NOTE: This disposition is nonprecedential.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: 1 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 condition—Acute Disseminated Encephalomyelitis (ADEM). 

The Special Master considered and appropriately weighed 

all of the evidence presented by Ms. Orloski. We, thus, affirm.

BACKGROUND

On October 23, 2014, Ms. Orloski received a flu vaccination. Later that day, Ms. Orloski went to the emergency 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. Orloski 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 experiencing a number of neurological symptoms and other issues. 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. Additionally, some of Ms. Orloski’s medical records fail to mention her symptoms and/or vaccinations.

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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 compensation should be provided and, if so, the amount of the compensation. 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. Orloski’s medical records, background on Ms. Orloski’s alleged 

disease or injury, a theory of causation, and any non-vaccine 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 report did not properly address the topics identified in the 

Special Master’s prior order. On October 17, 2018, Ms. Orloski indicated that she did not intend on submitting any 

further reports. During a November 13, 2018 status conference, Ms. Orloski requested additional time to supplement the record with medical literature and other evidence 

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4 ORLOSKI v. HHS

related to her causation theory. The Special Master ordered that such evidence be filed by December 13, 2018. 

On December 12, 2018, Ms. Orloski motioned for a ruling on the record and submitted five exhibits consisting of 

additional medical records, two pieces of medical literature, and an affidavit. In response, the government filed 

an expert report from Dr. Subramaniam Sriram who concluded 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 photographs purporting to show an injection site reaction from 

her Tdap vaccination. On October 31, 2019, the Special 

Master issued a decision denying Ms. Orloski compensation 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 capricious” 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 

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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 Table, 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 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. 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 opinions, but they fail to address a mechanism for how either 

or both vaccines could cause ADEM. Although Dr. Degenhardt 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 opinions, but we disagree. A review of the Special Master’s 

opinion shows that the Special Master considered Dr. Degenhardt’s opinions but found them too conclusory and underdeveloped 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 (Appellant’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 Orloski had provided. But nothing in the Special Master’s opinion 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 Dimitrios Karussis and Panayiota Petrou, discusses inflammatory 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 diagnosis”; and (3) “despite a close temporal relation to vaccinations, 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 hypotheses and is ultimately a discussion of frequency of ADEM 

with respect to vaccines, rather than a study showing causation. The second article cited by Ms. Orloski, “Acute Disseminated Encephalomyelitis following Vaccination 

against Hepatitis B in a Child: A Case Report and Literature Review,” by Yuan et al., is a case study of a twelveCase: 20-1754 Document: 45 Page: 6 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, influenza, 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 evidentiary record.

Lastly, as to Althen prong one, Ms. Orloski contends 

that the immediate onset of her symptoms after her vaccinations helps establish her burden under this prong. But 

as the Special Master correctly noted, “a proximate temporal 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 similar 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, Special 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).

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8 ORLOSKI v. HHS

Because Ms. Orloski must prevail as to all three Althen

prongs, our decision upholding the Special Master’s decision as to prong one is sufficient to affirm her decision. 

CONCLUSION

We have considered Ms. Orloski’s remaining arguments and find them unpersuasive. For the reasons set 

forth above, we affirm the Special Master’s denial of entitlement under the Vaccine Program.

AFFIRMED

COSTS

No costs. 

Case: 20-1754 Document: 45 Page: 8 Filed: 01/14/2021