D'Angiolini v. Hhs

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

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

JOSEPH MICHAEL D’ANGIOLINI, * No. 99-578V

* Special Master Christian J. Moran

Petitioner, *

* Filed: March 27, 2014

v. *

* hepatitis B vaccine; yeast allergy;

SECRETARY OF HEALTH * chronic fatigue syndrome (“CFS”);

AND HUMAN SERVICES, * systemic lupus erythematosus

* (“SLE”); autoimmune syndrome

Respondent * induced by adjuvants (“ASIA”).

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

Barry W. Krengel, Dolchin, Slotkin & Todd, P.C., Philadelphia, PA, for petitioner;

Heather L. Pearlman, United States Dep’t of Justice, Washington, DC, for

respondent.

PUBLISHED DECISION DENYING ENTITLEMENT TO COMPENSATION 1

Joseph D’Angiolini alleges that he experienced an adverse, and possibly

allergic, reaction to the hepatitis B vaccination which caused him to develop

chronic fatigue syndrome (“CFS”), systemic lupus erythematosus (“SLE”), and

autoimmune syndrome induced by adjuvants (“ASIA”). Mr. D’Angiolini seeks

compensation pursuant to the National Childhood Vaccine Injury Compensation

Program, 42 U.S.C. §§ 300aa-10 through 34 (2012).

Mr. D’Angiolini primarily relies on the testimony of Dr. Frank Vasey, a

board certified rheumatologist who has treated Mr. D’Angiolini since 2000, and

1

The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17,

2002), requires that the Court post this decision on its website. Pursuant to Vaccine Rule 18(b),

the parties have 14 days to file a motion proposing redaction of medical information or other

information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by the special

master will appear in the document posted on the website.

Dr. Yehuda Shoenfeld, a specialist in autoimmune disease. In their testimony,

Doctors Vasey and Shoenfeld discussed Mr. D’Angiolini’s alleged injuries

including CFS, SLE and ASIA. Mr. D’Angiolini’s experts also provided various

theories to explain how the hepatitis B vaccine could have caused Mr.

D’Angiolini’s alleged injuries. Mr. D’Angiolini’s diagnoses and causation theories

were opposed by respondent’s expert witnesses: Dr. Robert W. Lightfoot, also a

board certified rheumatologist, and J. Lindsay Whitton, PhD, who specializes in

virology and immunology. For the reasons set forth below, Mr. D’Angiolini failed

to establish persuasively that he does in fact suffer from any of his alleged

injuries, including CFS, SLE and ASIA, and thus, has not demonstrated that he is

entitled to compensation.

This decision is organized into the following topics:

Contents

I. Procedural History ...............................................................................................2

II. Standards for Adjudication ................................................................................16

III. Facts ..................................................................................................................17

IV. General Assessment of Witnesses ....................................................................38

V. Yeast Allergy ....................................................................................................45

VI. Chronic Fatigue Syndrome ...............................................................................51

VII. Lupus ................................................................................................................75

VIII. ASIA................................................................................................................94

IX. Conclusion .....................................................................................................100

I. Procedural History

This case is one of the oldest cases pending at the Office of Special Masters.

This unusually lengthy procedural history certainly does not accord with the quick

case processing Congress anticipated. See H.R.Rep. No. 99–908, reprinted in 1986

U.S.C.C.A.N. 6344, 6344. But, the amount of time for this litigation reflects an

attempt to allow Mr. D’Angiolini to develop his case fully and persuasively.

Mr. D’Angiolini, represented by Clifford Shoemaker, filed his petition on

August 4, 1999, alleging that the hepatitis B vaccine caused him to experience an

adverse reaction. Pet., filed Aug. 4, 1999, at 1. Around this same time, Mr.

D’Angiolini’s mother sent a letter to her son’s employer initiating a claim for

2

workers’ compensation benefits. See exhibit 58 (decision of worker’s

compensation judge) at 4-5. The workers’ compensation proceeding produced

testimony from Mr. D’Angiolini’s doctors, Mr. D’Angiolini, and Mr.

D’Angiolini’s mother.2 Although the judge denied Mr. D’Angiolini’s claim for

workers’ compensation benefits, exhibit 58 at 8, the outcome in that forum has

played no role in the evaluation of the evidence in this case.

Early in the history of Mr. D’Angiolini’s claim in the Vaccine Program, his

case was included in a group of cases in which attorneys representing petitioners,

attorneys from the government, and the Office of Special Masters were attempting

to devise a procedure to expedite the resolution of numerous cases involving the

hepatitis B vaccine. See Pet’r’s Status Rep’t, filed Feb. 15, 2000; Pet’r’s Status

Rep’t, filed July 3, 2002 (requesting a stay); see also Hennessey v. Sec’y of Health

and Human Servs., 91 Fed. Cl. 126 (Fed. Cl. 2010).

One approach was to organize cases by injuries. For example, cases in

which the petitioners alleged that hepatitis B vaccine caused demyelinating

diseases were treated similarly. See Peugh v. Sec'y of Health and Human Servs.,

No. 99–638V, 2007 WL 1531666 (Fed. Cl. Spec. Mstr. May 8, 2007) (hepatitis B

vaccine caused Guillain–Barré syndrome); Werderitsh v. Sec'y of Health and

Human Servs., No. 99–310V, 2006 WL 1672884 (Fed. Cl. Spec. Mstr. May 26,

2006) (hepatitis B vaccine caused multiple sclerosis); Gilbert v. Sec'y of Health

and Human Servs., No. 04–455V, 2006 WL 1006612 (Fed. Cl. Spec. Mstr. Mar.

30, 2006) (hepatitis B vaccine caused Guillain–Barré syndrome and chronic

inflammatory demyelinating polyneuropathy); Stevens v. Sec'y of Health and

Human Servs., No. 99–594V, 2006 WL 659525 (Fed. Cl. Spec. Mstr. Feb. 24,

2006) (hepatitis B vaccine caused transverse myelitis).

2

Mr. D’Angiolini collected the depositions of his treating doctors and filed them as one

comprehensive exhibit, exhibit 50. Because there is no separate pagination within exhibit 50,

this decision cites to the pdf pagination. In addition, a parenthetical identifies the page number

of the specific deponent. For example, “Roman Dep. Tr. 16” refers to page 16 of the transcript

for Dr. Roman’s deposition.

Similarly, Mr. D’Angiolini and his mother testified before the workers’ compensation

judge on three days. He filed this set of transcripts as exhibit 51. A parenthetical specifies the

date of the worker’s compensation hearing. For example, “June 7, 2001 W.C. Trial Tr. 14”

refers to page 14 of the transcript created on June 7, 2001 before the workers’ compensation

judge.

3

Mr. D’Angiolini’s case became, for a period, the lead case to obtain a ruling

whether the hepatitis B vaccine can cause chronic fatigue syndrome. See Pet’r’s

Status Rep’t, filed Mar. 29, 2004; order, filed Apr. 2, 2004. The goal of Mr.

Shoemaker was to identify experts who could testify at “a hearing on the general

issue of causation, or the question of whether hepatitis B vaccination ‘can’ cause

CFS.” Pet’r’s Status Rep’t, filed June 16, 2004. Mr. D’Angiolini’s counsel

identified four doctors upon whom the petitioners intended to rely: Mark Geier,

Harold T. Pretorius, Joseph A. Bellanti, and Carlo Tornatore. Pet’r’s Status Rep’t,

filed Aug. 13, 2004.

In 2005, Mr. D’Angiolini’s attorney worked to present reports from these

doctors as well as two French doctors, Romain K. Gherardi and Marc Girard.

Counsel explained that he was exploring whether components of the hepatitis B

vaccine, including thimerosal, yeast, and aluminum in the adjuvant could

contribute to an adverse reaction. Pet’r’s Status Rep’t, filed Mar. 14, 2005, at 3-4;

Pet’r’s Status Rep’t, filed Apr. 19, 2005. By October 7, 2005, the list of potential

experts had grown to eight (the six whom counsel had previously identified plus

Charles Poser and Yehuda Shoenfeld). Pet’r’s Status Rep’t, filed Oct. 7, 2005.

On February 2, 2006, petitioner’s counsel filed three reports into the

D’Angiolini case file. These reports were written by Drs. Geier, Poser, and

Shoenfeld. Exhibits 29-31.

The chief special master reassigned this case and six other cases involving

chronic fatigue syndrome to the undersigned on February 21, 2006. A status

conference to discuss the many cases involving the hepatitis B vaccine was held on

March 27, 2006. In this status conference, it became apparent that an omnibus

proceeding to address the claim that the hepatitis B vaccine can cause chronic

fatigue syndrome was not needed. By this time, the number of cases involving the

hepatitis B vaccine and chronic fatigue syndrome had decreased to a more

manageable number of cases shifting the emphasis to develop the record for Mr.

D’Angiolini’s case specifically. See Pet’r’s Status Rep’t filed Oct. 7, 2005, table A

(17 cases). Mr. D’Angiolini’s attorney stated that he did not intend to reply upon

opinions of Dr. Tornatore, Dr. Gherardi, or Dr. Girard.

After Mr. D’Angiolini filed all documents about his medical condition, the

parties recognized apparent conflicts among the sources of information. See

Resp’t’s Rep’t, filed June 28, 2006, at 6-7. These inconsistencies led to a hearing

4

during which percipient witnesses testified about Mr. D’Angiolini’s health.3 This

process produced Findings of Fact, originally issued on April 29, 2010 and re-

issued on May 18, 2010. This ruling primarily focused upon his health between

1996 (the year before Mr. D’Angiolini was vaccinated) and 1998 (the year after he

was vaccinated).4

Because the April 29, 2010 Findings of Fact appeared to resolve the genuine

issues of material facts, Mr. D’Angiolini sought an opinion from an expert that a

dose of the hepatitis B vaccine harmed him. See 42 U.S.C. § 300aa—13(a)(1).

Eventually, Mr. D’Angiolini filed reports from three experts, Yehuda Shoenfeld,

Frank Vasey, and Harold Buttram.5 The Secretary filed reports from two experts,

Robert W. Lightfoot, Jr. and Lindsay Whitton. All together, the parties submitted

15 reports from experts. These reports cited numerous articles, most of which the

parties submitted as exhibits.

The first report came from Dr. Vasey, a rheumatologist who has treated Mr.

D’Angiolini since 2000. In this report, Dr. Vasey stated that Mr. D’Angiolini

“suffers from a rare Hepatitis B vaccine reaction which has permanently disabled

him.” Dr. Vasey explained “the obvious explanation for Mr. D’Angiolini’s

reaction is the known yeast sensitivity documented at age 3 years.” Exhibit 83 at

4.

The next report was Dr. Shoenfeld’s report.6 Dr. Shoenfeld specializes in

the study of autoimmune diseases.

3

For reasons involving geography and schedules, the hearing was held in three separate

sessions. The first session was on March 21, 2007, and the last session was on April 21, 2008.

The transcript for this fact hearing (transcript pages 1-706), and the expert hearing which

followed in January 2013 (transcript pages 707-1665) are cited in this decision as “Tr.”

4

The Findings of Fact describe the procedural events, including Mr. D’Angiolini’s

change of counsel, in more detail.

5

As discussed below, about one year after Mr. D’Angiolini filed Dr. Buttram’s report, he

withdrew it.

6

This chronology skips over the October 12, 2010 report from Dr. Shoenfeld that Mr.

D’Angiolini mistakenly filed as exhibit 84. The October 12, 2010 report is obviously a draft and

was not intended to be filed. Exhibit 87 at 1.

5

Dr. Shoenfeld reviewed Mr. D’Angiolini’s medical history. He found that

the hepatitis B vaccine “unleashed the emergence of [chronic fatigue syndrome],

which then evolved into a clear cut diagnosed systemic lupus erythematosus.”

Exhibit 87 at 8.7 “Mr. D’Angiolini also fulfilled the criteria suggested by us for

[autoimmune syndrome induced by adjuvants] syndrome.” Id.8

In this report, Dr. Shoenfeld also addressed whether the onset of Mr.

D’Angiolini’s problems occurred within a time for which it was appropriate to

infer that a vaccination caused the condition. Dr. Shoenfeld stated “in the past, to

show a cause and effect of vaccine autoinflammatory reaction, we assumed that the

period between the vaccine and the reaction has to be somewhere between 3 weeks

. . . to 3 months. Better analysis of the cases of ASIA taught us that the period may

extend to months or even years.” Id. at 7.

On February 2, 2011, Mr. D’Angiolini filed a three-page supplemental

report from Dr. Vasey. Dr. Vasey provided three theories to explain a possible

causal connection between the hepatitis B vaccinations and Mr. D’Angiolini’s

injury. Exhibit 93.

These reports were discussed at a status conference. The Secretary indicated

that she intended to obtain a responsive report.

The Secretary filed a report from Dr. Lightfoot, a rheumatologist. His report

starts with a comprehensive description of Mr. D’Angiolini’s medical history.

Exhibit A at 4-14. Dr. Lightfoot goes on to question or to disagree outright with

statements of Mr. D’Angiolini’s experts. For example, Dr. Lightfoot quotes Dr.

Shoenfeld as stating that Mr. D’Angiolini has a “‘clear cut diagnosed SLE,’” but

Dr. Lightfoot asserts that Dr. Shoenfeld’s statement is “simply a misstatement of

fact. SLE is not the diagnosis of any other clinician.” Exhibit A at 16, quoting

exhibit 87 at 8.

7

The page numbers refer to the pagination centered at the top of the page.

8

In addition to chronic fatigue syndrome, systemic lupus erythematosus, and

autoimmune syndrome induced by adjuvants, Dr. Shoenfeld’s report briefly mentions

fibromyalgia. Exhibit 87 at 11. Fibromyalgia is not relevant because Mr. D’Angiolini did not

pursue a claim based upon fibromyalgia. See Pet’r’s Suppl. Br., filed June 4, 2012.

6

Dr. Lightfoot emphasized that in 1996, which was before Mr. D’Angiolini

was vaccinated, his obsessive compulsive disorder “was interfering with his care”

and “his neuropsychiatric state was deteriorating before the vaccination.” Exhibit

A at 18. Dr. Lightfoot found “nothing to document a sudden change or worsening

of petitioner’s symptoms coincident with each vaccination.” Id.

Dr. Vasey’s next report challenged Dr. Lightfoot’s representation that Mr.

D’Angiolini did not change dramatically after his vaccination. Dr. Vasey wrote

that Mr. D’Angiolini, “despite some psychological problems, functioned at a high

level and was well liked at his job as a mental health technician and could play and

teach guitar. Promptly after his hepatitis B vaccinations he could do neither.”

Exhibit 94 (report dated May 16, 2011) at 3.

Dr. Shoenfeld also responded to Dr. Lightfoot’s April 27, 2011 report by

writing a short report in which Dr. Shoenfeld cited 41 articles.9 Dr. Shoenfeld

expressed a theory of what happened to Mr. D’Angiolini. “The adjuvant is

chronically stimulating the immune system, thus leading to [an] avalanche of

various autoantibodies, hyper-gamma globulinemia, and various clinical

presentations characterized by severe fatigue . . . and neurological damage.”

Exhibit 95 (report dated May 30, 2011) at 2.

The next status conference was held on July 13, 2011. The parties discussed

a June 7, 2011 order that had posed questions to Dr. Vasey and Dr. Shoenfeld and

instructed Mr. D’Angiolini to obtain supplemental responses from them. The two

recent reports (exhibits 94 and 95), although filed after the June 7, 2011 order,

were actually written before June 7, 2011. When asked why Dr. Vasey and Dr.

Shoenfeld did not address the questions in the June 7, 2011 order, Mr.

D’Angiolini’s attorney stated that he did not recall seeing the June 7, 2011 order

and, therefore, had not sent the order to the experts. Thus, in the July 13, 2011

status conference, Mr. D’Angiolini was directed, again, to file supplemental

reports from Dr. Vasey and Dr. Shoenfeld.

In addition, the parties started to plan for a hearing. The parties anticipated

that the earliest mutually convenient dates would be in January or February 2012.

In a subsequent status conference, the parties selected February 13-14, 2012.

Orders, filed July 13, 2013 and Sept. 13, 2013.

9

Mr. D’Angiolini, however, did not file all the articles cited.

7

Mr. D’Angiolini filed the requested supplemental reports from Dr. Vasey

and Dr. Shoenfeld on September 7, 2011. The questions posed to Dr. Vasey were

primarily about his understanding of Mr. D’Angiolini’s health. In response to

those questions, Dr. Vasey stated “I agree with Dr. Lightfoot that at no time when I

cared for [Mr. D’Angiolini] did he meet the criteria for lupus.” Exhibit 96 at 1.

Dr. Vasey stated that he did not know if Mr. D’Angiolini was allergic to yeast. Id.

at 2. Dr. Vasey also indicated that “Mr. D’Angiolini suffers from an autoimmune

condition in that he has chronic flu-like symptoms which clearly developed

synchronously with his Hepatitis B vaccination.” Id. at 3.10

Like Dr. Vasey, Dr. Shoenfeld also responded to the questions contained in

the June 7, 2011 order. In response to a question about a yeast allergy, Dr.

Shoenfeld stated “[t]he yeast allergy, if it exists, is not important for the claim of a

long life [chronic fatigue syndrome] following the vaccine. . . . I believe that the

case of the CFS [is] not due [to] yeast allergy but due to adjuvant effect.” Exhibit

97 at 1. The adjuvant effect was part of Dr. Shoenfeld’s answer to a question

about elevated immunoglobulin levels. He stated that the adjuvant effect caused

chronic stimulation of Mr. D’Angiolini’s immune system and this chronic

stimulation was manifest in high levels of immunoglobulins. Id. In another

portion of his supplemental report, Dr. Shoenfeld stated that the adjuvant used in

the hepatitis B vaccine, aluminum, was deposited into Mr. D’Angiolini’s muscles,

leading to macrophage myofasciitis and causing chronic fatigue. Id. at 3.

In addition, Dr. Shoenfeld responded to questions about Mr. D’Angiolini’s

diagnosis. Dr. Shoenfeld cited five medical records that supported the lupus

diagnosis. He also cited four doctors who diagnosed Mr. D’Angiolini as having

chronic fatigue syndrome. Exhibit 97 at 2.

Since Mr. D’Angiolini had filed four reports (two from Dr. Shoenfeld and

two from Dr. Vasey), the Secretary had an obligation to disclose Dr. Lightfoot’s

response before any hearing. The Secretary submitted a supplemental report from

him as exhibit R on October 6, 2011. In response to Dr. Vasey, Dr. Lightfoot

10

As discussed below, Mr. D’Angiolini pursues claims that he suffers from a yeast

allergy, CFS, SLE and ASIA, but not an unspecified autoimmune condition as indicated in Dr.

Vasey’s report. Thus, Dr. Vasey’s unspecified autoimmune theory is not discussed further. See

Vaccine Rule 8(f)(1) (waiver of any fact or argument not raised specifically in the record before

the special master).

8

noted a simple difference in opinion regarding Mr. D’Angiolini’s health before and

after vaccination. Exhibit R at 1.

For Dr. Shoenfeld, Dr. Lightfoot’s response was more involved. Dr.

Lightfoot questioned whether aluminum as an adjuvant in the vaccine could cause

the harm as theorized by Dr. Shoenfeld. Dr. Lightfoot questioned the validity of

the macrophage myofasciitis condition and did not understand how aluminum,

which Dr. Shoenfeld said was deposited into muscles, could cause neurologic

problems, like cognitive impairments. In addition, Dr. Lightfoot noted that Dr.

Shoenfeld had not explained very well why he stated that Mr. D’Angiolini suffered

from lupus, especially since Dr. Vasey had agreed that Mr. D’Angiolini did not

suffer from lupus. Exhibit R.

Dr. Lightfoot’s report dated October 4, 2011, was anticipated to complete

the series of pre-trial reports. Thus, the undersigned issued a lengthy order,

requiring the submission of briefs before the hearing. The purpose of the order

was to afford the parties an opportunity to center their evidentiary presentations.

This concentration would particularly assist Mr. D’Angiolini because, as the

petitioner, he bore the burden of proof and because his attorney had not previously

tried a case in the Vaccine Program. The order required Mr. D’Angiolini to set

forth his evidence on each disputed element of his case, starting with the diagnoses

and continuing through each of the three Althen prongs. See Althen v. Sec’y of

Health & Human Servs. 418 F.3d 1274, 1278 (Fed. Cir. 2005); see also order, filed

Oct. 27, 2011. Shortly after the order for pre-trial briefs, another order submitted

into the record an article discussing aluminum compounds in vaccines as court

exhibit 1001.

On December 22, 2011, Mr. D’Angiolini filed a two-page supplemental

report from Dr. Shoenfeld with four articles. Exhibit 132. A more significant

submission was Mr. D’Angiolini’s pre-trial brief on January 5, 2012.

The January 5, 2012 brief presented Mr. D’Angiolini’s view of his case.

Primarily based upon the April 29, 2010 Findings of Fact, Mr. D’Angiolini

summarized the relevant facts of his medical history. He asserted that within one

week of the first dose of the hepatitis B vaccine, he was feeling “flu-ish.” Pet’r’s

Br. at 2, citing Findings of Fact at 24. He made a similar assertion, regarding his

reaction to the second dose. Id. Mr. D’Angiolini’s brief also maintained that in

the summer of 1997, he had “fatigue and overwhelming aches and pains.” Pet’r’s

Br. at 2, citing Findings of Fact at 28.

9

In regard to the appropriate diagnosis for Mr. D’Angiolini, he claimed that

he suffered from autoimmune syndrome induced by adjuvant, chronic fatigue

syndrome, systemic lupus erythematosus, and fibromyalgia. Pet’r’s Br. at 5. For

ASIA, CFS, and lupus, Mr. D’Angiolini cited to some evidence in which medical

records purportedly identified the sign or symptom fitting the relevant diagnostic

criterion. Id. at 5-9.

For the medical theory causally connecting the hepatitis B vaccination to any

injury suffered by Mr. D’Angiolini, his brief was relatively short. It covered this

topic in a single paragraph, discussing the adjuvant. Based upon Dr. Shoenfeld’s

reports, Mr. D’Angiolini asserted:

[the] hepatitis B vaccine’s adjuvant chronically stimulates the immune

system, which causes the immune system to break its tolerance of its

own constituents. The adjuvant can be deposited in the muscle, which

disrupts muscle fiber, which causes fatigue. When adjuvant diffuses

into the brain as nanoparticles, it causes damage to the brain cells,

which leads to cognitive impairment, memory loss and other

neurological manifestations.

Id. at 10.

For the logical sequence of cause and effect, Mr. D’Angiolini stated that he

was relying upon Dr. Shoenfeld. In addition, Mr. D’Angiolini identified various

doctors who linked his health problems to his hepatitis B vaccination. Id. at 11-12.

For the appropriate temporal relationship, Mr. D’Angiolini stated that Dr.

Shoenfeld’s report indicated that an autoinflammatory reaction can be anywhere

from “weeks to months, even years.” Mr. D’Angiolini also asserted that he

“manifested [an] autoinflammatory reaction within one (1) week of receiving his

first dose of Hepatitis B vaccine.” Id. at 12, citing Findings of Fact at 24.

Finally, Mr. D’Angiolini presented his witness list. He included Dr.

Shoenfeld, Dr. Vasey, and Dr. Harold Buttram. Id. at 13.

The day after Mr. D’Angiolini filed his pre-trial brief, he filed a 30-page

report from Dr. Buttram. Exhibit 153. As alluded to earlier, Mr. D’Angiolini

eventually withdrew this report. Hence, the details of Dr. Buttram’s opinion are

largely irrelevant to the outcome of the case. However, the submission of Dr.

Buttram’s report disrupted the progression of the case.

10

A status conference was held on January 9, 2012. Mr. D’Angiolini’s

attorney represented that he had not solicited Dr. Buttram’s report. Rather, Mr.

D’Angiolini’s mother had contacted Dr. Buttram and obtained it. Mr.

D’Angiolini’s attorney stated that he told Mr. D’Angiolini and his mother that he

would file the report, although it might delay the case. As Mr. D’Angiolini’s

attorney expected, the Secretary’s attorney expressed concern about needing to

respond to the report from a new expert so quickly.

The temporary solution was to divide the hearing. On February 12-13, 2012,

Dr. Shoenfeld, Dr. Vasey, and Dr. Lightfoot would testify. On a different date, Dr.

Buttram and an expert retained by the Secretary would testify. In light of this plan,

the Secretary was instructed to respond to Mr. D’Angiolini’s pre-trial brief, but to

set aside Dr. Buttram’s report temporarily. Order, filed Jan. 20, 2012.

The Secretary filed her pre-hearing brief on January 19, 2012. She disputed

each of the four potential diagnoses Mr. D’Angiolini had proposed (ASIA, lupus,

CFS, and fibromyalgia). Resp’t’s Br. at 5-8. As to the medical theory, the

Secretary quoted the portion of Mr. D’Angiolini’s brief quoted above. The

Secretary argued that Dr. Shoenfeld’s adjuvant-based theory was not reliable. Id.

at 16-17. For the logical sequence of cause and effect, the Secretary emphasized

that many of Mr. D’Angiolini’s problems appeared before the hepatitis B

vaccinations. Immediately after the vaccinations, Mr. D’Angiolini did not

experience any adverse reaction. Id. at 17, citing Findings of Fact at 25-29.

For the proximate temporal relationship, the Secretary also challenged Mr.

D’Angiolini’s proof. The Secretary stated “Dr. Shoenfeld opined that the earliest

onset time for [an autoinflammatory] reaction is three weeks.” Id. at 19, citing

exhibit 87 at 7. Mr. D’Angiolini’s brief argued that he had “‘manifested

autoinflammatory reaction within one (1) week of receiving his first dose Hepatitis

B vaccine.’” Id., quoting Pet’r’s Br. at 12. Thus, according to the Secretary, Mr.

D’Angiolini’s claim “would be too soon to have been vaccine-related.” Id.

After the Secretary’s brief, Mr. D’Angiolini filed 19 articles, exhibits 155-

73. Although all discussed ASIA, Mr. D’Angiolini did not submit an expert report

explaining the significance of those articles.

A lengthy pre-trial conference was held on February 1, 2012. Three topics

dominated the discussion. First, the Secretary questioned whether she was given

adequate notice of the newly filed articles. Second, Mr. D’Angiolini’s version of

his medical history was inconsistent with the Findings of Fact on the important

11

topic of his health in the days immediately after the hepatitis B vaccinations. For

example, while Mr. D’Angiolini cited to page 24 of the Findings of Fact for the

proposition that he felt “flu-ish” after the second dose of the vaccine, this portion

of the findings of fact merely presented Mr. D’Angiolini’s claim. However, his

claim was not accepted. The next paragraph begins “[a] preponderance of the

evidence does not support a finding that Mr. D’Angiolini was feeling flu-ish.”

This discrepancy jeopardized Mr. D’Angiolini’s claim because if his symptoms

were fundamental to his expert’s opinion, then his expert’s opinion could not be

accepted. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415 (Fed. Cir.

1993).

The third topic at the February 1, 2012 pre-trial conference was the timing

prong from Althen. As the Secretary argued in her pre-trial brief, Mr.

D’Angiolini’s case did not add up correctly. Dr. Shoenfeld stated that the

minimum amount of time for a vaccine autoinflammatory reaction was three

weeks. Exhibit 87 at 7. Yet, Mr. D’Angiolini stated he felt flu-ish only one week

after the vaccination. Pet’r’s Br. at 10. The undersigned explained in the pre-trial

conference that if Mr. D’Angiolini’s evidence were credited, he would not prevail

because he could not establish the third prong of Althen. See Bazan v. Sec’y of

Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).

Under these circumstances, Mr. D’Angiolini requested a suspension of the

hearing and his request was granted. The Secretary was given a deadline for Dr.

Lightfoot’s next supplemental report to respond to the recently filed articles about

ASIA. The Secretary was also given a deadline to submit an initial report from

Lindsay Whitton, who was responding to Dr. Buttram’s report.

The Secretary filed Dr. Whitton’s report on March 15, 2012, as exhibit V.

Because his report responded to Dr. Buttram’s report, which was later withdrawn,

most of Dr. Whitton’s comments do not affect the outcome of the case. The

Secretary, however, has not withdrawn Dr. Whitton’s report and he offered a small

amount of testimony at the hearing. See Tr. 1594-662.

The next two reports from experts concerned ASIA. Dr. Lightfoot’s March

19, 2012 report appears as exhibit II. Dr. Lightfoot criticized ASIA, saying “the

criteria are so non-specific as to make it unclear whether ASIA is a syndrome at

all. It is my feeling that ASIA remains a hypothesis until such time as its

proponents can validate their criteria and sharpen them quantitatively.” Exhibit II

at 3.

12

Dr. Shoenfeld had a chance to respond. Unfortunately, some (but not all) of

Dr. Shoenfeld’s criticisms attacked Dr. Lightfoot on a personal level. Exhibit 188.

The final expert report was written by Dr. Shoenfeld to address the temporal

relationship. Dr. Shoenfeld’s theory was that the adjuvant in a vaccine can cause

“chronic and persistent stimulation of the immune system.” Exhibit 189 at 2.

Differences in number of vaccinations, in the interval between vaccinations, and in

the type of vaccinations contribute to a variable development of problems. Dr.

Shoenfeld stated “the first signs or symptoms and lab results . . . will be seen

progressively and sometimes after months and even years.” Id. at 3.

Dr. Shoenfeld did not specify when Mr. D’Angiolini’s problem began,

although Dr. Shoenfeld listed a series of events, spanning from 1997 to 2004, in his

report. Exhibit 189 at 4-7. Dr. Shoenfeld did assert that “[a]ny initial reactions

experienced by Mr. D’Angiolini should be considered allergic reactions as a result

of his allergy to yeast.” Id. at 4.

Having received these supplemental reports from Dr. Shoenfeld, Mr.

D’Angiolini incorporated many of these ideas into his supplemental pre-trial brief

filed on June 4, 2012. The Supplemental Brief contained some alterations in most

of Mr. D’Angiolini’s case, except for the section regarding Althen prong two. In

regard to any assertions in the January 5, 2012 brief that were not consistent with

the Findings of Fact, Mr. D’Angiolini “expressly rescinded” them. Pet’r’s Suppl.

Prehr’g Br. at 1 n.1; accord id. at 12 n.6. Unlike the January 5, 2012 brief that had

put forward four conditions, the June 4, 2012 brief advanced three --- ASIA, lupus

and CFS. Id. at 2-5.11

Although the brief attempted to identify medical records that indicated Mr.

D’Angiolini suffered from signs or symptoms related to ASIA, lupus, and CFS, the

significance of many citations was unclear. For example, petitioner referred to a

letter from Dr. Black dated March 29, 1999 (exhibit 9 at 2) as evidence for

fulfillment of a minor ASIA criteria described as “[t]he appearance of

autoantibodies or antibodies directed at the suspected adjuvant.” Pet’r’s Suppl.

Prehr’g Br. at 3. Although Dr. Black’s letter indicated an increase in

gammaglobulins, there is no indication that these immunoglobulins were of a type

11

In a June 12, 2012 status conference, Mr. D’Angiolini’s attorney confirmed that he

intentionally withdrew the claim that Mr. D’Angiolini suffered from fibromyalgia.

13

directed at the suspected adjuvant. Mr. D’Angiolini also referred to a record from

Dr. Buttram as evidence of arthralgia and arthritis where no joint or arthritic pain

was indicated. Pet’r’s Suppl. Prehr’g Br. at 2, citing exhibit 14 at 4.

The June 4, 2012 brief expanded the theory causally connecting the hepatitis

B vaccinations to any of these conditions. In this brief, Mr. D’Angiolini’s attorney

asserted that the

Hepatitis B aluminum adjuvant . . . chronically stimulates the immune

system, which causes the immune system to break its tolerance to its

own constituents. The chronic and persistent stimulation of the

immune system by the adjuvant causes the expression of diverse

clinical manifestations. . . . Here they were diagnosed as ASIA, CFS

and/or Lupus[-]like symptoms.

Pet’r’s Suppl. Prehr’g Br. at 7-8.

A final change concerned the temporal relationship, which corresponds to

Althen prong 3. Mr. D’Angiolini asserted that “the autoinflammatory reaction can

be seen, in terms of time between receiving the initial hepatitis B vaccination and

the subsequent ‘boost injections,’ within weeks to months of the ultimate diagnosis

of an autoimmune reaction.” Pet’r’s Suppl. Prehr’g Br. at 12.

The parties discussed Mr. D’Angiolini’s Supplemental Brief in a status

conference on June 12, 2012. The most significant substantive topic was whether

the evidence cited in support of a diagnosis actually supported the diagnosis. In

this respect, the Secretary contemplated filing a motion for summary judgment

with respect to the claim that Mr. D’Angiolini suffered from lupus, although the

Secretary eventually declined to pursue this motion.

The discussion about the proper diagnosis prompted Mr. D’Angiolini to file

another submission. Although submitted as “exhibit 191,” this document is more

like a brief in that Mr. D’Angiolini’s attorney argued why identified medical

records support a diagnosis. Exhibit 191 was more effective and more persuasive

than either Mr. D’Angiolini’s January 5, 2012 brief or his June 4, 2012

supplemental brief.

The efforts to reschedule the hearing for mutually convenient dates

culminated in a June 27, 2012 scheduling order, setting the case for a hearing from

January 14, 2013 to January 18, 2013. The parties planned to have Dr. Shoenfeld,

14

Dr. Vasey, and Dr. Lightfoot testify for the three days. Dr. Buttram and Dr.

Whitton would testify on the final two days.

Between June 27, 2012 and the next pre-trial conference, which was held on

January 3, 2013, there was relatively little activity. Mr. D’Angiolini was awarded

approximately $200,000 in attorneys’ fees and costs on an interim basis. Decision,

filed July 18, 2012. The undersigned submitted two more exhibits into the record.

Order, filed July 20, 2012. The parties reported that efforts to settle the case were

not successful. Pet’r’s Status Rep’t, filed Nov. 1, 2012.

Once it appeared certain that the case was proceeding to hearing, the

undersigned submitted two additional medical articles into the record. Order, filed

Jan. 9, 2013. These articles concerned whether yeast in the hepatitis B vaccine can

cause an adverse reaction. Exhibits 1004-05. The parties were alerted to have

their experts prepared to testify about these articles.

The hearing began on January 14, 2013, when Mr. D’Angiolini called Dr.

Shoenfeld to testify. Dr. Shoenfeld generally testified in accord with his reports.

But, Dr. Shoenfeld also presented articles that he had not cited and had not been

filed into the record. The Secretary objected because the October 2, 2012 order for

pretrial submissions restricted the discussion of articles that had not been filed into

the record. Tr. 777-86.

After Dr. Shoenfeld’s testimony, Dr. Lightfoot testified. His testimony, too,

mostly tracked what he had stated in his reports. The next witness was Dr. Vasey,

who appeared via videoconferencing. Dr. Vasey completed his testimony on

January 16, 2013.

When these witnesses were testifying, Mr. D’Angiolini was attempting to

arrange for Dr. Buttram to testify, as scheduled, on January 17, 2013. Mr.

D’Angiolini’s attorney eventually learned that Dr. Buttram could not participate

for reasons that could not be solved with a simple postponement of his testimony.

Consequently, Mr. D’Angiolini withdrew Dr. Buttram’s report entirely. While the

Secretary acceded to the withdrawal of Dr. Buttram’s report, the Secretary

maintained that she still intended to call Dr. Whitton to address some aspects of

Dr. Shoenfeld’s testimony. Tr. 1591-93.

Dr. Whitton was the final witness and he testified on January 17, 2013. He

addressed allergy and whether Mr. D’Angiolini was allergic to yeast. Tr. 1594-

1662.

15

After the hearing concluded, the parties chose to submit briefs. Mr.

D’Angiolini filed a primary brief, the Secretary filed one brief, and Mr.

D’Angiolini filed a reply brief. With the submission of Mr. D’Angiolini’s reply

brief, the case is ready for adjudication.

II. Standards for Adjudication

Petitioners are required to establish their cases 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 & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations

omitted). Proof of medical certainty is not required. Bunting v. Sec’y of Health

& Human 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 & Human 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 & Human Servs., 219

F.3d 1357 (2000); Hodges v. Sec’y of Health & Human 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).

Mr. D’Angiolini has established, by a preponderance of the evidence, most

of the elements set forth in 42 U.S.C. § 300aa--11(c), including that he received a

vaccine listed on the Vaccine Table, the hepatitis B vaccine. The disputed issue is

whether the hepatitis B vaccine caused Mr. D’Angiolini an injury.

Here, the parties dispute whether Mr. D’Angiolini suffered any injury for

which he seeks compensation. In this circumstance, Mr. D’Angiolini bears the

burden of establishing that he suffers from a condition for which he seeks

compensation. Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339,

1346 (Fed. Cir. 2010), Lombardi v. Sec'y of Health & Human Servs., 656 F.3d

1343, 1352 (Fed. Cir. 2011) (“under Broekelschen, identification of a petitioner’s

injury is a prerequisite to an Althen analysis of causation”). In doing so, the

special master is “not ‘diagnosing’ vaccine-related injuries.” Knudsen v. Sec'y of

Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994). Rather, the special

master evaluates the evidence presented and determines whether the petitioner has

16

met his burden of establishing that he suffers from the disease. See Lombardi, 656

F.3d at 1353-56 (reviewing evidence that the special master considered in

determining whether petitioner suffered from a particular disease and finding that

the special master’s factual findings were not arbitrary or capricious).

After petitioners establish that they suffer from a particular condition, they

must establish that the vaccine caused that injury. For causation-in-fact claims, the

Federal Circuit set forth a three-prong test. Althen, 418 F.3d 1274.12 To receive

compensation, a petitioner must satisfy the Althen test by a preponderance of

evidence. The preponderance of evidence standard is also used for finding facts

about Mr. D’Angiolini’s health.

III. Facts

A. Health before First Dose of Hepatitis B Vaccination

Mr. D’Angiolini was born in 1966. Tr. 143. When he was approximately

11 or 12 years old, Mr. D’Angiolini had the first symptoms of obsessive

compulsive disorder (“OCD”), and was later diagnosed with that disorder. Exhibit

24 at 5-7. A psychologist provided some counseling to him as an adolescent,

although the psychologist was primarily seeing Mr. D’Angiolini as part of her

work in counseling a member of Mr. D’Angiolini’s family. Tr. 88, 108. Mr.

D’Angiolini’s OCD did not prevent him from graduating from high school. He

entered college but did not graduate. Exhibit 16 at 14; Tr. 660.

When he was approximately 20 years old, he started developing headaches

three or four times a week. Exhibit 24 at 6. In August and September 1996, Mr.

D’Angiolini was experiencing headaches three or four times per week and his

OCD behaviors were intensifying. Dr. Debra Roman prescribed Fiorciet for his

headaches. Exhibit 23 at 35-36; exhibit 50 pdf 255 (Roman Dep. Tr. 16); Tr. 665-

68.

However, in August and September 1996, Mr. D’Angiolini’s physical health

was otherwise fine. Blood tests were normal. Exhibit 23 at 99-102. He played

12

Section VI.D presents the Althen test in more detail.

17

basketball and rollerbladed. Exhibit 51 pdf 26 (June 7, 2001 W.C. Trial Tr. 14);

Tr. 93.

Mr. D’Angiolini was working two jobs. He worked at Pottstown Medical

Center as a technician for mental health patients. Tr. 150-51, 409-11. He also

worked part-time as a music instructor at Bachman’s Music Store, earning about

$100 per week. Exhibit 16 at 296-301.

On the other hand, Mr. D’Angiolini’s mental health was not good. His

psychologist, Nancy Casella, referred him to a psychiatrist, Dori Middleman,

because Mr. D’Angiolini’s OCD symptoms were increasing and were disruptive to

his relationship with his fiancée. The psychologist anticipated that Dr. Middleman

would prescribe medications to help Mr. D’Angiolini. Exhibit 56 at 2; Tr. 98; see

also Tr. 319, 480-81, 665-69.

The first appointment between Dr. Middleman and Mr. D’Angiolini

occurred on October 29, 1996. Mr. D’Angiolini was having headaches that were

causing him either to arrive late for work or to miss work entirely. Dr. Middleman

diagnosed him as having OCD with a sexual compulsion and prescribed Prozac.

Exhibit 24 at 5-7; Tr. 6-17.

Mr. D’Angiolini continued to see Dr. Middleman throughout the remainder

of 1996, with both in-person and telephone consultations. Mr. D’Angiolini

continued to have headaches and Dr. Middleman added another medication,

amitriptyline. Exhibit 24 at 7-8.

In January 1997, Mr. D’Angiolini found a new job as a mental health

technician at Valley Forge Medical Center. After a pre-employment physical

examination, he was found capable of performing the job’s duties. Exhibit 16 at

174, 176-78; exhibit 51 at pdf 17 (June 7, 2001 W.C. Trial Tr. 5).

Around this time, Mr. D’Angiolini’s engagement was ending. He was both

sad and relieved about its end. Tr. 223, 338, 484; exhibit 56 at 2; see also exhibit

24 at 9; exhibit 51 at pdf 153 (May 31, 2002 W.C. Trial Tr. 15); Tr. 544-45. In

February 1997, Mr. D’Angiolini told Dr. Middleman that he was having difficulty

sleeping and attributed the problem to the end of his engagement. Dr. Middleman

stopped amitriptyline and prescribed a different drug, trazodone. Two weeks later,

Mr. D’Angiolini was having less anxiety. Exhibit 24 at 9-10; Tr. 24-25.

Mr. D’Angiolini started working at Valley Forge Medical Center on March

3, 1997. Exhibit 51 at pdf 190 (May 31, 2002 W.C. Trial Tr. 52); exhibit 16 at 37.

18

In the context of his employment, he received his first dose of the hepatitis B

vaccine on March 18, 1997. Exhibit 16 at 162, 233; Tr. 569-570.

B. Condition from March 18, 1997, the date of the first dose of the

hepatitis B vaccination, through October 24, 1997, the date of the third

dose of hepatitis B vaccine.

In the days immediately following the March 18, 1997 hepatitis B

vaccination, Mr. D’Angiolini continued to work at Valley Forge. Tr. 231-32. His

employment records show that between March 14, 1997 and March 27, 1997 (two

weeks), he worked 81 hours. Exhibit 16 at 93. His employment records do not

show that he missed work due to sickness during these two weeks, but do show

absences due to illnesses at other times. See exhibit 16 at 179-80. His

performance as a mental health technician met his employer’s standards. Id. at 31

(evaluation covering March 3, 1997 through May 31, 1997). In the week

following March 18, 1997, Mr. D’Angiolini also saw 15 students at Bachman’s

Music Store. Exhibit 16 at 304. Mr. D’Angiolini did not establish that he was

“flu-ish” a few days after the first vaccination. See Findings of Fact at 22 n.9.

On April 18, 1997, Mr. D’Angiolini received the second dose of the hepatitis

B vaccine. Exhibit 16 at 162, 233; Tr. 236, 590. Again, in the days and weeks

immediately following this immunization, he maintained his employment. See

exhibit 16 at 263 (Valley Forge), 305-07 (Bachman’s Music Store); see also Tr.

596-600. Mr. D’Angiolini failed to establish that he was experiencing flu-like

symptoms after this vaccination. See Findings of Fact at 23.

In May 1997, Mr. D’Angiolini was sleeping 15 hours a day and drinking

coffee to stay awake at work. Exhibit 24 at 11 (Dr. Middleman’s notes from May

22, 1997); exhibit 51 at pdf 193 (May 31, 2002 W.C. Trial Tr. 55). He was having

headaches that were more severe, and that he described as migraines. Exhibit 24 at

11; exhibit 51 at pdf 49 (June 7, 2001 W.C. Trial Tr. 37).

Following Mr. D’Angiolini’s visit with Dr. Middleman on May 22, 1997, he

did not see her again until September 22, 1997. In this interlude, Mr. D’Angiolini

had one visit with a doctor, Joshua Bray, on July 29, 1997.13 Mr. D’Angiolini

13

Mr. D’Angiolini also saw Dr. Bray after he developed more severe problems in

November 1997. Because of Mr. D’Angiolini’s reliance on Dr. Bray’s records, additional

(…continued)

19

reported that he had “nasal stuffiness, AM bloody/yellow discharge.” Dr. Bray

diagnosed a sinus infection and prescribed a medication. Exhibit 61. Mr.

D’Angiolini missed some days of work due to sinusitis in July and August 1997.

Exhibit 16 at 175, 179-80. Throughout the summer 1997, Mr. D’Angiolini also

taught music at Bachman’s. Exhibit 16 at 305-09; Tr. 613-15.

The Findings of Fact resolved a dispute over Mr. D’Angiolini’s health in the

summer 1997. Although he maintained that he was fatigued during the summer,

Joint Statement, filed October 19, 2009, at 11-12, the Findings of Fact did not

credit this testimony. Mr. D’Angiolini did not seek medical attention for being

fatigued and on the one occasion when he did seek medical care, Mr. D’Angiolini

did not mention fatigue as a problem. Findings of Fact at 27.

On October 6, 1997, Mr. D’Angiolini saw Dr. Middleman and Mr.

D’Angiolini told her that he was depressed. This was the first time Dr. Middleman

noted “depression” for Mr. D’Angiolini. Exhibit 24 at 12; Tr. 62.

On October 24, 1997, Mr. D’Angiolini received his third dose of the

hepatitis B vaccine. Exhibit 16 at 162, 233.14

C. Health after October 24, 1997, the date of the third dose of

hepatitis B vaccine

On November 4, 1997, Mr. D’Angiolini requested an appointment with Dr.

Middleman on an emergent basis. She saw him the next day. Mr. D’Angiolini

stated he was sleeping 12-15 hours per day, not taking care of his apartment, and

not tending to his appearance. He reported that he had returned to visiting

prostitutes and was tempted to prostitute himself. Exhibit 24 at 13; Tr. 36, 75-76;

see also exhibit 51 at pdf 164 (May 31, 2002 W.C. Trial Tr. 26). Dr. Middleman

information about Dr. Bray is presented in the context of the post-November 1997 treatment.

See section III.C.1 below.

14

As discussed during the entitlement hearing, Tr. 712, the Findings of Fact contain an

error in describing Mr. D’Angiolini’s health in the days immediately after he received the third

dose of the hepatitis B vaccine. Although the factual findings state that Mr. D’Angiolini was

fatigued by October 30, 1997, there is no persuasive evidentiary support for this finding. The

undersigned therefore corrects this factual finding and finds instead that Mr. D’Angiolini was not

fatigued in the weeks following this third vaccination.

20

recommended that Mr. D’Angiolini seek inpatient care for his sexual behavior at

either the Keystone Center or Northwestern Institute. Exhibit 24 at 13; Tr. 36-37.

Mr. D’Angiolini did not take her recommendation. Tr. 623.

November 5, 1997, was also the last date Mr. D’Angiolini worked at Valley

Forge Medical Center. Exhibit 51 at pdf 20 (June 7, 2001 W.C. Trial Tr. 8);

exhibit 53 ¶ 11. He stopped working because he was both mentally and physically

incapable of taking care of himself. He was not showering or shaving. Exhibit 51

at pdf 20-21 (June 7, 2001 W.C. Trial Tr. 8-9). He began a leave of absence from

Valley Forge the next day. Exhibit 16 at 118, 150. Mr. D’Angiolini’s employment

with Bachman’s Music Store also terminated around this time. See exhibit 51 pdf

18, 40 (June 7, 2001 W.C. Trial Tr. 6, 28); exhibit 16 at 311.

1. Treatment with Dr. Bray in late 1997 and early 1998

On November 6, 1997, Mr. D’Angiolini saw Dr. Bray. As mentioned

earlier, see footnote 12 above, Dr. Bray’s later records are a primary basis for

many of Mr. D’Angiolini’s claims, particularly with respect to Mr. D’Angiolini’s

assertion that he suffers from lupus. The Secretary, however, argues that Dr.

Bray’s letters “are not medical records.” Resp’t’s Posthr’g Br. at 30. Due to the

importance of Dr. Bray and his records, his background and the origin of his

records are described in some detail.

Preliminarily, information about Dr. Bray comes from various sources. In

July 2003, Mr. D’Angiolini filed records from Dr. Bray as exhibit 17. Although

the earliest record authored by Dr. Bray contained in exhibit 17 is a letter dated

November 30, 1999, see exhibit 17 at 15; Tr. 313, Mr. D’Angiolini saw Dr. Bray

before November 30, 1999. Mr. D’Angiolini did not file those earlier records

before the fact hearing held on August 8, 2007. See Tr. 309-10.

On December 3, 2007, Mr. D’Angiolini filed records his former attorney had

obtained from Dr. Bray’s office, covering treatment from July 1997 to February

1998. In total, there were four appointments and Dr. Bray’s typed notes appear on

16 lines. Exhibit 61.

On April 16, 2008, Mr. D’Angiolini, again acting through his former

attorney, filed three letters from Dr. Bray. The dates of the letters are November 6,

1997, November 13, 1997, and January 22, 1998. Each letter is typed and signed.

Two letters are one paragraph and one letter is two paragraphs. Exhibit 73.

21

On December 19, 2011, Mr. D’Angiolini’s current attorney filed a four-page

letter that Dr. Bray wrote to an insurance company on May 9, 2002. In this letter,

Dr. Bray summarized not only the care that Dr. Bray had provided but also

information provided by other doctors. Dr. Bray stated that he last treated Mr.

D’Angiolini on May 9, 2002, the date of the letter, although no notes of treatment

were provided. Exhibit 131.

Other information about Dr. Bray comes from testimony given in either the

workers’ compensation proceeding or this claim. In both settings, Mr. D’Angiolini

and his mother testified about Dr. Bray’s treatment of Mr. D’Angiolini. Although

Dr. Bray testified as part of the case for workers’ compensation benefits, the scope

of the testimony was intended to be limited to when Mr. D’Angiolini learned that

the hepatitis B vaccine harmed him. See exhibit 50 at pdf 205 (Bray Dep. Tr. 5).

These disparate sources of information combine to show the following facts about

Dr. Bray’s treatment of Mr. D’Angiolini.15

Dr. Bray graduated medical school in 1948 and became licensed to practice

medicine in Pennsylvania in 1950. He was a general practitioner, not board

certified in any field, and did not hold himself out as a specialist in any field of

medicine. Exhibit 50 at pdf 206 (Bray Dep. Tr. 6). Ms. D’Angiolini described Dr.

Bray as “a country doctor. . . . [I]f you had a cold, you didn’t make an appointment

with him. You just went in and he would see you. . . . First come, first serve.” Tr.

491. Mr. D’Angiolini, too, stated that Dr. Bray was “a country guy.” Tr. 313;

accord exhibit 51 at pdf 45 (June 7, 2001 W.C. Trial Tr. 33).

Mr. D’Angiolini began seeing Dr. Bray in 1987 or 1988. Tr. 313. However,

there are no documents reflecting any appointments. Dr. Bray stated that his first

appointment with Mr. D’Angiolini was on February 5, 1996, although there are

also no documents reflecting this appointment. Exhibit 50 at pdf 208 (Bray Dep.

Tr. 8).

The first appointment for which there is a record occurred on July 29,

16

1997, between the dates on which Mr. D’Angiolini received the second and third

15

In some of the quotations from Dr. Bray’s records, the capitalization has been changed

without notation.

16

Mr. D’Angiolini did not recall when he had most recently seen Dr. Bray before the July

29, 1997 visit. Tr. 615-16.

22

doses of the hepatitis B vaccine. See Findings of Fact at 27. At this appointment,

Mr. D’Angiolini was complaining of “nasal stuffiness” and “AM bloody / yellow

discharge.” Dr. Bray’s impression was sinus infection and he prescribed

erythromycin. There is no indication of fatigue or tiredness. Exhibit 61.

The next appointment was on November 6, 1997, which was the day after

Mr. D’Angiolini stopped working. His mother brought him to see Dr. Bray. Tr.

433, 492. Dr. Bray’s typed notes indicate that Mr. D’Angiolini was complaining

of “extreme fear, feel[ing] immobilized, afraid to leave the house, not caring for

himself or his environment.” Exhibit 61. Ms. D’Angiolini testified that Dr. Bray

did not perform a physical examination, Tr. 493, and Dr. Bray’s notes appear in

accord with this recollection. Dr. Bray’s impression was “severe depression /

adjustment disorder / panic disorder / agoraphobia” and he prescribed amitriptyline

and Valium. Exhibit 61.

Dr. Bray wrote a letter addressed “To Whom It May Concern” on November

6, 1997. Dr. Bray stated that Mr. D’Angiolini was under his care for “major

depression” and Dr. Bray stated that Mr. D’Angiolini could not work. Exhibit 73

at 3.

A follow up appointment was held seven days later on November 13, 1997.

The office notes are two typed lines, indicating that Mr. D’Angiolini had not

improved and that Dr. Bray was increasing the dose of amitriptyline. Exhibit 61.

The letter associated with this visit is similar. It states that Mr. D’Angiolini is

being treated for “major depression” and “panic disorder” and cannot work.

Exhibit 73 at 1. Dr. Bray signed Mr. D’Angiolini’s application for disability

benefits on December 15, 1997. Exhibit 16 at 145-46. In Mr. D’Angiolini’s

application for disability benefits, Dr. Bray described his symptoms as “crying,

unable to stay awake, not caring for self, shortness of breath, dizziness, heart races,

chest pain, extreme fear, feel immobilized, afraid to go out.”

Dr. Bray’s next activity was writing a letter in support of Mr. D’Angiolini’s

claim for disability benefits on January 22, 1998. There are no office notes

associated with this visit and the letter essentially repeats the information in the

November 6, 1997 and November 13, 1997 letters. Exhibit 73 at 2; cf. exhibit 16

at 97 (letter from insurance company to Mr. D’Angiolini in response to Dr. Bray’s

letter).

The last office notes from Dr. Bray are dated February 12, 1998. Dr. Bray

recorded that Mr. D’Angiolini was complaining of “severe anxiety and increased

23

symptoms.” Dr. Bray prescribed BuSpar and continued other medications.

Exhibit 61.

2. Treatment with Other Doctors in 1998

Mr. D’Angiolini continued to see Dr. Middleman and Ms. Casella, the

psychologist who was counseling him. They diagnosed him as suffering from

OCD, anxiety, and depression. Exhibit 24 at 15, 17; exhibit 61 at 1; Tr. 45-49.

In April 1998, Mr. D’Angiolini reported that he was “quite active” and

running. Exhibit 15 at 12; but see Tr. 505-06, 630. On April 12, 1998, Mr.

D’Angiolini went to Leigh Valley Hospital because of a headache and chest pain.

Mr. D’Angiolini described the chest pain as “mild” and his headaches as “typical

for his migraines other than being a bit longer lasting.” Exhibit 15 at 12.

By the end of April 1998, Mr. D’Angiolini was not taking care of his

apartment and the local Board of Health became involved. Mr. D’Angiolini’s

mother cleaned his apartment and moved her son to her house. Tr. 255-56, 437-38;

exhibit 51 at pdf 198 (May 31, 2002 W.C. Trial Tr. 60); exhibit 54 ¶ 32-34 (Ms.

D’Angiolini’s affidavit describing her observations of Mr. D’Angiolini when he

was living with her); exhibit 51 at pdf 39 (June 7, 2001 W.C. Trial Tr. 27) (Mr.

D’Angiolini’s testimony).

In June, July and August 1998, Mr. D’Angiolini saw Ms. Casella. She

believed that he could not work. For the July 1998 form to certify Mr.

D’Angiolini’s entitlement to disability benefits, Ms. Casella wrote that Mr.

D’Angiolini “continues to struggle regularly with sleeping difficulties. He finds

that living with parents causes other stress in his life because of sometime volatile

relationship with father. Panic attacks continue and he’s having difficulty getting

himself on a functional schedule.” Exhibit 16 at 111. Her diagnoses were

“adjustment disorder with depressed mood” and “panic disorder with agoraphobia

severe.” Id.

On October 10, 1998, Mr. D’Angiolini saw Dr. Gregory Bach, whose

letterhead states that he is board certified in family medicine and addiction

medicine. Exhibit 5 at 21.17 Dr. Bach’s handwritten notes, which are difficult to

17

Dr. Shoenfeld stated that Dr. Bach is a specialist in infectious diseases. Tr. 854-55.

24

decipher, indicate that Mr. D’Angiolini’s chief complaints included “sweats,

[weight] gain, stomach problems, heart palpitations, twitching headache, neck

stiffness, light sensitivity, light head, confusion, difficulty with speech, mood

swings, depression.” Dr. Bach’s impressions included: “1. Fibromyalgia, 2.

Chronic fatig. 3. Myopathy.” Id. at 26. This October 10, 1998 reference to chronic

fatigue appears to be the earliest reference to this symptom in Mr. D’Angiolini’s

medical records by a medical doctor. See Tr. 1281. Dr. Bach ordered an

echocardiogram and also blood work. Exhibit 5 at 26; see also Tr. 440-41, 684.

In most respects, the blood work was normal, including a showing that Mr.

D’Angiolini did not have antinuclear antibodies. Exhibit 5 at 12-13; exhibit 23 at

87-92. The echocardiogram was basically normal, although it did reveal mild

hypokinesis. Exhibit 23 at 115. “Hypokinesis” means abnormally decreased

mobility, motor function, or activity. Dorland’s Illustrated Medical Dictionary 903

(32nd ed. 2012) (“Dorland’s”).

On November 10, 1998, Mr. D’Angiolini had an appointment with Dr.

Roman for the first time after he received the hepatitis B vaccination. He

complained about headaches, nausea, depression / anxiety, and fatigue. Exhibit 23

at 32; see also exhibit 50 at pdf 151, 268 (Genovese Dep. Tr. 62; Roman Dep. Tr.

29). Tests that she ordered indicated that Mr. D’Angiolini was infected with or

had been infected with the Epstein-Barr virus. Exhibit 50 at pdf 263, 267 (Roman

Dep. Tr. 24, 28). Dr. Roman was concerned about how Mr. D’Angiolini’s heart

was functioning. Therefore, she referred him to additional doctors for testing. See

exhibit 23 at 114; exhibit 50 at pdf 312 (Roman Dep. Tr. 73).

Mr. D’Angiolini told a cardiologist (Dr. Weber) that he was having

“dyspnea on exertion when he is doing a strenuous exercise such as heavy lifting

or walking while carrying a heavy parcel” for one year. Exhibit 6 at 17 (record

dated Nov. 13, 1998). Mr. D’Angiolini’s heart was tested in SPECT cardiac

perfusion scan on November 20, 1998. The result showed a “mild decrement in

LVEF, 44% with questionable borderline inferior wall ischemia.” Exhibit 17 at 5.

Mr. D’Angiolini was diagnosed as having cardiomyopathy. Exhibit 5 at 6 (report

of Dr. Frederic J. Weber); see also Tr. 510.

Mr. D’Angiolini went to the Penn Center for Healing, where Dr. Anne

Norris saw him. His chief complaint was “fatigue.” The history Dr. Norris

obtained recounts that Mr. D’Angiolini had “sudden onset fatigue” in late June

25

1997. Her record indicates that Mr. D’Angiolini has “been out of work for a year

[secondary to] fatigue.”18 Dr. Norris created a series of notes, corresponding to the

ancillary symptoms associated with CFS. For example, she stated that Mr.

D’Angiolini did not get refreshing sleep, did get headaches, but did not have either

joint symptoms or muscle pain. Dr. Norris’s impression was “not CFS by criteria.”

Exhibit 22 at 4 (Nov. 17, 1998).

By December 1998, Dr. Middleman had lost touch with Mr. D’Angiolini.

She was sufficiently concerned about him that she called Ms. Casella. Exhibit 24

at 19; Tr. 54-55.

3. Return to Dr. Bray and Treatment with Dr. Buttram and

Dr. Waisbren in 1999

After the visit with Dr. Norris in November 1998, Mr. D’Angiolini had one

follow-up appointment with her. Exhibit 22 at 2 (Jan. 19, 1999). Following this

appointment, there appears to be a gap in visits with doctors. Resumed medical

attention began in August 1999.

According to a letter Dr. Bray wrote on June 20, 2002, “[o]n August 3, 1999,

while on the internet, I came across information about a fund for people injured by

the hepatitis B vaccination. . . . The patient’s mother, Cynthia D’Angiolini, came to

my office on August 5, 1999[,] and I gave her the information and the name of a

Doctor who might be able to help Joseph.” Exhibit 16 at 229.19 Mr. D’Angiolini

18

This history is not entirely consistent with the Findings of Fact.

19

This letter does not appear in any of the files Mr. D’Angiolini obtained directly from

Dr. Bray. Rather, the source of this information is Mr. D’Angiolini’s employment records from

Valley Forge Medical Center. In the course of the workers’ compensation proceeding, Mr.

D’Angiolini’s employer challenged the accuracy of the account in which Dr. Bray told Ms.

D’Angiolini about the Vaccine Program. See exhibit 16 at 336 (post-hearing brief). This

assertion was the basis of the employer’s argument that Mr. D’Angiolini’s claim for workers’

compensation benefits was untimely. On the other hand, Mr. D’Angiolini testified that Dr. Bray

first suggested that there was a causal connection between the hepatitis B vaccine and his

condition. Exhibit 51 at pdf 120 (August 3, 2001 W.C. Trial Tr. 60).

26

identified this doctor as Burton Waisbren. Exhibit 51 at pdf 52, 54 (June 7, 2001

W.C. Trial Tr. 40, 42).20

It is worthwhile to interrupt the recitation of Mr. D’Angiolini’s medical

history with a brief discussion of his legal claims. On August 4, 1999, Mr.

D’Angiolini, acting through Attorney Clifford Shoemaker, filed the pending case

in the Court of Federal Claims. Also, on November 29, 1999, Mr. D’Angiolini’s

mother sent a letter notifying Valley Forge Medical Center that the hepatitis B

vaccinations harmed her son. Exhibit 16 at 68; see also exhibit 51 at pdf 210-11

(May 31, 2002 W.C. Trial Tr. 72-73). Hence, from early August 1999, Mr.

D’Angiolini was alleging that the hepatitis B vaccinations injured him.

On October 6, 1999, Mr. D’Angiolini saw Dr. Harold Buttram, whose office

is in Quakertown, Pennsylvania, which is relatively near Mr. D’Angiolini’s home.

Exhibit 17 at 125. Dr. Buttram ordered a series of laboratory tests. Id. at 126-30.

After the results of these tests were reported to Dr. Buttram, he saw Mr.

D’Angiolini again on November 1, 1999. Dr. Buttram wrote a handwritten letter,

stating in its entirety:

Joseph D’Angiolini was seen by me Oct 6th and again today

[November 1, 1999]. He is now disabled with chronic fatigue and

myocarditis.

He was in excellent health until he had a series of hepatitis B

immunizations March, April, [and] October 1997.

He was badly crippled after 2nd injection, virtually bed fast [sic] after

the third. All of heart-related symptoms date back to that time.

A causal relation of the hepatitis [vaccine] with his present

myocarditis is highly probable.

Exhibit 17 at 125. Dr. Buttram’s letter appears in Dr. Bray’s file, although nothing

in Dr. Buttram’s letter indicates that Dr. Buttram mailed the letter to Dr. Bray.21

20

Dr. Bray stated that he did not refer Mr. D’Angiolini to Dr. Waisbren. Exhibit 50 at

pdf 229-30 (Dr. Bray Tr. at 29-30). If Dr. Bray did not refer Mr. D’Angiolini to Dr. Waisbren,

then it is likely that Dr. Bray referred Mr. D’Angiolini to Harold Buttram. The only doctors

whom Mr. D’Angiolini saw at the end of 1999 were Dr. Buttram and Dr. Waisbren.

27

On November 30, 1999, Dr. Bray wrote another letter to the disability

insurance company in support of Mr. D’Angiolini’s claim for benefits. This letter

is noticeably longer than Dr. Bray’s previous letters. One possible explanation is

that Mr. D’Angiolini or Mr. D’Angiolini’s mother provided Dr. Bray with letters

from Doctors Weber (a cardiologist), Bach (a specialist in family medicine and

addiction counseling), and Black (a gastroenterologist). In any event, a portion of

Dr. Bray’s letter states:

Joseph M. D'Angiolini is a patient under my care. He was originally

put out [sic] on disability for depression. He had come to my office

on November 6, 1997, after seeing a psychologist who felt he was

depressed due to argument with his father. He complained of chest

pain, shortness of breath, palpitations, feeling like he would pass out,

sweating, color changes, and extreme fatigue, aches and pains, etc. . . .

He has a history of allergies (penicillin, sulfa, yeast, cigarette smoke,

seasonal allergies) and sinus problems.

He returned to my office for medications but had no improvement in

his condition. After treating him for quite a length of time the

psychologist informed him that she felt his problem was [a] medical

problem and recommended he get a full medical workup. The

physical workup revealed that he has cardiomyopathy; global

hypokinesis of the left ventric[le], and decreased LVEF, questionable

inferior wall ischemia. In addition he has Chronic Fatigue Syndrome;

depression is secondary to his physical condition and the limitations

and changes in his lifestyle due to his health.

***

He is 100% completely and totally disabled due to chronic fatigue and

pain. He is not able to work in any capacity. He will be reevaluated

in 6 months.

21

Additional details about Dr. Buttram’s treatment of Mr. D’Angiolini appear in exhibit

36.

28

Exhibit 17 at 15. At his deposition, Dr. Bray explained that the diagnoses of

cardiomyopathy, etc. as well as the diagnoses of chronic fatigue syndrome and

depression came from another doctor. Exhibit 50 at pdf 228 (Bray Dep. Tr. 28).

On December 9, 1999, Mr. D’Angiolini saw Dr. Burton A. Waisbren, whose

office is located in Milwaukee, Wisconsin.22 See exhibit 20 at 10, 21 (intake form

dated December 9, 1999). Mr. D’Angiolini’s mother brought him to the

appointment. Tr. 443. Dr. Waisbren stated, in his deposition, that people from all

over the country come to see him because he had stated that hepatitis B vaccine

can cause autoimmune diseases and information about his opinions was available

on the internet. Exhibit 50 at pdf 13-17 (Waisbren Dep. Tr. 9-13).

Dr. Waisbren is board certified in internal medicine. He described himself

as having “particular expertise in immunology and infectious diseases and critical

care.” Exhibit 50 at pdf 8 (Waisbren Dep. Tr. 4). He stated that there is not a

certifying body for immunology. He also stated that although there is a certifying

body for infectious diseases, he did not attempt to obtain board certification

because he had already been teaching infectious disease and immunology for at

least 15 years. Exhibit 50 at pdf 17-18 (Waisbren Dep. Tr. at 13-14).

During the December 9, 1999 appointment, Dr. Waisbren obtained

information about Mr. D’Angiolini’s history, conducted a physical examination,

and ordered multiple laboratories studies. He wrote a lengthy case report about

Mr. D’Angiolini, which he sent to Dr. Bray. Exhibit 17 at 37-43.23 For Mr.

D’Angiolini’s history, Dr. Waisbren recounted:

22

In a document dated December 8, 1999, which is one day before Dr. Waisbren saw Mr.

D’Angiolini, Dr. Waisbren offered a “presumptive diagnosis.” Dr. Waisbren stated “Post

vaccinal encephalomyelitis and acquired auto immunity involving in addition to the central

nervous system the heart and muscles. Theoretically this is due to a combination of antigens one

of which exhibits molecular mimicry.” Exhibit 21 at 39.

23

Dr. Waisbren also wrote to Professor Peter H. Meyers, an attorney, who supervises a

clinic at George Washington University Law School, asking Professor Meyers to assist Mr.

D’Angiolini with his claim in the Vaccine Program. Exhibit 17 at 36. This referral was

unnecessary because Mr. Shoemaker already represented Mr. D’Angiolini in the Vaccine

Program.

29

After the first hepatitis B injection he experienced malaise and muscle

and joint aches and headaches.

After a second injection in April, 1997, he noted severe headaches and

had several episodes of blacking out. He also developed severe

fatigue.

He was given a third injection after which he became completely

unable to function and went into a fugue that lasted a year. He

remembers little of it other than he lay disheveled in his unke[m]pt

apartment and was unable to perform daily hygiene and food

preparation. After this time, a psychiatrist who had been treating him

for depression decided that there was an organic cause for his

problem. He then moved in with his devoted parents who gave him

general support.

In mid-1998 he was seen by a variety of doctors, none of whom could

make a definitive diagnosis regarding his extreme fatigue, muscle

pains, and impaired cognitive ability.

Exhibit 17 at 37. Dr. Waisbren’s conclusion was:

This young man is suffering from post vaccinal encephalomyelitis and

generalized autoimmunity due to the hepatitis B vaccine. At this point,

he is completely disabled.

The syndrome of post vaccinal encephalomyelitis is well-

established in the medical literature. Vann Roogens standard test in

virus disease listed hundred[] of reports in the medical literature in its

regard. The enclosed two case reports report two similar cases due to

hepatitis B vaccination.

Id. at 39. Dr. Waisbren also proposed a “hypothetical analysis.” He stated:

The multiple autoimmunity syndrome we witness here is the result of

multiple immune challenges that fit into the syndrome of Root-

Bernstein who has noted it to occur in AIDS patients. Four criteria for

this syndrome are 1.) molecular mimicry between an antigen and

human tissue, 2.) compl[e]mentarity between a second antigen and the

first one, 3.) the presence of an immune adjuvant that could have been

supplied in this case by a bacterial infection (muramyl peptide) or the

30

aluminum in the vaccine, and 4.) an HLA pattern that precedes

autoimmunity.

Id. at 41. It appears that Dr. Waisbren sent several articles that called into question

the safety of hepatitis B vaccine to Dr. Bray. Authors of those articles included

Bonnie Dunbar, Barbara Loe Fisher, and Dr. Waisbren. See exhibit 17, passim. In

his deposition, Dr. Bray characterized Dr. Waisbren as a “super specialist.”

Exhibit 50 at pdf 232 (Bray Dep. Tr. 32).

4. Correspondence from Dr. Bray in 2000 and 2002

It appears that Dr. Bray saw Mr. D’Angiolini again in February 2000.

Exhibit 17 at 159 (tests for blood collected on February 2, 2000).24 On February

22, 2000, Dr. Bray wrote another letter to the insurance company. (This letter is

one on which Mr. D’Angiolini heavily relies.)

He had extreme fatigue, chest pain, palpitations, [shortness of breath]

with exertion, nausea, diaphoresis, aches and pains, and etc., mid to

late June of 1997. His symptoms continued to increase; all he was

able to do was sleep and drag himself to work. Due to his extreme

fatigue he was not able to care for himself or his environment. He felt

like something was wrong with his brain in that he wasn't able to

concentrate and was having memory/thinking problems. . . .

Approximately October 26, 1997, his condition became worse. He

felt "dead", all his symptoms increased; he was sleeping all the time,

felt as though his heart was pounding through his chest, had extreme

chest pain, shortness of breath, diaphoresis, felt as though he would

pass out, his joints and muscles ached, and etc. He felt anxious,

panicky and depressed due to his health. Because he was sleeping[]

excessively, feeling depressed and panicky, and had an altercation

with his father in September 1997, it was assumed that he was

suffering from Depression and Panic Disorder. HOWEVER, onset of

the illness and symptoms preceded the altercation by several months.

24

There are no office notes from Dr. Bray for a visit in February 2000.

31

Id. at 109-10. Dr. Bray’s letter also identified the following diagnoses as present in

Mr. D’Angiolini: “Systemic Autoimmune Disease, Cardiomyopathy, Post

Encephalomyelitis, Depression secondary to chronic illness and

limitations/changes in lifestyle due to illness.”25 Dr. Bray then listed more than 20

“subjective symptoms” and more than 20 “objective clinical findings” and

commented that “[t]he onset of the illness was mid to late June of 1997.” Id. Dr.

Bray repeated much of this information in another letter concerning Mr.

D’Angiolini’s disability insurance benefits after Dr. Bray saw Mr. D’Angiolini on

September 16, 2000. Exhibit 16 at 247.

Dr. Bray wrote a final letter to the insurance company on May 9, 2002,

which was a day that Dr. Bray saw Mr. D’Angiolini. Exhibit 131. The

background information about Mr. D’Angiolini’s health in 1997 is the same as the

history in the February 22, 2000 letter. Dr. Bray, for the first time, summarizes

visits with Doctors Bach, Norris, Weber, Black, Day, Buttram, Waisbren, Bellanti,

Mandel, and Vasey. However, there is no indication that Dr. Bray was aware of

Mr. D’Angiolini’s treatment with Dr. Middleman.

Dr. Bray stated that Mr. D’Angiolini “clearly meets the 1982 revised criteria

for classification of Systemic Lupus Erythematosus, of the American College of

Rheumatology (See attached copy; the patient's objective findings found on

physical examination in my office or on lab studies are highlighted for your

convenience), involving multiple body systems; central nervous

system/neurological, cardiovascular, joint, muscle, renal and mental.” Other

diagnoses are repeated from the February 22, 2000 letter, including

“cardiomyopathy, post encephalomyelitis, neuropathy, [and] depression.” Id. Dr.

Bray listed numerous subjective symptoms, many more than were listed

previously. Dr. Bray also repeated the objective clinical findings and added results

of a physical examination. Id. at 6.

25

Dr. Waisbren used the term “post vaccinal encephalomyelitis.” Exhibit 17 at 39.

However, Dr. Bray’s reports consistently say “post encephalomyelitis.” Whether Dr. Bray

intended to drop the word “vaccinal” is not clear.

32

5. Visits with Doctors Other than Dr. Bray in 2000 through

26

2003

As Dr. Bray mentioned in his May 9, 2002 letter, Mr. D’Angiolini saw other

doctors, including Dr. Bellanti, Dr. Mandel, and Dr. Vasey.

The appointment with Dr. Joseph Bellanti was on March 2, 2000. Exhibit 3

at 1. Dr. Bellanti’s letter was written to Mr. D’Angiolini’s attorney, Mr.

Shoemaker, id., and Mr. D’Angiolini saw Dr. Bellanti at Mr. Shoemaker’s request.

Tr. 635. On the questionnaire for Dr. Bellanti, Mr. D’Angiolini stated that he is

allergic to yeast, exhibit 3 at 4, and Dr. Bellanti recounted this allergy in the letter

to Mr. Shoemaker, id. at 1-2. Dr. Bellanti’s letter also stated that “[w]ithin 24

hours of receiving the [first dose of the hepatitis B] vaccine he developed

symptoms of malaise, muscle and joint pains, headaches and an overall ‘flu like’

syndrome.” Exhibit 3 at 1. Dr. Bellanti concluded his letter by stating, “I strongly

suspect that there is a causal relationship between the hepatitis B vaccination

which he received and the symptoms which he is undergoing.” Id. at 2.

A few days after seeing Dr. Bellanti, Mr. D’Angiolini passed out while

walking and fractured his thumb. Exhibit 13 at 8-9. He had an operation to repair

the fracture. Exhibit 14 at 60-62. During the convalescence for his thumb fracture,

Mr. D’Angiolini saw Dr. Scott M. Fried. Dr. Fried stated that Mr. D’Angiolini

was “back playing the guitar for a number of hours at a time and also the piano.

He is really not limited in any activities.” Exhibit 19 at 3. Mr. D’Angiolini, in the

hearing, denied that he was playing the guitar or the piano. See Tr. 635-38.

On July 28, 2000, Mr. D’Angiolini had an appointment with Dr. Buttram.

Dr. Buttram’s history states that Dr. Waisbren from Wisconsin saw Mr.

D’Angiolini in December 1999, and Dr. Waisbren diagnosed Mr. D’Angiolini with

“post vaccinal encephalitis and generalized autoimmunity.” Dr. Buttram’s

impression was “post vaccinal encephalitis and severe fatigue.” Exhibit 36 at 3-4.

26

Since the events after 2000 occurred more than three years after Mr. D’Angiolini’s

most recent hepatitis B vaccination, this recent history is presented more summarily. For

example, Mr. D’Angiolini saw Dr. Roman periodically. Exhibit 23 at 8-28; exhibit 50 at pdf

276-77 (Roman Dep. Tr. 37-38). The details of these visits with Dr. Roman do not affect the

outcome of Mr. D’Angiolini’s claim for compensation. Thus, this decision discusses only the

most relevant medical records.

33

On September 29, 2000, Mr. D’Angiolini saw Frank Vasey, a

rheumatologist at the University of South Florida College of Medicine. Exhibit

133 at 18. Dr. Vasey, as discussed below, wrote reports stating that the hepatitis B

vaccine harmed Mr. D’Angiolini and testified to that harm at the hearing. See

sections IV.A, V.A.1, and VII.A.1 below. During the September 29, 2000

appointment, Mr. D’Angiolini provided a history to Dr. Vasey.

Mr. D’Angiolini’s account, as written by Dr. Vasey, begins:

he had been in good health until 03/97, at which point he was advised

by his employer to have the hepatitis B vaccine. After the first

injection he developed promptly some headaches and flu-like

symptoms. These problems persisted over several weeks, and he

received another vaccination in 04/97, “I was out of it.” He was

dragging himself to work.

Id. In connection with the third dose of the vaccination, Dr. Vasey’s understanding

was: Mr. D’Angiolini “had another reaction with chest pain, shortness of breath,

sweats and worsening of his flu-like symptoms. By 11/97, he had been granted a

short-term disability. . . . He saw a psychiatrist, who eventually concluded that he

had an organic problem.” Id.

In terms of Mr. D’Angiolini’s current problems, Mr. D’Angiolini told Dr.

Vasey that he had “chronic fatigue, muscle and joint pain.” Id. Dr. Vasey

conducted a physical examination, too. Dr. Vasey’s impression was that Mr.

D’Angiolini “has an immune reaction to hepatitis B vaccination. This is

complicated by chronic fatigue and fibromyalgia.” Dr. Vasey recommended that

Mr. D’Angiolini limit his activity level. Id. at 18-19.

Following Dr. Vasey’s examination of Mr. D’Angiolini, Dr. Vasey wrote a

letter to the judge presiding over Mr. D’Angiolini’s claim for workers’

compensation benefits pending in Pennsylvania. Dr. Vasey stated “On reviewing

his clinical course I believe he suffered an unusual immune mediated reaction to

his Hepatitis B vaccine.” Dr. Vasey continued: “Because the recognition of this

problem is at the case report level[,] well intention[ed] honest physicians could

contest my opinion.” Dr. Vasey recommended that the judge postpone the hearing

scheduled in the workers’ compensation claim to accommodate Mr. D’Angiolini’s

illness and “to allow better understanding of the immunology and epidemiology of

the vaccine reactions.” Exhibit 133 at 23.

34

In March 2001, Mr. D’Angiolini again saw Dr. Buttram, whose history

noted Mr. D’Angiolini’s pending claims for disability benefits and workers’

compensation benefits. Dr. Buttram’s impressions were hepatitis B and influenza

vaccine reactions, myocarditis, encephalomyelitis, neuropathy, chronic fatigue,

fibromyalgia, and temporal arteritis. Exhibit 36 at 1-2. Another appointment with

Dr. Buttram was on August 7, 2001. Exhibit 14 at 8-10.

In July 2001, Mr. D’Angiolini returned to Dr. Waisbren, whom he had

previously seen in 1999. Proceedings in Mr. D’Angiolini’s workers’ compensation

claim may have prompted these appointments as Dr. Waisbren directed his report

to Mr. D’Angiolini’s attorney.27 Dr. Waisbren confirmed his 1999 opinion that the

hepatitis B vaccine had harmed Mr. D’Angiolini. Dr. Waisbren indicated that Mr.

D’Angiolini had “some unsteadiness on his feet, some hesitance of speech, and a

markedly positive fibromyalgia test.” Exhibit 16 at 241-42.28

On September 19, 2001, Mr. D’Angiolini had his second appointment with

Dr. Vasey. Exhibit 133 at 17. The third appointment was on July 30, 2003. Id. at

16.

On June 3, 2003, Mr. D’Angiolini saw Harold Pretorius, M.D., whose office

is in Cincinnati, Ohio. Dr. Pretorius’s file includes records from a 1998 test on Mr.

D’Angiolini’s heart, the May 1999 echocardiogram, and reports from Dr. Weber.

Exhibit 40 at 4-11. Dr. Pretorius noted that Mr. D’Angiolini’s physician was

“Frank Vasi” [sic]. Id. at 2. Dr. Pretorius’s history indicated, among other things,

that Mr. D’Angiolini had “[s]yncope causing several automobile accidents and a

fall with fracture of the left thumb, myalgia, chronic fatigue and somnolence, . . .

severe headaches recently requiring daily analgesics.” Dr. Pretorius also stated

that Mr. D’Angiolini’s lab tests showed “low C3 complement, positive double-

stranded DNA, antimitochondrial, anti-smooth muscles and antimyocardial

antibodies.” Id.29

27

The judge in the workers’ compensation case first received testimony in Mr.

D’Angiolini’s case on June 7, 2001. Exhibit 51 at pdf 13-15 (June 7, 2011 W.C. Trial Tr. 1-3).

28

The fibromyalgia test appears as exhibit 21 at 51.

29

None of the lab tests produced with Dr. Pretorius’s file show low C3 complement, etc.

On the other hand, the 1998 heart study, which is included in Dr. Pretorius’s file, indicated that

Mr. D’Angiolini had global hypokinesis.

35

Dr. Pretorius administered a SPECT scan of Mr. D’Angiolini’s brain.30 Dr.

Pretorius noted three results. There was a “[n]ormal posterior dynamic flow study

tracer distribution” and a “[n]ormal stimulated cerebral perfusion.” However,

there was also a “[d]ecreased baseline (FDG) right parieto-occipital, left temporal

and cerebellar tracer distribution.” Dr. Pretorius stated that this abnormal finding

was “consistent with nonspecific neurodegeneration.” Id. at 3. After ruling out

several conditions such as multiple sclerosis, Dr. Pretorius suggested that the

results may be consistent with “[l]upus-like cerebritis (evidenced also by positive

double-stranded DNA antibodies) related to repeated antigen (vaccine) exposure

. . . most likely in a patient with multiple documented allergies.” Id. at 2. What Dr.

Pretorius did with these results is not readily apparent.31

6. Cleveland Clinic Doctors, including Doctors Hanson and

Galatro, in 2004 and 2005

On June 30, 2004, Mr. D’Angiolini had an appointment with an office of the

Cleveland Clinic located in Naples, Florida. An advanced registered nurse

practitioner and Maurice Hanson, a neurologist, saw him at this visit, which

appears to have been Mr. D’Angiolini’s first visit to the Cleveland Clinic. Exhibit

37 at 22, 29. Dr. Hanson’s notes indicate that Mr. D’Angiolini brought with him

medical records from other doctors, including Doctors Bray and Bach. Dr. Hanson

also recounted that Dr. Bellanti “thought that he had an autoimmune disease

related to vaccinations with hepatitis B.” Id. at 24. At this point, Dr. Hanson’s

impression was “there is some conflicting data and many interpretations, all of

which need to be further elucidated,” and Dr. Hanson referred Mr. D’Angiolini for

additional consultations. Id.

One of these consultations was for a neuropsychological examination, which

according to Dr. Hanson, took place in Philadelphia. Following that consultation,

Mr. D’Angiolini saw Dr. Hanson again on September 23, 2004. Dr. Hanson

30

SPECT is an acronym standing for single-photo emission computed tomography.

Dorland’s at 1742.

31

Dr. Pretorius’s report appears not to be included in any treating doctor’s records.

Nevertheless, the expert witnesses discussed Dr. Pretorius’s SPECT scan in their reports. See

exhibit 97 at 2 (Dr. Shoenfeld); exhibit A at 7-8 (Dr. Lightfoot); exhibit 153 at 1 (Dr. Buttram).

36

determined that the notes from the neuropsychological examination “did not

document any evidence of psychosis or a psychiatric disorder.” Id. at 25.

Dr. Hanson referred Mr. D’Angiolini to a specialist in infectious disease,

Margaret J. Gorensek. Dr. Gorensek’s history is again relatively lengthy, drawing

upon reports of different doctors. She stated “the patient had so many evaluations,

so many differing opinions, that there is no one consistent opinion which makes it

more suspicious that there really is not any significant opinion.” Exhibit 37 at 21.

It appears that Dr. Gorensek ordered a series of laboratory tests. Id. at 26; see also

id. at 1-17 (results).

On October 19, 2004, Mr. D’Angiolini had an appointment with Dr. Hanson

on an “emergent basis” because of severe headaches. In this record, Dr. Hanson

stated that Mr. D’Angiolini had been diagnosed with cardiomyopathy. Dr. Hanson

referred Mr. D’Angiolini to Dr. Galatro, a cardiologist. Dr. Hanson’s examination

of Mr. D’Angiolini on October 19, 2004, was “essentially normal.” Id. at 26-27.

An echocardiogram and more laboratory tests were done. Id. at 1-19.

On November 19, 2004, Mr. D’Angiolini returned to the Cleveland Clinic

and saw Dr. Hanson. Dr. Hanson noted that he (Dr. Hanson) had consulted Dr.

Galatro. Whether Dr. Galatro actually saw Mr. D’Angiolini on this date is less

clear because her notes do not contain any details. Exhibit 37 at 19. Dr. Hanson,

however, recounted that “I rather agree with Dr. Galatro that this is an autoimmune

disorder which falls presum[ably] into the lupus category.” Id. at 25. Dr. Hanson

again referred Mr. D’Angiolini to more doctors, but records of a consultation with

Dr. Goodwin and an ear, nose, and throat specialist do not appear in the record.

Dr. Hanson concluded “I will see him back a later date.” Id.

A note evidencing a further appointment with Dr. Hanson does not appear in

the record. However, Mr. D’Angiolini saw Dr. Galatro on June 22, 2005, which

was his most recent visit to the Cleveland Clinic. Dr. Galatro recorded, as part of

Mr. D’Angiolini’s history, that he “has chronic fatigue syndrome, SLE, and

cardiomyopathy.” Her assessment includes “[m]ild cardiomyopathy” and “SLE,”

but not chronic fatigue syndrome. Dr. Galatro prescribed medication for his

cardiomyopathy but did not recommend any particular treatment or study

specifically for SLE. Id. at 20.

7. Recent Visits with Dr. Vasey

When Mr. D’Angiolini testified in April 2008, he stated that he was not

functioning very well. Tr. 688. He stated that he had neurological problems and

37

“horrible” physical pain. Tr. 690. When asked about his current doctors, Mr.

D’Angiolini stated that he saw Dr. Vasey about twice a year. Tr. 693.

Dr. Vasey’s records confirm that he saw Mr. D’Angiolini about twice a year

from 2003 to 2009. Exhibit 133 at 1-15. By the time of the hearing in January

2013, Mr. D’Angiolini’s most recent appointment with Dr. Vasey was on June 6,

2012. Tr. 1525; exhibit 196.

IV. General Assessment of Witnesses

The Federal Circuit has made clear that special masters have the

responsibility “to assess the reliability of testimony, including expert testimony.”

Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1325 (Fed. Cir.

2010). The Federal Circuit expects that special masters will “make determinations

as to the reliability of the evidence presented to them and, if appropriate, as to the

credibility of the person presenting that evidence.” Id. at 1326.

These instructions are the basis for a general evaluation of the witnesses who

testified at the January 2013 hearing: Doctors Vasey, Shoenfeld, Lightfoot and

Whitton.

A. Dr. Vasey

Among the people who testified, Dr. Vasey stands in a unique position. He

actually treated Mr. D’Angiolini. Mr. D’Angiolini first came to Dr. Vasey in

2000, which is approximately three years after the vaccinations at issue. Since

2000, Dr. Vasey has periodically examined, ordered various tests for, and

recommended treatment for Mr. D’Angiolini. See exhibit 133.

As a treating doctor, Dr. Vasey’s opinion warrants very careful

consideration. Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317,

1326 (Fed. Cir. 2006). Here, Dr. Vasey’s diagnoses are worth a great deal. No

one has criticized the care that he provided to his patient. No one has suggested

that Dr. Vasey should have ordered more tests and no one has suggested that Dr.

Vasey misinterpreted the results of the tests he ordered. In short, there is every

reason to defer to Dr. Vasey’s assessment of the disease that afflicts Mr.

D’Angiolini. As discussed below Dr. Vasey’s opinion that Mr. D’Angiolini does

not suffer from SLE is almost definitive evidence on that point.

38

However, there is a difference between a doctor’s opinion regarding

diagnosis and a doctor’s opinion regarding etiology. Doctors “may testify to both

[diagnosis and etiology] but the reliability of one does not guarantee the reliability

of the other.” Tamraz v. Lincoln Electric Co., 620 F.3d 665, 674 (6th Cir. 2010).

In this case, once the relevant question passes beyond diagnosis to causation,

Dr. Vasey’s opinion becomes much less strong. 32 He does not have any special

training in immunology, which is the most relevant discipline. See Terran v. Sec'y

of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999) (stating that

“[T]he rules of evidence require that the trial judge determine whether the

testimony has a reliable basis in the knowledge and experience of the relevant

discipline.”). Although Dr. Vasey opined that the hepatitis B vaccine harmed Mr.

D’Angiolini, Dr. Vasey struggled to articulate a theory about how the hepatitis B

vaccine harmed him. Tr. 1555-61. Dr. Vasey eventually offered molecular

mimicry. Tr. 1560. But, his knowledge about molecular mimicry was limited.

Thus, his opinion about molecular mimicry was not persuasive. See Shapiro v.

Sec'y of Health & Human Servs., 105 Fed. Cl. 353, 359 (Fed. Cl. 2012) (denying

motion for review in relevant part and ruling that the special master was not

arbitrary in finding that Dr. Shoenfeld failed to establish that molecular mimicry

was a reliable theory to explain how the hepatitis B vaccine can cause chronic

fatigue syndrome), aff’d without opinion, 503 Fed. Appx. 952 (Fed. Cir. 2013).

In addition to Dr. Vasey’s relative unfamiliarity with the immunologic

principles undergirding the theory of molecular mimicry, there is also a question

about the information provided to Dr. Vasey. As alluded to earlier, Dr. Vasey was

not Mr. D’Angiolini’s treating doctor in 1997, when he received the hepatitis B

vaccines. Mr. D’Angiolini did not start seeing Dr. Vasey until 2000, and,

therefore, Dr. Vasey lacks any first-hand knowledge about Mr. D’Angiolini’s

health in the months following the vaccinations. Dr. Vasey did not

contemporaneously see or evaluate Mr. D’Angiolini for his alleged vaccine-related

symptoms and complaints. For this aspect of Mr. D’Angiolini’s history, Dr. Vasey

32

On one occasion, a district court has excluded Dr. Vasey’s testimony regarding

causation as unreliable under Daubert. See Norris v. Baxter Healthcare Corp., 397 F.3d 878

(10th Cir. 2005) (affirming exclusion of evidence and grant of summary judgment); but see

Hopkins v. Dow Corning Corp., 33 F.3d 1116, 1124-25 (9th Cir. 1994) (holding that district

court did not abuse its discretion in admitting Dr. Vasey’s testimony).

39

must rely upon Mr. D’Angiolini and his mother, who, by this time, were convinced

that the hepatitis B vaccine harmed him.

The patient’s subjective understanding that a vaccine harmed him is

understandable. After all, petitioners in the Vaccine Program have been presumed

to file their lawsuits alleging that a vaccine caused them some injury in good faith.

See Grice v. Sec'y of Health & Human Servs., 36 Fed. Cl. 114, 121 (Fed. Cl.

1996). A potential problem is that patients may remember their histories

inaccurately.

At Mr. D’Angiolini’s initial appointment with Dr. Vasey, Mr. D’Angiolini

provided a history. Since many of the details are important, it is set out at length.

[Mr. D’Angiolini] had been in good health until 03/97, at which point

he was advised by his employer to have the hepatitis B vaccine. After

the first injection he developed promptly some headaches and flu-like

symptoms. These problems persisted over several weeks, and he

received another vaccination in 04/97, “I was out of it.” He was

dragging himself to work. He could sleep for 24 straight hours.

Apparently at that point, no one related these findings to the hepatitis

B vaccination. Finally, in 10/97, he had a third injection as noted in

the prescribed course. He had another reaction with chest pain,

shortness of breath, sweats and worsening of his flu-like symptoms.

By 11/97, he had been granted a short-term disability. He noted the

‘brain fog’ was severe. He saw a psychiatrist, who eventually

concluded that he had an organic problem.

Exhibit 8 at 1.

Many statements in this history are not in accord with the Findings of Fact,

which were based upon contemporaneously created medical records that were not

available to Dr. Vasey. To start, Mr. D’Angiolini’s description of himself as being

in “good health” before the March 1997 vaccination leaves out much. Before the

vaccination, he was seeing Dr. Middleman because his OCD was contributing to

the breakup of his engagement and he was having headaches for which Dr.

Middleman was prescribing medications. On the other hand, Mr. D’Angiolini was

in “good health” in the sense that he was working at two jobs and did not have any

physical impediments.

Mr. D’Angiolini’s headaches are important. In 2000, he told Dr. Vasey that

after the first vaccination he “developed promptly some headaches.” Actually,

40

both Dr. Middleman’s and Dr. Roman’s notes show that Mr. D’Angiolini was

complaining about and being treated for headaches before the vaccination.

Mr. D’Angiolini also told Dr. Vasey that after the first vaccination he

developed “flu-like symptoms [that] persisted over weeks,” apparently through the

next vaccination in April 1997. Mr. D’Angiolini’s recitation that he had “flu-like

symptoms” in March or April 1997 was found not to be persuasive in the Findings

of Fact.

Thus, the information available to Dr. Vasey in 2000 about Mr.

D’Angiolini’s health in 1997 was inaccurate. The history suggests a dramatic

change from good health to a prompt multi-week persistence of flu-like symptoms.

As determined in the Findings of Fact, Mr. D’Angiolini suffered from some

problems, such as headaches, before the vaccination and his health did not decline

drastically until months later. The differences between Mr. D’Angiolini’s health

before and after vaccination as found, on the one hand, in the Findings of Fact and,

on the other hand, in Mr. D’Angiolini’s history to Dr. Vasey in 2000, are

significant.

In 2000, based in part on the inaccurate information given to him, Dr. Vasey

formed an opinion that Mr. D’Angiolini “suffered an unusual immune mediated

reaction to his Hepatitis B vaccine.” Dr. Vasey communicated this opinion to the

judge presiding over Mr. D’Angiolini’s claim for workers’ compensation benefits

in a letter dated October 12, 2000. In this letter, Dr. Vasey wrote that an adverse

reaction to the hepatitis B vaccine was recognized “at the case report level.” As

such, “well[-]intention[ed] honest physicians could contest my opinion.” Dr.

Vasey recommended an indefinite postponement of Mr. D’Angiolini’s workers’

compensation trial because of Mr. D’Angiolini’s health and “to allow time for

better understanding of the immunology and epidemiology of the vaccine

reactions.” Exhibit 133 at 23.

Dr. Vasey presented essentially this same opinion in his reports submitted

for this litigation. Dr. Vasey’s fundamental assumptions about Mr. D’Angiolini’s

health in 1997 did not change in the ensuing ten years. But, these assumptions

were not supported by the Findings of Fact. Consequently, Dr. Vasey’s opinion

about causation, although well intended, cannot be credited. See Burns, 3 F.3d at

417.

41

B. Dr. Shoenfeld

Dr. Shoenfeld has a very impressive background in medicine, in general, and

in immunology, more specifically. Within the specialty of immunology, Dr.

Shoenfeld holds himself out as an auto-immunologist, meaning that he has focused

on diseases in which the body’s immune system attacks itself. Although the

Secretary pointed out that “auto-immunology” is not a recognized sub-specialty in

the sense that one could not seek treatment by an autoimmunologist as easily as

with a rheumatologist, Tr. 1458-60, there is little doubt that if there were such a

specialty, Dr. Shoenfeld would qualify.

Dr. Shoenfeld is listed as a contributing author in more than 1,000 articles

appearing in peer-reviewed journals. His knowledge of the literature is

encyclopedic. He spontaneously recalled articles reporting studies throughout his

testimony. E.g. Tr. 1559.33

Dr. Shoenfeld has been writing about the possibility that various vaccines

cause autoimmune disease since 1996. See exhibit 85 at 65. Beginning in 2006,

Dr. Shoenfeld has appeared in Vaccine Program cases to express an opinion that a

vaccine caused the petitioner’s injury. His participation in these cases contributed

to Dr. Shoenfeld’s conception of the entity he calls autoimmune syndrome induced

by adjuvant (also known as “ASIA”). Dr. Shoenfeld’s assertion that Mr.

D’Angiolini suffers from ASIA is discussed at length below. See section VIII.

Similarly, sections VI and VII, below, discuss Dr. Shoenfeld’s assertion that Mr.

D’Angiolini suffers from chronic fatigue syndrome and SLE.

Although Dr. Shoenfeld’s knowledge about medical articles was detailed,

Dr. Shoenfeld had a much less firm grasp on the medical records about Mr.

D’Angiolini. For example, Dr. Shoenfeld was not sure that he reviewed Dr.

Middleman’s records. Tr. 1474. Dr. Middleman was the psychiatrist who was

holding appointments with Mr. D’Angiolini in the six months before vaccination

and for approximately a year after his third hepatitis B vaccination. Exhibit 24. As

the best source for information about Mr. D’Angiolini’s health during this critical

time, Dr. Middleman’s records are very important and underlie many of the

33

While impressive, Dr. Shoenfeld’s citation to articles that were not filed into the record

can cause problems in a hearing as neither the Secretary’s attorney nor the Secretary’s expert

witness can review those previously uncited articles.

42

Findings of Fact. As such, Dr. Shoenfeld should have certainly reviewed those

records.

Dr. Shoenfeld’s testimony suggested that he did not know Mr. D’Angiolini’s

medical history. Dr. Shoenfeld asserted that Mr. D’Angiolini had a “severe

reaction” to the first dose of the hepatitis B vaccine. Exhibit 87 at 3. However, his

report did not cite to any records documenting this “severe reaction,” id., and when

cross-examined on this point, he also could not identify the basis for his assertion.

Tr. 832-39. Dr. Shoenfeld further asserted that between April 18, 1997 and May

27, 1997, Mr. D’Angiolini did not complete his assignments at work. Tr. 840-41.

But, the employer’s record does not corroborate this assertion.

C. Dr. Lightfoot

Dr. Lightfoot graduated from medical school in 1961. He followed that

education with more intensive focus on rheumatology. In addition to seeing

patients, Dr. Lightfoot maintained an academic career, including many years as a

professor at the Medical College of Wisconsin. For approximately one decade, he

served as the chief of the rheumatology division for that institution. From

Wisconsin, he moved to the University of Kentucky in 1987. There, he was a

professor and the division director of allergy, immunology and rheumatology until

2003. Exhibit B at 2.

Consistent with his academic positions, Dr. Lightfoot has written

approximately 40 articles appearing in peer-reviewed journals. He has also

contributed chapters to books. The subject of most of his publications has been

rheumatology. Exhibit B at 14-23.

As a rheumatologist, Dr. Lightfoot has seen many people who either have

lupus or were suspected to have lupus. Tr. 1128 (approximately 30 percent of Dr.

Lightfoot’s 1,000 current patients have lupus). This background makes him well

qualified to assess whether Mr. D’Angiolini has lupus. However, Dr. Lightfoot

has relatively less experience in treating patients with chronic fatigue syndrome or

OCD. See Tr. 1158, 1337, 1401-02. Consequently, his opinion with respect to

those conditions cannot be given the same weight.

Dr. Lightfoot’s background was the subject of intense questioning during

voir dire. Mr. D’Angiolini’s counsel’s questions elicited testimony that Dr.

Lightfoot had not studied vaccines or their possible adverse effects. Tr. 1081-90.

These admissions led to an argument that Dr. Lightfoot was not qualified to

43

express an opinion on the ultimate question in this case, whether the hepatitis B

vaccinations harmed Mr. D’Angiolini.

As Mr. D’Angiolini’s counsel recognized, even if the objection to Dr.

Lightfoot’s qualification to opine about whether the vaccine caused Mr.

D’Angiolini a disease were sustained, Dr. Lightfoot would remain qualified to

testify about whether Mr. D’Angiolini suffered from a particular disease. See Tr.

1088-89. In this regard, Dr. Lightfoot stands in roughly the same shoes as Dr.

Vasey, who expressed an opinion that a vaccine harmed Mr. D’Angiolini without

testifying that he has studied vaccinations. The logical extension of Mr.

D’Angiolini’s argument is that only doctors who have studied immunology, maybe

only doctors who have studied vaccinology, would be qualified to testify in

Vaccine Program cases. This standard would excessively elevate the minimally

acceptable qualifications.34

Moreover, Dr. Lightfoot’s experience seems to make him more qualified

than Dr. Vasey to opine on immunologic topics. After the challenge to Dr.

Lightfoot’s background arose during voir dire, the Secretary elicited additional

testimony. Dr. Lightfoot described how rheumatologists treat patients for diseases

that are autoimmune in origin, including lupus. In addition, Dr. Lightfoot stated

that he reviewed the articles cited by Dr. Shoenfeld and understood the

immunologic concepts involved. Tr. 1121-28. Consequently, when Mr.

D’Angiolini’s attorney interposed objections to specific questions intending to

elicit Dr. Lightfoot’s opinion regarding causation, Mr. D’Angiolini’s objection was

overruled. See, e.g. Tr. 1194-98. Dr. Lightfoot’s opinion was admitted and its

worth will be weighed in sections below.

D. Dr. Whitton

Dr. Whitton was born in Scotland and obtained the equivalent of a medical

degree in 1979. Five years later, he obtained a Ph.D. after studying herpes virus

transcription.

In 1989, he joined the Scripps Research Institute in La Jolla, California. At

that institution, he has taught neuropharmacology and immunology. He has acted

34

Incidentally, this raised bar would probably cause more problems for petitioners, who

bear the burden of proof, than for respondent.

44

as the editor of Virology since January 2006. In 2007, he declined an offer for a

similar position for the Journal of Virology. He has written more than 160 articles

published in peer-reviewed journals. Exhibit W at 2-12; Tr. 1600-03. After a

presentation of his qualifications at the hearing on February 17, 2013, he was

recognized was an expert in the areas of virology and immunology. Tr. 1603.

Dr. Whitton’s testimony was relatively short because most of the issues on

which he had opined had become moot.35 His testimony focused on allergy and

whether Mr. D’Angiolini was allergic to yeast. This topic was within the scope of

his expertise.

The testimony of Doctors Vasey, Shoenfeld, Lightfoot and Whitton are

discussed extensively in the following parts, which are organized by condition for

which Mr. D’Angiolini seeks compensation. To restate, he claims a yeast allergy,

chronic fatigue syndrome, lupus, and ASIA.

V. Yeast Allergy

Mr. D’Angiolini’s claim about his allergy to yeast has fluctuated throughout

this litigation. The ebbs and flows are, therefore, discussed in section A. At the

end of the day, because Mr. D’Angiolini is putting forward a claim about yeast

allergy, general information about yeast and typical allergic reactions is presented

in section B. This foundation is the predicate for the conclusion, found in section

C, that Mr. D’Angiolini did not establish that the yeast component in the hepatitis

B vaccine caused an allergic reaction.

35

As explained in the procedural history, in 2012, the Secretary retained Dr. Whitton to

participate after Mr. D’Angiolini unexpectedly identified Dr. Buttram as a testifying witness in

late 2011. Dr. Whitton’s report directly responded to Dr. Buttram’s opinions. See exhibit V.

During the hearing, Mr. D’Angiolini’s attorney announced that he was not going to call Dr.

Buttram. Tr. 1590. The Secretary, however, maintained that she intended to call Dr. Whitton to

testify concerning Mr. D’Angiolini’s alleged yeast allergy. Tr. 1590-93.

45

A. Procedural History, including Experts’ Opinions, Regarding

Yeast Allergy

1. Initial Reports from Dr. Shoenfeld, Dr. Vasey, and Dr.

Lightfoot

Dr. Shoenfeld’s December 26, 2010 report about Mr. D’Angiolini

specifically mentions that Mr. D’Angiolini has an allergy to yeast. Exhibit 87 at 3.

This notation means that Dr. Shoenfeld was aware of this “fact.” However, Dr.

Shoenfeld did not identify yeast as a potential mechanism for an adverse reaction.

His report focused on the causative role of the aluminum adjuvant. Id. at 7-8.

Unlike Dr. Shoenfeld who did not rely upon a yeast allergy, Dr. Vasey’s

initial report found the yeast allergy very important. Dr. Vasey stated that Mr.

D’Angiolini “was known to be allergic to yeast.” Exhibit 83 at 2 ¶ 4. Dr. Vasey

did not identify the basis for this statement. Nevertheless, to Dr. Vasey, “the

obvious explanation for Mr. D’Angiolini’s reaction is the known yeast sensitivity

documented at age 3 years.” Id. at 3.

When Dr. Lightfoot responded to Dr. Vasey’s report and Dr. Shoenfeld’s

report, Dr. Lightfoot carefully called into question the accuracy of the assertion

that Mr. D’Angiolini was allergic to yeast. See exhibit A at 4-5, 18. Dr.

Lightfoot’s detailed review of the medical records justified revisiting the previous

Finding of Fact on this issue.

Given the uncertainty about Mr. D’Angiolini’s alleged yeast allergy, the

undersigned sought supplemental information from Mr. D’Angiolini’s experts

about whether each thought Mr. D’Angiolini was allergic to yeast. Dr. Vasey’s

response was “I don’t know. I would not recommend injecting him with yeast.”

Exhibit 96 at 2.

Dr. Shoenfeld’s response was stronger. He dismissed the yeast allergy. He

wrote:

The yeast allergy, if it exists, is not important for the claim of a long

life CFS following the vaccine. Allergy is an acute condition, while

the CFS after the [hepatitis B] vaccine is a chronic process and a

chronic result. Mr. D’Angiolini does not have to be tested for yeast

allergy. I believe that the case of the CFS [is] not due [to] yeast

allergy but due to adjuvant effect.

46

Exhibit 97 at 1.

It appeared that these submissions put the alleged yeast allergy to rest. One

of petitioner’s experts, Dr. Vasey, stated that he did not know whether Mr.

D’Angiolini was allergic to yeast. The other of petitioner’s experts, Dr. Shoenfeld,

stated that any yeast allergy “is not important.” Mr. D’Angiolini seemed to agree

with the view that the yeast allergy was not relevant. His initial pre-hearing brief,

filed on January 5, 2012, did not use the term “yeast” at all.

2. Dr. Buttram’s Report

Mr. D’Angiolini’s submission of Dr. Buttram’s report on January 6, 2012,

brought the yeast allergy to the surface again. In reciting Mr. D’Angiolini’s

relevant medical history, Dr. Buttram referenced cytotoxic testing, exhibit 153 at

10, and a December 1, 2010 anti-saccharomyces cerevisiae antibody (“ASCA”)

test, id. at 6. Dr. Buttram emphasized the contribution of the yeast allergy by

placing in bold the sentence stating “The presence of yeast allergy in [Mr.

D’Angiolini’s] case would have further intensified the allergic reaction.” Id. at 21.

Dr. Buttram’s conclusion was:

My diagnoses in the case of Joseph D'Angiolini were:

Adverse reactions to Hepatitis B vaccines involving mercury and

aluminum toxicities resulting in encephalitis, myocarditis,

neuropathies, temporal arteritis, and chronic fatigue.

Yeast allergy is listed as a contraindication to hepatitis B vaccine

administration in Physician's Desk Reference. Joe was allergic to

yeast and tested positive for Anti Saccharomyces Cerevisiae

Antibodies, the yeast that is in the Hepatitis B Vaccine. He should not

have received this vaccine.

Id. at 29.

3. Developments after Submission of Written Reports

At this point, Mr. D’Angiolini’s experts were not consistent. Mr.

D’Angiolini’s alleged yeast allergy was not significant to Dr. Shoenfeld and Dr.

Vasey. But, the yeast allergy was the causative mechanism for Dr. Buttram. Mr.

D’Angiolini’s own position was not clear. Although Mr. D’Angiolini’s attorney

had filed Dr. Buttram’s report at the request of his client and Ms. D’Angiolini, Mr.

47

D’Angiolini’s attorney did not discuss yeast allergy in his Supplemental

Prehearing Brief, filed on June 4, 2012.

During the January 3, 2013 pre-trial conference, the undersigned inquired

about the yeast allergy. Mr. D’Angiolini’s attorney intended to call Dr. Buttram,

whose opinion relied upon the yeast allergy. In light of this representation, the

undersigned filed, on January 9, 2013, two articles related to yeast allergy. Court

exhibits 1004 and 1005.

Before Dr. Buttram testified, Mr. D’Angiolini called Dr. Shoenfeld. Dr.

Shoenfeld’s view was that yeast is one of four vaccine components that may

trigger ASIA. Tr. 770-78, 803, 823. In support of his view, Dr. Shoenfeld cited a

recently published article. Exhibit 197 (Maurizio Rinaldi et al., Anti-

Saccharomyces cerevisiae Autoantibodies in Autoimmune Diseases: from Bread

Baking to Autoimmunity, 45 Clinical Revs. Allergy Immunology 2 (2013)). This

testimony prompted an objection from the Secretary. Mr. D’Angiolini’s attorney

and Dr. Shoenfeld explained that the submission of Court Exhibits 1004 and 1005

inspired Dr. Shoenfeld’s theory with respect to how Mr. D’Angiolini’s yeast

allergy had harmed him. Tr. 774-75.

This explanation is confusing. Mr. D’Angiolini’s alleged yeast allergy was a

potential issue throughout the case. In March 2005, Mr. D’Angiolini indicated that

because yeast is a component of the hepatitis B vaccine, an allergy to yeast may

play a potential role in vaccine-caused CFS. Pet’r’s Status Rep’t, filed Mar. 14,

2005, at 4. The alleged allergy was mentioned in the Findings of Fact. Dr.

Shoenfeld mentioned Mr. D’Angiolini’s yeast allergy in his October 12, 2010

report. Exhibit 84. Dr. Shoenfeld, subsequently, stated that Mr. D’Angiolini’s

chronic fatigue syndrome was “not due [to] yeast allergy, but due to adjuvant

effect.” Exhibit 97 at 1. After this direct statement from Dr. Shoenfeld that the

yeast allergy does not affect his opinion, it seems surprising that a special master’s

order would provoke additional reflection from Dr. Shoenfeld, given his decades of

experience in immunology.

In any event, Dr. Shoenfeld’s testimony was provided. Despite the ongoing

dispute documented in the experts’ supplemental reports and testimony, Mr.

D’Angiolini’s posthearing briefs do not discuss the validity of his yeast allergy

claim. See Pet’r’s Posthr’g Br.; see also Pet’r’s Posthr’g Reply Br. In response to

the Secretary’s posthearing assertion that Mr. D’Angiolini’s yeast allergy claim is

not supported by evidence, Mr. D’Angiolini relies on the Findings of Fact alone

without discussion of the subsequent record. Pet’r’s Posthr’g Reply Br. at 1. In

48

accord with the Vaccine Act’s directive for a special master to consider the record

as a whole, 42 U.S.C. § 300aa—13(a)(1), the evidence regarding yeast is

discussed. Topics include background information about yeast and Mr.

D’Angiolini’s medical history.

B. Basic Information about Yeast

The process of manufacturing the hepatitis B vaccine involves yeast. Genes

from the hepatitis B virus that encode the hepatitis B surface antigen are inserted

into common baker’s yeast. The growth of the baker’s yeast, also known as

Saccharomyces cerevisiae, allows for the production of the hepatitis B surface

antigen, which is the basis for the hepatitis B vaccine. Exhibit 1004 (Grotto) at

329-30; exhibit 1005 (DiMiceli) at 703.

However, “[a]s a result of biochemical and biophysical purification, there is

no detectible yeast DNA and only trace amounts of yeast proteins (1-5%) in the

final vaccine products.” Exhibit 1005 (DiMiceli) at 703; accord exhibit 1004

(Grotto) at 330. Nevertheless, one author stated that adverse reaction “may occur

because of the minute quantities of yeast proteins present in the vaccine.” Exhibit

1004 at 333.36 This possibility appears remote, at best, as the same author

continued: “The potential of these proteins to induce a hypersensitivity reaction in

primed individuals was examined by measuring of IgG and IgE antibody to yeast

before and after three dose of vaccine. No significant increases occurred in most

individuals and in those who experienced increases there was no correlation with

clinical symptoms.” Id.

36

The possibility that yeast might cause an adverse reaction is consistent with the

package insert that notes that a hepatitis B vaccine is contraindicated for people with allergies to

yeast. See exhibit 17 at 98 (excerpt from Physician’s Desk Reference for Energix-B). However,

a contraindication does not establish causality. See Werderitsh v. Sec'y of Health & Human

Servs., No. 99-319V, 2005 WL 3320041, at *8 (Fed. Cl. Nov. 10, 2005), citing 21 C.F.R. §

600.80(l).

49

When people who are allergic to yeast encounter yeast, they most likely

react within two days. Tr. 943 (Dr. Shoenfeld); cf. Tr. 1622 (Dr. Whitton

describing most yeast allergies as a delayed type hypersensitivity reaction).

C. Mr. D’Angiolini’s (Alleged) Allergy to Yeast

The best way to determine whether someone is allergic to yeast is to test the

person with a reliable test. Mr. D’Angiolini has not identified any reliable test

demonstrating an allergy to yeast.37

Alternatively, a yeast allergy could be suspected, if not confirmed, by

experience. See Tr. 943 (Dr. Shoenfeld “[T]he diagnosis of allergy should be done

by the patient, not by a physician.”). This appears to be the path taken by Mr.

D’Angiolini.

Mr. D’Angiolini first suspected he was allergic to yeast when he was 10

years old and visiting Walt Disney World with his family. He ate a slice of pizza

and vomited. From this episode, he concluded that he was allergic to yeast. Tr.

154; see also exhibit 51 at pdf 187-89 (May 31, 2002 W.C. Trial Tr. 49-51).38

However, when Mr. D’Angiolini was asked about his relevant medical

history in the course of seeking treatment, he did not include yeast on those forms.

He did list other allergens, such as penicillin and sulfa. Exhibit 17 at 121-22 (letter

37

Two tests, arguably, could show Mr. D’Angiolini’s allergy to yeast. The first is a

cytotoxic test for yeast that Dr. Buttram administered to Mr. D’Angiolini. Exhibit 43 at pdf 3.

However, articles cited by Dr. Whitton convincingly demonstrate that a cytotoxic test is not a

reliable test for allergies. Exhibit KK (Food and Drug Administration, Compliance Policy Guide

Sec. 370.100 Cytotoxic Testing for Allergic Diseases (1985), available at

http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm123806

.htm); exhibit LL (I. Leonard Bernstein et al., Allergy Diagnostic Testing: An Updated Practice

Parameter, 100.3 Annals Allergy, Asthma & Immunology S1 (2008)).

Second, during the hearing, Mr. D’Angiolini submitted a December 1, 2010 report

showing the presence of ASCA to IgA and IgG. Exhibit 198. The experts were consistent that

this test provided no information about whether Mr. D’Angiolini had an allergy, which is

measured by IgE, to yeast. Tr. 1064-67, 1655.

38

The attorney representing Mr. D’Angiolini’s employer objected to allowing Ms.

D’Angiolini to testify about an alleged yeast allergy because there was no testing for the allergy.

50

dated Sept. 13, 1998); exhibit 22 at pdf 4 (notes dated Nov. 17, 1998); exhibit 14 at

29 (questionnaire dated Oct. 6, 1999).

After Mr. D’Angiolini began pursuing compensation for his hepatitis B

vaccination (either through a claim for workers’ compensation or for Vaccine

Program benefits), he began listing yeast among his allergies in histories provided

to treating doctors. See exhibit 17 at 15 (Dr. Bray’s Nov. 30, 1999 letter); exhibit

14 at 67 (letter dated Nov. 4, 1999, stating “yeast exposure gives him a headache”).

In accord with the history that Mr. D’Angiolini gave to them, doctors sometimes

included yeast allergies in their reports. These doctors, however, did not conduct

any tests to confirm the allergy.

No persuasive evidence establishes that Mr. D’Angiolini suffered an adverse

reaction to the yeast component in the hepatitis B vaccine. As discussed above,

any allergic reaction to yeast would be apparent within approximately a few days

of exposure. However, the evidence in this case does not persuasively establish

that Mr. D’Angiolini was in ill health in the days immediately following any dose

of the hepatitis B vaccine. As discussed in the context of the Findings of Fact, the

parties disputed Mr. D’Angiolini’s condition after vaccinations. Much of Mr.

D’Angiolini’s testimony was not credited because it was in either direct or indirect

conflict with medical records created contemporaneously. In addition, even Mr.

D’Angiolini did not claim that he had an immediate reaction.

D. Synopsis of Yeast Allergy

For these reasons, the record does not support a finding that Mr. D’Angiolini

reacted adversely to the hepatitis B vaccine because of a yeast allergy. Therefore,

to be entitled to compensation, Mr. D’Angiolini will need to pursue other avenues.

VI. Chronic Fatigue Syndrome

While the alleged yeast allergy was sometimes a less prominent part of Mr.

D’Angiolini’s case, his allegation that the hepatitis B vaccine caused him to suffer

chronic fatigue syndrome has always been front and center. In 2004, Mr.

D’Angiolini’s attorney was promoting this case as the lead case about hepatitis B

vaccine and chronic fatigue syndrome, although other cases involving the hepatitis

B vaccine and chronic fatigue syndrome have proceeded separately. Mr.

D’Angiolini and the Secretary presented extensive evidence about chronic fatigue

syndrome.

51

The evidence relates to the following topics. First, there is information

about what chronic fatigue syndrome is. See section VI.A. Second, this evidence

is used to evaluate a fundamental aspect of Mr. D’Angiolini’s claim, one which the

parties strenuously disputed, whether Mr. D’Angiolini established that he suffers

from chronic fatigue syndrome. See section VI.B. For the reasons explained

therein, Mr. D’Angiolini did not establish this predicate. Nevertheless, the

following two sections assume that Mr. D’Angiolini could proceed to the next

steps in his claim. Thus, section C sets forth the well-established elements for a

causation-in-fact claim and section D analyzes the evidence related to the three

prongs of Althen.

A. Basic Information about Chronic Fatigue Syndrome

In the phrase “chronic fatigue syndrome,” each term contributes to the

meaning of the phrase. “Chronic” is defined as “persisting over a long period of

time.” Dorland’s at 359. “Fatigue” has many meanings and interpretations. In

this instance, it may best be described as a “loss of power or capacity to respond to

stimulation.” Id. at 685. A “syndrome” is a “set of symptoms that occur together.”

Id. at 1819; accord Tr. 1157. In chronic fatigue syndrome, the primary feature is,

obviously, fatigue. To qualify as chronic fatigue syndrome, the fatigue must be

accompanied by various other ancillary symptoms. Tr. 728, 1157-60. The

associated symptoms are discussed in more detail in section VI.B.2(b), below.

Although reports of conditions resembling chronic fatigue syndrome date

back many years, chronic fatigue syndrome became more widely known in the

1980s. Tr. 947-49. Many of the articles about chronic fatigue syndrome were

published in that decade.

How many people are afflicted with CFS is a matter of some dispute. One

study reported that the prevalence of CFS is between 0.4 and 2.0 per cent.39

Exhibit 34 (O. Zachrisson et al., Immune Modulation with a Staphylococcal

Preparation in Fibromyalgia/Chronic Fatigue Syndrome: Relation Between

Antibody Levels and Clinical Improvement, 23 Eur. J. Clin. Microbiol. Infect. Dis.

98 (2004)) at 98. In the view of one attorney, chronic fatigue syndrome is “a

source of considerable dispute within and beyond the medical community. Some

39

“Prevalence” refers to “the number of cases of a disease that are present in a population

at a specified time.” Dorland’s at 1513.

52

observers estimate that millions of CFS victims exist, but remain undiagnosed,

while others remain unconvinced that CFS is anything more than a collection of

symptoms of chronic depression.” Monique C.M. Leahy, Proof of Chronic Fatigue

Syndrome and Fibromyalgia, 99 Am. Jur. Proof of Facts 3d 1, § 2 (2008).

B. Has Mr. D’Angiolini Established, by Preponderant Evidence, that

He Suffers from Chronic Fatigue Syndrome?

A preliminary question is whether CFS is an appropriate diagnosis for Mr.

D’Angiolini. One aspect of his case is to establish, by a preponderance of the

evidence, that he actually suffers from a condition that he alleges was caused by a

vaccine. Broekelschen, 618 F.3d at 1346.

When doctors diagnose a disease, the doctor evaluates the person’s signs and

symptoms and compares them to the diagnostic criteria. Doctors involved in Mr.

D’Angiolini’s care have gone through this process with Mr. D’Angiolini and

reached inconsistent conclusions. Similarly, the doctors retained in this litigation

have also come to different conclusions with respect to Mr. D’Angiolini’s

diagnosis. Dr. Shoenfeld has opined that Mr. D’Angiolini suffers from CFS.

Exhibit 97 at 3; Tr. 801, 828-29. In contrast, Dr. Lightfoot has opined that

depression is a better diagnosis. Exhibit A at 14-15, 18; Tr. 1162.

1. Criteria

Diagnostic criteria help researchers understand a condition by promoting

uniform case definition and case assessment. Without this common understanding,

researchers in different disciplines may use different nomenclature, hindering

progress in understanding the disease. This was certainly the case for chronic

fatigue syndrome, which was given many different names. Exhibit 34 (M.C.

Sharpe et al., A report – CFS: guidelines for research, 84 J. Royal Society of

Medicine 118 (1991)) at 118.40

By 1988, researchers proposed the name “chronic fatigue syndrome.” These

same researchers attempted to define the condition, but their “definition proved to

be unsatisfactory in practice.” Id. Other proposed definitions were also

40

According to Dr. Shoenfeld, another name for CFS is “postvaccinal encephalitis.” Tr.

740. However, that term does not appear in the list given in the Sharpe article.

53

inadequate. Consequently, a group of interested British researchers met to propose

“recommendations for the conduct and reporting of future studies of patients with

chronic fatigue.” Id. at 119.

In 1994, an international chronic fatigue study group authored “a set of

research guidelines for use in studies of the chronic fatigue syndrome.” Exhibit U

(Keiji Fukuda et al., The Chronic Fatigue Syndrome: A Comprehensive Approach

to Its Definition and Study, 121 Ann. Intern. Med. 953 (1994)) at 953. These

guidelines are frequently referred to as either the Fukuda standards or the CDC

standards because the lead author of the study, Dr. Fukuda, worked for the Centers

for Disease Control and Prevention. Id. at 958. The Fukuda group drew upon the

experience with the British guidelines, which are cited as reference 4 in the Fukuda

article. Id. at 957.

The Fukuda criteria include both inclusionary and exclusionary factors

(attached hereto as “Appendix A”). First, the person must suffer from “chronic

fatigue,” meaning “self-reported persistent or relapsing fatigue lasting 6 or more

consecutive months.” Exhibit U (Fukuda) at 954. This fatigue must be severe

enough to cause a “substantial reduction in previous levels of occupational,

educational, social, or personal activities.” Id. at 956; accord Tr. 960 (Dr.

Shoenfeld). A more extensive explanation of fatigue appeared in the previous

British guidelines. Among other points, the British researchers emphasized fatigue

“is a subjective sensation and has a number of synonyms, including tiredness and

weariness.” Exhibit 34 (Sharpe) at 120.

The subjective and self-reported nature of the fatigue continues to make

diagnosing CFS a challenge for doctors. Dr. Shoenfeld explained that there is no

laboratory test to diagnose CFS and that it is “very difficult to diagnose chronic

fatigue syndrome.” Tr. 811.

Chronic fatigue, by itself, does not satisfy the diagnostic criteria for CFS.

The person must also have “four or more of the following symptoms . . .

concurrently present for ≥6 months: 1) impaired memory or concentration, 2) sore

throat, 3) tender cervical or axillary lymph nodes, 4) muscle pain, 5) multi-joint

pain, 6) new headaches, 7) unrefreshing sleep, and 8) post-exertion malaise.”

Exhibit U (Fukuda) at 955. The inclusion of these ancillary features “generated the

most disagreement” among the study group. The authors added that the

controversy over the ancillary symptoms “underscores the need to establish

54

specific features of the chronic fatigue syndrome and the validity of any chronic

fatigue syndrome case definition.” Id. at 957.41

When presented with chronic fatigue, the doctor was expected to evaluate

the patient for “underlying or contributing conditions.” Exhibit U (Fukuda) at 954.

For example, the doctor will test a person’s thyroid to see if it is underactive

because an underactive thyroid can cause fatigue. If the person suffers from

hypothyroidism, the doctor treats it. This patient, although suffering from chronic

fatigue, would not fit the diagnostic criteria for CFS. Tr. 1158. Another example

is chronic fatigue due to cancer. Tr. 862.42

The more challenging question --- and the one that is more germane to Mr.

D’Angiolini’s case --- is depression. “It is difficult to interpret symptoms typical

of the CFS in the setting of illnesses such as major psychotic depression.” Exhibit

U (Fukuda) at 957. Depression can make people feel fatigued. Tr. 1346. The

Fukuda criteria tried to eliminate people with depression from the group of people

satisfying the diagnostic criteria for CFS. Tr. 1161. Fukuda wrote that evaluating

doctors should obtain a history that, among other things, “covers medical and

psychosocial circumstances at the onset of fatigue [as well as] depression or other

psychiatric disorders.” The doctor should examine the patient’s mental status with

“[p]articular attention . . . directed toward current symptoms of depression or

anxiety. . . . Evidence of a psychiatric or neurologic disorder requires that an

appropriate psychiatric, psychological, or neurological evaluation be done.”

Exhibit U (Fukuda) at 954.

In the Fukuda criteria, “[a]ny past or current diagnosis of major depressive

disorder with psychotic or melancholic features” “exclude[s] a patient from the

diagnosis of unexplained chronic fatigue.” Id. at 955. On the other hand, the list

of conditions that do not exclude a CFS diagnosis includes “anxiety disorders,

somatoform disorders, nonpsychotic or nonmelancholic depression.” Id. at 956.

41

Dr. Shoenfeld asserted that after the CDC released its criteria, the American College of

Rheumatology revised the definition of chronic fatigue to eliminate the ancillary symptoms. Tr.

859-60, 865. But, later Dr. Shoenfeld agreed with the Fukuda criteria, including the inclusions

of the ancillary symptoms. Tr. 964. In any event, Mr. D’Angiolini included the ancillary

symptoms in his brief. Pet’r’s Posthr’g Br. at 5, citing Dorland’s at 1851.

42

In the transcript, the word “cancer” is incorrectly transcribed as “counsel.”

55

Dr. Lightfoot explained that separating the group of people with depression

from the group of people with chronic fatigue syndrome is very difficult. Dr.

Lightfoot pointed out that the common, at least partially successful, treatments for

CFS are antidepressant medications. Tr. 1345-47.

Dr. Shoenfeld appears to share Dr. Lightfoot’s view. Dr. Shoenfeld was

listed as a co-author of a paper stating “some of the [Fukuda] criteria are difficult

to interpret and opinions differ regarding the classification of chronic fatigue cases

with a history of psychiatric illnesses.” Exhibit 186 (Nicola Bassi et al., Chronic

Fatigue Syndrome: Characteristics and Possible Causes for its Pathogenesis, 10

Isr. Med. Assoc. J. 79 (2008)) at 79. However, in his testimony, Dr. Shoenfeld

seemed to indicate that a person could suffer from both depression and chronic

fatigue syndrome. Tr. 819-20, 858-59.

2. Mr. D’Angiolini’s Presentation

As set out above, the CFS criteria include two affirmative aspects, which are

chronic fatigue and a mix of ancillary symptoms. Due to the prominence of fatigue

in the diagnosis, Mr. D’Angiolini’s symptoms relating to chronic fatigue are

presented by themselves in section a below. The eight potential ancillary

symptoms are collectively discussed in section b.43

a) Chronic Fatigue

Determining whether Mr. D’Angiolini was sufficiently fatigued to meet this

aspect of the CFS criteria involves two challenging factors. First, there is the

definition of fatigue. Dr. Shoenfeld and Dr. Lightfoot consistently discussed that

the fatigue involved in CFS is a fatigue so severe that, in Dr. Shoenfeld’s analogy,

a mother could not rise from bed to take her kindergartener to school. Tr. 753.

The fatigue that most people experience from life’s typical activities does not

qualify as the fatigue present in chronic fatigue syndrome.44 Tr. 849-50.

43

In addition to these affirmative aspects, a diagnosis of CFS can be ruled out by a

number of exclusionary factors, including “major depressive disorder.” Exhibit U (Fukuda) at

955-56. This is discussed briefly in section 3 below.

44

Dr. Lightfoot stated that Mr. D’Angiolini was fatigued “for some time before the

vaccination.” Tr. 1161. However, it appears that Dr. Lightfoot was not distinguishing between

“ordinary” fatigue and severe fatigue.

56

Second, there is the challenge in figuring out what symptoms Mr.

D’Angiolini experienced approximately 15 years ago. As discussed in the

Findings of Fact, in October 1996, Mr. D’Angiolini “did not have any problems

with being fatigued.” The Findings of Fact mention places in the medical records

where Mr. D’Angiolini is described as having problems with sleep, drinking

coffee, and reporting tiredness. For example, on March 24, 1997, Mr. D’Angiolini

told Dr. Middleman that he was sleeping 15 hours a day. Exhibit 24 at 10. When

this record was called to Dr. Shoenfeld’s attention, Dr. Shoenfeld stated this

episode was not the start of Mr. D’Angiolini’s CFS because it “was one event.”

Tr. 974; but see Tr. 849 (Dr. Shoenfeld listing sleeping 16 hours as one factor

contributing to Mr. D’Angiolini’s diagnosis of CFS).

Around this time when Mr. D’Angiolini reported he slept for 15 hours in one

day, he was working two jobs. He was maintaining his job as a mental health

technician at Valley Forge Medical Center and Hospital and his evaluation from

this time indicated that he was performing very well. Exhibit 16 at 31-32.45 In

addition, he was also teaching guitar on a part-time basis, usually working on

Saturdays and Sundays at Bachman’s Music Store. Exhibit 16 at 304-12.

Mr. D’Angiolini’s employment history solves both challenges listed above.

First, Fukuda defined the fatigue in CFS as one debilitating enough to cause a

“substantial reduction in previous levels of occupational, educational, social, or

personal activities.” Exhibit U (Fukuda) at 956. In line with this limitation, Dr.

Shoenfeld listed not going to work and not playing music as factors contributing to

Mr. D’Angiolini’s diagnosis for chronic fatigue syndrome. Tr. 848-49; see also Tr.

1058 (Mr. D’Angiolini was functioning before the vaccines because he was “a very

productive person”). When questioned about the Fukuda definition of fatigue, Dr.

Lightfoot, too, stated that he would look to when Mr. D’Angiolini lacked the

strength “to go out and compete in the marketplace or engage in his hobbies.” Tr.

1347.46

45

Dr. Shoenfeld assumed that Mr. D’Angiolini was not completing his assignments at

work because he was tired. Tr. 841. But, Mr. D’Angiolini’s employer’s records do not support

that assumption. Exhibit 16 at 31-32.

46

Although Dr. Middleman was not speaking about Fukuda’s definition of fatigue, she

stated “when someone is unable to work, and that suggests a change in the level of functioning[,]

that change [in function] has to be accounted for in some way.” Tr. 49.

57

Second, unlike the accuracy of a psychiatrist’s record, which depends

largely on the historian’s ability to recall what has happened, Mr. D’Angiolini’s

employment records are objective. These records show that Mr. D’Angiolini

worked at both Valley Forge Medical Center and the music store until November

5, 1997. Findings of Fact at 33, citing exhibit 51 at pdf 18 (June 7, 2001 W.C.

Trial Tr. 6); exhibit 53 ¶ 11; exhibit 16 at 311.

Consequently, the sudden reduction of Mr. D’Angiolini’s employment

occurred at the beginning of November 1997. The reason for the decrease in

activities is not entirely clear. Dr. Middleman’s notes from November 5, 1997,

mention sporadic suicidal feelings for four months, visits with prostitutes, not

taking care of his apartment, and not changing his clothes. Her notes do not

mention any problem with fatigue, tiredness, or lethargy. Exhibit 24 at 13.

The next day, Mr. D’Angiolini’s mother brought him to her physician, Dr.

Bray. Dr. Bray’s entry for this day, which is typed, states that Mr. D’Angiolini

complained about “extreme fear, . . . chest pain, [shortness of breath], palpitations,

[and] dizziness.” Dr. Bray diagnosed Mr. D’Angiolini as suffering from “Severe

Depression” and prescribed amitriptyline and Valium. Exhibit 61. Again, Dr.

Bray’s notes, which appear to be created contemporaneously with the appointment,

do not indicate that Mr. D’Angiolini was complaining about fatigue, etc.47

Moreover, Dr. Shoenfeld acknowledged that agoraphobia, suicidal ideation, and

panic attacks are not symptoms of chronic fatigue. Tr. 867.

Another confounding piece of evidence regarding Mr. D’Angiolini’s fatigue

is a report from April 1998, when Mr. D’Angiolini went to a local emergency

room for a long duration headache with occasional nausea, photophobia, and chest

pain. Exhibit 15 at 12. He informed his doctors that he was “active” and “runs.”

Id.; see also Findings of Fact at 33. Dr. Shoenfeld, apparently unaware of this

record, declared “[s]omebody with chronic fatigue will not play basketball. . . . He

will not run five kilometers.” Tr. 1461.

47

More than two years later, Dr. Bray wrote a letter in support of Mr. D’Angiolini’s

claim for medical leave benefits. In 1999, Dr. Bray stated that “[d]ue to the extreme fatigue he

was not able to care for himself or his environment.” Exhibit 17 at 15. Similarly, two more

years later, Dr. Bray wrote another letter in support of Mr. D’Angiolini’s claim for disability

benefits. Dr. Bray repeated that Mr. D’Angiolini “reported sleeping up to 16 hours a day and

still feeling fatigued.” Exhibit 131 (letter dated May 9, 2002).

58

These factors make determining when Mr. D’Angiolini started having severe

fatigue difficult. Dr. Shoenfeld’s testimony about playing basketball is tantamount

to a concession that Mr. D’Angiolini was not suffering chronic fatigue (let alone

chronic fatigue syndrome) in April 1998.48

On October 10, 1998, Mr. D’Angiolini saw Gregory Bach, whose letterhead

states that he is board certified in family medicine and addiction medicine. Exhibit

5 at 21. Dr. Bach’s handwritten notes, which are difficult to decipher, indicate that

Mr. D’Angiolini’s chief complaints included “sweats, [weight] gain, heart

palpitations, twitching, headache, neck stiffness, light sensitivity, light head,

confusion, [difficulty with] speech, mood swings, depression.” Dr. Bach’s

impressions included: “1. Fibromyalgia, 2. Chronic fatig. 3. Myopathy.” Id. at 26.

This October 10, 1998 reference to chronic fatigue appears to be the earliest

reference to this symptom in Mr. D’Angiolini’s medical records. See Tr. 1281.

Dr. Shoenfeld made two inferences from Dr. Bach’s recitation of “chronic

fatig.” First, Dr. Shoenfeld understood that the chronic fatigue must have been

present for at least several months. If the fatigue had a shorter duration, the doctor

would have said “tiredness of one or two days.” Tr. 842. Second, in Dr.

48

Mr. D’Angiolini’s briefs shed little light on this topic. For example, Mr. D’Angiolini’s

supplemental prehearing brief, which was filed in response to an order seeking further support

for the disputed diagnoses, fails to discuss fatigue. Instead, the supplemental brief lists the

ancillary symptoms only. Pet’r’s Suppl. Prehr’g Br., filed June 4, 2012, at 3-4.

In Mr. D’Angiolini’s posthearing brief, to support the assertion that he had fatigue, Mr.

D’Angiolini cites to a portion of Dr. Shoenfeld’s testimony in which Dr. Shoenfeld was

responding to questions from the undersigned. Pet’r’s Posthr’g Br., filed May 21, 2013, at 6,

citing Tr. 961-75. The portion of these 14 pages that is most specific about the onset of Mr.

D’Angiolini’s fatigue is still quite vague:

THE COURT: Okay. So, if we use a definition of fatigue that results in

substantial reduction in previous levels of occupational, educational, social and

personal activities, so significant fatigue, when did Mr. D’Angiolini start having

fatigue?

THE WITNESS: I believe that it was definitely after the vaccines. If I will recall

well, it was after the second vaccine, but don’t catch me in my word, but

definitely it was after the vaccines.

Tr. 961.

59

Shoenfeld’s opinion, Dr. Bach’s use of “fatig.” is an abbreviation for chronic

fatigue syndrome. Tr. 852-53.

Following the visit with Dr. Bach, Mr. D’Angiolini went to the Penn Center

for Healing, where Dr. Anne Norris saw him. His chief complaint was “fatigue.”

The history Dr. Norris obtained recounts that Mr. D’Angiolini had “sudden onset

fatigue” in late June 1997. Her record indicates that Mr. D’Angiolini has “been

out of work for a year [secondary to] fatigue.”49 Dr. Norris created a series of

notes, corresponding to the ancillary symptoms associated with CFS. For example,

she stated that Mr. D’Angiolini did not get refreshing sleep, did get headaches, but

did not have either joint symptoms or muscle pain. Dr. Norris’s impression was

“not CFS by criteria.” Exhibit 22 at 4 (Nov. 17, 1998).

On November 10, 1998, Dr. Roman saw Mr. D’Angiolini at the East

Norriton Family Practice. Mr. D’Angiolini was complaining about fatigue.

Exhibit 23 at 32; see also exhibit 50 at pdf 268-72 (Roman Dep. Tr. 29-33). Dr.

Roman ordered more tests and also referred Mr. D’Angiolini to Dr. Buttram as

well as other doctors. Exhibit 50 at pdf 312 (Roman Dep. Tr. 73).

One of the doctors to whom Dr. Roman referred Mr. D’Angiolini was a

cardiologist, Dr. Weber. Mr. D’Angiolini told Dr. Weber that, for one year, he was

having “dyspnea on exertion when he is doing a strenuous exercise such as heavy

lifting or walking while carrying a heavy parcel.” Exhibit 6 at 17 (record dated

Nov. 13, 1998). This report implies that Mr. D’Angiolini was exercising, meaning

that it is unlikely that he was having the fatigue associated with chronic fatigue

syndrome. Dr. Weber’s record does not mention fatigue.

b) Ancillary Symptom Overview

As previously stated, the Fukuda guidelines list eight other problems of

which four are necessary to establish a diagnosis of CFS. Fukuda qualifies this

general list of problems in two respects. The first limitation is that all of the

symptoms “must have persisted or recurred during 6 or more consecutive months

of illness.” Exhibit U (Fukuda) at 954. The second qualification is that the

symptoms “must not have predated the fatigue.” Id. at 956.

49

This history is not entirely consistent with the Findings of Fact.

60

(1) Ancillary Symptom #1: Impaired Memory or

Concentration

Mr. D’Angiolini identified ten records listing memory or concentration as a

problem. Pet’r’s Suppl. Prehr’g Br. at 3-4. The earliest of these records was

created on October 6, 1999. Exhibit 14 at 21-22.50

The Secretary asserts that Mr. D’Angiolini began seeing Dr. Middleman

before the vaccinations for various problems, including “problems with his

memory.” Resp’t’s Posthr’g Br. at 2, citing Findings of Fact 17-22 and exhibit 24

at 5-8.

(2) Ancillary Symptom #2: Post-exertional Malaise

Mr. D’Angiolini has identified more than 10 medical records that, in his

view, indicate that he suffered from post-exertional malaise. Pet’r’s Suppl. Br., tab

B, at 2. Although Mr. D’Angiolini cited the November 10, 1998 visit with Dr.

Roman during which Mr. D’Angiolini complained about fatigue, Dr. Roman’s

notes do not indicate a problem with post-exertional malaise. See exhibit 23 at 32.

Dr. Weber’s November 13, 1998 record does refer to post-exertional malaise by

indicating that Mr. D’Angiolini had shortness of breath after strenuous activities.

Exhibit 6 at 17.

About one year later, which is after Mr. D’Angiolini began seeking

compensation in the Workers’ Compensation proceeding and in the Vaccine

Program, he reported to doctors problems with fatigue after exertion. E.g. exhibit

14 at 22 (record dated Oct. 6, 1999, stating “Have no energy to do anything. If I

do something[,] for 4 days after I’m wiped out”); exhibit 36 at 15-18 (record dated

Oct. 6, 1999, from Dr. Buttram).

(3) Ancillary Symptom #3: Unrefreshing Sleep

Reports of unrefreshing sleep appear throughout Mr. D’Angiolini’s medical

records. On three occasions in February 1999, which is before he received the first

50

As discussed previously, in 1999 and 2002, Dr. Bray wrote letters indicating that Mr.

D’Angiolini had memory or concentration problems going back to November 6, 1997. However,

Dr. Bray’s notes from November 6, 1997 do not reflect problems in memory or concentration.

61

dose of the hepatitis B vaccine, Mr. D’Angiolini told Dr. Middleman about

problems with his sleeping. Exhibit 24 at 9-10.

He also told Dr. Middleman about problems with sleeping after the

vaccinations. Exhibit 24 at 10-15. When Mr. D’Angiolini saw Dr. Roman in

November 1998, he reported lengthy sleeping since summer 1997. Exhibit 23 at

32.

(4) Ancillary Symptom #4: Muscle Pain

On May 22, 1997, Mr. D’Angiolini told Dr. Middleman that he was having

“body aches.” Exhibit 24 at 11; Tr. 30. This may have been an isolated instance

as Dr. Middleman’s records do not report more complaints of muscle pain.

More frequent reports of muscle pain start toward the end of 1999. On

October 6, 1999, Mr. D’Angiolini’s chief complaint to Dr. Buttram included

“constant joint and muscle pain.” Exhibit 36 at 15. Dr. Bray listed “aches and

pains” in his November 30, 1999 letter. Dr. Waisbren’s December 13, 1999 letter

mentioned, among other problems, “muscle pains.” Exhibit 21 at 9.

(5) Ancillary Symptom #5: Joint Pain

The reports about muscle pain from 1999 overlap with reports of joint pain.

(6) Ancillary Symptom #6: Headaches of a New Type

or Severity

As discussed in the Findings of Fact, Mr. D’Angiolini had headaches before

his vaccination. His psychiatrist, Dr. Middleman, was prescribing medications to

help with his headaches.

Mr. D’Angiolini also experienced headaches after vaccination. See exhibit

23 at 32. However, Mr. D’Angiolini has not persuasively established that the

headaches were of a new type or severity.

(7) Ancillary Symptom #7: Sore Throat that is

Frequent or Recurring

For this feature Mr. D’Angiolini identified only records from his October 6,

1999 visit with Dr. Buttram. Pet’r’s Suppl. Prehr’g Br., tab B, at 3. The list of

62

chief complaints included “intermittent sore throat.” Exhibit 14 at 22. Dr.

Buttram’s handwritten notes repeat this problem. Exhibit 36 at 18.

These records appear isolated. For the December 9, 1999 visit with Dr.

Waisbren, there is a no check for sore throat. Exhibit 20 at 21. Dr. Bray’s

November 30, 1999 letter does not include sore throat.

(8) Ancillary Symptom #8: Tender Cervical or

Axillary Lymph Nodes

Like the sore throat symptom just discussed, the only references cited by Mr.

D’Angiolini come from the October 6, 1999 visit with Dr. Buttram. Again, these

mentions stand in isolation. Dr. Waisbren did not find any problem with Mr.

D’Angiolini’s lymph nodes. Exhibit 20 at 23. When Mr. D’Angiolini visited the

Cleveland Clinic in 2004, Dr. Gorensek found “no significant adenopathy.”

Exhibit 37 at 22.

3. Assessment of the Evidence

Mr. D’Angiolini’s assertion that he has CFS suffers from many

shortcomings. Primarily, there is a problem determining when his fatigue began.

The lack of clarity on this point is a significant flaw because CFS is a disease about

fatigue.

Mr. D’Angiolini occasionally linked his abrupt cessation of employment in

early November 1997, to fatigue. However, when Mr. D’Angiolini saw doctors in

November and December 1997, he described other problems but not fatigue.

Furthermore, his running in April 1998, as reflected in the visit to the emergency

room, shows that he was capable of sustained physical exercise. Exhibit 15 at 12.

Mr. D’Angiolini’s ability to exercise further complicates the assessment of

medical records created in the latter half of 1998, when he saw Doctors Bach,

Roman, Norris, and Weber. While Mr. D’Angiolini sometimes reported he was

having fatigue, he also reported that the fatigue (or shortness of breath) was

associated with strenuous activities. Among these doctors, Dr. Norris appears to

have been especially solicitous about the possibility that Mr. D’Angiolini suffered

from CFS because her notes present information about not only Mr. D’Angiolini’s

63

fatigue but also the ancillary symptoms associated with CFS. Her conclusion that

Mr. D’Angiolini was not suffering from CFS, therefore, is very valuable.51

If Mr. D’Angiolini were given the benefit of the doubt that his chronic

fatigue began in July 1998, he would still need to establish that he suffered from

four of eight ancillary symptoms to meet the criteria for CFS.52 As summarized in

the chart below, Mr. D’Angiolini has at least a viable argument for one or two

symptoms, depending on when the fatigue started. If his fatigue began in July

1998, then the post-exertional malaise started around the same time but his muscle

pain and joint pain started more than a year later. On the other hand, if Mr.

D’Angiolini’s fatigue began around October 1999, then the post-exertional malaise

would have pre-dated the fatigue and no longer qualifies as a supporting symptom.

Symptom Assessment Supporting CFS

Diagnosis?

Impaired Memory Existed before vaccination and before No

fatigue

Post-exertional Malaise Started around August 1998 Possibly

Unrefreshing Sleep Existed before vaccination and before No

fatigue

51

Dr. Norris’s affirmative statement that Mr. D’Angiolini did not meet the diagnostic

criteria for CFS is more persuasive than Dr. Bach’s statement on which Mr. D’Angiolini relies.

See Pet’r’s Posthr’g Br. at 6 (citing Dr. Bach as one treating doctor who diagnosed Mr.

D’Angiolini with CFS). First, strictly speaking, Dr. Bach’s notation of “chronic fatig.” is

ambiguous because it could mean “chronic fatigue” or “chronic fatigue syndrome.” Second,

there is little information in Dr. Bach’s own record to support a determination that Mr.

D’Angiolini suffered from four of the eight ancillary symptoms needed for a diagnosis of chronic

fatigue syndrome. Third, Dr. Bach includes “depression” as one of Mr. D’Angiolini’s chief

complaints. Depression can exclude the diagnosis of chronic fatigue syndrome.

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If Mr. D’Angiolini’s chronic fatigue began in July 1998, this date would be

approximately nine months after his third and final dose of the hepatitis B vaccine in October

1997. Pursuant to the third prong of Althen, Mr. D’Angiolini would be required to show that

nine months is an appropriate interval to infer causation.

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Muscle Pain Started around October 1999 Possibly

Joint Pain Started around October 1999 Possibly

Headaches Existed before vaccination and before No

fatigue

Sore throat Insufficient evidence No

Tender lymph nodes Insufficient evidence No

The lack of corroborating ancillary symptoms is significant because not all

cases of “chronic fatigue” qualify as “chronic fatigue syndrome.” See Lombardi,

656 F.3d 1354 (finding special master was not arbitrary in rejecting petitioner’s

claim that she suffered from chronic fatigue syndrome). Dr. Shoenfeld recognized

the challenges in fulfilling the actual diagnostic criteria for chronic fatigue

syndrome when he, as a co-author, wrote “only about 1% of patients who are given

the diagnosis in primary care settings meet the criteria for CFS.” Exhibit 186

(Bassi) at 79.

Finally, because Mr. D’Angiolini has not persuasively demonstrated that he

fits the affirmative portion of the CFS diagnostic criteria, examining the relevant

exclusionary factors is not needed. This aspect would be particularly challenging

because the Fukuda article distinguishes between “major depressive disorders,”

and “nonpsychotic or nonmelancholic depression.” The former exclude the

diagnosis of CFS while the latter permits the diagnosis. Exhibit U (Fukuda) at

955-56. Whether Dr. Lightfoot, who is a rheumatologist, possesses the requisite

experience to opine on which side of this line Mr. D’Angiolini falls is quite

uncertain.

Mr. D’Angiolini’s failure to present preponderant evidence that he suffers

from CFS precludes an award of compensation based upon this disease. See

Broekelschen, 618 F.3d at1350. In this circumstance, Mr. D’Angiolini has not

established that he does in-fact, suffer from CFS. See Lombardi, 656 F.3d at 1352.

Nevertheless, an examination of the Althen factors may promote judicial

efficiency.

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C. Standards for Adjudicating a Causation-in-Fact Claim

If Mr. D’Angioli

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