Case: 20-1754 Document: 45 Page: 1 Filed: 01/14/2021
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
MARY ORLOSKI,
Petitioner-Appellant
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee
______________________
2020-1754
______________________
Appeal from the United States Court of Federal Claims
in No. 1:17-vv-00936-LKG, Judge Lydia Kay Griggsby.
______________________
Decided: January 14, 2021
______________________
VERNE E. PARADIE, JR., Paradie & Rabasco, Lewiston,
ME, for petitioner-appellant.
KYLE POZZA, Vaccine/Torts Branch, Civil Division,
United States Department of Justice, Washington, DC, for
respondent-appellee. Also represented by JEFFREY B.
CLARK, C. SALVATORE D'ALESSIO, HEATHER LYNN
PEARLMAN, CATHARINE E. REEVES.
______________________
Case: 20-1754 Document: 45 Page: 2 Filed: 01/14/2021
2 ORLOSKI v. HHS
Before MOORE, REYNA, and CHEN, Circuit Judges.
CHEN, Circuit Judge.
Ms. Mary Orloski appeals a decision of the United
States Court of Federal Claims (Claims Court) affirming a
decision of the Special Master finding that Ms. Orloski
failed to meet her burden to show a causal link between her
influenza (flu) and tetanus-diphtheria-acellular-pertussis
(Tdap) vaccinations and her claimed autoimmune condi-
tion—Acute Disseminated Encephalomyelitis (ADEM).
The Special Master considered and appropriately weighed
all of the evidence presented by Ms. Orloski. We, thus, af-
firm.
BACKGROUND
On October 23, 2014, Ms. Orloski received a flu vac-
cination. Later that day, Ms. Orloski went to the emer-
gency room with visual disturbances, however, her visual
symptoms resolved that same day. Over the next few days,
Ms. Orloski stated that she began to experience tingling
and numbness in her limbs. On December 2, 2014, Ms. Or-
loski saw a doctor for her symptoms and he dismissed her
symptoms as stress related. On November 18, 2015, Ms.
Orloski received a Tdap vaccination. Ms. Orloski stated
that subsequent to the Tdap vaccination, she started expe-
riencing a number of neurological symptoms and other is-
sues. The record in this case contains Ms. Orloski’s medical
records for doctors’ visits between November 18, 2015 and
May 4, 2017. During that time, Dr. Alexandra Degenhardt
suggested that Ms. Orloski had ADEM resulting from her
vaccinations. Ms. Orloski’s other treating physicians,
Dr. David Preston, Dr. Robert Stein, and Dr. Haatem Reda,
all opined that either Ms. Orloski did not have ADEM or
her symptoms were not caused by the vaccinations. Addi-
tionally, some of Ms. Orloski’s medical records fail to men-
tion her symptoms and/or vaccinations.
Case: 20-1754 Document: 45 Page: 3 Filed: 01/14/2021
ORLOSKI v. HHS 3
On July 13, 2017, Ms. Orloski filed a claim with the
Claims Court for vaccine injury compensation under the
National Vaccine Injury Compensation Program (Vaccine
Program). Following receipt of a petition for compensation
under the Vaccine Program, the Claims Court designates a
Special Master to issue a decision on whether compensa-
tion should be provided and, if so, the amount of the com-
pensation. 42 U.S.C. § 300aa-12(d).
When Ms. Orloski filed her petition, she included one
exhibit consisting of her medical records. J.A. 1–2. On
June 6, 2018, the Special Master directed Ms. Orloski to
file an expert report and supporting medical literature by
July 16, 2018. On July 16, 2018, Ms. Orloski filed seven
pages of medical records from Dr. Degenhardt. On July 18,
2018, in response to an inquiry from the Special Master as
to whether Ms. Orloski planned to submit an expert report,
Ms. Orloski stated that she would request additional time
to consult Dr. Degenhardt. Thus, on August 15, 2018, the
Special Master ordered Ms. Orloski to file a formal expert
report and supporting medical literature by October 22,
2018. The Special Master requested that the report discuss
the expert’s qualifications, pertinent facts from Ms. Orlo-
ski’s medical records, background on Ms. Orloski’s alleged
disease or injury, a theory of causation, and any non-vac-
cine potential causes. On October 2, 2018, Ms. Orloski filed
a single page report from Dr. Degenhardt stating that
there is a clear temporal relationship between ADEM and
the vaccine. On October 15, 2018, the Special Master again
ordered Ms. Orloski to file a formal expert report by no
later than November 14, 2018, noting that the one-page re-
port did not properly address the topics identified in the
Special Master’s prior order. On October 17, 2018, Ms. Or-
loski indicated that she did not intend on submitting any
further reports. During a November 13, 2018 status con-
ference, Ms. Orloski requested additional time to supple-
ment the record with medical literature and other evidence
Case: 20-1754 Document: 45 Page: 4 Filed: 01/14/2021
4 ORLOSKI v. HHS
related to her causation theory. The Special Master or-
dered that such evidence be filed by December 13, 2018.
On December 12, 2018, Ms. Orloski motioned for a rul-
ing on the record and submitted five exhibits consisting of
additional medical records, two pieces of medical litera-
ture, and an affidavit. In response, the government filed
an expert report from Dr. Subramaniam Sriram who con-
cluded that Ms. Orloski did not have ADEM and that the
onset of Ms. Orloski’s symptoms was too remote from either
vaccination to support causation. On April 3, 2019, the
Special Master contacted Ms. Orloski to inquire about
whether she intended to file a responsive expert report.
Ms. Orloski responded with a second affidavit and two pho-
tographs purporting to show an injection site reaction from
her Tdap vaccination. On October 31, 2019, the Special
Master issued a decision denying Ms. Orloski compensa-
tion under the Vaccine Program, finding that Ms. Orloski
had failed to meet her burden of proof that the vaccines
were the cause of her claimed injury. On March 17, 2020,
the Claims Court affirmed the Special Master’s decision.
We have jurisdiction pursuant to
28 U.S.C. § 1295(a)(3)
and 42 U.S.C. § 300aa-12(f).
DISCUSSION
We review an appeal in a vaccination case from the
Claims Court de novo, applying the same standard to the
Special Master’s decision that the Claims Court applied.
Milik v. Sec’y of Health & Human Servs.,
618 F.3d 1339,
1345 (Fed. Cir. 2016). We review the Special Master’s legal
conclusions without deference and discretionary rulings for
abuse of discretion. Lampe v. Sec’y of Health & Human
Servs.,
219 F.3d 1357, 1360 (Fed. Cir. 2000). We review the
Special Master’s factual findings using an “arbitrary or ca-
pricious” standard.
Id.
To receive compensation under the Vaccine Program,
Ms. Orloski must demonstrate either that: (1) she suffered
a “Table injury” by receiving a covered vaccine and
Case: 20-1754 Document: 45 Page: 5 Filed: 01/14/2021
ORLOSKI v. HHS 5
subsequently developing a listed injury within the time
frame prescribed by the Vaccine Injury Table or (2) that
she suffered an “off-Table injury,” one not listed on the Ta-
ble, as a result of her receipt of a covered vaccine. Moberly
v. Sec’y of Health & Human Servs.,
440 F.3d 1317, 1319–
20 (Fed. Cir. 2006). Ms. Orloski does not allege a Table
injury and therefore she must prove that her injury was
caused-in-fact by a covered vaccine. Althen v. Secretary of
Health and Human Services,
418 F.3d 1274 (Fed. Cir.
2015), sets forth a three-pronged test used to determine
whether a petitioner has established a causal link between
a vaccine and the claimed injury: (1) a medical theory caus-
ally 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 proxi-
mate temporal relationship between vaccination and in-
jury.
Id. at 1278. In this case, the Special Master found
that Ms Orloski did not meet her burden of proof under any
of the Althen prongs, and the Claims Court agreed.
Ms. Orloski argues that the evidence she submitted
was sufficient to establish prong one of Althen. Appellant’s
Br. at 18. Under the first Althen prong, Ms. Orloski must
offer a scientific or medical theory that the vaccine at issue
can cause the type of injury alleged. Althen, 418 F.3d at
1278. “Simply identifying a ‘plausible’ theory of causation
is insufficient of a petitioner to meet her burden of proof.”
LaLonde v. Sec’y of Health & Human Servs.,
746 F.3d 1334,
1338 (Fed. Cir. 2014) (citing Moberly, 592 F.3d at 1332).
Ms. Orloski primarily relies on Dr. Degenhardt’s opin-
ions, but they fail to address a mechanism for how either
or both vaccines could cause ADEM. Although Dr. Degen-
hardt diagnosed Ms. Orloski with ADEM as a reaction to
her vaccinations, she did not provide any reasoning for how
or why they would cause such a reaction. J.A. 147. Under
the deferential review standard we must apply, we see no
reversible error as to the Special Master’s evaluation of
Dr. Degenhardt’s opinions. Ms. Orloski argues that the
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6 ORLOSKI v. HHS
Special Master refused to consider Dr, Degenhardt’s opin-
ions, but we disagree. A review of the Special Master’s
opinion shows that the Special Master considered Dr. De-
genhardt’s opinions but found them too conclusory and un-
derdeveloped to be persuasive. J.A. 16. Next, Ms. Orloski
argues that the Special Master incorrectly required her to
provide an outside expert opinion to prove her claim (Ap-
pellant’s Br. at 17–18), but we read the Special Master’s
statements differently. To be sure, the Special Master gave
Ms. Orloski several opportunities to bolster her case and
provide a more detailed expert report than what Ms Orlo-
ski had provided. But nothing in the Special Master’s opin-
ion demands that a petitioner must submit an expert
report in order to prove her case.
Ms. Orloski also submitted two articles purporting to
establish a medical theory as required by the first Althen
prong. The first article, “The spectrum of post-vaccination
inflammatory CNS demyelinating syndromes,” by Di-
mitrios Karussis and Panayiota Petrou, discusses inflam-
matory central nervous system diseases related to
vaccines. J.A. 148–57. With respect to ADEM, the article
provides the following information: (1) “ADEM can occur
in any age but is mainly a disease of children and young
adults with a mean age of onset of 5–6 years and a higher
incidence in males”; (2) “[e]ncephalopathy, occurring in up
to 74% of patients, is considered mandatory for definite di-
agnosis”; and (3) “despite a close temporal relation to vac-
cinations, there is no concrete evidence of a clear
pathogenetic correlation.” J.A. 149–50. The article also
discusses two hypothetical pathogenic hypotheses, but fails
to review each to discuss the reasonableness of the hypoth-
eses and is ultimately a discussion of frequency of ADEM
with respect to vaccines, rather than a study showing cau-
sation. The second article cited by Ms. Orloski, “Acute Dis-
seminated Encephalomyelitis following Vaccination
against Hepatitis B in a Child: A Case Report and Litera-
ture Review,” by Yuan et al., is a case study of a twelve-
Case: 20-1754 Document: 45 Page: 7 Filed: 01/14/2021
ORLOSKI v. HHS 7
year-old child who suffered from ADEM three weeks after
receiving a hepatitis B vaccination. J.A. 158. The article
contains a single relevant sentence: “Postvaccination
ADEM has been associated with several vaccines such as
rabies, diphtheria-tetanus-polio, smallpox, measles,
mumps, rubella, Japanese B encephalitis, pertussis, influ-
enza, hepatitis B, and the Hog vaccine.” J.A. 159–60. The
article, however, fails to address the causation between the
flu and Tdap vaccines and Ms. Orloski’s ADEM. Thus, the
Special Master’s conclusion that Ms. Orloski failed to prove
the first Althen prong with the two submitted articles by
preponderance of the evidence is supported by the eviden-
tiary record.
Lastly, as to Althen prong one, Ms. Orloski contends
that the immediate onset of her symptoms after her vac-
cinations helps establish her burden under this prong. But
as the Special Master correctly noted, “a proximate tem-
poral association alone does not suffice to show a causal
link between vaccination and injury.” J.A. 17 (quoting
Grant v. Sec’y of Health & Human Servs.,
956 F.2d 1144,
1148 (Fed. Cir. 1992)). In view of the foregoing, we affirm
the Special Master’s analysis as to Althen prong one, which
properly considered the evidence “taken separately or in
the aggregate.” 1 J.A. 16
1 Ms. Orloski also noted that there were instances in
the Vaccine Program in which other special masters had
established that the flu vaccine could cause ADEM or sim-
ilar injuries. Appellant’s Br. at 22; see e.g., Caruso v. Sec’y
of Health & Human Servs., No. 13-700V, at *14 (Fed. Spec.
Mstr. Sept. 26, 2017). As we have previously stated, Spe-
cial Masters are not bound by the decisions of other special
masters and further, special masters are not required to
distinguish non-binding decisions of other Special Masters.
Boatmon v. Sec’y of Health & Human Servs.,
941 F.3d 1351,
1358-59 (Fed. Cir. 2019).
Case: 20-1754 Document: 45 Page: 8 Filed: 01/14/2021
8 ORLOSKI v. HHS
Because Ms. Orloski must prevail as to all three Althen
prongs, our decision upholding the Special Master’s deci-
sion as to prong one is sufficient to affirm her decision.
CONCLUSION
We have considered Ms. Orloski’s remaining argu-
ments and find them unpersuasive. For the reasons set
forth above, we affirm the Special Master’s denial of enti-
tlement under the Vaccine Program.
AFFIRMED
COSTS
No costs.
