Switzer v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 18-1418V
Filed: August 29, 2022
************************* *
*
TRICIA SWITZER, As Executor of the *
*
Estate of Richard Feider, Sr., * TO BE PUBLISHED
*
Petitioner, *
*
* Decision on Entitlement; Influenza
v. * Vaccine; Pneumococcal Vaccine;
* Systemic Inflammatory Response
SECRETARY OF HEALTH AND *
* Syndrome (“SIRS”); Multiple Organ
HUMAN SERVICES, * Dysfunction Syndrome (“MODS”); Acute
* Kidney Injury (“AKI”).
Respondent. *
*
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Andrew Downing, Downing, Allison & Jorgenson, Phoenix, AZ, for Petitioner
Voris Johnson, U.S. Department of Justice, Washington, DC, for Respondent
DECISION ON ENTITLEMENT 1
Oler, Special Master:
On September 17, 2018, Tricia Switzer (“Petitioner”), as executor of the estate of Richard
Feider, Sr. (hereinafter “Mr. Feider” or “Vaccinee”), filed a petition for compensation under the
National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq. 2 (the “Vaccine
Act” or “Program”) alleging that Mr. Feider suffered from vaccine-induced Systemic
Inflammatory Response Syndrome (“SIRS”) that progressed to multiple organ dysfunction and
death, and which resulted from the influenza and Prevnar 13 vaccinations he received on
1 This Decision will be posted on the United States Court of Federal Claims’ website, in accordance with
the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Decision will be available to
anyone with access to the internet. As provided in 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties
may object to the Decision’s inclusion of certain kinds of confidential information. To do so, each party
may, within 14 days, request redaction “of any information furnished by that party: (1) that is a trade secret
or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files
or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.”
Vaccine Rule 18(b). Otherwise, this Decision will be available to the public in its present form. Id.
2National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa
(2012).
1
September 20, 2016. Pet. at 1, 7. For the reasons discussed in this decision, I find that although
Petitioner presented preponderant evidence that the flu vaccine can cause SIRS, she has not
demonstrated that that the vaccines Mr. Feider received “did cause” his condition.
I. Procedural History
Petitioner filed a petition on September 17, 2018, alleging that Mr. Feider developed
vaccine-induced SIRS from the influenza and Prevnar 13 vaccinations he received on September
20, 2016. Pet. at 1, 7. Petitioner claimed these vaccinations resulted in Mr. Feider’s subsequent
death on October 9, 2016. Id. at 6, 8.
Petitioner filed medical records on September 20, and September 25, 2018. Exs. 1-6, 7-8.
On July 11, 2019, Respondent filed a Rule 4(c) Report stating Petitioner has not met her burden
of proving entitlement to compensation under the Vaccine Act. Resp’t’s Rep. at 14.
Between October 2019 and July 2020, the parties filed a series of expert reports from their
respective experts, Dr. Shoenfeld, Dr. Fife, and Dr. Morel. Exs. 9, A, C, 40, 41, AA, and BB.
I held a status conference on August 20, 2020 and then issued an order with additional
questions for both parties’ experts. See Scheduling Order dated August 21, 2020, ECF No. 35.
On September 1, 2020, Petitioner filed an expert report from Dr. Shoenfeld responding to
my questions. Ex. 56. On October 19, 2020, Respondent filed reports from Drs. Fife and Morel.
Exs. HH, JJ.
On February 19, 2021, Petitioner filed a Motion for a Ruling on the Record. ECF No. 40.
On April 20, 2021, Respondent filed a response. ECF No. 41. On May 18, 2021, Petitioner filed a
reply brief. ECF No. 42. On June 14, 2021, the parties filed a joint status report indicating the
record was complete, and that this matter was now ripe for a decision. ECF No. 44.
II. Medical Records
A. Relevant Pre-Vaccination History
Mr. Feider had a prior medical history that included coronary artery disease requiring a
four-vessel bypass, aortic stenosis requiring an aortic valve replacement in 2013 (Ex. 3 at 1),
peripherical vascular disease (Ex. 4 at 1), hypertension, hyperlipidemia, renal vascular disease, a
heart murmur. He was previously a cigarette smoker. See Ex. 8 at 281 (noting he smoked 40 pack
years, and quit in 1984).
On July 19, 2016, Mr. Feider visited Dr. Inkee Min, a nephrologist, at the Buffalo Medical
Group for a follow-up appointment related to his chronic renal failure due to hypertensive
nephrosclerosis and atrophic right kidney. Ex. 4 at 54-55. In a letter written by physician assistant
(“PA”) Robert Hynes, it was noted that Mr. Feider’s renal function was stable. Id.
2
On September 20, 2016, Mr. Feider received the influenza vaccination in his right deltoid
and the pneumococcal (Prevnar 13) vaccination in his left deltoid. Ex. 2 at 1; Ex. 8 at 996. He was
72 years old at the time of vaccination.
B. Post-Vaccination History
Mr. Feider was transported to the Buffalo Veterans Affair (“VA”) Hospital ER department
via ambulance on September 24, 2016. Mr. Feider reported that he had received the influenza and
pneumococcal vaccines on September 20 th and the following day, developed a cough, felt feverish
and unwell. Ex. 8 at 982. Mr. Feider stated he felt better on Thursday and most of the day on Friday
(September 23 rd), but late that night experienced a sudden onset of shortness of breath and
difficulty breathing. Id. Mr. Feider had a fever of 104.5ºF and was started on solumedrol. Id. at
980. Mr. Feider underwent an EKG, x-ray, and blood samples were taken for cultures. Id. The
leading diagnosis was pneumonia and sepsis. Id. at 985. Mr. Feider had rales in both lungs, left
more than right, and was experiencing mildly labored breathing. Id. at 984.
On the same day, Mr. Feider was examined by Dr. Jaime Bittner who recorded the
following history of present illness:
Patient presents with a one day history of sudden SOB (shortness of breath) with
fever. Patient felt relatively healthy yesterday and went to his usual cardio rehab,
went home had lunch, went out to dinner and felt like his usual self. He was
watching TV last night and at 11pm began to feel warm, shaky, and had a “tough
time breathing”…. Patient got a Flu shot and pneumovax on Tuesday, then felt
warm and slept all day Wednesday but was back to his usual state of health by
Thursday.
Ex. 8 at 946. Mr. Feider’s fever was 100.2ºF. Id. at 947. The EKG, x-ray, and cultures were
negative for the most common infectious sources. Id. at 102, 241-43. Mr. Feider’s active issues
included shortness of breath, fever, leukocytosis, AKI (acute kidney injury), CKD (chronic kidney
disease), hypokalemia, history of CAD (chronic artery disease), and HTN (hypertension). Id. at
952-53.
On the same day, Mr. Feider was also seen by Dr. Vasvi Singh, a cardiology fellow, and
Dr. Sunil Baldwa, a cardiologist, for a cardiology consult. Ex. 4 at 343-45, 349-51. Drs. Singh and
Baldwa diagnosed Mr. Feider with severe sepsis, mild troponin elevation, status post bioprosthetic
aortic valve replacement and coronary artery bypass grafting, sinus bradycardia, severe peripheral
arterial disease, hypertension, and hyperlipidemia. Id. at 350. Mr. Feider’s sepsis was treated with
antibiotics and hydration. Id. Around 10:45pm on September 24, 2016, Mr. Feider’s temperature
was down to 97.4ºF. Id. at 56.
During the early morning hours of September 25, 2016, Mr. Feider began experiencing
hypoxic respiratory failure, prompting a transfer to the ICU and intubation with mechanical
ventilation. Ex. 8 at 899-901. Mr. Feider had diffuse crackles in all lung fields bilaterally. Id. at
900. Mr. Feider was subsequently seen by Drs. Adil Shujaat and Benjamin Segerson, internal
medicine doctors, that same day. Id. at 887-92. Mr. Feider was given an arterial line placement in
3
his right wrist and hemodialysis catheter. Id. at 904. Dr. Rajiv Ranjan, a nephrologist, noted that
Mr. Feider was not producing urine and his renal function was continuing to deteriorate. Id. at 872.
On September 26, 2016, Mr. Feider was seen by Dr. Thomas Russo, an infectious diseases
consultant, for “hypoxic respiratory failure, possible pneumonia.” Ex. 8 at 323-25. Dr. Russo noted
that Mr. Feider’s sputum culture contained “very rare red blood cells, 1-2+ white blood cells, very
rare squamous epithelial cells,…” Id. at 324-25. Mr. Feider’s x-ray revealed mild interval
improvement of pulmonary edema, and superimposed infection could not be completely excluded.
Id. at 325. It was Dr. Russo’s impression that Mr. Feider was experiencing acute hypoxic
respiratory failure and had possible community acquired pneumonia. Id. at 325. Dr. Russo also
noted it was “difficult to differentiate pulmonary edema from extensive bilateral pneumonia.” Id.
On the same day, Mr. Feider was seen for a cardiology consultation. Ex. 4 at 446-53. It
was noted that his condition was either pneumonia, idiopathic pneumonia, acute respiratory
distress syndrome (ARDS), or pulmonary edema. Id. at 448. Mr. Feider’s CT scan was negative
for a stroke. Id. Mr. Feider’s echocardiogram revealed mild concentric left ventricular
hypertrophy, mild to moderate mitral regurgitation, and mild to moderate valvular aortic stenosis.
Id. at 447.
On September 27, 2016, Dr. Jahan Porhomayon, a critical care doctor, observed Mr.
Feider’s symptoms related to his congestive heart failure and hypertension had improved with
dialysis. Ex. 8 at 812. Mr. Feider’s hypoxia has also improved but had developed a rash or petechia
with unknown etiology. Id.
On September 28, 2016, Mr. Feider was seen for a hematology consult for his anemia and
a worsening thrombocytopenia. Id. at 315, 320. Mr. Feider had a history of thrombocytopenia with
a baseline range of 95,000-120,000 platelets since 2011. Id. at 315. Mr. Feider was anemic upon
admission. Id. Mr. Feider’s platelet count had dropped to 60,000 at one point but had rebounded
to 83,000. Id. at 320.
On September 30, 2016, Mr. Feider underwent a failed extubation. Ex. 8 at 739-40, 42. Dr.
Russo returned to Mr. Feider the same day and assessed him as follows: “?? CAP [community-
acquired pneumonia]- finishing 7 days of antibiotics today. I suspect his pulmonary failure is
probably not due to infection.” Id. at 732.
On October 1, 2016, Mr. Feider was noted to be afebrile after antibiotics and his white
blood cell count was at 8.7 (normal). Ex. 8 at 702. Dr. Pietrantoni, a pulmonary and critical care
physician, noted that it was unlikely to be CAP (community acquired pneumonia) given these
improvements and the pneumonia had resolved. Id. at 702, 705. Mr. Feider was given additional
dialysis, which he seemed to have tolerated well. Mr. Feider was also anuric. Id. at 703.
On October 2, 2016, Mr. Feider underwent a head and lung CT. Ex. 8 at 624. Dr. Amy Kao
interpreted Mr. Feider’s chest CT and noted that his “heart shadow is accentuated by AP technique
and appears mildly enlarged. Trachea is deviated to the right as before… diffuse interstitial pattern
persists. Findings are nonspecific but may relate to ARDS or pulmonary edema.” Id. at 625. Dr.
4
Alice Smith interpreted the head CT and noted “age-related changes without evidence of acute
intracranial event.” Id.
On October 3, 2016, a bronchoscopy was performed on Mr. Feider. Ex. 8 at 634-36. The
findings revealed:
normal carina, no endobronchial masses/lesions seen. Right upper lobe bronchial
tree appeared normal. There was bloody secretion coming out the RML (right
middle lobe) and RLL (right lower lobe). Also RLL and RML mucosa appeared
erythematous. Left upper lobe bronchial tree was normal. There were also bloody
secretions coming the LLL (left lower lobe) and the mucosa was erythematous. No
endobronchial lesions or masses.
Id. at 635-36. Samples were also taken during the bronchoscopy from the RLL and LLL which
revealed: acute inflammation, blood and mucoid material,… no evidence of fungal, bacterial or
acid fast micro-organisms on GMS, Gram and AFB special stain in the RLL; and rare atypical
degenerate squamous epithelial cells were seen in the LLL. Id. at 1001. The samples were grown
for five days and showed no growth of microorganisms. Id. at 235-37.
On October 5, 2016, Dr. John Sellick Jr., another infectious diseases consultant, visited Mr.
Feider again because his WBC had risen to 30,000. Ex. 8 at 280-83. Mr. Feider also had a
temperature of 100.6ºF. Id. at 281. Dr. Sellick noted that Mr. Feider’s cultures were negative, with
the exception of yeast, which was unlikely to be pathogenic. Id. at 282. Mr. Feider resumed
antibiotics. Id. at 283.
In the early hours of October 6, 2016, Mr. Feider was observed to hypotensive and was not
responding to IV fluids. Ex. 8 at 467, 475. Mr. Feider’s WBC was decreasing but his ALT (alanine
transaminase) and AST (aspartate aminotransferase) levels were rising. Id. at 472-73. In a
nephrology note, it was noted that “[Mr. Feider] was getting [hemodialysis] but [blood pressure]
started to decrease and currently has been started on levophed 3 due to hypotension.” Id. at 460.
Mr. Feider was removed from levophed the next day. Id. at 253.
On October 8, 2016, Mr. Feider underwent another head and chest CT and was noted to
have hypodensities concerning for a stroke. Ex. 8 at 412. The chest CT revealed “diffuse fluffy
opacities which could representing [sic] pulmonary edema, ARDS or pneumonia. Without
significant change from last exam.” Id. at 403. The ICU resident informed Mr. Feider’s family that
the stroke possibly affected the occipital lobe, parietal lobe, and possibly the brainstem, and Mr.
Feider’s prognosis was “not very good.” Id. at 396.
3 Levophed: trademark for a preparation of norephinephrine bitartrate, Dorland’s Online Medical
Dictionary, Levophed, https://www.dorlandsonline.com/dorland/definition?id=28164. Norepinephrine
bitartrate is “used to restore the blood pressure in certain cases of acute hypotension, and to improve cardiac
function during decompensation associated with congestive heart failure or cardiovascular surgery,
administered intravenously.” Norepinephrine bitartrate, https://www.dorlandsonline.com/dorland/
definition?id=93415 (last accessed August 16, 2022).
5
On October 9, 2016, Mr. Feider underwent a chest x-ray which revealed: “similar central
pulmonary vascular congestion and diffuse interstitial opacities, most confluent at the lung bases,
which could be due to pulmonary edema versus pneumonia.” Ex. 8 at 376. The ICU doctors
informed Mr. Feider’s family that he was unresponsive and suffered a stroke. Id. at 396-97. Mrs.
Feider asked for life support be discontinued and Mr. Feider died on October 9, 2016 at 5:14p.m.
Id. at 371-74.
Dr. Porhomayon, an ICU attending physician, authored Mr. Feider’s discharge summary.
Ex. 8 at 248-49. Mr. Feider’s primary diagnosis was “death [secondary to] multiple organ
dysfunction syndrome.” Id. at 248. Secondary diagnoses treated included:
septic shock, acute renal failure, hyperkalemia, hyperphosphatemia,
hypermagnesemia, acute hypoxic respiratory failure, acute cerebrovascular
accident, community-acquired pneumonia, flash pulmonary edema, hypertensive
emergency, hypertension, hypotension requiring vasopressors, anemia, renal artery
stenosis, coronary artery disease with bypass grafting, chronic kidney disease,
hyperlipidemia, peripheral vascular disease s/p aortofemoral bypass graft, carotid
stenosis, aortic valve replacement, peripheral neuropathy, hypokalemia,
hypocalcemia, hypomagnesemia, malnutrition, transaminitis, rhabdomyolysis,
muscle wasting, constipation, thrombocytopenia, delirium/agitation, ? propofol
infusion syndrome, and ? ARDS.
Id. at 248-49.
III. Petitioner’s Statement
Ms. Switzer filed a statement with her petition, recounting the events in late September to
October 2016. Ex. 1. Ms. Switzer provided some background information on her father, Richard
Feider, Sr. Id. at 1. Mr. Feider retired from the U.S. Postal Service in 2002 and was happily married
for 49 years. Id. at 1. Mr. Feider was a veteran of the Air Force and had been on active duty in
Vietnam. Id.
Mr. Feider attended a medical appointment on September 20, 2016, when he also received
the flu and pneumonia vaccines. Ex. 1 at 2. Subsequently, he returned home, ate lunch and within
a few hours began to feel unwell. Id. He stated he had a headache, was feeling tired and achy, and
went to bed early. Id. The next day, Mr. Feider remained in bed with a fever and had flu-like
symptoms. Id.
On September 23, 2016, Mr. Feider had difficulty breathing and body shakes; he was taken
to the “Veteran’s Hospital ER.” Ex. 1 at 2. He was given oxygen for his breathing issues and tested
for flu and pneumonia based on his symptoms. Id. Mr. Feider was soon admitted and prophylactic
antibiotics and medication were given to reduce Mr. Feider’s fever. Id. Ms. Switzer stated hospital
staff believed that Mr. Feider could have contracted the flu or pneumonia when he got his shots,
or alternatively they stated his illness was “too coincidental and was likely related to the shot.” Id.
Mr. Feider remained in good spirits although he was not improving. On September 25, 2016, Ms.
6
Switzer returned to the hospital and saw Mr. Feider intubated and in a drug-induced coma. Id. at
3. Doctors were also concerned about Mr. Feider’s kidneys at this time. Id.
Mr. Feider’s condition worsened over the next two weeks. Ex. 1 at 3. Ms. Switzer recalls
a nurse telling her mother that she believed he was having a severe reaction to his vaccination. Id.
A doctor informed them that Mr. Feider’s cultures were negative for flu and pneumonia so it
couldn’t have been the shot. Id. Mr. Feider began to fill up with fluid because of his low-
functioning kidneys; the hospital was performing dialysis every other day. Id.
On October 6, 2016, Mr. Feider was undergoing dialysis when his blood pressure dropped.
Ex. 1 at 3. On October 8, 2016, Mr. Feider underwent a “brain scan” and the doctors stated that he
may have had a stroke during the October 6, 2016 dialysis session as he had very low brain activity.
Id.
On October 9, 2016, Petitioner gathered with the rest of her family at the hospital where
they were informed that Mr. Feider was septic, his organs were failing, and there was no chance
of recovery. Id. Mr. Feider was removed from life support that day. Id.
Ms. Switzer states that the medical professionals were not able to give her a diagnosis, but
his death certificate listed his cause of death as multisystemic organ failure due to sepsis
pneumonia. Ex. 1 at 4. This statement was signed by Ms. Switzer on September 14, 2018. Id.
IV. Expert Opinions and Qualifications
A. Petitioner’s Expert: Dr. Yehuda Shoenfeld
1. Qualifications
Dr. Shoenfeld founded The Center for Autoimmune Disease at Sheba Medical Center,
which is affiliated with the Sackler Faulty of Medicine at Tel-Aviv University. Ex. 9 at 1. He was
the Laura Schwarz-Kipp Chair for Research of Autoimmune Diseases at Tel-Aviv University and
an Emeritus professor at Tel-Aviv University, teaching medical students and research candidates.
Id. Dr. Shoenfeld's research focuses on autoimmune and rheumatic diseases, and he has published
more than 2060 peer-reviewed papers. Id. Dr. Shoenfeld has also authored and edited 28 books
and is on the editorial boards of 32 journals in the field of autoimmunity and rheumatology. Id. at
1-2.
2. Expert Reports
Dr. Shoenfeld filed four expert reports in this case. Exs. 9 (hereinafter “First Shoenfeld
Rep.”), 40 (hereinafter “Shoenfeld Response to Fife”), 41 (hereinafter “Shoenfeld Response to
Morel”), and 56 (hereinafter “Shoenfeld Response to Questions”).
In his first expert report, Dr. Shoenfeld theorized that concomitant administration of the
quadrivalent inactivated influenza vaccine and the 13-valent pneumococcal conjugate vaccine
caused Mr. Feider to develop SIRS, respiratory failure with signs of interstitial lung disease (ILL),
7
and acute kidney injury and ultimately, death. First Shoenfeld Rep. at 9. Dr. Shoenfeld opined that
receiving vaccinations, along with undergoing major surgery, suffering an infection, or
experiencing major trauma, may trigger a systemic inflammatory response in the body. Id.
Maintaining a proper balance of pro- and anti-inflammatory cytokines is critical to regulating the
body’s systemic inflammatory response; any dysregulation of this balance can lead to SIRS and
Multi-Organ Dysfunction Syndrome (MODS). Id. at 10. Dr. Shoenfeld stated that Mr. Feider’s
symptoms were consistent with the diagnostic criteria for SIRS, including tachycardia, tachypnea,
leukocytosis,4 fever or hypothermia, and leukopenia,5 or bandemia.6 Id. at 11. Dr. Shoenfeld also
suggested that the lack of a confirmed infection made SIRS the proper diagnosis of Mr. Feider’s
condition. Id.
Dr. Shoenfeld drew parallels between Mr. Feider’s clinical progression with cases of SIRS
in six volunteers that were triggered by an intravenous dose of a superagonist anti-CD28
monoclonal antibody (mAb),7 a T cell surface activation marker, that led to rapid induction of pro-
inflammatory cytokines. First Shoenfeld Rep. at 11. All six patients developed initial clinical signs
consistent with the criteria for SIRS, and they later displayed respiratory distress, pulmonary
infiltrates, and renal impairment, mirroring Mr. Feider’s course. Id. citing Suntharalingam et al.,
Cytokine Storm in Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412, 355 N ENG J
MED 10, 1018-28 (2006) (filed as Ex. 39).
Dr. Shoenfeld pointed out that acute lung injury (ALI) and acute kidney injury (AKI) were
both present in Mr. Feider, and that ALI and its more severe form – acute respiratory distress
syndrome (ARDS) – can lead to respiratory failure. First Shoenfeld Rep. at 12. Dr. Shoenfeld
4 Leukocytosis is “a transient increase in the number of leukocytes in the blood; seen normally with
strenuous exercise and pathologically accompanying hemorrhage, fever, infection, or inflammation.”
Leukocytosis, Dorland’s Online Med. Dictionary, https://www.dorlandsonline.com/dorland/definition
?id=28055&searchterm=leukocytosis (last accessed August 18, 2022).
5 Leukopenia is “reduction in the number of leukocytes in the blood below about 5000 per mm.”
Leukopenia, Dorland’s Online Med. Dictionary, https://www.dorlandsonline.com/dorland/definition?id=
28093&searchterm=leukopenia (last accessed August 18, 2022).
6 Bandemia is a finding that involves “[t]he presence of more than 6% of immature neutrophils (band cells)
in the blood. This finding indicates infection, inflammation, or some other significant physical
stress.” Bandemia, TABER’S CYCLOPEDIC MEDICAL DICTIONARY 243 (23d ed. 2017).
7 “Monoclonal antibodies are synthesized by a single clone of B lymphocytes or plasma cells and have
identical structure and antigen specificity…. The identical copies of the antibody molecules produced
contain only one class of heavy chain and one type of light chain… monoclonal antibodies (mAbs) are
produced in large quantities against a plethora of antigens for use in diagnosis and sometimes treatment.
mAbs are homogenous and widely employed in immunoassays, single antigen identification mixtures,
delineation of cell surface molecules, and assays of hormone and drugs in serum, among other uses…
Monoclonal antibodies have been radioactively labeled and used to detect tumor metastases, to differentiate
subtypes of tumors with monoclonal antibodies against membrane antigens or intermediate filaments, to
identify microbes in body fluids, and for circulating hormone arrays. mAbs may be used to direct
immunizations or radioisotopes to tumor targets with potential for tumor therapy.” Illustrated Dictionary
of Immunology 504-05 (3d ed. 2009).
8
suggested that Mr. Feider’s older age contributed to a different immune response signature to the
influenza vaccine than normal. A normal post-vaccination type 1 cytokine signature would be
characterized by IFN-γ cytokine, but a study showed that only TNF-α was associated with
seroconversion after influenza vaccination in elderly subjects. Id. at 13; citing Bloch et al.,
Production of TNF-alpha ex vivo is predictive of an immune response to flu vaccination in a frail
elderly population, 27 EUR CYTOKINE NETW 3, 63-67 (2016) (filed as Ex. 24). Dr. Shoenfeld
opined that Mr. Feider’s SIRS was caused by an elevation of pro-inflammatory cytokines such as
TNF-α to compensate for his defective influenza-specific IFN-γ response, related partially to age.
First Shoenfeld Rep. at 13. While Dr. Shoenfeld admitted that systemic inflammatory reactions to
influenza vaccines are very rare, certain genetic predispositions may be involved with
polymorphisms of receptor antagonists that could lead to the uncontrolled inflammation that is a
central component of ALI/ARDS. Id. Dr. Shoenfeld theorized that, although the definitive cause
of Mr. Feider’s AKI was not identified, severe body pain and highly elevated creatine kinase levels
matched the diagnostic criteria for rhabdomyolysis; 8 he cited nine cases of AKI induced by
rhabdomyolysis following influenza vaccination to support his claim. Id. at 14.
Dr. Shoenfeld challenged Dr. Fife’s proposition that Mr. Feider developed community-
acquired pneumonia, pointing to the interpretation of the X-ray images and chest CT as having
“differential considerations includ[ing] pulmonary edema, ARDS or diffuse pneumonia.”
Shoenfeld Response to Fife at 2. Dr. Shoenfeld stated that the diagnosis of community acquired
pneumonia was not substantiated and was questioned by the infectious diseases consultant, who
noted, “Pneumonia – difficult to say if he has a pulmonary infection. However, he did present with
a fever of 104+ and has no other clear source.” Id. at 2-3; citing Ex. 8 at 326. According to the
Infectious Diseases Society of America guidelines, “a failure of treatment or a deterioration in
hospitalized patients with community-acquired pneumonia should have been considered after 72
hours of initial treatment” and should lead to a complete re-evaluation of the patient to potentially
uncover an alternative diagnosis. Id. at 2. Instead, treatment with antibiotics continued and was
not effective. Id. Dr. Shoenfeld pointed out that ARDS was included in the differential diagnosis,
and ARDS belongs to the group of ILL. Id. at 3. Dr. Shoenfeld charged that the prior published
case reports showing SIRS and lung injury induced by the same vaccines made his assessment
more credible than the lack of comprehensive patient evidence did for a diagnosis of community
acquired pneumonia. Id.
Dr. Shoenfeld also filed an expert report in response to Dr. Morel’s report. Dr. Shoenfeld
challenged Dr. Morel’s assertion that “there is no literature to suggest that any vaccine can lead to
the set of symptoms that would justify the diagnosis of SIRS”. Shoenfeld Response to Morel at 2.
Immune response in adults is normally less intense than in children because of developed
immunity and previous exposure to the same vaccines. Id. However, Dr. Shoenfeld noted that there
are at least 10 published cases of adults developing SIRS after receiving influenza or
pneumococcal vaccines, five of which involved patients aged 57-86. Id. Dr. Shoenfeld addressed
Dr. Morel’s claims about the administration of mAb targeting CD28. Dr. Morel argued that the
immune response following mAb administration would be stronger than a natural response to
8 Rhabdomyolysis is the “disintegration or dissolution of muscle, associated with excretion of myoglobin in
the urine.” Rhabdomyolysis, Dorland’s Online Med. Dictionary, https://www.dorlandsonline.com/dorland
/definition?id=43665&searchterm=rhabdomyolysis (last accessed August 18, 2022).
9
vaccination, though she admitted that Mr. Feider’s age and atherosclerosis were both factors that
were associated with an increased inflammatory environment. Id. Dr. Shoenfeld opined regarding
the causal chain between those factors and Mr. Feider’s illness. Dr. Shoenfeld argued that
vaccination could still lead to the same overall inflammatory context that was observed in Mr.
Feider, particularly if there was a genetic predisposition to exaggerated inflammatory-immune
response to pneumococcal vaccines. Id. at 3. Dr. Shoenfeld defended his claim by pointing out that
the pneumonia diagnosis was questioned by the infectious diseases expert, that the sputum gram
stain was negative at the time of testing in confirming pneumonia, and that antibiotics were
ineffective in treating Mr. Feider’s condition. Id.
Dr. Shoenfeld also addressed Dr. Morel’s theory about T cell response and cytokine
production being confined to the lymph nodes and evading wider detection in the systemic
circulation. Shoenfeld Response to Morel at 3. Dr. Shoenfeld noted that none of the 26 patients in
Dr. Morel’s cited study developed SIRS after receiving the flu vaccine, making it difficult to draw
conclusions about cytokine levels and distribution in patients who develop SIRS. Id. Dr. Shoenfeld
suggested that the short half-life of cytokines in the blood also makes them difficult to detect, but
that more stable biomarkers correlated with pro-inflammatory cytokines in SIRS like C-reactive
protein (CRP) have been found at elevated levels in at least four cases of SIRS following influenza
or pneumococcal vaccination. Id. Dr. Shoenfeld conceded that the fact that CK levels did not rise
until 10 days into Mr. Feider’s course suggested that rhabdomyolysis did not start until late in the
case and could not have caused AKI. Id. at 4. Dr. Shoenfeld still argued that AKI could be caused
by vaccination, highlighting that AKI is one of the most common dysfunctions in SIRS. Id.
B. Respondent’s Expert: Dr. Kenneth Fife
1. Qualifications
Dr. Fife received his medical degree and Ph.D. in microbiology from Johns Hopkins
University. Ex. B (hereinafter “Fife CV”) at 1. Dr. Fife is an Emeritus Professor of Medicine in
the Division of Infectious Diseases at the Indiana University School of Medicine. Fife CV at 1. He
is a Fellow of the American College of Physicians and a fellow of the Infectious Diseases Society
of America. Id. Dr. Fife has written 151 peer-reviewed publications, is board certified in internal
medicine, and is board eligible in infectious diseases. Id.
2. Expert Reports
Dr. Fife filed three expert reports in this case. Exs. A (hereinafter “First Fife Rep.”), AA
(hereinafter “Second Fife Rep.”), and HH (hereinafter “Third Fife Rep.”). Dr. Fife theorized that
Mr. Feider developed community-acquired pneumonia more than three days after receiving and
independent of the influenza and pneumococcal conjugate vaccines. First Fife Rep. at 2-3. Dr. Fife
noted that Mr. Feider’s symptoms of fatigue and subjective fever (said he “felt warm”) a day after
receiving the vaccines were commonly experienced symptoms shortly after receiving either the
influenza or the pneumococcal conjugate vaccines. Id. at 2. Mr. Feider received regular influenza
vaccinations between 2008 and 2013 as well as the pneumococcal polysaccharide vaccine in 2013
but never showed any significant reactions to those immunizations. Id. at 1. He reported feeling
normal the following days and was able to resume normal activities without disturbance, including
10
participating in cardiac rehab exercises and going out to dinner, and Dr. Fife noted that this was
consistent with Mr. Feider’s lack of history of significant reactions to those immunizations. Id.
The recurrence of feelings of warmth as well as a non-productive cough and shortness of breath
only developed around 11 pm on the third day after the administration of the vaccinations. Id. at
2. Although many medical providers noted that Mr. Feider received two vaccinations before
arriving at the hospital, none attributed his symptoms or condition to the vaccines, and community-
acquired pneumonia was listed on the discharge (death) summary. Id.
Dr. Fife discussed Dr. Shoenfeld’s arguments, pointing out that SIRS is a vague set of
signs/symptoms present in many infections and in inflammatory conditions, including pneumonia,
and that temporal proximity of the symptoms with the vaccinations was not dispositive of any
causal relationship between them. First Fife Rep. at 3. Dr. Fife also disagreed with Dr. Shoenfeld’s
conclusion that “[t]here are no other causes to explain this deterioration after the vaccine”, saying
that Dr. Shoenfeld completely ignored the diagnosis of community-acquired pneumonia given by
every provider who evaluated Mr. Feider. Id.
Dr. Fife noted that an admission sputum smear was not diagnostic and all blood cultures
were negative in confirming an infection; however he emphasized that sputum smears “are positive
in only about one-third of cases of community-acquired pneumonia and nearly half of all cases of
severe sepsis have negative blood cultures.” First Fife Rep. at 3. Additionally, Mr. Feider’s cough
was non-productive and was unlikely to produce a useful sputum specimen. Id. Dr. Fife pointed
out that although the bronchoalveolar lavage fluid lacked microorganisms like bacteria that would
indicate pneumonia, that result was unsurprising because Mr. Feider had been taking antibiotics
for 10 days before the procedure. Id. at 1. Dr. Fife noted that negative smear tests and cultures
during treatment do not exclude a possible pneumonia diagnosis, and Mr. Feider’s underlying
conditions and presenting symptoms gave him “about a 1 in 3 chance of dying of pneumonia during
this hospitalization, so the ultimate outcome is not surprising.” Id. at 3.
Dr. Fife’s second report was filed in response to Dr. Shoenfeld’s expert report. Second Fife
Rep. Dr. Fife discussed Dr. Shoenfeld’s cited literature that indicated 10 cases of ILL were
attributed to the influenza vaccine. Dr. Fife pointed out that each case cited by Dr. Shoenfeld was
documented with bronchoscopy and lung biopsy and provided additional evidence of allergic-type
reactions in the lungs. Second Fife Rep. at 1. No such tests were conducted in Mr. Feider’s case.
Id. Dr. Fife also indicated that although pneumonia “is the most common infectious cause of death
in the U.S.”, it is frequently culture negative, even with sepsis. Id. Dr. Fife defended his assertion
by pointing out that pneumonia remained the consensus diagnosis of all providers who cared for
Mr. Feider, and it was consistent with the clinical data. Id.
C. Respondent’s Expert: Dr. Penelope Morel
1. Qualifications
Dr. Morel received her medical degree from the University of Southampton School of
Medicine and received a doctor of medicine from the University of Geneva, Switzerland. Ex. D
(hereinafter “Morel CV”) at 1. Dr. Morel received training in rheumatology at Stanford University
during a postdoctoral fellowship. Morel CV 1. Dr. Morel is currently a professor of immunology
11
and medicine at the University of Pittsburgh where she teaches medical, graduate, and
undergraduate students immunology and directs a course for MD/PhD students on molecular
medicine. Id. at 1-2. Although she does not presently see patients, she has been engaged in basic
and clinical immunology research and has maintained an NIH funded laboratory since 1991. Id. at
1. Dr. Morel’s primary area of research has been the field of autoimmunity. In particular, she has
examined genetic predispositions in various human autoimmune conditions including T1D,
rheumatoid arthritis, and systemic sclerosis focusing on human leukocyte antigen and Fc receptor
alleles. Id. Dr. Morel has written over 70 peer-reviewed articles and 38 invited reviews or chapters.
Id. at 2.
2. Expert Reports
Dr. Morel filed three expert reports in this case. Exs. C (hereinafter “First Morel Rep.”),
BB (hereinafter “Second Morel Rep.”), and JJ (hereinafter “Third Morel Rep.”).
In her first report, Dr. Morel opined that pneumonia induced Mr. Feider’s inflammatory
environment, and that his atherosclerosis, age, and possible production of alarmins from dead or
dying cells contributed to an exaggerated pro-inflammatory cytokine response. First Morel Rep.
at 3. Dr. Morel noted that, although Mr. Feider had signs suggestive of SIRS as Dr. Shoenfeld
proposed, “including fever, high respiratory rate and elevated WBC count,” SIRS has a very broad
definition that is oversensitive. Id. Almost every patient admitted to the ICU fulfills the criteria for
SIRS because non-infectious trauma, burns, and even relatively mild infections can result in SIRS
symptoms. Id. Dr. Morel argued that, although Mr. Feider’s cultures and serology tests came back
negative, such results can occur in cases of severe sepsis with co-morbidities, and Mr. Feider had
longstanding and severe atherosclerosis, chronic kidney disease, and hypertension. Id. Dr. Morel
indicated that a study of 330 patients admitted to the hospital with acute myocardial infarction
(MI) found that 209 of them had SIRS. Id. Dr. Morel pointed out that troponin levels in Mr. Feider
were normal upon admission but rose substantially several hours later, and that this rise was
indicative of ischemic myocardial injury. Id. at 2.
Dr. Morel also opined as to whether SIRS could be caused by vaccines, noting that there
is no literature to suggest that any vaccine can lead to the set of symptoms defining SIRS. First
Morel Rep. at 2. The pediatrics textbook Dr. Shoenfeld referenced to support his claim that
vaccines can cause SIRS did not cite any literature to support that assertion, and Dr. Morel
suggested that the textbook was probably outdated because it was published in 2011. Id. at 4. Dr.
Morel noted that Mr. Feider’s initial symptoms of warmth and fatigue passed after one day, and
two studies examining the effects of combined flu and PCV13 vaccinations in over 1000
individuals in each respective study demonstrated slight increases in systemic side effects in
subjects, but no serious adverse events as seen in diagnoses of SIRS. Id. at 2. A positive SIRS
diagnosis requires a large surge in cytokine production that is detectable systemically, but most
vaccines, including flu, do not increase cytokine levels sufficiently to be detected without ultra-
sensitive assays, above 20 pg/ml. Id. at 5. Dr. Morel opined that Dr. Shoenfeld’s studies alluded
to cytokine release in response to vaccines that was detected following in vitro stimulation of cells
rather than for systemic circulation. Id. One study that Dr. Shoenfeld referenced that did examine
systemic circulation found the levels of some cytokines rise, but others fell, and all remained below
detection levels without ultra-sensitive assays. Id.
12
Dr. Morel opined that reactions to influenza and pneumococcal vaccines that are
administered in the arm are confined to the lymph node for T cells with specificity for influenza
and pneumococcal antigens. First Morel Rep. at 5. Dr. Morel contrasted this with Dr. Shoenfeld’s
cited publication describing SIRS induction in six volunteers receiving mAb targeting CD28. Id.
The antibody in that study was a superagonist that had high activity and caused “simultaneous
activation of a very large number of T cells” when administered directly in the circulatory system.
Id. Dr. Morel noted that this differs from the more limited activation observed with T cells with
antigen specificity for influenza and pneumonia when vaccines are administered in the arm and
that drain to the lymph node. Id. Dr. Morel also opined that Mr. Feider more likely had a secondary
immune response because of pre-existing immunity from receiving the vaccines previously. A
secondary immune response is characterized by a cytokine response peak at 12 hours that subsides
within 24 hours post-vaccination. Id. at 4-5. In Mr. Feider’s case, his deterioration that required
hospitalization began three days later. Id.
Dr. Morel also addressed Dr. Shoenfeld’s theory of vaccination-induced rhabdomyolysis
and AKI. She opined that elevated urea and creatinine are indicative of AKI, while elevated levels
of creatine kinase (CK) are indicative of rhabdomyolysis. First Morel Rep. at 3. Notably, Mr.
Feider’s urea and creatinine levels were elevated when he was admitted to the hospital, and there
was other evidence supporting SIRS. Id. However, CK levels were normal at the time of hospital
admittance and did not increase until ten days later. Id. According to Dr. Morel, this indicates
rhabdomyolysis could not have occurred until later in Mr. Feider’s case and was probably
reflective of MODS. Id. Dr. Morel pointed out that the case reports Dr. Shoenfeld highlighted in
which rhabdomyolysis occurred shortly after influenza vaccine had distinguishable facts from Mr.
Feider’s case. All patients in the case reports had muscle pain and weakness and high CK levels at
the time of hospital admittance, while Mr. Feider symptoms did not include weakness or muscle
pain, and initially included low CK levels. Id. at 6.
In her second report, Dr. Morel addressed the case reports cited by Dr. Shoenfeld
describing severe reactions following influenza and/or pneumococcal vaccination. Although each
cited case indicated a reaction of some kind, none of the cases noted disease following vaccination.
Second Morel Rep. at 1. None of the cases were classified as SIRS, and no case cited led to MODS
or death. Id. Dr. Morel discussed Dr. Shoenfeld’s theory that Mr. Feider had an enhanced
inflammatory environment and/or genetic predisposition that caused SIRS following vaccination
that was characterized by high levels of circulating cytokines. Id. She stated that patients with
cryopyrin-associated periodic syndrome (CAPS) in Dr. Shoenfeld’s cited study developed local
reactions within hours of receiving the vaccine, and all recovered in a few days, unlike Mr. Feider.
Id. at 1-2. Cytokine levels in vaccination cases do not rise above ultrasensitive-assay detection
levels, let alone the levels observed in diseases that cause cytokine storm responses, like SARS-
CoV-2. Id. at 2. Dr. Morel also pointed out that CRP is a non-specific reactive protein that can be
elevated in cases of infection, inflammation, and many other conditions, and may not be dispositive
of SIRS. Id. Dr. Morel further opined that Mr. Feider’s chronic kidney disease (CKD) was
exacerbated by pneumonia and that this resulted in Mr. Feider developing AKI, not the vaccines
he received. Id. at 2.
13
V. Applicable Law
A. Petitioner’s Burden
Under the Vaccine Act, a petitioner may prevail in one of two ways. First, a petitioner may
demonstrate that she suffered a “Table” injury—i.e., an injury listed on the Vaccine Injury Table
that occurred within the time period provided in the Table. § 11(c)(1)(C)(i). “In such a case,
causation is presumed.” Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed.
Cir. 2006); see § 13(a)(1)(B). Second, where the alleged injury is not listed in the Vaccine Injury
Table, a petitioner may demonstrate that she suffered an “off-Table” injury. § 11(c)(1)(C)(ii).
For both Table and non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1324 (Fed. Cir. 2010); see
also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or speculation
is insufficient under a preponderance standard). Proof of medical certainty is not required. Bunting
v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, a petitioner
must demonstrate 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 (Fed. Cir. 1999)); Pafford v. Sec’y of Health
& Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a Vaccine
Program award based solely on his assertions; rather, the petition must be supported by either
medical records of by the opinion of a competent physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen. Althen requires that petitioner establish by preponderant evidence that the
vaccinations he received caused her injury “by providing: (1) a medical theory causally connecting
the vaccination and the injury; (2) a logical sequence of cause and effect showing that the
vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship
between vaccination and injury.” Id. at 1278.
Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must
only be “legally probable, not medically or scientifically certain.” Id. at 549.
Petitioner may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325-26). Special Masters, despite their expertise, are not empowered by
statute to conclusively resolve what are complex scientific and medical questions, and thus
14
scientific evidence offered to establish Althen prong one is viewed “not through the lens of the
laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of
Health & Hum. Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility … in many cases may be
enough to satisfy Althen prong one” (emphasis in original)), vacated on other grounds, 844 F.3d
1363 (Fed. Cir. 2017). But this does not negate or reduce a petitioner’s ultimate burden to establish
her overall entitlement to damages by preponderant evidence. W.C. v. Sec’y of Health & Hum.
Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted).
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326 (“medical 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). Medical records are generally viewed
as particularly trustworthy evidence, because they are created contemporaneously with the
treatment of the patient. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir.
1993).
However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 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, 746 n.67 (2009) (“there 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”). As with expert testimony offered to establish a
theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the
reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence also present in the record -- including conflicting
opinions among such individuals. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742,
749 (2011) (not arbitrary or capricious for 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., No. 06-522V 2011 WL 1935813 at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot.
for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without op., 475 Fed. App’x 765 (Fed. Cir.
2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine
can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health &
Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand on other grounds, 105
15
Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013). Koehn v. Sec’y of Health
& Hum. Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for
review den’d (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Law Governing Analysis of Fact Evidence
The process for making factual determinations in Vaccine Program cases begins with
analyzing the medical records, which are required to be filed with the petition. Section 11(c)(2).
The special master is required to consider “all [] relevant medical and scientific evidence contained
in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s
report which is contained in the record regarding the nature, causation, and aggravation of the
petitioner’s illness, disability, injury, condition, or death,” as well as the “results of any diagnostic
or evaluative test which are contained in the record and the summaries and conclusions.” Section
13(b)(1)(A). The special master is then required to weigh the evidence presented, including
contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum. Servs., 3
F.3d 413, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to
afford greater weight to contemporaneous medical records than to other evidence, such as oral
testimony surrounding the events in question that was given at a later date, provided that such
determination is evidenced by a rational determination).
Medical records created contemporaneously with the events they describe are generally
trustworthy because they “contain information supplied to or by health professionals to facilitate
diagnosis and treatment of medical conditions,” where “accuracy has an extra premium.” Kirby v.
Sec’y of Health & Hum. Servs., 997 F.3d 1378 (Fed. Cir. 2021) citing Cucuras, 993 F.2d at 1528.
This presumption is based on the linked proposition that (i) sick people visit medical professionals;
(ii) sick people honestly report their health problems to those professionals; and (iii) medical
professionals record what they are told or observe when examining their patients in as accurate a
manner as possible, so that they are aware of enough relevant facts to make appropriate treatment
decisions. Sanchez v. Sec’y of Health & Hum. Servs., No. 11-685V, 2013 WL 1880825 at *2 (Fed.
Cl. Spec. Mstr. Apr. 10, 2013) mot. for rev. denied, 142 Fed. Cl. 247, 251-52 (2019), vacated on
other grounds and remanded, 809 Fed. Appx. 843 (Fed. Cir. Apr. 7, 2020).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03-1585V, 2005 WL
6117475 at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records
are generally found to be deserving of greater evidentiary weight than oral testimony -- especially
where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also
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), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony
which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)).
However, there are situations in which compelling oral 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) (“like any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the factual
16
predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475 at *19 (“[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, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent and
compelling.” Sanchez, 2013 WL 1880825 at *3 (citing Blutstein v. Sec’y of Health & Hum. Servs.,
No. 90-2808V, 1998 WL 408611 at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person’s failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional’s failure to document everything
reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony;
or (4) a person’s purposeful recounting of symptoms that did not exist. LaLonde v. Sec’y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making
a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory connecting the vaccine to the injury often
requires a petitioner to present expert testimony in support of his or her claim. Lampe v. Sec’y of
Health & Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony
is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert
v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Hum.
Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195
F.3d 1302, 1316 (Fed. Cir. 1999). “The Daubert factors for analyzing the reliability of testimony
are: (1) whether a theory or technique can be (and has been) tested; (2) whether the theory or
technique has been subjected to peer review and publication; (3) whether there is a known or
potential rate of error and whether there are standards for controlling the error; and (4) whether the
theory or technique enjoys general acceptance within a relevant scientific community.” Terran,
195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-95).
The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial fora. Daubert factors are employed by judges to exclude
evidence that is unreliable and potentially confusing to a jury. In Vaccine Program cases, these
factors are used in the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health
& Hum. Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 743. In this matter, (as in numerous other Vaccine Program cases), Daubert has not
17
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.
Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A “special master is entitled to
require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592
F.3d at 1324. Weighing the relative persuasiveness of competing expert testimony, based on a
particular expert’s credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Id. at 1325-26 (“[a]ssessments as to the
reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec’y
of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously
explained that special masters are expected to consider the credibility of expert witnesses in
evaluating petitions for compensation under the Vaccine Act”).
D. Consideration of Medical Literature
Finally, although this decision discusses some but not all of the medical literature in detail,
I have reviewed and considered all of the medical records and literature submitted in this matter.
See Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We
generally presume that a special master considered the relevant record evidence even though [s]he
does not explicitly reference such evidence in h[er] decision.”); Simanski v. Sec’y of Health &
Hum. Servs., 115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is ‘not required to discuss every
piece of evidence or testimony in her decision.’” (citation omitted)), aff’d, 601 F. App’x 982 (Fed.
Cir. 2015).
VI. Analysis
Under Althen’s first prong, the causation theory must relate to the alleged injury. Petitioner
must provide a “reputable” medical or scientific explanation, demonstrating that the vaccines
received can cause the type of injury alleged. Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d
1352, 1355-56 (Fed. Cir. 2006). The theory must be based on a “sound and reliable medical or
scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir.
1994). It must only be “legally probable, not medically or scientifically certain.” Id. at 549.
A. Althen Prong One
I note at the outset that Dr. Shoenfeld’s causation theory is difficult to follow. It is unclear
whether he opines that the flu and pneumococcal vaccines caused Mr. Feider to develop SIRS,
which in turn led to ARDS and AKI, or whether Mr. Feider’s vaccines caused him to develop
18
SIRS, ARDS, and AKI through separate processes. It also appears that Dr. Shoenfeld attributes
rhabdomyolysis in Mr. Feider to a separate, vaccine-induced process.
Petitioner ultimately summarized her theory of the case as follows:
The increase of pro-inflammatory cytokines induced by vaccination contribute to
the overall inflammatory context (taking into account the age of the patient and his
severe atherosclerosis which are associated with the increased production of pro-
inflammatory cytokines) and lead to the decompensation. Loss of local control of
the release of the cytokines led to Systemic Inflammatory Response Syndrome
(SIRS) and Multi-Organ Dysfunction Syndrome, which included acute respiratory
distress syndrome (ARDS) and acute kidney injury (AKI). The Rhabdomyolysis,
which occurred later in Mr. Feider[’s] case, is also related to the influenza vaccine,
since there are published case reports of rhabdomyolysis and AKI after influenza
vaccine.
Shoenfeld Response to Questions at 1. 9
Dr. Shoenfeld provided the following flow chart to depict his causation theory in this case.
Shoenfeld Response to Questions at 1.
9 However, in this same report, Dr. Shoenfeld similarly stated that Mr. Feider’s ARDS was influenza
vaccine-associated interstitial lung disease. Id. at 3. In a previous report, Dr. Shoenfeld supported his
position that the vaccines Mr. Feider received caused him to develop ARDS. He said, “Case reports of
Influenza vaccine-induced ILD [have] been published…” (Shoenfeld Response to Fife at 3), suggesting
that the mechanism at play in this case is similar to those described in the case reports. Because it stretches
reason to suggest that the flu and/or pneumococcal vaccines caused Mr. Feider to experience three separate
vaccine reactions, I have analyzed Petitioner’s prong one theory in terms of whether the flu/pneumococcal
vaccines can cause SIRS, which subsequently leads to ARDS and AKI.
19
I note that in a different Vaccine Program case, a special master held that the petitioner
established the MMR vaccine can cause SIRS, shock, and multiorgan dysfunction syndrome.
Ahlum v. Sec’y of Health & Hum. Servs., No. 12-763V, 2018 WL 4323623 (Fed. Cl. Spec. Mstr.
Aug. 16, 2018). See also, Bragg v. Sec’y of Health & Hum. Servs., No. 08-477V, 2012 WL 404773(Fed. Cl. Spec. Mstr. Jan. 18, 2012) (finding that the flu vaccine can cause SIRS).
1. Flu Vaccine Can Cause SIRS
Following the vaccines on September 20, 2021, Mr. Feider reported feelings of warmth
and fatigue on September 21 and 22. These symptoms abated on September 23, and Mr. Feider
reported feeling back to normal until 11:00pm on September 24. Mr. Feider then reported feeling
warm and having a shortness of breath. At the hospital, Mr. Feider had hypoxia, a fever, elevated
respiratory and heart rates, and an elevated white blood cell count. Dr. Shoenfeld opined that these
symptoms were consistent with the diagnostic criteria for SIRS, and Drs. Fife and Morel agreed.10
First Shoenfeld Rep. at 11; Fife Rep at 2-3; First Morel Rep. at 3. See also, Respt’s Post Hearing
Brief at 13.
Dr. Shoenfeld opined with respect to the role of abnormal cytokine response in an immune-
mediated inflammatory reaction to the influenza and pneumococcal vaccines. “It is well accepted
that the loss of local control of the release of these cytokines leads to systemic inflammation and
potentially deleterious consequences including the Systemic Inflammatory Response Syndrome .
. . .” First Shoenfeld Rep. at 9.
In support of his position, Dr. Shoenfeld cited to Talaat et al., a study that reports the
increase of specific cytokines within hours postvaccination. Talaat et al., Rapid changes in serum
cytokines and chemokines in response to inactivated influenza vaccination, 12 INFLUENZA OTHER
RESPI VIRUSES, 202-10 (2018) (filed as Ex. 18) (hereinafter “Talaat”).
Dr. Shoenfeld also referenced Jaffer et al., Cytokines in the systemic inflammatory response
syndrome: a review, 2 HSR PROC INTENSIVE CARE CARDIOVASC ANESTH 3, 161-75, 174 (2010)
(filed as Ex. 35) (hereinafter “Jaffer”). Jaffer noted that “The inflammatory process involves the
release of a pro- and anti- inflammatory cytokines. Anti-inflammatory cytokines act to localize
and prevent over exuberant inflammation; it is a loss of this local control that leads to systemic
inflammation and potential deleterious consequences, including SIRS . . . .” Id. at 162.
Such loss of local control over anti-inflammatory cytokines in immune response has been
characterized in several different groups. One includes elderly subjects, who have been
documented to have an impaired IFN-γ anti-inflammatory response. Bernstein et al., Cytokine
production after influenza vaccination in a healthy elderly population, 16 VACCINE 18, 1722-31,
10 As Dr. Morel noted in her report, “SIRS is defined by four variables: fever, tachycardia, increased
respiratory rate and elevated white blood cell (WBC) count.” First Morel Rep. at 3; see also Vincent et al.,
Sepsis definitions: time for change, 381 LANCET 774-75 (2013) (filed as Ex. J). Dr. Morel stated “[t]his a
very broad definition and, as discussed in a recent article, it may be overly sensitive. Virtually every patient
admitted to an ICU fulfils the criteria of SIRS since SIRS can be caused by many non-infectious processes
including trauma, burns and ischemia reperfusion.” First Morel Rep. at 3.
20
1723 (1998) (filed as Ex. 22). Another study noted “prolonged innate immune activation with
impaired response in older adults . . . .” Mohanty et al., Prolonged proinflammatory cytokine
production in monocytes modulated by interleukin 10 after influenza vaccination in older adults,
211 J INFECT DIS. 7, 1174-84, 1183 (2015) (filed as Ex. 23). Dr. Morel agreed that the elderly have
an altered inflammatory response, “there is a progressive increase with age of the production of
inflammatory cytokines,” and opined that other chronic inflammatory conditions like
atherosclerosis could produce a similar signature. First Morel Rep. at 3. Additionally, certain
polymorphisms of cytokines and receptor antagonists of clinical relevance have been described as
genetic predispositions for overactive systemic inflammatory reactions to influenza vaccines.
Feezor, Moldawer, Genetic Polymorphisms, Functional Genomics and the host Inflammatory
Response to Injrut and Inflammation, 9 FRONT IMMUNOL, 15-37 (2003) (filed as Ex. 25)
(hereinafter “Feezor”). “[M]uch of the host response is a direct reflection of heritable trait,
accounting for interpersonal differences, and allowing for genetic detection.” Feezor at 15.
While inflammatory reactions to influenza vaccines and particular genetic predispositions
are rare, as Drs. Fife and Morel point out, such occurrences have been documented, and they do
occur. Von Elten et al., Systemic inflammatory reaction after pneumococcal vaccine: A case series,
10 HUM VACCINES IMMUNOTHER, 1767-70 (2014) (filed as Ex. 45) (hereinafter “Von Elten). “The
5 patients in this series all had leukocytosis, fever, and large local inflammatory reactions
following influenza and PS23 vaccinations. Based on the known side effects of the PS23 vaccine
. . . we believe these reactions were due to the PS23 vaccine.” Von Elten at 1768. It is also notable
that Mr. Feider had atherosclerosis, he was 71 when he died, and he fit within the age group
described by Dr. Shoenfeld for a defective IFN-γ response that could lead to over compensatory
production of pro-inflammatory TNFα. First Shoenfeld Rep. at 13; Bloch et al., Production of
TNF-alpha ex vivo is predictive of an immune response to flu vaccination in a frail elderly
population, 27 EUR CYTOKINE NETW. 3, 63-67 (2016) (filed as Ex. 24) (hereinafter “Bloch”).
Bloch at 64.
I also note that Nelson Textbook of Pediatrics lists influenza vaccine reaction as a potential
cause of SIRS. NELSON TEXTBOOK OF PEDIATRICS at 309 (Robert M. Kliegman et al. eds., 19th ed.
2011) (filed as Ex. 36) (hereinafter “Nelson Textbook of Pediatrics”). The fact that Nelson
Textbook of Pediatrics is from 2011 and does not list references to support the assertion that
vaccines can cause SIRS, as Dr. Morel stated (First Morel Rep. at 4), does not refute broad medical
consensus. I find that Petitioner has presented preponderant evidence that the flu vaccine can cause
SIRS.
2. Vaccine-Induced Rhabdomyolysis
Medical providers documented that Mr. Feider came into the hospital with identifiable
AKI, and 10 days into treatment had severely elevated creatine kinase levels (37,258 U/l, normal
range 21-232 U/l) that was indicative of rhabdomyolysis. Ex. 8 at 107; First Shoenfeld Rep. at 14.
Dr. Shoenfeld’s theory shifted with respect to this issue. In his first report, filed on October
14, 2019, he opined as follows:
21
In the case of [l]ate Mr. Feider, we confront concurrent systemic inflammatory
response syndrome, respiratory failure with signs of interstitial lung disease and
acute kidney injury probably resulting from rhabdomyolysis after concomitant
administration of quadrivalent inactivated influenza vaccine and 13-valent
pneumococcal conjugate vaccine, leading to his death.
First Shoenfeld Rep. at 9. In his report filed on April 20, 2020, Dr. Shoenfeld acknowledged that
Mr. Feider’s rhabdomyolysis did not cause his AKI. He stated:
Dr. Morel states that since CK levels were normal at the time of admission, and
they did not start to rise until 10 days into his course, on October 5, rabdomyolysis
[sic] appears to have occurred late in Mr. Feider’s case and was probably reflective
of multiple organ dysfunction syndrome (MODS), but was not related to
vaccination and did not cause acute kidney injury (AKI). While this appears to be
true, we think that AKI in the case of Mr. Feider is still linked to vaccination. AKI
is one of the most frequent organ dysfunctions in the course of SIRS. This is
consistent with the fact, that Mr. Feider had SIRS, respiratory failure and AKI
simultaneously at the time of hospital admission.
Shoenfeld Response to Morel at 4.
In his report responding to my questions, Dr. Shoenfeld opined that “The Rhabdomyolysis,
which occurred later in Mr Feider[’s] case, is also related to the influenza vaccine, since there are
published case reports of rhabdomyolysis and AKI after influenza vaccine.” Shoenfeld Response
to Questions at 1.
As support for this most recent position, Dr. Shoenfeld cited cases of rhabdomyolysis-
induced AKI following influenza vaccination. First Shoenfeld Rep. at 27-29, Table 1, entitled
“Summary of cases of acute kidney injury following rhabdomyolysis after influenza vaccine.” See
also Patel & Shah, Vaccine-Associated Kidney Diseases: A Narrative Review of the Literature, 30
SAUDI J KIDNEY DIS TRANSPL 5, 1002-05 (2019) (filed as Ex. 59). These examples describe
patients who complained of muscle pain and weakness following vaccination. Additionally,
creatine kinase (CK) levels were well over the normal range, where five times the upper limit of
normal is used as diagnostic criteria for rhabdomyolysis. First Shoenfeld Rep. at 14. Most cases
developed symptomology within 1-2 days after vaccination, though several either had symptom
onset or were admitted to the hospital as many as seven days after vaccination. Id. 27-29, Table 1.
Other studies have established that an immune-mediated necrotizing myopathy (IMNM) and
subsequent renal damage can occur related to statin/fibrate therapy or influenza infection, but the
precise mechanism with infection is unclear. Allenbach et al., 224th ENMC International
Workshop: Clinico-sero-pathological classification of immune-mediated necrotizing myopathies,
28 NEUROMUSCUL DISORD 1, 87-99 (2016) (filed as Ex. 31) (hereinafter “Allenbach”).
The evidence presented regarding whether the flu vaccine can cause rhabdomyolysis
consists of case reports. While case reports are not robust evidence, they do constitute some
evidence with which petitioners can meet their burden in the Vaccine Program. See Contreras v.
Sec’y of Health & Hum. Servs., 107 Fed. C. 280 (Fed. Cl. 2012); see also Capizzano 440 F.3d at
22
1325-26. However, in this case, it is undisputed that Mr. Feider developed rhabdomyolysis after
AKI, and thus the rhabdomyolysis did not cause the AKI. See Ex. 8 at 916 (nephrologist on
September 24, 2016 documenting “No rhabdomyolysis as [of] now. Will foll[o]w with CK level
tomorrow.”); First Morel Rep. at 6 (opining that Mr. Feider did not have rhabdomyolysis at the
time of his hospital admission, and instead developed it 10 days later); Shoenfeld Response to
Morel at 4 (agreeing with Dr. Morel that rhabdomyolysis occurred as a result of MODS). Because
of this, I have not analyzed whether the flu vaccine can cause rhabdomyolysis.
3. MODS, ARDS, and AKI as Complications of SIRS
Dr. Shoenfeld noted that “[i]f the balance between pro- and anti- inflammatory cytokines
is not maintained, dysregulation occurs leading to SIRS and multiple end organ effects”, including
ARDS, MODS, and AKI. First Shoenfeld Rep. at 10. “In people, MODS is most commonly a
sequela to severe sepsis or septic shock, but it also develops secondary to trauma, neoplasia, or
other causes of the systemic inflammatory response syndrome (SIRS).” Osterbur et al., Multiple
Organ Dysfunction Syndrome in Humans and Animals, 28 J VET INTERN MED 4, 1141-51 (2014)
(filed as Ex. 62) (hereinafter “Osterbur”). Osterbur at 1141. The uncontrolled inflammation seen
in SIRS is also a central issue in the development of ALI and its more severe form, ARDS. Lin et
al., Regulatory T Cells and Acute Ling Injury: Cytokines, Uncontrolled Inflammation, and
Therapeutic Implications, 9 FRONT IMMUNOL 1545 (2018) (filed as Ex. 26) (hereinafter “Lin”).
See also Nelson’s Textbook of Pediatrics at 4 (stating that “[t]he inflammatory cascade initiated
by shock can lead to … acute respiratory distress syndrome (ARDS).”
Notably, “[s]everal studies have also reported a number of cytokines – such as TNF- α, IL-
1B, IL-6, IL-17, and IL-33 – were increased in the acute stages of ARDS/ALI”, the same cytokines
overproduced in patients with abnormal cytokine responses. Lin at 1; Bloch at 64. Relatedly, both
ARDS and AKI have been found to be frequent complications of SIRS. Chakraborty & Burns,
Systemic Inflammatory Response Syndrome, STATPEARLS PUBLISHING (2020) (filed as Ex. 58)
(hereinafter “Chakraborty”). Chakraborty at 10. Abnormal TNF-α and endotoxin production
appear to be predominant mechanisms for inducing apoptosis and AKI in certain forms of MODS,
and Dr. Morel conceded that AKI is common in patients with severe sepsis. Osterbur at 1145; Ex.
JJ at 1. Therefore, Dr. Shoenfeld’s assertions that SIRS can cause the MODS, ARDS, and AKI are
supported by preponderant evidence.
B. Althen Prong Two
Under Althen’s second prong, a petitioner must “prove a logical sequence of cause and
effect showing that the vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. The
sequence of cause and effect must be “'logical' and legally probable, not medically or scientifically
certain.” Id. A petitioner is not required to show “epidemiologic studies, rechallenge, the presence
of pathological markers or genetic disposition, or general acceptance in the scientific or medical
communities to establish a logical sequence of cause and effect.” Id. (omitting internal citations).
Capizzano, 440 F.3d at 1325. Instead, circumstantial evidence and reliable medical opinions may
be sufficient to satisfy the second Althen prong.
23
1. Preponderant Evidence Demonstrates that Mr. Feider was Unwell the Day of
and the Day after Vaccination Followed by an Improvement in his Symptoms
before his Hospitalization, a Clinical Course that is Inconsistent with
Petitioner’s Prong One Theory
The medical records document that Mr. Feider received the flu and pneumonia vaccines on
Tuesday, September 20, 2016; then the records demonstrate that he felt unwell on Wednesday,
September 21; he was improved on Thursday, September 22 and Friday September 23 such that
he went about his normal activities. Then on September 23 at around 11:00pm, Mr. Feider
experienced a sudden onset of shortness of breath and difficulty breathing.
The Buffalo VA Hospital ER department’s medical records from September 24, 2016
document that Mr. Feider reported receiving the influenza and pneumococcal vaccines on
September 20 th and the following day, developed a cough, felt feverish and unwell. Ex. 8 at 982.
By Thursday, September 22, 2016, Mr. Feider indicated that he felt “much improved.” Id. He also
felt well on Friday, September 23 rd until 11:00pm that night when he experienced a sudden onset
of shortness of breath and difficulty breathing. Id.During an examination on September 24, 2016, Dr. Jaime Bittner recorded the following
history of present illness:
Patient presents with a one day history of sudden SOB (shortness of breath) with
fever. Patient felt relatively healthy yesterday and went to his usual cardio rehab,
went home had lunch, went out to dinner and felt like his usual self. He was
watching TV last night and at 11pm began to feel warm, shaky, and had a “tough
time breathing”…. Patient got a Flu shot and pneumovax on Tuesday, then felt
warm and slept all day Wednesday but was back to his usual state of health by
Thursday.
Ex. 8 at 946.
Additionally, the medical records from a different consultation on September 24, 2016
document that Mr. Feider received the flu and pneumonia vaccines on September 20, and that
evening began having “some myalgias and subjective fever.” Ex. 8 at 353. The record notes that
Mr. Feider did not check his temperature. Id. These symptoms persisted all day on Wednesday. Id.This medical record notes that Mr. Feider “recovered well [] on Thursday.” Id. The record then
states that Mr. Feider “felt increasing dyspnoeic [sic] overnight with cough and productive of
sputum with fever from evening. y’day.” Id.Petitioner’s affidavit described a history on the day of vaccination and the next day
(Tuesday, September 20 and Wednesday, September 21) that is consistent with the medical
records. Ms. Switzer averred that within a couple of hours post-vaccination, Mr. Feider began to
feel unwell. Ex. 1 at 2. According to Petitioner, Mr. Feider “had a headache [] was feeling tired
and achy and went to bed early.” Id. Petitioner stated that on Wednesday, Mr. Feider spent most
of the day in bed or on the couch “with a fever and flu like symptoms.” Id. These assertions are
supported by the medical records discussed above.
24
However, in describing Mr. Feider’s condition on Thursday, September 22 and Friday,
September 23, Ms. Switzer provided a different account than the contemporaneous medical
records. She stated, “[h]e continued to have these symptoms [a fever and flu-like symptoms] on
Thursday and Friday as well. Both nights he awoke with night sweats so badly that the sheets
needed to be changed.” Ex. 1 at 2. This account differs from Mr. Feider’s statements upon his ER
admission and to Dr. Bittner where he indicated that by Thursday he was “much improved” and
“back to his usual state of health”, and that on Friday, he “felt well” and “felt like his usual self.”
Ex. 8 at 982; Ex. 4 at 946.
Contemporaneous medical records generally deserve greater evidentiary weight than oral
testimony -- especially where such testimony conflicts with the record evidence. Cucuras, 993
F.2d at 1528; see also 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), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992)
(citing United States v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held
that oral testimony which is in conflict with contemporaneous documents is entitled to little
evidentiary weight.”)).
Petitioner contends that her affidavit is not inconsistent with the medical records, and
points to two records which do not discuss Mr. Feider’s improvement. Pet’r’s Reply 1-2 (citing
Ex. 8 at 343-45; Ex. 8 at 300). The first record is from a cardiology consultation which took place
on September 24, 2016. Ex. 8 at 343. This record documents the following:
According to the patient, he received influenza and pneumococcal immunization
on Tuesday September 20 th. He then states the following day (Wednesday), he
started having cough and feeling warm and unwell. Late Friday evening he started
developing difficulty breathing, along with cough and some sputum and so called
ambulance [due to] worsening breathing…
Ex. 8 at 343. This record does not discuss how Mr. Feider was feeling on Thursday or on Friday
before the late evening. Accordingly, while this record is not inconsistent with Petitioner’s
affidavit, it does not support the contested point that Mr. Feider remained in poor health during
this period of time.
Petitioner also pointed to a pulmonary consultation on October 3, 2016 with Dr. Sarkis as
support for her claim in her affidavit that Mr. Feider was still sick on Thursday and Friday. The
notes from this visit indicate that Mr. Feider
presented on 9/24 for hypoxemia, respiratory distress. He was at his baseline prior
to admission (runs 0.5 mile on treadmill, attends cardiac rehab), up until he received
flu and pneumonia vaccine on 9/20. Since, he started complaining of worsening
dyspnea, productive cough.
Ex. 8 at 300. This record is similarly silent regarding Mr. Feider’s state of health on Thursday
September 22 and Friday September 23 rd. Like the cardiology consultation from September 24,
2016, this record does not speak to how Mr. Feider was feeling during this timeframe. Because of
25
that, I have credited the detailed contemporaneous medical records over these less detailed records
and Petitioner’s affidavit. It is difficult to imagine that Mr. Feider erroneously provided the same
history of a recovery on Thursday and most of the day on Friday to three different medical
providers.
Petitioner suggests that the contemporaneous medical records lack information about Mr.
Feider’s poor health on Thursday and Friday because he was unwell with a fever of 104.5˚ upon
presentation and likely had “difficulty relaying a complete history.” Pet’r’s Reply at 2. This
argument is unavailing as Mr. Feider’s initial ER admission, when he was extremely unwell, makes
note of his improved condition on Thursday and Friday. See Ex. 8 at 982.
Petitioner additionally attempts to explain this one and one half day recovery by noting that
Mr. Feider was taking Motrin and drinking fluids. Pet’r’s Reply at 3. Petitioner points to a medical
record from September 24, 2016 in support of her position. This record documents: “He took
motrin, OTC tab 2 days ago for myalgias.” Ex. 8 at 916. While two days before September 24 is
September 22, I find this record only provides minimal support for Petitioner’s position. As
discussed extensively above, no medical record documents that Mr. Feider was experiencing
myalgias on September 22. In fact, the records that discuss how he was feeling on this date all
document that he was much improved and back to his normal state of health. I therefore find it is
likely that the myalgias referenced in this note include Mr. Feider’s reported myalgias from
September 21, that are documented in this same medical record. See id. at 911. This note indicating
Mr. Feider took Motrin two days ago does not overcome the weight of the medical record evidence
in this case. Further, Petitioner’s argument that Mr. Feider was taking Motrin and drinking fluids
(and thus felt better) does not account for the fact that Mr. Feider described that he was “back to
his usual state of health” by Thursday. Being back to one’s normal state of health is different than
feeling improvement due to self-medication.
Ultimately, this point is an important one, as Mr. Feider’s one and one half day recovery is
inconsistent with Petitioner’s theory of causation, which relies on the overproduction of cytokines.
Talaat et al. studied cytokine response in 20 healthy adults after they received the influenza
vaccine. Talaat noted the following: “In our study, we extend our analysis into the first hours
following TIV administration and identified temporal patterns of serum cytokine and chemokine
changes which occurred as early as 3 hours postimmunization, generally peaking at approximately
24 hours.” Talaat at 207. Talaat demonstrates that cytokines peak within 24 hours after vaccination.
Petitioner’s contention that intravenous drug dosing of monoclonal antibody (mAb)
mirrored the progression of Mr. Feider’s course is also inconsistent with Petitioner’s causation
theory. The study notes the following:
Within 90 minutes after receiving a single intravenous dose of the drug, all six
volunteers had a systemic inflammatory response characterized by a rapid induction
of proinflammatory cytokines and accompanied by headache, myalgias, nausea,
diarrhea, erythema, vasodilatation, and hypotension. Within 12 to 16 hours after
infusion, they became critically ill, with pulmonary infiltrates and lung injury, renal
failure, and disseminated intravascular coagulation.
26
Suntharalingam et al., Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody
TGN1412, 355 N ENGL J MED 10, 1018-28 (2006) (filed as Ex. 39) (hereinafter “Suntharalingam”).
Suntharalingam at 1018. The following charts depict the rapid increase and then decrease in
cytokines after infusion of TGN1412.
Id. at 1025. Similar to Talaat, this study depicts the rapidity of the cytokine response.
Respondent provided a study that also demonstrated a short temporal pattern for cytokine
changes postimmunization in the lymph node, where the majority of cytokines are confined and
produced. Chatziandreou et al., Macrophage Death following Influenza Vaccination Initiates the
Inflammatory Response that Promotes Dendritic Cell Function in the Draining Lymph Node, 18
CELL REP 10, 2427-40 (2017) (filed as Ex. 27-20) (hereinafter “Chatziandreou”).
The Chatziandreou study states the following:
Among the tested cytokines, we detected a rapid and significant secretion of IL-1α
and IFN-β in the LN within the first 90 min p.v. To evaluate the duration and
magnitude of the inflammatory reaction, we examined the levels of additional
inflammatory molecules in the first 24 hr p.v. We observed a significant peak in the
secretion of MIG, IP-10, KC, MCP-1, MIP-1α, and MIP-1β at 12 hr, followed by
an abrupt decrease by 24 hr p.v.”
Id. at 2431.
27
Petitioner’s study shows that severe local reactions occur within hours of receiving the
vaccine and continue without an intermission of symptoms for persons with genetic
predispositions for immune response, such as cryopyrin-associated periodic syndrome (CAPS).
Walker et al., Brief Report: Severe Inflammation Following Vaccination Against Streptococcus
pneumoniae in Patients with Cryopyrin-Associated Periodic Syndromes, 68 ARTHRITIS &
RHEUMATOLOGY 2, 516-20 (2017) (filed as Ex. 51). “The local adverse reaction to the PPV23 was
similar in all patients and developed a few hours after the injection, with pain, redness, and local
swelling.” Id. at 518.
The medical literature suggests that vaccination would have induced an immediate surge
in cytokine production if Mr. Feider had an inflammatory immune response, and is inconsistent
with Petitioner’s claim that “[t]his mirrors the progression of Mr. Feider’s course.” 11 First
Shoenfeld Rep. at 12. The medical records are clear and indicate that Mr. Feider’s course included
one and one half days of improvement between the time of vaccination on September 20, 2016
and hospital evaluation on September 24, 2016. Ex. 8 at 982. As Dr. Morel pointed out, any
immune response to the vaccines “would have subsided by 24 hrs post-vaccination and could not
have led to the development of SIRS, that began 3 days after Mr. Feider received his vaccines.”
First Morel Rep. at 4.
I gave Dr. Shoenfeld an opportunity to address the question of Mr. Feider’s improvement.
In an order directing the experts to answer several of my questions, I posed the following question
to Dr. Shoenfeld: “How does the fact that Petitioner was feeling better fit into the theory that
Petitioner’s injury was caused by a cytokine cascade?” See Order dated Aug. 21, 2020; ECF No.
35. Dr. Shoenfeld responded as follows: “Actually, the Petitioner states that Mr. Feider continue[d]
to have fever and flu-like symptoms on Wednesday, Thursday and Friday before he was
transported by the ambulance to the hospital. So Mr. Feider did not feel better.” Shoenfeld
Response to Questions at 2. This statement failed to answer my question, and is belied by the
medical records, discussed herein. See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417
(Fed. Cir. 1993) (stating that a special master need not credit the opinion of an expert when the
expert “based his opinion on facts not substantiated by the record.”). In sum, the one and one half
day improvement in Mr. Feider’s clinical course is inconsistent with his theory of causation and
11 Petitioner’s claims about vaccine-induced rhabdomyolysis are similarly suspect. The studies cited by
Petitioner indicate that creatine kinase (CK) levels, an important marker used in diagnosing and assessing
rhabdomyolysis, “rise approximately 2 to 12 hours after the onset of muscle injury, peak[] within 24 to 72
hours, and then decline[] at the relatively constant rate of 39% of the previous day’s value”, where
maintenance of CK levels may be indicative of a syndrome. Khan, Hospital, Rhabdomyolysis, 67 NETH J
MED 9, 272-83 (2009) (filed as Ex. 28) (hereinafter “Khan”). Khan at 276. As Dr. Shoenfeld conceded, Mr.
Feider’s CK levels were normal at the time of hospital admission, and “r[h]abdomyolysis appears to have
occurred late in Mr. Feider’s case” when CK levels rose 10 days into treatment, itself more than three days
after vaccination. Shoenfeld Response to Morel at 4. Notably, seven out of nine of Petitioner’s own cases
indicate rhabdomyolysis following influenza vaccination had symptom onset within 48 hours of
vaccination, and the remaining were noted within seven days without a clear indication of time of symptom
onset. First Shoenfeld Rep. at 27-29, Table 1. Additionally, the studies cited by Dr. Shoenfeld refer to statin
therapy and influenza causes of rhabdomyolysis. Id. at 15. The connection between these studies and
influenza vaccination is unpersuasive and unresolved by Dr. Shoenfeld’s discussion of statin-induced
muscle toxicity. Id.
28
means that Petitioner cannot meet her burden of establishing that the vaccine “did cause” Mr.
Feider’s condition.
2. Mr. Feider’s Diagnosis of Community-Acquired Pneumonia is Supported by
the Record
Community-acquired pneumonia is very common, accounting for as many as 500,000
hospitalized cases per year; pneumonia is recognized as the most common infectious cause of
death in the United States. Second Fife Rep. at 1; Marston et al., Incidence of community-acquired
pneumonia requiring hospitalization. Results of a population-based active surveillance Study in
Ohio, 157 ARCH INTERN MED 15, 1709-18 (1997) (filed as Ex. CC); Miniño et al., Deaths: final
data for 2008, 59 NATL VITAL STATE REP, 1-126 (2011) (filed as Ex. EE). Despite its frequency,
many patients who are diagnosed with community-acquired pneumonia culture negative, even
with sepsis. Mosevell et al., Inflammatory Mediator Profiles Differ in Sepsis Patients With and
Without Bacteremia, 9 FRONT IMMUNOL, 691 (2018) (filed as Ex. DD).
Mr. Feider’s treating physicians consistently documented that he likely suffered from
community-acquired pneumonia. See, e.g., Ex. 8 at 358 (noting clinical picture of pneumonia); Ex.
8 at 381 (assessing “respiratory failure secondary to pneumonia vs. CHF exacerbation”); Ex. 8 at
384 (documenting “AKI aft[e]r viral pneumonia”); Ex. 8 at 394 (stating “PVD admitted for
Parainfl[ue]nza viral pneumonia with a complicated course since then with multiorgan failure”);
Ex. 8 at 405 (noting a primary diagnosis of “resp failure. probable pneumonia”); Ex. 8 at 990
(documenting that “Pt has febrile picture w/ cough 3 days ago that was th[]ought to be resolving
but blossomed tonight w/ SOB and hypoxia which certainly can be caused by his CHF and
pneumonia.”). Ex. 8 at 916 (noting “72 yo male with h/o recent flu shot 43 [sic] days ago, followed
by worseni[ng] cough and dyspoea [sic] with fever, myalgias, with clinical picture with
Pneumonia, espe Rt side -lower and mid zones…”). None of his treating physicians attributed Mr.
Feider’s clinical course to the vaccines he received. His primary diagnosis after his death was
multiple organ dysfunction syndrome. Ex. 8 at 248. Community-acquired pneumonia was listed
as a secondary diagnosis. Id.
In weighing evidence, special masters are expected to consider the views of treating
doctors. Capizzano, 440 F.3d at 1326. The views of treating doctors about the appropriate
diagnosis are often persuasive because the doctors have direct experience with the patient whom
they are diagnosing. See McCulloch v. Sec’y of Health & Hum. Servs., No. 09-293V, 2015 WL
3640610, at *20 (Fed. Cl. Spec. Mstr. May 22, 2015).
In addition to some of his treating physicians, both Dr. Morel and Dr. Fife opined that Mr.
Feider suffered from community-acquired pneumonia. First Fife Rep. at 3; Second Fife Rep. at 1;
Third Fife Rep. at 1; First Morel Rep. at 6; Second Morel Rep. at 2; Third Morel Rep. at 2. 12
12Of note, Dr. Morel also opined that AKI is “quite common” in cases of community-acquired pneumonia.
Third Morel Rep. at 1. She went on to state that “Mr. Feider had long[]standing CKD with severely reduced
blood supply to one of his kidneys and compromised circulation to the other one. Thus, he was most
vulnerable to additional AKI when he acquired pneumonia.” Id. at 1-2.
29
Dr Shoenfeld opined that Mr. Feider did not suffer from community-acquired pneumonia
because he had negative blood and sputum tests, and because he did not respond to antibiotics.
Dr. Fife opined that although Mr. Feider’s sputum smear and bronchoalveolar lavage
lacked evidence of infection, this result should have been unsurprising because Mr. Feider was
treated with antibiotics for 10 days before the samples were taken. Third Fife Rep at 1.
Additionally, such tests come back positive in only around one-third of cases of community-
acquired pneumonia. First Fife Rep. at 3. Rosón et al., Prospective Study of the Usefulness of
Sputum Gram Stain in the Initial Approach to Community-Acquired Pneumonia Requiring
Hospitalization, 31 CLIN INFECT DIS, 869-74 (2000); (filed as Ex. G). Additionally, Dr. Fife noted
that “nearly half of all cases of severe sepsis have negative blood cultures.” First Fife Rep. at 3.
See also Gupta et al., Culture-Negative Severe Sepsis Nationwide Trends and Outcomes, 150
CHEST,1251-59 (2016) (filed as Ex. H). Dr. Morel agreed with Dr. Fife, stating that “all cultures
and serology tests came back negative, which is not unusual in cases of severe sepsis with co-
morbidities.” First Morel Rep. at 3.
Petitioner alleges Mr. Feider’s failure to respond to antibiotics suggests that the
“relationship between the vaccines, received by the patient, and his health problems appear[s] to
be more credible” than the diagnosis of community-acquired pneumonia. Shoenfeld Response to
Fife. at 3. Dr. Shoenfeld emphasized this point, quoting the Infectious Disease Society of America
guidelines which state that “treatment failure, deterioration or progression in hospitalized patients
with community-acquired pneumonia should [only] be considered after 72 h of initial treatment
with antibiotics.” 13 Id. at 2.
Certainly if Mr. Feider had responded to antibiotics, the question of whether he had a
bacterial infection would be moot. However, the fact that he did not respond to antibiotics does
not provide conclusive evidence that Mr. Feider did not have community-acquired pneumonia.
Ultimately, the question of diagnosis is a difficult one that Mr. Feider’s treating physicians
struggled with. The medical evidence presented on this point suggests that Mr. Feider likely had
community-acquired pneumonia, a fact which further reduces the strength of Petitioner’s showing
under the second Althen prong. Stone/Hammit v. Sec’y of Health & Hum. Servs., 676 F.3d 1373,
1380 (Fed. Cir. 2012).
I conclude that the course of Mr. Feider’s illness, which included a one and one half day
improvement in symptoms, is not consistent with Dr. Shoenfeld’s cytokine-based theory of
causation. Further, the fact that Mr. Feider’s treating physicians reasonably considered
community-acquired pneumonia as his correct diagnosis causes me to conclude that Petitioner has
failed to establish the vaccines Mr. Feider received “did cause” his condition.
13I note that Dr. Shoenfeld omitted the word “only” between the words “should” and “be”. First Shoenfeld
Rep. at 3; Goncalves at 6.
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C. Althen Prong Three
The timing prong contains two parts. First, a petitioner must establish the “timeframe for
which it is medically acceptable to infer causation” and second, she must demonstrate that the
onset of the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed.
Cl. 532, 542-43 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012),
aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013).
Dr. Shoenfeld spent little time discussing how Petitioner satisfied the third Althen prong.
He opined that “[t]he time of the symptoms’ onset coincided with the period of cytokine response
to the influenza vaccination.” First Shoenfeld Rep. at 13.
Petitioner reinforced this point in her brief and in her reply brief. She stated: “Mr. Feider’s
onset of systemic symptoms “within a couple of hours” fits perfectly within the expected
timeframe of an initial cytokine response to vaccination.” 14 Pet’r’s Reply at 18; see also Pet’r’s
Post-Hearing Brief at 34. Petitioner continued, stating that “[a]fter producing a cytokine response
to vaccination, Mr. Feider then continued to progress to a dysregulated SIRS reaction, meaning
the anti-inflammatory cytokines failed to arrest the cytokine storm.” Pet’r’s Reply at 12.
As discussed earlier in this decision, I find that Mr. Feider experienced myalgias, subjective
fever, and felt generally unwell the day of and the day after vaccination. He was then “much
improved” within 48 hours of vaccination and returned to his “usual state of health”. Ex. 8 at 946,
982. He remained well for one and one half days and then developed a sudden onset of shortness
of breath and difficulty breathing. Id. at 982.
Dr. Morel opined that any immune response to the vaccines “would have subsided by 24
hrs post-vaccination and could not have led to the development of SIRS, that began 3 days after
Mr. Feider received his vaccines.” Morel Rep. at 4. This opinion is consistent with the medical
literature filed in this case. See e.g., Chatziandreou, Talaat.
Accordingly, I find that the onset of Mr. Feider’s illness that eventually led to his death did
not occur “within a couple of hours” of vaccination. Instead, Mr. Feider suffered general side
effects from his vaccines, from which he recovered; he then developed a sudden onset of shortness
of breath and difficulty breathing three and one half days after vaccination. Petitioner has not
presented preponderant evidence that this onset interval is medically acceptable to infer vaccine
causation, given his cytokine-based theory. Because of this, Petitioner has not presented
preponderant evidence with respect to the third Althen prong.
VII. CONCLUSION
This is a tragic case and I extend my sympathy to Ms. Switzer’s family for their loss.
14Petitioner cited to the Talaat study, noting that it “addresses the timing of the cytokine response after the
influenza vaccination.” Pet’r’s Post-Hearing Brief at 34. Indeed, Talaat concluded that “[s]erum cytokines
changed rapidly following TIV and generally peaked at 24 hours.” Talaat at 202.
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However, upon careful evaluation of all the evidence submitted in this matter, including the
medical records, medical literature, the affidavits, as well as the experts’ opinions, I conclude that
Petitioner has not shown by preponderant evidence that she is entitled to compensation under the
Vaccine Act. Her petition is therefore DISMISSED. The clerk shall enter judgment
accordingly. 15
IT IS SO ORDERED.
s/ Katherine E. Oler
Katherine E. Oler
Special Master
15Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by each filing (either jointly
or separately) a notice renouncing their right to seek review.
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