“The special master’s decision often times is based on the credibility of the experts and the relative persuasiveness of their competing theories.”
How later courts described this case
- “The special master’s decision often times is based on the credibility of the experts and the relative persuasiveness of their competing theories.”
- noting that “close calls” are resolved in petitioner’s favor
- noting that special masters are bound by both § 13(b)(1) and Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and “reliable”
- stating that an “expert opinion is no better than the soundness of the reasons supporting it” (citing Fehrs v. United States, 620 F.2d 255, 265 (Ct. Cl. 1980))
Written by the judges who cited it.
The opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: February 16, 2021
*************************
CLAYTON T. COLEMAN, * PUBLISHED
*
Petitioner, * No. 18-352v
*
v. * Special Master Nora Beth Dorsey
*
SECRETARY OF HEALTH * Ruling on Entitlement; Causation-in-Fact;
AND HUMAN SERVICES, * Influenza (“Flu”) Vaccine; Sweet’s
* Syndrome.
Respondent. *
*
*************************
David A. Tierney, Rawls Law Group, Richmond, VA, for petitioner.
Sarah C. Duncan, U.S. Department of Justice, Washington, DC, for respondent.
RULING ON ENTITLEMENT1
I. INTRODUCTION
On March 7, 2018, Clayton T. Coleman (“petitioner”) filed a petition for compensation
under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42
U.S.C. § 300aa-10 et seq. (2012).2 Petitioner alleged that he suffered from Sweet’s syndrome
1
The undersigned intends to post this Ruling on the United States Court of Federal Claims’
website. This means the Ruling will be available to anyone with access to the internet. In
accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact
medical or other information, the disclosure of which would constitute an unwarranted invasion
of privacy. If, upon review, the undersigned agrees that the identified material fits within this
definition, the undersigned will redact such material from public access. Because this published
Ruling contains a reasoned explanation for the action in this case, undersigned is required to post
it on the United States Court of Federal Claims’ website in accordance with the E-Government
Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services).
2
The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C. §§ 300aa-10 to -34 (2012). All citations in this Ruling to individual sections of the
Vaccine Act are to 42 U.S.C. § 300aa.
and development of arthralgia as the result of an influenza (“flu”) vaccination he received on
February 3, 2016. Petition at Preamble (ECF No. 1).
After a review of the record as a whole, expert reports and medical literature, briefing by
the parties, and for the reasons set forth below, the undersigned finds by preponderant evidence
that the petitioner is entitled to compensation.
II. PROCEDURAL HISTORY
Petitioner filed his petition on March 7, 2018, alleging that he suffered from Sweet’s
syndrome and development of arthralgia caused by a flu vaccine administered to him on
February 3, 2016. Petition at Preamble. On March 13, 2018, petitioner filed medical records
and affidavits. Petitioner’s Exhibits (“Pet. Exs.”) 1-13. On November 1, 2018, respondent filed
respondent’s Rule 4(c) Report. Respondent’s Report (“Resp. Rept.”), filed Nov. 1, 2018 (ECF
No. 12). At that time, respondent was unable to formulate an opinion because the Division of
Injury Compensation Programs (“DICP”) did not have the opportunity to review the case. Id. at
9.
On February 15, 2019, petitioner filed an expert report with accompanying medical
literature. Pet. Exs. 14-31. Petitioner filed additional medical records and a motion to issue
subpoena on February 25, 2019. Pet. Exs. 32-35; Pet. Motion (“Mot.”) to Issue Subpoena, filed
Feb. 25, 2019 (ECF No. 17). The court granted petitioner’s motion the next day. Order Granting
Mot. to Issue Subpoena dated Feb. 26, 2019 (ECF No. 19).
On July 2, 2019, respondent filed a responsive expert report with accompanying medical
literature. Resp. Exs. A-B. Petitioner filed a supplemental expert report on September 18, 2019.
Pet. Exs. 36-41.
The case was reassigned to the undersigned on October 1, 2019. Order Reassigning Case
dated Oct. 1, 2019 (ECF No. 27). The parties then filed a Joint Status Report on October 24,
2019, requesting a Rule 5 status conference. Joint Status Rept., filed Oct. 24, 2019 (ECF No.
29).
The Rule 5 status conference was held on November 21, 2019. See Rule 5 Order dated
Nov. 22, 2019 (ECF No. 30). During the Rule 5 conference, the undersigned concluded that
Sweet’s syndrome was the proper diagnosis and that her preliminary findings were that
“petitioner would likely be able to satisfy all three Althen Prongs if this case proceeds to a
hearing.” Id. at 2; see Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir.
2005). In response to one of petitioner’s treating physicians questioning whether petitioner’s
medication, allopurinol, was a possible trigger, the undersigned directed petitioner to “submit a
memorandum and affidavit detailing when he started, discontinued, and resumed his use of
allopurinol, along with any adverse symptoms he may have experienced during the interim
period.” Rule 5 Order at 2. The undersigned encouraged the parties to engage in settlement
negotiations. Id. at 3.
2
On January 6, 2020, petitioner filed his memorandum and affidavit addressing his use of
allopurinol and additional medical records. Pet. Exs. 42-44. Petitioner filed additional medical
records in February and March 2020. Pet. Exs. 45-46. On April 22, 2020, the parties filed a
Joint Status Report indicating that respondent was not interested in settlement and the parties
wished to proceed with a Ruling on the Record to determine whether petitioner was entitled to
compensation. Joint Status Rept., filed Apr. 22, 2020 (ECF No. 44).
Petitioner filed his motion for a Ruling on the Record on July 6, 2020. Pet. Mot. for
Ruling on the Record (“Pet. Mot.”), filed July 6, 2020 (ECF No. 48). Respondent filed his
response to petitioner’s motion on September 4, 2020. Resp. Response to Pet. Mot. (“Resp.
Response”), filed Sept. 4, 2020 (ECF No. 49). On November 3, 2020, petitioner filed his reply.
Pet. Reply, filed Nov. 3, 2020 (ECF No. 50).
The matter is now ripe for adjudication.
III. ISSUES TO BE DECIDED
The parties dispute causation. Petitioner alleged he has suffered from a variety of
symptoms related to Sweet’s syndrome which began four days after the administration of the
vaccine. Pet. Mot. at 1. Petitioner averred he is entitled to compensation as outlined by the
evidence presented in the relevant medical records and expert reports. Id.
Respondent argued petitioner has not satisfied his burden to demonstrate a reliable
medical theory causally connecting the flu vaccine to Sweet’s syndrome, a “logical” sequence of
cause and effect showing that the flu vaccination was the cause of his injury, or an appropriate
temporal association between his flu vaccination on February 3, 2016 and his Sweet’s syndrome
as required under the Althen Prongs. Resp. Response at 2-3.
IV. FACTUAL SUMMARY
A. Sweet’s Syndrome
Acute febrile neutrophilic dermatosis—or Sweet’s syndrome—is a rare inflammatory
skin condition characterized by fever, neutrophilia,3 tender erythematous,4 skin lesions (papules,
nodules, and plaques), and a diffuse infiltrate consisting predominantly of mature neutrophils.
3
Neutrophilia is an increase in white blood cells due to inflammation. Neutrophilia, Dorland’s
Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=33918&
searchterm=neutrophilia (last visited Jan. 27, 2021).
4
Erythema is redness of the skin due to inflammation. Erythema, Dorland’s Med. Dictionary
Online, https://www.dorlandsonline.com/dorland/definition?id=17187 (last visited Jan. 27,
2021).
3
Pet. Ex. 17 at 1.5 Fever is the most frequent symptom followed by cutaneous manifestations. Id.
at 5. Skin lesions are often distributed asymmetrically, most frequently appearing on the upper
extremities, face, and neck. Id. Ocular inflammation is also a common extracutaneous
manifestation. Resp. Ex. A, Tab 1 at 6.6 Arthralgias, malaise, headache, and myalgias are
additional symptoms that frequently occur in Sweet’s syndrome. Id. Biopsy may be necessary
for correct diagnosis. Pet. Ex. 17 at 14.
Sweet’s syndrome presentation can be classical (idiopathic), malignancy-associated, or
drug-induced. Pet. Ex. 17 at 2. Classical or idiopathic Sweet’s syndrome predominantly affects
women and may be associated with infection, inflammatory bowel disease, or pregnancy. Id. at
3. Several medications have been associated with drug-induced Sweet’s syndrome, especially
following the administration of granulocyte-colony stimulating factor. Id. at 4. The
pathogenesis of Sweet’s syndrome is not well understood, but factors theorized to contribute to
the development of this disorder include hypersensitivity reactions, cytokine dysregulation, and
genetic susceptibility. Resp. Ex. A, Tab 1 at 4. Studies suggest Sweet’s syndrome is probably
an immune-complex mediated process. See Pet. Exs. 17, 18,7 26.8
Skin hypersensitivity9 is a Sweet’s syndrome-associated feature characterized by
dermatosis-associated skin lesions appearing at sites of cutaneous trauma. Pet. Ex. 17 at 7.
These include the sites where procedures such as biopsies, intravenous catheter placement,
vaccination, and venipuncture. Id.; see also Resp. Ex. A, Tab 1 at 6. A hypersensitivity reaction
to an eliciting bacterial, viral, or tumor antigen may promote the development of Sweet’s
syndrome. Pet. Ex. 17 at 13.
B. Summary of Relevant Facts
Petitioner was forty years old when he received a flu vaccine in his left arm on February
3, 2016 during an annual examination conducted by his primary care provider (“PCP”), Dr.
5
Phillip R. Cohen, Sweet’s Syndrome – A Comprehensive Review of an Acute Febrile
Neutrophilic Dermatosis, 2 Orphanet J. Rare Diseases 34 (2007).
6
Joseph F. Merola, Sweet Syndrome (Acute Febrile Neutrophilic Dermatosis): Pathogenesis,
Clinical Manifestations, and Diagnosis, UpToDate (2019).
7
Abu S. M. Giasuddin et al., Sweet’s Syndrome: Is the Pathogenesis Mediated by Helper T Cell
Type 1 Cytokines?, 39 J. Am. Acad. Dermatology 940 (1998).
8
Shahzad Raza et al., Insight into Sweet’s Syndrome and Associated-Malignancy: A Review of
the Current Literature, 42 Int’l J. Oncology 1516 (2013).
9
Hypersensitivity is a state of altered reactivity in which the body reacts with an exaggerated or
inappropriate immune response to what is perceived to be a foreign substance. Hypersensitivity,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?
id=24004&searchterm=hypersensitivity (last visited Jan. 27, 2021).
4
Derek Einhorn. Pet. Ex. 3 at 2; Pet. Ex. 5 at 12. At the time of vaccination, he was taking
allopurinol,10 sertraline, hydrochlorothiazide, tamsulosin, and sildenafil. Pet. Ex. 5 at 10.
On February 9, 2016, petitioner returned to Dr. Einhorn complaining of a rash and fever
and chills. Pet. Ex. 5 at 14-15. Dr. Einhorn noted grouped pustules and vesicles on the right side
of his neck and on both wrists and diagnosed petitioner with bullous impetigo.11 Id. at 14. Dr.
Einhorn prescribed Bactrim and Mupirocin topical ointment. Id.
The next day, on February 10, 2016, petitioner presented to dermatologist Dr. Leonard
Kerwin at Associated Dermatology. Pet. Ex. 8 at 1. Dr. Kerwin noted a red, painful, itchy, and
severe rash present for four days located on petitioner’s hand, neck, face, and leg. Id. Petitioner
reported that he had received a flu vaccine the week prior. Id. Dr. Kerwin diagnosed a drug
eruption. Id. Dr. Kerwin counseled petitioner that drug eruptions may result from any class of
medications with the offending agents started 1-2 weeks prior to the eruption. Id. Dr. Kerwin
advised petitioner to discontinue Bactrim and prescribed Triacinolone acetonide topical cream,
Valtrex, and an injection of celestone. Id.
On February 15, 2016, petitioner returned to Associated Dermatology and presented to
Dr. Leonard Cetner. Pet. Ex. 8 at 3. Dr. Cetner reported petitioner was “following up for drug
eruption which started 2 days following his flu vaccine.” Id. He noted “[p]olycyclic
erythematous edematous urticarial plaques and with erythema nodosum-like lesions distributed
on the left proximal posterior upper arm, right buttock, and right antecubital skin.” Id. at 3, 5-6.
Petitioner stated he felt better for 48-72 hours after the celestone injection, but then his rash
began to flare again, and he experienced joint aches and tenderness, swelling, and malaise. Id. at
3. Dr. Cetner diagnosed petitioner with worsening unspecified dermatitis, with a differential
diagnosis of serum sickness vs. erythema multiforme vs. exanthem vs. parvovirus. Id. Dr.
Cetner performed a punch biopsy in the left upper arm. Id. The punch biopsy revealed
superficial to mid-dermal perivascular, interstitial, and focally perifollicular dermatitis with
neutrophils, scattered eosinophils, and segmental marked papillary dermal edema with no
definitive fungal organisms identified. Id. at 8. Primary diagnosis was hypersensitivity reaction,
such as drug eruption. Id. Petitioner received another injection of celestone and was advised to
see an ophthalmologist for possible eye involvement. Id. at 3-4.
On February 16, 2016, petitioner was seen by ophthalmologist Dr. David Shepherd. Pet.
Ex. 9 at 1-2. Dr. Shepherd recorded an auto-immune reaction to flu vaccine leading to eye
discharge, red and irritated eyes, and blurry vision. Id. at 1. Dr. Shepherd diagnosed petitioner
10
Allopurinol is a pharmaceutical treatment for gout and kidney stones. Allopurinol, Dorland’s
Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?
id=1854&searchterm=allopurinol (last visited Dec. 28, 2020).
11
Bullous impetigo are skin eruptions which begin as small vesicles that enlarge to form blisters
with erythematous rims; the lesions later rupture and form a thin, varnish-like crust. Bullous
Impetigo, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=82053&searchterm=impetigo%20bullosa
(last visited Feb. 8, 2021).
5
with dry eye syndrome of the right eye related to flu vaccine reaction and squamous blepharitis
of the left lower eyelid. Id. at 2.
Petitioner had a follow up visit with Dr. Kerwin on February 17, 2016, for left proximal
posterior upper arm, right buttock, and right antecubital unspecified dermatitis. Pet. Ex. 8 at 7.
Dr. Kerwin noted an overall improvement and less joint pain. Id. He also noted petitioner’s
ophthalmology evaluation was negative. Id. Dr. Kerwin’s impression was erythema elevatum
diutinum, with associated diagnoses of serum sickness vs. erythema multiforme. Id. Prednisone
and valacyclovir were continued. Id. Petitioner then returned to Dr. Kerwin’s office on
February 18, 2016 complaining of a pain intensity of 6/10, swelling, stiffness, and night sweats.
Id. at 13. Dr. Kerwin’s assessment remained the same and he administered a Kenalog injection.
Id.
On February 25, 2016, petitioner returned to Dr. Kerwin for a follow-up. Pet. Ex. 8 at 12.
Petitioner reported pain 4/10. Id. Dr. Kerwin advised petitioner to finish his prednisone
prescription, administered another injection of celestone, and referred petitioner to
rheumatologist, Dr. Stephen Portney. Id.
Petitioner presented to Dr. Einhorn on March 1, 2016 due to his ongoing rash. Pet. Ex. 5
at 16. On exam, petitioner’s left ankle had diffused swelling and there were scattered pustules on
his neck and on both arms. Id. at 17. Dr. Einhorn noted, “serum sickness reaction following flu
shot continue to follow with dermatologist slowly improving. . . . May need to consult with
rheum[atology] or immunology if symptoms persist and re other forms of flu vaccine in future.”
Id.
On March 8, 2016, petitioner presented to rheumatologist Dr. Portnoy. Pet. Ex. 10 at 1-5.
Dr. Portnoy reported petitioner “was in his usual health and had an [flu] vaccine February 3,
2016 at the time he had a physical examination. He developed an undocumented fever within
the same 24 hours and noted a rash on his posterior neck 2 days later.” Id. at 1. “He has
received several intramuscular steroid injections which provide 3-5 days of benefit but his pain
then recurs.” Id. Physical examination revealed tenderness and pain in petitioner’s joints and
erythematous rashes. Id. at 2-3. Dr. Portnoy’s impression concluded, “[h]e’s had a rash with
biopsy revealing possible hypersensitivity response” that “occurred after a[] [flu] vaccine and I
cannot exclude an association with this. Although I cannot exclude serum sickness, some his
symptoms occurred fairly soon after the vaccine. I cannot exclude that his rash could be
associated with other medication he is currently taking.”12 Id. at 3. Dr. Portnoy advised further
serologic studies to evaluate petitioner for underlying autoimmune abnormality and indicated
that since petitioner was having significant issues with pain, steroid injections would not be a
suitable long-term form of therapy. Id. at 4.
On April 29, 2016, petitioner returned to Dr. Kerwin, whose impressions and therapies
remained unchanged. Pet. Ex. 8 at 16. Pain was 8/10. Id. On May 13, 2016, petitioner was
seen by dermatologist Dr. Michael Dorman. Id. at 17. Dr. Dorman documented 13% of
12
Petitioner’s medications included allopurinol, tamsulosin, hydrochlorothiazide, and sertraline.
Pet. Ex. 10 at 2.
6
petitioner’s body was covered by the rash. Id. Dr. Dorman also noted petitioner was referred to
Dr. David Fivenson and that he was going on a trip to Mexico. Id.
On June 21, 2016, petitioner presented to dermatologist Dr. Fivenson. Pet. Ex. 11 at 13-
17. Dr. Fivenson noted itchy, painful rash with extreme joint pain. Id. at 15. He reported onset
of over three months which occurred after the flu shot. Id. Dr. Fivenson stated, “[a]fter review
of the prior medical records available, the patient’s history and physical examination, I favor
sweet’s vs [linear IgA bullous disease] as the likely diagnosis. Skin biopsy and direct
immunofluorescence have been suggested/ordered to help establish the diagnosis.” Id. at 16. Dr.
Fivenson performed a skin punch biopsy. Id. at 17. On June 30, 2016, Dr. Fivenson diagnosed
petitioner with acute febrile neutrophilic dermatosis with findings consistent with the clinical
impression of Sweet’s syndrome. Id. at 12. He instructed petitioner to stop taking allopurinol
since it could be a “possible trigger” of his Sweet’s syndrome. Id.
On July 22, 2016, Dr. Portney diagnosed Sweet’s syndrome by biopsy. Pet. Ex. 10 at 6.
On October 14, 2016, Dr. Portney noted, “flu . . . ? Sweet’s syndrome.” Id. at 7. On October
25, 2016, petitioner presented to Dr. Fivenson who stated “[r]ash has improved but still present
on [left] arm and [left] neck.” Pet. Ex. 11 at 3. Petitioner followed up with Dr. Portney on April
21, 2017, and Dr. Portney stated his rash and joint pain had resolved. Pet. Ex. 10 at 9-10.
C. Affidavits
1. Petitioner
Petitioner reported he began to feel “feverish” and “achy” on the evening of February 3,
2016, after he received the flu vaccination. Pet. Ex. 1 at 1. He felt worse that weekend and had
full body aches and fever as if he “had a severe flu.” Id. On February 7, 2016, he noticed a rash
spreading on his back and neck. Id. Petitioner presented to Dr. Einhorn on February 9, 2016,
and Dr. Einhorn prescribed antibiotics for petitioner’s painful and itchy rash that spread to his
face. Id. However, the rash spread to petitioner’s eyes on February 10, 2016, and Dr. Einhorn
referred petitioner to the dermatologist for further evaluation. Id.
Petitioner averred his rash began on his back and quickly spread to his wrists, arms, and
shoulders, and onto his face, eyes, and hairline. Pet. Ex. 1 at 1. Petitioner had “severe joint pain
in [his] wrists and thumbs.” Id. The joint pain spread to petitioner’s ankles, legs, back, and
shoulders and caused numbness, burning, and tingling sensation in his legs. Id. at 1-2.
Petitioner’s pain was so intense he could not hold a pen or walk for three months. Id. at 2. Due
to this, petitioner was unable to attend his uncle’s funeral, and was unable to participate in his
normal everyday activities. Id.
After vaccination petitioner stated he could not take his normal trips to the grocery store,
help with household chores, or engage in the active lifestyles of his eight children. Pet. Ex. 1 at
2. For example, he could not take his kids to practices or tournaments or participate in group
camping and hiking trips. Id. Petitioner reported he was able to continue his work as a
Supervising Operator at a power plant with the exception of eight days he took off due to pain.
Id. at 3. Petitioner stated his condition slowed the process of obtaining his engineer’s license,
7
but he completed the required testing and is up to date on all required qualifications for his job.
Id.
a. Issue Related to Whether or Not Petitioner’s Allopurinol Medication
Caused or Contributed to Sweet’s Syndrome
Petitioner stated in his second affidavit he had taken allopurinol since 2005 for kidney
stone prevention. Pet. Ex. 42 at 1. Petitioner averred he stopped taking the medication for
almost eight weeks when Dr. Fivenson diagnosed his condition, but has “since resumed taking
allopurinol.” Id.
In his memorandum, petitioner averred that allopurinol is cited repeatedly as a current or
active medication in records from Novidocs, Oakland Orthopedic Surgeons, Associated
Dermatology, Newland Medical Associates, and Michigan Institute of Urology between June
2014 and March 2016. Pet. Ex. 43 at 2.
On June 30, 2016, Dr. Fivenson noted, “[s]top allopurinol to see if that is the possible
trigger for your Sweet’s syndrome.” Pet. Ex. 43 at 2; Pet. Ex. 11 at 33. Petitioner stated, Dr.
Fivenson’s direction is the only mention in the medical record of discontinuation. Pet. Ex. 43 at
2. At petitioner’s subsequent follow-ups with Dr. Fivenson, they did not discuss petitioner’s
discontinuation of allopurinol, the effects of discontinuation, or a resumption of it. Id. at 2-3.
Except for the eight weeks after June 30, 2016, when petitioner discontinued taking allopurinol,
petitioner resumed taking it, and continues to take it, “with no effect.” Id. at 4.
2. Patricia Coleman
Patricia Coleman, petitioner’s mother, also submitted an affidavit on petitioner’s behalf.
Pet. Ex. 2. Ms. Coleman stated after the February 3, 2016 flu vaccination, she observed lesions
all over petitioner’s body, especially on his face, head, neck, torso, and arms on April 3, 2016.
Id. at 1. Ms. Coleman stated petitioner complained of exhaustion and severe joint pain. Id. She
said there was no change by May 2016. Id.
Petitioner moved in with his parents at the end of July 2016. Pet. Ex. 2 at 1. Ms.
Coleman reported the lesions were improving as petitioner visited his doctors, but his joint pain
and exhaustion did not change. Id. Petitioner and his mother would take walks together, but
petitioner’s pain necessitated frequent stops and he needed rest for hours after. Id. Ms. Coleman
stated petitioner was not out of shape or led a sedentary life prior to vaccination. Id.
Ms. Coleman reported by April 2017, most of petitioner’s pain and his skin lesions were
gone. Pet. Ex. 2 at 1. She stated petitioner has periodic joint pain, but for the most part is
healthy now. Id.
D. Expert Reports
1. Petitioner – Dr. M. Eric Gershwin
8
a. Background and Qualifications
Dr. Gershwin is a Distinguished Professor of Medicine with the University of California,
Davis, where he currently holds a chaired professorship in honor of Jack and Donald Chia. Pet.
Ex. 15 at 2. Dr. Gershwin received his undergraduate degree, summa cum laude, from Syracuse
University and his medical degree from Stanford. Id. He has an honorary doctorate from the
University of Athens, in recognition for his lifetime contribution in immunology and medicine.
Id. He has also been awarded the AESKU prize in Autoimmunity in 2008, in recognition of his
lifetime contribution in immunology. Id. He is also fellow with the American Association for
the Advancement of Science. Id. He is board certified in internal medicine, rheumatology, and
allergy and clinical immunology. Id. at 3. Dr. Gershwin authored two expert reports. Pet. Exs.
14, 36.
b. Opinion
i. Diagnosis
In regard to diagnosis, Dr. Gershwin opined that petitioner developed the idiopathic form
of Sweet’s syndrome. Pet. Ex. 14 at 2. Dr. Gershwin noted there were a number of other
diagnoses considered, including viral infection, erythema multiforme, serum sickness, Stevens-
Johnson syndrome, and hypersensitivity reaction. Id. at 1. However, Dr. Fivenson ultimately
diagnosed Sweet’s syndrome as consistent with petitioner’s second punch biopsy. Id. at 2.
ii. Althen Prong One: Medical Theory of Causation
Dr. Gershwin opined the mechanism for Sweet’s syndrome remains enigmatic, but most
likely is due to abnormal cytokine production following vaccination. Pet. Ex. 14 at 2. More
specifically, he stated Sweet’s syndrome develops as a result of cytokine production and
inflammasome activation in a genetically susceptible host, which can lead directly to
neutrophilia and the abnormal neutrophil infiltrates within lesions. Pet. Ex. 36 at 2.
Dr. Gershwin opined Sweet’s syndrome is an inflammatory syndrome and may likely be
due to activation of the inflammasome with an underlying genetic predisposition. Pet. Ex. 36 at
2. He cited Heath and Ortega-Loayza13 who state, “[t]he exact pathogenesis of Sweet’s
syndrome is unclear; however[,] . . . findings include an improved understanding of
inflammasome activation . . . and genetic contributions.” Pet. Ex. 39 at 1. “Mutations in
isocitrate dehydrogenase I (IDHI) have been identified as a possible connection to [Sweet’s
syndrome] pathogenesis.” Id. at 6. The authors explained that “IDHI catalyzes reactions leading
to alterations in histones and DNA, causing differential gene expression.” Id. This suggests the
mechanism underlying Sweet’s syndrome is the “dysfunctional activation of the inflammasome
and IL- 1β pathway.” Id. Dr. Gershwin stated vaccination is a stimulator of the immune
response, and thus catalyzes inflammasome activation. Pet. Ex. 36 at 2.
13
Michael Heath & Alex Ortega-Loayza, Insights into the Pathogenesis of Sweet’s Syndrome,
10 Frontiers Immunology 1 (2019).
9
According to Dr. Gershwin, Sweet’s syndrome has been previously associated with
vaccination. Pet. Ex. 14 at 2. Though, due to the uncommon frequency of Sweet’s syndrome
following vaccination, epidemiologic studies do not have sufficient power to establish causation.
Id. However, Dr. Gershwin did cite a number of different case reports in the medical literature
documenting Sweet’s syndrome following vaccination. For example, Carpentier et al.,14
documented a previously healthy 36-year-old woman who received a BCG vaccination in her left
arm and ten days later developed Sweet’s syndrome lesions on her abdomen and limbs. Pet. Ex.
16. Gunawardena et al.15 described eighteen case reports of Sweet’s syndrome. Pet. Ex. 19. In
two of the case reports, patients developed Sweet’s syndrome following smallpox vaccination.
Id. One patient was a 47-year-old woman who received a secondary smallpox vaccination and
three days later developed a fever with itching, redness, and swelling around the vaccination site.
Id. at 2. The eruption spread to her chest and both arms and affected her eyes. Id. Another 70-
year-old woman developed a fever approximately three days post smallpox vaccination and had
erythematous eruptions on her extremities approximately four days later. Id. at 5.
Additionally, Dr. Gershwin cited the article by Jovanoic et al.,16 who documented a 45-
year-old woman who developed Sweet’s syndrome 12 hours after flu vaccination. Pet. Ex. 22 at
1. Maddox and Motley17 similarly found a 36-year-old woman who received a pneumococcal
vaccine after an emergency splenectomy developed Sweet’s syndrome approximately seven days
later. Pet. Ex. 23 at 1. Pedrosa et al.18 described a 52-year-old man who developed Sweet’s
syndrome fifteen days after receiving a pneumococcal vaccine. Pet. Ex. 24 at 1. Radeff and
Harms19 documented a case report of a 23-year-old woman who developed Sweet’s syndrome 15
days after BCG vaccination. Pet. Ex. 25 at 3. Finally, Tan et al.20 reported a 46-year-old man
with HIV who suffered from an eruption two days after a flu vaccination. Pet. Ex. 30 at 1.
Olivier Carpentier et al., Sweet’s Syndrome After BCG Vaccination, 82 Acta Dermatology
14
Venereology 221 (2002).
D.A. Gunawardena et al., The Clinical Spectrum of Sweet’s Syndrome (Acute Febrile
15
Neutrophilic Dermatosis) – A Report of Eighteen Cases, 92 Br. J. Dermatology 363 (1975).
16
Marina Jovanoic et al., Acute Febrile Neutrophilic Dermatosis (Sweet’s Syndrome) After
Influenza Vaccination, 52 J. Am. Acad. Dermatology 367 (2005).
P.R. Maddox & R.J. Motley, Sweet’s Syndrome: A Severe Complication of Pneumococcal
17
Vaccination Following Emergency Splenectomy, 77 Br. J. Surgery 809 (1990).
18
Ana Filipa Pedrosa et al., Sweet’s Syndrome Triggered by Pneumococcal Vaccination, 32
Cutaneous Ocular Toxicology 260 (2013).
19
Boris Radeff & M. Harms, Acute Febrile Neutrophilic Dermatosis (Sweet’s Syndrome)
Following BCG Vaccination, 66 Acta Dermatology Venereology 357 (1986).
20
Tan et al., Bullous Sweet’s Syndrome Following Influenza Vaccination in a HIV-Infected
Patient, 45 Int’l J. Dermatology 1254 (2006).
10
In response to Dr. Matloubian’s report, Dr. Gershwin cited Cohen and Kurzrock,21 to
explain that Sweet’s syndrome is a rare disease characterized by the presence of fever, elevated
neutrophil count, painful red papules, nodules, and plaques. Pet. Ex. 36 at 2 (citing Pet. Ex. 38).
Cytokines directly or indirectly play a role in the etiology of lesions on the skin and because the
syndrome is systemic, lesions do not always appear at the site of vaccination as would be
expected if it was an allergic response. Pet. Ex. 36 at 2.
Dr. Gershwin stated that the medical literature provides support that a patient’s genetic
susceptibility influences the immune response to flu vaccination. Pet. Ex. 36 at 2. The
Castrucci22 article found that preexisting immunity affects flu vaccine responsiveness in host
bodies. Pet. Ex. 40 at 1. The article stated, “[p]olymorphisms of any of the involved genes in
the molecular interactions within the immune-system reflect the high variability between
individuals to respond efficiently to vaccines.” Id. at 3. Forero et al.23 emphasized, “[t]he host
innate immune response to [flu] virus is a key determinant of pathogenic outcomes and long-
term protective immune response against subsequent exposures.” Pet. Ex. 41 at 1.
iii. Althen Prong Two: Logical Sequence of Events
Dr. Gershwin opined that there is a logical sequence of cause and effect here. Pet. Ex. 36
at 2. Sweet’s syndrome is associated with certain medications and drugs, infections,
autoimmune diseases, neoplasia, and pregnancy. Pet. Ex. 14 at 2. However, Dr. Gershwin stated
there is no evidence that petitioner had an autoimmune disease, nor evidence that he had an
antecedent infection, used a drug thought to stimulate Sweet’s syndrome, or had underlying
neoplasia. Id. Dr. Gershwin asserted “[t]he vaccination [wa]s the only known immune stimulus
found in this case.” Pet. Ex. 36 at 2. Petitioner had no other underlying predisposing factors that
could be attributed to his development of Sweet’s syndrome. Pet. Ex. 14 at 3.
Petitioner was diagnosed with the idiopathic form of Sweet’s syndrome, which has
previously been associated with vaccination. Pet. Ex. 14 at 2. Dr. Gershwin opined that genetic
susceptibility, which has been reported with Sweet’s syndrome, is most likely what happened in
petitioner. Id. Petitioner most likely had abnormal cytokine production following vaccination,
which then led to the development of his Sweet’s syndrome. Id. In summary, Dr. Gershwin
opined “[petitioner] is an example of a very rare event in a genetically susceptible host following
cytokine production to a vaccine.” Id. at 3.
21
Phillip R. Cohen & R. Kurzrock, Sweet’s Syndrome Revisited: A Review of Disease
Concepts, 42 Int’l J. Dermatology 761 (2003).
22
Maria R. Castrucci, Factors Affecting Immune Responses to the Influenza Vaccine, 14 Hum.
Vaccines & Immunotherapeutics 637 (2018).
23
Adriana Forero et al., Evaluation of the Innate Immune Responses to Influenza and Live-
Attenuated Influenza Vaccine Infection in Primary Differentiated Human Nasal Epithelial Cells,
35 Vaccine 6112 (2017).
11
In regard to whether allopurinol played a causal role in petitioner’s illness, Dr. Gershwin
stated petitioner was taking allopurinol May 7, 2014, and continued it without interruption until
June 2016. Pet. Ex. 36 at 1. Petitioner resumed taking it in August 2016. Id. Dr. Gershwin
opined it is unlikely that allopurinol caused petitioner’s Sweet’s syndrome. Id. Case reports
demonstrate that symptoms most commonly occur shortly after beginning the medication. Id. In
Polimeni et al.,24 Sweet’s syndrome occurred eight days after allopurinol initiation. Pet. Ex. 37
at 2. In contrast, Dr. Gershwin stated petitioner had taken allopurinol for at least two years
before the onset of his rash. Pet. Ex. 36 at 1.
iv. Althen Prong Three: Proximate Temporal Relationship
Dr. Gershwin reported petitioner’s flu vaccination was on February 3, 2016 and his rash
was noted on February 7, 2016. Pet. Ex. 36 at 1; Pet. Ex. 1 at 1. Petitioner presented to Dr.
Einhorn on February 9, 2016 for evaluation of his rash. Pet. Ex. 14 at 1. Therefore, Dr.
Gershwin opined, there is a proximate temporal relationship of four days between vaccination
and injury. Pet. Ex. 36 at 2.
2. Respondent – Dr. Mehrdad Matloubian
a. Background and Qualifications
Dr. Mehrdad Matloubian is a Clinical Professor at the University of California, San
Francisco. Resp. Ex. A at 1. He received his undergraduate degree, summa cum laude, his
medical degree, and his Ph.D in virology from University of California, Los Angeles. Id. Dr.
Matloubian completed his fellowship, residency, and post-doctoral fellowship at University of
California, San Francisco. Id. He is board-certified in internal medicine and rheumatology. Id.
at 2. He has an active rheumatology practice and is an associate director of the Molecular
Medicine Consult Service. Id. at 3. Dr. Matloubian authored one expert report. Resp. Ex. A.
b. Opinion
i. Diagnosis
As for diagnosis, Dr. Matloubian stated, “even though at first [petitioner’s] treating
physicians considered entities such as serum sickness, erythema multiforme, and erythema
elevatum diutinum, he was eventually diagnosed with Sweet[’s] syndrome based on a second
biopsy and discussion at a dermatology grand rounds.”25 Resp. Ex. A at 4-5. Petitioner’s
rheumatologist could not find any evidence of an inflammatory arthritis or an associated
autoimmune disease. Id. at 5. Petitioner’s rash completely resolved, did not recur, and there was
no evidence of joint inflammation while off immunosuppressive therapy. Id. Therefore, Dr.
24
G. Polimeni et al., Allopurinol-Induced Sweet’s Syndrome, 2 Int’l J. Immunopathology
Pharmacology 329 (2016).
25
In his report, Dr. Matloubian primarily used the wording “Sweet syndrome.” However, for
consistency purposes, the undersigned will use “Sweet’s syndrome.”
12
Matloubian agreed with the diagnosis of Sweet’s syndrome based on the pathologic findings of
petitioner’s skin biopsy as well as his eventual response to therapy. Id.
ii. Althen Prong One: Medical Theory of Causation
Dr. Matloubian disagreed with Dr. Gershwin that the flu vaccine could cause Sweet’s
syndrome as a result of elevated cytokine production in a genetically susceptible host. Resp. Ex.
A at 6. He opined that Dr. Gershwin’s theory was speculative and based on only general
assertions regarding genetic susceptibility. Id. Dr. Matloubian also asserted that Dr. Gershwin
did not provide any persuasive medical literature beyond a few case reports of rare occurrences
of Sweet’s syndrome in temporal association with immunization. Id.
Dr. Matloubian opined that the pathogenesis of Sweet’s syndrome is not known, but he
agreed that it is thought to be an immune-mediated illness. Resp. Ex. A at 8. Dr. Matloubian
referenced the Sweet’s syndrome literature review authored by Joseph Merola, stating that
Sweet’s syndrome involves the recruitment of neutrophils to the skin and responds to
immunomodulating agents, such as steroids. Id. (citing Resp. Ex. A, Tab 1 at 4). Dr.
Matloubian stated that because cytokines are involved in all aspects of the immune system and
responses, their dysregulation has been postulated to play a role in pathogenesis of Sweet’s
syndrome. Id. However, the exact mechanism that leads to recruitment of neutrophils to the
skin, and what leads to cytokine dysregulation, is not understood. Id. Additionally, in regard to
the role of cytokine dysregulation in association with vaccination, Dr. Matloubian cited the 2011
IOM committee report26 which found “no evidence that directly or indirectly supports the
oversecretion of cytokines as an operative mechanism” related to vaccination. Id. (citing Resp.
Ex. A, Tab 2 at 12).
After reviewing Dr. Gershwin’s cited case reports on the occurrence of Sweet’s
syndrome in association with immunization, Dr. Matloubian concluded that none of the reports
provided any insight on a possible mechanism. Resp. Ex. A at 6. Dr. Matloubian stated that
Carpentier et al. and Maddox and Motley documented onset after administration of the BCG and
pneumococcal vaccines, but he believed these to be flawed comparisons because the components
of these vaccines are fundamentally different than the components of the flu vaccine. Id. (citing
Pet. Exs. 16, 23). The BCG and pneumococcal vaccines consist of specific types of bacterium
while the flu vaccine is composed of a virus with protein antigens. Id.
Additionally, Dr. Matloubian noted that Carpentier et al., Gunawardena et al., and Radeff
and Harms case reports indicate Sweet’s syndrome lesions appeared at the site of vaccination,
suggesting that there might have been an infectious process in the development of the disease.
Resp. Ex. A at 6-7 (citing Pet. Exs. 16, 19, 25). Dr. Matloubian stated that the Gunawardena et
al. case report complicates a supposed direct causal relationship with the vaccine component
itself by documenting a co-existing infectious agent at the site of vaccination. Id (citing Pet. Ex.
19).
26
Comm. to Rev. Adverse Effects of Vaccines, Inst. of Med., Adverse Effects of Vaccines:
Evidence and Causality (Kathleen Stratton et al. eds., 2011).
13
Dr. Matloubian opined that “[d]espite hundreds of millions of [flu] vaccines administered
annually worldwide for decades, the medical literature has only a handful of case reports of an
association with Sweet[’s] syndrome.” Resp. Ex. A at 7. Further, Dr. Matloubian stated the case
reports provided by Dr. Gershwin associating Sweet’s syndrome with the flu vaccine provide
little support for Dr. Gershwin’s proposed mechanism of causation. Id. First, Jovanovic et al.
documented skin lesions that occurred within 12 hours after flu immunization and also occurred
at the site of vaccination. Pet. Ex. 22 at 1. Dr. Matloubian stated the rapidity of onset of
symptoms and lesions within hours makes it unlikely that it was due to vaccine-specific T cell
and antibody responses. Resp. Ex. A at 7. Tan et al. also described an HIV positive man who
developed Sweet’s syndrome two days after a flu vaccination. Id. (citing Pet. Ex. 30). The
authors noted that Sweet’s syndrome in general has been associated with the HIV infection itself,
thus making it difficult to reach a conclusion regarding causality due to the flu vaccination. Id.
(citing Pet. Ex. 30 at 3).
Dr. Matloubian also opined that the time of onset recorded in the various case reports
cited by Dr. Gershwin does not “encompass one unifying immunologic mechanism for how a
vaccine component can lead to Sweet[’s] syndrome.” Resp. Ex. A at 7. The reported timeframe
for onset of lesions after any vaccination in the articles range from as early as 12 hours post-
vaccination to 15 days. Id.
Additionally, Dr. Matloubian found that petitioner’s article by Philip Cohen contradicted
Dr. Gershwin’s theory of causation. Resp. Ex. A at 7-8 (citing Pet. Ex. 17). Cohen stated there
is “a bona fide association between Sweet’s syndrome probably exists with” cancer, infections,
inflammatory bowel disease, medications, and pregnancy. Pet. Ex. 17 at 9. However, the author
described the association between vaccination and development of Sweet’s syndrome as
“remains to be established.” Id. at 13 tbl.7. With regard to vaccination and other conditions
named in the article, the author wrote, “indeed, the detection of that condition in an individual
with Sweet’s syndrome may merely represent a coincidental occurrence.” Id. at 10. Thus,
opined Dr. Matloubian, “experts who write on the pathogenesis of Sweet[’s] syndrome regard
the reported rare associations between vaccinations and Sweet[’s] syndrome as more likely
coincidental rather than causal.” Resp. Ex. A at 8.
iii. Althen Prong Two: Logical Sequence of Events
Dr. Matloubian opined that Dr. Gershwin’s theory of logical sequence of cause and effect
was speculative based on the fact he did not provide any evidence of petitioner’s genetic
susceptibility. Resp. Ex. A at 6. Dr. Gershwin attributed the rare occurrence of Sweet’s
syndrome in the petitioner to “a rare event in a genetically susceptible host” without providing
any information about the petitioner’s genetic susceptibility. Id.
Dr. Matloubian stated that many of Dr. Gershwin’s case reports detailing Sweet’s
syndrome reactions after BCG and pneumococcal vaccinations were unrelated to petitioner’s
case because petitioner received the flu vaccine. Resp. Ex. A at 6. Further, Dr. Matloubian
noted that some of petitioner’s case reports, Carpentier et al., Gunawardena et al., and Radeff and
14
Harms, indicated that Sweet’s lesions appeared at the site of vaccination, which he asserted did
not occur in petitioner’s case.27 Id. at 6-7.
Additionally, Dr. Matloubian highlighted that the Gunawardena et al. authors noted that
there was a “seasonal bias” in their case series of Sweet’s syndrome with half of them occurring
“during the months of January and February.” Resp. Ex. A at 8 (citing Pet. Ex. 19 at 6).
Coincidentally, Dr. Matloubian opined “the petitioner developed his Sweet[’s] syndrome in
February, which is consistent with the seasonal bias observed by the authors of this paper.” Id.
The concept of seasonality of a disease is highly suggestive of “a possible unrecognized and
potentially difficult to diagnose infectious cause.” Id. Dr. Matloubian reinforced that in 70% of
the cases of Sweet’s syndrome the cause is unknown. Id.
Dr. Matloubian reiterated that there is no clarity on the pathogenesis of Sweet’s
syndrome, and therefore, Dr. Gershwin’s opinion that the petitioner developed the disease after
the flu vaccine because of his “bad genes and bad luck” is speculative. Resp. Ex. A at 8. After a
review of petitioner’s medical records, Dr. Matloubian stated “[t]here is no indication in the
petitioner’s personal medical history or family history that he has a propensity to a dysregulated
immune response to vaccinations or infections.” Id. Without further evidence of petitioner’s
genetic makeup in his medical history, Dr. Matloubian stated that neither he nor Dr. Gershwin
can state what predisposed petitioner to developing Sweet’s syndrome. Id. Petitioner’s personal
and family history showed no autoinflammatory or autoimmune diseases, and his medical
records demonstrated he had no prior adverse responses to infections or vaccines. Id. at 9. Dr.
Matloubian opined, “[t]aken together, these observations do not support a genetic susceptibility
or propensity in the petitioner to have exaggerated cytokine responses to immunizations,
especially with an inactivated, non-adjuvanted [flu] vaccine.” Id.
Although raised as an issue in the case, Dr. Matloubian did not take a position about
petitioner’s allopurinol medication. He did not state whether it was more likely than not that
allopurinol caused or contributed to Sweet’s syndrome.
iv. Althen Prong Three: Proximate Temporal Relationship
Dr. Matloubian noted there are some discrepancies in the medical records regarding the
onset of petitioner’s rash. Resp. Ex. A at 4. Based on petitioner’s affidavit, he developed fever
and body pain within 12 hours after vaccination and then noted a rash four days after his
immunization. Id.; see Pet. Ex. 1 at 1. Petitioner first documented his rash when he saw Dr.
Einhorn on February 9, 2016, however, the date of onset for the rash was not noted. Resp. Ex. A
at 4. Dr. Kerwin and Dr. Portney documented that the rash began three days after vaccination.
Id. However, on his February 15, 2016 visit, Dr. Cetner stated that the rash started “2 days
following his flu vaccine.” Id.; Pet. Ex. 8 at 3. Dr. Matloubian opined petitioner developed
Sweet’s syndrome within approximately four days of his February 3, 2016 flu vaccination.
27
Dr. Matloubian’s statement appears to be erroneous. The medical records show that petitioner
received the flu vaccination in the left arm on February 3, 2016. Pet. Ex. 3 at 2. On February
15, 2016, Dr. Cetner documented skin lesions on the left upper arm. Pet. Ex. 8 at 3. Therefore,
it appears that petitioner did have skin lesions on the left upper arm, the site of vaccination.
15
V. DISCUSSION
A. Standards for Adjudication – Causation
The Vaccine Act was established to compensate vaccine-related injuries and deaths.
10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as
a simple, fair and expeditious means for compensating vaccine-related injured persons. The
Program was established to award ‘vaccine-injured persons quickly, easily, and with certainty
and generosity.’” Rooks v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 1, 7 (1996) (quoting
H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).
Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The
preponderance standard requires a petitioner to demonstrate that it is more likely than not that the
vaccine at issue caused the injury. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315,
1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health
& Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, petitioner must prove that the
vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing
about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum.
Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)); see also Pafford v. Sec’y of Health & Hum.
Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). The received vaccine, however, need not be the
predominant cause of the injury. Shyface, 165 F.3d at 1351. A petitioner who satisfies this
burden is entitled to compensation unless respondent can prove, by a preponderance of the
evidence, that the vaccinee’s injury is “due to factors unrelated to the administration of the
vaccine.” § 13(a)(1)(B).
B. Causation Theory
To receive compensation under the Program, petitioner must prove either: (1) that he
suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a
vaccine that he received, or (2) that he suffered an injury that was actually caused by
vaccination. See §§ 13(a)(1)(A) and 11(c)(1); Capizzano v. Sec’y of Health & Hum. Servs., 440
F.3d 1317, 1319-20 (Fed. Cir. 2006). Petitioner must show that the vaccine was “not only a but-
for cause of the injury but also a substantial factor in bringing about the injury.” Moberly, 592
F.3d at 1321 (quoting Shyface, 165 F.3d at 1352-53).
Because petitioner does not allege that he suffered a Table injury, he must prove that the
vaccine he received caused his injury. To do so, he must establish, by preponderant evidence:
(1) a medical theory causally connecting the vaccine and injury (“Althen Prong One”); (2) a
logical sequence of cause and effect showing that the vaccine was the reason for the injury
(“Althen Prong Two”); and (3) a showing of a proximate temporal relationship between the
vaccine and injury (“Althen Prong Three”). § 13(a)(1); Althen, 418 F.3d at 1278.
The causation theory must relate to the injury alleged. Thus, petitioner must provide a
reputable medical or scientific explanation for his theory, although the explanation need only be
“legally probable, not medically or scientifically certain,” it must be “sound and reliable.”
16
Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019); Knudsen v.
Sec’y of Health & Hum. Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Petitioner cannot
establish entitlement to compensation based solely on assertions. Rather, a vaccine claim must
be supported either by medical records or by the opinion of a medical doctor. § 13(a)(1). In
determining whether petitioner is entitled to compensation, the special master shall consider all
material contained in the record, including “any . . . conclusion, [or] medical judgment . . . which
is contained in the record regarding . . . causation.” § 13(b)(1)(A). The undersigned must weigh
the submitted evidence and the testimony of the parties’ offered experts and rule in petitioner’s
favor when the evidence weighs in his favor. See Moberly, 592 F.3d at 1325-26 (“Finders of
fact are entitled—indeed, expected—to make determinations as to the reliability of the evidence
presented to them and, if appropriate, as to the credibility of the persons presenting that
evidence.”); Althen, 418 F.3d at 1280 (noting that “close calls” are resolved in petitioner’s
favor).
C. Analysis
1. Althen Prong One: Medical Theory of Causation
Under Althen Prong One, petitioner must set forth a medical theory explaining how the
received vaccine could have caused the sustained injury. Andreu, 569 F.3d at 1375; Pafford, 451
F.3d at 1355-56. Petitioner’s theory of causation need not be medically or scientifically certain,
but it must be informed by a “sound and reliable” medical or scientific explanation. Boatmon,
941 F.3d at 1359; see also Knudsen, 35 F.3d at 548; Veryzer v. Sec’y of Health & Hum. Servs.,
98 Fed. Cl. 214, 223 (2011) (noting that special masters are bound by both § 13(b)(1) and
Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and “reliable”). If
petitioner relies upon a medical opinion to support her theory, the basis for the opinion and the
reliability of that basis must be considered in the determination of how much weight to afford the
offered opinion. See Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed.
Cir. 2010) (“The special master’s decision often times is based on the credibility of the experts
and the relative persuasiveness of their competing theories.”); Perreira v. Sec’y of Health &
Hum. Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (stating that an “expert opinion is no better
than the soundness of the reasons supporting it” (citing Fehrs v. United States, 620 F.2d 255, 265
(Ct. Cl. 1980))).
Here, the undersigned finds that petitioner has shown by preponderant evidence a sound
and reliable theory that a flu vaccination can cause Sweet’s syndrome, and therefore, petitioner
has satisfied the first Althen prong. This finding is based on petitioner’s expert’s opinions,
medical literature, case reports, and previous Program cases.
Petitioner’s theory, as proffered by Dr. Gershwin, is that Sweet’s syndrome can manifest
due to abnormal cytokine production following vaccination. More specifically, he stated Sweet’s
syndrome develops as a result of cytokine production and inflammasome activation in a
genetically susceptible host. Dr. Matloubian agreed with the proposed auto-immune mechanism,
but he opined that the specific pathogenesis of Sweet’s syndrome is not known. Dr. Matloubian
referenced the literature stating that Sweet’s syndrome involves the recruitment of neutrophils to
the skin and responds to immunomodulating agents. Therefore, both experts identify the same
17
mechanism reflecting the current state of knowledge regarding the pathogenesis of Sweet’s
syndrome.
This mechanism is supported by medical literature authored by Heath and Ortega-Loayza
and by Joseph Merola. Heath and Ortega-Loayza state “[t]he exact pathogenesis of Sweet’s
syndrome is unclear; however[,] . . . findings include an improved understanding of
inflammasome activation . . . and genetic contributions.” Pet. Ex. 39 at 1. The authors add that
“[m]utations in isocitrate dehydrogenase I (IDHI) have been identified as a possible connection
to [Sweet’s syndrome] pathogenesis.” Id. at 6. “IDHI catalyzes reactions leading to alterations
in histones and DNA, causing differential gene expression,” which suggests the mechanism
underlying Sweet’s syndrome is the “dysfunctional activation of the inflammasome and IL- 1β
pathway.” Id. Dr. Gershwin stated vaccination is a stimulator of the immune response, and thus
catalyzes inflammasome activation.
Further, Dr. Gershwin established that Sweet’s syndrome has been previously associated
with vaccination. While case reports cannot establish causation, they do provide some evidence
of causation. Dr. Gershwin cited a number of case reports in the medical literature documenting
Sweet’s syndrome following vaccination. In regard to Sweet’s syndrome following flu
vaccination, Dr. Gershwin cited the article by Jovanoic et al., documenting a 45-year-old woman
who developed Sweet’s syndrome 12 hours after flu vaccination, and Tan et al., who reported a
46-year-old man with HIV who suffered from Sweet’s syndrome two days after flu vaccination.
Although this condition is rare, the Program has previously awarded compensation to a
petitioner in a Sweet’s syndrome case associated with flu vaccination. See Cagle v. Sec’y of
Health & Hum. Servs., No. 16-693V, 2018 WL 5929378, at *1 (Fed. Cl. Spec. Mstr. Oct. 17,
2018). While Program case law is not binding, the undersigned takes note of past decisions in
favor of petitioners.
While Dr. Matloubian asserted that Dr. Gershwin’s theory of susceptibility to Sweet’s
syndrome due to genetic predisposition was speculative, this theory is supported by the medical
literature. Castrucci found that preexisting immunity affects flu vaccine responsiveness in hosts
bodies, stating “[p]olymorphisms of any of the involved genes in the molecular interactions
within the immune-system reflect the high variability between individuals to respond efficiently
to vaccines.” Pet. Ex. 40 at 3. Additionally, Forero et al. emphasized “[t]he host innate immune
response to [flu] virus is a key determinant of pathogenic outcomes and long-term protective
immune response against subsequent exposures.” Pet. Ex. 41 at 1. The fact that the specific
nature of petitioner’s genetic susceptibility is not known does not defeat his claim as the state of
scientific knowledge has not yet reached this degree of expertise. Under these circumstances,
where medical knowledge as to genetic susceptibility is unknown because it is not yet tested for,
it would be a harsh result to penalize petitioner for failure to prove a specific genetic
predisposition. In short, scientific certainty is not required. Boatmon, 941 F.3d at 1359; see also
Knudsen, 35 F.3d at 548. The preponderance standard requires a petitioner to demonstrate that it
is more likely than not that the vaccine at issue caused the injury. Moberly, 592 F.3d at 1322
n.2. Proof of medical certainty is not required. Bunting, 931 F.2d at 873.
18
For all of these reasons, undersigned finds that petitioner has provided preponderant
evidence of a sound and reliable causal theory, satisfying Althen Prong One.
2. Althen Prong Two: Logical Sequence of Cause and Effect
Under Althen Prong Two, petitioner must prove by a preponderance of the evidence that
there is a “logical sequence of cause and effect showing that the vaccination was the reason for
the injury.” Capizzano, 440 F.3d at 1324 (quoting Althen, 418 F.3d at 1278). “Petitioner must
show that the vaccine was the ‘but for’ cause of the harm . . . or in other words, that the vaccine
was the ‘reason for the injury.’” Pafford, 451 F.3d at 1356 (internal citations omitted).
In evaluating whether this prong is satisfied, the opinions and views of the vaccinee’s
treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d
at 1326 (“[M]edical records and medical opinion testimony are favored in vaccine cases, as
treating physicians are likely to be in the best position to determine whether a ‘logical sequence
of cause and effect show[s] that the vaccination was the reason for the injury.’” (quoting Althen,
418 F.3d at 1280)). Medical records are generally viewed as trustworthy evidence, since they are
created contemporaneously with the treatment of the vaccinee. Cucuras, 993 F.2d at 1528. The
petitioner need not make a specific type of evidentiary showing, i.e., “epidemiologic studies,
rechallenge, the presence of pathological markers or genetic predisposition, or general
acceptance in the scientific or medical communities to establish a logical sequence of cause and
effect.” Capizzano, 440 F.3d at 1325. Instead, petitioner may satisfy his burden by presenting
circumstantial evidence and reliable medical opinions. Id. at 1325-26.
In regard to Althen Prong Two, the undersigned finds petitioner provided preponderant
evidence that the February 3, 2016 flu vaccination caused his Sweet’s syndrome. This finding is
based primarily on the records and opinions of petitioner’s treating physicians, Dr. Gershwin’s
expert opinion, and the supportive case reports.
Petitioner’s medical records establish that prior to his flu vaccination, he did not have any
dermatological problems. One week after his flu shot, petitioner presented to Dr. Kerwin on
February 10, 2016, who diagnosed petitioner with a drug eruption. On February 15, 2016,
petitioner presented to Dr. Cetner. Dr. Cetner noted “[p]olycyclic erythematous edematous
urticarial plaques and with erythema nodosum-like lesions distributed on the left proximal
posterior upper arm, right buttock, and right antecubital skin.” Pet. Ex. 8 at 3. Dr. Cetner
performed a punch biopsy and the primary diagnosis was hypersensitivity reaction. Dr.
Shepherd recorded an auto-immune reaction to flu vaccine on February 16, 2016. On March 1,
2016, petitioner was evaluated by Dr. Einhorn who noted, “serum sickness reaction following flu
shot. . . . May need to consult with rheum[atology] or immunology if symptoms persist and re
other forms of flu vaccine in future.” Pet. Ex. 5 at 16. Petitioner presented to rheumatologist Dr.
Portnoy on March 8, 2016. Dr. Portnoy’s impression was “rash with biopsy revealing possible
hypersensitivity response,” which “occurred after a[] [flu] vaccine and I cannot exclude an
association with this. Although I cannot exclude serum sickness, some his symptoms occurred
fairly soon after the vaccine. I cannot exclude that his rash could be associated with other
medication he is currently taking.” Pet. Ex. 10 at 3. On October 14, 2016, Dr. Portney noted,
“flu . . . ? Sweet’s syndrome.” Id. at 7.
19
In summary, these treating physicians questioned whether there was an association
between petitioner’s flu vaccination and his Sweet’s syndrome.
Petitioner’s clinical course is similar to case reports filed by petitioner’s expert. Jovanoic
et al. and Tan et al. documented reports of Sweet’s syndrome following flu vaccination.
Jovanoic et al. describe a 45-year-old woman who developed classical Sweet’s syndrome 12
hours after flu vaccination. Pet. Ex. 22 at 1-2. The patient developed erythematous papules on
her legs 12 hours after vaccination, and two days later, the lesions became tender. She then
developed erythematous plaques on the injection site on the left arm, back, face, arms, and legs,
and a flu-like syndrome with fever. Id. at 2. Tan et al. report a 46-year-old man diagnosed with
HIV two years prior and previously in good health who suffered from an eruption two days after
a flu vaccination. Pet. Ex. 30 at 1. The patient presented to his physician with a fever and
multiple indurated red plaques with bullae and necrosis at the site of vaccination. Id. The
authors found “[t]he patient had no apparent triggers for [Sweet’s syndrome] other than the [flu]
vaccination.” Id. at 2.
Like the patients in these two case reports, petitioner had no dermatological conditions
prior to flu vaccine administration. Following vaccination in his left arm, petitioner developed a
fever and felt as if he had a severe flu the evening after vaccination. Four days later he noticed a
rash spreading on his back and neck. By February 15, 2016, Dr. Cetner, a dermatologist, noted
lesions distributed on petitioner’s left upper arm—the site of vaccination. Therefore, based on a
review of the medical records, it appears that petitioner did have lesions at the site of vaccination
consistent with case reports.
Further, there is no evidence to suggest that petitioner’s Sweet’s syndrome was caused by
an alternative cause or factor unrelated to vaccination. In his work-up, Dr. Cetner ruled out
varicella zoster-virus, other associated viruses, and associated fungal organisms. Pet. Ex. 8 at 4,
9, 11, 21. Petitioner also did not have any identified autoimmune disorders. In regard to
allopurinol, Dr. Gershwin stated petitioner was taking allopurinol two years prior to vaccination
and continued it without interruption until June of 2016. Dr. Gershwin opined it is unlikely that
allopurinol caused petitioner’s Sweet’s syndrome because case reports demonstrate that
symptoms most commonly occur shortly after beginning a new medication. Of note, Dr.
Matloubian did not attribute petitioner’s rash and symptoms to another cause.
With regard to the second Althen prong, the undersigned finds there is preponderant
evidence to support a logical sequence of cause and effect showing the February 3, 2016 flu
vaccination to be the cause of petitioner’s Sweet’s syndrome. See Althen, 418 F.3d at 1278.
3. Althen Prong Three: Proximate Temporal Relationship
Althen Prong Three requires petitioner to establish a “proximate temporal relationship”
between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been
equated to mean a “medically acceptable temporal relationship.” Id. The petitioner must offer
“preponderant proof that the onset of symptoms occurred within a timeframe which, given the
medical understanding of the disease’s etiology, it is medically acceptable to infer causation-in-
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fact.” 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 time frame must also coincide with the theory of
how the relevant vaccine can cause the injury alleged (under Althen Prong One). Id.; Koehn v.
Sec’y of Health & Hum. Servs., 773 F.3d 1239, 1243 (Fed. Cir. 2014); Shapiro v. Sec’y of
Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl.
353 (2012), aff’d mem., 503 F. App’x 952 (Fed. Cir. 2013).
Based on medical records, affidavits, both expert reports, and a review of the record as a
whole, the undersigned finds the onset of petitioner’s Sweet’s syndrome occurred approximately
three to four days after vaccination. Petitioner received the flu vaccination February 3, 2016 and
presented to Dr. Einhorn on February 9, 2016 for evaluation of a rash. On February 10, Dr.
Kerwin noted a red, painful, itchy, and severe rash present for four days. The timing of onset
shows a proximate temporal relationship between vaccination and injury, and is consistent with
the case reports of Sweet’s syndrome injuries described after vaccination. The temporal
association is appropriate given the mechanism of injury. Thus, petitioner has satisfied the third
Althen prong.
VI. CONCLUSION
Based on the record as a whole, medical records, affidavits, and the petitioner’s expert
opinions, the undersigned finds there is preponderant evidence to satisfy all three Althen prongs
and to establish petitioner’s February 3, 2016 flu vaccination caused his Sweet’s syndrome.
Thus, the undersigned finds petitioner has established by preponderant evidence that he is
entitled to compensation. A separate damages order will issue.
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Special Master
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