VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_14-vv-00697
Package ID: USCOURTS-cofc-1_14-vv-00697
Petitioner: Mary Schoeberlein
Filed: 2014-01-11
Decided: 2018-02-20
Vaccine: influenza
Vaccination date: 2012-09-13
Condition: granulomatosis with polyangiitis (GPA)
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Mary Schoeberlein claims that an influenza vaccination administered on September 13, 2012, significantly aggravated her pre-existing condition, granulomatosis with polyangiitis (GPA), formerly known as Wegener's granulomatosis. She alleged that the vaccine prompted the production of antibodies contributing to a worsening of her GPA through a mechanism called bystander activation. The court considered medical records, expert reports from Dr. Eric Gershwin (petitioner's expert) and Dr. Thomas Forsthuber (respondent's expert), and heard oral testimony. The court found that Ms. Schoeberlein failed to establish her case on a more-likely-than-not basis. The court noted issues with Dr. Gershwin's experience and credibility, found his bystander activation theory unpersuasive and lacking scientific rigor, and noted his inability to clearly articulate the timing of symptom onset under his theory. Furthermore, the court found that Ms. Schoeberlein's disease progression appeared consistent with the natural course of untreated GPA, not a vaccine-aggravated condition. Consequently, the court denied compensation.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_14-vv-00697-0
Date issued/filed: 2018-02-20
Pages: 3
Docket text: PUBLIC DECISION (Originally filed: 1/11/2018) regarding 97 DECISION of Special Master. Signed by Special Master Christian J. Moran. (MRG) Service on parties made.
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Case 1:14-vv-00697-UNJ Document 106 Filed 02/20/18 Page 1 of 3
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * * * * * *
MARY SCHOEBERLEIN, *
* No. 14-697V
Petitioner, * Special Master Christian J. Moran
*
v. * Filed: January 11, 2018
*
SECRETARY OF HEALTH * entitlement, bench ruling, flu
AND HUMAN SERVICES, * vaccine, Wegener’s granulomatosis.
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * * * * *
Mark T. Sadaka, Mark T. Sadaka, LLC, for petitioner;
Darryl R. Wishard, United States Dep’t of Justice, Washington, DC, for respondent.
UNPUBLISHED DECISION DENYING COMPENSATION1
Ms. Schoeberlein claims that an influenza vaccination, given to her on September 13,
2012, significantly aggravated her pre-existing (but undiagnosed) condition formerly known as
Wegener’s granulomatosis, now known as granulomatosis with polyangiitis (“GPA”). After Ms.
Schoeberlein filed her medical records, the undersigned directed that the expert reports would
constitute the experts’ direct testimony at any hearing. The parties filed a series of reports from
Dr. Eric Gershwin (petitioner’s expert) and Dr. Thomas Forsthuber (respondent’s expert).
A hearing was held on January 10, 2018. After the parties submitted all their evidence,
the undersigned issued a bench decision, finding that Ms. Schoeberlein had failed to establish
that she was entitled to compensation. See Doe/17 v. Secʼy of Health & Human Servs., 84 Fed.
Cl. 691, 704 n. 18 (2008) (noting “[e]ven a special master’s ruling on entitlement may be
delivered from the bench, with no written opinion”).
The undersigned is issuing this document for two reasons. First, this document will
become available to the public pursuant to 42 U.S.C. § 300aa—12(d)(4).
Second, this document provides an abbreviated recitation for the basis of decision. See
Hebern v. United States, 54 Fed. Cl. 548 (2002) (example of a judge from the United States
1 The E-Government Act, 44 U.S.C. § 3501 note (2012) (Federal Management and
Promotion of Electronic Government Services), requires that the Court post this decision on its
website. Pursuant to Vaccine Rule 18(b), the parties have 14 days to file a motion proposing
redaction of medical information or other information described in 42 U.S.C. § 300aa-12(d)(4).
Any redactions ordered by the special master will appear in the document posted on the website.

Case 1:14-vv-00697-UNJ Document 106 Filed 02/20/18 Page 2 of 3
Court of Federal Claims formalizing a bench ruling denying a motion for review). As explained
in the bench ruling, the undersigned considered all the evidence, including the medical records,
expert reports, medical articles, and oral testimony. The undersigned’s consideration of this
evidence began when the evidence was received, as outlined in the recitation of the case’s
procedural history. See also Vaccine Rule 5 (providing for a framework in which special
masters evaluate the evidence, and even make tentative findings and conclusions, prior to issuing
a decision).
Ms. Schoeberlein bore a burden to establish her case on a more-likely-than-not basis. 42
U.S.C. § 300aa-13(a); Bunting v. Secʼy of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir.
1991). The elements of a significant aggravation case are set out in Loving v. Secʼy of Health &
Human Servs., 86 Fed. Cl. 135 (2009). See W.C. v. Secʼy of Health & Human Servs., 704 F.3d
1352, 1357 (Fed. Cir. 2013).
As explained in more detail in the bench ruling, Ms. Schoeberlein failed to meet her
burden of proof for several overlapping reasons. These include the following:
First, Ms. Schoeberlein relied upon an expert, Dr. Gershwin, who has relatively little
experience in treating patients with GPA. While Dr. Gershwin’s relatively small amount of
direct experience with GPA actually exceeds the negligible experience of Dr. Forsthuber, Ms.
Schoeberlein bears the burden of presenting a persuasive case. See Dean v. Sec’y of Health &
Human Servs., No. 13-808V, 2017 WL 2926605 at *18 n.12 (Fed. Cl. Spec. Mstr. June 9, 2017)
(noting that the opinions of an expert need not be accepted merely because they are more
credentialed on the topic than the opposing expert).2 Dr. Gershwin’s relative unfamiliarity with
GPA appeared to affect his opinion as he changed / revised / clarified his written reports during
his oral testimony. Overall, Dr. Gershwin’s presentation and demeanor reduced his credibility.
Second, Ms. Schoeberlein did not establish the persuasiveness of Dr. Gershwin’s theory
that the flu vaccination would prompt the production of antibodies contributing to a worsening of
Ms. Schoeberlein’s GPA (known as bystander activation). Dr. Gershwin’s pre-trial reports did
not explain the bystander activation theory in either an understandable or persuasive way. The
literature filed by the petitioner did not illuminate this topic. In contrast, Dr. Forsthuber
established, much more persuasively, that bystander activation is the flimsiest of the widely
proposed hypotheses offered to try to explain how autoimmune diseases originate. Dr.
Forsthuber also supported his opinion with studies that showed that the flu vaccination tends to
elicit antibodies to flu antigens only. These studies undermined Dr. Gershwin’s opinion.
Third, the problems with the bystander activation theory make crediting Dr. Gershwin’s
opinion regarding the timing difficult. See Langland v. Sec'y of Health & Human Servs., 109
Fed. Cl. 421, 443 (2013) (“With no reputable theory as to how the vaccination could cause the
injury, [examining the temporal relationship] is not possible.”). Despite opportunities in pre-
hearing reports and in questioning at the hearing, Dr. Gershwin did not present a clear opinion
about how long the production of antibodies via the bystander activation theory would take and,
accordingly, how long it may take for symptoms to begin developing. His inability to do so was
2 Both parties would have benefited from retaining doctors who routinely treat patients
with vasculitis or kidney disease.
2

Case 1:14-vv-00697-UNJ Document 106 Filed 02/20/18 Page 3 of 3
consistent with the theory’s lack of scientific rigor.3 This lack of clarity was a problem because
Ms. Schoeberlein started having nausea, which can be a symptom of renal disease, the day of the
vaccination. Exhibit 6 at 6. Whether or not this nausea was consistent with petitioner’s
bystander activation hypothesis—or refutes petitioner’s hypothesis by showing that she began
showing symptoms of renal disease too early for the vaccine to be the cause—is undeterminable
due to the weakness of petitioner’s medical theory. As noted in Bazan v. Secʼy of Health &
Human Servs., 539 F.3d 1347, 1353 (Fed. Cir. 2008), special masters may consider whether the
symptoms arose before the time predicted under petitioner’s medical theory.
Finally, and perhaps most importantly, a preponderance of the evidence established that
Ms. Schoeberlein’s course appeared to track the predicted course for untreated GPA. Dr.
Gershwin and Dr. Forsthuber agreed that by July 2012, Ms. Schoeberlein was manifesting
symptoms of GPA—her nosebleeds. While her treating doctors did not recognize that she was
suffering from GPA until January 2013, by the time her kidneys were failing, this was consistent
with testimony and articles from both parties indicating that GPA often goes undiagnosed. Dr.
Forsthuber established—and Dr. Gershwin agreed—that before doctors learned how to treat
GPA, patients often died of kidney failure within six months of onset. Thus, the progression of
Ms. Schoeberlein’s GPA was not quicker than expected and was not more severe than expected.
In fact, Dr. Forsthuber stated that Ms. Schoeberlein’s disease progression has been better than
average.
In summary, for the reasons noted above and further elucidated in the bench ruling, the
undersigned finds that the petitioner has not met her burden of proof under the Vaccine Act. The
evidence does not support, by a preponderance of the evidence, that Ms. Schoeberlein’s
vaccinations significantly aggravated her GPA.
The undersigned further directs the Clerk’s Office to enter judgment based upon the
decision in this case if a motion for review is not filed. When the time for filing a motion for
review (see Vaccine Rule 23) begins to run is for an appellate tribunal to decide.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
3 As the United States Supreme Court noted in Daubert v. Merrell Dow Pharmaceuticals, Inc.,
falsifiability of a hypothesis is a central characteristic of scientific knowledge. 509 U.S. 579, 593
(1993).
3