CHRISTIAN J. MORAN, Special Master.
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.
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.
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 ¶ 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."
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.
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, 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."
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."
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 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.
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."
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;
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.
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 (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;
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;
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."
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."
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:
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
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,
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.
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.
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.,
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.
Mr. Contreras filed a motion for review, which was granted. The April 5, 2012 entitlement decision was vacated and the case was remanded.
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.
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.
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
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:
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."
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."
Mr. Contreras filed a second motion for review. In his objections, Mr. Contreras argued, among other things, that:
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."
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
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 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.
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."
After the Secretary disclosed Dr. Sladky's alcohol problem and consequent licensing problems in Georgia, Mr. Contreras discovered the additional misrepresentation on Dr. Sladky's CV concerning the expiration of his Pennsylvania license.
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."
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."
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."
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."
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
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
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.
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.
In
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."
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
As noted, Chief Judge Becker's
The approach taken in
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.
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
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."
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.
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.
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.
In a trial before the court, the right of a judge to weigh the expert's credibility was implicitly recognized in
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:
But, the Federal Circuit's resolution of
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."
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.
The Federal Circuit's reversal in Andreu led to a conclusion that special masters should not consider an expert's credibility.
Nevertheless, after
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."
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.
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.
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.
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.
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.
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."
On the basis of these four factors, the chief special master in
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
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
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.
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.
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.
Within the Vaccine Program, the reliability of an expert's opinion is often analyzed using the
The Remand Decision analyzed all the evidence regarding the theory that the hepatitis B vaccine can cause transverse myelitis via molecular mimicry.
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.
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).
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.
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.
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.,
For his opinion regarding timing, Dr. Sladky easily meets the
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.
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.,
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.
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."
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;
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.
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.
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.
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.,
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 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.
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."
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.
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 appeared to possess prudent judgment. For example, he declined the position of editor for one important journal because he was already 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.
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.
The Court previously set forth the parties' respective burdens and the elements of compensation.
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.
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."
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. 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
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:
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.
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.
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."
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.
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.
The possibility that Mr. Contreras might suffer from "atypical" Guillain-Barré syndrome was a consideration very early in his hospitalizations.
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),
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.
The analysis of Mr. Contreras's arguments regarding timing was divided into discrete sections. These were:
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.
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."
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.
The Entitlement Decision's third section on timing was a multi-part discussion about medical articles. The Odoardi article was a significant reason Mr. Contreras was denied compensation, warranting a part by itself.
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.
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, even if Dr. Sladky's evidence were entirely excluded, Kakar would have minimal weight for the reasons Dr. Whitton explained.
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.
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.
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
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.
Next, there is a synopsis of 11 types of evidence. An asterisk marks the sections in which Dr. Sladky is mentioned.
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."
The Remand Decision found "the testimony of Dr. Whitton to be the most persuasive."
If all evidence originating with Dr. Sladky were struck, would the result change? The answer is no.
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."
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.
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 (
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.,
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.
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."
This argument, however, is belied by
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.
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.
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.
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.
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,
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.
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.
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.
Dr. Sladky also did not affect the analysis of the first three
For the fourth
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 exhibit H (Zipp).
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.,
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.
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 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."
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.
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 (
On the whole, striking Dr. Sladky's evidence does not change the outcome regarding
The remaining
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.
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.
In the absence of a finding that the vaccinations caused Mr. Contreras's transverse myelitis, the cause of his tragic disease remains unknown.
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 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
As discussed in section II.A, the response in the Remand Decision was closer to
The evidence among the three cases is much different. In
In
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.
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).
Citations to
If outside evidence were an appropriate source for finding inconsistent opinions, then there would be more examples of Dr. Steinman's inconsistency.
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.