Rocha v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

**********************

OMARY ROCHA, *

Executor for the Estate of * No. 16-241V

NESTOR ROCHA, * Special Master Christian J. Moran

*

Petitioner, *

*

v. *

* Filed: February 1, 2024

SECRETARY OF HEALTH *

AND HUMAN SERVICES, *

*

Respondent. *

**********************

Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner;

Kimberly Shubert Davey, United States Dep’t of Justice, Washington, DC, for

respondent.

DECISION DENYING ENTITLEMENT TO COMPENSATION 1

Omary Rocha is the executor of the estate of her husband, Nestor Rocha.

She alleges that an influenza (“flu”) vaccine caused Mr. Rocha to suffer from

vasculitis, leading to his death. The Secretary disputes this claim. In support of

her claim, petitioner submitted expert reports and medical literature from

pathologist Dr. Steven Rostad and neurologist Dr. Lawrence Steinman. The

Secretary countered with reports and literature from pathologist Dr. Barbara

1

Because this Decision contains a reasoned explanation for the action taken in this case,

it must be made publicly accessible and will be posted on the United States Court of Federal

Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in

accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal

Management and Promotion of Electronic Government Services). This means the Decision will

be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the

parties have 14 days to identify and move to redact medical or other information, the disclosure

of which would constitute an unwarranted invasion of privacy. Any changes will appear in the

document posted on the website.

Ducatman and rheumatologist Dr. Mehrdad Matloubian. The parties also

developed their arguments through briefs, and a hearing was held December 1

through December 3, 2021.

As explained below, Ms. Rocha is not entitled to compensation. Ms. Rocha

has not established by a preponderance of the evidence that the flu vaccine caused

or worsened vasculitis in Mr. Rocha or contributed to his death.

The experts retained by Ms. Rocha disagreed with the Secretary’s experts,

and with one another, over Mr. Rocha’s diagnosis. The opinion begins with an

overview of proposed diagnoses. Section II provides Mr. Rocha’s background and

medical history, and Section III provides the procedural history of the case.

Section IV goes over the qualifications of the parties’ experts, and Section V

follows with analysis of their dispute over Mr. Rocha’s diagnosis. The opinion

concludes with a brief consideration of significant aggravation in Section VI and

an analysis of causation-in-fact in Section VII.

I. Conditions

Although Mr. Rocha suffered from multiple illnesses, an extensive

discussion can be limited to three topics. They are vasculitis, cryoglobulinemia,

and cryoglobulinemic vasculitis.

A. Vasculitis

Vasculitis means there is “inflammation of a blood or lymph vessel.”

Dorland’s Med. Dict. at 2026 (33rd ed.). Vasculitis can be classified into different

types, often depending upon the size of the affected blood vessel. Tr. 111, 148,

219, 422. 2 Vasculitis can be diagnosed by clinical and/or lab findings, although

“classification criteria and diagnostic criteria do not necessarily require

2

Although Dr. Rostad asserted that Mr. Rocha may have suffered from “postvaccine

autoimmune vasculitis,” Exhibit 55 at 12, he conceded on cross-examination that he could not

point to any literature using this terminology. Tr. 263; see also Tr. 456-57 (Dr. Ducatman’s

testimony that she had never heard the terms “post vaccine autoimmune vasculitis or PAV” prior

to this case).

2

microscopic confirmation of a pathologic process that is a defining feature of a

disease.” Jennette at 2. 3

The process of reaching a diagnosis of vasculitis can take a long time. Tr.

147. Some tests, such as a test for sedimentation rate or “sed rate”, can detect

inflammation but inflammation does not necessarily indicate vasculitis. See Tr.

46-47, 128, 463, 555. Other tests, such as a magnetic resonance angiography or

angiogram, screen more specifically for vasculitis. Tr. 116, 198.

Vasculitis can occur in the blood vessels found in different organs. Tr. 148,

596. Among the different organs, the gastrointestinal track tends to be a rare

location for vasculitis. Tr. 210, 512, 618. A clinician might order a biopsy of an

affected organ to look for evidence of vasculitis. Tr. 420. A biopsy, however, can

come back negative if the sample is obtained from an area without lesions. Tr.

113, 147. Doctors, including pathologists, attempt to determine the type of

vasculitis, although further subtyping is not always possible. Tr. 151, 219, 422-23,

597-98.

An accurate diagnosis of vasculitis can affect a person’s treatment. Tr. 221.

For example, because the manifestations of vasculitis can resemble the signs and

symptoms of a viral infection, doctors want to rule out infectious causes. Tr. 104,

147. When doctors suspect vasculitis, the doctors will prescribe medications to

suppress the immune system. Tr. 104, 118 (discussing use of rituximab), 152, 221.

The doctors want to suppress the immune system because the immune system is

believed to be acting aberrantly. Tr. 154.

Although the immune system is involved in the pathogenesis of vasculitis,

details about how most vasculitides originate are not known. Tr. 151. Some

proposed mechanisms involve (1) a T cell driven process, (2) immune complexes,

and (3) autoantibodies. Tr. 153-54 (Dr. Rostad’s discussion of Guillevin &

Dörner 4); see Tr. 426 (Dr. Ducatman’s discussion of an autobody mediated

vasculitis), 460 (Dr. Ducatman’s testimony that some vasculitides are autoimmune

in origin). This three-part list is consistent with the testimony that some, but not

all, vasculitides involve immune complexes. See Tr. 200, 225. Some types of

3

J.C. Jennette et al., Special Article - 2012 Revised International Chapel Hill Consensus

Conference Nomenclature of Vasculitides, 65 ARTHRITIS & RHEUMATISM 1 (2012); filed as

Exhibit 57 and Exhibit II.

4

Loic Guillevin & Thomas Dörner, Vasculitis: mechanisms involved and clinical

manifestations, 9 ARTHRITIS RES. & THER. Suppl. 2 (2007); filed as Exhibit 80.

3

vasculitides are associated with infections such as a hepatitis C and a hepatitis B

infection. Tr. 166, 285-86. Another virus associated with vasculitis is the varicella

virus. Tr. 328, 504 (Dr. Matloubian’s testimony that varicella zoster vasculitis is a

“rare” entity).

B. Cryoglobulinemia

Cryoglobulins are “immunoglobulins, not present in normal serum, that

undergo reversible precipitation as serum cools.” Dorland’s at 433 (33rd ed.

2020); accord Exhibit A (Dr. Matloubian Report) at 11, Tr. 130 (Dr. Rostad), Tr.

410 (Dr. Ducatman). “Cryoglobulinemia,” in turn means “the presence of

cryoglobulin in the blood, associated with a variety of clinical manifestations,

including Raynaud phenomenon, vascular purpura, . . . vasculitis, . . . neurologic

manifestations, . . . and glomerulonephritis.” Dorland’s at 433; accord Tr. 279-80.

The experts distinguished between having cryoglobulinemia and having

symptoms of cryoglobulinemia. (Another condition called cryoglobulinemic

vasculitis is discussed below). Strictly speaking, the term “cryoglobulinemia”

refers to the presence of cryoglobulins in the serum. Tr. 279-82 (Dr. Rostad), 469

(Dr. Ducatman), 545-56 (Dr. Matloubian). A person could have cryoglobulins in

his blood for a long time and not necessarily experience any health problems. Tr.

196, 280 (Dr. Rostad: cryoglobulins are “a lab artifact”), 546 (Dr. Matloubian).

Cryoglobulins might become manifest if a person goes out in the cold and the cold

causes the cryoglobulins to precipitate, turning his hands blue. Tr. 469; see also

Tr. 176-78. However, cold insensitivity occurs in conditions other than

cryoglobulinemia. Tr. 589.

When a person with cryoglobulinemia develops symptoms, a different term

could be used. Dr. Ducatman prefers the term “cryoglobulinemic syndrome” to the

term “vasculitis.” Tr. 469. Dr. Rostad recognized that other people might say

“cryoglobulinemia” when a more precise term would be “cryoglobulinemic

syndrome.” Tr. 282. Another manifestation of cryoglobulinemic syndrome can be

having a rash (purpura). Tr. 413.

C. Cryoglobulinemic Vasculitis

A person with both vasculitis and cryoglobulinemia suffers from

cryoglobulinemic vasculitis. “Between 2% and 15% of cryoglobulin positive

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patients are considered to develop cryoglobulinemic vasculitis.” Braun at 89. 5

“Cryoglobulinemic vasculitis” means a person has “vasculitis in small vessels with

cryoglobulin immune deposits.” Dorland’s at 1996. Again, from the point of view

of a self-described “picky and pedantic pathologist,” vasculitis means

“inflammation in the wall of a blood vessel.” Tr. 469 (Dr. Ducatman).

Dr. Matloubian opined that certain types of cryoglobulin can be associated

with chronic infections, such as hepatitis B. Exhibit A (Matloubian Report) at 10.

Dr. Ducatman’s expert report also noted that cryoglobulinemia can be associated

with hepatitis B. Exhibit CC (Ducatman Report) at 8.

Petitioner’s experts disagreed. Dr. Rostad challenged Dr. Ducatman’s

argument that cryoglobulinemia is associated with hepatitis B, suggesting instead

that such science has not been confirmed and that it is primarily associated with

hepatitis C. Exhibit 84 at 4; Tr. 166, 186; see also Cacoub (giving support for

cryoglobulinemia for hepatitis C, not hepatitis B). 6

Preponderant evidence supports a finding that a hepatitis B infection can

cause cryoglobulinemic vasculitis. Exhibit A (Dr. Matloubian Report) at 10,

Exhibit CC (Dr. Ducatman Report) at 8, Tr. 283-86 (Dr. Steinman), Exhibit 46 at 7

(Dr. Steinman Report), Tr. 502 (Dr. Matloubian).

A person with cryoglobulinemic vasculitis may have a variety of signs and

symptoms. Renal problems are frequent. Braun at 91; Tr. 444, 547. Other

problems include “palpable purpura that usually occurs in the lower extremities.”

Braun at 89. The course of cryoglobulinemic vasculitis may wax and wane. Tr.

612.

II. Events in Mr. Rocha’s Life

Mr. Rocha’s life is divided into eight different periods, starting with the time

before he received the allegedly causal vaccination. Other periods generally

conform to treatment at different facilities.

5

Gerald S. Braun et al., Cryoglobulinemic vasculitis: classification and clinical and

therapeutic aspects, 83 POSTGRAD MED. J. 87 (2007); filed as Exhibit 82.

6

Patrice Cacoub et al., Cryoglobulinemia Vasculitis, 128 AM. J. OF MED. 950 (2015);

filed as Exhibit O.

5

A. Before Vaccination

Mr. Rocha’s pre-vaccination medical history is complex. The medical

records, affidavits, and testimony about his health are summarized within section

II.A.1 below. To understand the significance of Mr. Rocha’s health, the opinions

from the parties’ four experts are discussed in section II.A.2, below. Then, various

assessments are made.

1. Summary of Evidence

Nestor H. Rocha was born in Uruguay on July 13, 1943. Exhibit 2 at 1. He

moved to the United States in 1969, and roughly six months after meeting his

future wife in the summer of 1971, they married. Tr. 10. Mr. Rocha and his wife

had two children, a son and daughter. Tr. 18.

According to a history given in 2014, following a 2001 trip to South

America, Mr. Rocha developed red lesions on his leg, though it was uncertain from

where these lesions came. Exhibit 10 at 227. Although the lesions subsequently

healed, hypopigmentation remained on both of his legs. Id.

In May 2006, Mr. Rocha underwent a uropathy testing, which showed

“[d]ysmorphic erythrocytes indicating mild glomerular and/or renal tubular

bleeding.” Exhibit 6 at 25. He also underwent a CT scan of the abdomen and

pelvis. Id. at 22. The results showed Mr. Rocha’s

kidneys function symmetrically and are normal in size, configuration and

axis. There is slight fullness of the left renal collecting system. There are no

obvious renal masses or calculi. There is no evidence of radiopaque ureteral

or bladder calculi. The urinary bladder and prostate gland are normal. There

is no free fluid in the abdomen or pelvis.

Exhibit 6 at 22.

On November 1, 2010, Mr. Rocha sought care from Dr. Ramon Ledon

based on a referral for a colorectal cancer screen. Exhibit 7 at 7. Dr. Ledon also

addressed Mr. Rocha’s “gastroesophageal reflux disease and Hepatitis B.” Id. At

the appointment, Mr. Rocha presented as normal, with no jaundice, ulcers, lesions,

or rashes, and his gait was normal. Dr. Ledon’s assessment of Mr. Rocha found

that he had “Chronic Persistan[t] Hep B not C[hr]onic Active.” Id. at 9. Dr. Ledon

ordered blood tests and stated he would observe Mr. Rocha given that the “anti

virals offered side effects.” Id. His blood results from these tests showed low red

blood cell, hemoglobin, hematocrit, and platelet counts (4.2, 13.0, 39.6, and 126,

6

respectively) and high creatinine and nitrogen levels (3.0, 62, respectfully). Id.at

27-28.

On November 17, 2010, Mr. Rocha underwent a colonoscopy, which

revealed severe chronic gastritis, mildly active and focal mild activity in his

stomach. Exhibit 7 at 16.

Mr. Rocha returned to Dr. Ledon for care on November 23, 2010, where he

was treated for duodenitis, gastritis, and an H. pylori infection. Exhibit 7 at 18.

Mr. Rocha was prescribed Carafate. Id. at 19. Roughly one week later, Mr. Rocha

underwent another blood test, which showed low red blood cell, hematocrit, and

platelet counts (3.96, 37.8, and 117 respectively), and high levels of creatinine and

nitrogen (1.85 and 46, respectively). Exhibit 15 at 5-6.

In February 2011, Mr. Rocha sought care from Dr. Ledon for a follow-up

regarding his gastritis and H. pylori infection. Dr. Ledon ordered Mr. Rocha to

stop taking the Carafate and planned to wean him off proton pump inhibitors.

Exhibit 7 at 22.

In February 2012, Mr. Rocha sought care from Dr. Alan P. Krieger for his

lower urinary tract problems. Exhibit 6 at 9. Outside of exhibiting symptoms

regarding nocturia, Mr. Rocha presented as normal. Id. Dr. Krieger ordered a

blood test. Id. at 10.

On July 19, 2012, Mr. Rocha underwent a blood test at the direction of Dr.

Fernandez. The results showed high BUN and creatinine levels (47 and 1.66) and

low platelet levels (122). Exhibit 4 at 28. He also showed abnormalities regarding

his occult blood and red blood cell counts. Id. at 29.

Mr. Rocha saw nephrologist James Agresti on August 20, 2012. Mr. Rocha

reported a significant past history of hypertension and rheumatoid arthritis, and

that he was at one time on methotrexate. Exhibit 4 at 18. He gave no other history

of renal disease. Dr. Agresti wrote, “I suspect that [Mr. Rocha] has chronic kidney

disease probably secondary to age related changes along with hypertension.” Id.

A neurologist, Victor Hugo Pareja, evaluated Mr. Rocha on September 5,

2012. Mr. Rocha stated that he was “experiencing numbness, tingling and cramps

in [both] lower extremities.” Exhibit 20 at 2. Dr. Pareja also stated that Mr. Rocha

has “a history of a right foot drop 7 years ago with some residual weakness.” Id.

Dr. Pareja performed a nerve conduction study and electromyogram. These tests

revealed “evidence of a moderate sensorimotor predominantly demyelinating

polyneuropathy affecting the lower extremities.” Id. at 3.

7

In February 2013, Mr. Rocha conducted a yearly follow-up with Dr. Krieger.

During the visit, Mr. Rocha presented as normal. Exhibit 6 at 2. His medical

history included hypertension, enlarged prostate, previous tuberculosis, and

varicose veins. At the time, the only medication he listed as taking was Flomax.

However, Mr. Rocha’s wife’s affidavit states he was also on “a small dose of

antihypertensive medication for slightly elevated blood.” Exhibit 54 at 1; see also

Exhibit 6 at 9 (noting Mr. Rocha was taking Avapro on February 7, 2012).

Mr. Rocha was described as “extremely energetic, lively, active, and

charismatic” prior to October 18, 2013. Exhibit 54 (affidavit from Omary Rocha,

filed June 19, 2018) at 1. Mr. Rocha performed various “labor intensive” jobs for

employment, such as working in restaurants, construction, mechanics, as well as

working as an independent trucker. Tr. 10; see also Exhibit 9 at 11 (noting Mr.

Rocha was “previously employed as a driver”). Mr. Rocha began working very

early, starting his days at 4:00 AM. Tr. 10. Family described Mr. Rocha as being

“one of the hardest workers and healthiest men” they had met. Exhibit 53 at 1

(affidavit from Carmen Bucco, filed June 19, 2018). Despite retiring in 2008, Mr.

Rocha continued working construction jobs with his cousin roughly two-to-three

times a week, building decks, bathrooms, kitchens, and even breaking cement to

build patios. Tr. 13. He also performed typical handyman tasks for neighbors and

friends. Id. at 14. For example, in 2012, Mr. Rocha’s daughter, Sandra Rocha,

purchased a property, where Mr. Rocha helped reconstruct the basement. Tr. 14;

see also Exhibit 53 at 1. This included “breaking down brick walls and ripping up

concrete.” Exhibit 53 at 1.

Mr. Rocha and his wife were also “avid ballroom dancers.” Tr. 15. Mr.

Rocha’s daughter testified that in the summer of 2013—the summer right before

Mr. Rocha received his influenza vaccine—Mr. Rocha and his wife “put on [a]

show for their friends and . . . just danced the night away.” Id.

2. Expert Commentary

Dr. Rostad noted that Mr. Rocha’s erythrocyte sedimentation rate in 2012

was very low. Tr. 46-47. Dr. Rostad explained that sedimentation is a surrogate

marker for inflammation or an inflammatory marker. Id. at 48. He stated, “a

patient who might have vasculitis might have much higher values because of the

increased number of inflammatory markers or proteins that accelerate that

sedimentation rate.” Id. at 47. He also noted that the antinuclear antibody was

recorded as negative, which would be another negative measure of autoimmunity.

Id. at 48.

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Overall, Dr. Rostad found “very little wrong with Mr. Rocha’s health” prior

to vaccination. Tr. 49. He stated that it was exactly what he would expect from a

“vibrant, very active, physically active individual” such as Mr. Rocha’s daughter

had described. Id. at 50. Dr. Rostad noted how much Mr. Rocha moved in his

daily activities and opined that “if [Mr. Rocha] had a peripheral neuropathy, it

certainly wasn’t present in the activities that were described . . . at this point, his

neuropathy was not a significant problem for him.” Id. Dr. Rostad agreed that Mr.

Rocha had gastritis prior to vaccination and tested positive for the H. Pylori

infection. Tr. 209.

Dr. Steinman stated that Mr. Rocha “had kidney abnormalities beforehand”

and had “hepatitis B positive serology.” Tr. 340. Dr. Steinman opined that Mr.

Rocha had cryoglobulinemic vasculitis prior to his vaccination. Id. at 341.

Dr. Ducatman testified that Mr. Rocha had longstanding, chronic, and stable

cryoglobulinemia prior to his October 18, 2013 vaccination. Tr. 410. Dr.

Ducatman explained that Mr. Rocha had evidence of cryoglobulin (a protein

circulating in the blood that precipitates out below body temperature) prior to the

vaccination. Id. Dr. Ducatman noted that Mr. Rocha had a positive rheumatoid

factor twice during his illness in 2013-2014, and stated that the rheumatoid factor

is generally stable over time. Id. at 411. Further, Mr. Rocha was treated with

methotrexate, which is “a fairly toxic drug” that would not be given to a patient

who “just had some arthralgia on the off chance.” Id. With this, Dr. Ducatman

opined that it was “a very reasonable assumption, much more likely than not, that

[Mr. Rocha] had a preexisting rheumatoid factor,” i.e., cryoglobulin. Id. at 411-12.

Additionally, clinical symptoms of cryoglobulinemia – rash, neuropathy,

cold fingers, white and blue discoloration, and Raynaud’s phenomenon – were

present prior to his flu vaccination. See Exhibit 3 at 54-57; Tr. 413-14. Dr.

Ducatman noted Mr. Rocha’s chronic renal failure and explained that

cryoglobulinemia is associated with renal disease. Tr. 414. She opined that Mr.

Rocha’s history of chronic hepatitis B, which pre-existed the vaccination, could

“certainly . . . lead to the development of cryoglobulinemia.” Id. at 414-15; see

also Exhibit CC at 8.

Dr. Matloubian also stated that Mr. Rocha’s positive rheumatoid factor and

kidney findings were consistent with cryoglobulinemia, and further explained that

the association between hepatitis B and cryoglobulinemia is well-established. Tr.

501-02; see also Exhibit A at 10. He opined that, to a reasonable degree of

medical probability, Mr. Rocha had cryoglobulinemic vasculitis prior to his

vaccination. Tr. 504.

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3. Assessment

Dr. Rostad, Dr. Steinman, Dr. Ducatman, and Dr. Matloubian agreed that

before the vaccination, Mr. Rocha suffered from a hepatitis B infection. Tr. 284

(Dr. Rostad), 329 (Dr. Steinman), 415 (Dr. Ducatman), 502 (Dr. Matloubian); see

also Exhibit 12 at 392 (lab results from December 11, 2013, showing Mr. Rocha

was reactive to hepatitis B antigens and antibodies). They also agreed that before

the vaccination, Mr. Rocha had problems with his kidneys, manifesting as

abnormalities in his urine. Tr. 171-72 (Dr. Rostad), 335-36 (Dr. Steinman), 497-98

(Dr. Ducatman), 510 (Dr. Matloubian).

Dr. Rostad parts company from Dr. Steinman as well as from Dr. Ducatman

and Dr. Matloubian as to whether Mr. Rocha suffered from cryoglobulinemia

and/or cryoglobulinemic vasculitis. Tr. 176. However, ample evidence supports a

finding that, on a more likely than not basis, Mr. Rocha suffered from

cryoglobulinemic vasculitis. A key piece of evidence on this point is that Ms.

Rocha’s other expert, Dr. Steinman, stated that Mr. Rocha had cryoglobulinemic

vasculitis. Dr. Steinman’s oral testimony could hardly be clearer:

Q. Is it your opinion that Mr. Rocha had cryoglobulinemic vasculitis

prior to his influenza vaccination on October 18 of 2013?

A. Yes.

Tr. 340-41. Dr. Steinman further indicated that Mr. Rocha had lived with the

cryoglobulinemic vasculitis for “decades,” although this disease, in Dr. Steinman’s

view, did not cause Mr. Rocha much hardship. Tr. 345.

The opinions from Dr. Ducatman and Dr. Matloubian corroborate Dr.

Steinman’s opinion that Mr. Rocha suffered from cryoglobulinemic vasculitis. Tr.

447-48 (Dr. Ducatman), 491, 504 (Dr. Matloubian). Under the circumstances in

which three of four retained experts agree with a diagnosis, it is easy to find the

evidence preponderates in favor of finding that the diagnosis is correct.

A finding that Mr. Rocha had cryoglobulinemic vasculitis before the

vaccination carries some limited consequences for the remainder of the case. First,

this finding enhances the credibility of Dr. Matloubian, who first proposed the

diagnosis of cryoglobulinemic vasculitis. See Exhibit A at 11. Second and

correspondingly, this finding reduces the credibility of Dr. Rostad, whose opinion

was not joined by Dr. Steinman, an expert also retained by Ms. Rocha.

10

On the other hand, a finding that Mr. Rocha had cryoglobulinemic vasculitis

before the vaccination does not prevent Ms. Rocha from prevailing upon a claim

that the flu vaccination caused Mr. Rocha’s death. Dr. Steinman proposed that the

flu vaccine, via reactivation of a latent varicella zoster virus, caused Mr. Rocha to

develop a second vasculitis, a varicella zoster virus vasculitis:

Q. And then is it your opinion that [Mr. Rocha] developed a subsequent

vasculitis, a varicella zoster virus vasculitis after the vaccination?

A. Yes.

Q. So he had two types.

A. Something very bad happened after that vaccination. Yes.

Tr. 341. Furthermore, Dr. Matloubian and Dr. Ducatman have not opined that the

cryoglobulinemic vasculitis caused Mr. Rocha’s death. Tr. 455-56 (Dr.

Ducatman), 507 (Dr. Matloubian).

B. Date of Vaccination: October 18, 2013

Mr. Rocha visited his doctor, Jacqueline Fernandez, for a well adult patient

visit on October 18, 2013. Exhibit 3 at 2. At the visit, Dr. Fernandez recorded that

Mr. Rocha had generally normal vitals and presentation. Id.; see also id. at 1

(noting no skin lesions or discoloration). However, Mr. Rocha’s medical records

noted that Mr. Rocha had “benign prostatic hyperplasia, chronic kidney disease,

chronic progressive renal failure, impotence, unspecific idiopathic peripheral

neuropathy, peripheral nerve disease, platelet count below reference range, and

other nonspecific findings on examination of blood.” Id.; see also id. at 10. During

his visit with Dr. Fernandez, Mr. Rocha also received a fluvirin (“flu”) vaccine.

Exhibit 19 at 3. Dr. Fernandez ordered several labs and a chest x-ray as a

follow-up plan for Mr. Rocha. Exhibit 3 at 10-13.

Dr. Rostad described Mr. Rocha’s issues as “ongoing” as of the date of his

vaccination. Tr. 38-39. He noted a normal specific gravity measurement in the

urinalysis, indicating that Mr. Rocha was not dehydrated. Tr. 40-41. Dr. Rostad

opined that “a variety of conditions” could produce the small amount of blood in

Mr. Rocha’s urine, including benign prostatic hyperplasia. Tr. 42.

Dr. Steinman opined that Mr. Rocha had a preexisting vasculitis, but that “it

didn’t seem to have many severe consequences at all” and “didn’t seem to bother

him in any major way” until the flu shot on October 18, 2013. Tr. 331, 346.

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C. Ear Treatments (November 12, 2013 – December 3, 2013)

Approximately four weeks after Mr. Rocha received the flu vaccine, Mr.

Rocha sought care from an ear, nose, and throat doctor at the office of Dr. Diego

Saporta on November 12, 2013. He was treated by Robert D. Huang. Exhibit 5 at

4. The November 12, 2013 visit was the first of a series of visits in November

2013 for ear pain. Tr. 250-51.7 Mr. Rocha complained of having a “sensation of

clogged ear” and “ear ache[s] in the right ear . . . [that] started 4 days ago.”

Exhibit 5 at 4. Dr. Huang diagnosed Mr. Rocha with “Chronic Serous Otitis

Media” and prescribed him “Augmentin 875-125 mg,” “Allegra-D 12 Hour 60-120

mg,” and “Nasonex 50mcg/actuation.” Id.; accord Tr. 51. Augmentin is antibiotic

and Dr. Huang’s prescription of an antibiotic could mean that Mr. Rocha suffered

from a bacterial infection, although no culture was taken. Tr. 238.

On November 18, 2013, Mr. Rocha returned to Dr. Saporta’s office but saw

a different doctor---Dr. Saporta. The reason for the appointment was a

continuation of pain despite taking Augmentin. Exhibit 5 at 5. Upon an

examination of Mr. Rocha’s ears, Dr. Saporta observed that Mr. Rocha’s “right

auricle is erythematous . . . drum is dull and slightly retracted . . . Tympanogram at

right is Type B.” Id. Dr. Saporta diagnosed Mr. Rocha as suffering from “Acute

External Otitis.” Id. Dr. Saporta prescribed Medrol 4 mg and ordered Mr. Rocha

to contact him the next day. Id.; see also Tr. 51.

Medrol is a powerful steroid, which suppresses the immune system. Tr. 250.

Dr. Rostad opined that Medrol “could have easily influenced any immune

complement or any inflammatory conditions and calmed the inflammatory

condition as well.” Tr. 291. Dr. Rostad further explained that Medrol would have

suppressed the immune response of vasculitis, ameliorating the harmful

consequences. Tr. 302-03.

The experts the parties retained in this litigation differed in their

interpretation of these first two visits to an ENT doctor. On cross-examination, Dr.

Rostad seemed to indicate that Mr. Rocha was prescribed Medrol before Mr.

Rocha developed shingles. Tr. 254. Dr. Matloubian shared this interpretation. Tr.

529. On the other hand, Dr. Steinman attributed the beginning of Mr. Rocha’s

7

Ear problems, however, were not entirely unprecedented for Mr. Rocha. His January

23, 2012 visit with Dr. Saporta noted a history of bilateral serous otitis media, bilateral

myringotomy, and tubes in his ears. Exhibit 5 at 3.

12

Ramsay Hunt syndrome to the start of Mr. Rocha’s ear pain because Ramsay Hunt

syndrome can cause ear pain. Tr. 311-12. 8

Mr. Rocha returned to Dr. Saporta two days later on November 20, 2013.

Exhibit 5 at 6. During the visit, Dr. Saporta noted Mr. Rocha was “not getting

better, rather pain is worse” despite being on Augmentin. Id. In examining Mr.

Rocha’s ears, Dr. Saporta noted that there were “no major changes,” and again

indicated that Mr. Rocha’s “right auricle [wa]s erythematous.” Id. In addition to

examining Mr. Rocha’s ears, Dr. Saporta examined Mr. Rocha’s nose and neck.

Dr. Saporta did not indicate a rash was present. Id.; see also Tr. 253. Dr. Saporta

prescribed ciprofloxacin and noted that if Mr. Rocha’s condition did not improve,

he would consider consulting Dr. Jyung. Exhibit 5 at 6; see also Tr. 52, 239.

The next day, on November 21, 2013, Mr. Rocha returned to Dr. Saporta’s

office after Mr. Rocha’s wife “noticed some vesicles.” Exhibit 5 at 7. On

examination, Dr. Saporta recognized vesicles “in the immediate preauricular area

and in the concha . . . [and] also in the right temporal area.” Id. Vesicles are

manifestations of shingles. Tr. 240. Dr. Rostad stated that the presence of vesicles

is “highly suggestive or highly consistent with a varicella zoster or herpes zoster

infection.” Tr. 53.

During the exam, Dr. Saporta noted Mr. Rocha was walking “ataxic.” Dr.

Saporta diagnosed Mr. Rocha with two conditions. First, Dr. Saporta continued

the previous diagnosis of “acute otitis media.” Second, Dr. Saporta added a

diagnosis of Ramsay Hunt syndrome. Exhibit 5 at 7. He prescribed Valtrex 500

mg and suggested that Mr. Rocha discontinue taking Cipro. Mr. Rocha, however

wanted to continue on Cipro. Dr. Saporta’s report stated he would speak to Mr.

Rocha the next day if his condition worsened. Id.

Mr. Rocha’s development of Ramsay Hunt syndrome is one link in the chain

of events constructed by Dr. Steinman to explain how the flu vaccine harmed Mr.

Rocha. Exhibit 21 at 6. Additional details about Dr. Steinman’s theory are set out

in sections III.B.1 and VII.B.2 below.

Dr. Saporta continued to care for Mr. Rocha. On November 26, 2013, Mr.

Rocha returned to Dr. Saporta for care, explaining that he “has no pain” but

8

Dr. Steinman’s testimony is ambiguous as to whether he is referring to the appointment

with Dr. Huang, who prescribed Augmentin or the appointment with Dr. Saporta. Whether Dr.

Steinman was referencing the November 12 or the November 18 visit does not affect the

analysis.

13

“continues to be dizzy.” Exhibit 5 at 8. Dr. Saporta described the results of his

examination for different parts of Mr. Rocha’s body. For the right ear, the

“erythema [was] resolved. There are vesicles that are now dry.” Id. Mr. Rocha

had “clear fluid in the right middle ear.” Id. For the facial exam, Dr. Saporta

recognized “Incipient right facial paresis.” Id. The development of facial nerve

problems is consistent with a diagnosis of Ramsay Hunt syndrome. Tr. 53. Dr.

Saporta’s two diagnoses were: “Chronic Serous Otitis Media” and “Ramsay-Hunt

syndrome (Herpes Zoster Oticus).” Exhibit 5 at 8. Mr. Rocha was prescribed

prednisone and Dr. Saporta stated he would perform surgery on Mr. Rocha to place

tubes in his ears to relieve his pressure and inflammation. Exhibit 5 at 8; Tr. 54.

D. Hospitalization at Trinitas (November 27, 2013 to December 2,

2013).

Mr. Rocha’s stay in Trinitas concerned two different problems---his ear

trouble for which he was initially admitted, and kidney problems that were

discovered during his admission. For the sake of simplicity, these are discussed

separately.

1. Ear Problems

Mr. Rocha was admitted at Trinitas Regional Medical Center on November

27, 2013, when he underwent an operation in which the doctor placed tubes both

his ears. Exhibit 9 at 188; see also Tr. 240, 312, 366. The doctor performing the

procedure, which is known as a myringotomy, was Dr. Huang. Exhibit 9 at 9. Dr.

Huang’s preoperative and postoperative diagnoses were “Bilateral otitis media,

acute.” Id.

Dr. Huang’s diagnosis of “bilateral otitis media, acute” raised a small, and

ultimately inconsequential, issue during the hearing. The Secretary’s questions to

Dr. Steinman on cross-examination seemed to suggest that Dr. Huang implicitly

rejected the diagnosis of Ramsay Hunt syndrome. See Tr. 369-71. Dr.

Matloubian developed this point briefly. Tr. 514-16. After the hearing, the

Secretary referred to the potential conflicts in diagnoses. Resp’t’s Posthearing Br.,

filed May 2, 2022, at 36-37.

Doctors maintained Mr. Rocha’s diagnosis of Ramsay Hunt syndrome after

the myringotomy. In the report discharging Mr. Rocha from Trinitas, one of his

final diagnoses was “Ramsay Hunt syndrome status post myringotomy tube

placement.” Exhibit 9 at 22. Furthermore, in a follow up appointment that

occurred on December 3, 2013, the day after Mr. Rocha’s discharge, Dr. Saporta

14

included as diagnoses both “Acute otitis media” and “Ramsay-Hunt syndrome

(Herpes Zoster Oticus).” Exhibit 5 at 9; accord Tr. 67.

Thus, preponderant evidence supports a finding that Mr. Rocha suffered

from Ramsay Hunt syndrome. As to whether the flu vaccine contributed to Mr.

Rocha’s Ramsay Hunt syndrome, that question is deferred until section VIII.B.3

below.

2. Kidney Troubles

After Dr. Huang operated on Mr. Rocha, labs revealed that Mr. Rocha had

elevated levels of creatinine (3.0) and urea nitrogen (BUN) (62). Exhibit 9 at 14,

209. Although it appears that the labs results came back after the operation, the

blood was drawn at 7:30 AM, a time before the operation. See Exhibit 9 at 209

(listing time of blood draw), at 188 (listing time Dr. Huang dictated the operative

report); see also Tr. 55 (discussing morning labs).

Due to the laboratory values, Dr. Agresti was consulted at approximately

4:30 PM on November 27, 2013. Exhibit 9 at 10. Dr. Agresti described Mr.

Rocha as “known to me and was seen by me in August 2012.” Id. Dr. Agresti

obtained a history in which Mr. Rocha recounted that his “problems started

approximately 2 weeks ago when he developed apparently shingles involving the

right ear.” Id. When Mr. Rocha was taking amoxicillin, he developed “some

nausea and vomiting.” Id. Mr. Rocha informed Dr. Agresti that he “has not been

eating or drinking well.” Id. Mr. Rocha’s more distant medical history included

“chronic kidney disease” and “a history of rheumatoid arthritis.” Id. at 11.

Dr. Agresti’s impressions included “Acute kidney injury, which I suspect is

most likely secondary to dehydration.” Exhibit 9 at 12. Dr. Agresti admitted Mr.

Rocha to the hospital for IV fluids and ordered additional labs. Id. at 13; see also

Tr. 55.

During his stay at Trinitas, Mr. Rocha experienced gastrointestinal issues,

abdominal pain, dizziness associated with his Ramsay Hunt syndrome, and was

placed on IV fluids. Exhibit 9 at 14-18. He was seen by several doctors and had

various tests and studies. Id.

Mr. Rocha’s urine was analyzed after he provided a sample on November

29, 2013. One aspect showed the specific gravity for his urine was within the

normal range. Exhibit 9 at 215. According to Dr. Rostad, a normal finding is not

expected for someone suffering from dehydration. Tr. 61. Dr. Rostad recognized

15

that the normal specific gravity could reflect treatment (hydration) after being

admitted to the hospital on November 27, 2013. Tr. 64-65.

By December 2, 2013, Mr. Rocha’s “nausea, vomiting, [and] diarrhea [had]

improved. His laboratory results have also improved.” Exhibit 9 at 23. The

doctors, therefore, discharged him. His final diagnoses included “Acute renal

insufficiency,” “Dehydration,” and “Chronic kidney disease.” Id. at 22. He was

instructed to follow up with Dr. Saporta, Dr. Fernandez, and Dr. Agresti. Id. at 24.

As discussed above, the follow up appointment with Dr. Saporta did occur on

December 3, 2013. The other appointments did not occur as planned due to

intervening health problems.

3. Additional Expert Commentary

Without discussing the material from Trinitas specifically, Dr. Matloubian

opined that he did not see any medical records documenting Mr. Rocha manifested

signs and symptoms consistent with varicella zoster virus vasculitis. Tr. 506-07.

Although Dr. Steinman testified in rebuttal, he did not address this aspect of Dr.

Matloubian’s opinion.

E. Mr. Rocha’s 1st Emergency Room Visit - Barnabas Medical

Center (December 4-14, 2013)

As previously mentioned, on December 3, 2013, Mr. Rocha saw Dr. Saporta.

Exhibit 5 at 9. Later that evening, Mr. Rocha began having “night fevers and pain

in his stomach which continued, as well as weakness, vomiting and diarrhea.”

Exhibit 1 (affidavit of Sandra Rocha Bucco) at 1.

On the evening of December 4, 2013, Mr. Rocha went to Barnabas Medical

Center’s emergency room. Exhibit 1 at 2; Exhibit 12 at 9-10. He remained at

Barnabas for roughly ten days. Exhibit 12 at 22 (discharge summary). During this

admission, he was seen by a variety of specialists.9

1. Emergency Department

Mr. Rocha recounted his recent health problems starting with the ear pain

approximately two weeks earlier. Exhibit 12 at 59; see also Tr. 69-70. He had

9

The organization by specialty largely tracks the Secretary’s presentation of events in

Barnabas Medical Center. See Resp’t’s Posthearing Br. at 5-7. Although Ms. Rocha’s

posthearing brief does not contain much information about Barnabas, Ms. Rocha set forth some

material earlier. See Pet’r’s Prehearing Br., filed Oct. 22, 2020, at 5-7.

16

been having “diarrhea, vomiting, and abdominal pain.” He was admitted to the

hospital.

One of the earlier tests performed on Mr. Rocha was a CT scan of his

abdomen and pelvis. Mr. Rocha had ascites around the liver, spleen, and pelvis,

and inflammation. Exhibit 12 at 378-79; 381; see also Tr. 551-52. Ascites lead to

intravascular volume depletion and interfere with the ability of the kidneys to filter.

Tr. 551; see also Dorlands’s at 160.

2. Nephrology

A nephrologist, Naga Komati, saw Mr. Rocha on December 5, 2013.

Exhibit 12 at 167; see also Tr. 72-74. Based upon the history, laboratory studies,

the results of an abdominal CT scan, Dr. Komati assessed Mr. Rocha as having an

“Acute kidney injury, most likely acute tubular injury.” Exhibit 12 at 168. Dr.

Komati also proposed that Mr. Rocha could suffer from acute interstitial nephritis.

By December 8, 2013, a different nephrologist (Nita Shah) indicated that

Mr. Rocha’s rise in creatinine was “hemodynamic”, and Mr. Rocha required

“supportive care only.” Exhibit 12 at 113; accord Tr. 88. Dr. Shah carried that

opinion forward in her next reports. Exhibit 12 at 126 (Dec. 10, 2013), at 137

(Dec. 11, 2013), 150 (Dec. 12, 2013), and 159 (Dec. 13, 2013). After quoting one

of these reports, Dr. Matloubian wrote, “the rise in creatinine was attributed to

dehydration and not an autoimmune process.” Exhibit A at 5; accord Resp’t’s

Posthearing Br. at 6 (asserting without citing any evidence that “hemodynamic”

meant “due to dehydration”).

In Dr. Rostad’s view, either an acute tubular injury or an acute interstitial

nephritis could have been caused by vasculitis or inflammation. Tr. 88. Dr.

Rostad was not asked to comment upon a potential hemodynamic reason for any

decline in kidney functioning.

Respondent’s expert, Dr. Matloubian, opined that the changes in Mr.

Rocha’s kidney function during this time were due to dehydration, not Mr. Rocha’s

worsening of his cryoglobulinemic kidney disease, given that his renal issues were

corrected with hydration. Exhibit A (Matloubian Report) at 4, 9.

3. Gastroenterology

On December 5, 2013, the day after being admitted to St. Barnabas, Mr.

Rocha was seen by a gastroenterologist, Robert Schuman. Exhibit 12 at 102

(identifying Dr. Schuman as the doctor consulting on gastrointestinal issues), at

17

170-71 (consultation report). Dr. Schuman stated that “the etiology seems to be

infectious in nature,” although other possibilities remained. Id. at 171; see also Tr.

75-78.

An upper endoscopy was performed, and four samples were tested. The

results ruled out neoplasm, lymphoma and H. pylori. Exhibit 12 at 364; see also

Tr. 80-84. Dr. Rostad stated that these tests are unlikely to detect vasculitis. Tr.

84. Gastric vasculitis is “extraordinarily unusual or rare.” Id.

The doctors retained in this case could not clarify why Mr. Rocha had

problems in his gastrointestinal system. According to Dr. Ducatman, Mr. Rocha’s

GI symptoms were “never adequately explained.” Tr. 430. Dr. Matloubian stated,

“no one ever got a satisfactory answer [with] what was going on in his GI tract.”

Tr. 511. Dr. Rostad also testified that Mr. Rocha’s “gastrointestinal issues . . .

have not been fully explained.” Tr. 77.

4. Discharge

Mr. Rocha was discharged from Barnabas Medical Center on December 14,

2013. Exhibit 12 at 22-25. The report is particularly detailed in summarizing Mr.

Rocha’s course while hospitalized at St. Barnabas. The list of diagnoses at

discharge consisted of 11 items: nausea and vomiting, severe bipedal edema,

ascites, acute renal failure on chronic kidney disease, hypertension, recent shingles

to the right ear post status treatment, hepatitis, acute thrombocytopenia, chronic

protein malnutrition, low grade fevers with cough, and diastolic disfunction.

Exhibit 12 at 22. He was taking the following medications: amlodipine, carvedilol,

guaifenesin, hydrochlorothiazide, nystatin, and omeprazole. Id. at 25.

The doctors’ follow-up care plan included Mr. Rocha undergoing a CT scan

in approximately one month and to follow up with his primary care physician next

week. Exhibit 12 at 23. He was also instructed to see some of the doctors who had

seen him in the hospital including, Dr. Shah, Dr. Khot, and Dr. Schuman. Id. at 25.

5. Additional Expert Commentary

In his oral testimony, Dr. Rostad reviewed the detailed discharge report. Tr.

89-96. In this portion, Dr. Rostad emphasized that compared with his appointment

with Dr. Fernandez when he received the flu vaccine, Mr. Rocha developed new

symptoms. As example of new problems, Dr. Rostad pointed to abdominal

symptoms, such as “nausea, vomiting, diarrhea, [and] abdominal pain.” Tr. 91.

Dr. Rostad opined that these problems were unlikely to be derived from Mr.

Rocha’s chronic gastritis because (a) the Augmentin and Cipro would have treated

18

an infection with H. pylori and (b) the biopsies did not detect H. pylori. However,

in this portion of his testimony, Dr. Rostad did not explain why information

presented in the discharge summary supported a diagnosis of vasculitis.

During the hearing, Dr. Matloubian stated Mr. Rocha’s CT results,

particularly the nonspecific findings, would not prompt him to consider Mr. Rocha

as suffering from vasculitis. Tr. at 552. Moreover, according to Dr. Matloubian,

the medical records from St. Barnabas, which exceed 600 pages, do not mention

vasculitis. Id. at 521.

F. Follow-Up Care (December 23–28, 2013)

On December 23, 2013, Mr. Rocha sought care from the nephrologist who

previously treated him at Trinitas, Dr. Agresti. Mr. Rocha complained about

persistent abdominal discomfort and gastrointestinal distress. Exhibit 4 at 5; see

also Tr. 97-98. Dr. Agresti’s assessment notes showed Mr. Rocha’s chronic

kidney disease was stage 3 but stable, his hypertension was stable, but his edema

was worsening. Exhibit 4 at 6. Mr. Rocha was ordered to take Lasix and stop use

of Norvasc. Id.

Four days later, Mr. Rocha saw the hematologist / oncologist who treated

him in St. Barnabas, Dr. Khot, for a diagnosis of anemia. Exhibit 3 at 50-52; see

also Tr. 99-100. Mr. Rocha complained of weakness, fatigue, weight loss, and a

101⁰ Fahrenheit fever roughly every night. Exhibit 3 at 50. Additionally, Mr.

Rocha was still suffering from leg swelling and could hardly move around. Id.

Mr. Rocha underwent a complete blood count test, which showed that his

hemoglobulin and platelet levels had worsened (8.6 and 299 respectively). Id. at

52. However, Mr. Rocha’s shingles appeared to have resolved. Id. at 51. Dr.

Khot’s impression included “anemia of chronic DZ and inflammation.” Id. Dr.

Khot planned to have Mr. Rocha undergo another CT in a few weeks due to his

inflammation and edema. Mr. Rocha was ordered to stop taking Ferrex and

Procrit, and to follow-up with Dr. Khot in one week. Id. at 52.

G. Mr. Rocha Second Emergency Room Visit – Overlook Hospital

(December 29, 2013 – January 14, 2014)10

In the evening of December 29, 2013, Mr. Rocha sought care at the

Overlook Hospital emergency room after experiencing abdominal pain, nausea,

10

The medical records from Overlook exceed 1,300 pages. Thus, this decision focuses

upon the medical records the experts discussed in their testimony and the parties cited in their

briefs. Among the testifying experts, Dr. Steinman discussed Mr. Rocha’s medical records from

19

and vomiting. Exhibit 10 at 24. Mr. Rocha remained in Overlook until January

14, 2014, when he was transferred to another hospital. As Dr. Rostad stated, Mr.

Rocha’s health during this time in January reflected a “very complicated hospital

stay.” Tr. 126.

Upon admission, Mr. Rocha underwent a series of tests. A test did not

detect the presence of influenza A or influenza B antigen. Exhibit 10 at 39 (Dec.

30, 2013). A chest x-ray showed evidence of infiltrates, and Mr. Rocha was

admitted with pneumonia. Id. at 214. He was given heparin, starting on December

30, 2013. Id. at 236. Heparin has “potent anticoagulant properties.” Dorland’s at

834.

In the early days of his hospitalization at Overlook, Mr. Rocha saw a variety

of specialists. For example, Mr. Rocha saw the hematologist/oncologist who had

treated him previously (Dr. Khot). He also saw a specialist in infectious diseases, a

pulmonologist, and a gastroenterologist. For more details about these

consultations, see Pet’r’s Posthearing Br. at 6-8 and Resp’t’s Posthearing Br. at 8-

10. For purposes of resolving Mr. Rocha’s claim, the more important

consultations, and the ones that received much more attention from the experts, are

the consultations with a nephrologist and a rheumatologist.

The nephrologist who saw Mr. Rocha at Overlook on December 30, 2013

was Dr. Agresti. Exhibit 10 at 214-16. Dr. Agresti noted that Mr. Rocha “is well

known to me.” Id. at 214. Dr. Agresti discussed Mr. Rocha’s recent problems that

“started several months ago when he developed acute herpes zoster involving his

ear.” Id. Dr. Agresti briefly summarized treatment at Trinitas and St. Barnabas.

As part of Dr. Agresti’s review of systems, Dr. Agresti indicated that Mr.

Rocha’s “appetite has been quite poor. He has had persistent nausea and vomiting.

He has not been eating well.” Exhibit 10 at 215. One of the laboratory studies on

admission showed that his serum creatinine was 2.4. Id. at 214. Dr. Agresti’s

impression was: “1. Acute kidney injury, most likely secondary to dehydration. 2.

Chronic kidney disease secondary to age and nephrosclerosis. [and] 3. Pulmonary

infiltrates, possible pneumonia.” Id. at 215. He recommended continuing IV

hydration, adjusting all medications for renal failure, and following up with

hematology/oncology. Id.

Overlook the least. Consequently, this decision often cites testimony from Dr. Rostad, Dr.

Matloubian, and Dr. Ducatman.

20

The hematologist/oncologist, Dr. Khot, examined Mr. Rocha the next day

and diagnosed him as suffering from anemia, severe gastritis, elevated alkaline

phosphates, leg edema, possible pneumonia, acute renal insufficiency on chronic

renal insufficient, [and] chronic creatinine “around 1.4 to 1.8.” Exhibit 10 at 222.

Several other doctors saw Mr. Rocha between December 30-31, 2013. Dr.

Nicholas Maglaras’s notes show he thought Mr. Rocha’s fever was either caused

by infection, rheumatology, or a malignancy. Exhibit 10 at 213. Dr. Kunal

Grover’s notes suggested that Mr. Rocha’s ongoing nausea and vomiting might

have been due to “medication reaction given the acuity, as his LFTs were normal

approximately 1 month ago.” Id. at 220. Dr. Grover discontinued Mr. Rocha’s use

of “Reglan in favor of Zofran.” Id. Dr. Khot recommended Mr. Rocha continue

treatment for possible pneumonia and that he undergo QuantiFERON testing.” Id.

at 222. Dr. Juan Baez assessed Mr. Rocha for his fever and sepsis. Id. at 224. Dr.

Baez’s assessment was that:

A multisystem etiology suggests a probabl[e] connective tissue disorder

origin, questionable malignancy although so far workup is negative,

questionable reactivation TB viral, question[able] HIV. . . . He apparently

saw me about 5-6 years ago with a questionable positive HIV serology.

Exhibit 10 at 225.

Mr. Rocha’s first of a series of appointments with rheumatologist Dr.

Tanisha Mathur at Overlook occurred on January 1, 2014. Exhibit 10 at 227-29.

Dr. Mathur obtained two pieces of information about Mr. Rocha’s remote medical

history, which did not feature prominently in histories gathered by other doctors.

First, Mr. Rocha stated that in 2007, he “developed a footdrop on his right leg.

[Mr. Rocha and his wife] report that at that time patient used to have a lot of leg

cramps, and then, suddenly, after the severe leg cramp developed footdrop.” Id. at

227. This report contributes to Dr. Ducatman’s opinion that Mr. Rocha had

cryoglobulinemia prior to his October 18, 2013 flu vaccination. Tr. 464, 494-95.

Second, Mr. Rocha informed Dr. Mathur that he developed red lesions on his legs

after going to South America in 2001. Exhibit 10 at 227. Although the lesions

healed, he still had hypopigmentation on both lower extremities. Mr. Rocha also

mentioned that “his fingers become blue and white on exposure to cold.” Id.;

accord Tr. 178.

Dr. Mathur examined Mr. Rocha. She observed, among other things, a

“Hyperpigmented rash on lower extremities.” Exhibit 10 at 228; accord Tr. 102,

176-77. Dr. Mathur indicated that she had reviewed his laboratory studies,

21

including a urine analysis, showing “more than 50 RBCs.” Id. at 228. The

sedimentation rate was 85. Id.; see also Exhibit 10 at 513; Tr. 103, 127-28.

Dr. Mathur’s assessment and plan, which is found on page 229 of Exhibit

10, is relatively lengthy. She stated, “So far, based on labs and based on his

symptoms, it seems that an autoimmune condition such as vasculitis is a

possibility.” Dr. Mathur mentioned other possible conditions affecting Mr. Rocha

including: “medium vessel vasculitis like polyarteritis nodosa,” and “small-vessel

vasculitis such as granulomatosis with polyangiitis.” Dr. Mathur endorsed studies

that other doctors had ordered. To the list of laboratory tests, Dr. Mathur added a

check on “serum cryoglobulin.”

Dr. Mathur explained steps in the diagnostic process should involve

additional testing. She wrote:

Ideally to diagnosis vasculitis, would like to have a tissue

biopsy from involved organs which could include a

kidney biopsy given his renal insufficiency and evidence

of glomerulonephritis, or if possible, a lung biopsy since

it would be ideal to have tissue diagnosis if he were to

receive strong immunosuppression for vasculitis. Also

we can consider CT or MR angiogram of the abdominal

vessels to evaluate vasculature and look for changes from

vasculitis such as stenosis or narrowing in the abdominal

vessels.

Exhibit 10 at 229.

A test regarding Mr. Rocha’s serum cryoglobulin was performed by the

Mayo Medical Laboratories in Rochester, Minnesota. Exhibit 10 at 599-600; see

also Tr. 129. The parties refer to this test as the “January 1, 2014 test.” The result

was negative. Exhibit 10 at 599.

The two pathologists retained in this litigation differed over the accuracy of

the January 1, 2014 test for cryoglobulins. Dr. Rostad pointed to this test as

evidence that Mr. Rocha did not have cryoglobulins. Tr. 129, 217-18. In contrast,

in light of a subsequent positive test for cryoglobulin, Dr. Ducatman characterized

the January 1, 2014 result as a false negative. Dr. Ducatman explained that the test

for cryoglobulins is “finicky” because the sample needs to be maintained at a

certain (warm) temperature. Tr. 416. Dr. Ducatman suspected that the sample that

22

Overlook sent to the Mayo Clinic may not have stayed at the correct temperature.

Tr. 416-18.

Another test that Dr. Mathur recommended was imaging Mr. Rocha’s

abdomen. Exhibit 10 at 229. This study was done on January 2, 2014, and found a

small amount of ascites; no biliary dilation; and no common duct calculus. Exhibit

10 at 615-16.

It appears that starting around January 6, 2014, Mr. Rocha’s condition

appeared to improve. Exhibit 10 at 132. He was able to eat and to drink and to sit

up in bed, but his legs remained swollen up to his knees. Id.

To explore the possibility of vasculitis, Dr. Mathur had recommended a

biopsy of an affected organ, such as Mr. Rocha’s kidneys. Exhibit 10 at 229; see

also Tr. 111 (Dr. Rostad’s testimony that a reason for the kidney biopsy is to rule

out vasculitis). A renal biopsy was taken from Mr. Rocha on January 6, 2014 at

10:44 the morning. Exhibit 10 at 610. The results were interpreted by a physician

associated with Columbia University Hospital, Glen Markowitz. Exhibit 10 at

455-59; see also Tr. 105.

Later on January 6, 2014, Dr. Mathur, the rheumatologist, followed up with

Mr. Rocha. Exhibit 10 at 111-12; Tr. 104. This visit occurred at 12:45 P.M.

Exhibit 10 at 111. The handwritten note begins: “[Patient] had just returned from

kidney biopsy.” Id. Dr. Mathur expressly wrote that she was “await[ing] renal

pathology.” Id. at 112. Mr. Rocha reported that yesterday he had “less abd pain,

n, v [“n,v” probably being abbreviations for “nausea and vomiting”].” Dr. Mathur

indicated that it was “possible” Mr. Rocha had “mononeuritis multiplex [because

he] had foot drop in the last year.” Id. Dr. Mathur noted that she had started Mr.

Rocha on IV steroids on January 4 (two days earlier) “due to concerns for

vasculitis, however [she was] still waiting for confirmation of diagnosis.” For the

diagnosis of vasculitis, Dr. Mathur remained interested in obtaining an MR

angiogram to look for “changes suggestive of vasculitis.” Id. “Currently, [Mr.

Rocha is] unable to get [an] MR angiogram due to GFR.” 11 Id. Dr. Mathur

indicated “cyros pending.” Id.

11

“GFR” is an abbreviation for “glomerular filtration rate.” Dorland’s at 765. The

glomerular filtration rate refers to kidneys clearing substances. Dorland’s at 1570; see also

Rupert v. Sec'y of Health & Hum. Servs., No. 15-841V, 2021 WL 1832909, at *27 n.102 (Fed.

Cl. Spec. Mstr. May 1, 2021). Apparently, Dr. Mathur was concerned that Mr. Rocha’s kidneys

were not functioning well enough for him to have an MR angiogram.

23

Dr. Mathur saw Mr. Rocha again on January 8, 2014. Exhibit 10 at 119-20.

Mr. Rocha was “able to eat [and] drink.” He had “no nausea.” Id. at 119.

However, he “still” had “significant pedal edema.” Id. at 120. Dr. Mathur was

still waiting for the results regarding renal pathology. Without this information,

Dr. Mathur was proposing that it was “possible” for Mr. Rocha to have “PAN vs.

ANCA [negative] small vessel vasculitis.” Id. Dr. Mathur repeated her interest in

obtaining an MR angiogram to evaluate the vasculature in Mr. Rocha’s abdomen.

Id.; see also Tr. 116.

The renal biopsy showed Mr. Rocha was negative for antinuclear antibodies

(“ANA”), antineutrophil cytoplasmic antibodies (“ANCA”), hepatitis c antibodies

(“HCVAb”), and cryoglobulins. Exhibit 10 at 456. Dr. Markowitz indicated that

the results “are diagnostic of proliferative glomerulonephritis but are insufficient to

determine the degree of activity of chronicity.” Id. He added that “Etiologic

considerations for a proliferative glomerulonephritis in which the deposits stain

most intensely for IgM include[] infections (i.e. HCV), cryoglobulinemic,

autoimmune/collagen vascular (i.e. rheumatoid arthritis), dysprotein-associated,

and idiopathic forms of disease.” Id. Dr. Markowitz recommended repeating

cryoglobulin studies. Id.; see also Tr. 105-11.

Dr. Rostad acknowledged that Dr. Markowitz’s interpretation of the renal

biopsy does not suggest that Mr. Rocha suffered from vasculitis. Tr. 112. Dr.

Rostad, himself, reviewed the slides and Dr. Rostad, too, saw no evidence of

vasculitis. Tr. 112-15. Dr. Rostad discussed why a biopsy on tissues that were

apparently randomly collected might miss tissues containing evidence of vasculitis.

Dr. Rostad also suggested that Mr. Rocha’s January 6 renal biopsies indicated “an

immune-complex mediated proliferative glomerulonephritis.” Exhibit 55 at 9;

Exhibit 10 at 456.

It appears that a doctor requested that the tests for cryoglobulins be repeated

on January 9, 2014, but they were not received for several days. See Exhibit 10 at

576 (test results); see also id. at 141 (Dr. Mathur’s Jan. 13, 2014, note indicating

that tests for cryoglobulins were pending), 184 (Dr. Mathur’s Jan. 20, 2014 note

indicating that “serum cryoglobulins repeat on 1/9/2014 – Positive.”).

Doctors noted the results of the January 6, 2014 renal biopsy. For example,

the assessment from a hematologist / oncologist was “proliferative GN

24

[glomerulonephritis] [with] cyro vasculitis.” Exhibit 10 at 137. This January 12,

2014 handwritten note also indicated that Mr. Rocha was “doing okay.” Id. Other

doctors, whose names and specialties are not readily apparent on these handwritten

documents, also mentioned similar problems. See Exhibit 10 at 133 (“vasculitis /

glomerulonephritis”), 135 (a hospitalist’s Jan. 11, 2014 note stating

“glomerulonephritis / vasculitis – on steroids”).

By January 10, 2014, Mr. Rocha was being treated for vasculitis. Exhibit 10

at 133; see also id. at 137 (noting 01/12/14 treatment notes for “cryo vasculitis”).

Mr. Rocha was ultimately placed on IV steroids and a CBC was ordered to test for

anemia. Id. at 137-38.

An important record is a January 13, 2014 record by Dr. Mathur. Exhibit 10

at 140-41; see also Tr. 117-18. Dr. Mathur recorded that Mr. Rocha tolerated the

infusion of Rituximab well. He was negative for abdominal pain, nausea, and

vomiting. His pedal edema was improving. Exhibit 10 at 140. Dr. Mathur’s

assessment began with “proliferative GN [glomerulonephritis], likely

cryoglobulinemic vasculitis.” Id. at 141. She noted that repeat tests for “serum

cyro” was pending. Dr. Mathur also wrote: “clinically looking better, renal

function improving.” Id.

With the benefit of hindsight, it appears that January 13, 2014 marked the

date by which Mr. Rocha’s health had most improved. As Ms. Rocha maintained,

“Initially, there was improvement in Mr. Rocha’s renal function and GI symptoms,

but his condition deteriorated.” Pet’r’s Prehear’g Br. at 12, citing Exhibit 10 at

161.

Manifestations of a deterioration were observed on January 14, 2014, when a

hospitalist memorialized that Mr. Rocha felt weak and had a fever and chills.

Exhibit 10 at 143. On January 16, 2014, Mr. Rocha’s temperature was 100.6

degrees, while the day before it was 98.4 degrees. Id. at 150. The author of the

medical record, who is a specialist in metabolic medicine, wondered whether the

fever was due to “sepsis vs. vasculitis.” Id. A test from January 16, 2014 showed

that Mr. Rocha was infected with influenza A. Exhibit 10 at 561. 12

After the infection with influenza A was discovered, doctors noted this in

their treatment records. For example, Dr. Mathur saw Mr. Rocha at 4 PM on

January 16, 2014 and she memorialized that Mr. Rocha’s wife was “very

12

The flu vaccine is not 100 percent effective in preventing infection with a flu virus. Tr.

558 (Dr. Matloubian).

25

concerned about [Mr. Rocha’s] fevers, cough and new diagnosis of flu.” Exhibit

10 at 55. Dr. Mathur was concerned about the influenza A infection because Mr.

Rocha was immunosuppressed. She prescribed Tamiflu. Id. An infectious disease

doctor described the influenza infection as “likely just acquired.” Exhibit 10 at

161 (Jan. 17, 2014).

At around 9:30 PM on January 16, 2014, a nurse called for a rapid response

team to assist Mr. Rocha because of hypoxia. Exhibit 10 at 56. At this time, Mr.

Rocha’s “Chest Xray looks worse than yesterday.” Id. Mr. Rocha was transferred

to the intensive care unit.

The initial report from an ICU doctor began “Events of 1/16/14 noted.

[Patient with] development of [Right] mid-lower lung filed consolidation much

[changed] since 1/14/14.” Exhibit 10 at 159. The doctor’s impression was

“Multisystem organ dysfunction likely vasculitis, [with] GN.” Id. at 160. The

doctor wrote about a long discussion with Mr. Rocha’s wife because Mr. Rocha’s

prognosis was “guarded – poor.” Id.

A critical care resident stated that Mr. Rocha was suffering from hypoxic

failure “likely [secondary to] [respiratory] infection.” Exhibit 10 at 164. This

doctor also noted that Mr. Rocha had been diagnosed with vasculitis.

Over the next four days, a variety of doctors continued to treat Mr. Rocha

for his health problems, including his infection with influenza A. See Tr. 431

(testimony of Dr. Ducatman that Mr. Rocha “suddenly developed flu, and

everything that goes on after that is really relevant to his influenza infection, and

its complications and sequelae.”). Dr. Rostad touched upon medical records

created during this time. Tr. 120-26. With a handful of exceptions, the details of

this material do not affect Ms. Rocha’s claim that the flu vaccine injured Mr.

Rocha. See Pet’r’s Prehear’g Br. at 12-13; Resp’t’s Posthear’g Br. at 12.

After Mr. Rocha had been transferred to the ICU due to respiratory

problems, doctors received the results of the second test for cryoglobulins, which

had been ordered on January 9, 2014. On January 20, 2014, Dr. Mathur reported

that the test was positive. Exhibit 10 at 184; see also id. at 576. Unlike the earlier

test, which was sent to the Mayo Clinic, the positive January 9, 2014 test was done

at the Overlook Medical Center. Id. Again, the pathologists disputed the accuracy

of the result.

26

Dr. Ducatman credited the positive January 9, 2014 test as accurate. She

pointed out that the testing was done immediately and locally. Tr. 419. As such,

there is less chance the sample was handled incorrectly.

Contrastingly, Dr. Rostad viewed the January 9, 2014 test as returning a

false positive. His explanation, which he presented for the first time during the

hearing, was that Mr. Rocha was taking heparin on January 8, 2014. Tr. 129,

citing Exhibit 10 at 801. Dr. Rostad further asserted that heparin can complicate

the process of testing for cryoglobulins. Tr. 130, 182.

Dr. Rostad’s explanation lacks credibility. Mr. Rocha actually started

heparin on December 30, 2013. Exhibit 10 at 236. This chronology appears to

disrupt Dr. Rostad’s thesis. See Tr. 218. Moreover, according to Dr. Ducatman,

ingestion of heparin does not interfere with tests for cryoglobulin. Tr. 417.

Dr. Mathur’s assessment of January 20, 2014 included “cryoglobulinemic

vasculitis – [positive] serum cryoglobulins, [positive] kidney biopsy GN.” Exhibit

10 at 184. She also listed “worsening [respiratory] failure – Infection ([positive]

influenza) vs. vasculitis.” Id. Dr. Mathur recommended plasma exchange because

this procedure could help Mr. Rocha if his “worsening is related to circulating

antibodies.” Id. at 185.

A hematologist / oncologist followed up with Dr. Mathur’s recommendation

for plasma exchange on January 21, 2014 at 8:00 A.M. Exhibit 10 at 187; see also

Tr. 518-19. This doctor wrote “unlikely [illegible, potentially “sudden”] vasculitis,

favor more influenza but if rheum (Dr. Mathur) thinks it’s vasculitis and wants [I]

would arrange … plasma exchange.” Exhibit 10 at 187-88.

By noon on January 21, 2014, Mr. Rocha was experiencing acute hypoxic

respiratory failure. Exhibit 10 at 197. The family wanted to transfer his care to

Newark Beth Israel Hospital, where he could receive extracorporeal membrane

oxygenation (“ECMO”) support. Id.

The report discharging Mr. Rocha from Overlook listed 13 diagnoses. The

first was “Acute respiratory distress syndrome [“ARDS”] with multi-organ failure,

likely secondary to proliferative glomerulonephritis, likely cryoglobulinemia

vasculitis.” Exhibit 10 at 17. A pulmonologist at Beth Israel accepted Mr.

Rocha’s transfer.

27

H. Hospital Stay -- Newark Beth Israel Medical Center (January 21,

2014 – March 12, 2014) (Mr. Rocha’s Passing).

Mr. Rocha was hospitalized at Newark Beth Israel Medical Center for

approximately six weeks, during which his health declined. He died on March 12,

2014.

Over ninety exhibits were filed pertaining to Mr. Rocha’s various stays at

Newark Beth Israel. See Exhibits 11.1-11.96. While the medical records created

during Mr. Rocha’s final hospitalization are voluminous, relatively few contribute

to determining whether the flu vaccination harmed Mr. Rocha. See Pet’r’s

Prehearing Br. at 13-17; Resp’t’s Posthearing Br. at 12-15. The experts testified

about the medical records they considered significant. Tr. 135-45 (Dr. Rostad),

436-48 (Dr. Ducatman), 517-26 (Dr. Matloubian).13 The important events were

presented in a two-paragraph discharge summary:

History of Present Illness: This is a 70-year-old male with past medical

history of diabetes, hypertension, chronic kidney disease, hepatitis B

infection, history of tuberculosis during childhood, was recently diagnosed

with cryoglobulinemia vasculitis. Patient was being treated with steroids and

_____. [sic] His kidney biopsy showed proliferative glomerulonephritis. The

patient developed respiratory failure requiring mechanical ventilation. He

was transferred from Overlook Hospital for possible extracorporeal

membrane oxygenation placement in view of progressive respiratory failure.

Hospital Course: Patient was brought to our institution, underwent

extracorporeal membrane oxygenation placement. Overall, his course has

been protracted. This was followed by pneumo sepsis as well as

pneumothorax episodes. He was eventually weaned off the extracorporeal

membrane oxygenation and placed on a ventilator. His condition overall was

poor. He eventually succumbed to recurrent sepsis and went into septic shock

and eventually expired.

Exhibit 11 at 6.

Mr. Rocha’s death certificate documented his cause of death as

cardiopulmonary arrest from multi-organ failure, septic shock, and gram-negative

bacterium, in addition to other “significant conditions” such as vasculitis, ARDS,

and cryoglobulinemia. Exhibit 2 at 1. Respondent’s experts appear to disagree

13

Dr. Steinman did not testify about Mr. Rocha’s health while at Beth Israel.

28

with Mr. Rocha’s cause of death as presented on the death certificate. Dr.

Matloubian opined that although vasculitis was listed as a contributing factor in

Mr. Rocha’s death, he “did not think it played a role.” Exhibit BB at 2.

Dr. Ducatman commented that, in her opinion as a pathologist, the death

certificate lacks precision. She stated Mr. Rocha’s likely cause of death “[w]as

gram negative septicemia (which implies both shock and bacteremia as well as

multiorgan failure) due to ARDS due to Influenza infection (Influenza A 2009

H1N1) . . . . [and] list[ed] as other significant findings: erosive gastritis,

cryoglobulinemia, and chronic renal failure. The last two findings were chronic

and stable prior to other diseases and interventions.” Exhibit CC (Ducatman

Report) at 10. Moreover, Dr Ducatman pointed out that “[t]hree of the four of Mr.

Rocha’s admissions were not for cryoglobulinemia or cryoglobulinemic vasculitis,

they were for gastrointestinal symptoms and dehydration.” Id.

Petitioner’s experts opined that Mr. Rocha’s death was caused by vasculitis,

which was in turn caused by the flu vaccine. Dr. Rostad stated: “I believe vaccine-

induced vasculitis was indeed the cause of terminal medical course.” Exhibit 55 at

1. He proposed a theory that the vaccine triggered an “immune complex reaction

leading to vasculitis, renal involvement with immune complex proliferative

glomerulonephritis (ICPGN) and ultimately, other organ involvement and eventual

death.” Id. at 11. He noted that “[m]ultiple scientific reports have raised the

association between influenza vaccine and vasculitis,” and stated that “vasculitis

was the primary cause of death.” Id. at 19.

Dr. Steinman noted that the death certificate listed vasculitis as one of the

“other significant conditions contributing to death.” Exhibit 46 at 7. He theorized

that the flu vaccine triggered Ramsay Hunt in Mr. Rocha, which induced the

vasculitis that contributed to his death. Id. at 27.

III. Procedural History

A. Development before Expert Reports

Represented by Attorney Carol Gallagher, Omary Rocha, on behalf of Mr.

Rocha’s estate, claimed that the flu vaccine Mr. Rocha received on October 18,

2013 caused him to suffer vasculitis that caused his death. Pet., filed Feb. 18,

2016. Petitioner filed various medical records and affidavits over the next six

months. Exhibits 1-20.

29

The Secretary argued Ms. Rocha should not be entitled to compensation

because she did not establish causation between the flu vaccine and his vasculitis.

Resp’t’s Rep., filed Oct. 31, 2016, at 14.

B. Expert Reports

Following the Secretary’s report, the undersigned provided guidance about

the expected content of forthcoming expert reports. Order, issued Nov. 14, 2016;

see also Order, issued Nov. 30, 2016 (finalizing draft expert report instructions).

As discussed below, the parties eventually presented reports from a total of four

people. This group consists, in some respects, two pairs.

1. Neurologist and Rheumatologist

Ms. Rocha’s first expert report was prepared by Lawrence Steinman, a

neurologist, and was filed February 23, 2021. Ex. 21. Following a status

conference, petitioner filed a supplemental expert report from Dr Steinman.

Exhibit 46; see Order, issued Mar. 7, 2017 (discussing additional topics for Dr.

Steinmann to discuss in his report).

Dr. Steinman began his recitation of relevant medical events in Mr. Rocha’s

life with the October 18, 2013 flu vaccination. Exhibit 21 at 4. In other words, Dr.

Steinman did not extensively discuss Mr. Rocha’s pre-vaccination medical history.

Dr. Steinman proposed that in November 2013 (about one month after the flu

vaccination), Mr. Rocha suffered from Ramsay Hunt syndrome, also known as

herpes zoster oticus. Exhibit 21 at 4. This Ramsay Hunt syndrome was the result

of an immune response to the flu vaccine. Id. at 6. Dr. Steinman further indicated

that the activation of the previously latent herpes zoster virus “triggers vasculitis

which contributes to Nestor Rocha’s untimely death.” Id. at 26. Dr. Steinman

recognized that an infection with the hepatitis B virus could have contributed to the

Mr. Rocha’s vasculitis. Id. In his second report, Dr. Steinman stated that the

vasculitis “caused renal and cerebral damage, leading to imbalances in fluid and

electrolytes ultimately leading to [Mr. Rocha’s] demise.” Exhibit 46 at 2.

The Secretary then filed an expert report by Mehrdad Matloubian, a

rheumatologist, on October 23, 2017. Exhibit A. Dr. Matloubian supplemented his

report on January 10, 2018. Exhibit BB.

In contrast to Dr. Steinman, Dr. Matloubian emphasized Mr. Rocha’s health

before the vaccination. Dr. Matloubian stated that “Mr. Rocha’s medical history

contained multiple clues that are indicative of pre-existing but undiagnosed

30

cryoglobulinemic syndrome affecting multiple organs including his skin,

peripheral nervous system, and kidneys.” Exhibit A at 9.

Although Dr. Matloubian (like Dr. Steinman) summarized events in Mr.

Rocha’s life after the vaccination, Dr. Matloubian identified a different cause of

death. In the view of Dr. Matloubian, the “major contributor to Mr. Rocha’s death

was development of ARDS [acute respiratory distress syndrome] as the result of

influenza A H1N1 2009 infection.” Exhibit A at 13. Thus, Dr. Matloubian

challenged the assertion that any form of vasculitis contributed to Mr. Rocha’s

death. Id. at 3.

In addition to disputing what happened to Mr. Rocha, Dr. Matloubian did

not agree with the various causal mechanisms Dr. Steinman had offered to explain

how the flu vaccine can activate a herpes zoster virus. See Exhibit A at 14-20.

Petitioner filed a responsive expert report by Dr. Steinman on April 10,

2018. Exhibit 49. This report is approximately four pages. Dr. Steinman

primarily addressed cryoglobulinemia, the reactivation of a latent herpes zoster

virus, and the temporal interval. He also maintained his opinion that Mr. Rocha

suffered from vasculitis.

The reports from the experts were discussed in a status conference held on

May 8, 2018. See Order, issued May 9, 2018. During the status conference, the

parties agreed that “whether Mr. Rocha had vasculitis appears to be a central

question in determining if the vaccination can be linked to Mr. Rocha’s death.” Id.

at 1. The parties were, therefore, instructed to seek additional information from

doctors who treated Mr. Rocha. In addition, Ms. Rocha was directed to obtain

some clarifying information from Dr. Steinman, which Dr. Steinman provided in a

report dated May 30, 2018. Exhibit 51.

The parties eventually determined that the process of soliciting information

from doctors who treated Mr. Rocha was not likely to produce helpful evidence.

See Order, issued Oct. 26, 2018. Ms. Rocha was interested in possibly obtaining a

report from a pathologist, who might support the diagnosis of vasculitis. Id.

2. Pathologists

Ms. Rocha determined that she wanted to obtain a report from a pathologist

and filed a report from Steven Rostad, who is board-certified in anatomic

pathology and neuropathology. Exhibit 55 (dated May 29, 2019). Dr. Rostad

summarized Mr. Rocha’s medical records. Id. at 4-7. Dr. Rostad also personally

reviewed biopsy slides. Id. at 7-9. Although the biopsy slides did not show

31

evidence of vasculitis, Dr. Rostad “still suspected” this diagnosis based upon the

“pathology findings, in concert with the clinical, imaging and laboratory features.”

Id. at 9.

Although it may have seemed that Ms. Rocha planned to retain a pathologist

to supplement Dr. Steinman’s opinion that Mr. Rocha suffered from vasculitis

only, Dr. Rostad went further. He also opined that a flu vaccination can cause

vasculitis. Dr. Rostad’s “main theory” was “based on the concept of molecular

mimicry.” Exhibit 55 at 12. In explaining how vasculitis caused Mr. Rocha’s

death, Dr. Rostad disagreed with Dr. Matloubian’s suggestions that Mr. Rocha

suffered from cryoglobulinemic vasculitis, and that Mr. Rocha died from ARDS.

Id. at 18.

The introduction of a second expert led the Secretary to retain a second

expert. See Order, issued July 5, 2019. The Secretary presented the report from

Barbara Ducatman on October 10, 2019. Exhibit CC. 14 Dr. Ducatman is also a

pathologist, board-certified in anatomic pathology and clinical pathology.

Like the other experts, Dr. Ducatman reviewed Mr. Rocha’s extensive

medical records. She opined that before the vaccination, Mr. Rocha had

cryoglobulinemia associated with a chronic hepatitis B infection. Exhibit CC at 8.

With respect to vasculitis, Dr. Ducatman opined that Mr. Rocha may have suffered

from either cryoglobulinemia or cryoglobulinemic vasculitis. Id. at 9. But, either

condition was long-standing, probably related to his hepatitis B vaccination, and

not caused by the flu vaccination. Id. Dr. Ducatman indicated that a more precise

way to describe the cause of Mr. Rocha’s death was a death due to “gram negative

septicemia (which implies both shock and bacteremia as well as multiorgan failure)

due to ARDS to influenza infection.” Id. at 10.

Following the submission of Dr. Ducatman’s report, Ms. Rocha stated that

she did not intend to obtain another expert report. Pet’r’s Status Rep., filed Dec.

17, 2019. Thus, because the parties had completed the stage during which the

experts disclose their opinions and the bases for their opinions, the parties were

directed to file briefs in advance of a potential adjudication. Order, issued Dec. 20,

2019.

14

The Secretary originally designated Dr. Ducatman’s first report as Exhibit K.

However, the Secretary had already filed material as Exhibit K. Thus, Dr. Ducatman was refiled

as Exhibit CC. Order, issued Feb. 3, 2021.

32

The December 20, 2019 order allowed the parties a final opportunity to

present reports from experts to ensure that all opinions had been disclosed. Thus,

Ms. Rocha submitted a comprehensive supplemental report from Dr. Rostad on

March 12, 2020. Exhibit 84. Dr. Rostad continued to disagree about the potential

diagnoses, maintaining vasculitis and questioning cryoglobulinemia. Dr. Rostad

indicated that the conclusion that Mr. Rocha died from ARDS to be “speculative

without more definitive findings.” Id. at 14. Dr. Rostad stated that the “gram-

negative septicemia was secondary to systemic vasculitis, most likely due to

interruption in the integrity of the gastrointestinal system due to local ischemia of

the mucosa.” Id.

After representing Ms. Rocha for approximately four years, Ms. Gallagher

stopped representing her.15 Attorney Richard Gage substituted as counsel of

record on June 16, 2020.

Dr. Ducatman responded to the opinions from Dr. Rostad in supplemental

report, which the Secretary filed on July 6, 2020.16 Dr. Ducatman’s report was

relatively short (essentially two pages), and she maintained her previously

expressed opinions. Exhibit PP.

In a July 8, 2020 status conference, Ms. Rocha’s counsel, Mr. Gage, agreed

that the experts were finished disclosing their opinions. Order, issued July 8, 2020.

Thus, the order to present arguments through written briefs was reinstituted.

C. Pre-Hearing Briefs

Acting through Mr. Gage, Ms. Rocha submitted her first Pre-Hearing Brief

on October 22, 2020. The brief began with a recitation of Mr. Rocha’s medical

history, divided into periods roughly corresponding to hospitalizations. With

respect to Mr. Rocha’s health before the vaccination, Ms. Rocha cited her own

affidavit and the affidavit of the Rochas’s son-in-law, Carmen Bucco. Pet’r’s

Prehear’g Br., filed Oct. 22, 2020, at 1-2, citing Exhibits 53-54. Ms. Rocha did not

address the contention from Dr. Matloubian and Dr. Ducatman that Mr. Rocha

suffered chronic problems from before the vaccination. See id.

15

Ms. Rocha was awarded some compensation for costs Ms. Gallagher incurred. See

2019 WL 2406954 (April 30, 2019).

16

Originally, this report was labeled as Exhibit X. However, due to a repetition in the

letters, the report was later refiled as Exhibit PP. See Order, issued Feb. 3, 2021.

33

As for the elements of a petitioner’s case, Ms. Rocha started with the

diagnosis. She maintained that “It is medically probable that Mr. Rocha had a

systemic vasculitis. Systemic vasculitis is the only diagnosis that offers a unifying

diagnosis for all of Mr. Rocha’s symptoms and untimely death.” Pet’r’s Prehear’g

Br.at 17. Throughout this section, Ms. Rocha cited the reports from Dr. Rostad

(Exhibits 55 and 84) as well as the articles he cited. Ms. Rocha did not cite reports

from Dr. Steinman.

For the first prong of Althen, which requires a theory to explain how a

vaccine harmed a person, Ms. Rocha advanced Dr. Rostad’s theory of a vaccine

triggering immune complexes. Pet’r’s Prehear’g Br., filed Oct. 22, 2020, at 25.

She also proposed the theory of molecular mimicry. Id. at 29. In the context of

molecular mimicry, Ms. Rocha also relied upon Dr. Rostad, not Dr. Steinman. The

same is true for the second and third prongs of Althen: Ms. Rocha cited material

from Dr. Rostad, not Dr. Steinman. Id. at 32-35.

Ms. Rocha argued that the vaccine-induced vasculitis caused Mr. Rocha’s

death. She proposed two methods---either a direct method in which the vasculitis

led to multi-system organ failure or an indirect method in which the

immunosuppressive treatments for vasculitis increased Mr. Rocha’s vulnerability

to an infection. Pet’r’s Prehear’g Br. at 35.

Ms. Rocha advocated for a hearing to receive testimony orally. For her

witnesses, Ms. Rocha listed five people. Three people were percipient witnesses,

knowledgeable about Mr. Rocha’s health. The remaining two witnesses were Dr.

Rostad and Dr. Steinman. Pet’r’s Prehear’g Br. at 36.

Following review of Ms. Rocha’s brief, the undersigned noted the omission

of any reliance on Dr. Steinman’s opinions. Order, issued Oct. 26, 2020. After a

status conference, Ms. Rocha requested an opportunity to expand her brief. Order,

issued Nov. 4, 2020.

In a supplemental brief, filed on November 20, 2020, Ms. Rocha cited more

articles in her discussion of a theory. Ms. Rocha continued to focus upon the

opinions from Dr. Rostad, not Dr. Steinman. Pet’r’s Supp’l Br. at 4 n.1. As

required by the December 20, 2019 order, Ms. Rocha listed the articles on which

she was primarily relying.

Another status conference was held to discuss how Ms. Rocha was

proceeding. When asked whether Ms. Rocha was going forward with Dr.

Steinman, Ms. Rocha’s attorney, Mr. Gage, stated that he was not withdrawing Dr.

34

Steinman’s reports. Dr. Steinman, according to Mr. Gage’s representations in the

status conference, remained part of the petitioner’s case-in-chief. Based upon this

explanation, the Secretary’s attorney, Kimberly Davey, stated that she could

proceed. Order, issued Dec. 11, 2020.

The Secretary argued that Ms. Rocha was not entitled to compensation for

Mr. Rocha’s death via a Pre-Hearing Brief, filed Feb. 4, 2021. The Secretary

organized his summary of events in Mr. Rocha’s medical history around various

hospitalizations. This summary started with the medical visit during which Mr.

Rocha received his flu vaccination.

The Secretary addressed the elements of a petitioner’s case. With respect to

diagnosis, the Secretary raised three points: (1) Mr. Rocha did not suffer from

systemic vasculitis, (2) Mr. Rocha likely suffered from cryoglobulinemia, and (3)

regardless of which condition affected Mr. Rocha, Mr. Rocha suffered from it

before the vaccination. Resp’t’s Prehear’g Br. at 17-21.

For the theory by which a vaccine might have harmed Mr. Rocha, the

Secretary challenged Dr. Rostad’s opinion and Dr. Steinman’s opinion. Resp’t’s

Prehear’g Br. at 22-31. The Secretary also contended that Ms. Rocha’s evidence

for Althen prong 2 and Althen prong 3 was insufficient. For timing (Althen prong

3), the Secretary maintained his position that Mr. Rocha’s “condition was chronic,

long-standing, and certainly pre-dated [his] vaccination.” Id. at 34. The Secretary

also argued that if Mr. Rocha’s condition developed after the vaccination, then the

latency exceeded the time for which an inference of causation is appropriate. Id.

The Secretary devoted two sections of his brief to the topic of sequella.

First, for Dr. Steinman’s theory involving Ramsay Hunt syndrome, the Secretary

argued that Ms. Rocha had not established that varicella zoster virus leads to

vasculitis. Resp’t’s Prehear’g Br. at 36-37. Second, the Secretary contended that

an infection, not vasculitis, caused Mr. Rocha’s death. Id. at 37-39. The Secretary

did not identify articles supporting his position in this brief.

Ms. Rocha supported her claim in a four-page reply, filed on March 22,

2021. A primary theme of the reply was that the experts interpreted Mr. Rocha’s

medical records differently and a hearing should be held. One example concerned

the testing for cryoglobulins. Pet’r’s Prehear’g Reply at 2. Another example

concerned the cause of Mr. Rocha’s death. Id. at 3. Ms. Rocha did not reply to the

Secretary’s attacks on the theory (Althen prong 1).

35

Because the Secretary did not identify the primary articles on which he was

relying, the Secretary was given a second opportunity. Order, issued April 20,

2021. The Secretary did in a Supplemental Prehearing Brief, filed May 28, 2021.

This submission completed the parties’ written arguments before the hearing.

D. Hearing

Due to the complexities of Mr. Rocha’s medical history, the case was

scheduled for a hearing to receive oral testimony. Order, issued April 20, 2021

(proposing three days of hearing in December 2021). In a May 18, 2021 status

conference, the parties determined that December 1-3, 2021 was a mutually

convenient time. Order, issued May 19, 2021.

The hearing was held, as scheduled, on December 1-3, 2021 via WebEx

videoconferencing. Petitioner called Ms. Sandra Rocha Bucco, who is the

daughter of Mr. and Ms. Rocha. Petitioner also called her experts, Dr. Steinman

and Dr. Rostad. Respondent’s witnesses were his experts, Dr. Matloubian and Dr.

Ducatman. The experts’ testimony was more or less in accord with their reports.

Following the hearing, the parties were directed to file posthearing briefs, which

the parties submitted. Order, issued Dec. 6, 2021.

E. Posthearing Briefs

Ms. Rocha contended that she was entitled to compensation. Pet’r’s

Posthear’g Br., filed Mar. 9, 2022. More than one-half of her 21-page brief was

devoted to discussing Mr. Rocha’s medical history as described in the testimony

from Ms. Sandra Rocha Bucco and Dr. Rostad. Id. at 1-14.

Ms. Rocha’s analysis of the theory from Dr. Rostad was set forth in two

paragraphs, which mentioned both immune complexes and molecular mimicry.

Ms. Rocha presentation was:

As for Althen Prong One, a biologically plausible theory

connecting the vaccine to the injury, Dr. Rostad testified

in accordance with his reports and the medical literature.

He testified his theory involves a vaccine triggered

immune complex reaction leading to vasculitis. Tr., p.

241. Immune complex deposition is an important aspect

of the pathogenesis of vasculitis. Tr., p. 153-154. The

literature points to molecular mimicry as being the most

likely mechanism for the onset of immune mediated

vasculitis. Tr., p. 156, 157, 158. Dr. Rostad agrees with

36

the literature and believes molecular mimicry is the most

likely mechanism of autoimmunity in this case. Tr., p.

245, 300-301. The influenza vaccine has been reported as

the most common vaccine associated with vasculitis. Tr.,

p. 162.

Dr. Rostad explained:

vaccinations, like infections stimulate the immune

system. That antibody reaction can obviously form

immune complexes, and in certain circumstances,

it can be to other antigens of the body that they

weren’t necessarily intended to, the so-called

molecular mimicry hypothesis or theory. Those

circulating complexes can injure lots of different

organ systems, and that is the believed

pathophysiology of that vaccine -- post-vaccine

induced injury.

Tr., p. 163-164.

Pet’r’s Posthear’g Br. at 14. In this context, Ms. Rocha did not specify any

medical articles that supported Dr. Rostad’s theory by which a flu vaccine can

cause vasculitis.

In another portion of her brief, Ms. Rocha presented Dr. Steinman’s theory,

which she described as being “a little more nuanced.” Pet’r’s Posthear’g Br. at 18.

Her summary was longer, running approximately three pages. Ms. Rocha again

did not cite any medical articles supporting Dr. Steinman’s opinion.

With respect to the onset of a vaccine-induced injury, Ms. Rocha advanced

slightly different times. Dr. Rostad maintained that Mr. Rocha displayed kidney

and abdominal problems 39 days after vaccination. Pet’r’s Posthear’g Br. at 17,

quoting Tr. 164-65. Dr. Steinman, in contrast, linked Mr. Rocha’s vaccine-induced

problem to Mr. Rocha’s development of Ramsay Hunt syndrome. Pet’r’s

Posthear’g Br. at 20. Ms. Rocha discussed Dr. Steinman’s recognition that Mr.

Rocha suffered from cryoglobulinemic vasculitis “for decades.” Id., quoting Tr.

345-46. But Dr. Steinman blamed the vaccine-induced vasculitis, “not the

cryoglobulinemic which had preexisted” as leading to his death. Id. Thus, Ms.

Rocha stated in a footnote that “there is no evidence that any pre-existing condition

(real or potential) contributed to Mr. Rocha’s post-vaccination decline and death.

37

However, should the Special Master find otherwise, Dr. Steinman has presented a

strong case for significant aggravation.” Id. at 20 n.3.

The Secretary answered and continued to assert that Ms. Rocha was not

entitled to compensation. Resp’t’s Posthear’g Br., filed May 2, 2022. The

Secretary discussed Mr. Rocha’s medical history for approximately 15 pages. In

terms of analysis, the Secretary argued that the people he retained, Dr. Matloubian

and Dr. Ducatman, are better qualified to offer opinions than the people Ms. Rocha

retained, Dr. Steinman and Dr. Rostad. Id. at 19-21.

The Secretary’s assessment of diagnosis echoed the arguments that the

Secretary had presented in his February 4, 2021 Pre-Hearing Brief. The Secretary

continued to assert that Mr. Rocha did not have systemic vasculitis or varicella

zoster vasculitis. Instead, the better evidence, in the Secretary’s view, was that Mr.

Rocha suffered from cryoglobulinemia. In any event, the cryoglobulinemia or the

cryoglobulinemic vasculitis started long before the vaccination.

For the Althen analysis, the Secretary challenged the theories that Dr. Rostad

and Dr. Steinman offered. In this context, the Secretary commented upon various

articles about which the experts had testified. See Resp’t’s Posthear’g Br. at 29-

35. The Secretary also disputed Althen prongs two and three. Id. at 35-39.

Finally, the Secretary contended that Mr. Rocha’s death was not a sequella to any

injury induced by the vaccination. Id. at 40-41.

Ms. Rocha defended her position in a Reply, filed June 8, 2022, which is

essentially five pages. Ms. Rocha advanced three points. The first point was an

appropriate diagnosis is “immune complex mediated vasculitis.” Pet’r’s

Posthear’g Reply at 1. Second, the Secretary mistakenly elevated her burden with

respect to Althen prong one. In this context, Ms. Rocha did not respond to the

evidentiary challenges put forward in the Secretary’s brief. Third, Ms. Rocha

asserts that the Secretary has admitted that cryoglobulinemia is a distraction. Id. at

5.

Accordingly, the case is now ripe for adjudication.

F. Summary of Opinions regarding Mr. Rocha’s Health

As often seen in Vaccine Program cases, the parties and their experts dispute

whether a vaccine can cause a particular injury. However, this case is unusual in

that the experts differ on many aspects of the vaccinee’s health. The prominent

topics of dispute are presented in the following chart:

38

Dr. Steinman, Dr. Rostad, Dr. Matloubian, Dr. Ducatman,

neurologist pathologist rheumatologist pathologist

Mr. Rocha’s Cryoglobulinemia None Cryoglobulinemia, Cryoglobulinemia

pre-vaccine cryoglobulinemic

health vasculitis

problems

Consequence None Not History of Longstanding,

of any pre- applicable purpura, foot fairly stable, mild

vaccine because drop, and positive chronic renal

health Dr. Rostad rheumatoid factor failure (Tr. 442,

problem: did not but no acute 448)

accept any symptoms in time

pre- period leading up

vaccination to death.

health

problem.

Role of Critical Not Flu vaccine did Played no role in

Ramsay discussed not cause Ramsay death; very

Hunt Hunt syndrome; unlikely that flu

syndrome syndrome had vaccine caused

resolved by Ramsay Hunt

November 27, syndrome.

2013.

Cause of Mr. Vasculitis Vasculitis ARDS ARDS

Rocha’s

death

IV. Standards for Adjudication

A petitioner is required to establish her case by a preponderance of the

evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence

standard requires a “trier of fact to believe that the existence of a fact is more

probable than its nonexistence before [he] may find in favor of the party who has

the burden to persuade the judge of the fact's existence.” Moberly v. Sec’y of

Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations

39

omitted). Proof of medical certainty is not required. Bunting v. Sec’y of Health &

Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).

Distinguishing between “preponderant evidence” and “medical certainty” is

important because a special master should not impose an evidentiary burden that is

too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed.

Cir. 2009) (reversing special master's decision that petitioners were not entitled to

compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357

(Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed.

Cir. 1993) (disagreeing with dissenting judge's contention that the special master

confused preponderance of the evidence with medical certainty).

This evidentiary standard is used to evaluate various issues, starting with the

qualifications of the retained doctors. An assessment of the doctors’ expertise

underlies some of the analysis in weighing competing opinions regarding

diagnosis, which is discussed in section VI, below. After diagnosis, two

alternative means of recovery are discussed: significant aggravation in section VII

and causation-in-fact in section VIII.

V. Qualifications of Retained Doctors

Special masters may consider the relative expertise of testifying experts

when weighing the value of their opinion. See Depena v. Sec’y of Health & Hum.

Servs., No. 13-675V, 2017 WL 1075101 (Fed. Cl. Spec. Mstr. Feb. 22, 2017), mot.

for rev. denied, 133 Fed. Cl. 535, 547-48 (2017), aff'd without op., 730 Fed. App'x

938 (Fed. Cir. 2018); Copenhaver v. Sec’y of Health & Hum. Servs., No. 13-

1002V, 2016 WL 3456436 (Fed. Cl. Spec. Mstr. May 31, 2016), mot. for rev.

denied, 129 Fed. Cl. 176 (2016).

A. Doctors Whom Ms. Rocha Retained

Ms. Rocha retained two doctors. She first retained Dr. Steinman. Then, she

retained Dr. Rostad.

1. Lawrence Steinman

Dr. Steinman has often opined that a vaccine harmed a person through

written reports and oral testimony. As such, he is well-known to special masters

and an extensive amount of testimony about his qualifications was neither

presented nor required. See Tr. 306-07.

40

In brief, Dr. Steinman graduated from Harvard University Medical School in

1973. Since 1973, he has been affiliated with Stanford University Hospital,

attaining the rank of professor in 1991. He became board-certified in neurology in

1984. Exhibit 22 (curriculum vitae) at 1. A significant portion of Dr. Steinman’s

research involves how the immune system affects the neurologic system, such as in

multiple sclerosis. Tr. 330; see also Exhibit 22. For nearly a decade, Dr. Steinman

chaired Stanford University’s program in immunology. Exhibit 22 at 1.

In Dr. Steinman’s view, “Every patient with inflammatory demyelinating

disease has a vasculitis.” Exhibit 46 at 1; accord Tr. 330. He, therefore, estimated

that when he wrote his second report in 2017, he had treated more than 100

patients with vasculitis in the last five years. Exhibit 46 at 1. Also, within the last

five years, Dr. Steinman had treated seven patients with Ramsay Hunt syndrome.

Id. at 2. Dr. Steinman recognized that rheumatologists and nephrologists, as

opposed to neurologists, study cryoglobulins. Tr. 330.

Dr. Steinman was accepted as an expert in neuroimmunology. Tr. 307.

2. Steven Rostad

The second doctor whom Ms. Rocha retained, and the one on whom she

more heavily relied, was Steven Rostad. Dr. Rostad has not previously testified

before the undersigned and has worked on approximately five cases in the Vaccine

Program. Tr. 32, 267. Thus, his qualifications are presented more fulsomely.

Dr. Rostad earned his medical degree from the University of Washington in

1983. Exhibit 56 (curriculum vitae) at 1. He spent one year as an intern in

pathology at the University of Denver. Thereafter, the remainder of his career was

affiliated with the University of Washington. After a fellowship in

neuropathology, a term as a resident in anatomic pathology, a term as chief

resident in anatomic pathology---all at the University of Washington--Dr. Rostad

worked at CellNetix Pathology PLLC from 1988 to 2017. Exhibit 56 at 1; Tr. 32-

33. Dr. Rostad served as a clinical associate professor of pathology at the

University of Washington from 1990 to 2015. Exhibit 56 at 1; Tr. 34, 266. He

became board-certified in anatomic pathology and neuropathology in 1988.

Exhibit 56 at 2; see also Tr. 37.

His position at CellNetix Pathology overlapped with his role as an attending

pathologist / neuropathologist at Swedish Medical Center in Seattle, Washington.

Exhibit 56 at 1; Tr. 33-34, 269. In this role, Dr. Rostad examined tissue samples

from “virtually all organ sites with regards to the question of vasculitis,” including

41

the “skin, kidney, [and] lung.” Tr. 35; accord Tr. 37. Like other pathologists, Dr.

Rostad did not see patients clinically. Tr. 37.

Dr. Rostad explained that pathologists attempt to suggest a specific type of

vasculitis to the treating doctors. Tr. 219-221. However, because there are more

than 30 types of vasculitis and because stains provide little assistance in subtyping

vasculitis, Dr. Rostad is not able to provide details often.

After Dr. Rostad’s employment at CellNetix Pathology concluded at the end

of 2017, Dr. Rostad has continued to participate in medico-legal matters. Tr. 266-

67. He has presented opinions for both plaintiffs and defendants.

Dr. Rostad was recognized as an expert in pathology. Tr. 37.

B. Doctors Whom the Secretary Retained

Like Ms. Rocha, the Secretary also retained two doctors. The Secretary first

retained Dr. Matloubian and then Dr. Ducatman.

1. Mehrdad Matloubian

Dr. Matloubian has participated in several cases in the Vaccine Program. He

earned a Ph.D. in virology and a medical degree from the University of California,

Los Angeles in 1996. Exhibit B (curriculum vitae) at 1; Tr. 487. After an

internship and residency, Dr. Matloubian was a fellow in rheumatology for three

years at the University of California, San Francisco and had a post-doctoral

fellowship there. Exhibit B at 1.

In 2001, Dr. Matloubian began working as an assistant adjunct professor of

medicine at the University of California, San Francisco. He was promoted and

became an associate adjunct professor in 2013. Exhibit B at 2. He became board-

certified in rheumatology in 2013. Id. There was no question that Dr. Matloubian

was qualified as an expert in rheumatology. Tr. 486.

However, the Secretary proffered Dr. Matloubian as an expert in

immunology as well. The Secretary, therefore, solicited information about Dr.

Matloubian’s background in immunology. Dr. Matloubian explained that his

Ph.D. was in viral pathogenesis. Later, he studied lymphocytes, which are part of

the immune system, and ran his own laboratory exploring the immune responses to

chronic viral infections. Tr. 487. He also is the codirector of the immunology

course for medical students at the University of California, San Francisco.

42

Collectively, these factors led to his recognition as an expert in immunology. Tr.

488.

Although Dr. Matloubian is knowledgeable about immunology, his practice

focuses on rheumatology. Tr. 488. As a rheumatologist, he sees patients with

vasculitis. Moreover, because the University of California, San Francisco hospital

is a tertiary care center to which patients with difficult conditions are referred, Dr.

Matloubian sees more patients with vasculitis. Tr. 489-90. His duties include

participating in conferences with other rheumatologists in which doctors discuss

vasculitis. Tr. 490, 557. In 2017, Dr. Matloubian estimated that within the last

five years, he saw at least 50 patients with vasculitis. Exhibit A at 2.

As previously mentioned, Dr. Matloubian was recognized as an expert in

rheumatology and immunology. See Farag v. Sec'y of Health & Hum. Servs., No.

17-714V, 2023 WL 7203034, at *6 (Fed. Cl. Sept. 29, 2023) (recognizing Dr.

Matloubian as an expert in rheumatology and immunology); Braun v. Sec'y of

Health & Hum. Servs., No. 16-1098V, 2018 WL 2375751, at *15 (Fed. Cl. Apr.

24, 2018) (quoting a report from a doctor a petitioner retained as saying Dr.

Matloubian is “first and foremost a researcher with a sound background in

immunology”).

2. Barbara Ducatman

Dr. Ducatman’s participation in this case was the second time she worked in

the Vaccine Program. Exhibit CC at 1. When she has occasionally participated in

other medico-legal work, she has donated any earnings to her employer to fund

activities to teach residents. Id. at 1-2.

Dr. Ducatman earned her medical degree from Albany Medical College in

1979. She received additional training in anatomic pathology and clinical

pathology at the Mayo Clinic from 1979 to 1983. Exhibit SS (updated curriculum

vitae) at 4. In 1983, she became board-certified in anatomic and clinical

pathology. Id.

A significant portion (1996-2017) of Dr. Ducatman’s career was working in

the pathology department at the West Virginia University School of Medicine.

Exhibit SS at 5. She became a professor of pathology in 2017. Id. at 6. While at

West Virginia, Dr. Ducatman taught subjects in the second-year pathology course,

such as pulmonary pathology, head and neck pathology, and gynecologic

pathology. Tr. 405.

43

From West Virginia University, Dr. Ducatman moved to Oakland University

William Beaumont School of Medicine, where she is currently the assistant dean of

clinical affairs. Exhibit SS at 5-6. She also serves as a professor of pathology in

the same institution.

Dr. Ducatman has continued to act as a pathologist. She estimated that in

the last five years, she reviewed 50 cases in which a pulmonary vasculitis was

suspected. Exhibit CC at 1. She also reviewed approximately 5-10 cases in which

vasculitis was suspected in other organs, such as the skin. Id.

Dr. Ducatman was recognized as an expert in the field of pathology. Tr.

409.

C. Comparison

Here, on the topic of diagnosing vasculitis, Dr. Matloubian was superior to

Dr. Steinman. Dr. Steinman recognized that rheumatologists treat people suffering

from cryoglobulinemia. Tr. 330. Dr. Matloubian also works in a hospital that

receives people with complex cases of vasculitis. Tr. 489-90. On the other hand,

Dr. Steinman’s description of his experience with “vasculitis” seems overly broad

in that Dr. Steinman included any patient with a demyelinating disease. Tr. 330.

Between the two pathologists, Dr. Ducatman was superior. Her knowledge

about vasculitides was more advanced than Dr. Rostad’s knowledge on this topic.

She also made a favorable impression as someone who was primarily interested in

conveying information, as opposed to presenting an opinion that would assist the

party who had retained her in the litigation.

44

VI. Diagnosis

In Broekelschen v. Sec’y of Health and Hum. Servs., 618 F.3d 1339, 1346

(Fed. Cir. 2010), the Federal Circuit recognized that in some circumstances, the

special master may “first determine which injury was best supported by the

evidence in the record before applying the Althen test.” When petitioners do not

establish that the vaccinee suffered the condition they allege a vaccine caused, the

Althen analysis becomes superfluous. See Doe v. Sec'y of Dep't of Health & Hum.

Servs., 94 Fed. Cl. 597, 624 (2010), aff’d sub nom. Lombardi v. Sec'y of Health &

Hum. Servs., 656 F.3d 1343 (Fed. Cir. 2011).

A. Procedural History regarding Disputes over Diagnosis

The parties and the four experts they retained do not agree about the

conditions affecting Mr. Rocha. These disputes were initially disclosed in the

reports from the experts. However, the parties’ positions were “confusing.” Order

for Preadjudication Briefs, issued July 14, 2020, at 5 (summarizing expert reports).

Ms. Rocha asserted that Mr. Rocha suffered from “systemic vasculitis.”

Pet’r’s Prehear’g Br. at 17. She further maintained that Mr. Rocha suffered

manifestations of this vasculitis within approximately three weeks of his October

18, 2013 flu vaccination. Id. at 20. Ms. Rocha did not put forward a theory that

Mr. Rocha experienced varicella zoster vasculitis.

The Secretary advanced three points regarding diagnosis. First, the

Secretary argued that Mr. Rocha did not have vasculitis, but it was possible he had

cryoglobulinemic vasculitis. Resp’t’s Prehear’g Br. at 17. Second, Mr. Rocha had

cryoglobulinemia. Id. at 19-21. Third, either the cryoglobulinemia or the

cryoglobulinemic vasculitis started before Mr. Rocha’s vaccination. Id. at 21.

Ms. Rocha replied to the Secretary’s arguments regarding diagnosis with a

request for a hearing to receive oral testimony. Ms. Rocha argued that oral

testimony about diagnosis was especially important due to the inconsistencies

among the experts. Pet’r’s Prehear’g Reply at 1-3.

The experts did testify at the hearing. Their testimony largely did not

change the parties’ positions. However, the pathologists discussed the scope and

types of vasculitides.

Dr. Rostad stated that the etiology of most major types of vasculitis is

unknown, but that they can be grouped based on their histologic appearance, the

immune profile, and certain infections with which different types are associated.

45

Tr. 151. He testified that “it’s difficult to classify all types of vasculitis.” Id. at

199. Dr. Rostad would defer to a clinician as to whether the type of vasculitis

would affect a person’s treatment, but opined that the type can affect one’s

prognosis. Id. at 221-22. Dr. Rostad stated that the type of vasculitis Mr. Rocha

had was immune complex mediated and acknowledged that cryoglobulinemic

vasculitis is one of the many types of immune complex types. Id. at 226.

Dr. Ducatman disagreed with Dr. Rostad’s statement that it is difficult to

classify the different types of vasculitis. Tr. 423. She explained that, although

there is “some overlap” between the types, they have different clinical symptoms,

organs they affect, histologies, and treatments. Id. at 422. Dr. Ducatman testified

that she “make[s] these diagnoses all the time,” and she could not recall any recent

cases in which she diagnosed vasculitis but was unable to specify the type. Id. at

423.

Dr. Ducatman explained that identifying the precise type of vasculitis affects

treatment. Tr. 424-25. She also maintained that “systemic vasculitis” is not a type

of vasculitis because the term systemic refers to the presence of vasculitis

“throughout the body in different organs.” Tr. 424. Dr. Ducatman explained that

all types of vasculitis are potentially systemic; vasculitis may be organ-specific, or

may affect multiple organs. Tr. 424-25. “Even though you may call it systemic –

it’s a systemic form . . . It may only affect one organ initially . . . and then go in

another.” Tr. 425. Dr. Ducatman also stated that it is “highly unlikely to have . . .

multiple types of vasculitis in the same person.” Tr. 446. To her recollection, she

had never diagnosed a person with two types of vasculitis and had never seen such

in any of the hundreds of autopsies and biopsies she has performed. Id. at 446,

450.

Dr. Steinman testified that varicella zoster, and no other vasculitides,

accounted for Mr. Rocha’s clinical presentation. Tr. 340. It was his opinion that

Mr. Rocha had cryoglobulinemic vasculitis prior to his vaccine, and developed a

varicella zoster virus vasculitis after the vaccination, with onset in January 2014.

Id. at 340-41. Dr. Steinman also opined that Mr. Rocha’s kidney and perhaps GI

tract were affected by varicella zoster vasculitis. Id. at 343.

Dr. Matloubian disagreed with Dr. Steinman’s proposal that Mr. Rocha had

varicella zoster vasculitis. Tr. 504. He stated that if this had been the cause of

vasculitis in the other organs, he would expect Mr. Rocha to have signs and

symptoms of the varicella zoster vasculitis affecting his intracranial and cerebral

arteries, and symptoms of a stroke or aneurysms and bleeding in his head. Id. at

505.

46

After the hearing, just as she had argued in her prehearing brief, Ms. Rocha

contended that Mr. Rocha suffered from “systemic vasculitis” and that he

experienced symptoms within three weeks of the vaccination. Pet’r’s Posthear’g

Br. at 11-12. She maintained: “Preponderant evidence supports a finding that Mr.

Rocha developed vasculitis as a direct result of the flu vaccine.” Id. at 16-17. Ms.

Rocha stated that the flu vaccine caused an “immune complex reaction.” Id. at 14,

citing Tr. 241. Ms. Rocha did not discuss varicella zoster vasculitis.

In response, the Secretary added a new argument that Ms. Rocha’s assertion

of “vasculitis” without any description of the type of vasculitis did not satisfy

petitioner’s burden on Broekelschen. Resp’t’s Posthear’g Br. at 21-22. Otherwise,

the Secretary largely reargued the same three points: Ms. Rocha had not

established that Mr. Rocha suffered from systemic vasculitis or varicella zoster

vasculitis; Mr. Rocha suffered from cryoglobulinemia; and regardless of whether

Mr. Rocha had cryoglobulinemia or cryoglobulinemic vasculitis, his problem pre-

dated the flu vaccination. Id. at 23-29.

Ms. Rocha replied. She characterized Mr. Rocha’s condition as “immune

complex mediated vasculitis.” Pet’r’s Posthear’g Reply at 1. She further argued

that this degree of specificity is in accordance with Mager v. Sec’y of Health &

Hum. Servs., 158 Fed. Cl. 136, 154 (2022), appeal dismissed, No. 2023-2382,

2023 WL 7318303 (Fed. Cir. Nov. 7, 2023). She maintained that the doctors’

treatment for vasculitis proves that Mr. Rocha had vasculitis. Ms. Rocha also

characterized whether Mr. Rocha suffered from cryoglobulinemia before

vaccination as a “red herring.” She again did not offer varicella zoster vasculitis.

B. Assessment of Diagnosis

The collection of briefs identified three issues within the topic of diagnosis:

(1) whether a description of “systemic vasculitis” or “immune complex mediated

vasculitis” satisfies Broekelschen’s requirement; (2) whether Mr. Rocha suffered

from any type of vasculitis and, if so, when the vasculitis began; and (3) whether

Mr. Rocha suffered from varicella zoster vasculitis. These are taken up in turn.

1. Sufficiency of Proposed Diagnosis

The Secretary argues that Ms. Rocha has not presented preponderant

evidence showing that Mr. Rocha suffered from “systemic vasculitis.” Resp’t’s

Posthear’g Br. at 21-22. This argument rests upon Dr. Ducatman’s testimony that

there are many different vasculitides. Id.; Tr. 422. Dorland’s Medical Dictionary

lists more than 20 types. Dorland’s at 1996.

47

Ms. Rocha argues that, pursuant to Broekelschen, she does not need to

identify a more specific injury if “the possible diagnoses for the injury are variants

of the same disorder.” Pet’r’s Posthear’g Reply at 1. Here, she argues, “immune

complex mediated vasculitis could have varied expressions, but the pathogenesis

would be the same,” and the “symptoms are all on the same spectrum of immune

complex mediated vasculitis.” Id. Further, Ms. Rocha argues that the case “is not

about the type of immune complex mediated vasculitis Mr. Rocha had,” but

whether he had it at all. Id. at 2.

Pursuant to Broekelschen, a petitioner must demonstrate that a vaccinee

suffered from the injury that a vaccine is alleged to have caused. 618 F.3d at 1346.

Relatively few cases have wrestled with the question about whether a certain

condition is sufficiently defined to satisfy the terminology used in Broekelschen.

In Mager, the parties agreed that the vaccinee suffered from an epileptic

seizure disorder but disagreed as to the diagnosis; petitioner argued that it was

autoimmune epilepsy, and respondent argued juvenile myoclonic epilepsy. 2021

WL 3737056 at *2 (Fed. Cl. Spec. Mstr. July 29, 2021). The (undersigned) special

master found that petitioner had not met his burden to show that the vaccinee

suffered from autoimmune epilepsy and denied compensation. Id. at 12. The

decision was vacated and remanded. As the Court of Federal Claims explained,

although the case “involve[d] competing diagnoses, they are only competing in the

sense that the parties dispute them – not in the sense that they are mutually

exclusive.” 158 Fed. Cl. 136, 155 (2022). The parties agreed that the vaccinee

suffered from a seizure disorder, and thus “the ‘existence and nature of the injury’

was not in dispute.” Id. at 156 (quoting W.C. v. Sec’y of Health & Hum. Servs.,

704 F.3d 1352, 1357 (Fed. Cir. 2013)). These circumstances distinguished Mager

from Lombardi and Broekelschen, where the identification and nature of the injury

were in dispute, and “the question of causation turn[ed] on [the] injury.” Id. at 155

(quoting Broekelschen, 618 F.3d at 1346).

Here, the conditions that Ms. Rocha proposes are too general. To repeat, at

various points, she has maintained that Mr. Rocha suffered from “systemic

vasculitis,” Pet’r’s Posthear’g Br. at 12; “vasculitis,” Pet’r’s Posthear’g Br. at 16-

17, and “immune complex mediated vasculitis,” Pet’r’s Posthear’g Reply at 1.

Any of these diagnoses is too broad to meet petitioner’s burden under

Broekelschen. As Dr. Ducatman explained, different types of vasculitis are

distinguishable, and two types do not affect a single patient. Thus, Mr. Rocha’s

condition is distinguishable from the competing diagnoses in Mager, which were

not mutually exclusive. See 158 Fed. Cl. at 155. Dr. Ducatman was adamant that

“systemic vasculitis” is not a proper diagnosis and noted that different types of

48

vasculitis require different treatments. Dr. Rostad also acknowledged that different

types are associated with different viruses and have different prognoses. Because

the types of vasculitis are so distinct, a generalized injury of “system vasculitis” or

“immune complex mediated vasculitis” is not specific enough. See E.M. v. Sec'y

of Health & Hum. Servs., No. 14-753V, 2021 WL 3477837, at *35 (Fed. Cl. Spec.

Mstr. July 9, 2021) (finding that petitioner failed to show by preponderant

evidence that she suffered from “small vessel vasculitis,” as this is “not a disease in

and of itself, but rather is an umbrella diagnosis” encompassing several versions of

small vessel vasculitis, which each have differential diagnostic criteria).

Regardless, as found below in section II.A.3, the evidence preponderates in

favor of finding that Mr. Rocha suffered from a specific type of vasculitis –

cryoglobulinemic vasculitis – before he received the flu vaccine. This finding is

based upon all the evidence and is not simply an endorsement of the opinion from

a single expert. Sword v. United States, 44 Fed. Cl. 183, 188–89 (1999). Mr.

Rocha’s cryoglobulinemic vasculitis is discussed more thoroughly below.

2. Vasculitis in Mr. Rocha

Ignoring Dr. Steinman’s opinion that Mr. Rocha had longstanding

cryoglobulinemic vasculitis (Tr. 340-45), Ms. Rocha argues that the flu vaccine

caused Mr. Rocha to have vasculitis. Pet’r’s Posthear’g Br. at 16-17. However,

ample evidence supports a finding that Mr. Rocha had cryoglobulinemia for years

before the vaccination. See Exhibit A at 3-9 (Dr. Matloubian’s report summarizing

medical records). Admittedly, the evidence that Mr. Rocha suffered

cryoglobulinemic vasculitis (meaning that cryoglobulins were in Mr. Rocha’s

small vessels) is not quite as strong. Dr. Ducatman’s assessment was “50/50.” Tr.

441-42. However, the burden of proof for any factual issue is simply

preponderance of the evidence. Here, other evidence, including most significantly

Dr. Steinman’s opinion, tips the proverbial evidentiary scales to favor a finding

that Mr. Rocha suffer cryoglobulinemic vasculitis before the vaccination.

Ms. Rocha contends that before the vaccination, no doctor diagnosed Mr.

Rocha as suffering from cryoglobulinemia or cryoglobulinemic vasculitis, but after

the vaccination, doctors did diagnose Mr. Rocha with vasculitis. As a preliminary

point, Ms. Rocha’s contention is accurate on the facts. However, this simple

reliance on the date of diagnosis is not persuasive.

Although the parties’ experts disagreed as to the overall complexity in

diagnosing vasculitis, they agreed that diagnosing vasculitis may be difficult in at

least some cases. Tr. 219 (Dr. Rostad), 421, 423 (Dr. Ducatman). This challenge is

49

enhanced because Mr. Rocha was not being treated for his infection with hepatitis

B virus, an infection that is associated with vasculitis.

The difficulty in detecting vasculitis is reflected in the events at Trinity and

Barnabas. During these two hospitalizations, which totaled approximately 16 days,

doctors did not diagnose Mr. Rocha with vasculitis. Exhibit 9 at 22 (Trinity

discharge report); Exhibit 12 at 22 (Barnabas discharge report). This treatment

occurred when, according to Ms. Rocha, Mr. Rocha was suffering from a vasculitis

induced by his October 18, 2013 flu vaccination.

The doctor who first raised the possibility of vasculitis was the

rheumatologist at Overlook, Dr. Mather. On January 1, 2014, she stated that

“based on the labs and based on his symptoms, it seems that an autoimmune

condition such as vasculitis is a possibility.” Exhibit 10 at 229. Dr. Mather also

documented how a diagnostic possibility of vasculitis could be confirmed via

additional testing such as a kidney biopsy, lung biopsy, CT scan of the abdomen

and/or an MR angiogram. Id.

In any event, after Dr. Mather received Dr. Markowitz’s interpretation of the

kidney biopsy and the result of the second test for cryoglobulins, Dr. Mather

assessed Mr. Rocha was “cryoglobulinemic vasculitis.” Exhibit 10 at 184. The

Overlook discharge report stated that Mr. Rocha “likely [had] cryoglobulinemic

vasculitis.” Id. at 17.

As a matter of logic, a doctor’s detection of a disease does not establish the

date the disease began. Special masters have recognized that a person could be

suffering from a disease for months or years before the disease is diagnosed, and

multiple appellate opinions have upheld those findings. See, e.g., Milik v. Sec’y of

Health & Hum. Servs., 822 F.3d 1367, 1380 (Fed. Cir. 2016) (special master was

not arbitrary in determining that child-vaccinee had developmental delay before

vaccination); W.C., 704 F.3d at 1358 (special master was not arbitrary in relying

upon MRI lesions to find petitioner suffered from multiple sclerosis before

vaccination); Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1254 (Fed.

Cir. 2011) (special master was not arbitrary in finding that liver biopsy meant that

petitioner had liver disease for many years before vaccination); Spahn v. Sec’y of

Health & Hum. Servs., 133 Fed. Cl. 588, 599 (2017) (special master was not

arbitrary in finding that child-vaccinee suffered from obsessive-compulsive

disorder before vaccination); Hunt v. Sec’y of Health & Hum. Servs., 123 Fed. Cl.

509, 520-21 (2015) (special master did not err in finding child-vaccinee suffered

from undiagnosed multiple sclerosis before vaccination); Crutchfield v. Sec’y of

Health & Hum. Servs., 125 Fed. Cl. 251, 264 (2014) (special master was not

50

arbitrary in finding that results of A1c test for hemoglobin meant that petitioner’s

islet cell destruction began before vaccination); see also M.R. v. Sec’y of Health &

Hum. Servs., No. 16-1024V, 2023 WL 4936727 at *34 (Fed. Cl. Spec. Mstr. June

30, 2023) (special master distinguished when a neuroma was discovered from

when the neuroma began); Orm v. Sec’y of Health & Hum. Servs., No. 14-257V,

2023 WL 2984794 at *37 (Fed. Cl. Spec. Mstr. Mar. 24, 2023) (special master

determined petitioner had celiac disease before vaccination because anemia takes

long time to manifest); Specks v. Sec’y of Health & Hum. Servs., No. 15-491V,

2023 WL 2947619 at *42 (Fed. Cl. Spec. Mstr. Feb. 17, 2023) (special master

found petitioner’s POTS pre-existed vaccination and noting that the date of

diagnosis did not control the date of onset).

Dr. Mather’s diagnosis of cryoglobulinemic vasculitis returns the analysis in

this decision to its start. The foundational point is that a preponderance of the

evidence supports a finding that Mr. Rocha had cryoglobulinemic vasculitis of

many decades’ duration before the flu vaccination. Dr. Rostad’s attempts to

undermine Dr. Mather’s conclusions were largely ineffective. In this regard, Dr.

Rostad’s inability to propose a type of vasculitis diminished his credibility. See Tr.

198, 201; see also Tr. 423 (Dr. Ducatman stating that she “make[s] these diagnoses

all the time.”).

For all these reasons, Ms. Rocha has not persuasively shown that Mr. Rocha

developed vasculitis after the flu vaccine. Instead, the evidence persuasively

shows that he had cryoglobulinemic vasculitis before the vaccination.

3. Varicella Zoster Vasculitis

Dr. Steinman’s theory of the case involves the flu vaccine triggering a latent

herpes virus and the zoster infection causing vasculitis. Exhibit 21 at 6. Dr.

Steinman indicated that the first sign of the varicella zoster vasculitis was when

Mr. Rocha had Ramsay Hunt. Tr. 341-43.

The other experts did not agree that Mr. Rocha suffered from varicella zoster

vasculitis. On cross-examination, Dr. Rostad stated that Mr. Rocha did not have

the signs of varicella zoster vasculitis listed in an article about varicella zoster

vasculitis. Tr. 228. Dr. Matloubian maintained that he did not see any evidence

that Mr. Rocha suffered from varicella zoster vasculitis. Tr. 504. This testimony

was the basis for the Secretary’s argument that Mr. Rocha did not suffer from

varicella zoster vasculitis. Resp’t’s Posthear’g Br. at 24.

51

Ms. Rocha’s failure to present any argument that Mr. Rocha suffered from

varicella zoster vasculitis could constitute a forfeiture of a claim involving

varicella zoster vasculitis. Vaccine Rule 8(f)(1). But resolving this issue based

upon waiver or forfeiture is unnecessary, because the evidence does not

preponderate in favor of finding that Mr. Rocha had varicella zoster vasculitis. See

Tr. 504. This evidentiary finding resolves the issue against Ms. Rocha.

VII. Significant Aggravation

Theoretically, the finding that Mr. Rocha suffered from cryoglobulinemic

vasculitis before the flu vaccination does not necessarily end his case because he

could allege that the flu vaccination significantly aggravated his cryoglobulinemic

vasculitis. However, as a practical matter, the finding that the cryoglobulinemic

vasculitis existed before the flu vaccination means that Mr. Rocha’s estate cannot

receive compensation for two related reasons.

First, a claim for significant aggravation requires a showing that a vaccine

experienced “any change for the worse in a preexisting condition which results in

markedly greater disability, pain, or illness accompanied by substantial

deterioration of health.” 42 U.S.C. § 300aa–33(4). However, the evidence does

not support a finding that Mr. Rocha’s cryoglobulinemic vasculitis worsened

within a reasonable amount of time proximate to the vaccination. After the flu

vaccination, Mr. Rocha’s first heath problem was in his ears, leading to a diagnosis

of Ramsay Hunt syndrome. See Exhibit 5 at 7; see also section II.C, above. No

persuasive evidence connects vasculitis to an ear problem. The treatment for the

ear problem, the placement of tubes in Mr. Rocha’s ears, led to a hospitalization

during which renal troubles were detected as part of an apparently routine blood

test. Exhibit 9 at 14, 209. The treating nephrologist, Dr. Agresti, indicated that the

acute kidney injury is “most likely secondary to dehydration.” Id. at 12. Dr.

Matloubian concurred that that dehydration explained the temporary kidney

problems. Tr. 510.

Dehydration was also the basis for reduced kidney function according to the

nephrologist who treated Mr. Rocha during his hospitalization at Barnabas, Dr.

Shah. Exhibit 12 at 113. Dr. Matloubian again concurred. Exhibit A at 4-5, 9.

Furthermore, Dr. Matloubian and Dr. Ducatman opined that during Mr.

Rocha’s hospitalizations at Overlook and Beth Israel, Mr. Rocha’s

cryoglobulinemia and cryoglobulinemic vasculitis were stable. Tr. 439, 445, 448,

561. Ms. Rocha has not identified any evidence that persuasively shows that Mr.

Rocha’s cryoglobulinemic vasculitis worsened during his hospitalization.

52

This leads to the second reason for not compensating Ms. Rocha based upon

a theory that the flu vaccine significantly aggravated any pre-existing

cryoglobulinemic vasculitis---Ms. Rocha has not advanced this claim. Ms.

Rocha’s briefs filed before the hearing do not claim significant aggravation. At

best, after the hearing, Ms. Rocha mentioned this claim in a footnote. She argued:

Petitioner has not presented this as a significant

aggravation case because there is no evidence that any

pre-existing condition (real or potential) contributed to

Mr. Rocha’s post-vaccination decline and death.

However, should the Special Master find otherwise, Dr.

Steinman has presented a strong case for significant

aggravation under Loving v. Secretary of Health &

Human Services, 86 Fed. Cl. 135, 144 (2009).

Pet’r’s Posthear’g Br. at 20 n.3.

This two-sentence statement is not sufficiently developed to be persuasive.

See SmithKline Beecham, Corp. v. Apotex Corp., 439 F.3d 1312, 1320 (Fed. Cir.

2006) (explaining an argument needs to be developed, not just in footnote). Ms.

Rocha has not cited any evidence in which Dr. Steinman presented an opinion

regarding significant aggravation. It appears that Dr. Steinman mentioned a

potential “exacerbation” in responding to two questions on cross-examination. Tr.

345. Again, this evidence is too slight to constitute a persuasive basis for awarding

compensation. The lack of evidence is particularly noticeable because the

Secretary had argued before the hearing that Mr. Rocha’s cryoglobulinemia or

cryoglobulinemic vasculitis existed before the vaccination. Resp’t’s Prehear’g Br.

at 21. Thus, any claim for significant aggravation is too late. See Hirmiz v. Sec’y

of Health & Hum. Servs., 119 Fed. Cl. 209, 219-20 (2014) (declining to allow

petitioner to amend a petition to allege significant aggravation as part of a motion

for review), aff’d without op., 618 Fed. Appx. 1033 (Fed. Cir. 2015).

Accordingly, Ms. Rocha has not established with preponderant evidence that

the condition she alleges the flu vaccine caused (vasculitis) actually worsened

within a reasonable time after the vaccination. This finding is another sufficient

reason to deny compensation. Moreover, even if Ms. Rocha had persuasively

proven a sequence of events in which the flu vaccine preceded a worsening of the

vasculitis, Ms. Rocha would be required to establish that the flu vaccine caused the

worsening. As explained below, Ms. Rocha has not presented a persuasive theory

explaining how the flu vaccine can cause (or worsen) cryoglobulinemic vasculitis.

She therefore cannot prevail on a significant aggravation claim.

53

VIII. Causation-in-Fact

When pursuing an off-Table injury, a petitioner bears a burden “to show by

preponderant evidence that the vaccination brought about [the vaccinee’s] injury

by providing: (1) a medical theory causally connecting the vaccination and the

injury; (2) a logical sequence of cause and effect showing that the vaccination was

the reason for the injury; and (3) a showing of a proximate temporal relationship

between vaccination and injury.” Althen v. Sec’y of Health & Hum. Servs., 418

F.3d 1274, 1278 (Fed. Cir. 2005).

A. Althen Prongs 2 and 3

As discussed above, preponderant evidence supports a finding that Mr.

Rocha had cryoglobulinemic vasculitis before he received the October 18, 2013 flu

vaccine. A sequence of events in which the vaccination occurred after the onset of

the disease means that the vaccination did not cause the disease. Thus, Ms. Rocha

has not established “a logical sequence of cause and effect showing that the

vaccination was the reason for the injury.” Althen, 418 F.3d at 1278.

Likewise, that Mr. Rocha’s vasculitis pre-dated his vaccine necessarily

means that his symptoms did not arise within a “timeframe for which it is

medically acceptable to infer causation.” 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).

Accordingly, Ms. Rocha has not met her burden under Althen prong two or

three. See Locane v. Sec'y of Health & Hum. Servs., 685 F.3d 1375, 1381 (Fed.

Cir. 2012) (“Given the Special Master's finding that the illness was present before

the vaccine was administered, logically, the vaccine could not have caused the

illness.”). An analysis of the first Althen prong is therefore not necessary.

Nevertheless, a brief analysis is provided.

B. Althen Prong 1

The first Althen prong requires a petitioner to present a reliable and

persuasive medical theory. Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d

1351, 1359 (Fed. Cir. 2019) (citing Knudsen v. Sec’y of Health & Hum. Servs., 35

F.3d 543, 548 (Fed. Cir. 1994)). Ms. Rocha has advanced the theory of molecular

mimicry. See Pet’r’s Posthear’g Br. at 14.

54

1. Appellate Precedents regarding Molecular Mimicry

Because special masters are often called upon to evaluate the persuasiveness

of the theory of molecular mimicry, the Court of Federal Claims and the Court of

Appeals for the Federal Circuit have considered molecular mimicry in their

appellate role opinions from special masters. In December 2019, the undersigned

identified the leading precedents as W.C., 704 F.3d 1352, and Caves v. Sec’y of

Health & Hum. Servs., 100 Fed. Cl. 119 (2011), aff’d without op., 463 F. App’x

932 (Fed. Cir. 2012). Tullio v. Sec’y of Health & Hum. Servs., No. 15-51V, 2019

WL 7580149, at *12-14 (Fed. Cl. Spec. Mstr. Dec. 19, 2019), mot. for rev. denied,

149 Fed. Cl. 448 (2020). While Tullio describes those cases in more detail, their

essence appears to be that although molecular mimicry is accepted in some

contexts, special masters may properly require some empirical evidence to show

that a particular vaccine can cause a particular disease.

In the next approximately four years, appellate authorities reviewing

decisions involving molecular mimicry have generally endorsed the approach of

looking for some evidence that persuasively shows that a portion of a vaccine

resembles a portion of human tissue, which contributes to causing the disease, and

that the immune system will respond to the relevant amino acid sequence. 17

Chronologically, the list of more recent appellate cases begins with the opinion in

Tullio, which denied the motion for review. 149 Fed. Cl. 448, 467-68 (2020).

Another example in which the Court of Federal Claims held that the special

master did not elevate the petitioner’s burden of proof in the context of evaluating

the theory of molecular mimicry is Morgan v. Sec’y of Health & Hum. Servs., 148

Fed. Cl. 454, 476-77 (2020), aff’d in non-precedential opinion, 850 F. App’x 775

(Fed. Cir. 2021). In Morgan, the Chief Special Master found that petitioner had

not presented persuasive evidence about a relevant antibody. Id. at 477. The Chief

Special Master also noted that the articles about the relevant disease do not list the

wild flu virus as potentially causing the disease. Id. When examining this

analysis, the Court of Federal Claims concluded: “the Chief Special Master did not

raise the burden of causation in this case; petitioner simply failed to meet it.” Id.

17

The term “homology” is used when discussing molecular mimicry. “Homology” is

defined as “the quality of being homologous; the morphological identity of corresponding parts;

structural similarity due to descent from a common form.” Dorland’s at 868.

55

The Federal Circuit also evaluated the Chief Special Master’s approach in

Morgan. The Federal Circuit concluded: “We discern no error in the special

master’s causation analysis.” 850 F. App’x 775, 784 (Fed. Cir. 2021).

Most other recent appellate cases follow this path. See, e.g., Dennington v.

Sec’y of Health & Hum. Servs., 167 Fed. Cl. 640 (2023) (finding the special

master did not err in rejecting molecular mimicry because the theory was too

general), appeal docketed, No. 18-1303 (Fed. Cir. Dec. 1, 2023); Duncan v. Sec’y

of Health & Hum. Servs., 153 Fed. Cl. 642, 661 (2021) (finding the special master

did not err in rejecting a bare assertion of molecular mimicry); Caredio v. Sec’y of

Health & Hum. Servs., No. 17-79V, 2021 WL 6058835, at *11 (Fed. Cl. Dec. 3,

2021) (indicating that a special master did not err in requiring more than homology

and citing Tullio); Yalacki v. Sec’y of Health & Hum. Servs., 146 Fed. Cl. 80, 91-

92 (2019) (ruling that special master did not err in looking for reliable evidence to

support molecular mimicry as a theory); but see Patton v. Sec’y of Health & Hum.

Servs., 157 Fed. Cl. 159, 169 (2021) (finding that a special master erred in

requiring petitioner submit a study to establish medical theory causally connecting

flu vaccine to brachial neuritis).

Here, both Dr. Rostad and Dr. Steinman provided reports and literature to

contribute to Ms. Rocha’s molecular mimicry theory. 18 Dr. Ducatman and Dr.

Matloubian opposed this theory. The experts’ opinions are summarized.

2. Summary of the Evidence

Dr. Rostad’s reports and Dr. Ducatman’s responses focused primarily on Mr.

Rocha’s diagnosis. Their discussion of causation was limited. In his first report,

Dr. Rostad explained that molecular mimicry “is generally accepted as a primary

mechanism by which vaccines can lead to autoimmune disease.” Exhibit 55 at 12.

He stated that “Vaccines have been associated with autoimmune diseases in a

number of conditions,” and provided tables of various autoimmune diseases and

manifestations related to several different vaccines. Id. at 13, 15. Dr. Rostad

concluded: “The influenza vaccine initiated an autoimmune response towards

antigens possibly present in the endothelium of blood vessels, through the

mechanism of molecular mimicry.” Id. at 19.

18

Dr. Rostad also noted that other theories, such as epitope spreading, bystander

activation, and polyclonal activation “may work in isolation or in concert with each other.”

Exhibit 55 at 12. However, he did not discuss these theories beyond listing them, and they are

not included in the analysis here.

56

In response, Dr. Ducatman commented that “Dr. Rostad’s hypotheses are not

likely to represent the cause of [Mr. Rocha’s] demise,” and noted that

“cryoglobulinemia is a very infrequent result of influenza vaccination with only

two reported cases.” Exhibit PP at 2.

Dr. Steinman and Dr. Matloubian dedicated more of their reports to

causation. Dr. Steinman theorized that the flu vaccine activated an innate immune

response in Mr. Rocha, leading to activation of a latent herpes zoster virus,

culminating in Ramsay Hunt, which then triggered vasculitis. Exhibit 46 at 7. Dr.

Steinman performed BLAST searches to identify homologies between the flu

vaccine and the dorsal root ganglia, which is where the herpes zoster virus lies

latent. Id. at 5, 9. He explained that his criterion for a “relevant molecular mimic”

in his BLAST searches was based on the Gautam articles finding that homology

between 5 of 12 and 4 of 11 non-consecutive amino acids was sufficient to trigger

experimental encephalomyelitis. Id. at 13-15 (referencing the two Gautum articles

and the Bao article).19 Dr. Steinman stated that the nuclear factor kappa B-cell

signaling (NF-κB) cell – “the master regulator of inflammation” – is activated by

the flu vaccine and leads to the activation of zoster. Id. at 23; see also Tr. 325.

Dr. Matloubian disputed that an activated immune response could result in

Ramsay Hunt, stating that it is “the opposite of the generally accepted principle

that waning immunity or immunosuppression is the major cause of [varicella zoster

virus] reactivation.” Exhibit A at 16. He characterized the theory as “purely

speculative” and without scientific support. Id. Dr. Matloubian noted that the

studies cited by Dr. Steinman did not address whether the inactivated flu vaccine

can activate NF-κB where varicella zoster virus lies dormant, nor did the studies

show a long-lasting effect of the flu vaccine on the nervous system. Id. at 19.

Further, the studies indicated that activation of NF-κB should inhibit – not activate

– varicella zoster virus. Id. at 20.

Dr. Matloubian also commented on the BLAST searches, noting that none of

the articles Dr. Steinman cited “show any association between a T cell mediated

response to [the proteins he searched for] and development of an ‘inflammatory

19

Anand M. Gautum et al., A polyalanine peptide with only five native myelin basic

protein residues induces autoimmune encephalomyelitis, 176 J. EXP. MED. 605 (1992); filed as

Exhibit 34; Anand M. Gautum et al., A viral peptide with limited homology to a self peptide can

induce clinical signs of experimental autoimmune encephalomyelitis. 161 J. IMMUNOL. 60

(1998); filed as Exhibit 35; Lan Bao, Trafficking regulates the subcellular distribution of

voltage‑gated sodium channels in primary sensory neurons, 11 MOL. PAIN 61 (2015); filed as

Exhibit 36.

57

neuropathy.’” Exhibit A at 15-16. Additionally, many linear sequence homologies

exist, and “the vast majority of these are not associated with biologically relevant

autoimmune phenomena or actual human disease.” Id. at 15 (quoting Institute of

Medicine’s Committee to Review Vaccine Adverse Effects of Vaccines). Because

of this commonality, as well as the complexity by which T cells recognize foreign

peptides or antigens, “sequence homology itself is not sufficient evidence to prove

pathogenic molecular mimicry as agreed to by the [Institute of Medicine’s]

committee.” Id. at 16. Dr. Matloubian criticized Dr. Steinman’s reliance on the

two Gautam articles, as their findings relate to how specific antigen peptides

interact with specific mice, and do not mean that sequence homology implies

antigenicity. Id. at 16-17.

In response, Dr. Steinman “strongly disagree[d]” with Dr. Matloubian’s

statement that varicella zoster virus infection is caused by immune suppression

rather than activation. He explained that varicella zoster virus suppresses the NF-

κB pathway by down-modulating the interferon beta pathway. The varicella zoster

virus then goes into latency. However, the flu vaccine activates the interferon beta

pathway and thereby directly opposes NF-κB suppression, activating the varicella

zoster virus and resulting in Ramsay Hunt Syndrome. Exhibit 49 at 2-3. Dr.

Steinman did not address Dr. Matloubian’s critiques of his BLAST searches or

reliance on Gautam. Dr. Matloubian maintained his opinions in his second report.

Exhibit BB at 3.

At the hearing, when asked if his theory that NF-κB could trigger varicella

zoster virus reactivation was accepted in the medical community, Dr. Steinman

stated, “I believe it is, but that all depends on what you mean by accepted.” Tr.

356-57. He noted that he provided medical literature, but the studies he referenced

did not discuss NF-κB reactivating a latent varicella zoster virus. Tr. 358-61.

In contrast, Dr. Matloubian testified that the theory that NF-κB activation

triggers varicella zoster virus reactivation is not generally accepted in the medical

community, and he was unaware of any medical literature hypothesizing such. Tr.

527-28. Moreover, nothing in the literature supported the theory that the flu

vaccine activates the interferon beta pathway and thus opposes NF-κB suppression.

Tr. 532. He stated that nothing Dr. Steinman submitted persuaded him that NF-κB

activation would be beneficial to varicella zoster virus in any way. Id. at 532-33.

Dr. Matloubian explained that interferons are antiviral and interfere with virus

replication. When interferon activates NF-κB, it inhibits varicella zoster virus

replication. Id. Additionally, Dr. Matloubian stated that the literature Dr.

Steinman submitted actually contradicts his own theory and shows that NF-κB

inhibits varicella zoster virus replication. Id. at 535. Dr. Matloubian reiterated that

58

homology with amino acids is common and questioned the significance of Dr.

Steinman’s BLAST results. Id. at 562-63.

3. Analysis

Under Broekelschen, “a petitioner must provide a reputable medical or

scientific explanation that pertains specifically to the petitioner’s case.” 618 F.3d

at 1345 (emphasis added). Dr. Rostad’s conclusion that “The influenza vaccine

initiated an autoimmune response towards antigens possibly present in the

endothelium of blood vessels, through the mechanism of molecular mimicry,”

Exhibit 55 at 19, is not supported by the medical literature Dr. Rostad cited. These

articles largely discuss different vaccines, different types of vasculitis, or different

diseases altogether. See Exhibit 55 at 13-15 (Dr. Rostad discussing various

autoimmune diseases reported linked to several vaccines); see also Resp’t’s

Posthear’g Br. at 31 (noting that Exhibits 60, 68, 73, 74, and 81 discuss different

diseases and conditions); see also Tr. 257-64 (discussion of articles at hearing).

Ms. Rocha did not address the Secretary’s argument that the literature was

irrelevant, beyond stating that the Secretary was attempting to raise the burden of

proof. See Resp’t’s Posthear’g Reply at 3-4. Dr. Rostad’s bare molecular mimicry

theory, unaccompanied by literature linking the flu vaccine to cryoglobulinemic

vasculitis, is not reliable or persuasive to meet Ms. Rocha’s burden under first

Althen prong. See Sullivan, 2015 WL 1404957, at *18 (finding that expert had

“done no more than opine that it is intellectually conceivable that administration of

[vaccine] could result in injury]” where petitioner advanced bare molecular

mimicry theory and “offer[ed] a few alternative mechanisms, but they are

incompletely sketched out at best.”).

While Dr. Steinman was rather equivocal about whether his theory was

accepted in the medical community, Dr. Matloubian was firm that it was not.

Special masters may consider whether an opinion is generally accepted. Terran v.

Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999).

Furthermore, Dr. Steinman was not able to identify clear support for his theory in

literature. Although Dr. Steinman identified homologies with his BLAST

searches, “the finding of sequence homology does not necessarily mean the

similarity has significance to the immune system.” Tullio, 2019 WL 7580149, at

*15. Dr. Steinman did not provide any evidence demonstrating that the

homologies he identified were related to Mr. Rocha’s injury. See Brayboy v. Sec'y

of Health & Human Servs., No. 15-183V, 2021 WL 4453146, at *19 (Fed. Cl.

Spec. Mstr. Aug. 30, 2021) (“It also cannot be enough that a medical expert can

simply identify homologous peptides from a generic BLAST search that are not, in

any way, linked to the biological process that is dysfunctional or has suffered

59

injury.”). For these reasons, Dr. Steinman’s theory is also not reliable or

persuasive, and Ms. Rocha has not met her burden under Althen prong one.

IX. Conclusion

Mr. Rocha suffered from medical conditions before receiving a flu

vaccination on October 18, 2013. Indisputably, he suffered from an infection with

hepatitis B. He also, most likely, suffered from cryoglobulinemic vasculitis. Mr.

Rocha also suffered from additional health problems after receiving the flu

vaccination and the etiology of some of these health problems was elusive. This

uncertainty regarding the cause of Mr. Rocha’s decline and eventual death may

have led Ms. Rocha to believe that the flu vaccine caused Mr. Rocha’s health

problems. Ms. Rocha merits sympathy for the death of her husband.

However, the evidence does not support a finding that the flu vaccine caused

any adverse effect on Mr. Rocha’s health. The flu vaccine did not worsen his

cryoglobulinemic vasculitis, which existed before the vaccination.

Accordingly, Ms. Rocha is not entitled to compensation. The Clerk’s Office

is instructed to enter judgment in accordance with this decision unless a motion for

review is filed. Information about filing a motion for review, including the

deadline, can be found in the Vaccine Rules, available through the Court’s website.

IT IS SO ORDERED.

s/Christian J. Moran

Christian J. Moran

Special Master

60