed: May 8, 2020

SECRETARY OF HEALTH *

AND HUMAN SERVICES, * Guillain-Barré syndrome (“GBS), 

* alternative factor, infection,

Respondent. * surgery, statistics

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

Leah V. Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for 

petitioner; 

Linda S. Renzi, United States Dep’t of Justice, Washington, DC, for respondent. 

RULING FINDING ENTITLEMENT TO COMPENSATION1

Marie Brown alleges that within 42 days of receiving an influenza (flu) 

vaccination she developed a serious disease of her peripheral nervous system, 

Guillain-Barré syndrome (GBS). The Secretary agrees with this allegation, and, 

typically, this agreement would result in a finding that Ms. Brown is entitled to 

compensation because the Vaccine Injury Table associates flu vaccination with 

GBS that arises within 3-42 days of the vaccination. But, relying upon the reports 

of two experts, the Secretary has proposed alternative causes, a significant 

 

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 (http://www.cofc.uscourts.gov/aggregator/

sources/7). This posting will make the decision 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

infection and an operation Ms. Brown underwent approximately six weeks before 

she began to suffer from GBS. 

Ms. Brown and the Secretary have filed briefs regarding the proposed 

alternative causes. Although the Secretary has demonstrated that an infection and 

an operation can cause GBS, the Secretary has not met his burden of establishing, 

by preponderant evidence, that either the infection or the operation did cause Ms. 

Brown’s GBS. Therefore, Ms. Brown is entitled to compensation. 

I. Medical and Procedural History

A. Medical History

Ms. Brown was born in 1955. Exhibit 21 (affidavit) ¶ 1. For more than 30 

years, she taught in public schools before retiring in 2008. Id. ¶ 5. In 2015, she 

was independent, capable of driving, shopping, dancing, and attending football 

games. Id. ¶ 2. 

On May 30, 2015, Ms. Brown sought assistance at a local emergency room, 

complaining of 5-6 days of abdominal pain with constipation. When the pain 

became too intense to tolerate, Ms. Brown went to the emergency room. Exhibit 2 

at 169. She underwent an exploratory laparotomy. During this operation, the 

doctors removed an ovarian mass and she had a sigmoid resection. Ms. Brown 

was in septic shock and to maintain her blood pressure during the operation, the 

doctors gave her vasopressors and fluids. Id. at 176. The doctors left Ms. Brown’s 

abdomen open for approximately two days. Id. at 168 (discharge report). Then, 

the doctors returned Ms. Brown to surgery for washout and closure. Id. at 173-74. 

Ms. Brown’s hospitalization lasted until June 6, 2015. While recovering, 

Ms. Brown’s bowel function, diet, and level of activity improved. Id. at 168 

(discharge report). 

One day before leaving the hospital, Ms. Brown received two vaccines, the 

flu vaccine and the pneumococcal 13-valent vaccine. Exhibit 1 at 1. The flu 

vaccine is the basis of Ms. Brown’s petition. 

After discharge, Ms. Brown did well for a few weeks. However, around 

July 8, 2015, she stopped having output from her ostomy with intermittent 

abdominal pain. In addition, she experienced numbness in her hands and feet 

bilaterally. She, therefore, went to the emergency room on July 11, 2015. Exhibit 
3

2 at 151. After an examination and work-up, the doctor discharged her home. Id.

at 152. 

Two days later, July 13, 2015, Ms. Brown returned to the emergency room 

because she was not feeling better and was still experiencing pain and nausea. She 

was admitted to the hospital. Id. at 26 (emergency room report). 

During this July 2015 admission, a neurologist saw Ms. Brown. Ms. Brown 

told the neurologist that when she was admitted on July 13, 2015, she was weak in 

her lower extremities. Over the course of her hospitalization, she started to 

develop tingling of her lower extremities. After an examination, the neurologist 

diagnosed Ms. Brown as suffering from GBS. The neurologist ordered, among 

other things, plasma exchange. Id. at 37-39. 

This hospitalization lasted until August 4, 2015. When she was discharged, 

Ms. Brown was weak and lacked reflexes. Id. at 45-46. Upon leaving the hospital, 

she went to a long-term rehabilitation facility, where she stayed for approximately 

one month. Exhibit 3. 

Ms. Brown continued to follow up with neurologists for her GBS. In 

December 2015, she reported that she was experiencing less pain and she could 

walk well with a walker. Exhibit 11 at 11. On March 21, 2017, approximately 20 

months after Ms. Brown began to experience GBS, she saw a physician’s assistant

at her neurologist’s office. Ms. Brown sought clearance for an operation to treat a 

compression fracture in her spine. Exhibit 6 at 27. Her strength in her upper 

extremities was 5/5 and 4/5 in both lower extremities. Id. at 24. 

Ms. Brown had the operation, a lumbar kyphoplasty, for her compression 

fracture on April 4, 2017. Exhibit 2 at 246-47. While she was referred for 

neurosurgery for foraminal stenosis at L5/S1 and central canal stenosis at L1, she 

deferred the surgery because her lower extremity weakness from GBS was better. 

Exhibit 6 at 27. 

The most recent medical record appears to be from May 2018. She reported 

back pain, balance problems, and a burning sensation in her feet and fingers. 

Exhibit 12 at 5. 

B. Procedural History

The procedural history starts when the medical history ends. Ms. Brown 

filed her petition on June 4, 2018, alleging an on-Table case of flu vaccine—GBS. 
4

Pet. ¶ 4. The case was originally placed in the Special Processing Unit. Ms. 

Brown filed medical records periodically and her statement of completion on 

September 3, 2018. 

Approximately 11 months later, the Secretary completed his review of the 

medical reports and presented his evaluation. Resp’t’s Rep., filed Aug. 9, 2019. 

The Secretary conceded one aspect of the case, stating Ms. Brown “alleges that she 

suffered GBS within the Table time period set forth in vaccine Table for the flu 

vaccine, and the records support that allegation.” Id. at 6. 

The Secretary, however, declined to recommend that Ms. Brown was 

entitled to compensation. In the Secretary’s view, Ms. Brown’s GBS “was more 

likely than not caused by her severe abdominal infection and surgery, unrelated to 

the administration of her vaccinations.” Id. at 7. The Secretary based his view on 

a report from a neurologist whom he retained for litigation, Dara Jamieson. 

Dr. Jamieson opined that Ms. Brown met the diagnostic criteria for GBS. 

Exhibit A at 7. But, Dr. Jamieson asserted that “Given the lack of causative 

correlation between current influenza vaccination, and given the known causative 

correlation between both infections and surgery and the triggering of GBS, it is my 

opinion that Mrs. Brown’s GBS was likely triggered by her prior overwhelming 

gastrointestinal infection and her extensive surgeries.” Id.

Dr. Jamieson detailed the basis for her opinion. She stated that “GBS is 

often a post-infectious disorder . . . with two-thirds of patients reporting preceding 

respiratory or gastrointestinal symptoms within 4 weeks of the onset of weakness, 

usually by 10 to 14 days after the infection.” Id. at 8. Dr. Jamieson continued, 

“While the triggering linkage with prior surgery is less robust than with 

gastrointestinal or respiratory infections, recent surgical procedures have been 

shown to increase the risk of GBS, with the possibility of a combined synergistic 

effect of infections and surgery.” Id. at 9 (citing Yang and Rudent). Finally, Dr. 

Jamieson reached flu vaccinations. She recognized an increased incidence of GBS 

following the influenza A / H1N1 program in 1976. But, “Subsequent 

epidemiological studies of the incidence of GBS after influenza vaccination found 

slight to no increase in GBS risk with vaccination, depending on the type of 

vaccine and the method of analysis.” Id. at 9-10. 

After the filing of the Secretary’s report and Dr. Jamieson’s report, this case 

was transferred out of the Special Processing Unit. Order, issued Sept. 6, 2019. In 

the undersigned’s first status conference, Ms. Brown contended that Dr. 
5

Jamieson’s report should be struck from the record because her opinion relied on 

statistical information to choose surgery over vaccinations as the causative agent. 

The Secretary was directed to clarify various aspects of Dr. Jamieson’s opinion. 

Order, issued Oct. 11, 2019. 

Ms. Brown developed and slightly modified her argument in a five-page 

motion for ruling on the record. Ms. Brown contended that “Respondent’s defense 

of this Table case is legally impermissible. Dr. Jamieson’s opinion is based on 

statistical evidence specifically forbidden by the Court of Appeals for the Federal 

Circuit.” Pet’r’s Mot., filed Oct. 14, 2019, at 2 (citing Knudsen v. Sec’y of Health 

& Human Servs., 35 F.3d 543 (Fed. Cir. 1994)). 

Because Dr. Jamieson was already preparing a supplemental report in 

response to the October 11, 2019 order, the Secretary was instructed to file both 

her supplemental report and response to the motion for ruling on the record by 

November 25, 2019. Order, issued Oct. 31, 2019. 

On the deadline, the Secretary filed a motion to amend the schedule in three 

respects. Ms. Brown’s position regarding the requests was ambiguous. 

Regardless, the Secretary was permitted a short amount of additional time to file a 

supplemental report from Dr. Jamieson. The Secretary was allowed a longer 

amount of time to file a report from an immunologist. Lastly, the Secretary’s 

deadline for responding to the motion for ruling on the record was extended until 

14 days after the immunologist’s report was filed. Order, issued Dec. 2, 2019. 

The Secretary complied with the deadlines for his experts’ reports. The 

Secretary filed a supplemental report from Dr. Jamieson on December 16, 2019. 

Exhibit C. The Secretary also filed a report from an immunologist, Dr. Kedl, on 

January 9, 2020. Exhibit D. 

With respect to the pending motion for ruling on the record, the Secretary 

again requested additional time to file a response. Resp’t’s Mot., filed Jan. 23, 

2020. The Secretary was given a limited amount of time because the motion to 

which the Secretary was responding was only five pages and had been pending 

since October 14, 2019. The Secretary was also restricted to filing any additional 

motions for enlargement to times that corresponded to the amount of time being 

requested. For example, if the Secretary was requesting one week of additional 

time, the Secretary was required to file that motion for enlargement of time one 

week in advance. Order, issued Jan. 28, 2020 (setting deadline of Feb. 14, 2020). 
6

On February 7, 2020, the Secretary asked that the deadline for responding to 

the October 14, 2019 motion for ruling on the record be extended from February 

14, 2020 to April 7, 2020. The Secretary proposed that the parties engage in 

settlement discussions. However, Ms. Brown opposed this enlargement. Because 

Ms. Brown opposed the enlargement and because the Secretary had extended the 

deadline for responding many times previously, the Secretary’s motion was denied. 

Order, issued Feb. 10, 2020. 

The Secretary filed a response to Ms. Brown’s motion for ruling on the 

record on February 14, 2020. The Secretary argued that he “through his experts, 

has established by preponderant evidence that petitioner’s GBS was likely caused 

by a factor unrelated to her vaccination.” Resp’t’s Resp. at 6. The Secretary also 

“disagree[d] that the evidence relied upon by his experts is the type of bare 

statistical evidence rejected in Knudsen.” Id. at 7. 

After submitting two motions for enlargements of time, Ms. Brown filed a 

reply. Her motion for a ruling on the record is ready for adjudication. 

II. Vaccine Injury Table and Alternative Factors

In enacting the Vaccine Act that included a Vaccine Injury Table, Congress 

turned on its head the maxim “post hoc ergo propter hoc.” Shalala v. Whitecotton, 

514 U.S. 268, 270 (1995). When a petitioner establishes that she “sustained . . . 

any illness . . . set forth in the Vaccine Injury Table in association with [a] vaccine, 

. . . and the first symptom . . . of the onset . . . of any such illness . . . occurred 

within the time period after the vaccine administration set forth in the Vaccine 

Injury Table,” 42 U.S.C. § 300aa–11(c)(1)(C)(i), the petitioner gains a rebuttable

presumption that the vaccination caused the injury. The Secretary may rebut this 

prima facie showing by proving that the illness was in fact caused by “factors 

unrelated to the administration of the vaccine.” 42 U.S.C. § 300aa–13(a)(1)(B); 

accord Whitecotton, 514 U.S. at 270-71. 

In trying to establish a factor unrelated to the vaccination caused the injury, 

the Secretary’s burden is a “preponderance of the evidence.” Walther v. Sec’y of 

Health & Human Servs., 485 F.3d 1146, 1150 (Fed. Cir. 2007). A “preponderance 

of the evidence” is not the same as scientific certainty. Bunting v. Sec’y of Health 

& Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). 

Congress authorized the Secretary to modify the Vaccine Injury Table. 42 

U.S.C. § 300aa–14(c)(3); see also Terran v. Sec’y of Health & Human Servs., 195 
7

F.3d 1302, 1312-14 (Fed. Cir. 1999) (upholding the constitutionality of this aspect 

of the Vaccine Act). As relevant in Ms. Brown’s case, the Secretary proposed, on 

July 29, 2015, to modify the Vaccine Injury Table to link flu vaccine with GBS 

that arises in 3-42 days after vaccination. 80 Fed. Reg. 45132. The basis for this 

proposal was a set of “studies demonstrating a causal association between the 2009 

H1N1 and 1976 swine flu vaccines and GBS.” Id. at 45146. The Secretary 

recognized that “the degree of surveillance needed to detect an increased risk of 

one case per million vaccinations, as was seen with the monovalent 2009 H1N1 

vaccine, is unlikely to be routinely performed as strains in the flu vaccines change 

from year to year.” Id. The Secretary reasoned, “Although the scientific evidence 

does not show a causal association for current formulations of seasonal flu 

vaccines and GBS,” a modification to the Table was “in accordance with the 

ACCV Guiding Principles.” Id.

The Secretary announced he adopted this proposed modification on January 

19, 2017. 82 Fed. Reg. 6294. But, this adoption was delayed and became effective 

on March 21, 2017. 82 Fed. Reg. 11321. The flu vaccine—GBS link continues to 

be on the Vaccine Table today, and the Secretary has not proposed any 

modifications to the Vaccine Table to remove this link.

III. Analysis

Ms. Brown grounds her motion for ruling on the record on the argument that 

the Secretary’s experts are using statistical information improperly. In their 

briefing, the parties have identified three cases that discuss statistical information 

in the Vaccine Program. These are discussed in section A below. Following that 

discussion, section B below evaluates the opinions Dr. Jamieson and Dr. Kedl 

presented. 

A. Vaccine Program Precedent on Statistical Information

The parties have identified three appellate cases that discussed the use of 

statistical evidence. These are reviewed below.2

 

2 The discussion does not rely upon isolated quotes extracted from the 

decisions because the context affects the meaning of a court’s statement. BristolMyers Squibb Co. v. Teva Pharmaceuticals USA, Inc., 769 F.3d 1339, 1353 (Fed. 

Cir. 2014) (Taranto, J., dissenting from denial of a petition for rehearing en banc). 
8

1. Knudsen

In 1956, seven-month-old Debra Knudsen received her third dose of the 

diphtheria-pertussis-tetanus (“DPT”) vaccine. Later that day, she had a fever. 

That night, she woke with a high fever, troubled breathing and other more severe 

problems. Knudsen v. Sec’y of Health & Human Servs., No. 90-2067V, 1992 WL 

395631, at *1 (Fed. Cl. Spec. Mstr. Dec. 17, 1992), rev’d, 35 F.3d 543 (Fed. Cir. 

1994). 

Additional evidence demonstrated that Debra suffered an encephalopathy 

that caused life-long problems. Because this encephalopathy occurred within the 

time associated with a pertussis vaccination listed on the Vaccine Injury Table, the 

Knudsens were entitled to a rebuttable presumption that the DTP vaccine caused 

Debra’s encephalopathy. Id. at *9; see also Knudsen v. Sec’y of Health & Human 

Servs., 35 F.3d at 547 (Fed. Cir. 1994). 

The Secretary disputed the Knudsens’ right to compensation by arguing that 

Debra suffered a viral infection and this viral infection caused the encephalopathy. 

After considering Debra’s medical records as well as the testimony from doctors, 

including a doctor who treated Debra, the special master found that Debra suffered 

from a viral infection. 1992 WL 395631, at *1-9. The special master was 

persuaded, in part, by the testimony of the Secretary’s expert who had opined that 

a viral infection could explain all Debra’s symptoms. Id. at *9. The special master 

also held, as a matter of statutory interpretation, that the Secretary was not required 

to specify what type of virus infected Debra. Id. at *9-10. 

Finally, and most importantly for Ms. Brown’s case, the special master 

found that “There is a preponderance of the evidence that the encephalopathy 

Debra suffered on April 22, 1956 was caused by the viral infection.” Id. at *9. 

The special master’s reasoning was contained in two sentences. “Here, the experts 

agreed that the pertussis vaccine encephalopathy is a rarer event than viral 

encephalitis.” And, “Because viral infection is a more likely cause of the injury 

Debra suffered than DPT vaccine, having found that Debra suffered from a viral 

infection in April 1956, it is appropriate to conclude that it is more likely that 

Debra's encephalopathy was caused by the viral infection than by the DPT 

vaccine.” Id. Thus, the special master concluded that the Knudsens were not 

entitled to compensation. 

After a review by the Court of Federal Claims, the Knudsens brought their 

case to the Federal Circuit. It appears that on appeal, the parties did not challenge 
9

the finding of fact that Debra suffered a viral infection. While the Knudsens did 

contest the holding that the Secretary was not required to identify the type of virus, 

the Federal Circuit affirmed the special master’s holding. 35 F.3d at 548. This 

point was preliminary to the Federal Circuit’s examination of the special master’s 

finding regarding causation. 

The Federal Circuit characterized the appeal as raising “the question of what 

evidence is relevant to determining under the Vaccine Act that a condition or 

injury is unrelated to administration of the DTP vaccine, a question of law which 

we review de novo.” 35 F.3d at 547. The Federal Circuit “reject[ed] the 

government's argument, which again was relied on in the special master's decision, 

that evidence that there are more occurrences of encephalopathies caused by viral 

infections than there are encephalopathies caused by DTP vaccines is relevant.” 

The Federal Circuit explained: “The bare statistical fact that there are more 

reported cases of viral encephalopathies than there are reported cases of DTP 

encephalopathies is not evidence that in a particular case an encephalopathy 

following a DTP vaccination was in fact caused by a viral infection present in the 

child and not caused by the DTP vaccine.” Id. at 550. The Federal Circuit, then, 

looked at the remaining evidence. “This conflicting record evidence does not in 

our view either compel a finding of viral alternative causation nor preclude one. If 

the evidence is seen in equipoise, then the government has failed in its burden of 

persuasion and compensation must be awarded.” Id. Consequently, the Federal 

Circuit vacated the judgment, which had denied compensation, and remanded the 

matter back to the special master. 

2. Hart 

In the second case the parties identify as discussing statistics, Emma Hart, as 

the representative of the estate of her daughter, Manasseh Miclea, alleged that a 

measles-mumps-rubella vaccination caused Manasseh to suffer a disease known as 

hemophagocytic lymphohistiocytosis, abbreviated HLH. HLH is a disease that 

“seem[s] to be ‘triggered’ by some stimulus such as infection.” Hart v. Sec’y of 

Health & Human Servs., No. 01-357V, 2003 WL 23218077, at *2 (Fed. Cl. Spec. 

Mstr. Nov. 24, 2003), mot. for rev. granted, 60 Fed. Cl. 598 (2004). The special 

master, preliminarily, gave some credit to the theory that the MMR vaccine, which 

contains attenuated (live) viruses, could be the source of an infection that triggers 

HLH. Id. at *3. However, the special master declined to find that the MMR 

vaccine triggered Manasseh’s HLH because the Secretary presented evidence that 

persuaded the special master that an Epstein Barr viral infection caused 
10

Manasseh’s HLH. While conflicts in the evidence made the special master’s 

decision “difficult,” the special master ultimately found that Manasseh suffered 

from an active Epstein Barr infection. Id. at *4-8. 

Between the two potential causes—the MMR vaccine and the Epstein Barr 

virus, the special master found that the Epstein Barr virus was more likely the 

cause because it “has been identified as by far the most common trigger for HLH.” 

Id. at *4. The special master also ruled that Knudsen’s commentary about the use 

of “bare statistical” evidence was distinguishable in that Knudsen’s comments 

came in the context of an on-Table case. Because Ms. Hart was claiming an offTable injury, the special master “conclude[d] that the approach [he] used in 

analyzing the evidence concerning the Epstein-Barr virus in this case is not 

contrary to the Knudsen decision.” Id. at *11. The special master, thus, found that 

Ms. Hart was not entitled to compensation. 

Ms. Hart filed a motion for review. The “primary thrust [of Ms. Hart’s 

motion] [was] that the Special Master erred in relying on statistical evidence to 

conclude that EBV, rather than the MMR vaccine, was the most likely cause of 

Manasseh’s HLH. According to petitioner, this reliance on statistics flies in the 

face of Knudsen.” Hart v. Sec’y of Health & Human Servs., 60 Fed. Cl. 598, 604

(2004). To assess Ms. Hart’s argument, the Court evaluated Knudsen, cited many 

cases from disparate jurisdictions that considered probabilistic evidence, and 

referenced multiple law review articles on this topic. After this scholarly analysis, 

the Court also analyzed the studies on which the Secretary’s expert had relied. The 

Court concluded “In sum, while these studies certainly indicate that EBV can cause 

HLH, they provide no reasonable assurance that the observations extrapolated by 

[the Secretary’s expert] and others therefrom could be projected validly to the 

particular facts” of Manasseh’s case. Id. at 608. The Court elaborated, “additional 

evidence adduced must show that the probabilities expressed are extendable to the 

facts of a given case and link the so validated statistical evidence into an otherwise 

plausible chain of causation.” Id. at 609. Ultimately, the Court found that the 

Secretary’s evidence could not support the weight the special master had given it, 

vacated the special master’s decision, and remanded for additional consideration. 

Id. at 610. 

3. Holmes

In rebuttal, the Secretary relies on a case that resolved James Holmes’s claim 

that a tetanus and diphtheria (“Td”) vaccination caused him to suffer epilepsy. Mr. 

Holmes had received the Td vaccination at age 14. Holmes v. Sec’y of Health & 
11

Human Servs., 08-185V, 2011 WL 2600612, at *1 (Fed. Cl. Spec. Mstr. Apr. 26, 

2011). To support his claim, Mr. Holmes presented an opinion from Marcel 

Kinsbourne, a no-longer practicing neurologist. The Secretary retained Shlomo 

Shinnar, a practicing neurologist. Id. at *2 & n.9. 

The special master concluded, “This case was more a rout than a ‘battle of 

the experts.’ Most of the ‘facts’ upon which Dr. Kinsbourne relied were not 

established; he either misread or misinterpreted the medical records.” Id. at *20. 

In connection with the statistical information relevant to the issue in Ms. Brown’s 

case, the special master stated, “Based on James’ age and the lack of any febrile 

illness, I find the studies showing an increased risk of seizure disorders after 

complex febrile seizures are simply not relevant to his case.” Id. This finding, in 

turn, was based upon research showing that “in the studies of febrile seizures, 99% 

of the children were below seven years of age.” Id. at *17. Thus, for all these 

reasons, the special master denied compensation. 

Mr. Holmes filed a motion for review. One argument was that the special 

master wrongly relied upon statistical information. Holmes v. Sec'y of Health & 

Human Servs., 115 Fed. Cl. 469, 482 (2014). The Court rejected that argument, 

stating “the statistics to which petitioner objects are relevant to determining 

whether a Td vaccination could ever be considered the cause of an adolescent’s 

febrile seizures. The evidence that febrile seizures were not only phenomena of 

infancy and childhood but moreover were predominantly suffered by the very 

young has an obvious bearing on whether they could be the result of a vaccination 

administered to someone outside that age group.” Id. at 486. Consequently, the 

Court denied the motion for review. 

B. Reports from the Secretary’s Experts

These precedents guide the evaluation of the reports from Dr. Jamieson and 

Dr. Kedl. Dr. Jamieson wrote two reports, exhibits A and C. Dr. Kedl wrote one, 

exhibit D. 

While Dr. Jamieson offers infection and surgery as causes for GBS, she has 

not proposed any theory explaining how infection or surgery leads to GBS. 

Instead, her opinion rests upon epidemiologic studies. Exhibit A at 9; exhibit C at 

2. In preferring infection and surgery over flu vaccination as the cause for Ms. 

Brown’s GBS, Dr. Jamieson stated “the GBS risk with associated influenza 

vaccination is much less common, indicating a much more tenuous association 

than with infection and surgery.” Exhibit C at 2. She added “[t]he difference in 
12

the strengths of the linkage of the events indicate that it was the combination of 

surgery and infection, not vaccination that was the trigger for Mrs. Brown’s GBS.” 

Id.

Most of Dr. Kedl’s report focuses on presenting the opinion that “Any 

connection between vaccination and Mrs. Brown’s GBS lacks reliable 

epidemiological, medical and scientific support.” Exhibit D at 6. To support this 

opinion, he cites many studies, most of them published after 2013. Some of these 

studies evaluated the risk of GBS after seasonal flu vaccine. Other studies 

evaluated the risk of GBS after the H1N1 flu vaccine. Id. at 3-5. 

Dr. Kedl also discusses epidemiological studies that have detected an 

increased risk of GBS after infections, particularly Campylobacter jejuni. Id. at 4. 

Dr. Kedl “conclude[s] therefore that the fecal matter in Mrs. Brown’s abdominal 

cavity and ensuing life-threatening infection and septic shock, concomitant with 

her ovarian and adrenal masses and subsequent radical gynecological and 

gastrointestinal surgery, are considerably more than likely to have been the cause 

of her GBS than by any possible inflammatory consequences derived from her flu 

vaccine.” Id. at 6. 

Much of Dr. Kedl’s opinion is not relevant. While Dr. Kedl may hold the 

opinion that (seasonal) flu vaccination does not increase the incidence of GBS, the 

Secretary has created a rule that eliminates any need for Ms. Brown to present 

evidence about how a flu vaccination can cause GBS. Cf. Summar v. Sec’y of

Health & Human Servs., 24 Cl. Ct. 440, 443 (1991) (noting while whether 

diphtheria-tetanus-pertussis vaccine can cause a brain injury “may be a 

controversial question in the medical community, for this forum the question was 

already decided by Congress when it enacted the Vaccine Program”). 

Dr. Kedl and Dr. Jamieson both opine that infections and surgeries can cause 

GBS. On their surfaces, each opinion seems at least plausible. Thus, for sake of 

argument, the undersigned assumes that the Secretary has successfully established, 

through opinions supported by epidemiological studies, that infections and 

surgeries can cause GBS. See Pet’r’s Reply, filed Apr. 20, 2020, at 6 (“Petitioner 

does not contest that petitioner experienced sepsis or that she underwent surgery, 

and that both of these things can be associated with GBS.”). This use of 

epidemiological studies is consistent with the comment in Holmes, 115 Fed. Cl. at 

486, that statistical evidence can be used to show whether something (in Holmes, a 

vaccine, and here, an infection or a surgery) can ever cause a disease. 
13

Establishing an infection or a surgery can cause GBS is only one step in the 

Secretary’s overall burden. The Secretary must also establish, by preponderant 

evidence, that the infection or surgery did cause Ms. Brown’s GBS. 

On this point, the opinions from Dr. Kedl and Dr. Jamieson resemble the 

opinions rejected in Knudsen and Hart. In both cases, the vaccine could have 

caused the injury. In both cases, the Secretary retained an expert who opined that a 

viral infection (unspecified in Knudsen and the Epstein-Barr virus in Hart) was the 

more likely cause. In both cases, the basic reasoning was that viral infections more 

frequently cause the injury than vaccines. 

Dr. Kedl and Dr. Jamieson have essentially presented the same reasoning. 

See exhibit C at 2 (Dr. Jamieson: incidence of flu vaccination causing GBS is 

“much less common”); exhibit D at 3 (Dr. Kedl: describing the issue as whether 

“GBS as documented in the scientific literature is more commonly associated with 

infections or with vaccination”). 

Neither Dr. Kedl nor Dr. Jamieson have presented opinions that could 

support a finding in the Secretary’s favor. Thus, Ms. Brown’s motion for ruling on 

entitlement is GRANTED. She is entitled to compensation. 

While Ms. Brown is entitled to compensation, this ruling does not specify 

the extent of compensation. Dr. Jamieson opined that Ms. Brown “has had [an] 

excellent recovery from GBS with documentation of normal motor, sensory, 

coordination, reflex and gait examinations by approximately a year after the 

diagnosis.” Exhibit A at 10. In the damages phase of the case, Ms. Brown will be 

given an opportunity to connect her more recent problems to GBS. 

A separate order to guide the parties in quantifying the amount of 

compensation to which Ms. Brown is entitled will issue shortly. 

IT IS SO ORDERED.

s/Christian J. Moran

Christian J. Moran

Special Master