Court Opinion

ID: 4546764
Source: CourtListenerOpinion
Date Created: 2020-07-08 16:01:50.605459+00
Date Added: 2024-06-11T12:50:04.803359
License: Public Domain

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

      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.
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

                                            2
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.
                                              3
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.
                                              4
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).

                                             5
       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
                                               6
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).

                                              7
             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
                                              8
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

                                              9
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 &
                                                10
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
                                            11
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.

                                            12
      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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