The opinion
In the United States Court of Federal Claims
No. 15-1302V
(Filed: January 16, 2019)
(Re-Filed: February 5, 2019) 1
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JEFFREY PREPEJCHAL,
National Childhood
Petitioner, Vaccine Injury Act, 42
U.S.C. §§ 300aa-1 to -34
v. (2018); off-table claim;
motion for review; Althen
SECRETARY OF HEALTH test; severity requirement;
AND HUMAN SERVICES, influenza vaccine.
Respondent.
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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”).
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 three-
months 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.
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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
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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
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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
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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
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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. § 300aa-
13(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).
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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.
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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
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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
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