McCollum v. Hhs ( 2019 )

NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
MICHAEL MCCOLLUM,
Petitioner-Appellant
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee
______________________
2018-1623
______________________
Appeal from the United States Court of Federal Claims
in No. 1:14-vv-00790-LAS, Senior Judge Loren A. Smith.
______________________
Decided: February 25, 2019
______________________
RICHARD GAGE, Richard Gage, PC, Cheyenne, WY, ar-
gued for petitioner-appellant.
ROBERT PAUL COLEMAN, III, Vaccine/Torts Branch,
Civil Division, United States Department of Justice, Wash-
ington, DC, argued for respondent-appellee. Also repre-
sented by ALEXIS B. BABCOCK, C. SALVATORE D'ALESSIO,
GABRIELLE M. FIELDING, CATHARINE E. REEVES, JOSEPH H.
HUNT.
______________________
2 MCCOLLUM v. HHS
Before HUGHES, SCHALL, and STOLL, Circuit Judges.
SCHALL, Circuit Judge.
DECISION
Michael McCollum appeals the decision of the United
States Court of Federal Claims in McCollum v. Secretary of
Health & Human Services, 135 Fed. Cl. 735 (Dec. 21, 2017)
(“McCollum III”). In that decision, the Court of Federal
Claims denied Mr. McCollum’s motion for review of the de-
cision of the special master denying his claim under the
National Childhood Vaccine Injury Act of 1986, 42 U.S.C.
§§ 300aa-1 to -34, as amended (“Vaccine Act”), for compen-
sation for narcolepsy. See McCollum v. Sec’y of Health &
Human Servs., No. 14-790V, 2017 WL 5386613 (Fed. Cl.
Sept. 15, 2017) (“McCollum I”); see also McCollum v. Sec’y
of Health & Human Servs., No. 14-790V, Doc. 49 (Oct. 12,
2017) (denying reconsideration) (“McCollum II”). We af-
firm.
DISCUSSION
I.
Under the Vaccine Act, a petitioner seeking compensa-
tion may prove causation in one of two ways, depending
upon whether the case involves a “Table injury” or an “off-
Table injury.” See Moberly v. Sec’y of Health & Human
Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010). If the admin-
istered vaccine and injury are listed in the Vaccine Injury
Table, and the injury manifests itself within the specified
time period, a petitioner receives a presumption of a causal
link between the vaccination and the injury. See de Bazan
v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1351
(Fed. Cir. 2008); see also 42 U.S.C. § 300aa-11(c)(1)(C)(i)
(not requiring a showing of causation for a Table injury).
However, for an injury not listed in the Table, or for an in-
jury which does not occur within the specified time period,
a petitioner seeking compensation must prove causation in
MCCOLLUM v. HHS 3
fact. See de Bazan, 539 F.3d at 1351; see also 42 U.S.C.
§ 300aa-11(c)(1)(C)(ii) (requiring a showing of causation for
an off-Table injury). This appeal involves an off-Table in-
jury.
A petitioner asserting an off-Table injury must file an
affidavit and supporting documentation demonstrating
that the vaccine-related injury for which compensation is
sought was caused by a vaccine. Cloer v. Sec’y of Health &
Human Servs., 654 F.3d 1322, 1331 (Fed. Cir. 2011) (en
banc). Causation must be proved by a preponderance of the
evidence. See 42 U.S.C. § 300aa-13(a)(1) (“Compensation
shall be awarded . . . to a petitioner if the special master or
court finds . . . (A) that the petitioner has demonstrated by
a preponderance of the evidence the matters required in
the petition.”). When a petitioner claims to have suffered
an off-Table injury, we apply the test for causation in fact
outlined in Althen v. Secretary of Health & Human Ser-
vices, 418 F.3d 1274 (Fed. Cir. 2005):
[The petitioner’s] burden is to show by preponder-
ant evidence that the vaccination brought about
[his or] her 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 relation-
ship between vaccination and injury.
418 F.3d at 1278.
II.
On August 29, 2014, Mr. McCollum filed a petition for
compensation under the Vaccine Act, alleging that he suf-
fered from narcolepsy as the result of an influenza vaccina-
tion he received in the fall of 2011. In McCollum I, the
special master denied Mr. McCollum’s claim. 2017 WL
5386613, at *23. Weighing the evidence, the special master
found that Mr. McCollum had “not offered preponderant
4 MCCOLLUM v. HHS
reliable medical and scientific evidence sufficient to satisfy
the first Althen prong.” Id. at *19. The special master thus
concluded that Mr. McCollum had failed to satisfy the re-
quirement of providing a medical theory causally connect-
ing the vaccination he received and his injury. Addressing
the second Althen prong, the special master found that Mr.
McCollum likely did receive an influenza vaccination in the
fall of 2011. Id. at **19-20. The special master also found
that, “given the ambiguity of the evidence purportedly
showing [sleep problems relating to a variety of preexisting
interrelated illnesses and medical problems,]” he could not
conclude that Mr. McCollum’s narcolepsy “more likely than
not predated his receipt of the flu vaccine.” Id. at *21. The
special master nevertheless concluded that Mr.
McCollum’s “failure to establish a persuasive causal theory
[with respect to the vaccine he received] ultimately
doom[ed]” his showing with respect to Althen prong two.
Id. “Because the unadjuvanted H1N1 vaccine Mr.
McCollum likely received has not been shown to cause nar-
colepsy,” the special master wrote, “it does not matter how
consistent Petitioner’s arguments are with the causation
theory proposed but rejected.” Id. Finally, turning to the
third prong of Althen, the special master stated that “the
deficiencies in [Mr. McCollum’s] causation theory ma[d]e it
impossible for him to establish that onset of his narcolepsy
was temporally reasonable.” Id. at *22. The special master
stated that, “[a]bsent more compelling proof that the ver-
sion of the H1N1 vaccine in question administered in the
U.S. can cause narcolepsy, I cannot conclude that the pro-
posed timeframe herein has preponderant support.” Id.
After the special master denied his motion for reconsid-
eration, see McCollum II, Mr. McCollum moved for review.
The Court of Federal Claims denied the motion. See
McCollum III. Mr. McCollum now appeals. We have juris-
diction pursuant to 42 U.S.C. § 300aa-12(f).
MCCOLLUM v. HHS 5
III.
We review de novo decisions of the Court of Federal
Claims arising under the Vaccine Act, applying the same
standard as the Court of Federal Claims applied in its re-
view of the special master’s decision. Porter v. Sec’y of
Health & Human Servs., 663 F.3d 1242, 1248-49 (Fed. Cir.
2011). We owe no deference to the Court of Federal Claims
or the special master on questions of law. Andreu v. Sec’y
of Health & Human Servs., 569 F.3d 1367, 1373 (Fed. Cir.
2009). At the same time, we uphold the special master’s
findings of fact unless they are arbitrary or capricious. Por-
ter, 663 F.3d at 1249 (citing Broekelschen v. Sec’y of Health
& Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010)).
“Thus, although we are reviewing as a matter of law the
decision of the [Court of Federal Claims] under a non-def-
erential standard, we are in effect reviewing the decision of
the special master under the deferential arbitrary and ca-
pricious standard on factual issues.” Lombardi v. Sec’y of
Health & Human Servs., 656 F.3d 1343, 1350 (Fed. Cir.
2011) (quoting Lampe v. Sec’y of Health & Human Servs.,
219 F.3d 1357, 1369 (Fed. Cir. 2000)).
The arbitrary and capricious standard affords a fact
finder considerable deference. Under that standard, “[i]f
the special master has considered the relevant evidence of
record, drawn plausible inferences, and articulated a ra-
tional basis for the decision, ‘reversible error will be ex-
tremely difficult to demonstrate.’” Hazlehurst v. Sec’y of
Health & Human Servs., 604 F.3d 1343, 1349 (Fed. Cir.
2010) (quoting Hines v. Sec’y of Health and Human Servs.,
940 F.2d 1518, 1528 (Fed. Cir. 1991)). Thus, as long as a
special master’s factual finding is based upon evidence that
is “not wholly implausible, we are compelled to uphold that
finding as not being arbitrary or capricious.” Lampe, 219
F.3d at 1363.
Mr. McCollum makes two arguments on appeal. We
address them in turn.
6 MCCOLLUM v. HHS
IV.
Mr. McCollum’s first argument is that the special mas-
ter “impermissibly heightened the substantive law of what
needs to be proven under prong one of Althen.” Pet’r’s Br.
13. Mr. McCollum states that, in order to satisfy prong one,
a Vaccine Act petitioner “need only show a medically plau-
sible theory of how a vaccine theoretically can cause the
injury at issue.” Id. According to Mr. McCollum, however,
“[t]he special master erred by demanding scientific cer-
tainty.” Id.A.
Relevant to prong one of Althen, the medical theory Mr.
McCollum advanced before the special master was that in-
fluenza vaccines administered in the United States (con-
taining the H1N1 influenza strain) can provoke an
autoimmune process that (via the mechanism of molecular
mimicry) results in blockage of the hypocretin receptors in
the brain responsible for sleep regulation, thereby produc-
ing narcolepsy. McCollum I, 2017 WL 5386613, at *15.
In support of his theory, Mr. McCollum presented the
testimony of Dr. Marcel Kinsbourne. Dr. Kinsbourne
opined that the flu vaccine Mr. McCollum received caused
him to develop narcolepsy. McCollum I, 2017 WL 5386613,
at *6. Dr. Kinsbourne proposed that this occurred by way
of molecular mimicry. Id. In support of his theory, Dr.
Kinsbourne relied upon epidemiologic evidence involving
Pandemrix. Pandemrix is an inactivated, adjuvanted
H1N1 flu vaccine 1 administered in Europe and associated
1 A vaccine’s adjuvant enhances the effect of the vac-
cine’s antigen, here the H1N1 antigen, to increase the
adaptive immune response created by that antigen.
McCollum I, 2017 WL 5386613, at *7 n.18.
MCCOLLUM v. HHS 7
with a high rate of narcolepsy in a number of countries,
such as Finland. Id. at *7.
Before the special master, Mr. McCollum also pointed
to various studies and articles in the medical literature to
support his claim that his narcolepsy was the result of his
influenza vaccination. Among these were two articles by S.
Sohail Ahmed, et al.: (1) Narcolepsy, 2009 A (H1N1) Pan-
demic Influenza, and Pandemic Influenza Vaccinations:
What is Known and Unknown About the Neurological Dis-
order, the Role for Autoimmunity, and Vaccine Adjuvants,
50 J. Automimmunity 1, 7 (2014) (“Ahmed I”); and (2) An-
tibodies to Influenza Nucleoprotein Cross-React with Hu-
man Hypocretin Receptor 2, 7 Sci. Translational Med. 294
(2015) (“Ahmed II”). The Ahmed I authors proposed that
autoantibodies generated in response to a cross reaction
with the H1N1 components (via a molecular mimicry pro-
cess) contained in Pandemrix likely blocked hypocretin re-
ceptors to an extent sufficient to trigger narcolepsy in those
individuals susceptible to it. The work of Ahmed II’s au-
thors, in turn, led them to begin to suspect that the nucle-
oprotein (“NP”) antibody content of the H1N1-based flu
vaccines they studied was a more likely causal factor for
narcolepsy than the adjuvant in Pandemrix, as was previ-
ously suspected. McCollum I, 2017 WL 5386613, at *7.
Also before the special master was an observational ep-
idemiologic study filed by both Mr. McCollum and the Sec-
retary: Jonathan Duffy et al., Narcolepsy and Influenza A
(H1N1) Pandemic 2009 Vaccination in the United States,
83 Neurology 1823 (2014) (“Duffy”). Duffy’s authors stud-
ied the association between narcolepsy and the unadju-
vanted version of the H1N1 vaccine utilized in the United
States, retrospectively surveying 650,995 individuals vac-
cinated with an H1N1 strain flu vaccine in 2009. The study
failed to find an increase in narcolepsy. The Duffy authors
hypothesized that the H1N1 antigens in the version of the
vaccine they studied were themselves not sufficient to
8 MCCOLLUM v. HHS
increase the incidence of narcolepsy. McCollum I, 2017 WL
5386613, at *8.
B.
As noted above, the special master found that Mr.
McCollum had “not offered preponderant reliable medical
and scientific evidence sufficient to satisfy the first Althen
prong.” McCollum I, 2017 WL 5386613, at *19. Before
stating his findings, the special master set forth the law
pertinent to the inquiry before him:
Petitioners may satisfy the first Althen prong with-
out resort to medical literature, epidemiological
studies, demonstration of a specific mechanism, or
a generally accepted medical theory. [citing An-
dreu, 569 F.3d at 1378–79]. Special masters, de-
spite their expertise, are not empowered by statute
to conclusively resolve what are essentially thorny
scientific and medical questions, and thus scientific
evidence offered to establish Althen prong one is
viewed “not through the lens of the laboratorian,
but instead from the vantage point of the Vaccine
Act’s preponderant evidence standard.” Id. at
1380. Accordingly, special masters must take care
not to increase the burden placed on petitioners in
offering a scientific theory linking vaccine to injury.
Contreras v. Sec’y of Health & Human Servs., 121
Fed. Cl. 230, 245 (2015) (“[p]lausibility . . . in many
cases may be enough to satisfy Althen prong one”
(emphasis in original)), vacated on other grounds,
844 F.3d 1363 (Fed. Cir. 2017). But this does not
negate or reduce a petitioner’s ultimate burden to
establish his overall entitlement to damages by
preponderant evidence. W.C. v. Sec’y of Health &
Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013)
(citations omitted).
Id. at *12 (footnote omitted).
MCCOLLUM v. HHS 9
The special master began his analysis by recognizing
that “the proposition that narcolepsy is an immune-medi-
ated condition is fairly well-established” and that “the de-
crease in, or complete disappearance of, hypocretin caused
by autoantibodies produced via the mechanism of molecu-
lar mimicry likely results in a disruption in a person’s wake
cycle leading to narcolepsy.” McCollum I, 2017 WL
5386613, at *16. The special master also recognized the
literature associating narcolepsy with Pandemrix, as well
as “persuasive studies suggesting that the NP content of
Pandemrix-like versions of the flu vaccine may be an im-
portant causal factor.” Id.The special master turned next to what he regarded as
the two points upon which Mr. McCollum relied in his ar-
gument that the H1N1 vaccine that he received caused his
narcolepsy. The first point, based upon Ahmed II, was that
H1N1 flu vaccines administered in the United States dur-
ing the relevant time period contained levels of NP almost
comparable to that of Pandemrix, “allowing,” the special
master wrote, “for the conclusion that the vaccine [Mr.
McCollum] received could have the same cross-reactive ca-
pacity.” Id. at *17. The second point was that, according
to Mr. McCollum, there was reliable evidence suggesting
that the wild H1N1 virus can cause narcolepsy. In support
of this point, Mr. McCollum relied upon two articles: (1)
Fang Han, et al., Narcolepsy Onset is Seasonal and In-
creased Following the 2009 H1N1 Pandemic in China, 70
Am Neurological Ass’n 410, 410-17 (2011); and (2) Fang
Han, et al., Genome-Wide Analysis of Narcolepsy in China
Implicates Novel Immune Loci and Reveals Change in As-
sociation Prior to Versus after the 2009 H1N1 Influenza
Pandemic, 9 PLOS Genetics, no. 10, (2013). Id. at **8, 17.
As far as the first point was concerned, the special mas-
ter noted that there were “limits to the conclusiveness of
the Ahmed II findings about NP content.” McCollum I,
2017 WL 5386613, at *17. The special master also noted
that, “while Ahmed II shifts the focus on the likely primary
10 MCCOLLUM v. HHS
cause of narcolepsy away from the adjuvants contained in
the Pandemrix-like vaccines, it does not wholly eliminate
the adjuvant as possibly playing an important role (thus
reducing the applicability of its findings to the proposed
causal effects of unadjuvanted vaccines).” Id. Addressing
the second point, the special master concluded that, in view
of inconsistencies in the Han findings and the circum-
stances unique to the countries studied, “[t]he findings in
Han and similar articles may . . . only establish that the
development of narcolepsy requires a confluence of factors
(an H1N1 vaccine containing an adjuvant, coupled with an
ongoing pandemic involving the wild virus) – strengthen-
ing the conclusion that the capacity of the vaccine’s NP con-
tent to spark narcolepsy still requires other boosting
factors if it is to occur.” Id.The most important consideration for the special mas-
ter, however, was Duffy, which the special master regarded
as “the sole relevant epidemiologic evidence regarding the
impact of the version of the H1N1 flu vaccine administered
in the [United States].” McCollum I, 2017 WL 5386613, at
*17. The special master noted that Duffy involved forms of
flu vaccine administered in the United States (unadju-
vanted H1N1 flu vaccines), but yet Duffy observed no in-
crease in the occurrence of narcolepsy after receipt of the
vaccine by thousands of individuals. The special master
noted that, in a prior case, he had found Duffy “to be a re-
liable and persuasive piece of evidence.” Id. at *18. 2 The
special master stated that he viewed Duffy “as reasonable
evidence that calls into doubt Petitioner’s theory.” Id. The
2 See D’Tiole v. Sec’y of Health & Human Servs., No.
15-85, 2016 WL 7664475 (Fed. Cl. Nov. 28, 2016), aff’d 132
Fed. Cl. 421 (2017). We affirmed the decision of the Court
of Federal Claims denying review of the special master’s
decision. D’Tiole v. Sec’y of Health & Human Servs., 726
Fed. Appx. 809, 810-12 (Fed. Cir. 2018).
MCCOLLUM v. HHS 11
special master brought his analysis to a close with the fol-
lowing statement:
Weighing all of the above together, I find that Peti-
tioner has not offered preponderant reliable medi-
cal and scientific evidence sufficient to satisfy the
first Althen prong. The concept that an adjuvanted
version of the H1N1 vaccine comparable to Pan-
demrix could cause narcolepsy finds support in the
Ahmed articles plus other literature offered by Dr.
Kinsbourne. If Pandemrix were the version of the
vaccine at issue, none of the foregoing analysis
would be necessary. But the contention that the
NP content of an unadjuvanted H1N1 vaccine ad-
ministered in the U.S. is enough by itself to cause
narcolepsy is far weaker, and rebutted by reliable
and relevant epidemiologic evidence.
Id. at *19.
C.
We are unable to agree with Mr. McCollum that the
special master “impermissibly heightened the substantive
law of what must be proven under prong one of Althen.”
Pet’r’s Br. 13. Contrary to Mr. McCollum’s contention,
Pet’r’s Br. 20-23, the special master’s consideration of
Duffy did not amount to a de facto requirement of epidemi-
ological evidence to find this prong met. See Andreu, 569
F.3d at 1379 (“Although Althen and Capizzano [v. Sec’y of
Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006),]
make clear that a claimant need not produce medical liter-
ature or epidemiological evidence to establish causation
under the Vaccine Act, where such evidence is submitted,
the special master can consider it in reaching an informed
judgment as to whether a particular vaccination likely
caused a particular injury.”).
Moreover, after correctly setting forth the pertinent
law, see the quotation above from page *12 of McCollum I,
12 MCCOLLUM v. HHS
the special master weighed the evidence before him and ar-
rived at the conclusion that Mr. McCollum had failed to
satisfy the requirement of providing a medical theory caus-
ally connecting the vaccine he received and his injury. Be-
cause Mr. McCollum does not challenge the special
master’s fact findings, see Pet’r’s Reply Br. 2, his complaint
is with the way the special master weighed the evidence.
This argument cannot succeed, however. As we stated in
Porter, “[w]e do not reweigh the factual evidence, assess
whether the special master correctly evaluated the evi-
dence, or examine the probative value of the evidence or
the credibility of the witnesses – these are all matters
within the purview of the fact finder.” 663 F.3d at 1249(citations omitted). Having thoroughly reviewed the deci-
sion of the special master, and given the constraints upon
the scope of our review of that decision, we are unable to
say that the special master erred by imposing any kind of
an improper burden upon Mr. McCollum. We therefore de-
cline to disturb the special master’s finding that Mr.
McCollum failed to satisfy prong one of Althen.
VI.
Mr. McCollum’s second argument on appeal is that the
special master acted arbitrarily in “[i]gnoring [p]roof” of a
challenge-rechallenge specific to him. Pet’r’s. Br. 24. See
Capizzano, 440 F.3d at 1322 (“A rechallenge event occurs
when a patient who had an adverse reaction to a vaccine
suffers worsened symptoms after an additional injection of
the vaccine.”). Mr. McCollum claims that the special mas-
ter failed to address and analyze evidence in the record to
the effect that he experienced increased symptoms of nar-
colepsy after receiving a second influenza vaccination in
the fall of 2012. Pet. Br. 24-27.
We do not agree. To begin with, the record hardly con-
tains “proof” of challenge-rechallenge. It appears, at most,
the special master had before him Mr. McCollum’s refer-
ences to certain “post-vaccination symptoms.” McCollum
MCCOLLUM v. HHS 13
I, 2017 WL 5386613, at *21. The special master, however,
did not ignore this evidence. Rather, in finding that Mr.
McCollum had failed to meet the requirements of Althen
prong two, the special master stated:
I also note the testimony of the McCollums that Pe-
titioner received a second flu vaccine sometime
during his treatment at the Stanford Sleep Clinic
as somewhat suggestive of the uncertainty sur-
rounding the link between vaccination and his con-
dition (since it is not likely his treaters would have
been cavalier about exacerbating his condition had
they been certain of a causal connection), although
this evidence on this matter is fairly vague in the
record.
Id. at *21 n.29. Furthermore, as the Court of Federal
Claims noted in its review of the special master’s decision,
not only did the record not provide evidentiary support for
a challenge-rechallenge argument, but “Petitioner never
raised the challenge-rechallenge issue during the proceed-
ings before the Special Master, either in the expert testi-
mony or during trial testimony.” McCollum III, 135 Fed.
Cl. at 740-41. In short, we see no merit in Mr. McCollum’s
challenge-rechallenge argument.
CONCLUSION
For the foregoing reasons, we affirm the decision of the
Court of Federal Claims denying Mr. McCollum’s motion
for review of the decision of the special master.
AFFIRMED
No costs.