Contreras v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

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

JESSIE CONTRERAS, * No. 05-626V

*

Petitioner, * Special Master Christian J. Moran

*

v. * Filed: October 24, 2014

*

SECRETARY OF HEALTH * hepatitis B vaccine; tetanus-

AND HUMAN SERVICES, * diphtheria vaccine; transverse myelitis

* (TM); Guillain-Barré syndrome

Respondent. * (GBS); one-day onset; decision on

* remand; credibility of expert;

* reliability of expert.

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

Jeffrey S. Pop, Jeffrey S. Pop, Attorney at Law, Beverly Hills, CA, for petitioner;

Linda S. Renzi, United States Dep’t of Justice, Washington, DC, for respondent.

PUBLISHED DECISION ON REMAND DENYING ENTITLEMENT1

On June 16, 2003, Mr. Contreras received the hepatitis B vaccine and the

tetanus-diphtheria vaccine. Approximately 24 hours later, he started experiencing

symptoms that marked the onset of a very severe neurologic disease, transverse

myelitis. Mr. Contreras claims that the vaccinations, particularly the hepatitis B

vaccine, caused his neurologic problems and seeks compensation through the

National Childhood Vaccine Injury Compensation Program, codified at 42

U.S.C. § 300aa—10 through 34 (2006).

Judicial officials have issued four substantive rulings.2 In the most recent

one, the Court vacated a decision denying compensation and remanded for more

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.

specific findings of fact with respect to the experts’ credibility. This additional

fact-finding was necessitated by the revelation that Dr. Sladky, one of the two

experts who testified on behalf of the Secretary, misrepresented his background

and failed to disclose problems in his medical licensing. The dimensions of Dr.

Sladky’s misdeeds are set forth in a review of the procedural history of this case,

which is Section I below.

The remainder of the Decision attempts to respond to the Court’s three

instructions. First, the Court required an “unambiguous assessment” of Dr.

Sladky’s credibility and reliability. For the reasons discussed in Section II, Dr.

Sladky was not credible regarding his background, but credible for his substantive

opinions. His substantive opinions were reliable because they were based upon a

sound methodology. Second, the Court required an evaluation of the credibility of

all the testifying experts and a comparison among them. Section III explains that

Dr. Sladky’s credibility was less than all but one of the other testifying doctors.

Third, the Court directed an assessment of the issues without regard for Dr.

Sladky’s evidence. Section IV reviews the evidence regarding diagnosis, timing,

theory, and logical sequence of cause and effect. Excluding Dr. Sladky’s evidence

does not change the outcome.

Consequently, Mr. Contreras remains not entitled to compensation. The

Clerk’s Office is directed to enter judgment in accord with the decision unless

another motion for review is filed.

I. Procedural History Focused on Dr. Sladky’s Misconduct

On June 15, 2005, Mr. Contreras filed his petition. With it, Mr. Contreras

filed medical records and statements from three doctors who treated him, Dr. Fred

Kyazze, Dr. Mark Wagner, and Dr. Jeremy Garrett. Exhibits 11-13. Dr. Garrett

identified Mr. Contreras’s injury as “cervical transverse myelitis” and opined that

the hepatitis B vaccination caused the transverse myelitis. Exhibit 13 at 4 ¶ 7, 7 ¶

2

An April 5, 2012 Entitlement Decision denied compensation because Mr. Contreras did

not meet his burden of proof regarding the appropriate interval between vaccination and the

onset of the transverse myelitis. 2012 WL 1441315 (“Contreras 1”). The United States Court of

Federal Claims (“the Court”) vacated this decision and remanded with instructions. 107 Fed. Cl.

280 (2012) (“Contreras 2”). A November 19, 2013 Remand Decision again denied

compensation. 2013 WL 6698382 (“Contreras 3”). The Court also vacated the Remand

Decision. 116 Fed. Cl. 472 (2014) (“Contreras 4”).

Citations to Contreras 3 will include both the page number to the version published on

Westlaw and, to maintain consistency with Contreras 4, the page number of the slip opinion.

2

12 (“[Mr. Contreras’s] diagnosis was thus established as transverse myelitis”), 13 ¶

17. In addition, Mr. Contreras submitted an affidavit from Dr. Charles Poser. Dr.

Poser, unlike Dr. Garrett, stated that Mr. Contreras suffered from Guillain-Barré

syndrome and transverse myelitis. Yet, like Dr. Garrett, Dr. Poser also proposed

that the vaccinations caused the Guillain-Barré syndrome and transverse myelitis.

Exhibit 22 at 3 ¶ 4-5. Dr. Poser found a causal relationship despite “[t]he very

short latency of the neurological complications following the vaccination,” which

Dr. Poser acknowledged was “unusual.” Id. at ¶ 5. Dr. Poser did not otherwise

propose a mechanism by which a vaccine can cause a neurologic injury in one day.

See exhibit 22. Dr. Poser, later, authored another affidavit, expanding upon the

bases for his assertion that the vaccines can cause neurologic injury. Exhibit 23.

On October 27, 2005, the Secretary filed her report, pursuant to Vaccine

Rule 4. Before submitting Dr. Sladky’s first report, the Secretary raised the issue

of timing. Citing a 1994 report from the Institute of Medicine (IOM), the

Secretary asserted that “a plausible interval between vaccination and the onset of

symptoms is 5-45 days.” Resp’t’s Rep’t, filed Oct. 7, 2005, at 9.3 The Secretary

argued that Dr. Poser “offers no explanation as to how [Mr. Contreras’s] condition

could plausibly evolve within [24 hours]. Even the case studies referred to by Dr.

Poser do not describe symptoms immediately following vaccination.” Id. at 10.

The Secretary’s report concluded by maintaining that “the temporal relation

between vaccination and the onset of [Mr. Contreras’s] illness does not support the

conclusion that [Mr. Contreras’s] condition was caused by the administration of

the Hepatitis B vaccine; in fact, it supports the opposite,” and committed to submit

an expert report. Id.

The Secretary filed a report from Dr. Sladky dated October 21, 2005, and his

curriculum vitae (“CV”), which were initially labelled as exhibits A and B. These

appear in the record as exhibit I and exhibit J.

Dr. Sladky’s CV contained an error when it was submitted. Dr. Sladky

asserted that he was licensed to practice medicine in two states, Pennsylvania and

Georgia. However, it is now known that Dr. Sladky’s license in Pennsylvania had

expired in 1996, nine years earlier. The Court commented “Dr. Sladky’s CV,

3

The Secretary’s report contains two minor errors. First, while the Secretary recounts the

IOM’s estimate for latency as “5-45 days,” the IOM actually states “5 days to 6 weeks.” Second,

although the Secretary’s report accurately cites pages 37-49 of the 1994 IOM report (a more

precise citation is to page 45 and/or 47), the Secretary did not include those pages within the

document she actually submitted as exhibit A. She later filed pages 45-46 as exhibit F.

3

bearing no notation that his license in Pennsylvania had expired, misrepresented

Dr. Sladky’s credentials. Thus, the expert report filed by Dr. Sladky in 2005 was

supported by an inaccurate and misleading CV.” Contreras 4, 116 Fed. Cl. at 477.

Dr. Sladky’s error in presenting his qualifications appears not to have carried

over to his report. There is no evidence or allegation that Dr. Sladky’s first report

was erroneous in any respect. Dr. Sladky’s first report emphasized the timing was

not appropriate for causation. He stated “the brief interval between the hepatitis B

vaccine administration and the onset of symptoms of transverse myelitis in Jessie

Contreras is the most compelling evidence that immunization and demyelinating

disease, in this instance, are purely coincident.” Exhibit I at 3. He explained

“[a]utoimmune demyelinating disorders such as transverse myelitis are caused by a

complex cascade of immunological events ultimately acting in concert to cause

injury to constituents of the central nervous system.” Id.4 Dr. Sladky then asserted

“[i]t is virtually impossible to believe that the intricate process of immune

activation, tissue targeting and ultimately immunologic attack on the nervous

system could occur within a 24 hour interval.” Id. Dr. Sladky’s basis was the

1994 IOM article that found that “the duration from immunization to onset of

symptoms should fall between 5 days at a minimum and 6 weeks at maximum to

conform to biological plausibility.” Id. He also described the basis for the 1994

IOM findings, noting that the IOM used animal models. Id. at 4-5 (citing exhibit K

(Divya J. Mekala et al., IL-10-dependent Infectious Tolerance After the Treatment

of Experimental Allergic Encephalomyelitis with Redirected CD4+CD25+ T

Lymphocytes, 102(33) PNAS 11817 (2005)); and exhibit D (E.P.K. Mensah-

Brown et al., Neuroglial Response After Induction of Experimental Allergic

Encephalomyelitis in Susceptible and Resistant Rat Strains, 233 Cellular

Immunology 140 (2005))).

Thus, in 2005, timing was an important issue. Dr. Poser flagged the issue in

his first report, describing the latency as “unusual.” Exhibit 22 at 3 ¶ 5. The

Secretary raised this issue in her Rule 4 Report. Resp’t’s Rep’t, filed Oct. 7, 2005,

at 9. Separately, Dr. Sladky raised it in his October 21, 2005 report. Exhibit I.

Significantly, both the Secretary and Dr. Sladky relied upon the 1994 IOM report.

In the ensuing status conference, the then-presiding special master also discussed

the 1994 IOM report as well as Dr. Sladky’s opinion. The then-presiding special

master stated “whether there exists an adequate basis, grounded in principles of

4

Testimony from Dr. Steinman and Dr. Whitton elaborated on the concept of the

“complex cascade of immunological events.” See Tr. 123-38, 237-40, 413-23, 441-43.

4

immunology, for the special master to find that the interval of less than 24 hours…

medically appropriate” may be a “potentially dispositive issue.” Order, filed Nov.

18, 2005, at 2.5

The then-presiding special master’s response to the Secretary’s report and

Dr. Sladky’s report was to order Mr. Contreras to file a medical opinion from an

“immunologist or a neuroimmunologist.” Id. Mr. Contreras presented Dr.

Steinman’s first report on March 9, 2006. Exhibit 55. Dr. Steinman compared Mr.

Contreras’s asserted reaction to the vaccinations to a reaction to tuberculin. In Dr.

Steinman’s view because the latter reaction can take place in 24 hours, the former

reaction can happen in 24 hours as well. Id. at 3.

Following the submission of Dr. Steinman’s report, the formal progression

of Mr. Contreras’s litigation largely stalled. Instead, the parties attempted to

resolve the dispute using alternative dispute resolution (“ADR”).

During this interlude in the formal litigation, on August 19, 2008, Dr. Sladky

agreed not to practice medicine in Georgia while he was treated for alcohol

dependence. Resp’t’s Status Rep’t, filed May 1, 2013, at 4; see also Contreras 4,

116 Fed. Cl. at 476. Dr. Sladky, apparently, did not inform the Secretary that he

had agreed not to practice medicine because the Secretary did not disclose this

information until 2013. At the hearing, Dr. Sladky testified that he did not work on

Mr. Contreras’s case in 2008 or 2009. Tr. 321.

The then-chief special master conducted an ADR session on September 3,

2008. However, the parties did not resolve their differences. Accordingly, the

parties resumed pursuing a formal resolution of Mr. Contreras’s petition for

compensation. As the first step in this renewed process, the Secretary was ordered

to file a response to Dr. Steinman’s report. Orders, filed Apr. 3, 2008, Jan. 21,

2009, and Feb. 10, 2009. The Secretary did not rely upon Dr. Sladky, who had

previously opined in this case. Instead, the Secretary opted to retain Dr. Whitton,

who has extensive experience in immunology. See exhibit M (CV).

In 2009, the parties exchanged a series of reports written by Dr. Whitton and

Dr. Steinman. Exhibit L (Dr. Whitton’s Rep’t, filed Feb. 19, 2009); exhibit 105

5

While Mr. Contreras’s case was pending, the presiding special master adopted the 5-42

day interval between the introduction of an antigen and the development of a demyelinating

disease of the central nervous system. Fant v. Sec'y of Health & Human Servs., No. 02-1419V,

2007 WL 5161767, at *11 (Fed. Cl. Spec. Mstr. Mar. 9, 2007).

5

(Dr. Steinman’s Supp’l Rep’t, filed June 29, 2009); exhibit N (Dr. Whitton’s

Supp’l Rep’t, filed Sept. 8, 2009). In this back and forth, Dr. Whitton opined that

one day was not a sufficient amount of time to cause transverse myelitis and Dr.

Steinman maintained that it was. The Secretary’s continued use of Dr. Whitton in

2009 led to a question about whether the Secretary was maintaining her reliance on

Dr. Sladky.

Meanwhile, as the parties were exchanging expert reports, there were

additional (unknown) developments with Dr. Sladky. Less than one year after he

voluntarily relinquished his medical license on a temporary basis, Dr. Sladky’s

dependence on alcohol was the basis for a more serious action by the Georgia

Composite State Board of Medical Examiners. On June 19, 2009, the Georgia

Board suspended Dr. Sladky’s license indefinitely. Resp’t’s Status Rep’t, filed

May 1, 2013, at 4; see also Contreras 4, 116 Fed. Cl. at 476. Again, the

Secretary’s disclosure of this suspension came in 2013, approximately four years

after it occurred.6

On January 8, 2010, a status conference was held. It appeared that before

the interlude for ADR, the Secretary had been relying upon the opinion of Dr.

Sladky to respond to Dr. Poser, but after the litigation resumed, it appeared that the

Secretary was relying upon the opinion of Dr. Whitton as the Secretary had not

obtained a report from Dr. Sladky in response to Dr. Steinman’s report. Thus,

during the January 8, 2010 status conference, the parties discussed whether the

Secretary intended to present testimony from Dr. Sladky at the forthcoming

hearing. During this status conference, the Secretary apparently was ignorant of

the Georgia Board’s suspension of Dr. Sladky’s license.

In response to the order from the January 8, 2010 status conference, the

Secretary disclosed that she intended to call Dr. Sladky at the hearing. In this

context, the Secretary stated, “Dr. Sladky is preparing a supplemental expert report

to address the issues raised by petitioner’s expert, Dr. Steinman. Respondent will

file Dr. Sladky’s report, an updated curriculum vitae, and referenced medical

articles, no later than March 8, 2010.” Resp’t’s Status Rep’t, filed Jan. 27, 2010, at

1; accord Contreras 4, 116 Fed. Cl. at 477. The Court’s recitation of this status

report emphasized that respondent recounted Dr. Sladky “is preparing” a

supplemental report.

6

The Georgia Board’s suspension was a public consent order that is, now, available

through a website. Whether the Georgia Board made this order available to the public through

its website in 2009 is not known.

6

The Court cited the phrase “is preparing” as one piece of evidence that

showed Dr. Sladky was working on his supplemental report while his license to

practice medicine in Georgia was suspended. Other evidence supporting the same

proposition were “the detailed analysis of Dr. Steinman’s opinions in Dr. Sladky’s

second expert report” and “the date marked on Dr. Sladky’s report, March 4,

2010.” Contreras 4, 116 Fed. Cl. at 477.

On March 4, 2010, the Georgia Board issued another Public Consent Order.

The Georgia Board restored Dr. Sladky’s medical license on a probationary basis.

The Georgia Board conditioned Dr. Sladky’s retention of his license on several

factors, including continued participation in support groups for alcoholics,

supervision by another doctor, and restrictions on the number of hours and location

of his practice. Resp’t’s Status Rep’t, filed May 1, 2013, at 4-13.

March 4, 2010, is also the date at the top of Dr. Sladky’s supplemental

expert report. The Secretary filed this report, which is exhibit O, on March 8,

2010. The original submission lacked a signature. The Secretary submitted

another copy of the report dated March 4, 2010, still labelled as exhibit O, on

March 22, 2010. Dr. Sladky signed the second version.

Dr. Sladky’s supplemental report, exhibit O, matched his initial report,

exhibit I, with respect to his ultimate opinion --- that there was no evidence to

support the conclusion that the vaccinations caused Mr. Contreras’s transverse

myelitis. The primary basis for Dr. Sladky’s opinion --- that the timing was

insufficient --- remained the same.

Dr. Sladky did not reveal in his reports dated March 4, 2010, that the

Georgia Board had suspended his license and had restored his license to a

probationary status on the same day as he dated his report. The Court also noted

that the supplemental report remained “supported by an inaccurate and misleading

CV as to licensure in Pennsylvania.” Contreras 4, 116 Fed. Cl. at 477. The Court

also stated that “[t]here is no information in the record which explains why

respondent never filed an updated CV for Dr. Sladky to accompany his second

expert report, as promised in the January 27, 2010 status report.” Id.

On April 20, 2010, Dr. Sladky testified at the hearing held in California.

The Secretary asked general questions about Dr. Sladky’s background. Dr. Sladky

stated that he was employed in the Department of Pediatric Neurology at Emory

University. Tr. 274-75. He elaborated:

7

I'm senior faculty in pediatric neurology at Emory. I see

patients. I do a little bit of research. That's become

markedly attenuated as I get eaten by the clinical monster

as I think the rest of us are. And I teach medical

students, residents and fellows.

I see patients every week, usually five half days a week,

probably average 40-50 patients a week, and attend on

the inpatient neurology service roughly three months a

year, a little less. And during those periods, I have very

hectic months very much like the one Dr. Steinman just

survived. Congratulations, incidentally. We look at

those as benchmarks in moving along life. Pretty

standard, busy clinical and academic lifestyle.

Tr. 275. Dr. Sladky also provided information about his undergraduate education

(Yale University), his medical school (also Yale University), and fellowship

training (University of Pennsylvania). He stated he was board-certified in

pediatrics, neurology with a special competence in child neurology, and electro-

diagnostic medicine. Tr. 276. When the Secretary offered Dr. Sladky as an expert

witness in the area of pediatric neurology, the Secretary referenced Dr. Sladky’s

CV, exhibit J, which had been filed in 2005. Tr. 278.

The Court noted that Dr. Sladky’s description of his responsibilities

regarding seeing 40-50 patients per week was “misleading.” The Court determined

that in “the two-year period of time leading up to this testimony, Dr. Sladky was

licensed to practice medicine for eight and a half of those twenty-four months, and

more than one month of the time that he was licensed to practice medicine during

that period was under supervised probation.” Contreras 4, 116 Fed. Cl. at 479.

When given an opportunity to ask questions about Dr. Sladky’s background

on voir dire, petitioner’s counsel declined. Tr. 278. As the Court noted,

[Dr. Sladky] did not state, and was not asked to state,

whether he was licensed to practice medicine in

Pennsylvania and Georgia. He was not asked whether

his license to practice medicine was on probation (which

it was at the time he testified), and he was not asked

whether he had been subject to disciplinary proceedings

which led to the suspension of his license.

8

Contreras 4, 116 Fed. Cl. at 479.

At the hearing, there was relatively little testimony from Dr. Sladky about

the medically acceptable interval between vaccination and the onset of transverse

myelitis. The Secretary elicited some as part of Dr. Sladky’s direct examination.

Tr. 310.7 On cross-examination, Mr. Contreras asked Dr. Sladky about his opinion

regarding the minimal amount of time for an immune-mediated response. Tr. 329-

30. Otherwise, Dr. Sladky’s testimony was on other topics, including how

Hispanics respond to vaccinations.

Instead of using Dr. Sladky, the Secretary presented testimony from Dr.

Whitton about the immune system and how long the immune system requires to

generate a response that could lead to transverse myelitis. In support of his

opinion, Dr. Whitton testified about many articles, including Lafaille, Zamvil, and

Kakar. See Tr. 424-37, 441-43 (discussing exhibit 77 (Juan J. Lafaille, Myelin

Basic Protein-specific T Helper 2(Th2) Cells Cause Experimental Autoimmune

Encephalomyelitis in Immunodeficient Hosts Rather than Protect Them from the

Disease, 186(2) J. Experimental Med. 307 (1997)); exhibit 67 (Scott Zamvil et al.,

T-cell Clones Specific for Myelin Basic Protein Induce Chronic Relapsing

Paralysis and Demyelination, 317 Nature 355 (1985)); exhibit 72 (Atul Kakar &

P.K. Sethi, Guillain Barre Syndrome Associated with Hepatitis B Vaccination,

64(5) Indian J. Pediatrics 710 (1997))). Dr. Whitton was asked follow-up

questions about the anticipated interval. See Tr. 455-56, 462-64, 477-85.

After the parties submitted a set of briefs, it appeared that the Odoardi article

could potentially assist Mr. Contreras in establishing that one day was an

appropriate interval. Exhibit 118 (F. Odoardi et al., Blood-borne soluble protein

antigen intensifies T cell activation in autoimmune CNS lesions and exacerbates

clinical disease, 104(47) PNAS 18625 (2007)). While both Dr. Steinman and Dr.

Whitton had testified about Odoardi during the April 2010 hearing, their testimony

seemed incomplete. See Tr. 175 (Dr. Steinman), 243-46 (same) 479-82 (Dr.

Whitton). Consequently, the undersigned requested another hearing to hear

testimony from Dr. Steinman and Dr. Whitton. Order, filed June 6, 2011; see also

Contreras 2, 107 Fed. Cl. at 289 n.19 (the topic of the second hearing “is indicative

of the special master’s increasing focus on Dr. Steinman’s and Dr. Whitton’s

diverging opinions as to the science relevant to determine a medically-appropriate

7

Dr. Sladky also discussed the onset of Mr. Contreras’s neurologic problem, Tr. 279-81,

but the precise number of hours between vaccination and onset has never been a material fact.

9

timeframe for the onset of Jessie’s illness”). Dr. Sladky did not participate in this

hearing because his expertise was not in immunology on which timing is based.

After this second hearing, the case was submitted for adjudication. Mr.

Contreras was found not entitled to compensation because he had not established

that 24 hours is an appropriate temporal interval between vaccination and the onset

of symptoms. Contreras 1, 2012 WL 1441315 (Fed. Cl. Spec. Mstr. Apr. 5,

2012).8

Mr. Contreras filed a motion for review, which was granted. The April 5,

2012 entitlement decision was vacated and the case was remanded. Contreras 2,

107 Fed. Cl. 280.

While on remand, on May 1, 2013, the Secretary disclosed much of the

detrimental information about Dr. Sladky to Mr. Contreras and to the Office of

Special Masters.9 The Secretary’s citation to Shaffer Equip. Co. v. United States,

11 F.3d 450, 458-59 (4th Cir. 1993), suggested that the Secretary understood that

she was obligated to reveal information about her expert’s background once she

learned of the misrepresentations. Specifically, the Secretary revealed

Respondent has become aware that Dr. Sladky agreed not

to practice medicine in the state of Georgia from August

19, 2008 to March 18, 2009, and agreed to the indefinite

suspension of his license to practice medicine on June 17,

2009, and that on March 4, 2010, the suspension of his

license was lifted and his license to practice restored on a

probationary basis. The probation was terminated on

July 5, 2011. The details of the suspensions and

probation are set forth in the attached public orders of the

Georgia Composite Medical Board.

Resp’t’s Status Rep’t., filed May 1, 2013, at 1. In this status report, the Secretary

did not reveal that Dr. Sladky’s medical license for Pennsylvania had expired in

1996.

8

Section IV below discusses the reasoning in the Entitlement Decision in greater detail.

9

The Secretary filed substantively the same status report in every active case in which

Dr. Sladky had submitted a report. For closed cases, the Secretary submitted a letter notifying

the petitioner and the presiding special master of Dr. Sladky’s licensure issues.

10

Mr. Contreras, however, discovered the misrepresentation on Dr. Sladky’s

2005 CV. Mr. Contreras presented evidence from the Pennsylvania Department of

State that Dr. Sladky’s license to practice medicine in that state expired on

December 31, 1996. Pet’r’s Status Rep’t, filed May 10, 2013, at exhibit 2. In

response to Shaffer Equip., Mr. Contreras appeared to acknowledge that his case

was different in the sense that there was no evidence that the Secretary or her

attorneys actually knew of Dr. Sladky’s licensing problems. Pet’r’s Status Rep’t,

filed May 10, 2013, at 4-5. Mr. Contreras proposed that the “Special Master

should find that [Dr.] Sladky’s opinion and conclusion carry little, if any[,] weight,

due to the circumstances under which he was providing testimony.” Id. at 9. Mr.

Contreras did not propose striking Dr. Sladky’s evidence.

The Secretary was permitted to respond to Mr. Contreras’s arguments

regarding Dr. Sladky as part of her brief on remand. The Secretary mostly

addressed accusations about Dr. Sladky that Mr. Contreras did not substantiate, but

the Secretary did not address the accusation about Dr. Sladky’s Pennsylvania

license that Mr. Contreras did substantiate. The Secretary concluded that:

[T]he opinion[] of . . . Dr. Sladky [is] based upon sound

scientific principles that were clearly articulated at

hearing and supported by the medical literature.

Respondent’s disclosure of the temporary suspension and

later probationary status of Dr. Sladky’s license . . .

should not be used to circumvent the fact that petitioner

has failed to prove causation.

Resp’t’s Resp., filed June 12, 2013, at 39.

Mr. Contreras had the last word, repeating some of the problems with Dr.

Sladky. Pet’r’s Reply, filed Aug. 13, 2013, at 31-34. The reply brief argued that

Dr. Sladky’s testimony should be “scrutinized and given diminished importance.”

Id. at 34.

On November 19, 2013, a 76-page decision on remand denied entitlement.

Approximately two and half pages were devoted to Dr. Sladky’s background.

Ultimately, the remand decision concluded that “Dr. Sladky’s opinions retain some

value.” Contreras 3, slip op. at 7, 2013 WL 6698382, at *5. Dr. Sladky’s name

appears in the remand decision in approximately 20 places, which are discussed at

length below. The Remand Decision included a statement that the analysis

11

contained therein “does not rely upon Dr. Sladky’s opinion extensively.”

Contreras 3, slip op. at 71 n.51, 2013 WL 6698382, at *55 n.51.

Mr. Contreras filed a second motion for review. In his objections, Mr.

Contreras argued, among other things, that:

The Special Master heavily relied on the testimony of Dr.

Sladky, despite the fact that Dr. Sladky has been

discredited and failed to disclose to the Court and

Counsel that his medical license was suspended and later

he was on probation due to alcohol abuse problems at

times he rendered his opinions.

Pet’r’s Second Mot. for Rev., filed Dec. 19, 2013, at 2. This objection was

developed as the first argument in the motion for review.

After summarizing Dr. Sladky’s faults, Mr. Contreras concluded: “Dr.

Sladky’s lack of transparency and untruthfulness is appalling. He could not

actually see patients if he was suspended. Dr. Sladky’s medical license suspension

and later probation with restrictions when he testified is relevant. His incorrect

C.V. bears on his character and critically undermines his credibility as an expert.”

Id. at 5. Mr. Contreras’s motion for review argued that the Remand Decision’s

statement that “Dr. Sladky’s opinions retained ‘some’ value is a misnomer.” Id.

However, Mr. Contreras’s second motion for review did not argue for striking Dr.

Sladky’s opinion entirely.

In deciding the second motion for review, the Court reviewed the disclosures

that the Secretary made regarding Dr. Sladky’s licensing in Georgia and the

information Mr. Contreras presented regarding Dr. Sladky’s licensing in

Pennsylvania. In addition, the Court reviewed information that Dr. Sladky had

presented in other cases, including Roberts v. Sec'y of Health & Human Servs.,

No. 09-427V, 2013 WL 5314698 (Fed. Cl. Spec. Mstr. Aug. 29, 2013), and Raymo

v. Sec'y of Health & Human Servs., No. 11-654V, 2014 WL 1092274 (Fed. Cl.

Spec. Mstr. Feb. 24, 2014). Contreras 4, 116 Fed. Cl. at 480. The Court vacated

the November 19, 2013 Remand Decision and ordered another decision that more

explicitly discusses Dr. Sladky’s credibility and reliability. Id. at 484.

Upon remand, the parties were again ordered to file briefs. Order, issued

May 27, 2014. The Secretary’s brief, as discussed more thoroughly in section II.A

below, focused more upon the reliability of Dr. Sladky’s opinions and less upon

the credibility of Dr. Sladky. Resp’t’s Resp., filed June 23, 2014. Mr. Contreras

12

also filed a response. His primary argument was that “Dr. Sladky’s testimony must

be completely disregarded.” Pet’r’s Resp., filed July 21, 2014, at 1 (capitalization

changed without notation). This request from relief differed from the remedy

(increased scrutiny) for which Mr. Contreras previously advocated. See Pet’r’s

Reply, filed Aug. 13, 2013, at 34.10 Mr. Contreras argued that the result in his case

should match the outcome in Raymo. Pet’r’s Resp., filed July 21, 2014, at 3.

Beyond citing Raymo, Mr. Contreras did not cite other cases, not even Roberts, a

case in which the special master considered Dr. Sladky’s evidence but found it

unpersuasive.

Mr. Contreras’s July 21, 2014 response additionally discussed the

substantive issues in his case. For example, Mr. Contreras maintained that he

suffered from both Guillain-Barré syndrome and transverse myelitis. He also

argued that he had established that the hepatitis B vaccine caused his neurologic

injuries. Pet’r’s Resp., filed July 21, 2014, at 6-13.

A status conference was held on July 30, 2014. The parties indicated that

they did not wish to submit additional information. Thus, the case is again ready

for adjudication.

The remainder of this decision is organized into three large sections with

each section corresponding to a specific question the Court asked. The first section

addresses Dr. Sladky’s credibility and reliability. This section also encompasses

an evaluation of Mr. Contreras’s motion to strike Dr. Sladky’s evidence. The next

section compares Dr. Sladky’s credibility to other witnesses who testified either by

affidavit or in person. The third section assumes that Dr. Sladky’s evidence is not

part of the case and evaluates the remaining evidence. Before the conclusion, there

is a short section presenting “additional comments.”

II. Dr. Sladky’s Credibility and Reliability

A. Background, including Court’s Instructions and Parties’

Arguments

After the Secretary disclosed Dr. Sladky’s alcohol problem and consequent

licensing problems in Georgia, Mr. Contreras discovered the additional

10

Mr. Contreras could justify his changed position because the Court’s June 16, 2014

Opinion and Order revealed details about Dr. Sladky’s misrepresentations in other cases about

which Mr. Contreras was previously uninformed.

13

misrepresentation on Dr. Sladky’s CV concerning the expiration of his

Pennsylvania license. See Pet’r’s Status Rep’t, filed May 10, 2013. Mr. Contreras

concluded his submission by arguing that his testimony should be “scrutinized and

diminished.” Id. at 10.

The Remand Decision stated that Dr. Sladky’s opinion retained “some

value” (page 7) and added, in the context of the discussion regarding timing, “the

problems in Dr. Sladky’s licensing and the non-disclosure of these problems ha[ve]

minimal effect on this case.” Contreras 3, slip op. at 7, 71 n.51, 2013 WL

6698382, at *55 n.51. The Court held that this assessment was “ambiguous.”

Contreras 4, 116 Fed. Cl. at 481.

In directing the scope of the remand, the Court stated the special master

“must first determine whether or not Dr. Sladky is a credible witness providing

reliable opinions.” Id. at 483. The Court ordered the special master to “provide an

unambiguous estimation of Dr. Sladky’s credibility and reliability as an expert.”

Id. at 484. The Court instructed:

A distinction should be drawn between the content of Dr.

Sladky’s opinions, which may match the special master’s

view of the case, and the credibility of Dr. Sladky as an

expert who provided two expert reports and testimony in

this case. In essence, the question of credibility focuses

on whether Dr. Sladky was a reliable source of expert

opinion, not whether his opinions . . . were persuasive.

Id. at 484 n.12 (emphasis in original). Further, it appears that the Court expects

that Dr. Sladky’s credibility will be evaluated before the substance of his opinion is

weighed because, it appears, that if Dr. Sladky is not credible as a person, then his

opinion would be rejected entirely.

The Secretary’s most recent brief seems to miss this distinction between the

credibility of a person and the reliability of the opinion a person offers. The

Secretary asserted that “[i]n assessing the credibility of an expert witness, factors

such as education, board certification, academic achievements, publications and

clinical experience are relevant.” Resp’t’s Resp., filed June 23, 2014, at 4. These

factors, in the Secretary’s view, are also relevant in determining “whether the

expert possesses the underlying expertise to render an accurate and reliable

opinion. . . . No matter how qualified an expert is, his opinion is only as reliable as

the underlying scientific principles on which he relies.” Id. The Secretary’s

14

confusion between credibility and reliability is also evident later when the

Secretary argued that “[i]n assessing the credibility and reliability of Dr. Sladky’s

opinion in unambiguous terms, an emphasis should be placed on Dr. Sladky’s

professional qualifications and experience to offer a reliable opinion.” Id. at 8.

What is missing from the Secretary’s list of factors to consider in assessing

a person’s credibility is, perhaps, the most basic aspect. Did the person understand

and appreciate the oath obliging him (or her) to tell the truth? To place this factor

in context with a factor that the Secretary cited (education), does Dr. Sladky’s

graduation from Yale University affect his ability to speak honestly? The

Secretary does not grapple with the tension between misleading testimony

regarding qualifications and accurate testimony regarding other topics, such as the

significance of medical articles. At best, the Secretary conceded that “Respondent

does not dispute Dr. Sladky’s decision not to be forthcoming with the professional

ramifications of his alcoholism raises legitimate concerns regarding his

credibility.” Id. at 3. In this characterization, the Secretary skips past the Court’s

strong admonishments.11

In contrast, Mr. Contreras’s post-remand submission describes Dr. Sladky’s

misrepresentations. In his post-remand view, Mr. Contreras argues that “the only

remedy is to disregard his entire testimony.” Pet’r’s Resp., filed July 21, 2014, at 5

(emphasis omitted). In support, Mr. Contreras cites Raymo, a case in which the

chief special master refused to give weight to Dr. Sladky’s evidence.

While the Secretary can be faulted for not paying sufficient attention to Dr.

Sladky’s misconduct, Mr. Contreras goes to the other extreme. In his view, the

“only” penalty for an expert’s misrepresentations in qualifications is disregarding

the testimony entirely. However, this absolute consequence is not required in all

cases. Striking testimony from an expert who misrepresented his (or her)

background may be an appropriate penalty in some cases, but it is not the singular

11

The Court commented “Dr. Sladky was not candid about the events chronicled here

with either respondent’s counsel or the court. . . . Dr. Sladky’s curriculum vitae misrepresented

the state of his medical licensure at all times relevant to this litigation.” Contreras 4, 116 Fed.

Cl. at 476 (emphasis in original). “Thus, the expert report filed by Dr. Sladky in 2005 was

supported by an inaccurate and misleading CV.” Id. at 477. “Here, Dr. Sladky’s inaccurate CV

prevented the special master and petitioner from ascertaining the true nature of Dr. Sladky’s

medical practice and credentials at the times he opined as an expert in this case.” Id. “Dr.

Sladky’s testimony, like his CV, failed to fully represent the existing state of his credentials and

the existing conditions of his medical practice.” Id. at 479. Dr. Sladky’s testimony about the

nature of his practice “is misleading.” Id.

15

appropriate response. For example, in a case not involving Dr. Sladky, the

Secretary’s cross-examination revealed instances of an expert’s “resume padding,”

yet the special master proceeded to analyze the substance of the expert’s opinion.

Snyder v. Sec'y of Health & Human Servs., No. 01-162V, 2009 WL 332044, at

*14-15, *52 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), mot. for rev. denied, 88 Fed. Cl.

706, 744 n.65 (2009). In addition, as discussed by the Court, in Roberts, the

special master did not strike Dr. Sladky’s testimony. Instead, the special master

described Dr. Sladky’s opinion as “questionable” and found the petitioners’ experts

more reliable and persuasive. Contreras 4, 116 Fed. Cl. at 481 (citing Roberts,

2013 WL 5314698, at *9). Mr. Contreras does not present any reasoned basis for

preferring the outcome in Raymo, rather than the outcome in Roberts.

B. Standards for Adjudication

A survey of cases from other jurisdictions suggests that admitting evidence

relating to an expert witness’s failure to disclose problems with licensing tends to

be a question for the trial judge to consider as a matter of discretion. See George

L. Blum, Annotation, Propriety of questioning expert witness regarding specific

incidents or allegations of professional conduct or professional negligence, 11

A.L.R. 5th 1 (1993). For example, appellate courts have held cross-examination

about the expert’s record before a disciplinary board to be improper. Foley v. Mad

River Internal Med., No. 2006-311, 2007 WL 5313351 (Vt. 2007) (exclusion of

evidence sustained as within trial court’s discretion); Tormey v. Trout, 748 So.2d

303 (Fla. Dist. Ct. App. 1999) (finding admission of testimony to be harmless

error); Poole v. Univ. of Chicago, 542 N.E.2d 746, 750-51 (Ill. App. Ct. 1989)

(ordering new trial). Similarly, a district court acts within its discretion to exclude

testimony about misrepresentations in qualifications about a doctor in a

malpractice trial. White v. United States, 148 F.3d 787, 791-92 (7th Cir. 1998).

At the other end of a spectrum are cases in which courts have reasoned that

experts who misrepresent their qualifications should not be permitted to testify at

all. Hamilton v. Negi, No. 09-CV-0860, 2012 WL 1067857 (W.D. La. Mar. 15,

2012) (magistrate recommendation). A case that approved this result is In re

Unisys Savings Plan Litig., 173 F.3d 145 (3d Cir. 1999).

In Unisys, the plaintiffs alleged that their employer breached its fiduciary

duty as prescribed by the Employee Retirement Income Security Act of 1974. The

case was tried to the district court, not to a jury. The district court excluded the

testimony of the plaintiff’s proposed expert for three reasons, one of which was the

expert had testified untruthfully about his credentials during voir dire. Id. at 156.

16

The three-judge panel of the Third Circuit split in its review of the decision to

exclude the plaintiff’s witness.

The majority of the panel affirmed the district court’s decision to exclude the

testimony as within the trial court’s discretion. The majority reasoned that the fact

that the district court was acting as both the gatekeeper who admits expert

testimony and the finder of fact which weighs expert testimony was significant.

Once the district court judge found that he could not find the expert’s testimony

credible, the judge was not required to hear “the witness’s direct examination,

cross-examination, and rebuttal examination in an extended trial when [the judge]

knew that he would only reject it as unbelievable.” Id. at 157.

Chief Judge Becker dissented from the ruling regarding the admissibility of

the expert’s testimony. Chief Judge Becker distinguished two aspects of

reliability. In his view, the reliability of an expert’s opinion under Daubert

concerns the expert’s methodology. “Credibility plays no appropriate part in the

analysis of the reliability of a proposed expert’s methodology.” Unisys, 173 F.3d

at 166 (citing Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 593-94

(1993)). Because, according to the dissent, the expert’s methodology was

otherwise appropriate, the district court should have admitted the testimony. Chief

Judge Becker asserted “that there is a reasonable chance that, if the District Court

had given [the expert] the opportunity to present his testimony in full, it would

have found him to be a credible witness.” Id. at 173.

As noted, Chief Judge Becker’s Unisys opinion was a dissent. However, in

the next year, he wrote for a unanimous panel that reviewed a district court’s

decision to admit expert testimony in a case tried to a jury. Elcock v. Kmart Corp.,

233 F.3d 734 (3d Cir. 2000). The Third Circuit held that the district court erred in

admitting the expert’s testimony without conducting a Daubert hearing to address

the reliability of the expert’s testimony because of concerns about the expert’s

methodology. As guidance for the remand, the Third Circuit also discussed

whether the expert’s dishonesty should affect the reliability inquiry. (The expert

had pleaded guilty to embezzlement and knowing conversion of federal property.)

The Third Circuit held “in reaching our conclusion about the reliability of [the

expert’s] methods, we do not consider evidence regarding [the expert’s] credibility,

or his alleged character for untruthfulness.” Id. at 750. The Third Circuit declined

to follow the outcome of Unisys because, in part, the finder of fact in Elcock was a

jury, not a judge. Id. at 751. The District Court retained discretion to limit the

cross-examination about the details about the expert’s acts of dishonesty in front of

the jury.

17

The approach taken in Elcock has been used frequently. In several cases, the

trial court has permitted the expert to testify, has allowed the opposing side to

cross-examine the expert about the professional misconduct (and the failure to

disclose the misconduct), and expected that the finder of fact might consider the

misconduct. See, e.g., Pikas v. Williams Companies, Inc., No. 8-CV-101, 2013

WL 622234 (N.D. Okla. 2013) (despite actuary’s misrepresentation in his

qualifications, his declarations would be considered); In re Heparin Prod. Liab.

Litig., 803 F.Supp. 2d 712, 752 (N.D. Ohio 2011) (an expert who misrepresented

his qualifications would not be excluded but the jury would be instructed that it

may give his opinions greater scrutiny), aff'd sub nom. Rodrigues v. Baxter

Healthcare Corp., 567 F. App'x 359 (6th Cir. 2014); Fitzpatrick v. Teleflex, Inc.,

763 F.Supp. 2d 224, 236 (D. Me. 2011) (finding that the proffered person remains

an expert in accounting despite having his CPA license revoked and stating that if

the expert “testifies the factfinders will be allowed to hear about [his] difficulties

with the licensing authority and that in spite of his license being suspended, he

described himself as a CPA. A factfinder might well decide to give his opinion

little weight in light of his professional difficulties, or not”). On appeal, this

approach has been recognized as within the trial court’s discretion. Creighton v.

Thompson, 639 N.E.2d 234, 239-40 (Ill. App. Ct. 1994) (distinguishing Poole).

Notably, even the majority of the Third Circuit in Unisys recognized that

“‘appellate decisions affirming the trial court [regarding the qualifications of an

expert witness] do not necessarily stand for the proposition that the opposite ruling

would constitute error.’” In re Unisys, 173 F.3d at 157 n.17 (quoting Hanson v.

Baker, 534 A.2d 665, 667 (Me. 1987)).

Here, the Remand Decision attempted to follow the course for which Chief

Judge Becker advocated. Because Mr. Contreras had not filed a motion to strike

Dr. Sladky’s evidence and merely argued that this evidence receive greater

scrutiny, an explicit assessment about the admissibility of his testimony seemed

unnecessary. Therefore, the Remand Decision weighed the evidence coming from

Dr. Sladky. See 42 U.S.C. § 300aa—13 (directing special master to make decision

upon the entire record).

After the second remand, the status of Dr. Sladky’s evidence has changed in

two respects. First, the Court independently investigated Dr. Sladky’s disclosures

in other Vaccine Program cases, including Crosby v. Sec'y of Health & Human

Servs., No. 07-799V, 2012 WL 3758430 (Fed. Cl. Spec. Mstr. June 19, 2012).

18

Contreras 4, 116 Fed. Cl. at 478.12 Second, Mr. Contreras has now argued for the

striking of Dr. Sladky’s evidence. Pet’r’s Resp., filed July 21, 2014, at 1.

The Court’s instructions included a direction that “the special master must

address Dr. Sladky’s credibility and reliability in light of the consistent pattern of

misrepresentations by Dr. Sladky in his work as an expert for respondent and

provide an unambiguous estimation of Dr. Sladky’s credibility and reliability as an

expert.” Contreras 4, 116 Fed. Cl. at 484. The Court appears to have adopted,

implicitly, the views of the trial court and panel-majority from Unisys --- some

expert witnesses may be so untruthful that they cannot be trusted in any respect.

Nonetheless, the Court recognized that the initial evaluation of the expert’s

credibility and reliability is for the special master. Id. at 484 (citing Piscopo v.

Sec’y of Health & Human Servs., 66 Fed. Cl. 49, 53 (2005)).

C. Assessments

The Court has ordered evaluations of two aspects of Dr. Sladky, his

credibility and his reliability. The following sections attempts to respond to the

Court’s instructions regarding credibility and reliability.

1. Credibility

As suggested earlier, the parties’ briefs concerning the standards by which to

evaluate an expert’s credibility were not particularly helpful. The Secretary’s brief

tended to focus on factors that contribute to the expert’s reliability and

persuasiveness, while ignoring the factors that concern truthfulness. Mr.

Contreras, in turn, seemed to assume that once Dr. Sladky’s pattern of misconduct

was revealed, the sanction of striking his testimony would follow as a matter of

rote.

12

Coincidentally, one issue in Crosby resembles an issue Mr. Contreras’s case. As a

preliminary matter, the special master determined that the vaccinee (a child) started to experience

symptoms of transverse myelitis one day after vaccination. Crosby, 2012 WL 3758430, at *5.

The ensuing question, which matches a question in the case at hand, was whether 24 hours was a

sufficient amount of time for the vaccine to have caused transverse myelitis. Based upon the

evidence presented, the special master found “that 96 hours was the minimum amount of time

necessary for an adaptive immune response, which is the type of immune response petitioner

alleged caused the [transverse myelitis]. This evidence was agreed to by petitioner’s own

immunologist … [who] specifically testified that onset within 24 hours would not be an

appropriate time frame.” Id.

19

Neither party identified any Federal Circuit decisions addressing how a trial

court should respond to the revelation that an expert misrepresented his

qualifications. Independent research also has not discovered any Federal Circuit

cases. On the topic of the credibility of expert witnesses more generally, the

Federal Circuit has given limited, and arguably inconsistent, guidance.13 The

Federal Circuit has explicitly recognized that a “finder of fact has to make the

effort to decide which side has the stronger case. This can be based on the

demeanor of the witnesses (if so, the trial judge should say) or the intellectual

strength of the evidence based thereon.” Andrew Corp. v. Gabriel Elec., Inc., 847

F.2d 819, 824 (Fed. Cir. 1988) (quoting United States v. Gen. Motors Corp., 561

F.2d 923, 933 (D.C. Cir. 1977)).

In a trial before the court, the right of a judge to weigh the expert’s

credibility was implicitly recognized in Energy Capital Corp. v. United States, 302

F.3d 1314 (Fed. Cir. 2002). The Federal Circuit stated: “As for the relative weight

given to both sides’ expert witnesses, we accord the trial court broad discretion in

determining credibility because the court saw the witnesses and heard the

testimony.” Id. at 1329.

Consistent with those cases, which concerned judges as finders of fact, the

Federal Circuit has accepted a special master’s reliance upon an expert’s

credibility. The Federal Circuit commented:

Summarizing his assessment of the experts’ testimony on

the issue of causation, the special master credited Dr.

Snyder's evidence, but found the testimony given by Dr.

Conkling and Dr. Lewis “unpersuasive.” Those findings,

which are at the core of the special master's decision in

this case, are largely based on his assessments of the

credibility of the witnesses and the relative

13

Some of the inconsistency may stem from imprecision in the term “credibility.” See

Isaac v. Sec'y of Health & Human Servs., No. 08-601V, 2012 WL 3609993, at *19 (Fed. Cl.

Spec. Mstr. July 30, 2012) (stating “[w]hat is meant by credibility in the Vaccine Program is not

coextensive with the concept of reliability as applied to fact witnesses in a conventional trial

setting. In the Vaccine Program, the concept is closer to reliability than believability”) (footnote

omitted), mot. for rev. denied, 108 Fed. Cl. 743, aff’d without op., 540 Fed. Appx. 999 (Fed. Cir.

2013); cf. Haebe v. Dep’t of Justice, 288 F.3d 1288, 1300 (Fed. Cir. 2002) (noting imprecision in

the use of “deference” as it relates to “concepts of credibility and demeanor”).

20

persuasiveness of the competing medical theories of the

case.

Lampe v. Sec'y of Health & Human Servs., 219 F.3d 1357, 1361-62 (Fed. Cir.

2000) (affirming a judgment denying compensation because the special master’s

determinations are “virtually unchallengeable on appeal”).

But, the Federal Circuit’s resolution of Lampe included a dissenting opinion

from Judge Plager. Although acknowledging that “evaluations of credibility are

‘virtually unreviewable,’” the dissent asserted that “credibility is not really the

issue in this case.” Id. at 1373 (Plager, J., dissenting) (citation omitted). The

dissent proposed that the special master’s finding that petitioner’s experts were not

persuasive was arbitrary and capricious. Id. at 1374 (“my quarrel is with the

special master’s evaluation of the evidence”).

The Federal Circuit again discussed an expert’s credibility in a 2009 case

originating in the Vaccine Program. In that case, the special master found that

petitioners were not entitled to compensation for three reasons: “(A) conflicts

between [the child’s] clinical presentation and Dr. Tornatore’s [(the petitioners’

expert)] theory; (B) the weight of the medical research showing no connection

between DPT and afebrile seizures; and (C) my assessment of witness credibility.”

Andreu v. Sec’y of Health & Human Servs., No. 98-817V, 2008 WL 2517179, at

*5 (Fed. Cl. Spec. Mstr. May 29, 2008). When the case reached the Federal

Circuit, it stated, “[t]he special master framed her rejection of [petitioners’

expert’s] theory of causation under the rubric of a ‘credibility’ determination.”

Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir 2009).

The Federal Circuit held that this was an error because special masters may

not disguise an “erroneous legal standard” as a “credibility determination”

regarding an expert witness. Id. The dissent from Lampe was the sole authority

cited in support for the conclusion that a “trial court makes a credibility

determination in order to assess the candor of a fact witness, not to evaluate

whether an expert witness’ medical theory is supported by the weight of

epidemiological evidence.” Andreu, 569 F.3d at 1379. After identifying this error,

the Federal Circuit reviewed the evidence, found “the totality of the evidence . . .

sufficient to meet the Vaccine Act’s preponderant evidence standard,” and ruled

the petitioners were entitled to compensation, reversing the Court’s judgment,

based upon the special master’s dismissal. Id. at 1382.

21

The Federal Circuit’s reversal in Andreu led to a conclusion that special

masters should not consider an expert’s credibility. See Rotoli v. Sec’y of Health

& Human Servs., 89 Fed. Cl. 71, 80-81 (2009), rev’d on this ground sub nom.

Porter v. Sec'y of Health & Human Servs., 663 F.3d 1242 (Fed. Cir. 2011). But,

interpreting Andreu to mean that special masters may never consider an expert’s

credibility was held to be too extreme. The Federal Circuit explained:

[T]he Claims Court read Andreu to mean that it is

inappropriate for a special master to consider a

petitioner's expert's credibility in evaluating a petitioner's

showing of causation in fact.

The Claims Court's reading of Andreu is incorrect.

Indeed, this court has unambiguously explained that

special masters are expected to consider the credibility of

expert witnesses in evaluating petitions for compensation

under the Vaccine Act.

Porter, 663 F.3d at 1250. In this context, the Federal Circuit discussed opinions

issued after Andreu, including Moberly, 592 F.3d at 1325, and Broekelschen, 618

F.3d at 1347. Porter, 663 F.3d at 1250 (citing Andreu, 569 F.3d at 1379; Moberly

v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1325 (Fed. Cir. 2010); and

Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir.

2010)).

Nevertheless, after Moberly and Porter, special masters rarely comment

directly on an expert’s credibility (in the sense of truthfulness) for several reasons.

First, special masters may be faulted, after Andreu, of using credibility to escape

appellate review. Second, the experts usually appear to be speaking honestly.

Although the experts have differences in opinions and reach different conclusions,

those disagreements frequently appear to be caused by differences in backgrounds

and philosophies. In these circumstances, there is little to be gained by stating that

each expert testified truthfully. Third, special masters generally respect the experts

and appreciate their willingness to participate in the Vaccine Program. This

gratitude typically extends even to those experts whom special masters do not find

persuasive. Thus, special masters are often reluctant to criticize an expert on a

personal level, such as by saying the expert appeared to be lying or misleading.

But, when the special master needs to tell it like it is, the special master will

describe instances of dishonest conduct. See King v. Sec'y of Health & Human

Servs., 03-584V, 2011 WL 5926126, at *12 (Fed. Cl. Spec. Mstr. Sept. 22, 2011)

22

(citing cases involving Dr. Mark Geier); Baker v. Sec'y of Health & Human Servs.,

No. 99-653V, 2003 WL 22416622, at *33-36 (Fed. Cl. Spec. Mstr. Sept. 26, 2003)

(Dr. John Barthelow Classen), mot. for rev. denied, 61 Fed. Cl. 669 (2004), appeal

dismissed, 112 Fed. Appx. 35 (Fed. Cir. 2004); Mahaffey v. Sec'y of Health &

Human Servs., No. 01-392V, 2003 WL 22424989, at *12 (Fed. Cl. Spec. Mstr.

May 30, 2003), aff’d on other grounds, 368 F.3d 1378 (Fed. Cir. 2004).

The revelation that Dr. Sladky was not forthright in disclosing his Georgia

licensing problems places Mr. Contreras’s case among the minority of cases in

which the expert’s credibility (again, in the sense of truthfulness) is a factor. A list

of factors to consider in evaluating whether a person speaks credibly (or honestly)

is based upon jury instructions. These factors include: “(1) the witness’s

demeanor; (2) the witness’s motives, biases, interests, and prejudices; (3) whether

the witness is contradicted by prior inconsistent statements or by other evidence;

(4) the reasonableness of the witness’s testimony, in light of other evidence; and

(5) any other factors that bear on believability.” Hennessey v. Sec'y of Health &

Human Servs., No. 01-190V, 2009 WL 1709053, at *43 n.136 (Fed. Cl. Spec.

Mstr. May 29, 2009), mot. for rev. denied, 91 Fed. Cl. 126 (2010). This list of

factors to consider in evaluating the credibility of an expert witness from

Hennessey is very similar to the Merit System Protection Board’s list of factors to

consider in evaluating the credibility of a percipient witness. The MSPB’s factors

are

(1) The witness's opportunity and capacity to observe the

event or act in question; (2) the witness's character; (3)

any prior inconsistent statement by the witness; (4) a

witness’s bias, or lack of bias; (5) the contradiction of the

witness’s version of events by other evidence or its

consistency with other evidence; (6) the inherent

improbability of the witness’s version of events; and (7)

the witness’s demeanor.

Hillen v. Dep’t of the Army, 35 M.S.P.R. 453, 458 (1987), quoted in Haebe, 288

F.3d at 1301 n.30. By these standards, Dr. Sladky was credible at times and not

credible at other times.14

14

To be more precise, “credibility” in this context is roughly synonymous with honesty.

“Credibility” also has a measure of accuracy, attention to detail, forthrightness, and impartiality.

23

The evidence has revealed four instances where Dr. Sladky was not truthful

and all relate to his background. Presented in chronological order, beginning with

the earliest, these events occurred as follows. First, Dr. Sladky did not change his

CV to note that his license to practice medicine in Pennsylvania had expired

although Dr. Sladky changed his CV in other respects. Second, Dr. Sladky’s

alcoholism led to issues at the Georgia State Medical Board.15 Third, Dr. Sladky

failed to disclose the loss and restriction of his license. Fourth, Dr. Sladky testified

misleadingly about the nature of his practice.

This list also roughly corresponds to the degree of severity. Dr. Sladky’s

alcoholism does not, by itself, reduce Dr. Sladky’s credibility. The issues that

underlie Dr. Sladky’s alcoholism are not necessarily the same as an inability or an

unwillingness to speak truthfully. See Settle v. Basinger, No. 11CV1342, 2013

COA 18, ¶ 81-86, 2013 WL 781110, at *11-12 (Colo. App. Feb. 28, 2013), cert.

denied, 2013 WL 6804561 (Colo. 2013); State v. Porter, 738 A.2d 1271, 1274

(N.H. 1999). The problem, however, is that Dr. Sladky did not disclose how his

alcoholism affected his medical license.

The lack of disclosure (the third event) more significantly reduces Dr.

Sladky’s credibility than the mistake in Dr. Sladky’s CV (the first event). Dr.

Sladky should have indicated that his license to practice medicine in Pennsylvania

expired. His failure to show the correct status of his license was an error. But, the

error still appears to be an oversight, not an intentional effort to mislead the parties,

the undersigned, or the Court. The basis for this conclusion is that Dr. Sladky

would be unlikely to believe that the Secretary or he would gain any advantage in

litigation because he was licensed to practice medicine in two states (Pennsylvania

and Georgia), rather than one state (Georgia). The Court found that Dr. Sladky did

not correct the status of his Pennsylvania license in his CV submitted in other

cases, despite updates in other respects. Contreras 4, 116 Fed. Cl. at 478. This is

true. Nevertheless, this pattern does not show an intent to deceive. The pattern is

consistent with an oversight that remains unnoticed (and, therefore, uncorrected).16

If Dr. Sladky’s only fault were a misstatement about his licensure status in one

jurisdiction, he would be found credible to testify.

15

A sequence of events took place before the Georgia Board: a voluntary relinquishment

of Dr. Sladky’s license for a time, a suspension of his license, and the restoration of the license

with conditions. All these problems seem to flow from his alcoholism.

16

If an error in an expert’s CV were called to the expert’s attention and the expert did not

correct the error, the inference of intent to deceive could be found more readily.

24

However, as discussed at length, Dr. Sladky’s mistakes did not end with the

expired Pennsylvania license. He also failed to disclose that his Georgia license

was voluntarily relinquished, suspended, and restored on a probationary basis.

District courts, usually in the context of cases being tried to a jury, have not always

excluded the expert’s testimony due to misrepresentations in the proposed expert’s

qualifications. Instead, the district court has admitted the testimony, allowed

cross-examination, and left the finder of fact to weigh the expert’s testimony.

White, 148 F.3d at 791-92 (finding doctor’s credibility was a collateral issue);

Fitzpatrick, 763 F.Supp. 2d at 236 (finding expert remained qualified due to

experience); Pikas, 2013 WL 622234, at *2 (court considered declaration of

actuary when it ruled on damages issues).

Unlike the situation regarding the Pennsylvania license, Dr. Sladky’s lack of

disclosure for Georgia problems appears to be intentional. Dr. Sladky could easily

have understood that a doctor’s experience in treating patients may affect how a

special master evaluates testimony from that doctor. For example, a neurologist

with 15 years of experience may be more readily accepted than a neurologist with

only 5 years of experience. In not being forthcoming about his licensing issues in

Georgia, Dr. Sladky was implicitly representing himself as a doctor with

experience in neurology since at least 1983, when he received his board

certification. See exhibit J (CV) at 3. However, as the Court calculated, he could

not practice medicine for 15 and a half months. Contreras 4, 116 Fed. Cl. at 479.

Thus, he did not really have the experience he claimed.

In addition, the loss of his license leads to questions about why it was lost.

If the Georgia State Medical Board suspended Dr. Sladky’s license due to errors in

treating patients, then this disciplinary action would undermine Dr. Sladky’s

medical knowledge. It is relatively easy to find that Dr. Sladky feared answering

questions about why he lost his license and his fear motivated him to do what he

could to avoid answering those questions. What Dr. Sladky did to protect himself

was to remain silent. This was an error on Dr. Sladky’s part and this error appears

to be intentional.

The final factor weighing against Dr. Sladky’s credibility was his testimony

regarding his practice. He, again, did not disclose his Georgia licensure problems.

The Court found “Dr. Sladky’s testimony was misleading as to his experience and

qualifications to testify as an expert.” Contreras 4, 116 Fed. Cl. at 479.

On the basis of these four factors, the chief special master in Raymo found

that Dr. Sladky “demonstrated a lack of candor that, although not related directly to

25

the substance of [his] causation opinions, reflect[s] [a] willingness to, at the very

least, shade the truth.” Raymo, 2014 WL 1092274, at *16. Thus, the chief special

master in Raymo found that Dr. Sladky’s testimony should not be credited in any

respect and did not further analyze the substance of his testimony.

Given that Dr. Sladky testified in Mr. Contreras’s case, it is appropriate to

review the remainder of his testimony to look for places when he could be viewed,

in the words of the chief special master in Raymo, as shading the truth. See In re

Unisys, 173 F.3d at 173 (Becker, C.J., dissenting) (“there is a reasonable chance

that, if the District Court had given [the expert] the opportunity to present his

testimony in full, it would have found him to be a credible witness”). The

remainder of Dr. Sladky’s testimony should be considered in evaluating his

credibility because special masters should consider the entire record in making a

decision. 42 U.S.C. § 300aa—13.

Does Dr. Sladky’s substantive testimony demonstrate other examples of

presenting something other than the truth, the whole truth, and nothing but the

truth? Apart from the aspect of his testimony concerning his personal

qualifications, Dr. Sladky appeared accurate, honest, and forthcoming. Dr. Sladky

was accurate, for instance, in 2005, when he cited the 1994 IOM report for the

proposition this group of scientists found that the minimum amount of time for an

immune-mediated response is 5 days. Exhibit I at 3. The IOM actually does assert

“a conservative estimate of the limits of the latencies for both GBS and ADEM is

conserved to be from 5 days to 6 weeks.” Exhibit F at 45. Dr. Sladky’s reliance

on the 1994 IOM report does not appear to constitute an attempt to mislead the

special master or to shade the truth.

Moreover, Dr. Sladky was forthcoming in his substantive opinion. He was

not adverse to everything Mr. Contreras asserted. For example, Dr. Sladky

conceded that he did not identify any factor that could have caused Mr. Contreras’s

transverse myelitis. Tr. 299, 351. Dr. Sladky maintained that Mr. Contreras’s

previous exposure to the Epstein Barr virus did not make Mr. Contreras vulnerable

to developing transverse myelitis. Tr. 301. These opinions helped Mr. Contreras

because they negated the possibility of the Secretary mounting a defense based

upon a factor unrelated to a vaccine caused the transverse myelitis.

More significantly, Dr. Sladky assisted Mr. Contreras regarding Mr.

Contreras’s attempt to establish the first prong of Althen. Althen v. Sec'y of

Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). In the context of

considering whether a medical theory supported the claim that the hepatitis B

26

vaccine can cause transverse myelitis, Dr. Sladky was asked about the factors from

Daubert. Dr. Sladky stated that he believed that a majority of neurologists would

accept that vaccines can cause transverse myelitis. Tr. 386. The Remand Decision

discussed this concession. Contreras 3, slip op. at 46, 2013 WL 6698382, at *36.

For purposes of assessing Dr. Sladky’s credibility or his willingness to shade

the truth, it is important to recognize that Dr. Sladky was not compelled to opine

that the theory that vaccines can cause transverse myelitis is generally accepted.

He could have asserted that very few neurologists accepted this theory because

there was no way to verify Dr. Sladky’s assertion. This example demonstrates that

Dr. Sladky was willing to be honest about information that was detrimental to the

Secretary’s position on one occasion. Cf. Tr. 395 (Dr. Sladky testified that he

recommended that the Secretary compensate a petitioner in a case 12-13 years

earlier).

For his substantive opinions, Dr. Sladky appeared credible. When asked on

cross-examination whether he tried to be “fair and straightforward with the Court

on what [he] saw and what [his] opinions are,” Dr. Sladky responded affirmatively.

Tr. 328. Notably, the Secretary queried whether Dr. Sladky interpreted a peer-

review article incorrectly. Resp’t’s Resp., filed June 23, 2014, at 8. Yet, given this

challenge, Mr. Contreras did not propose that Dr. Sladky misinterpreted an article.

Mr. Contreras did not identify any instances in which Dr. Sladky arguably

presented a shaded opinion in substance. See Pet’r’s Resp., filed July 21, 2014; at

1-5.

On the whole, Dr. Sladky’s candor on substantive matters offsets his lack of

disclosures regarding personal matters. Dr. Sladky is sufficiently credible that his

testimony should be evaluated for its reliability.

2. Reliability17

Within the Vaccine Program, the reliability of an expert’s opinion is often

analyzed using the Daubert factors. See Caves v. Sec’y of Health & Human

Servs., 100 Fed. Cl. 119, 133 (2011), aff’d per curiam, 463 Fed. Appx. 932 (Fed.

Cir. 2012). This evaluation is usually for petitioner’s expert because the petitioner

usually bears the burden of demonstrating the reliability of the opinion. The

Daubert factors include:

17

The reliability of Dr. Sladky’s opinion does not take into account the lack of

disclosures that diminish his credibility.

27

(1) whether a theory or technique can be (and has been)

tested; (2) whether the theory or technique has been

subjected to peer review and publication; (3) whether

there is a known or potential rate of error and whether

there are standards for controlling the error; and, (4)

whether the theory or technique enjoys general

acceptance within a relevant scientific community.

Daubert, 509 U.S. at 592-95. Assessing the reliability of the expert’s opinion

usually includes considering the expert’s methodology. Gen. Elec. Co. v. Joiner,

522 U.S. 136, 146 (1998) (citing Daubert, 509 U.S. at 595).

The Remand Decision analyzed all the evidence regarding the theory that the

hepatitis B vaccine can cause transverse myelitis via molecular mimicry.

Contreras 3, slip op. at 43-48, 2013 WL 6698382, at *34-38. However,

Contreras 3 did not separately evaluate Dr. Sladky’s opinion. Because the Court

has required an appraisal of Dr. Sladky’s “reliability,” this task is undertaken now

with respect to Dr. Sladky’s opinions regarding diagnosis, timing, and causation.

See Contreras 4, 116 Fed. Cl. at 484.

a) Diagnosis

From October 2005 through the April 20, 2010 hearing, Dr. Sladky opined

that Mr. Contreras suffered from transverse myelitis and only transverse myelitis.

The aspect of Dr. Sladky’s opinion that Mr. Contreras suffered from transverse

myelitis was not contested. The second MRI showed a lesion in Mr. Contreras’s

spinal cord, indicating inflammation in his spinal cord. Exhibit 7 at 177, 1723.

The consensus among the experts about transverse myelitis establishes the

reliability of Dr. Sladky’s opinion for transverse myelitis.

The aspect of Dr. Sladky’s opinion that Mr. Contreras suffered from only

transverse myelitis (and not Guillain-Barré syndrome) is disputed. During this

litigation, Dr. Steinman and Dr. Poser revived Guillain-Barré syndrome. However,

a mere disagreement among experts does not necessarily make one expert’s

opinion unreliable. The opinion could be reliable but not persuasive.

Here, Dr. Sladky followed an appropriate methodology in ruling out

Guillain-Barré syndrome as a diagnosis for Mr. Contreras. See Tr. 281-93. Mr.

Contreras did not present any persuasive evidence that Dr. Sladky deviated from

general medical practice by, for instance, using an outdated set of diagnostic

28

criteria or ignoring test results.18 Dr. Sladky’s opinion regarding diagnosis is

reliable.

b) Timing

The next opinion from Dr. Sladky is an assertion that one day is not a

sufficient amount of time for a vaccine to cause a demyelinating disease. Dr.

Sladky expressed this opinion in his October 21, 2005 report (exhibit J at 4-5), in

his March 4, 2010 supplemental report (exhibit O at 2), and in his testimony on

cross-examination (Tr. 329).19

A substantial amount of evidence supports the reliability of Dr. Sladky’s

opinion. The most important article is the 1994 report from the Institute of

Medicine (IOM). Exhibits A, F, and V. Cases from the Vaccine Program have

cited the 1994 IOM report because of the expertise of the contributors to the IOM

report and Congress directed the IOM to research the safety of vaccines as part of

the Vaccine Program. See Kelley v. Sec'y of Health & Human Servs., 68 Fed. Cl.

84, 91 n.11 (2005); Kuperus v. Sec'y of Health & Human Servs., No. 01-60V, 2003

WL 22912885, at *10 (Fed. Cl. Spec. Mstr. Oct. 23, 2003); White v. Sec'y of

Health & Human Servs., No. 98-426V, 2002 WL 1488764, at *6, *11 (Fed. Cl.

Spec. Mstr. May 10, 2002) (setting forth petitioner’s arguments and accepting

petitioner’s argument regarding timing); Exhibit C (Institute of Medicine,

Immunization Safety Review: Hepatitis B Vaccine and Demyelinating

Neurological Disorders (Kathleen Stratton et al., eds. 2002)) at 2 (discussing

congressional mandate for vaccine safety research).20

18

Dr. Sladky appears to have weighed results of some tests particularly the Babinski

reflex differently than Dr. Steinman. But, assigning different weights to a test is not the same as

ignoring the test.

19

The Secretary, on direct examination, elicited a small amount of testimony from Dr.

Sladky about the timing between vaccination and onset. Tr. 279-81, 310 (discussing rodent

studies).

20

For examples of appellate authorities endorsing a special master’s reliance on reports

from the IOM other than the 1994 report, see Porter, 663 F.3d at 1252-54 (2002 report); Cucuras

v. Sec'y of Health & Human Servs., 993 F.2d 1525, 1529 (Fed. Cir. 1993) (1991 report); Isaac v.

Sec'y of Health & Human Servs., 108 Fed. Cl. 743, 768-74 (2013), aff’d, 540 Fed. Appx. 999

(Fed. Cir. 2013) (2011 pre-publication report); Terran v. Sec'y of Health & Human Servs., 41

Fed. Cl. 330, 337 (1998) (1991 report and different 1994 report), aff’d, 195 F.3d 1302, 1317

(Fed. Cir. 1999).

29

The 1994 IOM report stated that an immune-mediated response leading to a

demyelinating disease would take “5 days to 6 weeks.” Exhibit F at 45. The

Secretary cited the 1994 IOM report in her October 7, 2005 Rule 4 Report and Dr.

Sladky also cited it in his October 21, 2005 report. Exhibit J at 3.

Given the pedigree of the IOM report, Dr. Sladky’s reliance on it means that

his opinion easily surpasses the minimum standards for reliability. A methodology

of relying upon the work from a set of extremely well-qualified experts is sound.

Mr. Contreras has not called into question the findings of the 1994 IOM panel by

challenging their credibility or expertise.21

Other articles, although less prestigious than an IOM report, further buttress

the reliability of Dr. Sladky’s opinion regarding latency. Two articles collected

case reports of patients who developed neurological problems after vaccination.

One stated “[a]cute transverse myelitis . . . begins three to 14 days after an

antecedent immunization.” Exhibit 29 (L. Reik, Jr., Neurological complications of

immunization, 2 Neurology Infections & Epidemiology 69, 75 (1997)) at 7. In the

other case series, the minimum amount of time between vaccination and the onset

of neurologic symptoms was four days. Exhibit 34 (A. Tourbah et al., Encephalitis

after hepatitis B vaccination: Recurrent disseminated encephalitis or MS?, 53

Neurology 396 (1999)).

For his opinion regarding timing, Dr. Sladky easily meets the Daubert

criteria for peer review and general acceptance. Thus, his opinion is reliable.

c) Causation

A third opinion offered by Dr. Sladky was that the evidence did not support

a finding that the hepatitis B vaccine can cause transverse myelitis. One reason

was that the epidemiological studies, such as Touze, that investigated a possible

connection between the hepatitis B vaccine and demyelinating diseases and found

none. See exhibit I at 4 (citing exhibit E (E. Merelli & F. Casoni, Prognostic

factors in multiple sclerosis: role of intercurrent infections and vaccinations against

influenza and hepatitis B, 21 Neurological Science S853 (2000)); exhibit G

(Emmanuel Touze et al., Hepatitis B Vaccination and First Central Nervous

21

In the context of cross-examining Dr. Whitton, who relied upon yet another IOM

report, Mr. Contreras suggested that the IOM required scientific certainty. Tr. 464-66.

However, Dr. Whitton understood that the standard for proof in the Vaccine Program is more

likely than not. Tr. 500.

30

System Demyelinating Event: A Case-Control Study, 21 Neuroepidemiology 180

(2002)); and exhibit H (Frauke Zipp et al., No increase in demyelinating diseases

after hepatitis B vaccination, 5(9) Nature Medicine 964 (1999)). In emphasizing

the results of epidemiologic studies, Dr. Sladky downplayed the significance of

case reports. Tr. 295-97.

This methodology is reliable, both from a medical perspective and a legal

perspective. As discussed in the Remand Decision, Dr. Chen from the Centers of

Disease Control stated “[i]n the hierarchy of weight of scientific evidence, data

from well-designed randomized clinical trials clearly outweighs that from well-

controlled observational studies, which in turn, is hierarchically better than

uncontrolled observational studies, case series, and then finally, case reports.”

Exhibit 15 (Robert T. Chen et al., Epidemiology of Autoimmune Reactions

Induced by Vaccination, 16 Journal of Autoimmunity 309, 312 (2001)) at 4.

Similarly, the 2002 IOM panel placed little weight on case reports, commenting

“[c]ase reports are useful for describing the domain of concerns, but the data are

usually uncorroborated clinical descriptions that are insufficient to permit

meaningful comment or to contribute to a causality argument.” Exhibit C (2002

IOM) at 39. In addition, the Federal Judicial Center has published guidance to

judges, indicating that case reports are usually not sufficient to show causation.

David H. Kaye & David A. Freedman, Reference Guide on Statistics, in Reference

Manual on Scientific Evidence 211, 218 (Federal Judicial Center, 3d ed. 2011).

Thus, Dr. Sladky, in reaching his conclusion that the evidence does not show that

hepatitis B vaccine causes demyelinating diseases, followed an appropriate

methodology.22

Overall

Dr. Sladky satisfies the minimal standard for credibility. Dr. Sladky also

offered opinions based upon reliable methodologies. His opinions, therefore,

remain in the record and, to the extent that Mr. Contreras has argued that his

testimony should be stricken, Mr. Contreras’s request is denied.

22

Dr. Sladky’s methodology is appropriate for a doctor. The standards for this profession

differ from the standards special masters use in adjudicating claims. In the Vaccine Program, a

petitioner is not required to submit epidemiological studies, but when those studies are

submitted, the special master may consider them. Andreu, 569 F.3d at 1379.

31

III. Comparisons

The Court directed a second determination: “the special master must

compare Dr. Sladky’s credibility to the credibility of the experts for the petitioner

and the witnesses testifying for petitioner.” Contreras 4, 116 Fed. Cl. at 484. The

standards for reviewing an expert’s credibility were set forth in the preceding

section. See section II.B. The relevant factors include the testifying witness’s

demeanor. See Bailey v. United States, 54 Fed. Cl. 459, 461-63 (2002) (citing

cases), aff’d, 94 Fed. Appx. 828 (Fed. Cir. 2004). In accord with the Court’s

instructions, the following is an assessment of credibility listed from the least

credible to the most credible.

Dr. Wagner: Dr. Wagner’s background indicates that he is knowledgeable

about emergency room medicine and the records created on June 17, 2003, show

that he used his skills to stabilize Mr. Contreras. Exhibit 13 (CV) at 13-19; exhibit

6 (medical records). His testimony about how he cared for Mr. Contreras largely

tracked the records from that time. Tr. 67-90. His testimony about Mr.

Contreras’s signs and symptoms and Dr. Wagner’s response to those signs and

symptoms was believable. There is no doubt that Dr. Wagner sincerely thought

that transverse myelitis, Guillain-Barré syndrome, and other diseases were

potentially affecting Mr. Contreras.

Dr. Wagner’s differential diagnosis, although honest, is not worth as much

as the more definitive conclusion reached by Mr. Contreras’s treating neurologist,

Dr. Lake, that Mr. Contreras suffered from transverse myelitis and not Guillain-

Barré syndrome. Dr. Wagner’s opinion regarding diagnosis is discounted for two

reasons, neither of which implicates his credibility. First, Dr. Wagner saw Mr.

Contreras for approximately five hours. Tr. 91; see exhibit 6 at 9 (showing

examination time as 12:20); Tr. 67 (same); exhibit 6 at 5 (showing discharge time

as 4:59 P.M.). During this five-hour period, Mr. Contreras underwent one MRI.

However, after Mr. Contreras left Dr. Wagner’s hospital for a facility that provided

a higher level of care, Mr. Contreras had another MRI. See Tr. 89. This second

MRI, which Dr. Wagner never reviewed, was the basis for Dr. Lake’s conclusion

that Mr. Contreras suffered from transverse myelitis. See Tr. 84 (Dr. Wagner

acknowledging that an early MRI may not show transverse myelitis). The second

reason for crediting Dr. Lake’s opinion over Dr. Wagner’s opinion is that Dr. Lake

is a neurologist. She specializes in diseases that affect the nervous system, such as

transverse myelitis and Guillain-Barré syndrome. Thus, she had better information

about Mr. Contreras and is better qualified to interpret that information.

32

Although Dr. Wagner was credible but not persuasive in opining about Mr.

Contreras’s diagnosis, his opinion regarding etiology was much less credible. Dr.

Wagner is not a specialist is immunology or neurology, the two specialties most

relevant to Mr. Contreras’s claim. Tr. 90. In addition, Dr. Wagner displayed a

prejudice in favoring a claim that vaccines can cause harm. Dr. Wagner appeared

angry that a vaccine, given to him in the 1970’s, harmed him. Tr. 93.

In addition, as noted in the Entitlement Decision, Dr. Wagner informed his

opinion that the hepatitis B vaccine harmed Mr. Contreras based on a review of

only the reports of Drs. Garrett and Steinman, and not those of Drs. Sladky or

Whitton. Contreras 1, 2012 WL 1441315, at * 22 (citing Tr. 97-98). This

selective review suggests that Dr. Wagner formed an opinion about causation and

then looked for support for that opinion. He did not consider an opposing

viewpoint. This lack of neutrality made Dr. Wagner appear to be more of an

advocate than an expert who sees his role as being one to help the finder of fact

make informed decisions. Special masters have given biased testimony from

experts less weight. Brousard-Pacot v. Sec'y of Health & Human Servs., No.

09-107V, 2012 WL 5357478, at *13 (Fed. Cl. Spec. Mstr. Sept. 4, 2012) (rejecting

testimony of expert who “reasoned backwards”); Isaac, 2012 WL 3609993, at *23

n.37 (“[t]o the extent that [petitioner’s expert’s] opinion appears to be that of a

partisan rather than an objective expert, his opinion carries less weight”); Hopkins

v. Sec'y of Health & Human Servs., No. 00-746V, 2007 WL 5403504, at *6 (Fed.

Cl. Spec. Mstr. Dec. 14, 2007) (citing position statement of American Academy of

Emergency Medicine that a member must “impartially assist the Court”), mot. for

rev. denied, 84 Fed. Cl. 517 (2008).

This bias about the issues in Mr. Contreras’s case makes Dr. Wagner a

witness with less credibility than Dr. Sladky. Although Dr. Sladky was misleading

about his background, Dr. Sladky testified accurately about the issues in Mr.

Contreras’s case. Accurate testimony about the issues in the case is more

important to me than accurate testimony about a person’s background. Although

other finders of fact could reasonably weigh these factors differently, my sense is

that Dr. Wagner is less credible than Dr. Sladky.

Dr. Sladky: The next witness in terms of credibility is Dr. Sladky. He was

deceptive with respect to his background but forthright on issues involving Mr.

Contreras.

33

Dr. Steinman: Dr. Steinman’s credibility has not been called into question

in the way that Dr. Sladky’s credibility has been diminished. There has been no

argument that he was deceptive or misleading about his background.

Nonetheless, there are concerns about his credibility. Dr. Steinman’s

demeanor suggests that he saw his role as advocate for the party retaining him and

he, at times, used language to elicit an emotional response to favor Mr. Contreras.

Tr. 116, 155, 221 (“I’m trying to argue as strongly as I can”), 256, 262 (“I choose

to look at that part of the story to strengthen the case here for the Petitioner”), 535.

His interpretation of some articles seemed far-fetched and evidenced a willingness

to stretch to find some material to support his position.23 See Tr. 218-22. He was

not always precise in recounting what an experiment showed. See Tr. 243-49

(discussing exhibit 118 (Odoardi)).

Dr. Steinman also was inconsistent at times. Within Mr. Contreras’s case,

Dr. Steinman’s opinion about race and ethnicity seemed to fluctuate, depending

upon whether the result helped or hurt Mr. Contreras. Dr. Steinman argued that

epidemiological studies like Zipp (exhibit H) and Touze (exhibit G), which made a

causal connection between vaccinations and neurologic disease less likely, could

not be applied to Mr. Contreras because of his Hispanic ancestry. Tr. 192. Yet,

Dr. Steinman drew upon case reports of injuries occurring after vaccination in non-

Hispanic people as well as the Bogdanos study (exhibit 61) that also did not

involve Hispanics. Tr. 193-95, 256 (discussing Dimitrios-Petrou Bogdanos et al.,

A study of molecular mimicry and immunological cross-reactivity between

hepatitis B surface antigen and myelin mimics, 12(3) Clinical & Developmental

Immunology 217 (2005). This inconsistent treatment diminishes Dr. Steinman’s

credibility to some degree.24

23

Another special master made a similar appraisal of Dr. Steinman’s approach to

litigation. See Mueller v. Sec'y of Health & Human Servs., No. 06-775V, 2011 WL 1467938, at

*19 n.19 (Fed. Cl. Spec. Mstr. Mar. 16, 2011) (“advocating a position is not credible”).

24

While the example of racial background occurred solely within Mr. Contreras’s case,

Dr. Steinman appears to have offered an opinion in Mr. Contreras’s case that is inconsistent with

opinions Dr. Steinman offered in other cases. Whether evidence from other cases may be a

factor in determining an expert’s credibility is unclear. The Court stated that “a special master

should not base his findings on causation-in-fact in one case on other Vaccine Act cases.”

Contreras 2, 107 Fed. Cl. at 308. The Court also considered Dr. Sladky’s CV in Crosby.

Contreras 4, 116 Fed. Cl. at 478.

(continued…)

34

Dr. Poser: Dr. Poser submitted two affidavits and did not testify in person.

Thus, there was no opportunity to assess his demeanor.

There is no evidence to suggest that Dr. Poser was deceptive about his

background or made assertions in his affidavits that he knew were untruthful. In

that sense, Dr. Poser was credible.

On the other hand, Dr. Poser’s affidavits present generalities. For example,

although Dr. Poser recognized that the minimum time for an immune-mediated

reaction is usually five days, Dr. Poser also asserted that there would always be

people who react differently from the masses. Exhibit 23 at 3-4, ¶ 6. Dr. Poser did

not explain why an “outlier” could react in only one day. The lack of explicit

reasoning from Dr. Poser calls into question the reliability of his assertion. This

determination probably is better characterized as a lack of persuasiveness (as

opposed to a lack of credibility).

Dr. Garrett: Dr. Garrett, like Dr. Poser, testified by affidavit. Since he did

not appear in person, there was no opportunity to observe his demeanor.

Dr. Garrett appeared credible in his role as a treating doctor. When caring

for Mr. Contreras, he deferred to Dr. Lake’s opinion on diagnosis. Exhibit 7 at

136. He also refrained from speculating about the cause of Mr. Contreras’s

transverse myelitis when counseling Mr. Contreras’s parents. Id. at 147.

If outside evidence were an appropriate source for finding inconsistent opinions, then

there would be more examples of Dr. Steinman’s inconsistency. Cf. Holmes v. Sec'y of Health

& Human Servs., 115 Fed. Cl. 469, 490-91 (2014) (suggesting, but not deciding, that a special

master may consider other cases’ determination of an expert’s reputation and credibility). In

other cases, Dr. Steinman has asserted that the time for a vaccine to cause an injury via

molecular mimicry is several days. Dillon v. Sec'y of Health & Human Servs., No. 10-850V,

2013 WL 3745900, at *9 (Fed. Cl. Spec. Mstr. June 25, 2013) (Dr. Steinman “observed that the

medically accepted time frame for the onset of a post-vaccinal transverse myelitis would be a

few weeks”); Brown v. Sec'y of Health & Human Servs., No. 09-426V, 2011 WL 5029865, at

*21 (Fed. Cl. Spec. Mstr. Sept. 30, 2011) (“Dr. Steinman accepts a causal interval of a week or

two up to 10 weeks”); Ricci v. Sec'y of Health & Human Servs., No. 99-524V, 2011 WL

2260391, at *12 (Fed. Cl. Spec. Mstr. May 16, 2011) (quoting Dr. Steinman as testifying that the

process of molecular mimicry can damage a part of the brain and cause a seizure “within a week.

A lot short than that, we could have problems making the argument”), mot. for rev. denied, 101

Fed. Cl. 385 (2011). When the Secretary asked about at least one of these instances on cross-

examination, Dr. Steinman requested an opportunity to review the transcript from his earlier

testimony. Tr. 202.

35

In this litigation, Dr. Garrett opined that the hepatitis B vaccine caused Mr.

Contreras’s transverse myelitis. Dr. Garrett did not explain the reasoning for a

change in his views regarding etiology from first not knowing the cause, to then

identifying the vaccine as a cause. This lack of explanation undercuts Dr. Garrett’s

opinion. The Court has previously recognized that a special master may give less

weight to the statement of a treating doctor that is presented in the context of

litigation, especially when the treater’s statement “is devoid of any supporting

evidence.” Ruiz v. Sec'y of Health & Human Servs., No. 02-156V, 2007 WL

5161754, at *15 (Fed. Cl. Oct. 15, 2007).

Like Dr. Poser, Dr. Garrett’s conclusion that one day is an appropriate

temporal interval was not persuasive. He appeared to use a methodology in which

he looked for examples (case reports) of demyelinating diseases that appeared after

vaccination. The problem, as discussed in the Remand Decision, is that none of

the case reports Dr. Garrett cites shows such a quick onset. Contreras 3, slip op. at

52, 2013 WL 6698382, at *41. The lack of corroboration from the material that

Dr. Garrett cited makes his opinion less persuasive, and maybe less credible.

Dr. Kyazze: Dr. Kyazze appeared credible. He testified in accord with the

examination he conducted of Mr. Contreras on June 16, 2003. Exhibit 4 at 25; Tr.

43-52, 59-61 (indicating that Dr. Kyazze reviewed his records before testifying).

Dr. Kyazze appeared to care that what he was saying was accurate. For

example, he stated that although some infections cause an increase in white blood

cells, not all infections do. Tr. 53.

Similarly, he was not willing to exceed the basis of his knowledge. He

would not say that the vaccinations caused the transverse myelitis because he did

not know that assertion to be accurate. Tr. 56.

Overall, Dr. Kyazze was a believable doctor. He testified about what he

knew and refrained from testifying about what he did not know.

Dr. Whitton: Of all the testifying doctors, the most credible witness was

Dr. Whitton. His demeanor suggested that he undertook the role of an expert from

the perspective of someone who was asked to present a report. See Tr. 473. Dr.

Whitton, in contrast to Dr. Steinman, appeared interested in providing the most

accurate information, not the information that would help “his side” prevail.

Dr. Whitton appeared to possess prudent judgment. For example, he

declined the position of editor for one important journal because he was already

36

serving as an editor on another journal. Dr. Whitton did not want to hinder the

dissemination of multiple viewpoints. Tr. 410. Although he relied upon

epidemiological studies, he also appreciated that epidemiological studies are

limited. Tr. 469.

Before concluding that one day was not a medically appropriate interval

from which to infer causation, Dr. Whitton reviewed Dr. Steinman’s reports and

the articles cited in those reports with care. Dr. Whitton appeared to look to see if

anything supported Dr. Steinman’s views. See Tr. 434-38, 473. Dr. Whitton

brought a positive tone to the hearings. See Tr. 435, 438 (complimenting the work

of Dr. Steinman and colleagues at Stanford and calling Drs. Steinman and Poser

“renowned” neurologists). This lack of bias contributed to Dr. Whitton’s extremely

high credibility.25

IV. Adjudication after Excluding Dr. Sladky

For the reasons explained in Section II, Dr. Sladky is sufficiently credible

and sufficiently reliable that his evidence should remain in the record. Thus, the

outcome of the Remand Decision, a denial of compensation, does not differ.

Nonetheless, the Court’s third (and final) instruction was for the undersigned

to make alternative findings of fact without any consideration of Dr. Sladky’s

evidence. This section complies with the Court’s direction. The section begins

with the standards for adjudication, which are brief because they have been set

forth in earlier discussions and decisions in this case.

Next, there are four sections corresponding to four aspects of Mr.

Contreras’s case: diagnosis, timing, theory, and logical sequence. For each of

these sections, the Remand Decision is summarized, highlighting the citations to

Dr. Sladky’s evidence. Then, the effect of excluding Dr. Sladky’s evidence is

described. The same result is reached because of the strength of the other evidence

remaining in the case.

25

Another special master “found Dr. Whitton’s testimony on the lack of evidence for

molecular mimicry at work in humans after viral infection to be highly persuasive.” Hennessey,

2009 WL 1709053, at *53 n.156. Dr. Whitton “was an exceptionally good expert witness, one

who made difficult immunologic concepts readily understandable. His thoughtful (and helpful)

responses to questions both on cross-examination and from the court could serve as a model for

what expert testimony should be, and unfortunately, so rarely is.” Id. at *11.

37

A. Standards for Adjudication

The Court previously set forth the parties’ respective burdens and the

elements of compensation. Contreras 2, 107 Fed. Cl. at 291-92. Those statements

are incorporated into this decision.

In brief, Mr. Contreras seeks compensation on the theory that he suffered

Guillain-Barré syndrome, he must establish that he actually suffered from Guillain-

Barré syndrome. In addition, Mr. Contreras must satisfy the three prongs from

Althen. 418 F.3d 1274, 1278. For each of these aspects of Mr. Contreras’s case,

his burden of proof is the preponderance of the evidence.

B. Did Mr. Contreras Suffer from Guillain-Barré Syndrome in

Addition to Transverse Myelitis?

The first issue for resolution is identifying the disease or diseases afflicting

Mr. Contreras. As noted in the Remand Decision, everyone agrees that he suffers

from transverse myelitis. The second MRI revealed a lesion in Mr. Contreras’s

cervical spine. The radiologist interpreting the image (Dr. Lipson) and Mr.

Contreras’s treating neurologist (Dr. Lake) determined that this was evidence of

transverse myelitis, not Guillain-Barré syndrome. Exhibit 7 at 167-71, 177-78.

The discharge report from Miller’s Children’s Hospital identified Mr. Contreras’s

condition as “cervical transverse myelitis.” Id. at 6.

In this litigation, Mr. Contreras obtained an affidavit from Dr. Garrett. Dr.

Garrett was a member of the team of doctors who cared for Mr. Contreras during

his approximately two-month stay at Miller’s Children’s Hospital. In the part that

is pertinent to this aspect of the decision, Mr. Garrett averred that Mr. Contreras’s

disease was transverse myelitis. Exhibit 13 at 7.

Mr. Contreras also obtained two reports from Dr. Poser, of which the first

presented Dr. Poser’s opinion regarding the diseases affecting Mr. Contreras. Dr.

Poser recognized that “[t]he original diagnosis of [GBS] . . . was then changed to

cervical transverse myelitis as a result of a second MRI . . . on June 18, 2003,” yet

opined that “[f]rom the clinical examination and the MRI, it is clear that [Mr.

Contreras] suffered from a combination of [GBS] . . . and . . . transverse myelitis.”

Exhibit 22 at 2, ¶ 3, 3, ¶ 4.

Dr. Poser’s report, however, does not explain the bases for his opinion

regarding diagnosis. Dr. Poser’s assessment of the June 18, 2003 MRI conflicts

directly with the view of Dr. Lipson, who saw the MRI as not consistent with GBS.

38

Dr. Poser’s reference to Mr. Contreras’s clinical course is also in conflict with the

conclusions reached by Dr. Lake, who, after the June 18, 2003 MRI, consistently

stated that Mr. Contreras suffered from transverse myelitis. Dr. Poser’s report

leaves unanswered the question of why Dr. Poser thinks that his opinion about Mr.

Contreras’s diagnosis is more accurate than the opinions reached by the team of

doctors who cared for him. Despite the views of Dr. Lake, Dr. Lipson, and Dr.

Garrett, Mr. Contreras claimed that the vaccinations caused him to suffer both

transverse myelitis and Guillain-Barré syndrome. Pet. at 1; Pet’r’s Resp., filed

July 21, 2014, at 6-10.

In October 2005, Dr. Sladky wrote his first report. As to diagnosis, Dr.

Sladky agreed with the treating doctors that the diagnosis was transverse myelitis.

Exhibit I at 2. Both Dr. Garrett and Dr. Sladky discussed Mr. Contreras as

suffering from transverse myelitis only, not transverse myelitis and Guillain-Barré

syndrome. Thus, a complete disregard of Dr. Sladky’s October 2005 report does

not mean that the evidence concerning Mr. Contreras’s diagnosis is on Mr.

Contreras’s side entirely.

More evidence favoring Mr. Contreras’s position that he suffered from both

transverse myelitis and GBS came when Mr. Contreras filed Dr. Steinman’s first

report. Dr. Steinman agreed with the diagnosis of transverse myelitis. Dr.

Steinman also asserted “a secondary diagnosis of inflammatory

polyradiculopathy/polyneuropathy [Guillain-Barre Syndrome] could also be

made.” Exhibit 55 at 2 (bracketed material in original). Dr. Steinman did not

provide any basis for this conclusion.

Before Dr. Steinman had an opportunity to explain the basis for his

suggestion that “a secondary diagnosis” of Guillain-Barré syndrome “could also be

made,” exhibit 55 at 2, the Federal Circuit issued Broekelschen. 618 F.3d at 1325.

In Broekelschen, the Federal Circuit declared that in the circumstances of that case

“it was appropriate in this case for the special master to first determine which

injury was best supported by the evidence presented in the record before applying

the Althen test.” Broekelschen, 618 F.3d at 1346.26 Broekelschen, a binding

precedent, prompted attention to the correct diagnosis for Mr. Contreras. See

order, issued Feb. 16, 2010 (requesting the parties set forth their positions

regarding diagnosis in a pre-trial brief).

26

The Court held that “the Broekelschen exception to the general rule is inapplicable to

this case.” Contreras 2, 107 Fed. Cl. at 293.

39

In accord with the February 16, 2010 order, Mr. Contreras elicited testimony

from Dr. Steinman about the disease or diseases that affected Mr. Contreras. Dr.

Steinman stated that Mr. Contreras suffered from both transverse myelitis and

Guillain-Barré syndrome. He testified on direct examination:

I think there are elements of both transverse myelitis and

elements of Guillain-Barre. They’re nice textbook

entries where we talk about transverse myelitis as being

an inflammatory disease of the spinal cord, and a nice

textbook description[] of Guillain-Barre being an

inflammatory disease of the peripheral nerve. The

peripheral nerve ends at a certain varied definitive

boundary with the central nervous system. However, the

diseases unfortunately sometimes blend, and sometimes

you can have elements of both inflammations in the

central nervous system and inflammation in the

peripheral nervous system. And those are the realities we

have to deal with.

So Jesse Contreras had elements of both the transverse

myelitis and the Guillain-Barre. . . . [It’s] not possible to

say he had only one or only the other. He had elements

of both.

Tr. 118-19.

On cross-examination, Dr. Steinman was asked more about the basis for his

opinion that Mr. Contreras suffered from Guillain-Barré syndrome. He conceded

that none of the MRIs showed peripheral nerve involvement, although MRIs,

according to Dr. Steinman, are not very useful in detecting peripheral problems.

Tr. 184. Dr. Steinman agreed that a better method of testing peripheral nerves is

an electromyelogram (EMG), but the doctors did not order that test for Mr.

Contreras. Tr. 185. Dr. Steinman’s main support for his conclusion that Mr.

Contreras also suffered from Guillain-Barré syndrome was Mr. Contreras’s

Babinski’s response. Tr. 186, 255-56.27

27

Dr. Steinman’s testimony about the Babinski response was, unfortunately, not as clear

as it might have been. In this part of his testimony, Dr. Steinman stated:

(continued…)

40

Dr. Sladky disagreed with Dr. Steinman’s conclusion about the significance

of Mr. Contreras’s downward going Babinski reflex. To summarize, Dr. Sladky

opined that Mr. Contreras’s results should be considered in context, such as who

performed the test and when the test was performed and in the context of other

evaluations. Tr. 281-86, 333-34. This testimony tended to balance, to some

degree, Dr. Steinman’s testimony. This testimony was one place in the Remand

Decision where Dr. Sladky’s opinion was credited and not redundant with other

witness’s testimony. Contreras 3, slip op. at 11 n.6, 2013 WL 6698382, at *9 n.6.

If Dr. Sladky’s testimony is removed, then Mr. Contreras’s claim that he

suffered from two diseases is more plausible. The meaningful evidence would

include, on one hand, Dr. Steinman’s report and testimony, and, on the other hand,

the conclusions reached by Dr. Lake, Dr. Garrett, and the other doctors who treated

Mr. Contreras. In this circumstance, the evidence still preponderates in favor of

Mr. Contreras suffering from a single disease, transverse myelitis.

The Remand Decision found Dr. Lake’s opinion “highly persuasive.”

Contreras 3, slip op. at 30, 2013 WL 6698382, at *24. Similarly, the Remand

Decision found that, among the witnesses who testified, Dr. Garrett was the “most

persuasive.” Contreras 3, slip op. at 30, 2013 WL 6698382, at *25. This

assessment did not depend (and does not depend) on Dr. Sladky’s opinion. As

pointed out in the Remand Decision, Dr. Lake saw Mr. Contreras almost every day

for nearly three months. Dr. Lake, who performed a Babinski test on Mr.

Contreras, specifically revised her tentative diagnosis that Mr. Contreras suffered

from atypical Guillain-Barré syndrome due to the MRI results. Exhibit 7 at 1723.

Her conclusion was persuasive to Dr. Babbitt, who, as a resident, was assisting Dr.

Garrett in caring for Mr. Contreras. Id. at 123.

[Guillain-Barré syndrome] was the presentation and the lack of

Babinskis when the neurologist was eliciting the -- you know,

usually if you have severe damage to the upper motor neurons,

you're going to lose your plantar responses and you're going to

have an upgoing Babinski response. And that wasn't seen. So

again, I feel that this was a combination of Guillain-Barre and

transverse myelitis. It doesn't perfectly fit into either category.

Tr. 186.

It appears that when Dr. Steinman used the phrase “upper motor neurons,” he was

referring to nerves in the spinal cord meaning transverse myelitis. But, Dr. Steinman did not

explain (and was not asked to explain) how Mr. Contreras could have downgoing Babinski

response if he were suffering from both transverse myelitis and Guillain-Barré syndrome.

41

The combined value of Dr. Lake and Dr. Garrett --- without any assistance

from Dr. Sladky --- is greater than the opinion of Dr. Steinman. In most cases, the

treating doctors’ views about the disease that afflicts their patients are likely to be

persuasive because the doctors have the advantage of touching, seeing, and hearing

their patient.28 Occasionally, doctors retained in the Vaccine Program have such a

great amount of expertise in relatively arcane subjects that they are able to add

insights about a person’s diagnosis simply by reviewing the medical records. See,

e.g., Barclay v. Sec'y of Health & Human Servs., No. 07-605V, 2014 WL

2925245, at *1 (Fed. Cl. Spec. Mstr. Feb. 7, 2014) (respondent’s doctor

recommended genetic testing); cf. 42 U.S.C. § 300aa—13(b) (statements of

treating doctors are not binding on special masters). But, Mr. Contreras’s case is

not one in which the treating doctors’ diagnosis can be readily dismissed. Dr.

Steinman’s citation to the Babinski test provides a colorable basis for his

suggestion that Dr. Lake and Dr. Garrett missed the fact that Mr. Contreras was

suffering from not one, but two neurologic problems. But, ultimately, Dr. Lake’s

treatment of Mr. Contreras was thorough, caring, and professional. So was Dr.

Garrett’s. These factors, and not the opinion of Dr. Sladky, support the conclusion

in the Remand Decision that Mr. Contreras did not suffer from Guillain-Barré

syndrome.

The Remand Decision also discussed other evidence concerning the proper

diagnosis, but this other evidence is weak. While Dr. Whitton, in his first report,

accepted Dr. Poser’s and Dr. Steinman’s dual diagnosis, upon additional reflection,

Dr. Whitton backed away from that conclusion. Compare exhibit L at 3 with

exhibit N at 5. Dr. Poser, as discussed above, did not specify what factors in Mr.

Contreras’s MRI or his clinical presentation led Dr. Poser to add Guillain-Barré

syndrome. Finally, Dr. Wagner’s opinion that Mr. Contreras suffered from

atypical Guillain-Barré syndrome, exhibit 6 at 5, was based upon less than five

hours of observation and only one MRI. His opinion, although valuable in 2003,

when he transferred Mr. Contreras to a higher care facility, cannot match the

opinions of Doctors Lake and Garrett, who had much more information available

to them.

The possibility that Mr. Contreras might suffer from “atypical” Guillain-

Barré syndrome was a consideration very early in his hospitalizations. See exhibit

6 at 5 (Dr. Wagner); exhibit 7 at 1735 (Dr. Lake). Dr. Lake ceased to consider this

possibility once she received the second MRI. Exhibit 7 at 1723.

28

Dr. Sladky, too, recognized the value of Dr. Garrett’s opinion on diagnosis. Tr. 345.

42

In this litigation, Dr. Poser and Dr. Steinman have attempted to raise the

dual diagnosis again. In doing so, they appear to be straining to fit a square peg

into a round hole. Moreover, the persistence of Mr. Contreras’s arguments appears

to be overlooking the big picture of how his diagnosis fits with his claim for

compensation. As the Remand Decision attempted to explain, if, on a strictly

hypothetical basis, Mr. Contreras were persuasive in claiming that he suffered from

both a central nervous system problem (transverse myelitis) and a peripheral

nervous system problem (Guillain-Barré syndrome), see exhibit C (2002 IOM) at

28, Mr. Contreras’s claim for compensation in the Vaccine Program would be

more complicated. Mr. Contreras would be required to show how the hepatitis B

vaccination can cause neurologic problems in two areas of the body involving two

types of nerves within approximately one day of vaccination. See Tr. 447 (Dr.

Whitton’s opinion that one day is too short a latency period would not change

depending upon the demyelinating disease).

C. Timing

By far, the most important issue in this case has been the one-day interval

between vaccination and the onset of neurological problems. This issue has been

discussed throughout the case.

After the parties submitted briefs in 2011, Mr. Contreras was denied

compensation. The sole and sufficient reason was that Mr. Contreras did not

establish that the timing was medically appropriate for causation. Contreras 1,

2012 WL 1441315, at *23-24. The Entitlement Decision did not evaluate either

the second or third prong from Althen. The Entitlement Decision also did not

discuss whether factors other than the vaccines could have caused Mr. Contreras’s

transverse myelitis.29

The analysis of Mr. Contreras’s arguments regarding timing was divided

into discrete sections. These were:

29

In Mr. Contreras’s first motion for review, he argued that the exclusive focus on timing

(Althen prong 3) was an error. The Court, however, disagreed and, stated that a special master

may resolve a case based upon just one Althen prong. Contreras 2, 107 Fed. Cl. at 295. After

the Court’s first remand, the Federal Circuit has explicitly approved the resolution of a Vaccine

Program case without an evaluation of all Althen prongs. Hibbard v. Sec’y of Health & Human

Servs., 698 F.3d 1355, 1364-65 (Fed. Cir. 2012).

43

1. Steps Involved in Molecular Mimicry

2. How Much Time Does Molecular Mimicry Take

3. Observations of Molecular Mimicry in Medical Articles

a. Odoardi

b. Additional Medical Articles (Lafaille, Zamvil, Mensah-Brown,

Mekala, Ufret-Vincentry)

c. Kakar Case Report

d. Summary Regarding Medical Articles

4. Petitioner’s Explanation that Molecular Mimicry Can Occur in One Day

a. Tuberculin Response

b. Priming

5. Treating Doctors

a. Dr. Kyazze

b. Dr. Wagner

c. Dr. Garrett

6. Synopsis on Timing

The analysis largely, but not entirely, focused on the competing opinions of

Dr. Steinman and Dr. Whitton. For example, the basic explanation for molecular

mimicry came from Dr. Steinman upon which Dr. Whitton elaborated. In this

section, Dr. Sladky was cited only in a footnote and not for any substantive

information about molecular mimicry. Contreras 1, 2012 WL 1441315, at *10

n.10.

In the second section, the Entitlement Decision relied primarily upon Dr.

Whitton for finding that “at least five days is needed for molecular mimicry.” It

found one step in the process of molecular mimicry that takes three days by itself

and stated, “Dr. Whitton was superbly qualified to express [this] opinion.” This

section also credited Dr. Whitton’s reliance on the blood-brain barrier and noted

that “Dr. Steinman offered no persuasive response.” Contreras 1, 2012 WL

1441315, at *11-12.

This section also cited Dr. Sladky’s opinion in three places. It quoted Dr.

Sladky’s initial report. It also referenced Dr. Sladky’s opinion regarding the

blood-brain barrier as a “see also” cite, supporting Dr. Whitton’s testimony.

Finally, the summary paragraph mentioned Dr. Sladky’s opinion in conjunction

with Dr. Whitton’s opinion. Id. at 12.

The Entitlement Decision’s third section on timing was a multi-part

discussion about medical articles. The Odoardi article was a significant reason Mr.

44

Contreras was denied compensation, warranting a part by itself. Id. at 12 (stating

“[t]he most important article about the timing of molecular mimicry was exhibit

118”). This discussion did not include any citations to Dr. Sladky, who had not

testified about Odoardi. Although Dr. Steinman pointed to this article as an

experiment in which an animal developed a central nervous system problem within

one day of receiving an antigen that was roughly equivalent to a vaccination (see

exhibit 105 (Supp’l Rep’t) at 7; Tr. 243-46, 589-90), the article, in fact, did not

illustrate this chronology. The Entitlement Decision found persuasive Dr.

Whitton’s assessment that Dr. Steinman “did not understand” the Odoardi

experiment. Contreras 1, 2012 WL 1441315, at *13 (quoting Tr. 633). Dr.

Steinman’s misinterpretation of the article that appeared to be the most helpful

article to Mr. Contreras’s claim severely diminished Dr. Steinman’s

persuasiveness.

The next part discussed five medical articles. Three of them were cited by

Dr. Steinman. Two (Mensah-Brown (exhibit D) and Mekala (exhibit K)) came

from Dr. Sladky. Eliminating these two does not change the analysis because the

remaining three articles also did not show a one-day interval.

The third part of the section about medical articles on timing was a

discussion of a case report by Kakar. Exhibit 72. Kakar reported on a patient who

received the hepatitis B vaccine and developed a condition like Guillain-Barré

syndrome the next day. Id. The Entitlement Decision cited Dr. Sladky and Dr.

Whitton for their views that case reports usually do not provide valuable

information regarding causation. Contreras 1, 2012 WL 1441315, at *16-17.

Eliminating Dr. Sladky’s testimony would not affect the outcome because Dr.

Whitton’s similar testimony would remain. Moreover, the value that Dr. Sladky,

Dr. Whitton, or Dr. Steinman place upon any piece of evidence is not decisive

because the special master, ultimately, must evaluate all the evidence. See

Whitecotton v. Sec’y of Health & Human Servs., 81 F.3d 1099, 1108 (Fed. Cir.

1996) (“Congress desired the special masters to have very wide discretion with

respect to the evidence they would consider and the weight to be assigned that

evidence”).

While the witnesses’ comments about the (lack of) value about case reports

may be helpful, the undersigned did not need Dr. Sladky to testify, as he did, that

Kakar presents a sequence of events from which causality cannot be presumed. Tr.

298-99. The authors of the Kakar case report noted that one possibility was the

patient’s “GBS was unrelated to the vaccine.” Exhibit 72 (Kakar) at 711. Thus,

45

even if Dr. Sladky’s evidence were entirely excluded, Kakar would have minimal

weight for the reasons Dr. Whitton explained. See Tr. 430.

The section on medical articles concludes with a short summary, which

again mentions Dr. Sladky. However, in light of the overwhelming reliance on Dr.

Whitton, the result would have been the same in the absence of Dr. Sladky.

The fourth section of the Entitlement Decision discusses two explanations

for why Mr. Contreras could have reacted more quickly than expected by medical

science: tuberculin and priming. For tuberculin, the Entitlement Decision often

cited and eventually credited the testimony of Dr. Whitton. Although Dr. Sladky is

occasionally mentioned, citations to Dr. Sladky are usually to his testimony as a

supporting, not primary, authority. For priming, Dr. Sladky is not cited at all.

Contreras 1, 2012 WL 1441315, at *20-21.

The fifth section discusses the views of treating doctors whose testimony

Mr. Contreras presented either by affidavit (Dr. Garrett) or by affidavit and orally

(Dr. Kyazze and Dr. Wagner). This aspect did not cite Dr. Sladky. Contreras 1,

2012 WL 1441315, at *21-23.

After Mr. Contreras filed a motion for review, the Court vacated the

Entitlement Decision. Among other failures, the Entitlement Decision did “not

convince the court that the special master considered all the relevant evidence in

the record that bears upon Althen prong three.” Contreras 2, 107 Fed. Cl. at 296.

The Court stated “the special master committed legal error in failing to give the

opinions of Dr. Wagner and Dr. Garrett significant weight in his analysis of the

evidence relevant to Althen prong three.” Id. at 300. The Court also stated the

“special master erred when he crafted a higher standard of proof than that required

in de Bazan.” Id. at 303 (citation omitted). The Court also disagreed with the

special master’s reliance on Porter, which the Entitlement Decision had interpreted

as finding a special master’s attribution of little value for case reports not arbitrary

and capricious. Id. at 304. Consequently, the Court remanded the case with

specific instructions, including a re-analysis of Althen prong 3. Id. at 308-09.

In accord with these instructions, the Remand Decision re-evaluated the

evidence regarding timing, organized into the following parts. This section began

with a brief review of the previous adjudications, mentioning Dr. Sladky four times

--- once as a matter of procedural history, once in the context of a summary of his

testimony, and twice in conjunction with testimony from Dr. Whitton.

46

Next, there is a synopsis of 11 types of evidence. An asterisk marks the

sections in which Dr. Sladky is mentioned.

b) Synopsis of Evidence (*)

(1) Dr. Wagner

(2) Dr. Garrett

(3) Dr. Cheung

(4) Dr. Poser

(5) Dr. Steinman

(6) Dr. Sladky (*)

(7) Dr. Whitton

(8) Newly Cited Case Reports

(9) Other Case Reports

(10) Review Articles

(11) Animal Studies

The assessment of the evidence ran approximately four pages in which Dr.

Sladky’s testimony was cited twice. In the first place, Dr. Sladky’s opinion was

cited in conjunction with Dr. Whitton. The Remand Decision noted that Dr.

Sladky had opined that a one-day onset was “virtually impossible.” Contreras 3,

slip op. at 59, 2013 WL 6698382, at *46 (citing exhibit I at 3). The next sentence

indicated that Dr. Whitton had opined that it was “‘exceedingly unlikely’ that Mr.

Contreras could have developed an immune response to his vaccination within 24

hours.” Id. (citing exhibit N at 9). The second place where Dr. Sladky was cited

was in the context of describing the contents of the record. Id. at *47. Neither

citation to Dr. Sladky was consequential.

The Remand Decision found “the testimony of Dr. Whitton to be the most

persuasive.” Contreras 3, slip op. at 61, 2013 WL 6698382, at *48. Two reasons

for crediting Dr. Whitton’s testimony were his study, the Whitmire article, that

showed memory T cells in mice required at least three days to divide, and the

Odoardi article. Id. (citing exhibit L, tab 31 (Jason K. Whitmire, Tentative T Cells:

Memory Cells Are Quick to Respond, but Slow to Divide, 4 PLos Pathogens

e1000041 (2008)) at e1000042. Dr. Sladky did not enhance the value of the

Whitmire article or the Odoardi article. He did not testify about them.

If all evidence originating with Dr. Sladky were struck, would the result

change? The answer is no.

47

The fundamental problem with Mr. Contreras’s case is that his evidence is

not persuasive. Mr. Contreras bears the burden of “establish[ing] by a

preponderance of the evidence that his onset of symptoms occurred within a

timeframe for which it is medically acceptable to infer causation-in-fact.”

Contreras 2, 107 Fed. Cl. at 303. There is no dispute that the onset of symptoms

occurred approximately 24 hours after vaccination. The ensuing question,

therefore, becomes is 24 hours a “timeframe for which it is medically acceptable to

infer causation-in-fact?”

Mr. Contreras’s supporting evidence consists of the affidavit from Dr.

Garrett, the affidavit and testimony from Dr. Wagner, the affidavits from Dr.

Poser, and the affidavit and testimony from Dr. Steinman. Of these, Dr. Poser and

Dr. Wagner contribute very little. Although each says that the timing was

acceptable, neither presents any basis for the doctor’s opinion. Special masters are

not required to accept the unsupported testimony of an expert. Snyder, 88 Fed. Cl.

at 742 (citing Gen. Elec. Co., 522 U.S. at 146); see also Cedillo v. Sec'y of Health

& Human Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Gen. Elec. Co., 522

U.S. at 146).

On the face of it, Dr. Garrett and Dr. Steinman stand on ground that is more

solid. They cite many case reports in which the administration of different

vaccines preceded the onset of assorted illnesses. The details of the case reports

were presented in the Entitlement Decision (Contreras 1, 2012 WL 1441315, at

*16-17), and the Remand Decision (Contreras 3, slip op. at 55-57, 2013 WL

6698382, at *43-43). The details about vaccine / disease combination are largely

irrelevant. The logical fallacy of attempting to draw causal conclusions from

isolated reports can be temporarily set aside, too. For purposes of determining

whether Dr. Garrett, or Dr. Steinman, or Dr. Garrett and Dr. Steinman were

persuasive in opining that one day is a “medically acceptable” timeframe, the

temporal interval in the case reports is most important.

Except for Kakar (exhibit 72), the interval is usually not close to one day.

For example, Iniguez reported a case of transverse myelitis one week after a

hepatitis B vaccination. Exhibit 47 (C. Iniguez et al., Acute transverse myelitis

secondary to hepatitis B vaccination, 31(5) Rev. Neurol. 430 (2000)). How does

Iniguez’s report of a seven-day interval support Dr. Steinman, who cited Iniguez,

in asserting that one day is medically acceptable? Iniguez and most of the other

articles are entirely consistent with Dr. Whitton’s opinion that, assuming that

molecular mimicry actually explains how a vaccine can cause a demyelinating

disease, the process of molecular mimicry probably takes five days.

48

After elimination of the case reports in which the onset is five days or

longer, Dr. Garrett is similarly situated with Dr. Wagner and Dr. Poser.30 Dr.

Garrett asserted an opinion without any supporting basis. As a matter of law, the

opinion of doctor who treats a person is not elevated to such a favored status that

the special master must accept it. See 42 U.S.C. § 300aa—13(b); see also Ruiz,

2007 WL 5161754, at *15 (stating “The fact that [a treating doctor] did not identify

the hepatitis B vaccine as the cause of Ms. Ruiz's psychological injury until well

after his treatment relationship with petitioner had ended undermines the

persuasiveness of his findings”). To be persuasive, Dr. Garrett does not have to

dot every “i” and to cross every “t” because petitioners do not bear the burden of

proving their case to a scientific certainty. Bunting v. Sec’y of Health & Human

Servs., 931 F.2d 867, 872-73 (Fed. Cir. 1991). Yet, special masters may examine

petitioner’s case to see whether the expert’s opinion is “sound.” Knudsen v. Sec’y

of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994).

It might be argued that any examination of Dr. Garrett’s opinion is

erroneous. After all, Dr. Garrett treated Mr. Contreras and “treating physicians are

likely to be in the best position to determine whether a logical sequence of cause

and effect show[s] that the vaccination was the reason for the injury.” Capizzano v.

Sec'y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (citation

and quotation marks omitted).

This argument, however, is belied by Bazan. There, a petitioner presented

the opinion from her treating doctor that a repeat dose of the tetanus-diphtheria

vaccine caused the onset of a demyelinating disease of the central nervous system,

acute disseminated encephalomyelitis (“ADEM”), 11 hours later. The special

master did not accept the opinion of this treating doctor and credited, instead, the

opinion of the Secretary’s expert. On appeal, the Federal Circuit did not require

the special master to defer to the opinion of the treating doctor. The Federal

Circuit ruled that the special master’s finding regarding timing was not arbitrary or

capricious. Bazan v. Sec'y of Health & Human Servs., 539 F.3d 1347, 1352-53

(Fed. Cir. 2008).

30

Dr. Garrett cited an article written by Dr. Poser. Exhibit 13 at 11, ¶ 15 (citing exhibit

21 (Charles M. Poser, Neurologic syndromes that arise unpredictably, Consultant 45 (Jan.

1987))). In this 1987 article, Dr. Poser wrote that “[a]s a general rule, postvaccinal

complications develop between one and six weeks after vaccination, although shorter periods

have been reported… [T]his period can be as short as 12 to 24 hours.” Exhibit 21 (Posner) at 46-

47. Dr. Poser provided no basis for this assertion. In addition, Dr. Poser does not specify what

type of reaction could take place in 12 hours.

49

Although a simple review of the literature Dr. Garrett cited erodes the basis

for his conclusion that one day is medically acceptable, Dr. Steinman’s opinion is

slightly stronger. Certainly, the Kakar article, which presents a sequence in which

an Indian girl received a hepatitis B vaccine and then developed Guillain-Barré

syndrome (or something like GBS) within 24 hours, supports Dr. Steinman’s

opinion that one day is medically acceptable. As Dr. Steinman testified, the

presence of one case report makes the petitioner’s case more persuasive than if

there are no case reports. Tr. 164.

Two other articles are helpful to Mr. Contreras by reporting instances of

demyelinating diseases that developed less than five days after vaccination.

Douglas A. Kerr and Harold Ayetey cited a case report of transverse myelitis

developing two days after influenza vaccination.31 Exhibit N, tab 2 (Douglas A.

Kerr & Harold Ayetey, Immunopathogenesis of Acute Transverse Myelitis, 15(3)

Current Opinion in Neurology 339 (2002)). Sinsawaiwong presents an occasion

on which hepatitis B vaccination preceded Guillain-Barré syndrome by three days.

Exhibit 71 (Suwanna Sinsawaiwong & Pornpen Thampanitchawong, Guillain-

Barré Syndome Following Recombinant Hepatitis B Vaccine and Literature

Review, 83 J. Med. Assoc’n Thai 1124 (2000)).

In addition, there are two reports of diseases that are not demyelinating

diseases developing within one day of vaccination. These could lend some support

if the difference between the reported injury and demyelinating disease is ignored.

See exhibit 38 (B. Biacabe et al., A case report of fluctuant sensorineural hearing

loss after hepatitis B vaccination, 24 Auris Nasus Larynx 457 (1997)) (hearing

loss); and exhibit 45 (P.M. Bantz et al., Peripheral neurological symptoms after

hepatitis B virus vaccination, 96 Q. J. Med. 611 (2003)) (vertigo and dysarthria).

Thus, the core of Mr. Contreras’s case is Dr. Steinman’s opinion as

supported by at least one and potentially as many as five case reports. Does this

constitute a persuasive case? If the record consisted of only this material, it could

satisfy petitioner’s burden. But, there is other evidence and a special master may

consider evidence that contradicts a petitioner’s case before determining whether

the petitioner has met the burden of proof. Bazan, 539 F.3d at 1354.

31

Doctors Kerr and Ayetey noted that “such case reports must be viewed with caution, as

it is entirely possible that two events occurred in close proximity by chance alone.” Exhibit N,

tab 2 at 341.

50

Here, the Secretary presented Dr. Whitton’s report and testimony that

effectively undermined Mr. Contreras’s evidence, which came from Dr. Poser, Dr.

Garrett, Dr. Wagner, and Dr. Steinman. Dr. Whitton persuasively showed that the

process of a molecular mimicry reaction takes time. This time is measured in days,

not hours. Hence, one day is not a medically acceptable timeframe to infer

causation.

The Remand Decision also discussed theories by which Mr. Contreras

proposed that his circumstances made relying upon the normally accepted minimal

amount of time, five days, inappropriate. See Contreras 3, slip op. at 19-21, 2013

WL 6698382, at *16-17. He suggested five factors could have accelerated his

response: (1) previous exposures / priming, (2) his Hispanic ethnicity, (3) receipt

of two vaccines at once, (4) the adjuvant, and (5) exposure to previous infections

(the Epstein-Barr virus and mycoplasma pneumonia). The general impression left

about these ideas was that Mr. Contreras and Dr. Steinman were throwing out ideas

to see what would stick.

Mr. Contreras’s presentation on each of these topics was discussed in the

Remand Decision. The Remand Decision also cited the Secretary’s evidence,

which, at times, included Dr. Sladky. Even if Dr. Sladky’s evidence were

excluded,32 Mr. Contreras has failed to present persuasive basis for finding that any

of these proposed factors would make it possible for him to respond in one day,

when normal people would require at least five days.

The Entitlement Decision closed its analysis about timing with a quotation

from Dr. Whitton that a one-day onset presents a “black and white” issue. In Dr.

Whitton’s opinion, one day was well outside of any shades of grey about which

reasonable people could differ. Contreras 1, 2012 WL 1441315, at *23. On the

first motion for review, the Court wondered if the situation were truly as stark as

Dr. Whitton contended and suggested that if it were weighing the evidence in the

first instance, the evidence might present a “close call.” Contreras 2, 107 Fed. Cl.

at 307. Contreras 3 attempted to address the Court’s concern and cited Dr.

Whitton as an example of an immunologist who understands the relevant biologic

processes and the necessary amount of time for them. See Broekelschen, 618 F.3d

at 1345 (holding “a petitioner must provide a reputable medical or scientific

explanation that pertains specifically to the petitioner’s case”). Dr. Sladky’s

32

Regarding Mr. Contreras’s prior infections with Epstein-Barr virus and mycoplasma

pneumonia, Dr. Sladky testified that they played no role in his neurologic disease. This

testimony actually helps Mr. Contreras by eliminating potential alternative causes.

51

evidence added little to the analysis. Thus, eliminating the (meager) contributions

from Dr. Sladky does not change the undersigned’s view that the evidence is not

close. The evidence preponderates in favor of finding that the minimal amount of

time needed for molecular mimicry exceeds one day and is likely to be around five

days.

D. Theory

The initial Entitlement Decision did not address the first prong of Althen

because the finding that Mr. Contreras did not establish the third prong of Althen

was sufficient to deny compensation. Contreras 1, 2012 WL 1441315, at *1. As

part of its instructions for the first remand, the Court ordered a consideration of

prong one. Contreras 2, 107 Fed. Cl. at 295. The Remand Decision analyzed the

relevant evidence, which included evidence from Dr. Sladky, and concluded that

Mr. Contreras did not meet his burden of proof. Contreras 3, slip op. at 32-49,

2013 WL 6698382, at *26-39. Contreras 3 organized the analysis of Althen prong

1 into the following sections with an asterisk marking the sections in which Dr.

Sladky is mentioned:

1. Synopsis of Mr. Contreras’s Evidence

a. Dr. Kyazze

b. Dr. Wagner

c. Dr. Garrett

d. Dr. Poser

e. Dr. Steinman

2. Synopsis of the Secretary’s Evidence

a. Dr. Sladky *

b. Dr. Whitton

3. Assessment of Evidence

a. Treating Doctors

b. Dr. Poser and Dr. Steinman

c. Daubert Analysis of Molecular Mimicry Theory

i. Whether the theory of molecular mimicry can be (and has

been) tested

ii. Whether the theory or technique has been subject to peer

review and publication

iii. Whether there is a known potential error rate and whether

there are methods for controlling the error

iv. Whether the theory or technique enjoys general acceptance

within a relevant scientific community *

52

v. Epidemiologic studies *

vi. Case Reports *

4. Finding on Althen Prong One *

As mentioned in the Remand Decision, Dr. Sladky’s opinion played little

role in this analysis. Dr. Sladky could not affect how the opinions of the treating

doctors were weighed because he did not treat Mr. Contreras. The Remand

Decision found that the opinions of Dr. Lake and Dr. Cheung were better informed

than the opinions of Dr. Garrett and Dr. Wagner. Contreras 3, slip op. at 42, 2013

WL 6698382, at *34. Dr. Lake and Dr. Cheung each indicated that the

vaccinations did not cause Mr. Contreras’s transverse myelitis. Exhibit 7 at 126,

147.

Dr. Sladky also did not affect the analysis of the first three Daubert factors.

Mr. Contreras could have used the first two Daubert factors,33 concerning

testability and peer-review, to demonstrate the persuasiveness of Dr. Steinman’s

theory that the hepatitis B vaccine can cause transverse myelitis via molecular

mimicry. See Veryzer v. Sec'y of Health & Human Servs., No. 06-522V, 2010

WL 2507791, at *8 n.14 (Fed. Cl. Spec. Mstr. June 15, 2010) (quoting In re Paoli

R.R. Yard PCB Litigation, 35 F.3d 717, 744 (3d Cir. 1994)), mot. for rev. denied,

100 Fed. Cl. 344 (2011), aff’d without op., 475 Fed. Appx. 765 (Fed. Cir. 2012);

Robles v. Sec'y of Health & Human Servs., No. 90-3001V, 2000 WL 748169, at *2

n.10 (Fed. Cl. Spec. Mstr. May 19, 2000) (quoting Daubert, at 1316). Mr.

Contreras did not present any supporting evidence. Dr. Sladky did not contribute

to the lack of evidence from Mr. Contreras. Thus, the same result would have been

reached even if there were no evidence from Dr. Sladky.

For the fourth Daubert factor, concerning general acceptance, Dr. Sladky’s

testimony actually helped Mr. Contreras. Dr. Sladky’s concession on this factor, in

turn, was mentioned as part of the overall finding. Contreras 3, slip op. at 49, 2013

WL 6698382, at *38-39. Striking Dr. Sladky’s testimony would weaken this

specific aspect of Mr. Contreras’s case.

The next factor, epidemiological studies, is a place where Dr. Sladky’s

evidence played some role. Dr. Sladky was the expert who originally placed into

the record two studies the Remand Decision discussed, exhibit G (Touze) and

33

The third Daubert factor (error rate) does not apply to molecular mimicry.

53

exhibit H (Zipp). See exhibit I (Dr. Sladky’s Oct. 21, 2005 report) at 4.34 To avoid

any dispute about the scope of the Court’s instruction for removing Dr. Sladky’s

evidence, the Touze and Zipp articles will be disregarded.

Removing Touze and Zipp does not eliminate all epidemiological studies.

Dr. Whitton cited a very important study by Mikaeloff. Exhibit L, tab 29 (Yann

Mikaeloff et al., Hepatitis B vaccine and the risk of relapse after a first childhood

episode of CNS inflammatory demylination, 130 Brain 1105 (2007)). The

Mikaeloff article was informative because these researchers studied 356 people

who had experienced an episode of demyelination in their central nervous system

before age 16. These participants were given a dose of the hepatitis B vaccine and

followed for more than five years on average to see whether they had a relapse

lasting more than 24 hours. The authors found that the hepatitis B vaccine “was

not associated with a significant increase in the risk of relapse.” Exhibit L, tab 29

(Mikaeloff) at 1108.

In addition to Mikaeloff, Dr. Whitton cited other epidemiological studies,

although these were not as relevant. These studies analyzed a possible connection

between vaccinations and other neurological diseases, such as multiple sclerosis

and Guillain-Barré syndrome. See Contreras 3, slip op. at 39 n.29, 2013 WL

6698382, at *31 n.29.

The sixth factor (case reports) also did not depend on Dr. Sladky’s evidence.

Dr. Sladky was cited as providing testimony that supported a statement that case

reports may signal the need for additional study. Although the Remand Decision

cited Dr. Sladky, special masters are very familiar with this concept.

The role of case reports as a signal was part of a more basic question

concerning whether routine case reports provide meaningful information on which

an informed judgment on causation may be made. The Remand Decision cited

both Dr. Sladky and Dr. Whitton as people who find case reports carry relatively

34

The 2002 IOM report, which the Secretary had placed into evidence before Dr.

Sladky’s report, cited Touze and Zipp. Exhibit C (2002 IOM) at 57, 61. After Dr. Sladky’s

report, Dr. Steinman also cited to Touze and Zipp and Mr. Contreras submitted these studies as

exhibits 75 and 76. Conceivably, even if Dr. Sladky had not cited Touze and Zipp, Dr. Steinman

could have presented the epidemiological studies in accord with an expert’s duty to present all

relevant information to the judicial official. However, a voluntary presentation seems unlikely as

Dr. Steinman has not previously cited Touze and Zipp in relatively similar circumstances.

54

little value. The Remand Decision also noted that Dr. Poser and Dr. Steinman,

contrastingly, more readily valued case reports.

Ultimately, the opinion of any witness, including Dr. Sladky, about the

strength or weakness of the evidence is not particularly important. The views of

Dr. Steinman, Dr. Whitton, Dr. Poser, and Dr. Sladky are interesting because these

people are educated and trained in medicine. Thus, the undersigned considers and

reflects on those informed views in weighing the evidence. But, at the end of the

day, “Congress made clear that the initial decision in these cases was the Special

Master’s.” Hodges v. Sec'y of Health & Human Servs., 9 F.3d 958, 962 (Fed. Cir.

1993).

As suggested in the Remand Decision, the undersigned chooses to give

routine case reports little, if any, weight in determining causation. The

undersigned has reached this conclusion after hearing not only the testimony of Dr.

Sladky, Dr. Whitton, and Dr. Steinman, but also similar testimony from many

doctors in many different hearings. See Porter v. Sec'y of Health & Human Servs.,

No. 99-639V, 2008 WL 4483740, at *13 (Fed. Cl. Spec. Mstr. Oct. 2, 2008) (citing

cases), mot. for rev. granted sub nom., Rotoli, 89 Fed. Cl. at 86-87, reinstated,

Porter, 663 F.3d at 1254; Tiufekchiev v. Sec'y of Health & Human Servs., No.

05-437V, 2008 WL 3522297, at *9 (Fed. Cl. Spec. Mstr. July 24, 2008) (quoting

testimony from petitioner’s expert and citing cases). The undersigned has also

considered --- and the Remand Decision cited --- the teachings from the Reference

Manual on Scientific Evidence, published by the Federal Judicial Center. In

addition, numerous cases in which plaintiffs claim exposure to a substance caused

them harm have also discussed case reports. These, too, have affected the

undersigned’s orientation to the usefulness of case reports.

Against this background, Dr. Sladky’s testimony that case reports do not

provide meaningful information about causation amounts to little more than a drop

in a bucket. Even in the absence of Dr. Sladky’s evidence, the undersigned would

have assessed the case reports the same way. Although an appellate tribunal may

determine that the weight the undersigned assigned to case reports was arbitrary

and capricious (but see Porter, 663 F.3d at 1254 (ruling that the weight given to the

evidence including case reports was not arbitrary or capricious)); that finding

would be a determination about the undersigned’s weighing of the evidence, not

Dr. Sladky’s weighing of the evidence.

On the whole, striking Dr. Sladky’s evidence does not change the outcome

regarding Althen prong one. The main weakness in Mr. Contreras’s case was that

55

he failed to show the persuasiveness of Dr. Steinman’s theory as measured against

the Daubert factors. Dr. Steinman’s theory that the hepatitis B vaccine can cause

transverse myelitis via molecular mimicry is a plausible construct. But,

plausibility does not satisfy Mr. Contreras’s burden and the Secretary does not bear

the burden of establishing that a petitioner’s theory is impossible. See Moberly,

592 F.3d at 1322. The Remand Decision cited evidence from Dr. Sladky (Touze

and Zipp) because those studies further undermined Dr. Steinman’s theory that

molecular mimicry can explain how the hepatitis B vaccine can cause transverse

myelitis. But, striking those epidemiological studies does not strengthen Mr.

Contreras’s case, especially since another epidemiological study remains. In other

words, Mr. Contreras needed to have more positive support for Dr. Steinman’s

theory.35 Subtracting negative evidence does not equal adding positive evidence.

E. Althen Prong 2

The remaining Althen prong is the second. Because Mr. Contreras has not

established through preponderant evidence that the hepatitis B vaccine can cause

transverse myelitis (prong 1) and has not established that his transverse myelitis

arose in time for which it is medically acceptable to infer causation (prong 3), he

cannot establish “a logical sequence” between the vaccination and his transverse

myelitis. Nonetheless, in accord with the Court’s instructions, the evidence

regarding this element is again reviewed without any consideration of Dr. Sladky’s

evidence.

35

Saying that Mr. Contreras required more evidence to demonstrate the persuasiveness of

Dr. Steinman’s theory is not the same as saying that Mr. Contreras had to establish Dr.

Steinman’s theory to a level of medical certainty. See La Londe v. Sec'y of Health & Human

Servs., 110 Fed. Cl. 184, 201 (2013) (the petitioner’s expert “could not back up his hypothesis

with a reliable medical or scientific explanation. . . . [The special master] quite properly required

petitioner to carry her burden to bring forward a reliable or scientific explanation”), aff’d, 746

F.3d 1334, 1340 (Fed. Cir. 2014); Langland v. Sec'y of Health & Human Servs., 109 Fed. Cl.

421, 441 (2013) (“the Special Master did not commit a legal error by requiring a sufficiently-

detailed explanation” of how a vaccine can cause a disease); Taylor v. Sec'y of Health & Human

Servs., 108 Fed. Cl. 807, 819 (2013) (“the mere existence” of expert testimony about a theory “is

insufficient to satisfy the burden of showing a ‘persuasive’ medical theory --- this theory must

also preponderate”). Petitioners are required to present preponderant cases, not certain cases.

Hodges, 9 F.3d at 961-62 (“[t]he fact that the opinion of petitioner’s doctors was rejected does

not mean that the Special Master was demanding scientific certainty; he might simply have been

demanding some degree of acceptable scientific support when concluding that the [petitioners’]

claim for causation in-fact was not supported by a preponderance of the evidence”).

56

The Remand Decision addressed two types of evidence. The first type was

reports from treating doctors. The Remand Decision did not find persuasive the

testimony from Dr. Garrett and Dr. Wagner, and found more persuasive the

statements that Dr. Babbitt, Dr. Cheung, and Dr. Lake made during their course of

treating Mr. Contreras. Dr. Sladky’s evidence played no role regarding this first

type of evidence.

The second type of evidence was evidence of alternative cause as the Court

directed. See Contreras 2, 107 Fed. Cl. at 296-97. The Remand Decision cited Dr.

Sladky as not identifying any other potential cause. Contreras 3, slip op. at 73,

2013 WL 6698382, at *57 (citing Tr. 351). Dr. Sladky’s position was not special.

The treating doctors did not identify any possible other cause. See exhibit 7 at 6-8

(discharge report); exhibit 13 (Dr. Garrett’s affidavit) at 6-7 ¶ 12. Thus, even if Dr.

Sladky’s testimony were eliminated, there would still be no other alternative causal

factor.

As discussed in the Remand Decision, the lack of a known alternative factor

does not mean that the vaccinations caused Mr. Contreras’s transverse myelitis.

See Caves, 100 Fed. Cl. at 141; Fadelalla v. United States, 45 Fed. Cl. 196, 201

(1999). The lack of alternative factors might be more significant if Mr. Contreras

had established that the hepatitis B vaccine can cause transverse myelitis and if Mr.

Contreras had established that the hepatitis B vaccine can cause transverse myelitis

in one day. But, for the reasons explained above in sections IV.C-D, Mr. Contreras

has not established these predicates even if Dr. Sladky’s evidence is excluded.

In the absence of a finding that the vaccinations caused Mr. Contreras’s

transverse myelitis, the cause of his tragic disease remains unknown. See Tr. 263-

64 (Dr. Steinman: the vast majority of TM cases are idiopathic).

V. Additional Comments

On a personal level, Mr. Contreras’s episode with transverse myelitis was a

terrible ordeal. The attention given to him by Dr. Wagner, Dr. Garrett, Dr. Lake

and other doctors sustained him during a perilous time. It is fortunate that he has

recovered as much as he has, even though his health remains impaired. He

deserves sympathy for his suffering.

The process of litigating this Vaccine Program claim is, almost certainly,

bringing more disappointment to Mr. Contreras. For reasons not entirely within

Mr. Contreras’s control, the litigation has been an unduly lengthy process. The

fact that the most recent delay is to address misconduct by the Secretary’s expert

57

witness may be especially irritating. Mr. Contreras may understandably question

how the Secretary can prevail after relying upon a witness who was deceptive

about his background.

This Decision has attempted to demonstrate that the penalty for a witness’s

deception is not always the striking of the witness’s testimony. On occasion, a

reasonable remedy is to bar the witness from testifying and to strike all evidence

associated with that witness. The chief special master in Raymo took a similar

approach for Dr. Sladky by refusing to give his testimony any weight. But, another

special master kept Dr. Sladky’s evidence in the record. Roberts, 2013 WL

5314698, at *9. These two cases demonstrate that there can be more than one

(correct) answer to the question “what should happen to Dr. Sladky’s evidence?”

As discussed in section II.A, the response in the Remand Decision was

closer to Roberts than Raymo. However, the overall outcome in Mr. Contreras is

the opposite of the outcome in Roberts and Raymo. How can these disparate

outcomes be reconciled?

The evidence among the three cases is much different. In Roberts, the

primary dispute was whether the vaccinee suffered from transverse myelitis as

three of her treating doctors testified or suffered from an embolism as the

Secretary’s experts, Dr. Sladky and a neuroradiologist, testified. The special

master credited the views of the treating doctors. She found Dr. Sladky’s

testimony not “as reliable and persuasive as the testimony” of petitioner’s treating

doctors for multiple reasons, one of which was Dr. Sladky’s failure to disclose his

licensing problems. Roberts, 2013 WL 5314698, at *9. The special master also

considered that the Secretary’s neuroradiologist thought the vaccinee’s imaging

presented a close call between the two diagnoses. Thus, the balance of the

evidence was on petitioners’ side.

In Raymo, after the chief special master disregarded Dr. Sladky’s testimony,

the Secretary had “no other witnesses to counter Dr. Kinsbourne’s theory that [the

vaccinee] suffered from [acute transverse myelitis].” Raymo, 2014 WL 1092274,

at *2 n.9. The chief special master returned to the absence of evidence in

beginning her analysis. She stated:

Because I attach no weight to the opinions of Drs. Sladky

and Becker, Dr. Kinsbourne’s opinion is largely

unrebutted. Although I have considered the expert report

and testimony of Dr. Gill, her evidence was almost

58

exclusively focused on demonstrating that Dr. Becker's

theory regarding a vascular cause for [the vaccinee’s]

infarction was unsound, and thus is not relevant to the

causation theory still before me.

Id. at 17 (footnote omitted). The “largely unrebutted” testimony from Dr.

Kinsbourne persuaded the chief special master to find in petitioner’s favor.

Here, even if Dr. Sladky’s testimony were excluded, Mr. Contreras’s

evidence is far from “largely unrebutted.” There is conflicting evidence on

virtually every point. For example, Dr. Garrett’s opinion about the diagnosis does

not match the opinions of Dr. Steinman and Dr. Poser.

The most prominent example of a conflict in evidence, independent of Dr.

Sladky’s evidence, concerns timing. Here, the contest was largely between Dr.

Steinman and Dr. Whitton. Dr. Whitton persuasively explained why a one-day

interval between vaccination and the onset of neurologic symptoms associated with

a lesion in the cervical spine was not biologically possible. Dr. Whitton’s position

is in accord with the 1994 IOM report (exhibits A, F, and V). In contrast, Dr.

Steinman could present only weak and unpersuasive support for his opinion that all

the steps associated with molecular mimicry can happen within one day. Dr.

Whitton’s testimony on timing was very strong and persuasive, making Dr.

Sladky’s testimony on this topic redundant. See Hulbert v. Sec'y of Health &

Human Servs., 49 Fed. Cl. 485, 490 (2001) (ruling that special master did not

commit reversible error in declining to strike one expert’s testimony when the

denial of compensation rested upon the testimony of another expert), aff’d, 35 Fed.

Appx 899 (Fed. Cir. 2002).

VI. Conclusion

Contreras 4, 116 Fed. Cl. at 484, remanded this case for a discussion of three

issues. First, the Court ordered an assessment of Dr. Sladky’s credibility and

reliability. Dr. Sladky, despite some misleading testimony about his qualifications,

remained credible enough to offer opinions. His opinions were based upon a

reliable methodology. In conjunction with these findings, Mr. Contreras’s post-

remand motion to strike Dr. Sladky’s evidence is denied. Second, the Court

ordered a comparison of credibility among the different people who testified either

by affidavit or in person. Dr. Sladky falls near the bottom of the list and Dr.

Whitton is at the top. Third, the Court ordered an analysis of the evidence

remaining after Dr. Sladky’s evidence was removed. This analysis does not

59

change the outcome of the case. Mr. Contreras would still have failed to establish

the Althen prongs.

Mr. Contreras remains not entitled to compensation. The Clerk’s Office is

instructed to enter judgment in accord with this decision unless a motion for review

is filed. The Clerk’s Office is also instructed to provide this decision to the

presiding judge pursuant to Vaccine Rule 28.1(a).

IT IS SO ORDERED.

s/Christian J. Moran

Christian J. Moran

Special Master

60