In the United States Court of Federal Claims

No. 15-1302V

(Filed: January 16, 2019)

(Re-Filed: February 5, 2019)1

* * * * * * * * * * * * * * * * * * * * * * * * * *

JEFFREY PREPEJCHAL,

Petitioner,

v.

SECRETARY OF HEALTH 

AND HUMAN SERVICES,

Respondent. 

* * * * * * * * * * * * * * * * * * * * * * * * * *

Mark T. Sadaka, Englewood, NJ, for petitioner.

Mollie D. Gorney, Trial Attorney, United States Department of 

Justice, Civil Division, Torts Branch, Washington, DC, with whom were 

Joseph H. Hunt, Assistant Attorney General, C. Salvatore D’Alessio, Acting 

Director, and Catharine E. Reeves, Deputy Director, for respondent. 

OPINION

BRUGGINK, Judge.

Pending is petitioner’s motion for review of the Special Master’s 

decision of October 5, 2018, denying compensation for an injury allegedly 

caused by the influenza (“flu”) vaccine. The matter is fully briefed, and the 

court finds that oral argument is unnecessary. Because the Special Master 

was not arbitrary or capricious, did not abuse his discretion, and did not 

 

1 This opinion was held for fourteen days during which the parties were 

permitted to propose to chambers any appropriate redactions. The parties did 

not propose any redactions and thus we re-issue the decision without 

redactions. Rules of the United States Court of Federal Claims, App. B, Rule 

18(b) (“Vaccine Rules”).

National Childhood

Vaccine Injury Act, 42

U.S.C. §§ 300aa-1 to -34

(2018); off-table claim;

motion for review; Althen

test; severity requirement; 

influenza vaccine.
2

otherwise act unlawfully in determining whether petitioner demonstrated that 

the flu vaccine caused his injury, we deny the motion for review. 

BACKGROUND

On November 2, 2015, petitioner, Jeffrey Prepejchal, filed a petition 

for compensation under the National Childhood Vaccine Injury Act, 42 

U.S.C. §§ 300aa-1 to -34 (2018) (“Vaccine Act”). His petition alleged that, 

because of receiving the flu vaccine on November 7, 2012, he experienced 

“vaccine-induced soreness, swelling, phlebitis, and deep vein thrombosis” 

(“DVT”). Pet. at 1. The Special Master considered the petition on the record 

and concluded that Mr. Prepejchal did not establish entitlement to a damages 

award. Prepejchal v. United States, No. 15-1302V, 2018 WL 5782865 (Fed. 

Cl. Spec. Mstr. Oct. 5, 2018) (hereinafter “Decision”). We set out the 

background of Mr. Prepejchal’s claim below, which is derived from the 

background set out in the decision. 

Mr. Prepejchal is a fifty-year old medical charter pilot. He is on call 

in seven-day increments and generally flies a few days a week with flights 

usually lasting an hour or less. Mr. Prepejchal flew on four days during the 

two weeks preceding his vaccination. Prior to receiving the flu vaccine, his 

medical records reflect that he experienced right hip and left shoulder pain. 

Six months prior to his vaccine, May 7, 2012, he suffered from chronic left 

shoulder pain. His father had upper extremity DVT, but Mr. Prepejchal had 

not experienced DVT prior to his vaccination. 

On November 7, 2012, petitioner received the flu vaccine in his left 

deltoid muscle. An hour later, he experienced “soreness and mild pain.” 

Decision at 2 (quoting Pet’r’s Ex. 18 at 2). Nine days after experiencing mild 

pain, Mr. Prepejchal visited his primary physician, Dr. Walter Meeker, to 

seek treatment for swelling in his left arm. Dr. Meeker wrote that Mr. 

Prepejchal’s left arm was a “little sore.” Id. at 3 (quoting Pet’r’s Ex. 1 at 21). 

Mr. Prepejchal underwent an ultrasound and the radiology report 

stated that he had “‘near-complete occlusion’ of the subclavian, axillary, and 

basilic veins.” Id. (quoting Pet’r’s Ex. 2 at 38). Dr. Meeker diagnosed him 

with left arm DVT and prescribed two anticoagulants. Dr. Meeker wrote that 

he was “unsure how this is related to recent flu shot.” Id. (quoting Pet’r’s 

Ex. 1 at 21).
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On December 3, 2012, Mr. Prepejchal visited Darryl F. Lesoski, 

M.D., an occupational medicine specialist, to evaluate his DVT. The doctor 

noted that petitioner had a small bruise on his left bicep but no swelling in 

his left arm. Dr. Lesoski confirmed that Mr. Prepejchal had developed left 

upper extremity DVT of “questionable etiology,” but “[b]ecause of the 

unusual nature of this it is unlikely that it was related to the influenza 

vaccine.” Pet’r’s Ex. 2 at 12. 

Dr. Lesoski consulted a librarian, a hematologist, and an Occupational 

Health & Medicine practitioner list serv to conduct literature research and to 

determine whether there was a connection between upper extremity DVT and 

the flu vaccine. The literature research showed “that ‘administration of the 

influenza vaccine was actually prophylactic or protective of DVTs.’” 

Decision at 3 (quoting Pet’r’s Ex. 2 at 10) (emphasis omitted). The 

hematologist stated that “there was no association from her practice that was 

associated with this.” Pet’r’s Ex. 2 at 10. The practitioners’ responses found 

“no association” between the vaccine and DVT. Decision at 3 (quoting 

Pet’r’s Ex. 2 at 10).

Mr. Prepejchal routinely followed up with Dr. Meeker to test his 

blood’s clotting tendency, beginning with tests multiple times a week and 

tapering off over time. His last test was on January 31, 2013, less than threemonths post-vaccination. 

Six months later, on June 6, 2013, Mr. Prepejchal completed 

anticoagulation therapy and Dr. Meeker did not recommend further therapy 

because the risk of further DVT was low. Dr. Meeker suggested that 

petitioner avoid flu shots in the future. In 2014, Dr. Meeker wrote that Mr. 

Prepejchal’s DVT was “possibly related” to the flu vaccine. Decision at 4 

(quoting Pet’r’s Ex. 1 at 6.). Mr. Prepejchal has not had any recurrence of 

DVT since November 2012. 

In 2015, Mr. Prepejchal filed his petition alleging that the flu 

vaccination caused soreness, swelling, phlebitis, and DVT. Mr. Prepejchal 

submitted three export reports from Dr. M. Eric Gershwin. Dr. Gershwin is 

a Distinguished Professor of Medicine in the Division of 

Rheumatology/Allergy and Clinical Immunology at the University of 

California, Davis. He has been a resident at the Tufts-New England Medical 

Center and served at the National Institutes of Health as a Clinical Associate 

in Immunology. He has seen one case of Nicolau Syndrome and has testified 

in one case regarding Nicolau Syndrome.
4

Dr. Gershwin’s first report began, “I do not believe that there is any 

component of the influenza vaccine that would produce venous thrombosis. 

In other words, there is no immunological basis to associate the vaccine 

components with a clotting abnormality.” Pet’r’s Ex. 5 at 1. Instead, Dr. 

Gershwin “believe[d] that a mechanical injury from the injection led directly 

to the swelling and subsequent deep venous thrombosis.” Id. He continued, 

“The best analogy of this is a rare and diverse syndrome, which has been 

coined Nicolau Syndrome.” Id. He explained that Nicolau Syndrome (“NS”) 

is a rare reaction to an intramuscular injection that “is characterized by pain 

at the site of injection and including erythema and possibly even the chronic 

ulcers and scarring.” Id. He stated that it can affect deeper tissue and that it 

has been associated with all types of medicine, including vaccines. He 

referred to NS first as an analogy to Mr. Prepejchal’s injury, but later stated, 

“I believe Mr. Prepejchal’s thrombosis is most consistent with a local 

reaction similar to Nicolau Syndrome.” Id. Mr. Prepejchal was not 

diagnosed with NS. 

The report did not define DVT, explain how a mechanical injury 

during the flu vaccine administration would occur and lead to DVT, or draw 

a comparison between DVT and NS. Dr. Gershwin stated his opinion that 

NS can affect deep veins, but the Special Master did not find this to be 

supported by the literature. 

The supporting literature explained that NS “is a rare dermatological 

condition associated with intramuscular injections,” which “begins with 

instantaneous, severe pain at the site of injection, followed shortly thereafter 

by development of skin lesions.” Decision at 5-6 (citations omitted). It 

generally presents with “large areas of purplish plaque on the skin, and can 

include erythema (skin redness caused by capillary congestion), chronic 

ulcers, and scarring.” Decision at 6 (citations omitted). 

The Special Master requested clarity as to what type of specialists 

would be best-suited to speak to the presentation of NS. Dr. Gershwin’s 

second report responded that, because NS presents in a variety of ways, it 

may be referred to many practitioners, but that internists, such as Dr. 

Gershwin, and allergists are particularly qualified to discuss the syndrome. 

Respondent filed one expert report from Dr. Megha Tollefson. Dr. 

Tollefson is a board-certified Pediatric Dermatologist at the Mayo Clinic in 

Rochester, Minnesota. She completed residencies in both General Pediatrics 
5

and Dermatology at the Mayo Clinic. She was a one-year fellow in Pediatric 

Dermatology at Stanford University. 

Dr. Tollefson agreed that the flu vaccine has never been associated 

with DVT, but she disagreed that Mr. Prepejchal’s DVT was consistent with 

NS. She noted that NS generally involves immediate pain and skin changes 

either during or just after the injection. She cited supporting materials that 

NS generally occurs directly at the site of the injection. Dr. Tollefson 

distinguished Mr. Prepejchal’s experience by noting that he did not 

experience pain during or immediately after the injection, did not develop 

skin changes, and that his DVT did not involve the skin or muscle layers 

where the vaccination was administered. Dr. Tollefson also highlighted that 

Mr. Prepejchal’s medical records did not state a clear cause of his DVT and 

that both Mr. Prepejchal’s family history and profession created risk for the 

development of DVT.

Dr. Gershwin began his response by arguing that Dr. Tollefson had 

placed too much weight on Mr. Prepejchal’s piloting because his air travel 

was not prolonged, the DVT was in an upper extremity rather than lower 

extremity, and the DVT developed on the same side on which the flu vaccine

was administered. Dr. Gershwin noted that NS has several variations and 

provided a citation to a NS patient experiencing thrombosis. Dr. Gershwin 

pointed to Mr. Prepejchal’s 2018 affidavit in which he stated that he 

“experienced soreness and mild pain an hour after the injection.” Pet’r’s Ex. 

18. Dr. Gershwin agreed that Mr. Prepejchal may be predisposed to DVT 

based on his family history, but argued that his predisposition would make 

DVT more likely following an injury. 

After reviewing the record, including the medical history, experts’ 

reports, and literature, the Special Master found that petitioner did not prove 

by a preponderance that his injury was caused by the flu vaccine. He 

determined that Mr. Prepejchal failed to provide a plausible medical theory 

causally connecting the vaccination to his injury and to show a logical 

sequence of cause and effect between the flu vaccine and his injury, as 

required by the test set forth in Althen v. Sec’y of Health & Human Servs., 

418 F.3d 1274, 1278 (Fed. Cir. 2005).

On Althen prong one, the Special Master found that petitioner “failed 

to offer a cogent and reliable theory of causation.” Decision at 18. The 

Special Master based this conclusion on four contributing factors. First, 

petitioner conceded that there is no immunological connection between the 
6

flu vaccine and DVT. Second, although Dr. Gershwin had some familiarity 

with NS, accepting the causation theory would require accepting a 

mechanical injury theory on which Dr. Gershwin was not an expert. The 

Special Master acknowledged that Dr. Gershwin was well-credentialed, but 

that his credentials were not relevant to mechanical injuries giving rise to 

either NS or DVT. 

Third, the comparison to NS was faulty. The Special Master noted 

that petitioner was not diagnosed with NS and that no treater had ever 

mentioned NS. Also, NS and DVT are sufficiently different to make the 

comparison too tenuous. For instance, petitioner’s literature stated that NS 

presents with immediate and severe pain at the site of the injection, which 

Mr. Prepejchal did not allege he had experienced. Petitioner’s literature also 

stated that NS typically presents with death of tissue, which Mr. Prepejchal 

did not experience. Finally, the literature did not support a conclusion that 

the vaccination caused DVT, because the literature only addressed NS. 

Fourth, the Special Master found that petitioner’s argument that DVT is 

caused by a triggering event was unpersuasive. 

Regarding Althen prong two, the Special Master was unable to find 

by a preponderance of the evidence that Mr. Prepejchal’s DVT was caused 

by a vaccine. First, his treaters’ records were contradictory. The Special 

Master gave some weight to Dr. Meeker’s opinion that the vaccine may have 

been related to DVT, despite that Dr. Meeker’s earlier conclusion that he was 

unsure how the two were connected. The Special Master found Dr. Lesoski’s 

opinion that the vaccine and DVT were unconnected was more credible, 

because it was founded on independent research and consultation. 

Furthermore, the Special Master found that the record did not otherwise 

support the vaccination triggering DVT, akin to NS or not. Petitioner 

experienced some soreness after vaccine administration, but the extent of any 

pain or swelling immediately or in the nine days after vaccination was 

unclear. The Special Master conceded that there was temporal association 

between the vaccination and injury, but he found that the temporal 

association was not sufficient to demonstrate causation in fact. Because 

petitioner failed to demonstrate prongs one and two, showing a temporal 

relationship sufficient to prove prong three of the Althen test could not save 

the claim. 

Although the Special Master found that petitioner’s “failure to offer a 

plausible causation theory is a more fundamental failure in his evidentiary 

showing, his insufficient showing on the severity requirement is another 
7

basis for the claim’s dismissal.” Decision at 22. The Special Master applied 

the standard found in 42 U.S.C. § 300aa-11(c)(1)(D), which states that 

claimants must show that they suffered from the “residual effects or 

complications of such illness, disability, injury, or condition for more than 6 

months after the administration of the vaccine.” The Special Master found 

that Mr. Prepejchal’s condition “had mostly resolved by January 31, 2013—

less than three months after vaccination.” Decision at 21. Despite the 

petition stating that Mr. Prepejchal continued to experience symptoms 

through the time of filing, no evidence of such symptoms was included in the 

record. The Special Master compared Mr. Prepejchal’s petition to three other 

cases filed under the Vaccine Act in which petitioners received treatment 

after injury. The Special Master concluded that past cases found “that taking 

medication over a period of time, without evidence of other noticeable effects 

of an alleged vaccine-caused injury, only satisfies the six-month severity 

requirement when the medication treats symptomology that would otherwise 

be present over that time period.” Id. The Special Master found that 

petitioner did not meet the severity requirement, relying on the dates in the 

record and that the purpose of petitioner’s medication was stop future clots 

rather than to treat the existing clot. 

Finally, the Special Master found that, despite petitioner suggesting 

that a hearing would be useful, the matter could be decided on the record. 

The Special Master explained that the causation theory was self-evident from 

the expert reports and that live testimony from either the experts or Mr. 

Prepejchal was not necessary. The Special Master concluded that Mr. 

Prepejchal did not establish entitlement to compensation and dismissed his 

claim.

DISCUSSION

This court has jurisdiction to review the Special Master’s decision in 

accordance with 42 U.S.C. § 300aa-12. Our review is deferential, only 

setting aside decisions when they are “arbitrary, capricious, an abuse of 

discretion, or otherwise not in accordance with law . . . .” Id. § 300aa-12(e). 

When the Special Master has considered the relevant evidence and 

articulated a rational basis for the decision, reversible error is “extremely 

difficult to demonstrate.” Hines v. Sec’y Health & Human Servs., 940 F.2d 

1518, 1528 (Fed. Cir. 1991). This court does “not reweigh the factual 

evidence, assess whether the special master correctly evaluated the evidence, 

or examine the probative value of the evidence or the credibility of the 
8

witnesses–these are all matters within the purview of the fact finder.” Porter 

v. Sec’y of Health & Human Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011).

A petitioner may seek compensation for “any illness, disability, 

injury, or condition” sustained or significantly aggravated by a vaccine. 42 

U.S.C. §§ 300aa-11(c)(1), -13(a)(1)(A). When a petitioner seeks 

compensation for an injury caused by a vaccine other than those injuries 

listed on the Vaccine Injury Table, an off-table injury, petitioner must prove 

causation in fact. Althen, 418 F.3d at 1278 (citing 42 U.S.C. § 300aa13(a)(1)(A)). Petitioner must show that the vaccination caused the injury by 

proving three elements by a preponderance of the evidence: “(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. 

A different showing corresponds to each of the elements, but the same 

evidence may be used to prove more than one element. Id. First, petitioner 

must provide a reputable medical theory that demonstrates that the vaccine 

can cause the alleged injury. Althen, 418 F.3d at 1278. A petitioner is not 

required to submit medical literature, propose a generally accepted theory, or 

demonstrate proof of scientific certainty. See Andreu v. Sec’y of Health & 

Human Servs., 569 F.3d 1367, 1378 (Fed. Cir. 2009). Yet petitioner cannot 

prevail on “a ‘plausible’ or ‘possible’ causal link between the vaccination 

and the injury; he must prove his case by a preponderance of the evidence.” 

W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352,1356 (Fed. Cir. 

2013) (citing Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 

1332 (Fed. Cir. 2010)). “[A] mere showing of a proximate temporal 

relationship between vaccination and injury” is insufficient to prove actual 

causation. Althen, 418 F.3d at 1278.

To demonstrate a logical sequence of cause and effect, petitioner may 

use reputable medical or scientific evidence, including medical records. See 

Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. 

Cir. 2006) (citations omitted). Additionally, the treating physician’s opinion 

is entitled to weight, particularly because it was created contemporaneously. 

Id. Finally, petitioner must establish that there is a “medically-acceptable”

timeframe between the vaccination and alleged injury that is consistent with 

the theory of how the vaccine could cause the injury. de Bazan v. Sec’y of 

Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). 
9

Mr. Prepejchal raises three arguments: that the Special Master was 

arbitrary and capricious or abused his discretion by ignoring aspects of the 

expert reports and evidence submitted; that the Special Master improperly 

raised the six-month severity requirement; and that the Special Master should 

have held a hearing. For the reasons set out below, we find that the Special 

Master’s decision considered the evidence presented, applied the proper 

standard, and articulated why Mr. Prepejchal did not meet his burden. 

Petitioner asserts that the Special Master placed a higher burden on 

him than a preponderance of the evidence by ignoring aspects of the expert 

reports and evidence submitted. Petitioner does not state which literature or 

aspect of the reports that the Special Master ignored, but, in any event, the 

Special Master is not required to mention each piece of literature or to recite 

the theory word-for-word. See Moriarty v. HHS, 844 F.3d 1322, 1328 (Fed. 

Cir. 2016). Furthermore, the Special Master expressly referenced the NS 

literature that petitioner filed and considered whether NS and Mr. 

Prepejchal’s DVT were analogous. Decision at 18-19.

It appears that petitioner’s expert’s theory reasonably could have been 

understood in two ways: either a mechanical injury during vaccination led to 

the DVT, akin to the way NS presents, or a mechanical injury during 

vaccination in fact caused NS and the DVT is evidence of NS. This 

ambiguity could have been problematic, but respondent’s expert addressed 

both interpretations and the Special Master considered both viewpoints. Dr. 

Tollefson noted that the literature filed by both parties indicated that persons 

suffering from NS will experience pain during or immediately after the 

injection; contrary to the literature, Mr. Prepejchal did not suffer pain during 

or immediately after the injection. Moreover, he did not develop skin 

changes at the site of injection and his DVT did not involve the skin or 

muscle layers where the flu vaccine was given. Thus, respondent’s expert 

concluded that petitioner’s injury did not appear to be NS and the DVT also 

did not occur in the same way NS would occur. The Special Master drew 

similar distinctions between petitioner’s injury and NS, also noting that 

petitioner’s theory was not clear regarding a triggering event for the DVT: 

what was the mechanical injury and how did that lead to petitioner’s DVT? 

The Special Master had a rational basis for concluding that Mr. Prepejchal 

did not make the necessary showing under Althen prong one.

Furthermore, pursuant to Althen prong two, the Special Master 

considered the treating doctors’ opinions and found that Dr. Meeker’s

opinion was somewhat contradictory and ill-researched and that Dr. 
10

Lesoski’s opinion did not support petitioner’s theory. Dr. Meeker was unsure 

how Mr. Prepejchal’s DVT was related to the flu vaccine during the first 

visit; he later revised that opinion, without outside consultation, to 

recommend that Mr. Prepejchal avoid the flu vaccine in the future. Dr. 

Lesoski, on the other hand, conducted research before reaching the 

conclusion that Mr. Prepejchal’s DVT was unrelated to the flu vaccine. 

Neither treater referenced a mechanical injury. 

The Special Master’s decision reflects a close reading of the record 

followed by the drawing of conclusions; he did not insert himself as a 

medical expert or ignore some aspect of the record. In sum, the Special 

Master applied the appropriate burden and rationally found that petitioner did 

not make a sufficient showing under the first two Althen elements. 

Mr. Prepejchal also argues that it was inappropriate for the Special 

Master to raise the six-month severity requirement found in 42 U.S.C. § 

300aa-11(c)(1)(D) when respondent did not bring up the issue in its Vaccine 

Rule 4(c) report. The government argues that the Special Master permissibly 

raised the issue because Vaccine Rule 4(c) does not state that respondent 

waives arguments not raised and the severity standard is a statutory 

requirement that petitioner must meet. Vaccine Rule 4(c) states, 

[R]espondent must file a report setting forth a full and 

complete statement of its position as to why an award should

or should not be granted. The report must contain respondent’s 

medical analysis of petitioner’s claims and must present any 

legal arguments that respondent may have in opposition to the 

petition.

Although the rule does not state that arguments not raised are waived, 

respondent’s responsibility is to raise its arguments such that petitioner and 

the special master have notice of the details of its argument and the 

opportunity to review them and respond. We agree with the government that 

it was not inappropriate for the Special Master to raise the requirement, nor 

was it arbitrary and capricious, because the severity requirement is a statutory 

element that petitioner must meet prior to being awarded compensation. 

Given the lack of notice of this argument, however, the Special Master could 

have sought explanation or testimony from Mr. Prepejchal on this issue. 

Even if the Special Master should have sought more explanation of 

the role petitioner’s medication played in resolving his DVT rather than 
11

relying on inferences, the Special Master expressly stated that the insufficient 

causation evidence was the fundamental reason for denying petitioner’s 

claim. The severity requirement was an alternative basis for denying Mr. 

Prepejchal’s petition. Furthermore, petitioner’s argument that it was 

improper for the Special Master to conduct his own research is incorrect. The 

Special Master recited facts from the medical record and compared those 

facts to other decisions dealing with the severity requirement; such research 

is a basic aspect of legal reasoning. Thus, we will not disturb the Special 

Master’s conclusion. 

Finally, Mr. Prepejchal asserts that the Special Master abused his 

discretion by declining to hold a hearing despite questioning petitioner’s 

expert’s theory. Respondent correctly points out that the Special Master is 

not required to hold a hearing. The Vaccine Act provides that the Vaccine 

Rules should include a provision allowing for decision on the record, and the 

Vaccine Rules in fact state that the Special Master’s authority to hold a 

hearing is permissive, not mandatory. 42 U.S.C. § 300aa-12(d)(2)(D); 

Vaccine Rule 3(b)(2), 8(d); Burns v. Sec’y of Health & Human Servs., 3 F.3d

415, 417 (Fed. Cir. 1993). The Special Master found the Dr. Gershwin’s 

theory did not require further explanation, that he did not require live 

testimony to weigh credibility, and that petitioner’s medical record spoke for 

itself. The Special Master was not required to hold a hearing and reasonably 

explained his reasoning for declining to do so. 

CONCLUSION

In sum, because the Special Master rationally determined that 

petitioner did not demonstrate the first two prongs of the Althen test and the 

Special Master did not otherwise act arbitrarily or in violation of law, we 

affirm his decision. Accordingly, we deny petitioner’s motion for review. 

The clerk is directed to enter judgment accordingly. No costs.

s/Eric G. Bruggink

ERIC G. BRUGGINK

Senior Judge