Brown v. Secretary of Health and Human Services

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 COMPENSATION 1

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

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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.

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

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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.

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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.

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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).

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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

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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. Bristol-

Myers 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).

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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

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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

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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 off-

Table 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 &

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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

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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.

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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

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