VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-01322
Package ID: USCOURTS-cofc-1_17-vv-01322
Petitioner: David T. McDaniel
Filed: 2017-09-25
Decided: 2023-07-21
Vaccine: influenza
Vaccination date: 2016-12-12
Condition: immune-mediated myopathy, more likely than not dermatomyositis sine dermatitis
Outcome: denied
Award amount USD: 

AI-assisted case summary:
On September 25, 2017, David T. McDaniel filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that an influenza vaccine administered on December 12, 2016, caused him to develop an immune-mediated myopathy, more likely dermatomyositis sine dermatitis. Respondent, the Secretary of Health and Human Services, argued against compensation. The parties stipulated that Mr. McDaniel received the flu vaccine and most likely suffered from an immune-mediated myopathy, but disagreed on the specificity of the diagnosis and the onset of symptoms relative to the vaccination. Petitioner was represented by Douglas Lee Burdette, and Respondent was represented by Debra A. Filteau Begley. Special Master Nora Beth Dorsey presided over the case. 

Mr. McDaniel, born February 5, 1952, had a history of myopia, gammopathy, hyperlipidemia, dermatitis, chronic neck and back pain, and alcoholism. Prior to vaccination, on December 1, 2016, he presented with a one-month history of fatigue, sore muscles, chills, tingling in his arms and legs, increased weakness, and a feeling of losing muscle tone. Labs revealed elevated AST and ALT. On December 12, 2016, the day of vaccination, his AST and ALT remained elevated, and he received the flu vaccine (Fluvirin). Four days later, on December 16, 2016, he reported worsening weakness and paresthesias, difficulty walking, and pain. He was admitted to Good Samaritan Hospital, where his condition was assessed as rhabdomyolysis and generalized weakness, with a differential diagnosis including post-vaccine syndrome or viral-induced autoimmune neuropathy. He also reported a viral flu-like illness approximately two weeks prior to vaccination. Further evaluation at University of Washington Medical Center led to a discharge diagnosis of autoimmune myositis, possibly dermatomyositis sine dermatitis. 

Petitioner's expert, Dr. Thomas M. Zizic, opined that the flu vaccine triggered an autoimmune response through mechanisms like molecular mimicry, leading to dermatomyositis. He argued that Petitioner's symptoms began within 24 hours of vaccination and that pre-vaccination elevated liver enzymes were due to liver damage, not pre-existing muscle disease. Respondent's expert, Dr. Mehrdad Matloubian, opined that Mr. McDaniel's muscle disease began before vaccination, citing his pre-vaccination symptoms of fatigue, sore muscles, and loss of muscle tone, as well as elevated AST and ALT. Dr. Matloubian argued that the elevated enzymes were likely due to muscle injury, not liver disease, and that the onset of symptoms predated the vaccination by several weeks, citing Petitioner's own reports of feeling unwell prior to December 12, 2016. Dr. Matloubian also contended that the proposed mechanism of molecular mimicry was not supported by evidence linking the flu vaccine to immune-mediated myositis and that viral infections, such as CMV, were potential alternative causes. 

Special Master Dorsey found that Mr. McDaniel's immune-mediated myopathy was most likely dermatomyositis sine dermatitis. She determined that the onset of symptoms occurred as early as November 1, 2016, and by December 4, 2016, predating the vaccination. This finding was based on contemporaneous medical records from multiple providers, which were given more weight than Petitioner's declarations. The Special Master found Dr. Matloubian's explanation for the elevated AST and ALT levels (due to muscle disease) more persuasive than Dr. Zizic's (due to liver disease). 

Regarding causation, the Special Master found that Petitioner failed to establish the first Althen prong (medical theory) because the cited literature did not support molecular mimicry as a causal mechanism for flu vaccine-induced immune-mediated myopathy. She noted that while flu infections can cause viral myositis, this is typically due to direct muscle infection, not an autoimmune mechanism. Furthermore, the evidence did not establish a link between flu vaccination and autoimmune myositis, nor did it demonstrate molecular mimicry between the vaccine and muscle tissue. 

For the second Althen prong (logical sequence of cause and effect), the Special Master found that because onset predated vaccination, the vaccine could not have caused the illness. Even if it had, the presence of a preceding viral-like illness and CMV infection made it difficult to attribute 'but for' causation to the vaccination. 

For the third Althen prong (proximate temporal relationship), the Special Master reiterated that onset predated vaccination. She also found Dr. Zizic's proposed 24-hour onset time frame for molecular mimicry to be unsupported by medical literature or Program case law. 

Ultimately, Special Master Dorsey concluded that Mr. McDaniel failed to prove by a preponderance of the evidence that the flu vaccine caused his condition, and therefore, his petition was denied. The decision was issued on July 21, 2023.

Theory of causation field:
Petitioner David T. McDaniel alleged that an influenza vaccine administered on December 12, 2016, caused immune-mediated myopathy, specifically dermatomyositis sine dermatitis. Petitioner's expert, Dr. Thomas M. Zizic, proposed molecular mimicry, cross-priming, or immune complex formation as causal mechanisms, suggesting the vaccine triggered an autoimmune response. Dr. Zizic opined that symptoms began within 24 hours post-vaccination and that pre-vaccination elevated AST/ALT were due to liver disease. Respondent's expert, Dr. Mehrdad Matloubian, countered that symptoms began weeks before vaccination, citing Petitioner's pre-vaccination complaints and elevated AST/ALT as evidence of pre-existing muscle disease, not liver disease. Dr. Matloubian argued that molecular mimicry was not a scientifically supported mechanism for flu vaccine-induced myositis and identified viral infections (like CMV) as alternative causes. Special Master Nora Beth Dorsey found that symptom onset predated vaccination (as early as November 1, 2016), failed to find a medically accepted theory linking the flu vaccine to immune-mediated myopathy via molecular mimicry or other mechanisms, and determined that the temporal relationship was not proximate given the pre-vaccination onset and lack of support for a 24-hour onset with the proposed theory. Consequently, the petition was denied based on failure to prove all three Althen prongs of causation.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_17-vv-01322-0
Date issued/filed: 2023-07-21
Pages: 46
Docket text: PUBLIC DECISION (Originally filed: 6/26/2023) regarding 93 DECISION of Special Master. Signed by Special Master Nora Beth Dorsey. (mjf) Service on parties made.
--------------------------------------------------------------------------------
Case 1:17-vv-01322-UNJ Document 94 Filed 07/21/23 Page 1 of 46
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: June 26, 2023
* * * * * * * * * * * * * * * * * * * * * * * * *
DAVID T. MCDANIEL, * PUBLISHED
*
Petitioner, * No. 17-1322V
*
v. * Special Master Nora Beth Dorsey
*
SECRETARY OF HEALTH * Entitlement; Influenza (“Flu”) Vaccine;
AND HUMAN SERVICES, * Immune-Mediated Myopathy;
* Dermatomyositis; Diagnosis; Onset.
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Douglas Lee Burdette, Burdette Law, North Bend, WA, for Petitioner.
Debra A. Filteau Begley, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION1
I. INTRODUCTION
On September 25, 2017, David T. McDaniel (“Petitioner”) filed a petition for
compensation under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the
Program”), 42 U.S.C. § 300aa-10 et seq. (2018).2 Petitioner alleges that he suffered “an auto-
immune myopathy, more likely than not dermatomyositis,” as the result of an influenza (“flu”)
1 Because this Decision contains a reasoned explanation for the action in this case, the
undersigned is required to post it on the United States Court of Federal Claims’ website and/or at
https://www.govinfo.gov/app/collection/uscourts/national/cofc in accordance with the E-
Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of
Electronic Government Services). This means the Decision will be available to anyone with
access to the Internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to
identify and move to redact medical or other information, the disclosure of which would
constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the
identified material fits within this definition, the undersigned will redact such material from
public access.
2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C. §§ 300aa-10 to -34 (2018). All citations in this Decision to individual sections of the
Vaccine Act are to 42 U.S.C. § 300aa.

Case 1:17-vv-01322-UNJ Document 94 Filed 07/21/23 Page 2 of 46
vaccination administered on December 12, 2016. Petition at Preamble (ECF No. 1); Amended
(“Am.”) Petition at Preamble (ECF No. 7). Respondent argued against compensation, stating
that “this case is not appropriate for compensation under the terms of the Vaccine Act.”
Respondent’s Report (“Resp. Rept.”) at 1 (ECF No. 22).
After carefully analyzing and weighing the evidence presented in this case in accordance
with the applicable legal standards, the undersigned finds that Petitioner has failed to provide
preponderant evidence that his flu vaccine caused his immune-mediated myopathy. Thus,
Petitioner has failed to satisfy his burden of proof under Althen v. Secretary of Health & Human
Services, 418 F.3d 1274, 1280 (Fed. Cir. 2005). Accordingly, the petition shall be dismissed.
II. ISSUES TO BE DECIDED
The parties stipulate that Petitioner received the flu vaccine on December 12, 2016, and
that Petitioner most likely suffered from an immune-mediated myopathy. Joint Submission, filed
June 13, 2022, at 1 (ECF No. 77). However, “the experts appear to disagree on whether a more
specific diagnosis (i.e., dermatomyositis, polymyositis, or dermatomyositis sine dermatitis) is
appropriate.” Id.
The parties also disagree on onset, specifically whether onset was before or after the flu
vaccination administered on December 12, 2016. Petitioner’s Brief on the Issue of Entitlement
(“Pet. Br.”), filed June 13, 2022, at 3-4 (ECF No. 78); Resp. Response to Pet. Br. (“Resp.
Response”), filed Oct. 10, 2022, at 15-23 (ECF No. 91).
As for causation, the parties disagree as to whether Petitioner has satisfied all three
Althen prongs. Joint Submission at 1. Petitioner contends he has presented preponderant
evidence of all three Althen prongs, establishing his condition was caused-in-fact by his flu
vaccine on December 12, 2016. Pet. Br. at 6-8. Respondent disagrees and argues Petitioner
“failed to produce reliable evidence” of all three Althen prongs. Resp. Response at 13-19.
Petitioner does not allege a significant aggravation claim.3 Joint Submission at 1; Joint
Status Rept., filed Mar. 23, 2023 (ECF No. 89).
3 In his brief, Petitioner identified the issues to include the following question: “Did Petitioner
suffer an autoimmune inflammatory process (polymyositis/dermatomyositis) or an exacerbation
of that process as a direct and proximate result of his vaccination on December 12, 2016?” Pet.
Br. at 3. This statement suggested that Petitioner was pursuing a claim for significant
aggravation, although Petitioner’s expert reports and brief did not address the Loving prongs
relevant to such a claim. See Loving v. Secretary of Health & Human Services, 86 Fed. Cl. 135,
142-44 (2009). To seek clarification, the undersigned issued an order asking Petitioner whether
he was alleging a significant aggravation claim. Order dated Feb. 21, 2023 (ECF No. 88).
Thereafter, the parties filed a joint status report advising that Petitioner was not claiming
significant aggravation. Joint Status Rept., filed Mar. 23, 2023. Thus, the undersigned does not
address or adjudicate such a claim herein. Even if Petitioner had pursued a significant
aggravation claim, the outcome would have been the same, as he failed to prove by preponderant
evidence all three Althen prongs, which constitute Loving prongs four, five, and six.
2

Case 1:17-vv-01322-UNJ Document 94 Filed 07/21/23 Page 3 of 46
III. BACKGROUND
A. Medical Terminology
Inflammatory myopathies4 are a group of disorders classified based on their distinct
clinical and pathological characteristics into four subtypes, two of which are relevant here,
dermatomyositis and polymyositis,5 “characterized by the shared features of proximal skeletal
muscle weakness and by evidence of muscle inflammation.” Pet. Exhibit (“Ex.”) 33 at 1;6 see
also Resp. Ex. A, Tab 7 at 1.7 Dermatomyositis differs from polymyositis due to its
“associat[ion] with a variety of characteristic skin manifestations.”8 Pet. Ex. 33 at 1. Both
conditions are “multisystem disorders with a wide variety of clinical manifestations. Most
patients exhibit proximal skeletal muscle weakness.” Id. at 2. Muscles commonly affected
include the “deltoids and the hip flexors.” Id.
“Patients usually report a history of insidious or subacute development of the muscle
weakness, with gradual worsening over a period of several months before medical attention is
sought.” Pet. Ex. 33 at 2. “However, an acute onset is occasionally reported. Patients may
describe increasing difficulty climbing stairs, [and] getting up from a chair.” Id. “Muscle
atrophy is generally not seen in early cases, even in patients with marked weakness, but it may
occur in severe, longstanding disease.” Id.
Laboratory tests to assess for idiopathic inflammatory myopathies measure enzymes to
determine whether there is muscle injury. Pet. Ex. 39 at 1.9 Muscle enzymes are thought to be
released from injured or dying muscle fibers. Id. at 2. Characteristic lab findings of
dermatomyositis and polymyositis include “elevated levels of muscle enzymes,” such as
4 Myopathies include “any disease of a muscle.” Myopathy, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=32891 (last visited June 9, 2023).
5 Other articles filed by the parties define dermatomyositis and polymyositis as “autoimmune
myopathies.” See, e.g., Resp. Ex. A, Tab 2 at 1 (Andrew L. Mammen, Dermatomyositis,
Polymyositis, & Immune-Mediated Necrotizing Myopathy, in Current Diagnosis & Treatment in
Rheumatology (3rd. ed. 2013)).
6 Marc L. Miller & Ruth Ann Vleugels, Clinical Manifestations of Dermatomyositis and
Polymyositis in Adults, UpToDate, https://www.uptodate.com/contents/clinical-manifestations-
of-dermatomyositis-and-polymyositis-in-adults (last updated Jan. 30, 2017).
7 Marinos C. Dalakas, Inflammatory Muscle Diseases, 372 New Eng. J. Med. 1734 (2015).
8 For a discussion of common skin manifestations, see Resp. Ex. A, Tab 2, at 2. Petitioner did
not have skin manifestations.
9 Ira N. Targoff, Laboratory Testing in the Diagnostic and Management of Idiopathic
Inflammatory Myopathies, 28 Rheumatic Disease Clinics N. Am. 859 (2002).
3

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“[c]reatine kinase (CK)[10] . . . aspartate aminotransferase (AST),[11] and alanine aminotransferase
(ALT).”12 Pet. Ex. 33 at 7. CK has traditionally been thought to be the most useful lab test due
to its specificity and sensitivity for skeletal muscle injury. Pet. Ex. 39 at 4. “The transaminases,
AST and ALT, can be elevated in patients with muscle injury and vary with disease activity.” Id.
at 7. AST is “present in the liver” as well as “skeletal muscle,” while ALT is “present primarily
in the liver,” and thus, a “more specific marker of hepatocellular cell injury.” Pet. Ex. 41 at 2.13
Gamma-glutamyl transpeptidase (“GGT”) may also be tested to “evaluate elevations of other
serum enzyme tests.” Id. at 11. “Not infrequently, elevated AST and ALT levels are
misinterpreted as evidence of liver disease in patients with myopathy. To rule out liver disease, a
[] GGT level can be measured; GGT is usually released along with AST and ALT in liver
disease but not from damaged muscle.” Resp. Ex. A, Tab 2 at 4.
Dermatomyositis can occur in both children and adults and is characterized by “distinct
skin manifestations accompanying or preceding muscle weakness.” Resp. Ex. A, Tab 7 at 2.
The skin abnormalities may include “periorbital heliotrope (blue-purple) rash with edema;
10 CK is “an Mg2+-activated enzyme of the transferase class that catalyzes the phosphorylation
of creatine by ATP to form phosphocreatine. The reaction effectively stores the energy of ATP
as phosphocreatine in muscle and brain tissue and holds the muscle concentration of ATP nearly
constant during the initiation of exercise.” Creatine Kinase, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=11582 (last visited June 9, 2023). “It
occurs as three isoenzymes, each having two components composed of M (muscle) and of B
(brain) subunits. CK (BB) is found primarily in brain, CK (MB) primarily in cardiac muscle,
1 2
and CK (MM) primarily in skeletal muscle. Differential determination of isoenzymes is useful
3
for clinical diagnoses.” Id.
11 AST is “an enzyme of the transferase class that catalyzes the reversible transfer of an amino
group from aspartate to α-ketoglutarate to form glutamate and oxaloacetate.” Aspartate
Transaminase, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/
definition?id=4466 (last visited June 9, 2023). AST is “present in most eukaryotic cells,
occurring as distinct isozymes in mitochondria and cytosol. Both isozymes participate in the
malate-aspartate shuttle, and in the liver the reaction transfers excess metabolic nitrogen into
aspartate for disposal via the urea cycle.” Id. “The serum level of [AST] and that of other
transaminases are frequently elevated in a variety of disorders causing tissue damage.” Id.
12 ALT is “an enzyme of the transferase class that catalyzes the reversible transfer of an amino
group from alanine to α-ketoglutarate to form glutamate and pyruvate.” Alanine Transaminase,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=1509
(last visited June 9, 2023). “The reaction transfers nitrogen for excretion or for incorporation
into other compounds. The enzyme is found in serum and body tissues, especially in the liver.
Serum enzyme activity (SGPT) is greatly increased in liver disease and also elevated in
infectious mononucleosis.” Id.
13 Lawrence S. Friedman, Approach to the Patient with Abnormal Liver Biochemical and
Function Tests, UpToDate, https://www.uptodate.com/contents/approach-to-the-patient-with-
abnormal-liver-biochemical-and-function-tests (last updated Apr. 4, 2018).
4

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erythematous rash on the face, knees, [and] elbows . . . ; and a violaceous eruption (Gottron’s
rash) on the knuckles, which may evolve into a scaling discoloration.” Id. There may also be
manifestations of the fingernails and palms. Id. “Polymyositis is rare as a stand-alone entity and
is often misdiagnosed.” Id. It is a diagnosis of exclusion and is defined as “a subacute proximal
myopathy in adults who do not have rash, a family history of neuromuscular disease,” exposure
to drugs that are known to be toxic to muscle, or “the clinical phenotype of inclusion-body
myositis.” Id. at 2-4. Dermatomyositis and polymyositis can be “distinguished from each other .
. . by their histopathologic findings” on muscle biopsy. Pet. Ex. 33 at 11. Polymyositis is
“distinguished by the presence of T cells [endomysial inflammatory cell infiltrate] surrounding
and/or invading nonnecrotic muscle fibers,” whereas dermatomyositis is characterized by
“perifascicular atrophy.” Resp. Ex. A, Tab 4 at 3, 4 tbl.25.1.14
Increased rates of cancers have been noted in those with dermatomyositis and
polymyositis, especially in patients with dermatomyositis. Pet. Ex. 33 at 5. “Colonoscopy is
recommended for patients over the age of 50” who have been diagnosed with immune-mediated
myopathy. Resp. Ex. A, Tab 2 at 7; see also Resp. Ex. A, Tab 4 at 10-11 (discussing cancer
risks).
B. Procedural History
On September 25, 2017, Petitioner filed his petition, and on October 25, 2017, Petitioner
filed a declaration and supporting medical records.15 Petition; Pet. Exs. 1-9. On April 6, 2018,
Petitioner filed an expert report from Dr. Thomas M. Zizic. Pet. Ex. 10. Additional medical
records were filed on August 9, 2018. Pet. Ex. 31. Respondent filed his Rule 4(c) Report on
November 13, 2018, arguing against compensation. Resp. Rept. at 1, 12. Respondent
simultaneously filed a responsive expert report from Dr. Mehrdad Matloubian. Resp. Ex. A. On
February 4, 2019, Petitioner filed a supplemental expert report from Dr. Zizic, and Respondent
filed a responsive supplemental report from Dr. Matloubian on May 28, 2019. Pet. Ex. 32; Resp.
Ex. C. Petitioner filed a second supplemental report from Dr. Zizic on June 11, 2019. Pet. Ex.
45.
Subsequently, Respondent filed a status report indicating the parties wanted to schedule
an entitlement hearing. Status Rept., filed July 17, 2019 (ECF No. 32). The case was reassigned
to the undersigned on July 30, 2020. Notice of Reassignment dated July 30, 2020 (ECF No. 35).
At a status conference on August 27, 2020, the undersigned encouraged the parties to resolve the
case informally and ordered Petitioner to file updated medical records and a status report
indicating a demand was transmitted to Respondent. Order dated Aug. 27, 2020 (ECF No. 36).
Seven months later, Petitioner had still not filed updated medical records or submitted a demand
to Respondent. See Order dated Mar. 3, 2021 (ECF No. 45). Petitioner’s counsel was warned
that failure to show progress would result in an order to associate other counsel. Id.
14 Andrew Mammen, Autoimmune Muscle Disease, in 133 Handbook Clinical Neurology:
Autoimmune Neurology 467 (Sean J. Pittock & Angela Vincent eds., 3rd. ser. 2016).
15 Petitioner filed an amended petition on October 19, 2017. Am. Petition. It appears only the
paragraph numbering was modified from the original. See id.
5

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On March 15, 2021, Petitioner filed declarations of Petitioner and Petitioner’s wife,
Sandy McDaniel. Pet. Exs. 46-47. Petitioner filed additional medical records on May 17, 2021.
Pet. Exs. 48-49. The parties engaged in settlement negotiations but reached an impasse and
requested the case be submitted for a ruling on the record. Joint Motion for Ruling on the
Record, filed Apr. 11, 2022, at 1 (ECF No. 75). Petitioner submitted his brief in support of
entitlement on June 13, 2022, and Respondent filed his brief on October 10, 2022. Pet. Br.;
Resp. Response.
On February 21, 2023, the undersigned issued an order requesting guidance as to whether
Petitioner was pursuing a claim for significant aggravation, and the parties were directed to
confer and file a joint status report providing clarification. Order dated Feb. 21, 2023 (ECF No.
88). Petitioner filed a joint status report on March 23, 2023, advising that Petitioner was not
offering evidence of a significant aggravation claim, and advising that the record was complete
for adjudication. Joint Status Rept., filed Mar. 23, 2023.
This matter is now ripe for adjudication.
C. Medical History16
1. Pre-Vaccination Records
Petitioner was born on February 5, 1952. Pet. Ex. 2 at 1. Prior to vaccination, he had a
history myopia, gammopathy, hyperlipidemia, dermatitis, chronic neck and back pain,
alcoholism, and was a former smoker. Id. at 1, 44-45, 166; Pet. Ex. 7 at 1, 4; Pet. Ex. 8 at 1.
Petitioner sought treatment for intermittent arthralgias throughout 2015, but a rheumatology
consultation in March 2015 ruled out a systemic inflammatory disorder. See Pet. Ex. 2 at 43, 50;
Pet. Ex. 10 at 6-7; Resp. Ex. A at 2.
On December 1, 2016, Petitioner presented to his primary care provider (“PCP”) where
he saw Benjamin R. Cichon, certified physician assistant (“PA-C”). Pet. Ex. 2 at 50-52.
Petitioner complained of a one-month history of fatigue, sore muscles, and chills. Id. at 50. He
also complained of a tingling sensation in his arms and legs, “increased weakness,” and back
pain, and he felt “like he [was] losing a lot of his muscle tone.” Id. Physical examination was
normal, except for tenderness along his spine and some discomfort bilaterally in the cubital
tunnel area. Id. at 50-51. Petitioner was diagnosed with paresthesias, possible carpal
16 For the parties’ respective medical record summaries, see Pet. Br. at 1-3; Resp. Response at 1-
10.
6

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tunnel/cubital tunnel syndrome,17 and “increased arm and leg weakness with tingling.” Id. at 51.
Labs were ordered and Petitioner was referred to a neurologist.18 Id. Testing completed that day
revealed an elevated AST of 55 (normal range 10-35 U/L) and an elevated ALT of 57 (normal
range 9-46 U/L).19 Id. at 140.
Petitioner returned to his PCP on December 12, 2016. Pet. Ex. 2 at 55-59. He saw Dr.
John Dinh who noted that Petitioner’s recent lab results revealed “elevated liver enzymes” (AST
and ALT), but there was no mention of Petitioner’s symptoms reported on December 1, 2016.
Id. at 55. Lab testing repeated on this date revealed continuously elevated AST (63) and ALT
(73), and elevated ferritin20 of 701 (normal range 20-380 ng/mL). Id. at 125, 138. Hepatitis A,
B, and C titers were negative. Id. at 125, 139. Review of systems was negative and there were
no documented abnormalities based on the physical examination. Id. at 55-57. Neurological
examination documented normal sensation, normal strength in upper and lower extremities
bilaterally, and normal gait. Id. at 57. Petitioner received the flu vaccine (Fluvirin) at this visit
in his left deltoid. Id. at 58; Pet. Ex. 3 at 21.
2. Post-Vaccination Records
On Friday, December 16, 2016, four days after receiving his flu shot, Petitioner returned
to his PCP and reported that since receiving the flu shot on Monday, December 12, he had
developed weakness and paresthesias, mainly in his lower extremities. Pet. Ex. 2 at 60.
Petitioner described difficulty “getting up out of a chair” and walking. Id. Petitioner also
reported fatigue and painful joints, and that these symptoms “ha[d] been worsening daily since
[his] last visit.” Id. at 63. On examination, Petitioner exhibited “weakness below the hips,”
difficulty walking, and could not “get up out of the chair without assistance.” Id. at 60. His
17 Carpal tunnel syndrome is “an entrapment neuropathy characterized by pain and burning or
tingling paresthesias in the fingers and hand, sometimes extending to the elbow. Symptoms
result from compression of the median nerve in the carpal tunnel.” Carpal Tunnel Syndrome,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id
=110370 (last visited June 9, 2023). Cubital tunnel syndrome is “a type of entrapment
neuropathy with a complex of symptoms resulting from injury or compression of the ulnar nerve
at the elbow, including pain and numbness along the ulnar aspect of the hand and forearm and
weakness of the hand.” Cubital Tunnel Syndrome, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=110481 (last visited June 9, 2023).
18 It does not appear that Petitioner saw a neurologist prior to his admission to Good Samaritan
Hospital on December 16, 2016.
19 These were abnormalities for Petitioner. When these labs were checked in December 2015,
they were normal (22 and 21). Pet. Ex. 2 at 143.
20 Ferritin is “the iron-apoferritin complex, one of the chief forms in which iron is stored in the
body; it occurs at least in the gastrointestinal mucosa, liver, spleen, bone marrow, and
reticuloendothelial cells generally.” Ferritin, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=183386 (last visited June 9, 2023).
7

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upper extremities were normal. Id. Dr. Robert M. Alston noted that Petitioner’s elevated liver
enzymes required further evaluation and that his elevated ferritin level was suggestive of
inflammation. Id. Dr. Alston’s assessment was Guillain-Barré syndrome (“GBS”), and he
advised Petitioner to go to the emergency department (“ED”) for further evaluation. Id.
Petitioner presented to the ED at Good Samaritan Hospital on Friday, December 16,
2016, where he was seen by John B. Gillum, PA-C, for “body aches and weakness.” Pet. Ex. 5
at 103. Petitioner reported that his symptoms started five days prior when he had a flu shot. Id.
The night of his flu shot, Petitioner “noted some tremors in his left fifth and fourth finger. This
resolved and then he developed severe muscle aches in his calves and thighs. . . . Over the last 24
hours he felt more weakness and pain in his upper extremities.” Id.
Nursing notes stated that Petitioner received a “flu shot on Monday and by Monday
evening [Petitioner] was [complaining of] of lower extremity weakness that over the last couple
of days had gotten worse and progressed up arms.” Pet. Ex. 5 at 108. Petitioner was still able to
walk but stated “it [was] hard to move around.” Id. Onset was recorded as “3-7 days ago.” Id.
Physical examination showed weakness in Petitioner’s lower and upper extremities but
intact deep tendon reflexes. Pet. Ex. 5 at 105, 108. Lab tests showed elevated AST at 76, ALT
at 73, and CK at 674 (normal range 0-200 IU/L). Id. at 105-06, 189. A spinal tap revealed
mildly elevated protein (53; normal range 15-50 mg/dL), only one white blood cell, and high CK
of 687. Id. at 107, 190-91. Petitioner was admitted to the hospital for further evaluation. Id. at
106-08.
Later that day, Petitioner was evaluated by Dr. Nelson Yang. Pet. Ex. 5 at 93. Petitioner
again reported that he received a flu vaccine on Monday, and by Monday night, he felt the
“lateral [three] fingers of his left hand and were twitching. The next day, he woke up with pain
going down from his umbilical area all the way to the distal lower extremities.” Id. And on
Thursday, the day prior to admission, Petitioner started noticing bilateral shoulder pain and mild
arm weakness. Id. Petitioner also reported “he had a viral flu-like illness roughly [two] weeks
ago from today [December 16, 2016] prior to getting the flu shot as well and had recovered prior
to getting the flu shot.” Id. Petitioner reported he was an industrial construction worker and
worked with mercury light bulbs, and over the last five years he “must have had some exposure”
(to mercury) because some light bulbs would break and he did not wear any protection when
handling them. Id. at 93-94. On examination, Petitioner demonstrated minimal decease in
strength, but sensation was intact and deep tendon reflexes were present. Id. at 94.
Dr. Yang’s assessment was rhabdomyolysis and generalized weakness. Pet. Ex. 5 at 95.
Dr. Yang noted Petitioner “likely had myalgias from post-vaccine syndrome,” but that because
Petitioner had “a viral-like illness [two] weeks ago, . . . delayed reaction and delayed
autoimmune neuropathy could be on the differential as well.” Id. Petitioner expressed concern
for chronic mercury poisoning, which as Dr. Yang noted, can present with neurological
symptoms including numbness and tingling. Id. Mercury lab testing revealed normal results.
Id. at 219. Hepatitis C antibody test was positive with normal viral load.21 Id. at 204. The plan
21 These labs were collected on December 20, 2016. Pet. Ex. 5 at 204.
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was to observe Petitioner’s pain and weakness and if it continued, to have magnetic resonance
imaging (“MRI”) done. Id. at 95.
Additional diagnostic testing included a pelvic MRI done December 19, 2016, which was
abnormal, showing “diffuse and bilaterally symmetric abnormal [] signal involving nearly all of
the imaged muscular structures” in the pelvis to the mid-thigh area, as well as “mild
subcutaneous edema” and “presacral edema.” Pet. Ex. 5 at 187. The findings were “concerning
for myositis.” Id.
Petitioner had a neurology consultation on December 19, 2016 with Dr. Traci D. Ryan.
Pet. Ex. 5 at 96. Petitioner reported “that about [two] weeks ago he had a viral infection and had,
in general, been feeling pretty badly.” Id. “He had some blood drawn for his upcoming physical
and decided that he should go ahead and have a flu shot. He had a flu shot on Monday and then
about [three] days later developed a sense of weakness and pain and noticed that some of the
fingers on his left hand were twitching.” Id. Dr. Ryan noted Petitioner’s elevated labs. Id. at 97.
The assessment was “more likely [] a viral myositis.” Id. at 98. “How this [was] related to his
flu shot [was] uncertain. It may more likely be related to his recent viral illness.” Id. She did
“not see any other risk factors for him to develop rhabdomyolysis and therefore suspect[ed] that
this [was] a viral syndrome.” Id.
Also on December 19, Petitioner was seen by Helen Ward, a licensed independent
clinical social worker (“LICSW”), who wrote that Petitioner stated that “he [did not] have very
much trust in the medical field and he will ‘never get another flu shot again.’” Pet. Ex. 5 at 268.
Petitioner did not “think he was sick when he got his flu shot, he [thought] he was ‘fighting
something off.’” Id. Petitioner also reported that he had been “losing some muscle strength for a
while.” Id.
The next day, Dr. Ryan followed up with Petitioner and noted his CK elevated from the
day before. Pet. Ex. 5 at 122. Her assessment was rhabdomyolysis, with “viral etiology most
likely.” Id. Cytomegalovirus (“CMV”) immunoglobulin M (“IgM”) and immunoglobulin G
(“IgG”) test results from December 22, 2016 were positive. Id. at 209. A progress note authored
by Dr. Ryan on December 23 noted that CMV and Epstein-Barr virus (“EBV”) testing was
positive on quantitative PCR. Id. at 145, 219-20. She stated that “[w]ithout other signs of
inflammatory myositis [] viral myositis is the most likely diagnosis.” Id. at 145.
On December 24, 2016, Petitioner was seen by Dr. Elizabeth A. Lien, an infectious
disease specialist. Pet. Ex. 5 at 146. She did not believe the etiology of Petitioner’s illness was
infectious and suspected a “muscle issue.” Id.
The same day, a gastroenterology consult was performed by Dr. Abhishek Agarwal, who
noted that Petitioner’s CK had increased to 11,600. Pet. Ex. 5 at 98-99. AST and ALT were also
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elevated, AST greater than ALT. Id. at 99. Liver sonogram showed patchy hepatic steatosis.22
Id. Dr. Agarwal opined that elevation of liver enzymes was “likely secondary to muscle injury.”
Id. at 101. Dr. Agarwal observed that “mild elevation of AST/ALT can also be seen with
hepatotropic virus such as CMV/EBV[,] but the AST should not be [three] times the ALT.” Id.
at 102.
Petitioner was transferred to University of Washington Medical Center (“UW”) on
December 25, 2016, where he remained hospitalized for one month. Pet. Ex. 4 at 135.
Admission note by Dr. John Kyle Feller noted that Petitioner was transferred for a workup of
“worsening diffuse muscle aches and weakness.” Id. at 136. Petitioner reported that he had been
“in his usual state of health until roughly [three] weeks ago when he began feeling ‘crummy’
with no specific symptoms he could pinpoint.” Id. On December 12, “he went for a flu shot and
routine labs and in the following days reported that his symptoms began to worsen.” Id. He was
then referred to the ED by his PCP where he was admitted at Good Samaritan Hospital, and
subsequently transferred to UW for additional workup. Id. His labs on arrival to UW included
elevated AST of 634, elevated ALT of 114, and elevated CK of 16,000. Id.
That day, Petitioner was seen by rheumatologists Dr. Percy Guanzon Balderia and Dr.
Scott Pollock, who noted that Petitioner had “flu-like symptoms [two] weeks before onset of
muscle pain and a[] [flu] vaccine [two] days before.” Pet. Ex. 4 at 774. They noted his prior lab
results including abnormal AST, ALT, and CK, as well as positive CMV IgM and IgG, and
positive hepatitis C antibody with undetectable viral load. Id. Physical examination did not
reveal abnormalities of the skin or nails. Id. at 775. Diagnosis was “acute myositis with
rhabdomyolysis, differential include[d] viral myositis, necrotizing autoimmune myositis, toxic
myositis (alcohol),[23] polymyositis, [and] inclusion-body myositis.” Id. at 776. Additional labs
and diagnostic studies, including muscle biopsy, were ordered. Id.
Labs reported on December 26, 2016 showed positive CMV IgM and IgG, and CMV on
quantitative PCR. Pet. Ex. 4 at 1050. Antinuclear antibody (“ANA”) was positive (1:80),24 but
22 Steatosis is a fatty change. Steatosis, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=47052 (last visited June 22, 2023).
Hepatic refers to the liver. Hepatic, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=22172 (last visited June 22, 2023).
23 Physicians noted that while Petitioner reported drinking alcohol daily, he “denied binge
drinking and exposure to other medications that can cause myositis.” Pet. Ex. 4 at 776.
“Moreover, the urine drug screen . . . was negative.” Id.
24 ANAs are antibodies “found in the circulations of patients with various connective tissue
disorders.” Julius M. Cruse & Robert E. Lewis, Illustrated Dictionary of Immunology 65 (3rd
ed. 2009).
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other autoimmune markers were negative. Id. at 1052. Repeat myositis panel was negative,
except for “borderline” anti-PM/SCL-100.25 Id. at 1053, 1055.
Muscle biopsy done December 27, 2016 showed “myopathic changes” with “features
suggestive of an inflammatory myopathy.” Pet. Ex. 4 at 1059. The features that suggested an
inflammatory myopathy included “patchy HLA-class-I upregulation and some macrophage and
T-cell infiltrates . . . in addition to some patchy areas of perifascicular atrophy” that “can be seen
in dermatomyositis or immune myopathy with perimysial pathology (IMPP).” Id. Because
Petitioner had been on steroids, the “histological findings of an inflammatory/autoimmune
process may [have] be attenuated.” Id. The pathologists also discussed the “clinical concern of a
CMV-mediated process,” noting “at least one report . . . that CMV may propagate the
inflammatory myopathies dermatomyositis and polymyositis.”26 Id. The pathologists noted
there were “fewer reports of CMV-associated cases of rhabdomyolysis” as compared with flu,
coxsackie virus, and herpes viruses. Id. “Overall, the muscle demonstrate[d] non-specific
myopathic changes which may be related to inflammatory myopathy with possible etiologies
including autoimmune[], viral[,] or other infectious processes.” Id. An amended report was filed
following the findings after toluidine blue staining. Id. at 1061-62. These “additional studies . . .
include[d] mild, nonspecific changes.” Id. at 1062.
Petitioner was seen by infectious disease physician Dr. Wayne Liles on December 28,
2016. Pet. Ex. 4 at 692. Dr. Liles noted that Petitioner’s CMV PCR was positive, and there
were “two possible explanations for this:” (1) “low level reactivation of a virus in the context of
illness,” and (2) “CMV viremia at a much higher level previously (possibly causing his myositis)
and the infection [was then] in the process of resolving with low levels of virus.” Id. Dr. Liles
ordered that the CMV PCR be repeated. Id.
Steroids were administered for three days, followed by three days of intravenous
immunoglobulin (“IVIG”), and then Petitioner began a “course of methotrexate[27] and
25 Anti-PM/Scl autoantibodies are “[m]yositis-associated autoantibodies specific for the nuclear
antigen PM/Scl found among many patients with overlap syndrome with features such as
scleroderma and polymyositis/dermatomyositis.” Illustrated Dictionary of Immunology at 67.
26 The article referenced was filed as Resp. Ex. A, Tab 10 (Andreas E. R. Fasth et al., T Cell
Infiltrates in the Muscles of Patients with Dermatomyositis and Polymyositis Are Dominated by
CD28null T Cells, 183 J. Immunology 4792 (2009)).
27 Methotrexate is “a folic acid antagonist . . . used as an antineoplastic in treatment of a wide
variety of malignancies . . . administered orally. It is also used as an antipsoriatic and
antiarthritic.” Methotrexate, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=30930 (last visited June 11, 2023).
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rituximab”28 on January 11, 2017. Pet. Ex. 4 at 136. A myositis antibody panel on January 10
did not reveal any abnormalities. Pet. Ex. 5 at 221-22.
During his hospitalization, Petitioner experienced acute left calf deep vein thrombosis;
spontaneous retroperitoneal hematoma and thigh hematoma; factor XI deficiency29 requiring
extensive blood products for treatment; neuropathic pain that was improving; anasarca that
resolved with treatment; acute blood loss resulting in anemia that was stable at time of discharge;
and urinary retention that also resolved prior to discharge. Pet. Ex. 4 at 136-37; Pet. Ex. 5 at
496. Additionally, with treatment, Petitioner’s CK trended downward, and on discharge was in
the normal range. Pet. Ex. 4 at 136. On January 25, 2017, Petitioner was discharged to inpatient
rehabilitation. Id. at 136-38; Pet. Ex. 5 at 494, 988. His discharge diagnosis was “autoimmune
myositis, possibly [dermatomyositis] sine dermatitis.”30 Pet. Ex. 5 at 496; see also Pet. Ex. 4 at
136.
Petitioner received inpatient rehabilitation from January 25, 2017 until his discharge on
February 12, 2017. Pet. Ex. 5 at 985. Discharge summary notes indicated that during admission,
Petitioner had “episodic confusion.” Id. Neuropsychological testing was done which showed
“diffuse cognitive change[s].” Id. Labs showed normal CK throughout his stay. Id. At the time
of discharge, he required “24/7 supervision and supervision for all mobility and [activities of
daily living].” Id. at 986. He was able to walk with a walker for 250 feet but otherwise used a
wheelchair for mobility. Id.
Petitioner saw Dr. Balderia (rheumatology) for follow-up on March 2, 2017. Pet. Ex. 4 at
93. Dr. Balderia noted that Petitioner was “now able to walk with a cane,” but that he had
“weakness of both lower extremities.” Id. He was on prednisone 50 mg daily and tolerating his
medications. Id. Diagnosis was “acute myositis complicated by rhabdomyolysis, likely
autoimmune, biopsy consistent with dermatomyositis without associated typical skin findings.”
28 Rituximab is “a chimeric murine/human monoclonal antibody . . . used as an antineoplastic in
the treatment of CD20-positive, B-cell non-Hodgkin lymphoma; administered intravenously.”
Rituximab, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/
definition?id=43977 (last visited June 11, 2023).
29 Factor XI deficiency is “an autosomal bleeding disorder caused by mutations in the F11 gene
[], which encodes factor XI. It is characterized by reduced plasma factor XI levels, recurring
episodes of minor bleeding and mild bruising, menorrhagia, severe prolonged postsurgical
bleeding, and prolonged recalcification and partial thromboplastin times.” Factor XI Deficiency,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id
=68742 (last visited June 11, 2023).
30 Dermatomyositis sine dermatitis is a condition in which patients have all of the clinical criteria
of dermatomyositis, with the exception of rash. Resp. Ex. A, Tab 4 at 5 tbl.25; see also Pet. Ex.
33 at 1; Resp. Ex. A, Tab 3 at 1 (Marc L. Miller, Diagnosis and Differential Diagnosis of
Dermatomyositis and Polymyositis in Adults, UpToDate, https://www.uptodate.com/contents/
diagnosis-and-differential-diagnosis-of-dermatomyositis-and-polymyositis-in-adults (last
updated Dec. 20, 2017)).
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Id. at 95. Petitioner was advised to have screening for colorectal cancer due to association of
dermatomyositis with cancer.31 Id.
On March 26, 2017, Petitioner saw neurologist Dr. Michael David Weiss in a
consultation for evaluation and management of his weakness. Pet. Ex. 4 at 67. Petitioner
reported that he had improved and was “now 80% of normal.” Id. at 68. He had ongoing pain
and weakness of his right thigh. Id. His family reported that Petitioner “ha[d] not quite been
himself and can get confused.” Id. His family attributed his confusion to the steroids. Id.
Petitioner’s gait was steady, and he used a cane. Id. at 69. He was noted to have “tangential and
circumferential speech.” Id. Dr. Weiss suspected that Petitioner had “acute autoimmune
myopathy” although the cause was “unclear.” Id. at 70. He stated he “[m]ay consider [] [flu]
vaccine, though only rare case reports [were] found. Post-viral process may also be considered.
However, [Petitioner] did not report a clear [history] of infection prior to onset of symptoms.
Though did report that he did have general malaise.” Id. “As etiology [was] unclear, [Dr.
Weiss] plan[ned] on reviewing biopsy results with the neuropathologist on [March 31].”32 Id.
Prednisone taper was considered due to confusion and mood disturbances. Id.
An electrodiagnostic evaluation (electromyography (“EMG”)) was performed by Dr.
David A. Judish on May 11, 2017 for Petitioner’s right thigh weakness and atrophy. Pet. Ex. 9 at
5. Dr. Judish’s impressions were “severe right femoral neuropathy,” and “possible right
lumbosacral radiculopathy,” which could be “associated with his prior chronic low back pain,”
with “no [] evidence of myopathy.” Id. at 7. Dr. Judish recommend a “trial of bracing” for his
right thigh weakness. Id. at 13. Dr. Judish also recommended that Petitioner follow up with Dr.
Weiss at UW for “continued diagnostic input.” Id.
Petitioner was seen by Dr. Ingeborg Sacksen at the UW rheumatology clinic on June 28,
2017 for follow-up. Pet. Ex. 4 at 32-33. He remained on methotrexate 15 mg weekly and
prednisone 5 mg daily. Id. He had undergone an EMG which showed “right femoral
neuropathy,” and was otherwise doing well. Id. Physical examination revealed that Petitioner
was “comfortable appearing” and in “no apparent distress.” Id. at 34. He had “no tender or
swollen joints.” Id. He did have “right quadriceps [] atrophy with mild edema.” Id.
Neurological examination revealed that Petitioner was “alert and oriented,” and that he had
normal strength in his upper extremities and lower extremities, except for right knee extension,
which was 2/5. Id. at 34-35. He also had “diminished sensation to light tough bilateral lower
extremities.” Id. at 35. Dr. Sacksen diagnosed Petitioner with “autoimmune myopathy, most
likely [dermatomyositis].” Id. at 37. He noted that Petitioner had experienced significant
improvement since his earlier hospitalizations, and the plan was to continue the current regimen
of methotrexate and to continue the taper of prednisone. Id. at 38. Petitioner was also referred to
physiatry for his persistent right leg weakness. Id.
31 Records dated December 5, 2017 reference that Petitioner had a prior colonoscopy (one year
ago), but the results were not noted. Pet. Ex. 48 at 15.
32 There does not appear to be a note in the record reporting on any review with the
neuropathologist on March 31, 2017.
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On December 5, 2017, Petitioner returned to Dr. Sacksen for follow-up of his
“inflammatory myopathy.” Pet. Ex. 48 at 14. Physical examination revealed that Petitioner had
a “moderate sized effusion of the right knee,” with “mild [] laxity of the right lateral collateral
ligament [and] pain on the medical joint line.” Id. at 17. He also had “atrophy of the right
thigh.” Id. CK was normal at 98. Id. at 18. Impression was “inflammatory autoimmune
myopathy.” Id. Petitioner was on methotrexate, but due to his “heavy alcohol use,” it was
recommended that he transitioned to azathioprine. Id. at 18.
Thereafter, the records show visits from May through October 2018 (Holistic Health
Clinic Medical Records), which are difficult to read. Pet. Ex. 47 at 37-59. The note from
August 7, 2018 reflects that Petitioner continued to have problems with his right thigh and knee,
but he did not have pain, was very active, trimming trees, doing yard work, and “always
moving.” Id. at 47. The physician signature was illegible. See id. at 48.
On September 30, 2019, Petitioner presented to Holistic Health Clinic complaining of
low back pain that improved with stretching. Pet. Ex. 48 at 66. Physical therapy was discussed.
Id. He returned on February 12, 2020, complaining of shortness of breath with exertion for the
past six to eight months. Id. at 71. He also reported a cough for the past three months. Id. He
was active, “remodeling house,” mowing his yard, walking stairs, jumping rope, and walking.
Id. Mild wheezing was noted in the left upper lobe of the lung. Id. at 73. Chest x-ray was
normal with no acute findings. Id. at 79.
Records from August 27, 2020 noted Petitioner’s energy level was “getting better,” and
he continued to exercise by doing yardwork and landscaping. Pet. Ex. 48 at 81. Petitioner had
donated blood twice since February 2020. Id. On October 14, 2020, Petitioner again reported
shortness of breath, and he also reported right ear pain, nasal stuffiness, sneezing, and watery
itchy eyes. Id. at 89. There is also a reference to swelling in the leg. Id.
No additional records have been filed.
D. Declarations
1. Petitioner
Petitioner executed declarations in September 2017 and March 2021. Pet. Exs. 1, 46.
Petitioner recalled being “in a state of good health” prior to December 12, 2016. Pet. Ex. 1 at ¶
3. He said he had a physical that day and the doctor described him as a “well man.” Id. That
same day, he “had a flu shot and [his] life changed.” Pet. Ex. 46 at 1. “Within a few days after
the vaccination, [he] began feeling unusual pain in [his] joints and suffered from fatigue.” Pet.
Ex. 1 at ¶ 5. His “legs seemed weaker and [he] began having some numbness and tingling with
pain in [his] legs, but also to a lesser degree in [his] arms. [He] was having trouble getting up
from a chair and trouble walking.” Id.
On December 16, 2016, he went to Good Samaritan Hospital and was later transferred to
UW. Pet. Ex. 1 at ¶ 7. While at UW, he “was told that the flu shot had caused [his] muscles to
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react and that some of the muscle tissue was dead and/or dying, which was what was causing the
pain and weakness.” Id. at ¶ 8.
2. Sandy McDaniel
Petitioner’s wife, Mrs. McDaniel, executed a declaration in March 2021. Pet. Ex. 47 at 2.
Prior to Petitioner’s vaccination, Mrs. McDaniel described him as “a champion for his health”
and “very active.” Id. at 1. She alleged Petitioner “never missed a physical” and “[kept] a
record of any symptom that seemed out of the norm.” Id. She also alleged “[h]e would get his
blood work done prior to his appointment with the doctor so they could go over his notes and
blood work.” Id.
Mrs. McDaniel alleged Petitioner was “a healthy active man” that went for a physical on
a Monday and got the flu shot while he was there. Pet. Ex. 47 at 1. By Wednesday, he was not
feeling well and called the doctor and “told them that he thought he was having a reaction to the
flu shot.” Id. The doctors allegedly told him “it [was not] a live virus” and to take Tylenol and
rest. Id. “By Friday[,] he could barely walk.” Id. When he was admitted to Good Samaritan
Hospital that same day, she recalled Petitioner being in “immense pain.” Id.
According to Mrs. McDaniel, Petitioner was transferred to UW because “[t]hey couldn’t
figure out what was happening or what was wrong with him.” Pet. Ex. 47 at 1. She “heard talk
of . . . myositis of some type but no diagnosis.” Id. “His urine just kept getting darker and
darker and was told that he was losing muscle. He kept getting weaker and weaker with no
diagnoses.” Id. Even after Petitioner’s biopsy came back, Mrs. McDaniel alleged “they didn’t
agree as to the [diagnosis]. [They] were told it was [d]ermatomyositis, but he never had any skin
rash, the one symptom common to the disease.” Id. She recalled they had “[n]eurologists
disagree and state that they didn’t agree with that [diagnosis], but they couldn’t give us any other
reason for his symptoms.” Id. Mrs. McDaniel recalled Petitioner was “very confused and
psychotic” during his hospitalization. Id. at 1-2.
Mrs. McDaniel questioned “how [] a perfectly healthy man go[es] in for his annual
physical one day[,] and five days later, after a flu shot[,] ha[s] his life turned completely upside
down.” Pet. Ex. 47 at 2. It follows that she “[does not] understand how the government lawyers
say [Petitioner] had pre-existing conditions prior to the flu shot.” Id.
E. Expert Reports
1. Petitioner’s Expert, Dr. Thomas M. Zizic33
a. Background and Qualifications
Dr. Zizic has “more than [] 35 years of “medical training, experience providing clinical
care, and more than [] 15 years of full-time academic experience as a clinician, researcher and
teacher.” Pet. Ex. 10 at 1. Dr. Zizic earned his M.D. from Johns Hopkins University School of
33 Petitioner submitted three expert reports by Dr. Zizic. Pet. Exs. 10, 32, 45.
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Medicine (“Johns Hopkins”). Id.; Pet. Ex. 51 at 1. His internship, residency, and post-doctoral
fellowship in rheumatology were all at Johns Hopkins. Pet. Ex. 10 at 1. He is currently an
Associate Professor of Medicine and Physician at Johns Hopkins. Id.; Pet. Ex. 51 at 1. Dr.
Zizic’s research, which requires training and experience in rheumatology, toxicology,
pharmacology, and epidemiology, includes topics such as “polymyalgia rheumatica,
fibromyalgia, post-traumatic arthropathy, environmentally induced autoimmune disease,
rheumatoid arthritis, polymyositis, vasculitis[,] and a variety of other diseases that have an
immunologic basis.” Pet. Ex. 10 at 1; see also Pet. Ex. 51 at 18-25. Dr. Zizic has published over
100 articles and abstracts in peer-reviewed journals as well as several chapters in medicine
textbooks. Id.; Pet. Ex. 51 at 6-18.
b. Opinion
i. Diagnosis
In his first expert report, Dr. Zizic noted that after Petitioner was transferred to UW, he
was diagnosed with inflammatory myopathy. Pet. Ex. 10 at 34. He also noted that Petitioner’s
muscle biopsy was most consistent with dermatomyositis, and that Petitioner was diagnosed with
“dermatomyositis sine dermatitis.” Id. In his initial expert report, Dr. Zizic usually referenced
Petitioner’s diagnosis as “dermatomyositis.” See id. at 32-34.
In his second expert report, Dr. Zizic stated that he and Respondent’s expert, Dr.
Matloubian, “appear to agree that [Petitioner] suffered from an autoimmune inflammatory
process (polymyositis/dermatomyositis).” Pet. Ex. 32 at 1, 3. In his last expert report, Dr. Zizic
does not offer any further opinions as to Petitioner’s diagnosis. See Pet. Ex. 45.
In summary, while Dr. Zizic used the word dermatomyositis, he opined that Petitioner
had “an autoimmune inflammatory process (polymyositis/dermatomyositis).” Pet. Ex. 32 at 1, 3.
He also acknowledged that the muscle biopsy was most consistent with dermatomyositis, and
that Petitioner was diagnosed with “dermatomyositis sine dermatitis.” Pet. Ex. 10 at 34. In his
reports, there is no indication that Dr. Zizic’s opinions as to causation turn on a specific
characterization of Petitioner’s diagnosis, other than autoimmune inflammatory myopathy
(polymyositis/dermatomyositis).
ii. Onset
Prior to setting forth his opinions, in his first expert report, Dr. Zizic provided a
comprehensive summary of the medical records. Pet. Ex. 10 at 3-27. In the summary, Dr. Zizic
acknowledged that on December 1, 2016, Petitioner presented to his health care provider
complaining of “fatigue, sore muscles, and chills for [one] month.” Id. at 7. Petitioner also
complained of arm and leg tingling, that he was “mentally foggy,” had occasional chest pain, and
had lost “a lot of his muscle tone.” Id. Labs were significant for an elevated AST and ALT (55
and 57). Id. By December 16, Petitioner reported “difficulty getting up out of a chair,”
“weakness below the hips,” and “difficulty walking.” Id. at 8. CK was elevated at 674, and AST
and ALT were also elevated. Id.
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Dr. Zizic opined that “Petitioner developed dermatomyositis symptoms within 24 hours
after the [flu] vaccination.” Pet. Ex. 10 at 34. Dr. Zizic did not identify what these symptoms
were or explain why he believed they constituted the onset of Petitioner’s dermatomyositis.
Dr. Zizic disagreed with Dr. Matloubian that before vaccination, Petitioner had “pre-
existing subclinical muscle disease” as evidenced by elevated AST and ALT. Pet. Ex. 32 at 3.
In his second and third expert reports, Dr. Zizic devoted considerable time opining that to the
extent that Petitioner’s AST and ALT were elevated prior to vaccination, those elevations were
due to pre-existing liver damage. Id. at 2-3, 8; Pet. Ex. 45 at 1. He opined that Petitioner’s liver
injury also caused problems with synthesizing albumin and prothrombin. Pet. Ex. 32 at 3. Dr.
Zizic asserted that AST and ALT are “markers of liver injury.” Id. at 4. He discussed the
elevation of these enzymes, along with Petitioner’s liver ultrasound results on April 5, 2018,
which showed “patchy fatty liver or ‘hepatic steatosis.’” Id. Dr. Zizic discussed all the relevant
lab values (AST, ALT, GGT, albumin, and prothrombin) and provided a detailed summary of his
opinions. Id. at 4-8. He concluded that Petitioner “had an abnormal and fatty liver manifesting
as abnormal liver function in the production of albumin and prothrombin and hepatocellular
damage with elevation of transaminases.” Id. at 8.
In summary, Dr. Zizic opined that Petitioner had pre-existing liver disease, but he
disagreed that Petitioner had pre-existing muscle disease prior to vaccination. Pet. Ex. 32 at 2-3,
8; Pet. Ex. 45 at 1. Instead, Dr. Zizic averred that Petitioner had liver damage that “proceeded
and coincided with the polymyositis dermatomyositis which developed subsequent to the
vaccination.” Pet. Ex. 32 at 8.
iii. Althen Prong One
Regarding his medical theory of causation, Dr. Zizic opined that the flu vaccine
“triggered activation of B and/or T lymphocytes through molecular mimicry, cross-priming,
immune complex formation[,] or a combination of these,” due to “genetic susceptibility,
result[ing] in autoimmunity and the development of dermatomyositis.” Pet. Ex. 10 at 34.
Relying on a paper published by Schattner,34 Dr. Zizic set forth three conditions which
must be met to “establish a role for viral vaccines in the subsequent development of autoimmune
diseases.” Pet. Ex. 10 at 28. These conditions are (1) viral infections “should be linked to
autoimmunity,” (2) a “mechanism or mechanisms whereby exposure to viral antigens [in
infection or vaccination] leads to autoimmunity must be established,” and (3) “evidence must be
obtained that patients who have been vaccinated against viruses developed an autoimmune
disease, bearing in mind that association alone does not necessarily indicate causality.” Id.
(quoting Pet. Ex. 11 at 7).
34 Ami Schattner, Consequence of Coincidence? The Occurrence, Pathogenesis and Significance
of Autoimmune Manifestations After Viral Vaccines, 23 Vaccine 3876 (2005).
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Of interest, Schattner discussed her review of literature from 1966 through June 2004 that
discussed vaccination and autoimmune illnesses. Pet. Ex. 11 at 1. She explained that
“[w]henever controlled studies of autoimmunity following viral vaccines were undertaken, no
evidence of an association was found.” Id. Regarding the flu vaccine, Schattner noted that GBS
was the most commonly reported illness. Id. She did not discuss immune-mediated myositis,
polymyositis, or dermatomyositis.35 Id. at 1-9. Schattner concluded that “very few patients []
develop some autoimmune diseases following viral vaccination.” Id. at 1, 9. Schattner did not
conclude that the flu vaccine met her criteria for establishing a role for “viral vaccines in the
subsequent development of autoimmunity,” with regard to polymyositis and/or
dermatomyositis.36 See id.
Dr. Zizic generally discussed how various viral and bacterial infections trigger
autoimmune diseases. Pet. Ex. 10 at 28-29. Then he described how vaccinations may stimulate
the immune system with respect to rheumatoid arthritis. Id. at 29-30.37 Next, Dr. Zizic
described the mechanism of molecular mimicry. Id. at 30. He explained it happens “at times
[when] the body’s immune system produces antibodies to infectious agents or vaccines that
cross-react with self-molecules.” Id. The “foreign molecule, or piece of the molecule such as a
peptide, mimics a self-antigen such that the antibody to the foreign molecule (e.g., infectious
agent or vaccine) also reacts to a self-antigen producing an autoantibody.” Id. He further
explained that after “immunologic tolerance” is broken, “self-antigens replace the initial inciting
foreign antigen . . . and an autoimmune disease develops.” Id.
An example of a molecular mimicry induced illness described by Dr. Zizic is acute
rheumatic fever caused by antigens from the bacteria beta Streptococcus. Pet. Ex. 10 at 30. He
also provided two examples of an autoimmune illness associated with vaccines including
vaccine-induced arthritis, caused by the Lyme vaccine, and autoimmune vasculitis, which he
opined is associated with the hepatitis B vaccine. Id.
After providing examples of autoimmune illnesses that he contended are associated with
infections and vaccines, Dr. Zizic discussed the role of individual responses to vaccines as well
as genetic predisposition and its role in the development of autoimmunity. Pet. Ex. 10 at 31. He
explained that humans have an “immune repertoire of B and T cells that can consist of over 10
35 While myositis is listed in a table relevant to autoimmune manifestations after the flu vaccine,
the number of cases is not provided. Pet. Ex. 11 at 5 tbl.4.
36 Schattner also discussed adjuvants, such as thiomersal and aluminum, in vaccines, and the
potential roles of these substances. Pet. Ex. 11 at 7. However, there is no evidence that the flu
vaccine here contained either of these ingredients. Petitioner filed a hepatitis B vaccine
manufacture’s package insert. Pet. Ex. 23. However, Petitioner did not receive the hepatitis B
vaccine. The flu package insert relevant to the vaccination given to Petitioner was not filed.
Regardless, there is no evidence that the flu vaccine at issue contained thiomersal or aluminum.
37 Dr. Zizic discussed a number of theories relevant to rheumatoid arthritis, but these opinions do
not seem relevant here since Petitioner did not have that illness, so for the sake of brevity, these
opinions are not discussed.
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billion different B and T cell receptors.” Id. Some people have a unique repertoire that leads to
an “effective response to a vaccine,” conferring protection. Id. Others, however, do not have an
effective response, and they do not receive protection from vaccination. Id. Dr. Zizic attributed
these different responses to “genetic predisposition.” Id. And some individuals “have naïve or
memory cells in their repertoire that cross-react with antigens in the [] vaccine . . . leading to
cross-reactivity and molecular mimicry to self-antigens that then break tolerance to self . . .
caus[ing] autoimmune disease.” Id. Dr. Zizic provided an overview of how molecular mimicry
is thought to trigger autoimmunity in rheumatoid arthritis. Id.
Dr. Zizic then turned to the topic of the association between vaccination and
polymyositis/dermatomyositis. Pet. Ex. 10 at 32. Dr. Zizic asserted that there is “a large body of
evidence including case reports and epidemiological evidence” supporting an association
between these illnesses and vaccination. Id. He noted that these conditions are rare and the
annual “incidence is approximately 2-7 cases per million.” Id. He explained that the average
age of onset is 50 years of age, and that the time frame between vaccination and disease onset is
“24 hours to [two] months.” Id. There are many mechanisms that he identified which may cause
“post-vaccination autoimmunity against the skeletal muscle,” including molecular mimicry.38 Id.
In support of his opinions, Dr. Zizic cited several medical articles. The first is a literature
review by Stübgen39 about the “possible relationship between inflammatory myopathies and
vaccines.” Pet. Ex. 29 at 2. The review included publications from various databases as well as
reports based on the Vaccine Adverse Event Reporting System (“VAERS”)40 database. Id.
Stübgen identified case reports of polymyositis/dermatomyositis following vaccination,
including cases that occurred following the flu vaccination. Id. at 2-3. Stübgen noted that case
reports are anecdotal in nature, which “creates a potential for selection bias[] and provides only
limited potential to establish casual effects. Therefore, these case reports . . . should not be
interpreted as proof of cause[,] i.e., association does not equate to causation.” Id. at 3. Stübgen
also reviewed several retrospective studies, which showed that vaccinations “were not an
important trigger for [dermatomyositis/polymyositis].” Id.
38 The other mechanisms identified by Dr. Zizic are “epitope[] spreading, bystander activation,
release of cryptic epitopes, reactivation of memory T cells, activation of super antigens, direct
inflammatory damage on the muscle, formation of immune complexes, expression of [major
histocompatibility complex] antigens on non-immune cells[,] and patient genetic predisposition
to autoimmunity.” Pet. Ex. 10 at 32. He also referenced the role that adjuvants may play in
causing autoimmune illnesses. Id. There is no evidence in this case, however, that the flu
vaccine at issue contained an adjuvant.
39 Joerg-Patrick Stübgen, A Review on the Association Between Inflammatory Myopathies and
Vaccination, 13 Autoimmunity Rev. 31 (2014).
40 VAERS is a “national early warning system to detect possible safety problems in [] vaccines.”
About VAERS, https://vaers.hhs.gov/about.html (last visited June 12, 2023). “VAERS accepts
and analyzes reports of adverse events (possible side effects) after a person has received a
vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are
required to report certain adverse events.” Id.
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Stübgen’s review of VAERS reports did not show “evidence of an increase in the number
of [dermatomyositis/polymyositis] cases observed and reported among the 43.3 million civilians
immunized with the A/NJ/76 (swine flu) vaccine” administered in 1976 in the United States.
Pet. Ex. 29 at 4. Additionally, there was “no increase in the incidence rate of
[dermatomyositis/polymyositis]” in the “nearly [one] million vaccinated Army and Navy
personnel” during that same period. Id. Further, “there was no indication of an increase in the
number of [dermatomyositis/polymyositis] cases diagnosed at major medical institutions during
or following the 1976 national immunization program.” Id. at 4-5. Stübgen also searched the
VAERS database through 2013, and while acknowledging the limitations of using VAERS data,
concluded that it did “not establish epidemiological support for post-vaccination
[dermatomyositis/polymyositis].” Id. at 6. Finally, Stübgen reviewed studies examining the
effects of vaccination on patients with pre-existing dermatomyositis/polymyositis and concluded
that flu vaccination was “safe and effective in adult patients with
[dermatomyositis/polymyositis].”41 Id.
Additionally, Dr. Zizic cited a paper by Ferri et al.,42 presenting three case reports of
inflammatory myopathies after the 2009-2010 seasonal flu vaccine season in Italy. Pet. Ex. 30 at
1. In two cases there was “interstitial lung disease.” Id. at 2. In a third case, the patient had skin
involvement, and initially a “good response” to treatment, but after 40 days, succumbed to EBV-
related pneumonia. Id. The authors noted that the association between vaccination and illness
“may be coincidental; however, it is supposable that vaccine-related viral antigens and/or
adjuvants might play a triggering role . . . possibly in genetically predisposed subjects . . . in
keeping with [] clinical observations suggesting a possible link between myopathies and
infectious triggering agents.” Id. at 2-3.
iv. Althen Prong Two
Dr. Zizic summarized Petitioner’s clinical course prior to turning to his specific opinions
as to Prong Two. Pet. Ex. 10 at 33-34. He acknowledged that Petitioner saw his physician on
December 1, 2016 for “a viral syndrome with fatigue, sore muscles[,] and chills.” Id. at 33.
Petitioner also had some “tingling and numbness in his arms,” however, Dr. Zizic noted that
Petitioner’s neurological exam was normal, and “his strength [was] intact.” Id. Dr. Zizic also
acknowledged that on December 12, 2016, Petitioner’s lab studies “were notable for elevated
41 In the concluding section in Stübgen, the author stated that “[t]he phenomenon of post-
vaccination [inflammatory myopathies] likely exists, but the occurrence is rare.” Pet. Ex. 29 at
7. The basis of this statement is unclear given the conclusions that Stübgen reached regarding
each subsection of the article, as summarized in this paragraph, essentially finding no evidence
of an increase in dermatomyositis/polymyositis cases following vaccination. Moreover, the
undersigned notes that Respondent asserted that Table 3 in Stübgen is confusing, because it is
not clear how many patients are included. See Resp. Response at 27-28; Pet. Ex. 39 at 8-10
tbl.3. The undersigned agrees.
42 Clodoveo Ferri et al., Polymyositis Following Pandemic Influenza A (H1N1) and 2009-10
Seasonal Trivalent Vaccines, 2012 Case Reps. Rheumatology 836930.
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AST and ALT at 63 and 73[,] respectively.” Id. The flu vaccination at issue was administered to
Petitioner at that visit. Id. On the evening of receiving the flu shot, Petitioner “developed some
bilateral shoulder pain, and some weakness in his upper extremities.” Id. Dr. Zizic summarized
Petitioner’s course over the subsequent weeks, describing his progressive weakness,
paresthesias, difficulty getting out of bed, and walking. Id. He also noted Petitioner’s
progressively abnormal labs, including increasingly abnormal AST, ALT, and CK. Id. at 33. Dr.
Zizic completed his summary by discussing Petitioner’s muscle biopsy and transfer to UW, his
diagnosis, and treatment for myositis. Id. at 33-34.
After summarizing Petitioner’s clinical course, Dr. Zizic opined that Petitioner “did not
have any persistent rheumatic symptoms prior to vaccination.” Pet. Ex. 10 at 34. Dr. Zizic
attributed Petitioner’s “aches and pain” to “cervical spondylosis.”43 Id. Dr. Zizic concluded that
“there is nothing in the medical records to support any pre-existing autoimmune disease, nor any
inflammatory form of arthritis, nor anything to suggest inflammatory muscle disease.” Id. He
therefore concluded that “this is a logical sequence of cause (the [flu] vaccine was the only
perturbation to his immune system around the time of illness onset) and the effect (the
development of dermatomyositis). There is an absence of any other good explanation for a
triggering event.” Id.
In his second and third expert reports, Dr. Zizic opined that Petitioner’s elevated AST and
ALT enzymes pre-vaccination were not evidence of pre-existing myopathy, but instead evidence
that Petitioner had “an abnormal and fatty liver manifesting as abnormal liver function in the
production of albumin and prothrombin and hepatocellular damage with elevation of
transaminases.” Pet. Ex. 32 at 8. He agreed that AST, ALT, and CK are all “muscle enzymes
that may be elevated in patients with inflammatory myopathy.” Id. at 1. However, he
maintained that ALT was a “relatively specific indicatory of liver cell damage.” Id. at 2. Dr.
Zizic also explained that CK is specific to muscle, and therefore, it is the “most useful serum
enzyme for diagnosis” of patients with inflammatory myopathies. Id.
Dr. Zizic then explained that albumin levels can be affected by liver damage. Pet. Ex. 32
at 3. He opined that Petitioner’s low albumin levels on December 25, 2016 indicated liver
damage. Id. Additionally, on January 3, 2017, Petitioner had an abnormally prolonged
prothrombin time, which Dr. Zizic also attributed to liver injury. Id. These abnormalities, and
the finding of a fatty liver on sonogram suggested to Dr. Zizic that Petitioner had liver injury. Id.
Dr. Zizic provided a thorough description of these blood tests and cited medical articles to
support his opinions. Id. at 4-7. He also defined GGT, and cited literature noting GGT should
be used to distinguish whether the liver was the cause for elevated enzyme levels (AST and
ALT), particularly if there is a suspicion of alcohol abuse. Id. at 4, 6. After a discussion of liver
disease, Dr. Zizic concluded that Petitioner’s elevated AST and ALT before vaccine
administration was “classic[] for liver disease.” Id. at 7. And he opined that the specific values
43 During his hospitalization, Petitioner had an MRI of his cervical spine due to his history of
weakness. Pet. Ex. 5 at 184-85. The study showed “multilevel degenerative disc disease . . . [a]t
most mild central canal stenosis at C5-6 . . . [and] [a]t most mild neural foraminal stenosis at
multiple levels.” Id. at 185. There is no indication in Petitioner’s records that his physicians
attributed his weakness to these findings.
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and relationships between AST and ALT were also reflective of liver injury. Id. Dr. Zizic
opined that the Petitioner’s albumin and prothrombin abnormalities reflected abnormal liver
function. Id. at 8.44 In conclusion, Dr. Zizic averred that Petitioner had abnormal liver function
which “proceeded and coincided with the polymyositis dermatomyositis which developed
subsequent to the vaccination.” Id.
v. Althen Prong Three
Dr. Zizic opined that Petitioner “developed dermatomyositis symptoms within 24 hours
after the [flu] vaccination.” Pet. Ex. 10 at 34. Dr. Zizic did not identify what these symptoms
were or why he believed they constituted the onset of Petitioner’s illness.
Dr. Zizic did not discuss or explain how his alleged causal mechanism of molecular
mimicry can cause onset of immune-mediated myositis within 24 hours of vaccination. He only
stated that development of dermatomyositis “within 24 hours after the [flu] vaccination . . . is in
the timeline that was described . . . by Stübgen for an inflammatory myopathy after a
vaccination.” Pet. Ex. 10 at 34.
2. Respondent’s Expert, Dr. Mehrdad Matloubian45
a. Background and Qualifications
Dr. Matloubian is a “physician-scientist with basic science training in virology and
immunology and clinical training in adult rheumatology.” Resp. Ex. A at 1. He is board-
certified in rheumatology and internal medicine. Id.; Resp. Ex. B at 1-2. He received his M.D.
as well as a Ph.D in virology/immunology from University of California, Los Angeles. Resp.
Ex. A at 1; Resp. Ex. B at 1. He is currently an Associate Adjunct Professor at the University of
California, San Francisco, School of Medicine. Resp. Ex. B at 1. Dr. Matloubian’s research for
the past 20 years has been focused on “innate and adaptive immune responses, including those of
T and B cells, to acute and chronic viral infections.” Res. Ex. A at 1. He has published
numerous peer-reviewed articles in these areas. Id.; Resp. Ex. B at 10-13. As an immunologist
and board-certified rheumatologist who actively evaluates and treats patients, Dr. Matloubian is
qualified to address both diagnostic and immunological issues regarding “complex autoimmune”
diseases. Resp. Ex. A at 1.
b. Opinion
i. Diagnosis
Regarding diagnosis, Dr. Matloubian opined that Petitioner’s presentation of “progressive
muscle weakness affecting proximal muscle groups more than distal ones,” along with “elevated
44 For Dr. Zizic’s specific enumerated points regarding the lab values and his opinions about
them, see Pet. Ex. 32 at 7-8.
45 Respondent submitted two expert reports by Dr. Matloubian. Resp. Exs. A, C.
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muscle enzymes (CK, AST, and ALT),” were “consistent with a myopathy but not necessarily a
myositis (inflammatory muscle disease).” Resp. Ex. A at 10. Petitioner’s MRI, however, was
“consistent with myositis involving diffuse muscle groups.” Id. Muscle biopsy pathology
showed “non-specific inflammatory changes consistent with a myositis rather than myopathy.”
Id. And the pathologists who interpreted the biopsy “opined that the observed changes could be
due to an ‘autoimmune (dermatomyositis . . . ) viral or other infectious process.’” Id. (quoting
Pet. Ex. 4 at 1059). Thus, Petitioner’s treating physicians concluded that he had an “immune-
mediated myopathy” that was “difficult to further classify.” Id. (quoting Pet. Ex. 4 at 74).
Dr. Matloubian opined that Petitioner’s response to “immunosuppressive therapy with
normalization of his muscle enzymes and improvement of his muscle strength confirm[ed] an
immune mediated pathologic process.” Resp. Ex. A at 10. However, Dr. Matloubian explained
that Petitioner’s response to treatment “does not distinguish between an autoimmune response
and an immune-mediated response directed against an infectious agent, such as a virus.”46 Id.
Dr. Matloubian agreed with Petitioner’s physicians, that Petitioner had an “immune
mediated myopathy” that was “difficult to classify.” Resp. Ex. A at 10 (citing Pet. Ex. 4 at 74).
More specifically, Dr. Matloubian opined that Petitioner “most likely had either dermatomyositis
sine dermatitis or an infection-associated immune mediated myopathy.” Id. “Dermatomyositis
is an autoimmune disease that typically affects the muscles and the skin with a characteristic
rash. However, as the term ‘sine dermatitis’ indicates, in some cases the muscle disease can exit
without any skin disease.” Id.
ii. Onset
Dr. Matloubian opined that Petitioner’s muscle disease began before his vaccination on
December 12, 2016. Resp. Ex. C at 1. He based this opinion on his review of the medical
records, including Petitioner’s pre-vaccination elevated AST and ALT, and the fact that
Petitioner’s treating physicians did not attribute his elevated enzymes to liver disease, or
diagnose him with or treat him for liver disease. Id.
First, Dr. Matloubian reviewed the relevant entries in the medical records that formed the
basis of his opinions as to onset. Resp. Ex. A at 10-13. The records establish that Petitioner
presented to his physician on December 1, 2016, about two weeks before his flu vaccination,
46 An autoimmune response is “an immune response against an autoantigen.” Autoimmune
Response, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/
definition?id=103673 (last visited June 14, 2023). An immune response is “any response of the
immune system to an antigenic stimulus, including antibody production, cell-mediated
immunity, and immunologic tolerance.” Immune Response, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=103684 (last visited June 14, 2023).
“Immune response may follow simulation by a wide variety of agents.” Illustrated Dictionary of
Immunology at 358.
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complaining of “fatigue, sore muscles, [and] chills” for about one month.47 Id. at 10 (quoting
Pet. Ex. 2 at 50). At that visit, Petitioner also complained of “numbness/tingling” and that “he
[was] losing a lot of his muscle tone.” Id. (quoting Pet. Ex. 2 at 50).
Next, Dr. Matloubian cited record entries documenting instances where Petitioner related
the onset of his illness back in time, prior to vaccination on December 12, 2016. Resp. Ex. A at
10-11. For example, after Petitioner was hospitalized, an assessment note written by Helen
Ward, LICSW, on December 19, 2016, stated that “[Petitioner] pointed out that although he
doesn’t think he was sick when he got his flu shot, he thinks he was ‘fighting something off’ that
could have contributed to the symptoms he experienced after the shot and has been ‘losing some
muscle strength for a while.’” Id. at 10 (quoting Pet. Ex. 5 at 268).
Moving forward, on December 25, 2016, Dr. Feller documented that Petitioner reported
being “in his usual state of health until roughly [three] weeks ago when he began feeling
‘crummy’ with no specific symptoms he could pinpoint.” Resp. Ex. A at 10 (quoting Pet. Ex. 4
at 263). Dr. Matloubian opined that this note places onset on approximately December 4, 2016,
eight days prior to vaccination. Id.
Then, on January 8, 2017, it was documented that Petitioner “was feeling well until a few
weeks before his initial presentation to Good Sam[aritan], when he developed generalized
malaise (‘feeling crumby’).”48 Resp. Ex. A at 10 (quoting Pet. Ex. at 431). Dr. Matloubian
opined that based on this note, Petitioner’s symptoms preceded the flu shot he received on
December 12 “and were progressive.” Id.
Dr. Matloubian explained that this history from Petitioner, reported to his physicians and
other health care providers, shows that Petitioner reported “muscle aches and progressive loss of
muscle tone” as early as December 1, 2016 and admitted that he was “losing muscle strength”
before his flu vaccine on December 12, 2016, “consistent with the expected clinical course for
inflammatory myopathies, where muscle weakness as the presenting symptom evolves over
weeks to months.” Resp. Ex. A at 10-11. Thus, Dr. Matloubian opined that Petitioner’s
symptoms “most likely” began before December 1, 2016, and progressed to “clinically apparent
weakness that led to his hospitalization” on December 16, 2016. Id. at 11.
In support of his opinion, Dr. Matloubian cited a book chapter by Mammen about
dermatomyositis and polymyositis, which provides that “[s]ymmetric proximal muscle weakness
evolving over weeks to months is the presenting symptom in most patients.” Resp. Ex. A, Tab 2
at 2. According to Dr. Matloubian, it was not surprising that Petitioner did not have “difficulty
with tasks, such as getting up or going up stairs until around [December 14, 2016] . . . since a
great amount of muscle mass needs to be damaged and lost before the affected individual
becomes overtly symptomatic and debilitated.” Resp. Ex. A at 10. Further, he explained that
“subtle loss of strength” may not be observed by an examining physician, particularly where
weakness evolves “over weeks to months.” Id. at 10-11.
47 This note would place onset on November 1, 2016.
48 Petitioner was admitted to Good Samaritan on December 16, 2016.
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In addition to muscle weakness, Dr. Matloubian opined that there was “objective
evidence” in the form of lab results which also provide evidence that onset preceded vaccination.
Resp. Ex. A at 11. In his report, Dr. Matloubian provided the following table:
Id. at 11 tbl.1.
The table above shows that Petitioner’s AST and ALT were elevated on December 1 and
December 12, prior to administration of the flu vaccination. Resp. Ex. A at 11 tbl.1. Since
Petitioner’s AST and ALT were abnormal before vaccination, Dr. Matloubian opined that
Petitioner’s “muscle disease began before [his] immunization and was not caused by it.” Id. at
12.
According to Dr. Matloubian, AST and ALT are traditionally considered to be “liver
enzymes,” but they are also “muscle enzymes” since they are “released from damaged muscle
and elevated levels are often, but not always, found in patients with autoimmune myopathy.”
Resp. Ex. A at 11. He further stated that “this may lead to confusion in some clinical situations”
and trigger a workup for a possible underlying liver etiology, like it did in Petitioner’s situation.
Id. Dr. Matloubian again cited Mammen who wrote that “[n]ot infrequently, elevated AST and
ALT levels are misinterpreted as evidence of liver disease in patients with myopathy.” Resp. Ex.
A, Tab 2 at 4. To determine whether elevation of these enzymes is due to muscle or liver
damage, a serum GGT level can be measured; “GGT is usually released along with AST and
ALT in liver disease but not from damaged muscle.” Id.
Petitioner’s GGT was normal on December 24, 2016 (60; normal range of 8-78),
indicating that his elevated enzymes were due to muscle injury and not liver disease. Resp. Ex.
A at 11 (citing Pet. Ex. 5 at 211-13). Dr. Matloubian also referenced a note by gastroenterologist
Dr. Agarwal, who wrote that Petitioner’s “[l]iver enzyme elevations [were] likely secondary to
muscle injury. They should start improving when ongoing muscle injury stops.” Id. (quoting
Pet. Ex. 5 at 101). This note appears to indicate that Dr. Agarwal believed that Petitioner’s
elevated AST and ALT were caused by muscle injury and not liver damage.
Dr. Matloubian disagreed with Dr. Zizic that Petitioner’s elevated AST and ALT
indicated liver disease. Resp. Ex. C at 2. While Dr. Matloubian agreed generally that ALT is
“more liver-specific than AST,” he cited medical literature in support of the proposition that
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“ALT should not be considered as liver specific, as elevation of serum values can also be seen in
other clinical conditions, mainly, skeletal muscle injury due to inflammatory . . . conditions.” Id.
(citing Pet. Ex. 37 at 2).49
In response to Dr. Zizic’s assertions that Petitioner’s increase in AST and ALT levels
prior to vaccination reflected liver disease and was not attributable to his myositis or muscle
injury, Dr. Matloubian provided a thorough explanation of the relevant lab studies, including
albumin and prothrombin time, and detailed opinions. Resp. Ex. C at 2-4. He concluded that
based on the medical records, lab results, and clinical course, Petitioner’s low albumin level,
“which coincided with the peak of his muscle disease and normalized as his muscle disease
resolved, was most likely due to his inflammatory condition rather than a liver injury as alleged
by Dr. Zizic.” Id. at 3-4. Moreover, Dr. Matloubian emphasized that Dr. Agarwal did not
diagnose Petitioner with any illness that caused liver damage. See id. at 3; Resp. Ex. A at 4, 11.
Dr. Zizic opined that Petitioner’s prothrombin was decreased on January 3, 2017, due to
liver injury. Resp. Ex. C at 4 (citing Pet. Ex. 32 at 8). Dr. Matloubian took issue with this
opinion because “prolonged prothrombin time is not specific for liver disease,” but can occur for
many different reasons, including as a side effect from medications, gastrointestinal bleeding, or
problems with clotting factors. Id. Dr. Matloubian explained that when Petitioner’s prothrombin
time was drawn and reported on January 3, he had a retroperitoneal hematoma due to bleeding.
Id. After treatment with vitamin K, repeat testing on January 4 and 5, showed a normal
prothrombin time. Id. (citing Pet. Ex. 4 at 1031-33). Further, Petitioner’s previous prothrombin
times from December 25 through December 28 were normal. Id. (citing Pet. Ex. 4 at 1046-54).
Additionally, Petitioner did not have cirrhosis which can cause an abnormal prothrombin time
and a low albumin level. Id. at 5. Dr. Matloubian concluded that Petitioner’s “transiently
elevated prothrombin [level] . . . in the setting of acute retroperitoneal bleeding . . . corrected
with vitamin K,” was not a reflection of liver disease, as asserted by Dr. Zizic. Id. at 4.
In support, Dr. Matloubian cited an article by Friedman,50 which stated that a “prolonged
prothrombin time is not specific for liver disease,” since it may occur due to “consumption of
clotting factors” caused by severe bleeding. Resp. Ex. C, Tab 1 at 4. Prolonged prothrombin
time can also reflect vitamin K deficiency. Id. When bleeding is the cause, once treated, “the
prothrombin time typically returns to normal within 24 hours.” Id.
Dr. Matloubian also disagreed with Dr. Zizic’s assertion that Petitioner’s elevated AST
and ALT levels were caused by “nonalcoholic fatty liver disease suggested by steatosis on
49 Hamed A. Shabaneh Al-Tamimi & Rebecca McDonald, Elevated Alanine Aminotransferase
Levels Associated With Polymyositis: Can This Be Due to Muscle Injury?, 14 J. Clinical
Rheumatology 363 (2008).
50 Lawrence S. Friedman, Tests of the Liver’s Biosynthetic Capacity (eg, Albumin, Coagulation
Factors, Prothrombin Time), UpToDate, https://www.uptodate.com/contents/tests-of-the-livers-
biosynthetic-capacity-eg-albumin-coagulation-factors-prothrombin-time (last updated Sept. 4,
2018).
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imaging.”51 Resp. Ex. C at 4 (citing Pet. Ex. 32 at 5). Dr. Matloubian cited medical literature
which explained that patients with fatty liver disease may have normal AST and ALT levels, but
if elevated, these enzymes are “typically two to five times the upper limit of normal.” Id.
(quoting Resp. Ex. C, Tab 2 at 5).52 Because Petitioner’s levels did not meet this standard, Dr.
Matloubian opined that they were not characteristic of nonalcoholic fatty liver disease. Id. In
addition, Petitioner was not treated for nonalcoholic fatty liver disease. Id. at 5.
Lastly, Dr. Matloubian observed that during Petitioner’s month-long hospitalization, he
was seen by different specialists, including gastroenterologists and hematologists, but was never
diagnosed with liver disease. Resp. Ex. C at 5. Instead, his physicians attributed his abnormal
AST and ALT to muscle injury. Id. And several health care providers documented that
Petitioner reported symptoms prior to vaccination. Id. Petitioner’s elevated enzymes, which
were abnormal before vaccination, “normalized when his muscle disease was treated, indicating
that they were due to his muscle disease and not an underlying liver disease.” Id. Petitioner’s
decreased albumin level was not inconsistent with his inflammatory muscle disease, and his
elevated prothrombin level occurred “in the context of severe bleeding” and normalized after
“administration of vitamin K.” Id. Thus, Dr. Matloubian opined that Petitioner’s elevated AST
and ALT were “most likely due to muscle inflammation since they completely resolved when his
muscle disease was treated.” Id. at 1.
In summary, Dr. Matloubian concluded that Petitioner had abnormally elevated muscle
enzymes and weakness consistent with pre-existing subclinical dermatomyositis on December 1,
2016, prior to his vaccination. Resp. Ex. C at 5.
iii. Althen Prong One
The three criteria described by Schattner, and cited by Dr. Zizic, were used by Dr.
Matloubian as a framework for discussing whether the flu vaccine can cause an immune-
mediated myositis/dermatomyositis. Resp. Ex. A at 17.
Addressing the first criteria, that viral infections should be linked to autoimmunity, Dr.
Matloubian acknowledged that flu infections have been associated viral myositis, but the
pathogenesis is not attributed to an autoimmune mechanism. Resp. Ex. A at 17. Instead, viral
myositis is thought to be caused by “direct infection and destruction of muscle cells by the [flu]
51 “Nonalcoholic fatty liver disease . . . is the most common liver disorder in Western
industrialized countries, where the major risk factors” include “obesity, type 2 diabetes mellitus,
dyslipidemia, and metabolic syndrome.” Resp. Ex. C, Tab 2 at 2. For additional information,
see Resp. Ex. C, Tab 3.
52 Sunil G. Sheth & Sanjiv Chopra, Epidemiology, Clinical Features, and Diagnosis of
Nonalcoholic Fatty Liver Disease in Adults, UpToDate, https://www.uptodate.com/contents/
epidemiology-clinical-features-and-diagnosis-of-nonalcoholic-fatty-liver-disease-in-adults (last
updated Apr. 3, 2018).
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virus.” Id. In support of this opinion, Dr. Matloubian cited a paper by Desdouits et al.,53 a study
finding evidence that the etiology is due to direct infection of the muscles by the virus. Resp.
Ex. A, Tab 11 at 1.54 Also, Dr. Matloubian posited that in contrast to autoimmune myositis, viral
myositis is “a self-limited disease that resolves on its own and does not require
immunosuppressive therapy.” Resp. Ex. A at 17.
Regarding autoimmune mechanisms, Dr Matloubian was not aware of any form of
“autoimmune myositis occurring after a[] [flu] virus infection,” and to his knowledge, it “has not
been described in the medical literature.” Resp. Ex. A at 17. “Since the [flu] vaccine . . . [is] an
inactivated [] [flu] vaccine, it is biologically impossible for it to . . . infect and cause muscle
damage in a manner analogous to [flu] virus infection.” Id. Dr. Matloubian opined that “[s]ince
an autoimmune inflammatory myositis is not known to occur after a[] [flu] infection, it is
unlikely that a[] [flu] vaccine containing the same antigens would lead to [the disease] through
the proposed mechanisms, such as molecular mimicry.” Id. at 15. Thus, Dr. Matloubian
concluded that because the flu virus is not known to cause an autoimmune
myositis/dermatomyositis, the first Schattner criteria was not met here. Id. at 15-18.
The second Schattner criteria is a “mechanism or mechanisms whereby exposure to viral
antigens (be it during infection or vaccination) leads to autoimmunity must be established.” Pet.
Ex. 11 at 7. Dr. Matloubian provided a brief overview of molecular mimicry and described it as
“either sequence or structural similarity between a pathogen and self-molecule. When this
occurs, T or B cell responses directed at the pathogen will then cross-react with similar self-
antigens and cause damage to the host’s tissues.” Resp. Ex. A at 18. He explained that B cells
“make antibodies specific for one molecular pattern, either linear or three-dimensional,” and that
“[i]n contrast, T cells only detect small linear pieces of proteins in the context of [human
leukocyte antigens (“HLA”)][55] molecules.” Id. “Each HLA molecule follows specific rules
based on its structure for what peptides (linear pieces of protein) it can present to T cells. Many
autoimmune diseases are associated with a specific HLA molecule.” Id. As an example, Dr.
Matloubian noted that the autoimmune illness ankylosing spondylitis is associated with HLA-
B27. Id.
53 Marion Desdouits et al., Productive Infection of Human Skeletal Muscle Cells by Pandemic
and Seasonal Influenza A(H1N1) Viruses, 8 PLoS ONE e79628 (2013).
54 In another paper cited by Dr. Matloubian, however, the “possibility” of “autoimmune myositis
resulting from a viral infection” was briefly discussed, albeit as a “possibility.” Resp. Ex. A, Tab
9 at 2 (Michael D. Nauss et al., Viral Myositis Leading to Rhabdomyolysis: A Case Report and
Literature Review, 27 Am. J. Emergency Med. 372.e5 (2009)).
55 HLAs are “histocompatibility antigens governed by genes of the HLA complex (the human
major histocompatibility complex), a region on the short arm of chromosome 6 containing
several genetic loci, each having multiple alleles. . . . The A, B, C, and DR antigens are defined
and typed by serologic reactions. The D antigens are defined and typed by one-way mixed
lymphocyte culture (MLC) using panels of HLA-D-homozygous typing cells.” Human
Leukocyte Antigens, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com
/dorland/definition?id=56923 (last visited June 13, 2023).
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For the mechanism of molecular mimicry to occur with B cells, “specific antibodies
produced by that cell against a pathogen-associated structure must also detect a similar structure
on [] cells and tissues.” Resp. Ex. A at 18. For a T cell immune-mediated illness, “the same T
cells that are generated against a specific pathogen-drive peptide seen in the context of an HLA
molecule also have to see peptides derived from a self-protein in the context of that same HLA.”
Id.
Given this background, Dr. Matloubian opined that Dr. Zizic did “not provide[] any
evidence to suggest the existence of molecular mimicry between antigenic components of the
[flu] vaccine and those of muscles as the basis for how the vaccine could cause muscle injury.”
Resp. Ex. A at 18. According to Dr. Matloubian, the references by Dr. Zizic to support
molecular mimicry are not relevant to either rheumatoid arthritis or myositis. Id. at 19.
Dr. Matloubian also discussed Dr. Zizic’s references to the hepatitis B infection and its
association with vasculitis, which was referenced as an autoimmune illness. Resp. Ex. A at 19;
(citing Pet. Ex. 10 at 29-30). Dr. Matloubian opined that the mechanism by which hepatitis B
infections cause vasculitis is not molecular mimicry, but instead is “thought to be due to
deposition of immune complexes containing the hepatitis B viral antigens and antibodies against
them in vessel walls leading to inflammation and destruction.” Id.
In summary, regarding the second Schattner criteria, Dr. Matloubian opined that Dr. Zizic
failed to provide “any scientific evidence to support molecular mimicry between the [flu] virus
or vaccine and development of an immune mediated myositis, such as dermatomyositis.” Resp.
Ex. A at 16.
The third Schattner criteria is that “evidence must be obtained that patients who have
been vaccinated against viruses developed an autoimmune disease, bearing in mind that
association alone does not necessarily indicate causality.” Pet. Ex. 11 at 7. To analyze this
criteria, Dr. Matloubian reviewed the two articles cited by Dr. Zizic to support an association
between vaccination and autoimmune myositis, specifically the articles by Stübgen and Ferri et
al. Resp. Ex. A at 17-18; Pet. Exs. 29-30. Regarding Stübgen, Dr. Matloubian observed that the
article summarized case reports of different vaccines that were temporally associated with
myopathies but failed to provide “details of the cases, such as the possibility of a recent infection
or pre-existing subclinical diseases.” Resp. Ex. A at 17. Further, Stübgen concluded that
“retrospective and epidemiologic studies failed to ascertain an association between
[dermatomyositis/polymyositis] and vaccines; no significant increase in the incidence . . . was
reported after large vaccination campaigns.” Id. (quoting Pet. Ex. 29 at 1).
As for Ferri et al., Dr. Matloubian noted the authors conceded that they could not
“definitely exclude that the systemic manifestations following [flu] vaccination in [their] three
patients [may be] coincidental.” Resp. Ex. A at 18 (quoting Pet. Ex. 30 at 2). Dr. Matloubian
concluded that these articles did not support the third Schattner criteria. See id. at 15-18.
Moreover, Dr. Matloubian opined that these articles did not provide support for any mechanism
supporting flu vaccine associated autoimmune myositis. See id.
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In addition to analyzing causation using the Schattner framework suggested by Dr. Zizic,
Dr. Matloubian filed medical literature which illustrated that Petitioner’s theory of molecular
mimicry has not been acknowledged as a causal mechanism for dermatomyositis/polymyositis.
See Resp. Ex. A at 13-14, 18-19. For example, Dr. Matloubian cited the book chapter by
Mammen discussing the “pathogenic mechanisms underlying the autoimmune myopathies.”
Resp. Ex. A, Tab 4 at 12. Mammen explained that these mechanisms are “still poorly
understood.” Id. Regarding dermatomyositis, for instance, some studies show “damage to
intermediate-sized” blood vessels that “may cause ischemia” and muscle fiber atrophy. Id.
Other studies suggest that interferon56 induced gene expression may play a role in disease
causation. Id. Yet another explanation is that dermatomyositis is a “complement-mediated
microangiopathy.”57 Resp. Ex. A, Tab 7 at 5 fig.1. Further, the “factors that trigger
inflammatory muscle diseases remain unknown.” Id. at 9. Genetic risk factors have been
suggested. Id. Viruses have also been suggested as playing a causal role, but to date, “attempts
to amplify viruses . . . from the muscles have failed.” Id. The increased risk between
dermatomyositis and cancers, along with studies that have shown that cancer treatment can
positively affect prognosis in myositis, “suggests a possible mechanistic relationship.” Resp. Ex.
A, Tab 8 at 2.58 In summary, these references support Dr. Matloubian’s opinion that “the cause
of immune myopathies, such as dermatomyositis and polymyositis is not known.” Resp. Ex. A
at 13.
In conclusion, Dr. Matloubian opined that Petitioner has “not provided any scientific
evidence to support molecular mimicry between the [flu] [] vaccine and the development of an
immune mediated myositis, such as dermatomyositis.” Resp. Ex. A at 16.
iv. Althen Prong Two
Regarding the question of whether the evidence supports a logical sequence of cause and
effect, Dr. Matloubian opined that because Petitioner’s myositis began before his vaccination, it
was not caused by it. Resp. Ex. A at 12. In addition, because the flu vaccine did not have “any
significant effect” on Petitioner’s AST and ALT between December 12 and December 16, 2016,
when he was symptomatic and required hospitalization, Dr. Matloubian thought it was unlikely
that the vaccine played a role in causing or worsening the illness. Id. at 15.
56 Interferons refer to any “family of glycoproteins that exert virus-nonspecific but host-specific
antiviral activity by inducing the transcription of cellular genes coding for antiviral proteins that
selectively inhibit the synthesis of viral RNA and proteins. Interferons also have
immunoregulatory functions . . . [and] [p]roduction of interferon can be stimulated by viral
infection.” Interferon, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition?id=25558 (last visited June 13, 2023).
57 For a description of this theory, see Resp. Ex. A, Tab 7 at 5.
58 Ami A. Shah et al., Cancer-Induced Autoimmunity in the Rheumatic Diseases, 67 Arthritis &
Rheumatology 317 (2015).
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Next, Dr. Matloubian addressed alternative causes for Petitioner’s alleged vaccine-related
illness. He noted that Petitioner’s muscle biopsy findings were “non-specific,” suggesting the
cause “could be due to an autoimmune etiology or an infectious one.” Resp. Ex. A at 13. Dr.
Matloubian explained that while dermatomyositis is not necessarily considered to be post-
infectious, Petitioner had positive test results of “coxsackie and CMV, with evidence of ongoing
infection for [CMV].” Id. at 14. Further, both viruses were referenced by the pathologists in
Petitioner’s biopsy report “as potential causes of a viral myositis that could not be ruled out
based on the pathologic findings.” Id. (citing Pet. Ex. 4 at 1059). While Dr. Matloubian opined
that it was “unlikely that [P]etitioner’s CMV [was] the cause of his condition,” such “an
association ha[d] been described in a few case reports.” Id. He cited the study referenced by the
pathologist, authored by Fasth et al., reporting that CMV might play a role in triggering
dermatomyositis/polymyositis in some patients. Id. (citing Resp. Ex. A, Tab 10). Further, on
December 1, 2016, Petitioner was seen for illness, described as a “viral syndrome with fatigue,
sore muscles[,] and chills.” Id. at 16 (quoting Pet. Ex. 10 at 33) (citing Pet. Ex. 2 at 50). Dr.
Matloubian concluded that Petitioner had a “recent and active infection with CMV, a virus that
has been associated with development of an inflammatory myositis.” Id.
In addition to raising the question of whether a viral infection played a role in causing
Petitioner’s illness, Dr. Matloubian also described the association between dermatomyositis and
cancer. Resp. Ex. A at 13. Petitioner’s biopsy findings were more consistent with
dermatomyositis than polymyositis, however, Petitioner did not have the rash characteristic of
dermatomyositis. Id. Due to the absence of the classic rash, Petitioner’s physicians diagnosed
him with “dermatomyositis sine dermatitis” or “autoimmune myopathy.” Id. Dr. Matloubian
explained that the cause of dermatomyositis is not known, but he noted that there is “a strong
association between dermatomyositis and cancer” which “has been observed in multiple studies.”
Id. Cancers most commonly seen in association with dermatomyositis include colon cancer,
non-Hodgkin’s lymphoma, and melanoma. Id. The risk of cancer occurs in nine to 32% of
patients with dermatomyositis, and the risk window last up to at least five years after diagnosis.
Id. In addition to describing the increased risk of cancer in patients with dermatomyositis, Dr.
Matloubian described the mechanism by which autoimmunity is thought to occur as part of the
immune response that targets cancer cells.59 Id.
v. Althen Prong Three
Regarding prong three—whether there is a temporal association between vaccination and
the onset of Petitioner’s myopathy—Dr. Matloubian opined that onset preceded vaccination, and
therefore, there is “a lack of relationship between [Petitioner’s] immunization and progression of
his pre-existing symptoms.” Resp. Ex. A at 15.
Dr. Matloubian also refuted Dr. Zizic’s opinion that an onset of 24 hours was appropriate.
Dr. Matloubian averred that Petitioner “associated his disease with his immunization because of
symptoms he experienced the night of his vaccination.” Resp. Ex A at 15. Dr. Matloubian
opined that the onset of symptoms in “less than a day after vaccination does not fit with the
kinetics of T and B cell immune responses.” Id. at 15-16. Instead, the medically appropriate
59 For an explanation of this mechanism, see Resp. Ex. A at 14.
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time for onset of an immune response (molecular mimicry) dependent on T and B cells responses
would be seven to 14 days. Id. at 15. Thus, Dr. Matloubian opined it would be “biologically
impossible” for the flu vaccine to have triggered an immune response within one day. Id.
In conclusion, Dr. Matloubian opined that the Petitioner’s “development of an immune
mediated inflammatory myositis was more likely than not completely unrelated to his [flu]
immunization on [December 12, 2016].” Resp. Ex. A at 16.
IV. DISCUSSION
A. Standards for Adjudication
The Vaccine Act was established to compensate vaccine-related injuries and deaths. §
10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as
a simple, fair, and expeditious means for compensating vaccine-related injured persons. The
Program was established to award ‘vaccine-injured persons quickly, easily, and with certainty
and generosity.’” Rooks v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 1, 7 (1996) (quoting
H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).
Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The
preponderance standard requires a petitioner to demonstrate that it is more likely than not that the
vaccine at issue caused the injury. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315,
1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health
& Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). Petitioner need not make a specific type of
evidentiary showing, i.e., “epidemiologic studies, rechallenge, the presence of pathological
markers or genetic predisposition, or general acceptance in the scientific or medical communities
to establish a logical sequence of cause and effect.” Capizzano v. Sec’y of Health & Hum.
Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). Instead, Petitioner may satisfy his burden by
presenting circumstantial evidence and reliable medical opinions. Id. at 1325-26.
Petitioner must prove that the vaccine was “not only [the] but-for cause of the injury but
also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting
Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)); see also
Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). The received
vaccine, however, need not be the predominant cause of the injury. Shyface, 165 F.3d at 1351.
A petitioner who satisfies this burden is entitled to compensation unless Respondent can prove,
by a preponderance of the evidence, that the vaccinee’s injury is “due to factors unrelated to the
administration of the vaccine.” § 13(a)(1)(B). However, if a petitioner fails to establish a prima
facie case, the burden does not shift. Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).
“Regardless of whether the burden ever shifts to the [R]espondent, the special master
may consider the evidence presented by the [R]espondent in determining whether the [P]etitioner
has established a prima facie case.” Flores v. Sec’y of Health & Hum. Servs., 115 Fed. Cl. 157,
162-63 (2014); see also Stone v. Sec’y of Health & Hum. Servs., 676 F.3d 1373, 1379 (Fed. Cir.
2012) (“[E]vidence of other possible sources of injury can be relevant not only to the ‘factors
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unrelated’ defense, but also to whether a prima facie showing has been made that the vaccine
was a substantial factor in causing the injury in question.”); de Bazan v. Sec’y of Health & Hum.
Servs., 539 F.3d 1347, 1353 (Fed. Cir. 2008) (“The government, like any defendant, is permitted
to offer evidence to demonstrate the inadequacy of the [P]etitioner’s evidence on a requisite
element of the [P]etitioner’s case-in-chief.”); Pafford, 451 F.3d at 1358-59 (“[T]he presence of
multiple potential causative agents makes it difficult to attribute ‘but for’ causation to the
vaccination. . . . [T]he Special Master properly introduced the presence of the other unrelated
contemporaneous events as just as likely to have been the triggering event as the vaccinations.”).
B. Factual Issues
A petitioner must prove, by a preponderance of the evidence, the factual circumstances
surrounding his claim. § 13(a)(1)(A). To resolve factual issues, the special master must weigh
the evidence presented, which may include contemporaneous medical records and testimony.
See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a
special master must decide what weight to give evidence including oral testimony and
contemporaneous medical records). Contemporaneous medical records, “in general, warrant
consideration as trustworthy evidence.” Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d
1525, 1528 (Fed. Cir. 1993). But see Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378,
1382 (Fed. Cir. 2021) (rejecting the presumption that “medical records are accurate and complete
as to all the patient’s physical conditions”); Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed.
Cl. 532, 538 (2011) (“[T]he absence of a reference to a condition or circumstance is much less
significant than a reference which negates the existence of the condition or circumstance.”
(quoting Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam,
968 F.2d 1226 (Fed. Cir. 1992))), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d
mem., 503 F. App’x 952 (Fed. Cir. 2013).
There are situations in which compelling testimony may be more persuasive than written
records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec’y of
Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“[L]ike any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the
factual predicates for its application are weak or lacking.”); Lowrie v. Sec’y of Health & Hum.
Servs., No. 03-1585V, 2005 WL 6117475, at *19 (Fed. Cl. Spec. Mstr. Dec. 12, 2005)
(“[W]ritten records which are, themselves, inconsistent, should be accorded less deference than
those which are internally consistent.” (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a
determination regarding a witness’s credibility is needed when determining the weight that such
testimony should be afforded. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379
(Fed. Cir. 2009); Bradley, 991 F.2d at 1575.
Despite the weight afforded medical records, special masters are not bound rigidly by
those records in determining onset of a petitioner’s symptoms. Valenzuela v. Sec’y of Health &
Hum. Servs., No. 90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30, 1991); see
also Eng v. Sec’y of Health & Hum. Servs., No. 90-1754V, 1994 WL 67704, at *3 (Fed. Cl.
Spec. Mstr. Feb. 18, 1994) (Section 13(b)(2) “must be construed so as to give effect also to §
13(b)(1) which directs the special master or court to consider the medical records (reports,
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diagnosis, conclusions, medical judgment, test reports, etc.), but does not require the special
master or court to be bound by them.”).
C. Causation
To receive compensation through the Program, Petitioner must prove either (1) that he
suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a
vaccine that he received, or (2) that he suffered an injury that was caused by a vaccination. See
§§ 11(c)(1), 13(a)(1)(A); Capizzano, 440 F.3d at 1319-20. Petitioner must show that the vaccine
was “not only a but-for cause of the injury but also a substantial factor in bringing about the
injury.” Moberly, 592 F.3d at 1321 (quoting Shyface, 165 F.3d at 1352-53).
Because Petitioner does not allege that he suffered a Table Injury, he must prove a
vaccine he received caused his injury. To do so, Petitioner must establish, by preponderant
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.” Althen, 418 F.3d
at 1278.
The causation theory must relate to the injury alleged. Petitioner must provide a sound
and reliable medical or scientific explanation that pertains specifically to this case, although the
explanation need only be “legally probable, not medically or scientifically certain.” Knudsen v.
Sec’y of Health & Hum. Servs., 35 F.3d. 543, 548-49 (Fed. Cir. 1994). Petitioner cannot
establish entitlement to compensation based solely on his assertions; rather, a vaccine claim must
be supported either by medical records or by the opinion of a medical doctor. § 13(a)(1). In
determining whether Petitioner is entitled to compensation, the special master shall consider all
material in the record, including “any . . . conclusion, [or] medical judgment . . . which is
contained in the record regarding . . . causation.” § 13(b)(1)(A). The undersigned must weigh
the submitted evidence and the testimony of the parties’ proffered experts and rule in Petitioner’s
favor when the evidence weighs in his favor. See Moberly, 592 F.3d at 1325-26 (“Finders of
fact are entitled—indeed, expected—to make determinations as to the reliability of the evidence
presented to them and, if appropriate, as to the credibility of the persons presenting that
evidence.”); Althen, 418 F.3d at 1280 (noting that “close calls” are resolved in Petitioner’s
favor).
Testimony that merely expresses the possibility—not the probability—is insufficient, by
itself, to substantiate a claim that such an injury occurred. See Waterman v. Sec’y of Health &
Hum. Servs., 123 Fed. Cl. 564, 573-74 (2015) (denying Petitioner’s motion for review and
noting that a possible causal link was not sufficient to meet the preponderance standard). The
Federal Circuit has made clear that the mere possibility of a link between a vaccination and a
petitioner’s injury is not sufficient to satisfy the preponderance standard. Moberly, 592 F.3d at
1322 (emphasizing that “proof of a ‘plausible’ or ‘possible’ causal link between the vaccine and
the injury” does not equate to proof of causation by a preponderance of the evidence); Boatmon
v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359-60 (Fed. Cir. 2019). While certainty is
by no means required, a possible mechanism does not rise to the level of preponderance.
Moberly, 592 F.3d at 1322; see also de Bazan, 539 F.3d at 1351.
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V. ANALYSIS
A. Diagnosis
As Federal Circuit precedent establishes, in certain cases it is appropriate to determine the
nature of an injury before engaging in the Althen analysis. Broekelschen v. Sec’y of Health &
Hum. Servs., 618 F.3d 1339, 1346 (Fed. Cir. 2010). Since “each prong of the Althen test is
decided relative to the injury,” determining facts relating to the claimed injury can be significant
in a case where diagnosis is not clear. Id.
Here, Petitioner alleges that he suffered “an auto[]immune myopathy, more likely than
not dermatomyositis.” Am. Petition at Preamble. In their joint submission, the parties stipulate
that Petitioner most likely suffered from an “immune mediated myopathy.” Joint Submission at
1. The parties suggest, however, that the experts disagree on whether a more specifical diagnosis
is more appropriate. Id. Thus, the question is whether a ruling as to a diagnosis more specific
than “immune mediated myopathy,” is appropriate in order to resolve each of the Althen prongs
of causation.
The experts address diagnosis in their expert reports. Dr. Zizic opines that Petitioner’s
muscle biopsy was most consistent with dermatomyositis, and he also notes that Petitioner was
diagnosed with “dermatomyositis sine dermatitis.” Pet. Ex. 10 at 34. Dr. Matloubian opines that
while Petitioner’s myopathy was “difficult to [] classify,” he “most likely had [] dermatomyositis
sine dermatitis or an infection-associated immune mediated myopathy.” Resp. Ex. A at 10.
According to Dr. Matloubian, Petitioner’s diagnosis can be further characterized based on his
response to treatment. Petitioner had a positive response to immunosuppressive treatment. His
muscle enzyme levels returned to normal, and his muscle weakness improved. Based on these
facts, Dr. Matloubian opines that Petitioner had an immune-mediated condition. However, Dr.
Matloubian states that these facts do not allow one to distinguish between an autoimmune
response and an immune-mediated response directed against a particular trigger, like a viral
illness. Id.
The treating physicians address diagnosis throughout Petitioner’s clinical course. After
the muscle biopsy was performed on December 27, 2016, the pathologists’ assessment that “the
muscle demonstrate[d] non-specific myopathic changes which may be related to inflammatory
myopathy with possible etiologies including autoimmune[], viral[,] or other infectious processes”
was often referenced when describing diagnosis. Pet. Ex. 4 at 1059. When Petitioner was
discharged from UW, his discharge diagnosis was autoimmune myositis, possibly
dermatomyositis sine dermatitis. Dr. Balderia, the rheumatologist who saw Petitioner after his
hospitalization, used the diagnosis, “acute myositis complicated by rhabdomyolysis, likely
autoimmune, biopsy consistent with dermatomyositis without associated typical skin findings.”
Id. at 95. Dr. Sacksen’s diagnosis was “autoimmune myopathy, most likely [dermatomyositis]”
and “inflammatory autoimmune myopathy.” Id. at 37; Pet. Ex. 48 at 18. While a number of
different phrases were used to characterize Petitioner’s myopathy, on the whole, the diagnosis of
dermatomyositis without associated skin changes (dermatomyositis sine dermatitis) was the most
often referenced diagnosis, and was the diagnosis given to Petitioner by Dr. Balderia. Thus, the
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weight of the evidence suggests that more likely than not, Petitioner’s diagnosis is immune-
mediated myopathy (dermatomyositis without skin changes).
This finding is consistent with case law. The Federal Circuit has made clear that
“identifying [the Petitioner’s] injury is a prerequisite” to the Althen analysis. Broekelschen, 618
F.3d at 1346. However, it is not necessary to diagnose an exact condition. Astle v. Sec’y of
Health & Hum. Servs., No. 14-369V, 2018 WL 2682974, at *19 (Fed. Cl. Spec. Mstr. May 15,
2018). In Lombardi, the Federal Circuit explained that “[t]he function of a special master is not
to diagnose vaccine-related injuries, but instead to determine based on the record evidence as a
whole and the totality of the case, whether it has been shown by a preponderance of the evidence
that a vaccine caused the [P]etitioner’s injury.” Lombardi v. Sec’y of Health & Hum. Servs.,
656 F.3d 1343, 1351 (Fed. Cir. 2011) (internal quotation marks omitted) (quoting Andreu, 569
F.3d at 1382).
The diagnosis of immune-mediated myopathy, “more likely than not dermatomyositis,” is
consistent with the diagnosis plead by the Petitioner in his petition, it was referenced by both
experts, and Respondent agrees that the subtype is dermatomyositis, not polymyositis, and more
specifically dermatomyositis without skin changes is the most likely diagnosis. Therefore, the
undersigned finds that the appropriate diagnosis is immune-mediated myopathy,
dermatomyositis sine dermatitis.60
B. Onset
The medical literature filed by the parties establishes that immune-mediated myopathy is
characterized by proximal skeletal muscle weakness and evidence of muscle inflammation.
Patients usually report a history of subtle development of muscular weakness, with gradual
worsening over a period of several months before they seek medical care. Characteristic lab
findings include elevated AST, ALT, and CK. Petitioner’s medical records, both prior to and
after vaccination by several different health care providers, independently document that
Petitioner reported his symptoms began prior to vaccination on December 12, 2016.
The following records provide examples:
1) On December 1, 2016, Petitioner was seen by Mr. Cichon, PA-C, whose records
document that Petitioner reported a one-month history of fatigue, sore muscles, chills,
increased arm and leg weakness, and loss of muscle tone. Pet. Ex. 2 at 50-52. This
note places onset of symptoms on approximately November 1, 2016.
2) Labs drawn on December 1, 2016, revealed elevated AST and ALT (55 and 57). Pet.
Ex. 2 at 140. Petitioner saw Dr. Dinh on December 12 and labs drawn on this date
revealed continuously elevated AST and ALT (63 and 73). Id. at 125.
60 Throughout this analysis, the undersigned uses the words immune-mediated myopathy or
dermatomyositis when referencing Petitioner’s diagnosis.
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3) Four days later, December 16, 2016, Petitioner was admitted to Good Samaritan
Hospital where he was seen by Dr. Yang. Dr. Yang documented that Petitioner
reported a history of a “viral flu-like illness” about two weeks before admission, and
prior to receipt of the flu shot. Pet. Ex. 5 at 93. This note places onset on
approximately December 2, 2016.
4) On December 19, 2016, Helen Ward, LICSW, documented that Petitioner reported he
had been “fighting something off” and been “losing some muscle strength for a
while.” Pet. Ex. 5 at 268.
5) Petitioner was transferred to UW on December 25, 2016 where he was seen by Dr.
Feller, whose note indicates that Petitioner was in his “usual state of health until
roughly [three] weeks ago when he began feeling ‘crummy’ with no specific
symptoms.” Pet. Ex. 4 at 136. This note places onset on approximately December 4,
2016.
Petitioner also related his symptoms to his vaccinations. In those instances, however, he
did not negate the history in the reports noted above. Moreover, the histories provided by
Petitioner to his health care providers, as documented above, are not inconsistent with
Petitioner’s or his wife’s declarations, which do not speak to the onset of his muscle soreness,
weakness, loss of muscle, or his flu-like illness prior to vaccination. To the extent that they are
inconsistent with and/or contradict the health care providers’ histories documented in the
contemporaneous medical records and objective physical examinations or diagnostic testing, the
undersigned defers to the contemporaneous records as the most reliable source of information.
See Cucuras, 993 F.2d at 1528 (noting that “the Supreme Court counsels that oral testimony in
conflict with contemporaneous documentary evidence deserves little weight”); Doe/70 v. Sec’y
of Health & Hum. Servs., 95 Fed. Cl. 598, 608 (2010); Stevens v. Sec’y of Health & Hum.
Servs., No. 90-221V, 1990 WL 608693, at *3 (Cl. Ct. Spec. Mstr. Dec. 21, 1990) (noting that
“clear, cogent, and consistent testimony can overcome such missing or contradictory medical
records”); Vergara v. Sec’y of Health & Hum. Servs., No. 08-882V, 2014 WL 2795491, at *4
(Fed. Cl. Spec. Mstr. May 15, 2014) (“Special Masters frequently accord more weight to
contemporaneously-recorded medical symptoms than those recorded in later medical histories,
affidavits, or trial testimony.”).
This finding also extends to lay witness affidavits and testimony. Other special masters
faced with similar situations have found contemporaneous medical records more persuasive than
the affidavits and testimonies of lay witnesses. See, e.g., Rote v. Sec’y of Health & Hum. Servs.,
No. 90-036V, 1992 WL 165970, at *5 (Cl. Ct. Spec. Mstr. July 1, 1992) (finding the lay witness
testimony insufficient to overcome the weight of the contemporaneous medical records);
Bergman v. Sec’y of Health & Hum. Servs., No. 90-1252V, 1992 WL 78671, at *4 (Cl. Ct. Spec.
Mstr. Mar. 31, 1992) (same); Daiza v. Sec’y of Health & Hum. Servs., No. 90-1188V, 1992 WL
59709, at *4 (Cl. Ct. Spec. Mstr. Mar. 5, 1992) (same).
In summary, the medical records from different health care providers over the period of
Petitioner’s initial presentation and extending to his hospital admission document that Petitioner
reported that his symptoms began as early as November 1, 2016 and by December 4, 2016. The
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fact that at least four records place onset prior to vaccination is compelling evidence because
they are consistent even though they are written by different providers. In their totality, these
records provide persuasive evidence of onset. Thus, the undersigned finds that the initial
manifestation of Petitioner’s immune-mediated myopathy was as early as November 1, 2016 and
by December 4, 2016. Regardless of whether onset was November 1, 2016 or December 4,
2016, onset predated vaccination.
Moreover, there is objective evidence that Petitioner had elevated AST and ALT
enzymes prior to vaccination. Dr. Zizic’s position is that the elevated enzymes reflect liver
disease, not muscle damage, and therefore, they do not support a finding of onset prior to
vaccination. The undersigned, however, finds Dr. Matloubian’s explanation—that the pre-
vaccination elevations of AST and ALT were due to Petitioner’s muscle disease—more
persuasive and consistent with the treating physician opinions and diagnoses, medical literature,
and Petitioner’s overall clinical picture. Further, as explained by Dr. Matloubian, once Petitioner
received treatment for his muscle disease, his enzyme levels normalized. Lastly, again as noted
by Dr. Matloubian, Petitioner was not diagnosed with or treated for liver disease.
C. Althen Prong One
Under Althen prong one, Petitioner must set forth a medical theory explaining how the
received vaccine could have caused the sustained injury. Andreu, 569 F.3d at 1375; Pafford, 451
F.3d at 1355-56. Petitioner’s theory of causation need not be medically or scientifically certain,
but it must be informed by a “sound and reliable” medical or scientific explanation. Boatmon,
941 F.3d at 1359; see also Knudsen, 35 F.3d at 548; Veryzer v. Sec’y of Health & Hum. Servs.,
98 Fed. Cl. 214, 223 (2011) (noting that special masters are bound by both § 13(b)(1) and
Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and “reliable”). If
Petitioner relies upon a medical opinion to support her theory, the basis for the opinion and the
reliability of that basis must be considered in the determination of how much weight to afford the
offered opinion. See Broekelschen, 618 F.3d at 1347 (“The special master’s decision often times
is based on the credibility of the experts and the relative persuasiveness of their competing
theories.”); Perreira v. Sec’y of Health & Hum. Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994)
(stating that an “expert opinion is no better than the soundness of the reasons supporting it”
(citing Fehrs v. United States, 620 F.2d 255, 265 (Ct. Cl. 1980))).
The undersigned finds Petitioner has failed to provide preponderant evidence that the flu
vaccine can cause immune-mediated myopathy for the following reasons.
Dr. Zizic embraces molecular mimicry as the causal theory that explains how the flu
vaccination can cause an immune-mediated myopathy. He cited articles by Schattner, Stübgen,
and Ferri et al. to support his opinions. None of the articles cited, however, establish that
molecular mimicry has been posited as a causal mechanism for how the flu vaccine can cause
immune-mediated myopathy.
Schattner explains that “[d]espite significant recent advances in our understanding of the
pathogenesis of autoimmunity, many basic questions remain.” Pet. Ex. 11 at 2. While the
triggering infectious agent is defined in some “discrete illnesses such as reactive arthritis,
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rheumatic fever[,] or vasculitis associated with hepatitis B virus,” in “most [] autoimmune
diseases, no exogenous infectious agent could be identified.” Id. Schattner concluded that
“[v]ery few patients may develop some autoimmune diseases following viral vaccination (in
particular—arthropathy, vasculitis, neurological dysfunction[,] and thrombocytopenia).” Id. at 1.
Although myositis was listed as an autoimmune condition reported after flu vaccination in Table
4 of her article, Schattner did not otherwise reference it. See id. at 5 tbl.4. Schattner did not
identify myopathy as an autoimmune disease that follows vaccination. And she did not discuss
immune-mediated myopathy, dermatomyositis, or polymyositis. Schattner generally discussed
molecular mimicry; however, she did not discuss the mechanism in the context of the flu vaccine
and myopathy.
The three criteria Schattner required to “establish a role for viral vaccine in the
subsequent development of [] autoimmune diseases” were not discussed with respect to the flu
vaccine and immune-mediated myopathy. Pet. Ex. 11 at 7. However, application of the
Schattner criteria61 to the evidence here does not support a role for the flu vaccine in the
development of immune-mediated myopathy.
First, Petitioner has not established that flu infections lead to immune-mediated
myopathy. As explained by Dr. Matloubian, flu infections have been associated with viral
myositis. Although the pathogenesis of viral myositis is not known, direct infection of muscle
has been acknowledged as a potential cause. See Resp. Ex. A, Tab 1 at 2. Dr. Matloubian cites
Desdouits et al., which described a study that found evidence supporting a direct infectious
etiology. See Resp. Ex. A, Tab 11 at 1. Dr. Matloubian further opines that autoimmune
myopathy has not been reported following the flu vaccine. And Petitioner did not file evidence
rebutting Dr. Matloubian’s opinion in this regard.
Second, while Dr. Zizic posits the mechanism of molecular mimicry, he does not provide
preponderant evidence showing that molecular mimicry due to antigens or molecules in the
vaccine leads to immune-mediated myopathy. While Dr. Zizic discusses mimics relevant to
other illnesses, like rheumatoid arthritis, he did not identify any common antigenic components
between the vaccine and muscle tissue that could implicate molecular mimicry here. Dr.
Matloubian effectively and persuasively shows the weaknesses of Petitioner’s theory and failure
to demonstrate any evidence to support homology or other indices of molecular mimicry.
Third, there must be evidence that patients who have received the flu vaccine have
developed immune-mediated myopathy. While Dr. Zizic asserts that there is “a large body of
61 The undersigned analyzes the evidence using the Schattner criteria here because Petitioner’s
expert, Dr. Zizic, did so, and because the criteria provide a useful framework to discuss Althen
Prong One. However, the undersigned’s decision does not turn on these criteria, but is based on
the evidence, the case law relevant to the Althen Prongs, and on the requisite burden of proof—
preponderance of the evidence. While the criteria outlined by Schattner is a way to organize the
Althen Prong One analysis, the undersigned understands that petitioners are not required to
demonstrate a specific biologic mechanism which caused their disease, nor are they required to
present medical literature or epidemiological studies in support of their theory. See Knudsen, 35
F.3d at 549; Andreu, 569 F.3d at 1378-79.
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evidence” supporting an association between the flu vaccine and immune-mediated myopathies,
the undersigned finds the evidence lacking. Pet. Ex. 10 at 32. Stübgen concluded there was “a
possible causal link between immunizations and inflammatory myopathies.” Pet. Ex. 29 at 1.
Possibilities, however, are not sufficient to establish causation. See, e.g., Waterman, 123 Fed.
Cl. at 573-74; Moberly, 592 F.3d at 1322 (emphasizing that “proof of a ‘plausible’ or ‘possible’
causal link between the vaccine and the injury” does not equate to proof of causation by a
preponderance of the evidence). Retrospective studies showed that vaccinations were not
thought to be a trigger for dermatomyositis/polymyositis. And VAERS reports did not show any
increase in dermatomyositis/polymyositis cases following the swine flu vaccination campaign in
1976 in military personnel or at several large clinics and hospitals. Similarly, Stübgen’s search
of the VAERS database through 2013 did not support vaccination was associated with any
increase in dermatomyositis/polymyositis. Finally, Ferri et al. presented three case reports of
inflammatory myopathies after the 2009-2010 seasonal flu vaccine in Italy, but the authors
reached no conclusions as to causation.
Moreover, opining that molecular mimicry is a causal theory, without more, is
insufficient. See, e.g., McKown v. Sec’y of Health & Hum. Servs., No. 15-1451V, 2019 WL
4072113, at *50 (Fed. Cl. Spec. Mstr. July 15, 2019) (explaining that “merely chanting the magic
words ‘molecular mimicry’ in a Vaccine Act case does not render a causation theory
scientifically reliable, absent additional evidence specifically tying the mechanism to the injury
and/or vaccine in question” (emphasis omitted)); Johnson v. Sec’y of Health & Hum. Servs., No.
14-254V, 2018 WL 2051760, at *26 (Fed. Cl. Spec. Mstr. Mar. 23, 2018) (“Petitioners cannot
simply invoke the concept of molecular mimicry and call it a day. Rather, they need to offer
reliable and persuasive medical or scientific evidence of some kind (whether expert testimony or
literature) . . . .” (internal citations omitted) (emphasis omitted)); Mattus-Long v. Sec’y of Health
& Hum. Servs., No. 15-113V, 2022 WL 4242140, at *27 (Fed. Cl. Spec. Mstr. Aug. 31, 2022)
(noting “the mere mention of molecular mimicry is not a ‘get out of jail free card’ in the
Program, entitling claimants to compensation, merely because it has scientific reliability as a
general matter”); Sheets v. Sec’y of Health & Hum. Servs., No. 16-1173V, 2019 WL 2296212, at
*17 (Fed. Cl. Spec. Mstr. Apr. 30, 2019) (determining Petitioner had not satisfied Althen Prong
One when he did not relate molecular mimicry “to either the vaccines in question or Petitioner’s
own specific condition”).
Further, Dr. Zizic references other mechanisms by which the flu vaccine activated B or T
lymphocytes, including “cross-priming, immune complex formation[,] or a combination of
these.” Pet. Ex. 10 at 34. While some of these words or phrases may be related to the
mechanism of molecular mimicry, Dr. Zizic does not define or describe them. Instead, he
mentions these concepts in a conclusory manner without development or explanation of how
they could cause or contribute to disease. As such, Dr. Zizic’s references to these concepts are
conclusory in nature.
When evaluating whether petitioners have carried their burden of proof, special masters
consistently reject “conclusory expert statements that are not themselves backed up with reliable
scientific support.” Kreizenbeck v. Sec’y of Health & Hum. Servs., No. 08-209V, 2018 WL
3679843, at *31 (Fed. Cl. Spec. Mstr. June 22, 2018), mot. for rev. denied, decision aff’d, 141
Fed. Cl. 138 (2018), aff’d, 945 F.3d 1362 (Fed. Cir. 2020). The undersigned will not rely on
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“opinion evidence that is connected to existing data only by the ipse dixit of the expert.”
Prokopeas v. Sec’y of Health & Hum. Servs., No. 04-1717V, 2019 WL 2509626, at *19 (Fed.
Cl. Spec. Mstr. May 24, 2019) (quoting Moberly, 592 F.3d at 1315).
Lastly, there appear to be only two reasoned decisions in the Program where a petitioner
alleged immune-mediated myopathy (dermatomyositis type) following the flu vaccine, with one
granting and one denying entitlement to compensation.62 Whelan v. Sec’y of Health & Hum.
Servs., No. 16-1174V, 2019 WL 1061473 (Fed. Cl. Spec. Mstr. Jan. 28, 2019); Ulysse v. Sec’y
of Health & Hum. Servs., No. 15-451V, 2022 WL 2115248 (Fed. Cl. Spec. Mstr. May 19, 2022).
In Whelan, the Petitioner alleged that a flu vaccine caused her dermatomyositis. Whelan,
2019 WL 1061473, at * 1. The Petitioner did not develop symptoms until over two months
following vaccination; the flu shot was administered on October 4, 2013, and the Petitioner
presented to her physician in March 2014 complaining that in late January, she developed a rash
and weakness in her legs. Id. Molecular mimicry was the posited causal mechanism, although
Petitioner’s expert also alluded to other mechanisms. Id. at *3, *15. Respondent’s expert was
Dr. Matloubian, and like here, he effectively rebutted the opinions of Petitioner’s expert, opining
that the wild type of flu virus has not been shown to cause dermatomyositis. Id. at *5, *15.
Petitioner’s expert, Dr. Brawer, offered no opinion about what the expected onset time frame
should be (Althen prong three), whereas Dr. Matloubian opined that onset greater than eight
weeks was outside the expected range given the theory of molecular mimicry. Id. at *15. Now-
Chief Special Master Corcoran denied entitlement, finding Dr. Matloubian’s testimony
persuasive as to the lengthy onset and the Petitioner’s failure to show that the flu vaccine has
been associated with dermatomyositis. Id.
A different theory was advanced in Ulysse, with a favorable outcome for the Petitioner.
Ulysse, 2022 WL 2115248, at *1. There, the Petitioner primarily had skin manifestations, with
some muscle involvement, and the diagnosis was amyotrophic dermatomyositis versus mixed
connective tissue disease. Id. at *3-5. Several causal mechanisms were advanced, including
molecular mimicry. Id. at *6-8, *18-19. However, Chief Special Master Corcoran found that
Petitioner’s most compelling theory was related to the upregulation of cytokines, based on the
well-developed opinions of Petitioner’s expert, supported by reliable literature. Id. at *6-8, *18-
19. Moreover, Respondent’s expert failed to offer an effective rebuttal or even one medical
article in support of his opinions. Id. at *11, *18-19.
62 There are also three somewhat similar cases, distinguishable by virtue of the vaccines
administered and/or diagnosis. Durden v. Sec’y of Health & Hum. Servs., No. 05-163V, 2007
WL 4962000 (Fed. Cl. Spec. Mstr. Sept. 26, 2007) (analyzing overlap syndrome and
sclerodermatomyositis following diphtheria-tetanus vaccination); Rodd v. Sec’y of Health &
Hum. Servs., No. 13-122V, 2015 WL 8489035 (Fed. Cl. Spec. Mstr. Nov. 13, 2015) (analyzing
overlap syndrome, Sjogren’s syndrome, polymyositis, or anti-synthase syndrome following flu
vaccination); Rodriguez v. Sec’y of Health & Hum. Servs., No. 13-253V, 2017 WL 5563419
(Fed. Cl. Spec. Mstr. Oct. 26, 2017) (examining juvenile dermatomyositis following diphtheria-
tetanus-acellular pertussis, measles-mumps-rubella, polio, and Varicella vaccinations).
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Although decisions of other special masters are not binding, the undersigned generally
agrees with the special master’s reasoning in Whelan—that is, rejecting molecular mimicry and
finding that Dr. Matloubian effectively rebutted the causation opinions asserted. See Boatmon,
941 F.3d at 1358; Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998), aff’d,
191 F.3d 1344 (Fed. Cir. 1999). Also, both Whelan and the case at bar have an onset issue.
Here, onset predates vaccination, and in Whelan, it was too long after vaccination. Moreover,
the outcome in Ulysse does not conflict with the outcome here, as there was a different theory
advanced, supported by medical literature, and effectively unrebutted by Respondent’s expert.
For all of the reasons discussed above, the undersigned finds Petitioner has failed to
provide preponderant evidence with respect to the first Althen prong.
D. Althen Prong Two
Under Althen Prong Two, Petitioner must prove by a preponderance of the evidence that
there is a “logical sequence of cause and effect showing that the vaccination was the reason for
the injury.” Capizzano, 440 F.3d at 1324 (quoting Althen, 418 F.3d at 1278). “Petitioner must
show that the vaccine was the ‘but for’ cause of the harm . . . or in other words, that the vaccine
was the ‘reason for the injury.’” Pafford, 451 F.3d at 1356 (internal citations omitted).
Because Petitioner failed to prove Althen Prong One, it follows that he cannot prove
Althen Prong Two. However, even if Petitioner had proven Althen Prong One, the undersigned
finds Petitioner has failed to prove Althen Prong Two by preponderant evidence for the
following reasons.
First, because the undersigned finds that onset of Petitioner’s immune-mediated
myopathy occurred before vaccination, his flu vaccination could not have caused his illness.
Therefore, the question would turn to whether there is a logical sequence of cause and effect to
show that Petitioner’s vaccination caused a significant aggravation of his condition, however,
Petitioner did not allege a significant aggravation claim.63
Second, in evaluating whether this prong is satisfied, the opinions and views of the
vaccinee’s treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367;
Capizzano, 440 F.3d at 1326 (“[M]edical records and medical opinion testimony are favored in
vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.’”
(quoting Althen, 418 F.3d at 1280)). However, statements in a patient’s history referencing a
vaccination that is temporally associated with a condition, without more, does not meet the level
63 While one statement in Petitioner’s brief suggested Petitioner was pursuing a claim for
significant aggravation, Petitioner’s expert reports did not address the Loving prongs relevant to
such a claim. Pet. Br. at 3. Moreover, Petitioner later confirmed that he was not pursuing a
significant aggravation claim. Joint Status Rept., filed Mar. 23, 2023. Even if Petitioner had
pursued a significant aggravation claim, the outcome would be the same, as he failed to prove by
preponderant evidence all three Althen prongs, which constitute Loving prongs four, five, and
six. See Loving, 86 Fed. Cl. at 142-44.
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of preponderant evidence. See § 13(b)(1) (providing that “[a]ny such diagnosis, conclusion,
judgment, test result, report, or summary shall not be binding on the special master or court”);
Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 745 n.67 (2009) (“[T]here is nothing .
. . that mandates that the testimony of a treating physician is sacrosanct—that it must be
accepted in its entirety and cannot be rebutted.”); Robertson v. Sec’y of Health & Hum. Servs.,
No. 18-554V, 2022 WL 17484980, at *17 (Fed. Cl. Spec. Mstr. Dec. 7, 2022) (explaining “the
opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their
suppositions or bases”); Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011)
(finding it neither arbitrary nor capricious for a special master to weigh competing treating
physicians’ conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v.
Sec’y of Health & Hum. Servs., 100 Fed. Cl. 119, 136 (2011), aff’d, 463 F. App’x 932 (Fed. Cir.
2012).
There are two issues arising from opinions by Petitioner’s physicians evidenced in the
medical records—opinions regarding differential diagnoses and opinions related to alternative
causes.
The first issue concerns statements made by Petitioner to his health care providers
relating a temporal association of some of his symptoms back to the receipt of his flu
vaccination. In several instances, physicians considered the question of a causal association. For
example, after Petitioner was admitted to the hospital on December 16, 2016, Dr. Yang
considered two differential diagnoses, “post-vaccine syndrome” or a “delayed autoimmune-
immune neuropathy” due to the viral-like illness Petitioner had two weeks before admission.
Pet. Ex. 5 at 95. These differential diagnoses were contemplated before the muscle biopsy and
before Petitioner was diagnosed with immune-mediated myopathy. Later, neurologist Dr. Weiss
wrote that he considered two differential causes of Petitioner’s autoimmune myopathy, (1) the
flu vaccine, “though rare case reports found,” and (2) a “[p]ost-viral process.” Pet. Ex. 4 at 70.
The undersigned finds that physician statements expressing differential diagnoses, which
include a reference to the flu vaccine, without more, do not meet the level of preponderant
evidence. See § 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result,
report, or summary shall not be binding on the special master or court”). “A treating physician’s
recognition of a temporal relationship does not advance the analysis of causation.” Isaac v.
Sec’y of Health & Hum. Servs., No. 08-601V, 2012 WL 3609993, at *26 (Fed. Cl. Spec. Mstr.
July 30, 2012); see also A.T. v. Sec’y of Health & Hum. Servs., No. 16-393V, 2021 WL
6495241, at *28 (Fed. Cl. Spec. Mstr. Dec. 17, 2021) (finding that Petitioner’s treating
physicians “considered, though did not conclude,” that Petitioner’s vaccine significantly
aggravated her condition); Robertson, 2022 WL 17484980 at *17 (finding treating physicians’
statements of mere suspicion fall short of an opinion supporting vaccine causation); Cedillo v.
Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1347 (Fed. Cir. 2010) (concluding the special
master did not err in affording little weight to the opinions of Petitioner’s treating physicians
where “none of the treating physicians concluded that the [] vaccine caused [Petitioner’s]
[condition]”).
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Next, it is appropriate to consider alternative causes in evaluating whether prong two is
satisfied, and as described above, the opinions and views of the vaccinee’s treating physicians
are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326.
The physicians who cared for Petitioner raised the question of whether his immune-
mediated myopathy had a viral etiology. As described above, Dr. Yang questioned whether
Petitioner’s preceding viral-like illness played a causal role. Dr. Alton and Dr. Ryan likewise
documented their suspicion of a viral etiology, noting that Petitioner had tested positive for
CMV. And Dr. Weiss also considered a post-viral process.
As such, Dr. Matloubian discusses alternative causes for Petitioner’s alleged vaccine-
related illness. He notes that Petitioner’s muscle biopsy findings were non-specific, suggesting
the cause could be infectious. Dr. Matloubian explains that while dermatomyositis is not usually
thought of as being post-infectious, Petitioner had positive coxsackie and CMV test results, and
evidence of an ongoing infection with CMV. These were references by the pathologists in
Petitioner’s biopsy report of “potential causes of a viral myositis[] that could not be ruled out
based on the pathologic findings.” Resp. Ex. A at 14 (quoting Pet. Ex. 4 at 1059). The
pathologists cited Fasth et al., who reported that CMV might play a role in triggering
dermatomyositis/polymyositis in some patients. Id. (citing Resp. Ex. A, Tab 10). Further, on
December 1, 2016, prior to vaccination, Petitioner had a “viral syndrome with fatigue, sore
muscles[,] and chills.” Id. (quoting Pet. Ex. 10 at 33). Thus, Dr. Matloubian concludes that
Petitioner had a “recent and active infection with CMV, a virus that has been associated with
development of an inflammatory myositis.” Id. at 16.
The undersigned acknowledges that Petitioner is not required to eliminate other potential
causes in order to be entitled to compensation. See Walther v. Sec’y of Health & Hum. Servs.,
485 F.3d 1146, 1149-52 (Fed. Cir. 2007) (finding a petitioner does not bear the burden of
eliminating alternative independent potential causes). However, she finds it reasonable to
consider “evidence of other possible sources of injury”—here, Petitioner’s antecedent viral-
illness and CMV infection—to determine “whether a prima facie showing has been made that the
vaccine was a substantial factor in causing the injury in question.” Stone, 676 F.3d at 1379.
The fact that Petitioner had a preceding viral-like illness and a CMV infection, “makes it
difficult to attribute ‘but for’ causation to the vaccination.” Pafford, 451 F.3d at 1358-59; see
also Walther, 485 F.3d at 1151 n.4 (“Where multiple causes act in concert to cause the injury,
proof that a particular vaccine was a substantial cause may require the petitioner to establish that
the other causes did not overwhelm the causative effect of the vaccine.”). As such, the
undersigned finds this to be an additional reason why Petitioner has failed to prove that the flu
vaccine was the “but for” cause of his immune-mediated myopathy.
For the reasons described above, the undersigned finds that Petitioner has failed to
provide preponderant evidence of a logical sequence of cause and effect required under Althen
prong two.
E. Althen Prong Three
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Althen prong three requires Petitioner to establish a “proximate temporal relationship”
between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been
defined as a “medically acceptable temporal relationship.” Id. The Petitioner must offer
“preponderant proof that the onset of symptoms occurred within a time frame for which, given
the medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation-in-fact.” de Bazan, 539 F.3d at 1352. The explanation for what is a medically
acceptable time frame must also coincide with the theory of how the relevant vaccine can cause
the injury alleged (under Althen Prong One). Id.; Koehn v. Sec’y of Health & Hum. Servs., 773
F.3d 1239, 1243 (Fed. Cir. 2014); Shapiro, 101 Fed. Cl. at 542; see Pafford, 451 F.3d at 1358. A
temporal relationship between a vaccine and an injury, standing alone, does not constitute
preponderant evidence of vaccine causation. See, e.g., Veryzer, 100 Fed. Cl. at 356 (explaining
that “a temporal relationship alone will not demonstrate the requisite causal link and that
[P]etitioner must posit a medical theory causally connecting the vaccine and injury”), aff’d, 475
F. App’x 765 (Fed. Cir. 2012).
Based on the case law cited above, this Althen prong consists of two parts. Petitioner
must first establish the time frame within which it is medically acceptable to infer causation.
Secondly, he must show that the onset of his illness occurred during this time frame.
Petitioner’s expert, Dr. Zizic, opines that Petitioner’s symptoms began within 24 hours
after vaccination, however, he does not identify what these symptoms were or why he believes
they constitute the onset of Petitioner’s illness. Other than a cursory reference to the Stübgen
article, Dr. Zizic does not explain how an onset of 24 hours could occur given his posited theory
of molecular mimicry. In contrast, Respondent’s expert, Dr. Matloubian, opines that onset
preceded vaccination, and therefore, the vaccine did not cause Petitioner’s illness.
Petitioner’s reliance on Stübgen as to whether there is an appropriate temporal
association here is misplaced. Stübgen suggests several mechanisms relevant to dermatomyositis
including “completement-mediated microangiopathy” that destroys blood vessels, leading to
“hypoperfusion and inflammatory cell stress within the perifascicular regions,” not molecular
mimicry. Pet. Ex. 29 at 2. Further, while Stübgen includes tables listing several case reports
with an onset of 24 hours or one day, the facts of the cases are not included, so it is impossible to
verify the diagnosis or clinical course of those patients.
Because the undersigned finds that onset of Petitioner’s myopathy occurred before
vaccination, she agrees with Dr. Matloubian, that the flu vaccine could not have caused
Petitioner’s illness. Moreover, Petitioner has failed to explain how molecular mimicry could
cause the onset of immune-mediated myopathy within 24 hours of vaccination. And Program
cases do not support a 24-hour onset with molecular mimicry as the causation theory. See, e.g.,
Burgess v. Sec’y of Health & Hum. Servs., No. 17-688V, 2022 WL 17410582, at *35 (Fed. Cl.
Spec. Mstr. Nov. 7, 2022); Hock v. Sec’y of Health & Hum. Servs., No. 17-168V, 2020 WL
6392770, at *28-29 (Fed. Cl. Spec. Mstr. Sept. 30, 2020); O.M.V. v. Sec’y of Health & Hum.
Servs., No. 16-1505V, 2021 WL 3183719, at *48 (Fed. Cl. Spec. Mstr. June 16, 2021), mot. for
rev. denied, 157 Fed. Cl. 376 (2021).
45

Case 1:17-vv-01322-UNJ Document 94 Filed 07/21/23 Page 46 of 46
Therefore, the undersigned finds there is not preponderant evidence of a temporal
association between Petitioner’s receipt of his flu vaccination and the onset of his myopathy.
Even if he had proven Althen prong three, a temporal association, without more, is insufficient.
Moberly, 592 F.3d at 1323; Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144, 1148 (Fed.
Cir. 1992) (“[A] proximate temporal association alone does not suffice to show a causal link
between the vaccination and the injury.”). Thus, Petitioner is not entitled to compensation.
VI. CONCLUSION
The undersigned extends her sympathy to Petitioner for the illness that he has suffered.
This Decision, however, cannot be based on sympathy, but rather on the evidence and the law.
For the reasons discussed above, the undersigned finds that Petitioner has not established
by preponderant evidence that his flu vaccination caused his condition. Therefore, Petitioner is
not entitled to compensation and his petition must be dismissed.
In the absence of a timely filed motion for review pursuant to Vaccine Rule 23, the Clerk
of Court SHALL ENTER JUDGMENT in accordance with this Decision.
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Special Master
46

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_17-vv-01322-cl-extra-10734327
Date issued/filed: 2024-09-04
Pages: 1
Docket text: Supplementary opinion from CourtListener cluster 10267737
--------------------------------------------------------------------------------
    In the United States Court of Federal Claims
                                  OFFICE OF SPECIAL MASTERS
                                       (Filed: May 24, 2024)


* * * * * * * * * * * * * *
DAVID T. McDANIEL          *
                           *                                    No. 17-1322V
          Petitioner,      *
                           *                                    Special Master Dorsey
v.                         *
                           *                                    Attorneys’ Fees and Costs
                           *
SECRETARY OF HEALTH        *
AND HUMAN SERVICES,        *
                           *
          Respondent.      *
* * * * * * * * * * * * * *

Douglas Lee Burdette, Burdette Law, North Bend, WA, for petitioner.
Debra A. Filteau Begley, U.S. Department of Justice, Washington, D.C., for respondent.

                         DECISION ON ATTORNEYS’ FEES AND COSTS1

        On September 25, 2017, David T. McDaniel (“Petitioner”) filed a petition for
compensation under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the
Program”), 42 U.S.C. § 300aa-10 et seq. (2018).2 Petitioner alleges that he suffered “an auto-
immune myopathy, more likely than not dermatomyositis,” as the result of an influenza (“flu”)
vaccination administered on December 12, 2016. Petition at Preamble (ECF No. 1); Amended
(“Am.”) Petition at Preamble (ECF No. 7). On July 19, 2022, the undersigned filed her decision
finding petitioner is not entitled to compensation and dismissing petitioner’s claim for
insufficient proof. (ECF No. 93).


1
  Because this Decision contains a reasoned explanation for the action taken in this case, it must be made publicly
accessible and will be posted on the United States Court of Federal Claims' website, and/or at
https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002.
44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This
means the Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule
18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which
would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within
this definition, I will redact such material from public access.
2
 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine
Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to -34 (2018).
All citations in this Decision to individual sections of the Vaccine Act are to 42 U.S.C. § 300aa.
         On October 25, 2023, petitioner filed a motion for attorneys’ fees and costs. Motion for
Attorney Fees and Costs (“Fees App.”) (ECF No. 96). Petitioner requests compensation in the
amount of $95,430.58, representing $48,402.75 in attorneys’ fees and $47,027.83 in costs. Fees
App. at 3. Petitioner’s counsel states that petitioner “refused, despite several requests, to sign the
[General Order No. 9];” however, counsel states “to the best of [his] knowledge, petitioner has
not paid any costs of the claim.” Id. at 4, Fees App. Ex. 3 at 2. Respondent filed his response on
November 8, 2023, indicating that he “is satisfied the statutory requirements for an award of
attorneys’ fees and costs are met in this case.” Response at 2. (ECF No. 97). Petitioner did not
file a reply thereafter. The matter is now ripe for disposition.

      For the reasons discussed below, the undersigned GRANTS petitioner’s motion and
awards a total of $95,430.58.

           I.      Discussion

        Under the Vaccine Act, the special master shall award reasonable attorneys’ fees and
costs for any petition that results in an award of compensation. 42 U.S.C. § 300aa-15(e)(1).
When compensation is not awarded, the special master “may” award reasonable attorneys’ fees
and costs “if the special master or court determines that the petition was brought in good faith
and there was a reasonable basis for the claim for which the petition was brought.” Id. at
§15(e)(1). In this case, although the petition was eventually dismissed, the undersigned is
satisfied that the case possessed both good faith and reasonable basis throughout its pendency.
Respondent also has not advanced any argument that the claim lacked good faith or reasonable
basis. Accordingly, Petitioner is entitled to a final award of reasonable attorneys’ fees and
costs.

                       a. Reasonable Attorneys’ Fees

         The Federal Circuit has approved use of the lodestar approach to determine reasonable
attorney’s fees and costs under the Vaccine Act. Avera v. Sec’y of Health & Human Servs., 515
F.3d 1343, 1349 (Fed. Cir. 2008). Using the lodestar approach, a court first determines “an
initial estimate of a reasonable attorney’s fee by ‘multiplying the number of hours reasonably
expended on the litigation times a reasonable hourly rate.’” Id. at 1347-58 (quoting Blum v.
Stenson, 465 U.S. 886, 888 (1984)). Then, the court may make an upward or downward
departure from the initial calculation of the fee award based on other specific findings. Id. at
1348.

        Counsel must submit fee requests that include contemporaneous and specific billing
records indicating the service performed, the number of hours expended on the service, and the
name of the person performing the service. See Savin v. Sec’y of Health and Human Servs., 85
Fed. Cl. 313, 316-18 (2008). Counsel should not include in their fee requests hours that are
“excessive, redundant, or otherwise unnecessary.” Saxton v. Sec’y of Health and Human Servs.,
3 F.3d 1517, 1521 (Fed. Cir. 1993) (quoting Hensley v. Eckerhart, 461 U.S. 424, 434 (1983)). It
is “well within the special master’s discretion to reduce the hours to a number that, in [her]
experience and judgment, [is] reasonable for the work done.” Id. at 1522. Furthermore, the
special master may reduce a fee request sua sponte, apart from objections raised by respondent
                                                  2
and without providing a petitioner notice and opportunity to respond. See Sabella v. Sec’y of
Health & Human Servs., 86 Fed. Cl. 201, 209 (2009).

        A special master need not engage in a line-by-line analysis of a petitioner’s fee
application when reducing fees. Broekelschen v. Sec’y of Health & Human Servs., 102 Fed. Cl.
719, 729 (2011). Special masters may rely on their experience with the Vaccine Program and its
attorneys to determine the reasonable number of hours expended. Wasson v. Sec’y of Health
and Human Servs., 24 Cl. Ct. 482, 484 (Fed. Cl. Nov. 19, 1991) rev’d on other grounds and aff’d
in relevant part, 988 F. 2d 131 (Fed. Cir. 1993). Just as “[t]rial courts routinely use their prior
experience to reduce hourly rates and the number of hours clamed in attorney fee requests …
[v]accine program special masters are also entitled to use their prior experience in reviewing fee
application.” Saxton, 3 F. 3d at 1521.

                                   i. Reasonable Hourly Rates

       Petitioner requests the following hourly rates for the work of his counsel: for Mr.
Douglas Lee Burdette, $400.00 per hour for work performed from 2017-2023; and for Ms. Kelly
Burdette, $275.00 per hour for work performed from 2017-2023. These rates are consistent with
what counsel have previously been awarded for their Vaccine Program work, and the
undersigned finds them to be reasonable herein. See Arias v. Sec’y of Health & Human Servs.,
No. 16-808V, 2023 WL 3580598 (Fed. Cl. Spec. Mstr. May 22, 2023).

                                 ii.     Reasonable Hours Expended

        In reducing an award of fees, the goal is to achieve rough justice, and therefore a special
master may take into account their overall sense of a case and may use estimates when reducing
an award. See Florence v. Sec’y of Health & Human Servs., No. 15-255V, 2016 WL 6459592, at
*5 (Fed. Cl. Spec. Mstr. Oct. 6, 2016) (citing Fox v. Vice, 563 U.S. 826, 838 (2011). It is well
established that an application for fees and costs must sufficiently detail and explain the time
billed so that a special master may determine, from the application and the case file, whether the
amount requested is reasonable. Bell v. Sec'y of Health & Human Servs., 18 Cl. Ct. 751, 760
(1989); Rodriguez, 2009 WL 2568468. Petitioner bears the burden of documenting the fees and
costs claimed. Id. at *8.

        The undersigned has reviewed the submitted billing entries and finds the total number of
hours billed to be reasonable. The billing entries accurately reflect the nature of the work
performed and the undersigned does not find any of the entries to be objectionable. Respondent
also has not indicated that he finds any of the entries to be objectionable either. Petitioner is
therefore awarded final attorneys’ fees of $48,402.75.

                      b. Attorneys’ Costs

       Petitioner requests a total of $47,027.83 in attorneys’ costs. This amount is comprised of
acquiring medical records, postage, the Court’s filing fee and expert services performed by Dr.
Thomas Zizic. Fees App. Ex. 1 at 15-17. Dr. Zizic provided a total of three expert reports at a
                                                 3
rate of $400.00 per hour for 112.5 hours, totaling $43,400.00 (less the $1,600.00 retainer fee).
Fees App. Ex. 2 at 13-14, 17-18, 20. The undersigned has reviewed the requested costs and finds
them to be reasonable for the work performed in this case. Accordingly, the full amount of costs
shall be awarded.

             II.      Conclusion

        Based on all of the above, the undersigned finds that it is reasonable compensate
petitioner and their counsel as follows:

Attorneys’ Fees Requested                                                       $48,402.75
(Total Reduction from Billing Hours)                                                 -
Total Attorneys’ Fees Awarded                                                   $48,402.75

Attorneys’ Costs Requested                                                      $47,027.83
(Reduction of Costs)                                                                 -
Total Attorneys’ Costs Awarded                                                  $47,027.83

Total Attorneys’ Fees and Costs Awarded                                         $95,430.58

      Accordingly, the undersigned awards $95,430.58 in attorneys’ fees and costs, in the
form of a check payable jointly to petitioner and petitioner’s counsel, Mr. Douglas Lee
Burdette.

       In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of
Court SHALL ENTER JUDGMENT in accordance with this decision.3

         IT IS SO ORDERED.

                                                               s/Nora Beth Dorsey
                                                               Nora Beth Dorsey
                                                               Special Master




3
  Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice renouncing
the right to seek review.
                                                          4