Valeen v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
*************************
SCOTT VALEEN, *
* No. 16-390V
Petitioner, * Special Master Christian J.
* Moran
*
v. *
* Filed: November 30, 2021
SECRETARY OF HEALTH *
AND HUMAN SERVICES, * Entitlement; flu vaccine;
* GPA; prong one.
Respondent. *
*************************
Renée J. Gentry, Vaccine Injury Clinic, George Washington University School of
Law, Washington, DC, for petitioner;
Naseem Kourosh, United States Dep’t of Justice, Washington, DC, for respondent.
PUBLISHED DECISION DENYING COMPENSATION 1
Scott Valeen alleges that an influenza (“flu”) vaccine caused him to suffer
granulomatosis with polyangiitis (“GPA”). The parties have submitted reports
from experts and argued their positions through legal briefs. An assessment of this
information shows that Mr. Valeen has not met his burden of establishing that the
flu vaccine can cause GPA. Thus, his case is dismissed.
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.
I. Facts2
Before the vaccination, Mr. Valeen worked at an oil refinery. Exhibit 78 at
2. He suffered from diabetes type 2 and hypothyroidism. Exhibit 10 at 1. Mr.
Valeen received a flu vaccination on October 17, 2012, and he did not report any
adverse reactions. Exhibit 2 at 30.
Almost one year later, Mr. Valeen received another flu vaccination. Exhibit
2 at 30 (September 11, 2013). He alleges this September 11, 2013 vaccination
caused his GPA.
Mr. Valeen sought medical care from his primary care doctor, Dennis Tang,
on October 7, 2013. Mr. Valeen complained about nasal congestion, nosebleeds,
runny nose, postnasal drip, and sneezing for about 3 to 4 weeks. Exhibit 2 at 17.
While the estimate of 3 to 4 weeks places the onset of these problems either a few
days before or a few days after the vaccination (September 9-16, 2013), Mr.
Valeen averred that he began experiencing the symptoms on either September 21,
2013 or September 25, 2013. Exhibit 10 (affidavit, dated Apr. 7, 2016) and
Exhibit 14 (affidavit, dated June 16, 2016).
Following this October 7, 2013 appointment with Dr. Tang, Mr. Valeen saw
doctors over the next weeks. Eventually, in December 2013, Mr. Valeen was
hospitalized during which various tests were performed. He was diagnosed with
GPA. Exhibit 17 at 1 (discharge report). A pulmonologist (Dr. Maksoud) and a
rheumatologist (Dr. Elkhalili) also confirmed the GPA diagnosis. Exhibit 5 at 13-
14; exhibit 6 at 30-31.
The parties agree that GPA is an appropriate diagnosis for Mr. Valeen.
GPA is “a multi-system disease chiefly affecting males, characterized by
necrotizing granulomatosis vasculitis involving the upper and lower respiratory
tracks, glomerulonephritis, and various degrees of ANCA-associated type of small
vessel vasculitis. Most authorities consider this condition to be an aberrant
hypersensitivity reaction to an unknown antigen.” Dorland’s Illustrated Medical
Dictionary 796 (32d ed. 2012).
The recitation of events in Mr. Valeen’s life is abbreviated because the
2
outcome of this case largely turns on Althen prong one.
2
After the GPA diagnosis at the end of 2013, Mr. Valeen has continued to
receive treatment for GPA periodically. However, the details of the 6 years of
medical history do not affect the outcome of the case. 3
II. Procedural History
Mr. Valeen initiated this case on March 28, 2016. By August 22, 2016, Mr.
Valeen had filed his medical records.
The Secretary reviewed this material and recommended that compensation
be denied. Resp’t’s Rep., filed Oct. 31, 2013. The Secretary reasoned that Mr.
Valeen failed to provide a credible theory of causation connecting his vaccine to
his GPA. Id. at 8. Additionally, the Secretary noted that none of Mr. Valeen’s
treating physicians associated his vaccine with his condition. Id. Finally, the
Secretary argued that Mr. Valeen failed to offer a medically acceptable timeframe
between the date of his vaccination and the onset of his symptoms. Id.
The parties filed a series of reports from experts. To advance his case, Mr.
Valeen submitted a report of Yehuda Shoenfeld, an immunologist, on March 17,
2017. Exhibit 28. 4 The Secretary presented a report from Lindsay Whitton, a
medical researcher with a Ph.D. whose license to practice medicine is not in the
United States, and a report from Robert Lightfoot, a rheumatologist. Exhibit A;
exhibit C. Dr. Shoenfeld presented another report. Exhibit 77. Dr. Whitton wrote
a second report as well. Exhibit E. The parties also filed various medical articles
their experts cited.
The case was assigned to the undersigned on March 5, 2021. Mr. Valeen
filed updated medical records in April and May 2021. Because the parties had
submitted complete reports from their experts, the parties were instructed to
advocate for their positions in briefs. Order, issued May 21, 2021.
3
The parties summarized Mr. Valeen’s medical course in their briefs. See
Pet’r’s Br. at 2-4; Resp’t’s Br. at 2-12.
4
Mr. Valeen also submitted a report by Judy A. Mikovits and Francis W.
Ruscetti. However, Mr. Valeen later struck this report from the record. Pet’r’s
mot. to strike, filed Apr. 1, 2021; order, issued Apr. 6, 2021.
3
Mr. Valeen filed a primary brief on July 15, 2021, and a reply brief on
October 21, 2021. With the primary brief, Mr. Valeen submitted a short report
from Dr. Shoenfeld. Exhibit 87. Between Mr. Valeen’s primary brief and reply
brief, the Secretary submitted his brief as well as brief statements from Dr. Whitton
and Dr. Lightfoot. Exhibit F and I. With the submission of Mr. Valeen’s reply
brief, the case is ready for adjudication.
III. Standards for Adjudication
A petitioner is required to establish his case by a preponderance of the
evidence. 42 U.S.C. § 300aa-13(1)(a). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact's existence.” Moberly v. Sec’y of
Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
omitted). Proof of medical certainty is not required. Bunting v. Sec’y of Health &
Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed.
Cir. 2009) (reversing the special master’s decision that petitioners were not entitled
to compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d
1357 (Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961
(Fed. Cir. 1993) (disagreeing with the dissenting judge’s contention that the special
master confused preponderance of the evidence with medical certainty).
In a case, such as this case, in which a petitioner seeks compensation for an
injury not listed on the Vaccine Table, the Federal Circuit has defined the elements
of petitioner’s case. Petitioners bear a burden “to show by preponderant evidence
that the vaccination brought about [the vaccinee’s] injury by providing: (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.” Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed.
Cir. 2005).
4
IV. Analysis
Mr. Valeen’s case fails at least two of the three Althen prongs. This lack of
persuasiveness is most apparent for the first prong. Thus, the analysis begins there.
A. Althen Prong One: A Causal Theory Connecting the Vaccine and
GPA
Through Dr. Shoenfeld, Mr. Valeen has attempted to present a theory by
which the flu vaccine can cause GPA. However, Mr. Valeen’s claim that a flu
vaccine can cause GPA lacks persuasiveness in at least two respects.
1. Dr. Shoenfeld offers a theory based upon adjuvants but the
vaccine Mr. Valeen received does not contain adjuvants.
The March 21, 2021 order directed Mr. Valeen to set forth the theory by
which a flu vaccine can cause GPA. Order, issued Mar. 21, 2021, at 5-6. In
response to the order, Mr. Valeen explained Dr. Shoenfeld’s proposed mechanism
as “the influenza vaccination received by Mr. Valeen contained adjuvants, which
are not only capable of eliciting a hyperactivated immune response, they are
designed to do that very thing. This hyperactivated immune response increases the
likelihood of cross-reacting with human proteins . . . and . . . Mr. Valeen’s GPA is
the result of that autoimmunity.” Pet’r’s Br. at 17. After the Secretary challenged
Mr. Valeen’s proof on this element, Mr. Valeen again defined Dr. Shoenfeld’s
theory beginning with the assertion that “Mr. Valeen’s influenza vaccination
contained adjuvants.” Pet’r’s Reply at 2.
The brand of influenza vaccine that Mr. Valeen received is Fluzone. Exhibit
2 at 30. The experts dispute whether Fluzone contains any adjuvant.
Dr. Shoenfeld’s first report was inconsistent on this topic. At the beginning,
Dr. Shoenfeld stated that all seasonal flu vaccines administered in the United States
do not contain adjuvants. Exhibit 28 at 8. However, later, Dr. Shoenfeld
maintained that all vaccines need adjuvants. Id. at 24. 5
5
Dr. Shoenfeld reasoned that because the immune system’s first exposure to
any antigen produces only a weak immune response, an adjuvant is needed to
boost the strength of the immune response. Exhibit 28 at 24. This reasoning is
flawed because, in part, Dr. Whitton persuasively explained that some antigens
5
In contrast, Dr. Whitton stated that Fluzone does not contain an adjuvant.
Exhibit A at 7.6 Dr. Whitton cited the earlier portion of Dr. Shoenfeld’s report in
which Dr. Shoenfeld maintained that Fluzone does not contain an adjuvant. Id. at
9 (citing exhibit 28 at 8). Dr. Whitton later also noted that Dr. Shoenfeld was
mistaken when Dr. Shoenfeld asserted that all flu vaccines given in the United
States are not adjuvanted because one brand of flu vaccine, Fluad, does contain an
adjuvant. Exhibit E at 5-6.
Dr. Lightfoot did not discuss the presence (or lack) of adjuvant extensively.
At most, Dr. Lightfoot noted the inconsistency in Dr. Shoenfeld’s first report.
Exhibit C at 8-9 (citing exhibit 28 at 8, 24).
When given a chance to respond, Dr. Shoenfeld pointed to two components
of the Fluzone vaccine, formaldehyde and Triton X-100. To Dr. Shoenfeld, these
substances could function as an adjuvant. Exhibit 77 at 2-3.
Dr. Whitton, in turn, explained why formaldehyde and Triton X-100 are not
adjuvants. Exhibit E at 5-6. In support, Dr. Whitton submitted guidance from the
Centers for Disease Control and Prevention (“CDC”) that states that Fluzone does
not contain adjuvants. See exhibit E, tab 2, at 14 (Lisa A. Grohskoph et al., Ctrs.
for Disease Control & Prevention, Prevention and Control of Seasonal Influenza
with Vaccines 14 (2017)).
The parties’ briefs draw upon these portions of the expert reports. See
Resp’t’s Br. at 34; Pet’r’s Reply at 2.
Mr. Valeen has not presented persuasive evidence that Fluzone contains an
adjuvant. The strongest reason for finding that Fluzone does not contain an
adjuvant is the statement from the CDC. The CDC characterizes Fluzone as
unadjuvanted. See exhibit E, tab 2, at 14. This evidence is clear and convincing.
The finding that Fluzone does not contain an adjuvant is consistent with
statements involving Fluzone in other cases. A primary example is Dougherty v.
cause a strong immune response on their first interaction with a human being.
Exhibit A at 12.
Technically, in this portion of Dr. Whitton’s report, he was responding to
6
Ms. Mikovits’s assertion that Fluzone contains an adjuvant.
6
Secretary of Health & Human Services, No. 15-1333V, 2018 WL 3989519 (Fed.
Cl. Spec. Mstr. July 5, 2018), mot. for rev. denied, 141 Fed. Cl. 223 (2018). In
Dougherty, the petitioner alleged that a Fluzone vaccine caused her to suffer
narcolepsy with cataplexy. Id. at *1. Ms. Dougherty maintained that the Fluzone
vaccine can cause narcolepsy just as a different vaccine, Pandemrix, can cause
narcolepsy. Id. at *42. However, the special master did not agree with that
comparison because Fluzone is not adjuvanted. Id.While the unadjuvanted nature of Fluzone was a key part of the special
master’s analysis in Dougherty, portions of other decisions have mentioned that
Fluzone lacks an adjuvant. See Halverson v. Sec’y of Health & Hum. Servs., No.
15-227V, 2020 WL 992588, at *18 (Fed. Cl. Spec. Mstr. Feb. 4, 2020) (testimony
of respondent’s expert, Dr. Rose); Bantugan v. Sec’y of Health & Hum. Servs.,
No. 15-721V, 2019 WL 7602581, at *11 (Fed. Cl. Spec. Mstr. Dec. 20, 2019)
(testimony of respondent’s expert, Dr. Whitton); McCabe v. Sec’y of Health &
Hum. Servs., No. 13-570V, 2018 WL 3029176, at *30-31 (Fed. Cl. Spec. Mstr.
May 17, 2018) (testimony of respondent’s expert, Dr. Matloubian).
In light of this strong evidence, Dr. Shoenfeld faced a challenge to establish,
more likely than not, that Fluzone contains an adjuvant. Dr. Shoenfeld fell well
short of meeting this burden of presenting preponderant evidence on this point.
Dr. Shoenfeld identified two components of Fluzone that function as
adjuvants, formaldehyde and Triton X-100, which is also known as octylphenoxy
polyethoxyethanol. Pet’r’s Reply at 2. Formaldehyde is “added to inactivate (kill)
the virus.” Exhibit E at 6 (Dr. Whitton’s report). Then, the formaldehyde is
filtered from the vaccine, leaving (perhaps) a de minimis residue. Id. at 3. Dr.
Whitton’s discussion of formaldehyde’s use in vaccines is consistent with expert
testimony from other cases. See Murphy v. Sec’y of Health & Hum. Servs., No.
05-1063V, 2016 WL 3034047, at *19 (Fed. Cl. Spec. Mstr. Apr. 25, 2016) (the
DTaP vaccine is “chemically inactivated using formaldehyde”); Sucher v. Sec’y of
Health & Hum. Servs., No. 07-0058V, 2010 WL 1370627, at *27 (Fed. Cl. Spec.
Mstr. Mar. 15, 2010) (“A number of methods have been used for toxoiding
including . . . chemical treatments of the toxin or whole cells
with formaldehyde . . . .”); James ex rel. Chee v. Sec’y of Health & Hum. Servs.,
No. 09-284V, 2010 WL 4205699, at *10 (Fed. Cl. Spec. Mstr. Sept. 30, 2010)
(“[The] pertussis toxin is inactivated either through the use of glutaraldehyde
or formaldehyde or other chemicals to produce a toxoid.”). Additionally, Dr.
Whitton’s findings on the use of formaldehyde in vaccines is in accord with
7
testimony the undersigned has received in other cases. See Whitecotton v. Sec’y
of Health & Hum. Servs., 81 F.3d 1099, 1104 (Fed. Cir. 1996) (indicating that
special masters may draw upon their “accumulated expertise” in resolving cases).
The undersigned has heard much less, if any, testimony about Triton X-100
or octylphenoxy polyethoxyethanol. According to Dorland’s, octylphenoxy
polyethoxyethanol, which is also known as octoxynol 9, is “used as a surfactant in
pharmaceutical preparations.” Dorland’s at 1294. Dr. Whitton explained that
Triton X-100 disrupts the inactivated virus, causing a “‘split virus’ vaccine.”
Exhibit E at 3. This description resembles Dr. Shoenfeld’s description of the
purpose of Triton X-100: Triton X-100 is used “to both lyse cells to extract
proteins or organelles and to permeabilize cell membranes.” Exhibit 77 at 3.7 In
this context, Dr. Shoenfeld cites an article as reference 7, but Mr. Valeen neither
filed this article nor discussed it his briefs.
While Dr. Shoenfeld and Dr. Whitton agree that Triton X-100 is used as part
of the process of making the flu virus safe in the vaccine, they disagree over what
happens next. Dr. Shoenfeld states that “When mixed with the antigen,
formaldehyde-Triton X100 help to deposit and sequester the injected antigen. This
causes a dramatic increase in the antibody response.” Exhibit 77 at 3. In contrast,
Dr. Whitton states any Triton-X 100 is removed in the manufacturing process by
passing the mixture over a Triton-binding column. Exhibit E at 3. Neither Dr.
Shoenfeld nor Dr. Whitton cited any articles about the persistence or removal of
Triton-X 100 as Fluzone is manufactured. However, Dr. Whitton’s explanation is
persuasive because, in part, it implicitly matches the CDC’s statement that Fluzone
does not contain an adjuvant.
Consequently, Mr. Valeen has failed to establish, by preponderant evidence,
that Fluzone contains an adjuvant. Because Dr. Shoenfeld’s theory for how
Fluzone can cause GPA presupposes the presence of an adjuvant, the finding that
Fluzone is not adjuvanted eliminates the reliability of Dr. Shoenfeld’s opinion.
7
“Lyse” means “to cause or produce disintegration of a compound,
substance, or cell.” Dorland’s at 1074.
8
2. Even if Dr. Shoenfeld’s theory did not depend upon adjuvants,
his theory remains unpersuasive.
Although Mr. Valeen has twice described Dr. Shoenfeld’s theory as based
upon an adjuvanted vaccine, Pet’r’s Br. at 17 and Pet’r’s Reply at 2, conceivably,
Dr. Shoenfeld’s opinion could be stretched to present the theory of molecular
mimicry without requiring an adjuvant. “Petitioner’s theory of causation is the
influenza vaccine, specifically the antigens in the vaccine triggered multiple cross-
reactions with human proteins that resulted in Mr. Valeen developing GPA . . . .
Dr. Shoenfeld’s proposed biological mechanism is molecular mimicry.” Pet’r’s
Br. at 10-11.
Experts for petitioners often advance molecular mimicry as a theory to
explain how a vaccine can cause a variety of injuries. See, e.g., E.M. v. Sec’y of
Health & Hum. Servs., No. 14-753V, 2021 WL 3477837, at *18 (Fed. Cl. Spec.
Mstr. July 9, 2021). In the context of attempting to explain how the flu vaccine
can cause GPA, Dr. Shoenfeld’s use of molecular mimicry is underdeveloped,
vague, and, ultimately, unpersuasive.
The experts discussed molecular mimicry in their reports. In Dr.
Shoenfeld’s first report, he asserted that “hemagglutinin from Influenza A
virus . . . shares a conspicuous number of minimal immune determinants (i.e.
pentapeptides) with human proteins that are expressed in cilia or ciliated cells and
that, when altered, are involved in ciliary dyskinesia, a disorder characterized by
abnormalities and malfunction of motile cilia.” Exhibit 28 at 17.
The Secretary’s experts disagreed. Dr. Whitton stated that sequences of five
amino acids are “predictable and commonplace.” Exhibit A at 12. Dr. Whitton
also noted that Mr. Valeen was not diagnosed with ciliary dyskinesia. Id. at 11.
Referring to the opinion Ms. Mikovits and Mr. Ruscetti presented, Dr. Lightfoot
stated that “While it is likely that many vaccines contain amino acid sequences
found in human tissue, that does not indicate that immune cross-reactivity occurs.”
Exhibit C at 8. Dr. Lightfoot added that the basis for extrapolation from ciliary
dyskinesia to GPA is not clear. Id. at 9.
In response, Dr. Shoenfeld defended his position. He asserted “as few as
four or five homologous amino acids can constitute a crossreacting antigenic
determinant with pathologic consequences.” Exhibit 77 at 5. Dr. Shoenfeld also
stated that the “crossreactions induced by Fluzone hit multiple targets in the
organism’s DNA.” Id. at 7.
9
Dr. Whitton pointed to flaws in Dr. Shoenfeld’s opinion. Dr. Whitton
discussed the significance (or lack of significance) of strings of five amino acids.
Exhibit E at 7-8. In response to Dr. Shoenfeld’s comparison to ciliary dyskinesia,
Dr. Whitton maintained that this condition “is irrelevant to the case.” Id. at 9.
Both critiques seem to reduce the persuasive value of Dr. Shoenfeld’s
opinion. Dr. Whitton’s discussion that marching pentapeptides are common and
do not necessarily carry any immunologic significance seems credible. Exhibit A
at 11-12; see also T.M. v. Sec’y of Health & Hum. Servs., No. 08-284V, 2016 WL
11087157, at *17, 29 (Fed. Cl. Aug. 9, 2016), mot. for rev. denied, 133 Fed. Cl. 78,
90-91 (2017).
However, an extensive discussion of the value of pentapeptides is not the
primary reason for finding Dr. Shoenfeld’s use of molecular mimicry not credible
in this case. Even if Dr. Shoenfeld were correct that pentapeptides can be the basis
for a cross-attack, Dr. Shoenfeld has, at best, linked the matching amino acid
sequences to proteins “involved in ciliary dyskinesia.” Exhibit 28 at 17. Mr.
Valeen attempts to reinforce this connection by citing multiple articles about
ciliary dyskinesia. Pet’r’s Br. at 13-15.
However, neither Dr. Shoenfeld nor Mr. Valeen have explained how ciliary
dyskinesia, a disease with which Mr. Valeen was not diagnosed, resembles GPA,
the condition affecting Mr. Valeen. The only comparison Mr. Valeen draws
between GPA and ciliary dyskinesia is that Mr. Valeen’s symptoms “fit the
destruction or dysfunction in the cilia.” Pet’r’s Br. at 20. This gap is particularly
noticeable because Dr. Whitton and Dr. Lightfoot have pointed it out. The
Secretary echoed their contentions, arguing that a discussion of ciliary dyskinesia
“is irrelevant at best, given that petitioner’s alleged injury in this case is GPA, not
ciliary dyskinesia.” Resp’t’s Br. at 32. When given a final word, Mr. Valeen
presented no argument about how a process arguably leading to ciliary dyskinesia
would resemble a process leading to GPA. See Pet’r’s Reply at 5 (stating that
hemagglutinin shares peptides with human proteins that are expressed in cilia or
ciliated cells). Accordingly, Mr. Valeen has failed to present “a reputable medical
or scientific explanation that pertains specifically to the petitioner’s case.”
Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1345 (Fed. Cir.
2010).
Beyond the sequences of matching peptides, Dr. Shoenfeld identifies a series
of articles in which a person received a vaccine (often an influenza vaccine) before
developing a form of vasculitis. See Pet’r’s Br. at 11-13. Of this group, the
10
potentially most persuasive are a book chapter on vasculitides and an article about
giant cell arteritis and polymyalgia rheumatica. See exhibit 59 (Alessandra
Soriano et al., Vasculitides, in Vaccines and Autoimmunity (Yehuda Shoenfeld,
Nancy Agmon-Levin, and Lucija Tomljenovic eds. 2015)) and exhibit 37 (A.
Soriano et al., Giant Cell Arteritis and Polymyalgia Rheumatica After Influenza
Vaccination: Report of 10 Cases and Review of the Literature, 21 Lupus 153
(2012)).
The chapter and the article resemble each other. The lead author appears to
be the same. The basic methodology is identifying case reports in which vaccines
preceded the development of certain conditions. Compare exhibit 59 (chapter) at
223, with exhibit 37 (article) at 154. The authors appear to endorse the concept
“autoimmune syndrome induced by adjuvant” also known as ASIA. Exhibit 59 at
224-25 and exhibit 37 at 156.8 The authors suggest mechanisms by which
vaccines might possibly cause conditions.
The similarities continue in how the pieces conclude. In the earlier work,
the article published in the journal Lupus, the authors “recommend a systemic
research of previous vaccination in patients with recent onset of [giant cell
arteritis/polymyalgia rheumatica].” Exhibit 37 at 156. The latter work, the book
chapter, repeats this recommendation: “Further investigations are needed to clarify
the biologic plausibility of post-vaccination phenomena. Thus, surveillance
systems and registries can be important tools for retrospective as well as
prospective evaluations of all cases.” Exhibit 59 at 229.
However, the book chapter goes a little further: “The lack of evidence for
other causes of the symptoms and the coincidence regarding the vaccination in
most of the cases analyzed here strongly supports a causal relationship between the
vaccination and vasculitis onset, especially where a plausible temporal association
exists.” Id. Mr. Valeen relies upon this passage. Pet’r’s Br. at 11.
Neither the Soriano book chapter nor the Soriano article make Dr.
Shoenfeld’s opinion persuasive. See exhibit A at 10 (Dr. Whitton’s critique of the
Soriano article). In essence, both are collections of case reports. Case reports
8
Special masters have consistently rejected ASIA. E.g., Pearson v. Sec’y of
Health & Hum. Servs., No. 16-9V, 2019 WL 3852633, at *13 (Fed. Cl. Spec. Mstr.
July 31, 2019).
11
provide little, if any, reliable information for determining causation. See K.O. v.
Sec’y of Health & Hum. Servs., No. 13-472V, 2016 WL 7634491, at *11-12 (Fed.
Cl. Spec. Mstr. July 7, 2016) (discussing appellate precedent on case reports).
Because they present a sequence of events in which a vaccine occurred before the
onset of the disease, case reports cannot rule out the possibility of a coincidental
(not causal) relationship.
In sum, regardless of whether Dr. Shoenfeld’s theory requires an adjuvanted
vaccine, his opinions regarding the means by which a flu vaccine can cause GPA
are not persuasive. For these reasons, Mr. Valeen has not met his burden of proof
regarding the first Althen prong. Because the finding that Mr. Valeen has not
presented a reliable basis for concluding that the flu vaccine can cause GPA
resolves the case, the remaining Althen prongs can be discussed briefly.
B. Althen Prong Two: A Logical Sequence of Cause and Effect
With respect to this prong, the Federal Circuit has instructed special masters
to consider carefully the views of a treating doctor. Capizzano v. Sec’y of Health
& Hum. Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). Here, statements from
treating doctors do not assist Mr. Valeen. The May 21, 2021 Order directed him to
identify any passages in which a doctor associated his GPA with the vaccination.
Order, issued May 21, 2021, at 7. However, Mr. Valeen has not presented any
such evidence from treating doctors in his brief. Pet’r’s Br. at 18-20; see also
Resp’t’s Br. at 38 (“[N]one of petitioner’s treating physicians – including various
specialists who treated him for several years – drew a causal connection between
his flu vaccination and his GPA.”). Mr. Valeen merely argues that the nature and
onset of his symptoms align with Dr. Schoenfeld’s theory of causation. Pet’r’s Br.
at 20.
C. Althen Prong Three: A Showing of a Proximate Temporal
Relationship Between Vaccination and GPA
The timing prong of Althen actually contains two parts. A petitioner must
show the “timeframe for which it is medically acceptable to infer causation” and
the onset of the disease occurred in this period. Shapiro v. Secʼy of Health &
Hum. Servs., 101 Fed. Cl. 532, 542-43 (2011), recons. denied after remand on
other grounds, 105 Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed.
Cir. 2013).
12
The medically acceptable timeframe depends, at least in part, on the theory
being offered. Langland v. Sec’y of Health & Hum. Servs., 109 Fed. Cl. 421, 443
(2013). Here, as explained in section IV.A. above, Mr. Valeen has not presented a
persuasive medical theory to explain how the flu vaccine can cause GPA. Thus,
analyzing the medically acceptable amount of time becomes somewhat fanciful.
With respect to the interval of time for which an inference of causation is
medically appropriate, Dr. Shoenfeld’s opinion is confusing. Dr. Shoenfeld seems
to suggest that the onset of GPA after a second flu vaccination should be rapid.
Exhibit 28 at 24; see also Pet’r’s Br. at 21 (stating that “the rapidity of onset is
particularly compelling”). Yet, at the same time, Dr. Shoenfeld suggests that an
onset of symptoms two weeks after vaccination would also be appropriate. Exhibit
28 at 13; Pet’r’s Br. at 21. In response, the Secretary noted that Mr. Valeen
provided no support for his assertion that two weeks is a medically acceptable
timeframe for onset of symptoms. See Resp’t’s Br. at 39.
While Dr. Shoenfeld might clarify his opinion on timing at a hearing, this
clarification would be academic. Even if Mr. Valeen presented preponderant proof
that his GPA developed within the time for which an inference of causation is
appropriate, establishing this sequence of events would not necessarily mean that
Mr. Valeen is entitled to compensation. Grant v. Sec’y of Health & Hum. Servs.,
956 F.2d 1144 (Fed. Cir. 1992) (“Temporal association is not sufficient, however,
to establish causation in fact.”). The lack of preponderant evidence regarding the
other Althen prongs would still prevent Mr. Valeen from receiving compensation.
V. A Hearing is Not Required
Special masters possess discretion to decide whether an evidentiary hearing
will be held. 42 U.S.C. § 300aa-12(d)(3)(B)(v) (promulgated as Vaccine Rule 8(c)
& (d)), which was cited by the Federal Circuit in Kreizenbeck v. Sec’y of Health &
Hum. Servs., 945 F.3d 1362, 1365 (Fed. Cir. 2018).
Mr. Valeen has enjoyed a fair and full opportunity to present his case. After
Dr. Shoenfeld presented his opinion initially, Dr. Whitton and Dr. Lighthouse
critiqued it, persuasively pointing out gaps and flaws in Dr. Shoenfeld’s opinion.
Dr. Shoenfeld was then given an opportunity to respond but did not repair those
deficiencies. Mr. Valeen was given a further chance to shore up Dr. Shoenfeld’s
opinion during the briefing process, but any such efforts were not persuasive.
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VI. Conclusion
After receiving a flu vaccination, Mr. Valeen developed GPA. However,
Mr. Valeen has not met his burden of establishing, more likely than not, that the flu
vaccination caused his GPA. Accordingly, the Clerk’s Office is instructed to enter
judgment in accord with this decision unless a motion for review is filed.
Information about filing a motion for review, including the deadline, can be found
in the Vaccine Rules, available through the Court’s website.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
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