Harlow v. Secretary of Health and Human Services ( 2023 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
**********************
DUSTIN HARLOW, *
* No. 20-550V
Petitioner, *
* Special Master Christian J. Moran
*
v. *
* Filed: November 13, 2023
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
**********************
Edward Kraus, Kraus Law Group, LLC, Chicago, IL, for Petitioner;
Sarah Black Rifkin, United States Dep’t of Justice, Washington, D.C., for
Respondent.
PUBLISHED DECISION DENYING COMPENSATION 1
Dustin Harlow alleges that an influenza (“flu”) vaccine caused him to
develop a rare condition affecting his face, Melkersson-Rosenthal syndrome
(“MRS”). The Secretary disputes this claim. The parties developed their positions
by submitting reports from doctors retained for this litigation and by arguing their
cases through legal memoranda.
1 Because this Decision contains a reasoned explanation for the action taken in this case,
it must be made publicly accessible and will be posted on the United States Court of Federal
Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal
Management and Promotion of Electronic Government Services). This means the Decision will
be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the
parties have 14 days to identify and move to redact medical or other information, the disclosure
of which would constitute an unwarranted invasion of privacy. Any changes will appear in the
document posted on the website.
As explained below, Mr. Harlow is not entitled to compensation. He has not
established with preponderant evidence a theory by which the flu vaccine can
cause MRS. Thus, his case is DENIED.
I. Background about MRS
Clinical manifestations of MRS include “oro-facial swelling, relapsing facial
palsy and fissured tongue." Exhibit 14 (Mauro Cancian et al., “Melkersson-
Rosenthal syndrome: a case report of a rare disease with overlapping features,” 15
Allergy Asthma Clin Immunol 1 (2019)) at 2.
The incidence has been estimated to occur in 0.08% of the general
population. Id. at 3. “Onset of this disease is more frequent in young adults,
between the second and the third decades of life." Id.; accord Exhibit 15 (Ruozhuo
Liu & Shengyuan Yu, “Melkersson-Rosenthal syndrome: a review of seven
patients,” 20 Journal of Clinical Neuroscience 993 (2013)) at 994.
“The etiology of MRS is controversial, and various theories regarding its
underlying mechanisms have been proposed. Both genetic and acquired causes,
including underlying infection and immunologic insult, have been postulated." Id.
at 994. For an article proposing a genetic basis, see Exhibit C (E. Smeets et al.,
“Melkersson-Rosenthal syndrome and de novo autosomal t(9;2l)(p11;p11)
translocation,” 45 Clin. Genet. 323 (1994)).
II. Facts 2
In 2017, at the age of 31, Mr. Harlow was serving in the Air Force reserve.
In this context, he received a tuberculosis skin test on June 2, 2017 and a flu
vaccine on June 3, 2017. Exhibit 2 at 1.
Two days after receiving the flu vaccine, Mr. Harlow developed swelling of
his bottom lip and right eyelid. Exhibit 6 at 2 (record created on June 22, 2017).
Mr. Harlow initially sought treatment at a Walgreen’s urgent clinic. Exhibit 12 at
1-5 (June 17, 2017).
2 The parties do not dispute the relevant events in Mr. Harlow’s medical history. Order
for Briefs, issued April 5, 2022, at 4. For this reason and because the outcome does not depend
upon Mr. Harlow’s disease course, the facts are presented summarily. For a more detailed
account, see Pet’r’s Br., filed June 21, 2022, at 1-6, and Resp’t’s Br., filed Aug. 22, 2022, at 2-7.
2
When the problems persisted, Mr. Harlow sought treatment at an emergency
room. The doctor prescribed antibiotics and directed Mr. Harlow to seek care from
an ophthalmologist and an ears, nose and throat (“ENT”) specialist. Exhibit 6 at 6.
The ENT specialist prescribed a steroid medication and ordered a CT scan.
Exhibit 5 at 7. The CT scan showed some soft tissue swelling and a mildly
enlarged lymph node. Exhibit 6 at 10.
At the Scott Air Force Base, Paul Hirner, who identified himself as a
healthcare professional, submitted information to the Vaccine Adverse Event
Reporting Service (VAERS) on July 8, 2017. Mr. Hirner communicated that two
days after Mr. Harlow’s June 3, 2017 flu vaccine, he developed facial swelling and
a stye. Exhibit 1 at 3-7.
Mr. Harlow, eventually, was seen by a doctor who specializes in allergy and
immunology, Patrick Win. Based upon information available to Dr. Win, he
proposed that Mr. Harlow might suffer from MRS. Exhibit 8 at 7. Although Mr.
Harlow told Dr. Win his symptoms started after a flu vaccine, Dr. Win stated:
“This is unlikely related to his recent influenza vaccine.” Id. at 1, 7.
A punch biopsy of Mr. Harlow’s lip was performed on September 6, 2017.
The results revealed granulomatosis mucositis. Exhibit 7 at 29-30; Exhibit 3 at 9.
A dermatologist at Washington University, Rebecca Chibnall, saw Mr.
Harlow on October 20, 2017. In the history Dr. Chibnall obtained, Mr. Harlow
communicated that his symptoms started after a flu vaccine. Dr. Chibnall
suspected that Mr. Harlow was suffering from MRS. Exhibit 7 at 37. Dr. Chibnall
did not comment, affirmatively or negatively, on Mr. Harlow’s statement linking
the flu vaccine with his condition. Id. at 35-37.
After Dr. Chibnall’s diagnosis of MRS, most of the remaining medical
records chart the ups and downs of Mr. Harlow’s disease course. As such, these
medical records generally do not affect a determination of whether the June 3,
2017 flu vaccination caused Mr. Harlow’s MRS. However, a few records do bear
on the analysis of causation.
Mr. Harlow informed a physician’s assistant in the allergy and immunology
clinic, Erica Young, that the flu vaccine preceded his swelling. Thus, Mr. Harlow
was “now avoiding” vaccinations. Exhibit 9 at 23. Ms. Young did not concur with
or disagree with Mr. Harlow’s statement. See id.3
Upon referral from Dr. Chibnall, an ophthalmologist, Dr. Couch, saw Mr.
Harlow. The consultation report lists flu vaccine as an allergy. Exhibit 7 at 31
(April 26, 2018).
Due to an increase in swelling, representing a possible regression in Mr.
Harlow’s MRS, he returned to see Dr. Chibnall on October 16, 2018. Dr. Chibnall
stated that Mr. Harlow was “unable to receive [the] flu shot since this likely
precipitated his condition. Discussed extensively that he needs to try to have
everyone else immunized around him for herd immunity.” Exhibit 7 at 7.
The medical records submitted in this case do not extend beyond January
2020. See Pet’r’s Br. at 6; Resp’t’s Br. at 7. Via an affidavit, Mr. Harlow testified
that he continues to experience paralysis of his facial nerves. Exhibit 17 at 3. The
Air Force has deemed that he is “undeployable.” Exhibit 55; Exhibit 56.
III. Procedural History
The procedural history is relatively straightforward and non-eventful. Mr.
Harlow initiated this case by filing his petition on May 4, 2020. He identified
treating doctors supporting his claim via a status report filed on August 27, 2020.
After reviewing this information, the Secretary determined that
compensation should be denied. Resp’t’s Rep., filed Jan. 4, 2021. The Secretary
maintained that Mr. Harlow “has not offered an expert report or expert opinion.”
Id. at 7.
Mr. Harlow submitted a report from the doctor whom he retained, Eric
Gershwin, on January 15, 2021. Exhibit 20. The parties discussed this report in a
January 22, 2021 status conference and Mr. Harlow was ordered to obtain a
supplemental report from Dr. Gershwin because Dr. Gershwin’s first report did not
discuss timing. Dr. Gershwin filled that gap in another report, Exhibit 34, filed on
February 22, 2021.
The Secretary responded to the reports from Dr. Gershwin by filing a report
from Jonathan Miner, a rheumatologist. Dr. Miner agreed that Mr. Harlow
suffered from MRS. Dr. Miner indicated that while MRS often has a genetic basis,
Mr. Harlow was not tested for any genetic abnormalities. Exhibit A.
The Secretary was given an opportunity to seek genetic testing. Order,
issued May 14, 2021. The Secretary declined. Resp’t’s Status Rep., filed June 14,
2021.
4
The parties exchanged additional reports from their experts. See Exhibit 38
(Dr. Gershwin’s report, filed July 27, 2021); Exhibit J (Dr. Miner’s report, filed
Nov. 29, 2021); Exhibit 44 (Dr. Gershwin’s report, filed Dec. 21, 2021); Exhibit L
(Dr. Miner’s report, filed Feb. 9, 2022).
The parties were directed to support their positions through briefs. Order,
issued Apr. 5, 2022. This order alerted the parties that the case might be resolved
without a hearing. The parties submitted their briefs.
As to whether a hearing was needed, the parties differed to a degree. Mr.
Harlow requested an opportunity to present oral testimony from Dr. Gershwin and
to cross-examine Dr. Miner. Pet’r’s Br. at 25-26. The Secretary did not specify
whether the case should be resolved without a hearing. The Secretary suggested
that if a hearing were held, then each party should be allowed to elicit direct
testimony from the doctors whom they retained. Resp’t’s Br. at 21.
Whether an evidentiary hearing should be held is a question within the
discretion of special masters. 42 U.S.C. § 300aa-12(d)(3)(B)(v) (promulgated as
Vaccine Rule 8(c) & (d)), which was cited by the Federal Circuit in Kreizenbeck v.
Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1365 (Fed. Cir. 2018). The key
question is whether the parties have enjoyed a full and fair opportunity to present
their cases.
Here, Mr. Harlow has had a fair and full opportunity to present his case.
After Dr. Gershwin presented his initial opinion, Dr. Miner critiqued it.
Throughout the pendency of the case, Mr. Harlow was provided multiple
opportunities to present expert reports to show that the flu vaccination caused his
MRS. Mr. Harlow submitted supplemental expert reports from Dr. Gershwin. The
medical theory, proposed by Dr. Gershwin, was not persuasive enough to link Mr.
Harlow’s MRS to the flu vaccine. Therefore, a hearing is not needed to resolve
these issues.
IV. Standards for Adjudication
A petitioner is required to establish his case by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of
Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
5
omitted). Proof of medical certainty is not required. Bunting v. Sec’y of Health &
Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed.
Cir. 2009) (reversing special master’s decision that petitioners were not entitled to
compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357(Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed.
Cir. 1993) (disagreeing with dissenting judge’s contention that the special master
confused preponderance of the evidence with medical certainty).
In a case, such as this, in which petitioners are not seeking compensation for
an injury listed on the Vaccine Injury Table, petitioners must establish the vaccine
was the cause-in-fact of his injury. Petitioners bear a burden “to show by
preponderant evidence that the vaccination brought about [the vaccinee’s] injury
by providing: (1) a medical theory causally connecting the vaccination and the
injury; (2) a logical sequence of cause and effect showing that the vaccination was
the reason for the injury; and (3) a showing of a proximate temporal relationship
between vaccination and injury.” Althen v. Sec’y of Health & Hum. Servs., 418
F.3d 1274, 1278 (Fed. Cir. 2005).
V. Analysis
Of the three Althen prongs, the most critical is the first prong, which
concerns a theory. Because the lack of proof regarding one Althen prong renders
the analysis of other elements moot, the remaining two prongs are discussed only
briefly. See Hibbard v. Sec’y of Health & Hum. Servs., 698 F.3d 1355, 1365 (Fed.
Cir. 2012); Holmes v. Sec’y of Health & Hum. Servs., 115 Fed. Cl. 469, 488
(2014); Vaughan v. Sec’y of Health & Hum. Servs., 107 Fed. Cl. 212, 222 (2012).
A. Althen Prong One
A petitioner must establish a “a medical theory causally connecting the
vaccination and the injury.” Althen, 418 F.3d at 1278.
1. Mr. Harlow’s Evidence and Contentions
Citing Dr. Gershwin’s first report (Exhibit 20), Mr. Harlow maintains that
the flu vaccine “triggered an innate immune response that, by virtue of a genetic
homing defect in chemokine receptors in his facial tissue, caused immune cells to
traffic to the affected tissue and trigger a breach in immune homeostasis leading to
6
a persistent autoinflammatory condition known as Melkersson-Rosenthal
syndrome.” Pet’r’s Br. at 10. This theory necessarily involves a series of steps.
Initially, the person who eventually develops MRS due to a flu vaccine must
be an individual “with a genetic defect in chemokine homing in the facial tissues."
Pet’r’s Br. at 10. Mr. Harlow concedes that in MRS “the specific genetic defect
has not been identified.” Id.The second step is that a person receives the flu vaccine. The flu vaccine
initiates a response from the immune system.
The immediate response from the immune system includes the release of
proinflammatory cytokines and chemokines. Exhibit 22 (Caroline Hervé et al.,
“The How’s and What’s of Vaccine Reactogenicity,” 4 NPJ Vaccines 39 (2019)) at
2. Chemokines are “chemotactic cytokines that control the migration and
positioning of immune cells in tissues and are critical for the function of the innate
immune system.” Exhibit 29 (Caroline Sokol & Andrew Luster, “The Chemokine
System in Innate Immunity,” (2015)) at 1, quoted in Pet’r’s Br. at 14. Chemokines
“recruit innate immune effectors out of the circulation and into the tissue where, in
collaboration with other chemoattractants, they guide these cells to the very sites of
tissue injury.” Id. According to Mr. Harlow and Dr. Gershwin, during this
inflammatory stage, “non-antigen specific immune cells in the blood become
activated by the vaccination and contribute to innate immune cell activity.” Pet’r’s
Br. at 11-12, citing Exhibit 20 (Dr. Gershwin’s first report) at 7. 3
Next, in Dr. Gershwin’s theory, the chemokines home throughout facial
tissues. There, the chemokines attract immune cells that cause granulomatosis.
Pet’r’s Br. at 13-14. 4 Granulomatosis inflammation is often detected in biopsies
from people with MRS. Exhibit 27 (Wolfgang Zimmer et al., “Orofacial
manifestations of Melkersson-Rosenthal syndrome, A study of 42 patients and
3 Although Mr. Harlow sometimes describes this process as “bystander activation,” this
terminology may not be accurate. In an article Mr. Harlow cites (Pet’r’s Br. at 12), “bystander
activation . . . is characterized by auto-reactive B and T cells.” Exhibit 23 (Yovana Pacheco et
al., “Bystander activation and autoimmunity,” 103 J. Autoimmun. 1 (2019)) at 1. However, Dr.
Gershwin’s theory does not involve B cells or T cells.
4 Dr. Gershwin mentioned “trained” innate immunity. Exhibit 20 at 5, 16. In contrast,
Dr. Miner disputed Dr. Gershwin’s use of this concept. Exhibit J at 2. Resolution of this issue is
not required as “the concept of trained immunity is not an essential factor to understand how the
flu vaccine is capable of triggering MRS in a susceptible host.” Pet’r’s Br. at 15; accord Pet’r’s
Reply at 4.
7
review of 220 cases from the literature,” 74 Oral Surg Oral Med Oral Pathol. 610
(1992)) at 614, 616.
For evidence that this theory could explain how a flu vaccine can cause
MRS, Dr. Gershwin largely compared MRS to other autoinflammatory conditions.
See Pet’r’s Br. at 25-26 (MRS is an “autoinflammatory disorder with a
pathogenesis understood by analogy with other more common disorders”); see also
id. at 8, 10; Pet’r’s Reply at 2. Analogies were required because MRS is such a
rare disease such that its etiology “is not well understood.” Pet’r’s Br. at 8.
Mr. Harlow and Dr. Gershwin acknowledged that no epidemiological study
has detected an increased incidence in MRS after flu vaccination. This lack of
evidence does not matter because, in Dr. Gershwin’s view, the only valid
epidemiological study would involve only participants with a known genetic
predisposition to developing MRS. Pet’r’s Br. at 16, 24; see also Exhibit 38 at 1.
Furthermore, Mr. Harlow and Dr. Gershwin concede that they have not presented
any case reports presenting a sequence of events in which a flu vaccination
preceded the onset of MRS. In their view, the typical delay in diagnosis prevents
doctors from identifying any suspected triggers for MRS. Pet’r’s Br. at 15-16.
2. The Secretary’s Evidence and Contentions
Through Dr. Miner, the Secretary argued that Mr. Harlow’s evidence
regarding the proposed theory was not adequate. Resp’t’s Br. at 10-13. The
Secretary emphasizes that Mr. Harlow has identified neither epidemiologic studies
nor a single case report connecting the flu vaccine to MRS. Resp’t’s Br. at 12. Dr.
Miner focuses on the lack of case reports:
Even though MRS is rare, the administration of influenza
vaccines is common. If there were a strong association
between a common event (influenza vaccination) and this
rare event (onset of MRS), then we would at least expect
to see a series of case reports in the medical literature.
Indeed, in families genetically predisposed to MRS, we
might expect to observe disease onset after vaccination at
least in some people in some of those families, but no
such thing has been reported despite hundreds of cases.
Exhibit J at 1-2, quoted in Resp’t’s Br. at 12.
Otherwise, the Secretary points out that MRS has a genetic component and
Dr. Gershwin “admits that petitioner would have likely developed MRS at some
8
point, regardless of vaccination.” Resp’t’s Br. at 13, citing Exhibit 20 at 5. The
Secretary concludes this section of his brief with the statement “Dr. Gershwin has
failed to offer any evidence beyond a temporal association.” Resp’t’s Br. at 13. 5
3. Assessment
To demonstrate the reliability of Dr. Gershwin’s opinion, Mr. Harlow faces
an uphill climb because, as he admits, the etiology of MRS “is not well
understood.” Pet’r’s Br. at 8. Dr. Gershwin has not identified any medical articles
that present any useful information about why anyone develops MRS. Thus, it is
not surprising that this case lacks any medical articles on the narrower question as
to why a recipient of the flu vaccine could develop MRS. Although literature is
not required, Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir.
2005), “a scientific theory that lacks any empirical support will have limited
persuasive force.” Caves v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 119, 134
(2011), aff’d without opinion, 463 F. App’x 932 (Fed. Cir. 2012).
The spectrum of literature about MRS is extremely limited. Mr. Harlow’s
exhibit list identifies five distinct articles with “Melkersson-Rosenthal” in the
title. 6 The Secretary adds three other articles.
Ideas about the causes of MRS are similarly incomplete and undeveloped.
The authors of a 2011 article reporting two cases stated that “It is very hard to
correlate MRS to a specific etiologic agent and possibly it should be classified as
autoinflammatory disorder. Autoinflammatory disorders are characterized by
recurrent episodes of inflammation in the absence of pathogens, autoantibodies or
antigen specific T cells.” Exhibit 25 (Estela Kaminagakura & Jacks Jorge Jr.,
“Melkersson Rosenthal syndrome: a histopathologic mystery and dermatologic
challenge,” 38 J Cutan Pathol 241 (2011)) at 243.
The authors of a 2019 case report suggested that their subject’s MRS was
“probably triggered by a recent viral infection characterized by facial blistering."
Exhibit 14 (Mauro Cancian et al., “Melkersson-Rosenthal syndrome: a case report
of a rare disease with overlapping features,” 15 Allergy Asthma Clin Immunol 1
(2019)) at 5. Authors of another case report identified an instance of a parvovirus
infection preceding the onset of MRS. Exhibit D (A. De Maria et al.,
“Melkersson–Rosenthal syndrome associated with parvovirus b19 viraemia and
5 This statement overlooks the medical articles Dr. Gershwin cited.
6 Exhibit 14 is repeated as exhibit 43 and exhibit 15 is repeated as exhibit 26.
9
haemophagocytic lymphohistiocytosis,” 34 Clin and Experimental Dermatology
e623 (2009)).
A 2018 medical literature review, identifying more than 200 cases of MRS,
concluded that MRS is “an etiological obscure disease.” Exhibit 49 (Goetz Wehl
& Markus Rauchenzauner, “A Systematic Review of the Literature of the Three
Related Disease Entities Cheilitis Granulomatosa, Orofacial Granulomatosis and
Melkersson-Rosenthal Syndrome,” 14 Current Pediatric Review 196) at 196. They
added, “The etiology of MRS is only partly understood with genetic factors,
chronic infectious diseases, allergic reactions, and abnormalities of autoimmune
mechanisms as possible contributors.” Id. at 200. None of the approximately ten
articles in the record have identified any vaccine as a potential cause for MRS.
Against this background, Dr. Gershwin’s opinion does not carry Mr.
Harlow’s burden of proof. See Dycke v. Sec’y of Health & Hum. Servs., No. 18-
106V, 2023 WL 4310701 at *25 (Fed. Cl. Spec. Mstr. June 7, 2023) (not crediting
a theory Dr. Gershwin offered because, in part, “none of the medical literature filed
has identified any known cause of [giant cell arteritis]”). In essence, Dr. Gershwin
has proposed a theory in which the flu vaccine prompts the production of a specific
type of cytokine, chemokines, and the chemokines provoke other aspects of the
immune system to cause a disease.
Special masters have generally, although not universally, found theories
based upon cytokines unpersuasive. See Giesbrecht v. Sec’y of Health & Hum.
Servs., No. 16-1338V, 2023 WL 2721578, at *7 (Fed. Cl. Spec. Mstr. Feb. 8,
2023) (citing cases). As one special master explained, a petitioner’s expert starts
with one supported step (vaccines induce cytokines) and then leaps to an
unsupported step (cytokines are harmful):
Dr. Gershwin’s contentions about cytokine response to
vaccination, as bulwarked by reliable literature like
Chatziandreou, were medically and scientifically sound.
But he has outlined a theory in which the normal
cytokine upregulation anticipated by vaccination (and
even desired, as part of the vaccine’s efficacy) becomes
aberrant and damaging—without offering the evidence
needed to gauge even partly how this would actually
occur, and what impact it would have (whether on a
healthy person or one susceptible to autoimmune injury,
as is posited here). The fact that the initial/innate
response to vaccination transiently causes increased
10
cytokine levels (a fact that can easily be substantiated by
science, as studies often reveal) does not imply an
aberrant reaction ensues—and it cannot be assumed this
has occurred in a petitioner’s case, based solely on the
subsequent injury.
Putman v. Sec’y of Health & Hum. Servs., No. 19-1921V, 2022 WL 600417, at
*21 (Fed. Cl. Spec. Mstr. Jan. 31, 2022). In a case involving Dr. Gershwin,
another special master stated, “given the ubiquitous nature of cytokines in the
body, it cannot be enough to simply say ‘cytokines did it.’” Rupert v. Sec’y of
Health & Hum. Servs., No. 15-841V, 2021 WL 1832909, at *40 (Fed. Cl. Spec.
Mstr. May 1, 2021).
Here, Dr. Gershwin’s opinion appears even weaker than his opinions that
were rejected in Giesbrecht, Putman, and Rupert. Part of this weakness is due to
the lack of information about MRS generally. But, Mr. Harlow cannot use the lack
of knowledge as a justification for lowering his burden of proof. “The standard of
proof does not operate as a sliding scale that varies depending upon the quantity
and quality of the scientific evidence that is available.” Caves, 100 Fed. Cl. at 143.
Accordingly, Mr. Harlow’s evidence regarding Althen prong one falls short.
Based upon this finding, he is not entitled to compensation.
B. Althen Prong Two
This element requires “a logical sequence of cause and effect showing that
the vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. The
opinions of treating doctors can be quite probative. Cappizano v. Sec’y of Health
& Hum. Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006).
Here, the views of the treating doctors are mixed. The most evidentiary
valuable statements come from Dr. Win and Dr. Chibnall.7 The immunologist who
7 Two other mentions, Mr. Paul Hirner and Dr. Couch, carry less significance. Paul
Hirner submitted a VAERS report. Exhibit 1 at 3-7. However, whether Mr. Hirner has any
medical training is not clear and the report was submitted before Mr. Harlow was diagnosed with
MRS.
The notation of flu vaccine as an allergy in the record of the ophthalmologist, Dr. Couch,
could simply reflect information that Mr. Harlow provided to Dr. Couch. See Solak v. Sec’y of
Health & Hum. Servs., No. 14-869V, 2020 WL 9173158, at *33 (Fed. Cl. Spec. Mstr. Feb. 19,
2020) (noting that a treating doctor apparently wrote a “letter on the history of prior reaction that
Petitioner provided to him. . . I do not find it to be compelling evidence that Petitioner had an
adverse reaction to her prior flu vaccines”); Pearson v. Sec’y of Health & Hum. Servs., No. 17-
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first raised the possibility of MRS (Dr. Win) stated that “This is unlikely related to
his recent influenza vaccine.” Exhibit 8 at 7. On the other hand, after Dr. Chibnall
treated Mr. Harlow for approximately one year, she stated that the “flu shot . . .
likely precipitated his condition.” Exhibit 7 at 7.
If Mr. Harlow had met his burden regarding Althen prong one, then deciding
Althen prong two would be challenging as the evidence seems nearly balanced.
However, as a logical matter, the finding that a petitioner has not established that a
vaccine can cause an injury necessarily implies that the vaccine did not cause the
injury. See Temes v. Sec’y of Health & Hum. Servs., 151 Fed. Cl. 448, 464
(2020) (“the special master appropriately considered the lack of evidentiary
support for [petitioner’s] theory of causation to analyze whether there was
sufficient evidence to establish a logical sequence of a cause and effect showing
that the vaccines at issue were the reason for [the petitioner’s] injury”); Caves, 100
Fed. Cl. at 145 (2011).
Thus, neither an affirmative nor negative finding is made regarding Althen
prong two.
C. Althen Prong Three
The timing prong actually contains two parts. A petitioner must show the
“timeframe for which it is medically acceptable to infer causation” and the onset of
the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101
Fed. Cl. 532, 542-43 (2011), recons. denied after remand on other grounds, 105
Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013). The
medically acceptable timeframe depends, at least in part, on the theory being
offered. Langland v. Sec’y of Health & Hum. Servs., 109 Fed. Cl. 421, 443
(2013).
Here, Mr. Harlow proposes that “the medically accepted timeframe for
development of an autoinflammatory condition following a challenge to the innate
immune system is between 1-3 days.” Pet’r’s Br. at 20, citing Exhibit 35 (Lisa
Christian et al., “Serum Proinflammatory Cytokine Responses to Influenza Virus
Vaccine among Women during Pregnancy Versus Non-Pregnancy,” 70(1) Am J
Reprod Immunol. (2013)) [hereinafter Christian]. Mr. Harlow further points out
489V, 2019 WL 1150044, at *1 (Fed. Cl. Spec. Mstr. Feb. 7, 2019) (the “substantiation for some
of these preexisting allergies comes from records in which [petitioner] provided medical histories
to treaters, rather than from independent medical confirmation”).
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that he developed swelling in his lip and eyelid two days after the vaccination, and,
therefore fits the expected timeframe.
The Secretary argues that because Mr. Harlow has not presented a reliable
theory, he cannot show an appropriate temporal relationship “as there is not
expected timeframe to use as a measuring stick.” Resp’t’s Br. at 16.
The evidence on this point is relatively thin. The one article that Mr. Harlow
cited measured the amount of cytokines after flu vaccination produced by pregnant
women and non-pregnant women. Exhibit 35 (Christian). While a male, like Mr.
Harlow, might be roughly comparable to a non-pregnant woman in terms of the
cytokines he produced in response to the flu vaccine, the Christian article shows
how quickly some cytokines are produced after a vaccination and how long they
persisted. The production of cytokines, however, is not the final step in Dr.
Gershwin’s theory. After the cytokines (or chemokines) travel to the face, the
cytokines recruit other components of the immune system to produce swelling,
which can characterize MRS. See Pet’r’s Br. at 12-13. Mr. Harlow has not
identified any evidence that indicates the harm caused by adverse reaction
mediated through the innate immune system happens within three days of the
vaccination. This gap in evidence could be construed as a failure on Mr. Harlow’s
part to satisfy his burden regarding timing.
Whether Mr. Harlow meets his burden is, ultimately, an academic point.
Even if his condition arose within a medically appropriate time, proof on this one
element would not entitle him to compensation. See Grant v. Sec’y of Health &
Hum. Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992) (“Temporal association is not
sufficient, however, to establish causation in fact.”). A successful showing
regarding causation-in-fact requires Mr. Harlow establish a theory. As set forth
above, the evidence regarding the theory was inadequate.
VI. Conclusion
Mr. Harlow’s development of symptoms of what was eventually diagnosed
as MRS within three days of his receipt of a flu vaccine has led Mr. Harlow to
contend that the flu vaccine caused his MRS. In this litigation, Mr. Harlow
retained an expert who supported Mr. Harlow’s claim. However, the expert’s
opinion was not persuasive for the reasons set out above. Therefore, Mr. Harlow is
not entitled to compensation.
The Clerk’s Office is instructed to enter judgment in accord with this
decision unless a motion for review is filed. Information about filing a motion for
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review, including the deadline, can be found in the Vaccine Rules, which are
available on the website for the Court of Federal Claims.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
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