VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_05-vv-00626 Package ID: USCOURTS-cofc-1_05-vv-00626 Petitioner: J.C.R. Filed: 2005-06-15 Decided: 2017-11-22 Vaccine: hepatitis B; tetanus Vaccination date: 2003-06-16 Condition: transverse myelitis and/or Guillain-Barre syndrome Outcome: compensated Award amount USD: 1510023.53 AI-assisted case summary: On June 15, 2005, J.C. filed a petition under the National Vaccine Injury Compensation Program on behalf of his son, J.C.R., alleging that the Hepatitis B and Tetanus vaccines administered on June 16, 2003, caused transverse myelitis (TM) and/or Guillain-Barre syndrome (GBS). The case involved extensive litigation regarding entitlement. Initially, Special Master Christian J. Moran denied entitlement, focusing on the medically acceptable timeframe for molecular mimicry following vaccination. The Court of Federal Claims remanded the case multiple times, including for issues concerning expert evidence. Ultimately, in 2015, the Court of Federal Claims sustained the Special Master's denial of entitlement. However, the case later resolved by stipulation. The caption was amended to reflect J.C.R.'s adulthood, and the final public decision was reissued in redacted form on December 6, 2017, using initials. A corrected stipulation was filed on November 21, 2017, after an earlier stipulation and decision were stricken due to an error reported by the respondent. The respondent continued to deny that the vaccines caused or significantly aggravated J.C.R.'s condition. Nevertheless, the parties agreed to compensation. Chief Special Master Nora Beth Dorsey adopted the corrected stipulation on November 22, 2017. The award included a lump sum of $1,248,834.30 payable to J.C.R., comprising $48,328.00 for first-year expenses, $960,377.30 for past and future lost wages (reduced to net present value), and $240,129.00 for actual and projected pain and suffering (reduced to net present value). An additional lump sum of $261,189.23 was payable to J.C.R. and the California Department of Health Care Services to satisfy a Medicaid lien. The stipulation also included an amount sufficient to purchase an annuity contract, representing all damages available under the Vaccine Act. Petitioner's counsel was Jeffrey S. Pop, and respondent's counsel was Linda S. Renzi. Theory of causation field: Petitioner alleged that the Hepatitis B and Tetanus vaccines administered on June 16, 2003, to J.C.R. (age 13) caused transverse myelitis and/or Guillain-Barre syndrome, with onset approximately 24 hours later. The case involved extensive litigation, with Special Master Christian J. Moran repeatedly denying entitlement, questioning the 24-hour onset timeframe for molecular mimicry. The Court of Federal Claims initially sustained these denials but later remanded for further clarification regarding expert testimony, specifically concerning Dr. John T. Sladky, whose credibility and reliability were questioned due to undisclosed substance abuse and licensure issues. Ultimately, the case was resolved by a corrected stipulation, adopted by Chief Special Master Nora Beth Dorsey on November 22, 2017, with a final redacted decision issued on December 6, 2017. Respondent denied causation and significant aggravation. The award included a lump sum of $1,248,834.30 to J.C.R. ($48,328.00 for first-year expenses, $960,377.30 for past/future lost wages, and $240,129.00 for pain/suffering), plus $261,189.23 for a California Medicaid lien, and an amount for an annuity. Petitioner's counsel was Jeffrey S. Pop, and respondent's counsel was Linda S. Renzi. Petition filed June 15, 2005. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_05-vv-00626-0 Date issued/filed: 2014-06-16 Pages: 24 Docket text: PUBLIC DECISION (Originally filed: 5/19/2014 ) re: 210 Order on Motion for Review, Opinion Remanding to Special Master. Signed by Judge Lynn J. Bush. (TQ) Copy to parties. -------------------------------------------------------------------------------- Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 1 of 24 In the United States Court of Federal Claims No. 05-626 V (Filed June 16, 2014)1 * * * * * * * * * * * * * * * JESSIE CONTRERAS, * * Petitioner, * National Childhood Vaccine * Injury Act of 1986, 42 U.S.C. v. * §§ 300aa-1 to -34 (2012); Lack * of Clarity in Credibility and SECRETARY OF HEALTH AND * Reliability Determinations; HUMAN SERVICES, * Remand. * Respondent. * * * * * * * * * * * * * * * * Jeffrey S. Pop, Beverly Hills, CA, for petitioner. Linda S. Renzi, United States Department of Justice, with whom were Stuart F. Delery, Assistant Attorney General, Rupa Bhattacharyya, Director, Vincent J. Matanoski, Deputy Director, Voris E. Johnson, Jr., Assistant Director, Washington, DC, for respondent. ________________________________ OPINION AND ORDER ________________________________ BUSH, Senior Judge 1/ Pursuant to Rule 18(b) of Appendix B of the Rules of the United States Court of Federal Claims, this Opinion and Order was initially filed under seal on May 19, 2014. Pursuant to ¶ 4 of the ordering language, the parties were to propose redactions of the information contained therein on or before June 6, 2014. No proposed redactions were submitted to the court. Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 2 of 24 Now pending before the court is petitioner’s motion for review of the special master’s decision on remand, see Contreras v. Sec’y of Health & Human Servs., No. 05-626V, 2013 WL 6698382 (Fed. Cl. Spec. Mstr. Nov. 19, 2013) (Contreras III),2 which denied Jessie Contreras’s petition for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (2012) (the Vaccine Act).3 Although petitioner attacks the special master’s decision on many fronts, a threshold issue regarding the credibility of one of respondent’s experts and the reliability of that expert’s opinions prevents this court from reaching the remainder of petitioner’s arguments. Pet.’s Mot. at 2, 4-5; Resp.’s Resp. at 27-29. Because the credibility and reliability determinations of the special master regarding this particular expert are unclear, and because the extent of the special master’s reliance on the opinions of this expert for the entitlement decision is similarly unclear, the court must remand this case to the special master. BACKGROUND I. Factual History Prior decisions in this case provide ample factual background for Jessie’s alleged vaccine injury of transverse myelitis (TM) and Guillain-Barré Syndrome (GBS). See, e.g., Contreras v. Sec’y of Health & Human Servs., 107 Fed. Cl. 280 (2012) (Contreras II); Contreras v. Sec’y of Health & Human Servs., No. 05-626V, 2012 WL 1441315 (Fed. Cl. Spec. Mstr. Apr. 5, 2012) (Contreras I), vacated, 107 Fed. Cl. 280. The alleged injury occurred in 2003, approximately twenty-four hours after Jessie received inoculations containing the Hepatitis B vaccine (HepB) and tetanus-diptheria vaccine (Td). Jessie is now twenty-four years old. II. Procedural History 2/ The court cites not to the Westlaw version of the special master’s opinion on remand, but follows the practice of the parties and cites to the opinion version (Opin.) available on this court’s website. 3/ Hereinafter the court will refer to Mr. Contreras as “petitioner” or “Jessie,” because he was thirteen years old at the time of his alleged vaccine injury. 2 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 3 of 24 On June 15, 2005, Jessie’s father, acting for Jessie, filed a petition under the Vaccine Act. Petitioner initially engaged Dr. Charles M. Poser, M.D. as an expert. Respondent then engaged Dr. John T. Sladky, M.D. to opine on causation. Dr. Sladky’s initial report in 2005 was filed in response to Dr. Poser’s report. See Ex. I; see also Resp.’s Resp. at 27. Petitioner then engaged another expert, Dr. Lawrence Steinman, M.D. Dr. Steinman’s initial report was filed in 2006. A few years later, Dr. Sladky filed a second report to respond to Dr. Steinman’s report. See Resp.’s Resp. at 27. Dr. Sladky’s second report was filed on March 8, 2010 and re-filed on March 22, 2010. See Ex. P. Respondent had also engaged a second expert, Dr. J. Lindsay Whitton, M.D., Ph.D., who also responded to Dr. Steinman’s contentions. Drs. Steinman, Sladky and Whitton testified at the first evidentiary hearing in this case, held April 19-20, 2010.4 In Contreras I, the special master denied petitioner entitlement to compensation under the Vaccine Act. In Contreras II, this court vacated that opinion and remanded the case to the special master for a revised causation analysis. In Contreras III, the special master issued a revised causation analysis which again denied petitioner entitlement to compensation. Before the special master issued his decision, however, on May 1, 2013 the Secretary filed a status report revealing previously undisclosed information regarding Dr. Sladky. It is the special master’s ambiguous response to that disclosure of information that is the primary focus of this opinion. DISCUSSION I. Standard of Review This court has jurisdiction to review the decision of a special master in a Vaccine Act case. 42 U.S.C. § 300aa-12(e)(2). “Under the Vaccine Act, the Court of Federal Claims reviews the decision of the special master to determine if it is ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law[.]’” de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1350 (Fed. 4/ All citations to the transcript (Tr.) in this opinion are to the transcript of the 2010 hearing. 3 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 4 of 24 Cir. 2008) (quoting 42 U.S.C. § 300aa-12(e)(2)(B) and citing Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1277 (Fed. Cir. 2005)) (alteration in original). This court uses three distinct standards of review in Vaccine Act cases, depending upon which aspect of a special master’s judgment is under scrutiny: These standards vary in application as well as degree of deference. Each standard applies to a different aspect of the judgment. Fact findings are reviewed . . . under the arbitrary and capricious standard; legal questions under the “not in accordance with law” standard; and discretionary rulings under the abuse of discretion standard. Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). The third standard of review, abuse of discretion, is applicable when the special master excludes evidence or otherwise limits the record upon which he relies. See id. As this court has stated, the third standard applies to evidentiary rulings, including those regarding the qualifications of an expert: Notably, such [discretionary] rulings include determinations regarding the qualification of expert witnesses and the reliability of expert testimony. Piscopo v. Sec’y of Health & Human Servs., 66 Fed. Cl. 49, 53 (2005); see [Gen. Elec. Co. v. Joiner, 522 U.S. 136, 142-43 (1997)] (holding that “abuse of discretion is the proper standard of review of a [trial] court’s evidentiary rulings,” including determinations regarding the reliability of expert testimony under [Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993))]; [Terran ex rel. Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999)] (reviewing for abuse of discretion the Special Master’s decision to reject as unreliable the testimony of the petitioner’s expert). Determinations subject to review for abuse of discretion must be sustained unless “manifestly 4 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 5 of 24 erroneous.” Piscopo, 66 Fed. Cl. at 53; see Milmark Servs., Inc. v. United States, 731 F.2d 855, 860 (Fed. Cir. 1984) (holding that decisions that lie within the trial court’s discretion are to be sustained unless “manifestly erroneous”). Jarvis v. Sec’y of Dep’t of Health & Human Servs., 99 Fed. Cl. 47, 59 (2011). Thus, a special master’s determination as to the reliability of expert witness testimony is reviewed under the abuse of discretion, or manifestly erroneous, standard. Terran, 195 F.3d at 1316 (citing Burns v. Sec’y of Dep’t of Health & Human Servs., 3 F.3d 415, 416-17 (1993)); Milmark, 731 F.2d at 860 (citing Salem v. U.S. Lines Co., 370 U.S. 31, 35 (1962)). On the particular topic of a fact-finder’s determination as to the credibility of a testifying witness, the United States Court of Appeals for the Federal Circuit has often stated that such determinations are “‘virtually unreviewable.’” E.g., Bradley v. Sec’y of Dep’t of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993) (citing Hambsch v. Dep’t of Treasury, 796 F.2d 430, 436 (Fed. Cir. 1986)). The court has found no authority, however, which states that a credibility determination is immune from review, particularly where, as here, extrinsic evidence has subsequently been disclosed which shows a lack of candor on the part of an expert witness. For this reason, the court reviews the special master’s determinations regarding Dr. Sladky’s credibility and the reliability of Dr. Sladky’s expert opinions for manifest error. Unfortunately, the special master’s determinations in this regard are ambiguous and resist review absent further clarification. II. Analysis A. Dr. Sladky’s Opinions and Testimony Have Been Undermined By a Consistent Pattern of Misrepresentations to the Court and to Respondent’s Counsel 1. An Undisclosed History of Substance Abuse On May 1, 2013, the Secretary was obliged to disclose that Dr. Sladky, one of the two experts employed by respondent in this case, had a substance abuse 5 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 6 of 24 problem which led to the suspension and probationary restoration of his license to practice medicine at or around the time he was drafting an expert report and testifying at the 2010 hearing in this case.5 Some excerpts of this disclosure reveal that the Secretary and respondent’s counsel have only recently learned . . . 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. . . . Neither the Secretary nor respondent’s counsel was aware of the suspension or probationary status of Dr. Sladky’s license prior to or at the time he provided the expert witness services in this case. Status Report of May 1, 2013, at 1. Attached to the Secretary’s status report were a number of documents issued by the State of Georgia’s Composite State Board of Medical Examiners (Board), the earliest of which, dated June 17, 2009, provides an initial insight into Dr. Sladky’s alcohol dependence: On or about June 5, 2009, the Board received reliable information from Talbott Recovery Campus (“TRC”) that Respondent [Dr. Sladky] tested positive for alcohol in a urine drug/alcohol screen and, as a result, TRC recommends that Respondent enter inpatient treatment at TRC immediately. Id. at 14. This report of a failed urine test was just one manifestation of Dr. 5/ Dr. Sladky signed his second expert report on March 4, 2010, provided the report to respondent’s counsel by March 8, 2010, and testified in this case on April 20, 2010. 6 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 7 of 24 Sladky’s substance abuse problem and was the trigger for the Board’s disciplinary action which included: (1) the indefinite suspension of Dr. Sladky’s license to practice medicine on June 17, 2009, (2) the requirement that he receive inpatient treatment for his condition, and, (3) that he attend continuing care after treatment as required by the rehabilitation center’s staff. There were, however, earlier incidents that led to this and other disciplinary action by the Board. As recounted in a later Board decision dated March 4, 2010, [o]n or about August 19, 2008, Respondent [Dr. Sladky] was evaluated and treat[ed] for alcohol dependence at Ridgeview Institute (“Ridgeview”). Respondent notified the Board that he was in treatment and agreed not to return to the practice of medicine without the written express permission of the Board. Respondent completed treatment and was discharged on or about November 19, 2008. Status Report of May 1, 2013, at 4. Dr. Sladky was permitted to return to the practice of medicine on March 18, 2009. That return to practice was short-lived, however, because [s]oon after his return to practice, Respondent [Dr. Sladky] had several positive urine tests for ethyl glucuronide, in violation of both his monitoring agreement with Ridgeview and the terms of his Board Order [of March 18, 2009]. Id. at 5. Accepting the Board’s disciplinary actions in June 2009, Respondent [Dr. Sladky] entered the Talbott Recovery Campus (“TRC”) program on June 9, 2009 . . . . After completing inpatient treatment on July 31, 2009, Respondent then entered and completed intensive outpatient treatment, followed by aftercare. 7 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 8 of 24 Id. As of March 4, 2010, Dr. Sladky’s petition to lift the suspension of his medical license was granted. Dr. Sladky, however, was only granted a probationary license to practice medicine, under the supervision of a physician at his place of employment to monitor Dr. Sladky’s work, and under the supervision of a different physician to monitor Dr. Sladky’s treatment for alchoholism and his use of prescription medications, if any. This probation also included a number of conditions, such as: substance abuse treatment, including weekly group therapy sessions; participation in a support group such as Alcoholics Anonymous, including the requirement that he obtain a sponsor so that he could “work a daily recovery program”; unscheduled drug and alcohol screening tests; and, initial and quarterly reports from both his workplace supervising physician and his substance abuse treatment physician. Id. at 6-8. According to the Board’s order of March 4, 2010, Dr. Sladky would not “be eligible to petition for termination of probation until five (5) years of continuous sobriety from the effective date of this Consent Order.” Id. at 11. More than three and a half years before Dr. Sladky was due, at the earliest, to become eligible to petition for the termination of his probation pursuant to the Board’s order of March 4, 2010, the Board terminated the probation conditions on Dr. Sladky’s license to practice medicine in the State of Georgia, with no substantive commentary. Status Report of May 1, 2013, at 3. The record before the court does not show how the Secretary learned of: (1) Dr. Sladky’s undisclosed substance abuse problem; (2) the first agreement that he not practice medicine; (3) the second and indefinite suspension of his license to practice medicine; and, (4) the probation conditions imposed upon his license by the State of Georgia’s Composite State Board of Medical Examiners. What is clear from the record is that Dr. Sladky was not candid about the events chronicled here with either respondent’s counsel or the court. What is also clear is that petitioner was deprived of any opportunity to elicit testimony from Dr. Sladky as to the actual conditions of his medical practice because Dr. Sladky’s curriculum vitae misrepresented the state of his medical licensure at all times relevant to this litigation. 2. A Pattern of Misrepresentation in the Curriculum Vitae Dr. Sladky Submitted in This and Other Cases 8 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 9 of 24 a. Dr. Sladky’s Curriculum Vitae in This Case Dr. Sladky’s curriculum vitae (CV) was submitted by respondent along with his first expert report on October 27, 2005, and, pursuant to the special master’s instructions, was refiled as Exhibit J on December 2, 2005 to clarify the docket. The CV was dated “May 1, 1999,” even though it was submitted to the court six years after that date, and contained information that referenced responsibilities of Dr. Sladky extending to the year 2002. Ex. J at 5. Under the rubric “Licensure,” Dr. Sladky’s CV identified a license to practice medicine in Pennsylvania (No. MD-022838-E).6 Id. at 3. Respondent does not dispute that Dr. Sladky’s Pennsylvania license expired in 1996, well before the “May 1, 1999” date on the CV, and almost ten years before Dr. Sladky’s CV was filed in this case. In the court’s view, 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. As the special master and the parties prepared for the 2010 hearing in this case, almost five years after respondent had first filed Dr. Sladky’s CV, respondent’s counsel informed the special master and petitioner that respondent intends to call John Sladky, M.D., to testify at hearing. As of the filing of this status report, Dr. Sladky has indicated that he is making efforts to appear in person if possible, but will be available by phone, if necessary. 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. Status Report of January 27, 2010, at 1 (emphasis added). No updated CV was filed by respondent. 6/ Dr. Sladky’s license number in Pennsylvania, MD-022838-E, should not be read to include a designation “E” for “expired.” Active and expired medical licenses in that state may bear the “E” designation. 9 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 10 of 24 The court notes that as of January 27, 2010, Dr. Sladky’s license to practice medicine in Georgia was suspended and his license in Pennsylvania had expired many years before. The following evidence shows that Dr. Sladky was working on his second expert report while his sole “active” license to practice medicine (in Georgia) was suspended and before his suspended license (in Georgia) was reinstated (with probationary conditions) on March 4, 2010: (1) respondent’s counsel’s statement on January 27, 2010 that Dr. Sladky “is preparing” his second expert report; (2) the detailed analysis of Dr. Steinman’s opinions in Dr. Sladky’s second expert report; and, (3) the date marked on Dr. Sladky’s expert report, March 4, 2010, which was filed by respondent on March 8, 2010 (lacking a signature) and refiled (with a signature) on March 22, 2010. See Ex. P. Thus, Dr. Sladky’s first expert report was supported by an inaccurate and misleading CV as to licensure in Pennsylvania, and Dr. Sladky’s second expert report was again supported by an inaccurate and misleading CV as to licensure in Pennsylvania. Furthermore, his inaccurate and misleading CV failed to disclose that the second expert report had been composed, at least in part, while Dr. Sladky’s license to practice medicine in Georgia was suspended, and failed to disclose that the report was signed when his license to practice medicine was subject to probationary conditions. There 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. The court believes that a party in a vaccine injury case has a duty to update or supplement inaccurate information in the record before the special master. See Erve by Erve v. Sec’y of Health & Human Servs., 39 Fed. Cl. 607, 616 (1997) (discussing the obligations of litigants in vaccine cases to disclose relevant evidence, in light of the informal and cooperative discovery procedures used in these cases). 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. b. Dr. Sladky’s Curriculum Vitae in Other Vaccine Cases before This Court Dr. Sladky, to the court’s knowledge, has never submitted an accurate CV in the numerous vaccine cases for which he was engaged by the Secretary as an 10 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 11 of 24 expert. To cite perhaps the most egregious example of a misleading CV provided by Dr. Sladky, the court turns to Crosby v. Sec’y of Health & Human Servs., No. 08-799V (Fed. Cl. filed Nov. 10, 2008). The petition in that case was filed on November 10, 2008, during a time when Dr. Sladky was not permitted to practice medicine due to his substance abuse problem. As of September 29, 2009, respondent’s counsel in that case noted that Dr. Sladky “has indicated that he requires additional time to complete his review and prepare a report in this case.” Crosby Status Report of Sept. 29, 2009, at 1. Dr. Sladky’s license to practice medicine, as of September 29, 2009 when he was producing the expert report in Crosby, was suspended due to his substance abuse problem. Dr. Sladky’s expert report in Crosby was signed on October 26, 2009, when his license to practice medicine was still suspended due to his alcohol dependence. The CV that supported that expert report, dated “May 1, 2005” but filed November 2, 2009, asserts under “Licensure” that Dr. Sladky is licensed in both Pennsylvania and Georgia, although in truth he could not practice medicine in either state at the time his report and CV were filed. Crosby Notice of Filing of November 2, 2009, Ex. A Tab 1 at 3. Respondent won that case, at least in part, because “[b]oth parties presented well credentialed experts” and respondent’s experts, including Dr. Sladky, were found to be more persuasive by the special master. Crosby v. Sec’y of Health & Human Servs., No. 08-799V, slip op. at 2 (Fed. Cl. Spec. Mstr. June 20, 2012) (emphasis added). Respondent did not file a status report in that case disclosing the Secretary’s discovery of Dr. Sladky’s undisclosed substance abuse problem, licensure difficulties and lack of candor.7 To cite only a few more examples, Dr. Sladky’s pattern of submitting inaccurate CVs in vaccine cases cannot be described as anything other than consistent. In Case No. 09-293V, on April 22, 2011 respondent filed a “January 5, 2009” version of Dr. Sladky’s CV, asserting “Licensure” in Pennsylvania (although that license had expired approximately twelve years before the date of the CV) and “Licensure” in Georgia (although that license was suspended as of the date of the CV). In Case No. 08-763V, on May 24, 2010 respondent filed a “May 1, 2005” version of Dr. Sladky’s CV, asserting “Licensure” in Pennsylvania 7/ The court assumes this failure to disclose relevant information was inadvertent, because the Secretary was diligent in filing status reports in other vaccine cases for which Dr. Sladky was retained as an expert, whether or not those cases were open or closed. 11 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 12 of 24 (although that license had expired more than eight years before the date of the CV). In Case No. 10-717V, on September 30, 2011 respondent filed a “May, 2011” version of Dr. Sladky’s CV, which continued to assert “Licensure” in Pennsylvania (although that license had expired over fourteen years before the date of the CV). The court believes that it is wrong to assume that the submission of consistently inaccurate CVs was inadvertent or the product of laziness on Dr. Sladky’s part. He obviously was updating his CV throughout this period by changing the date on the first page of the document (although that date never appears to have matched the date of the expert report it supported). He also was, in some instances, adding recent publications to his CV. Furthermore, it is clear from the Crosby case, in particular, that Dr. Sladky had an updated, if inaccurate, CV dated “May 1, 2005” that was available to be filed by respondent on November 2, 2009 in that case, but which was not filed in early 2010 in this case, as promised by respondent’s counsel. The court cannot minimize the misrepresentations in the CVs Dr. Sladky has submitted in vaccine cases,8 and notes that Dr. Sladky was removed as an expert from at least one vaccine case (which later settled). See Resp.’s May 17, 2013 Status Report, Covin by Strand v. Sec’y of Health & Human Servs., No. 08-763V (Fed. Cl. closed Mar. 31, 2014). 3. Three Examples of Misleading or Incomplete Testimony Regarding Dr. Sladky’s Medical Practice a. Dr. Sladky’s Testimony in This Case There is no indication that Dr. Sladky perjured himself on April 20, 2010 in the evidentiary hearing before the special master in this case. He 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 8/ The special master commented that “it is difficult to say” whether the representations as to licensure in Pennsylvania on Dr. Sladky’s CV were “due to forgetfulness or due to intent.” Opin. at 7. That may be true when this case is viewed in isolation. It is harder to attribute the inaccuracies in Dr. Sladky’s CV to forgetfulness when one considers that Dr. Sladky exhibited a lack of candor regarding his licensure problems in multiple vaccine cases. 12 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 13 of 24 suspension of his license. There is also no indication that his employment status as “senior faculty” in the Department of Pediatric Neurology at Emory University School of Medicine was misrepresented. Tr. at 275. The court notes, however, that the testimony of Dr. Sladky was founded on the CV respondent submitted on December 2, 2005. See Tr. at 278; Ex. J. As noted supra, that CV, for which an updated version was never proffered, asserted licensure in Pennyslvania. That “May 1, 1999” CV also stated that Dr. Sladky was Chief of the Division of Pediatric Neurology at Emory, under the rubric “Hospital Appointments.” Ex. J at 3. Whether that hospital appointment was still in place when Dr. Sladky testified is unclear. In the court’s view, 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, as is further evidenced below. In general terms, Dr. Sladky testified that “I see patients,” that “I see patients every week,” and that “[I] attend on the inpatient neurology service roughly three months a year, a little less.” Tr. at 275. He described his work as a “[p]retty standard, busy clinical and academic lifestyle.” Id. More specifically, Dr. Sladky testified that “probably half” of his working hours are devoted to clinical time, and that “I see patients every week, usually five half days a week, probably average 40-50 patients a week.” Id. This testimony by Dr. Sladky was provided on April 20, 2010, forty-seven days after he was permitted to return to the practice of medicine in Georgia. If the court were to consider the two-year period of time leading up to this testimony, Dr. Sladky was only 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. When this factual context is considered, Dr. Sladky’s testimony that he sees patients every week; that probably half of his working hours are clinical time; that he attends on inpatient service a little less than three months a year; and that he probably averages 40-50 patients a week, is misleading. Whether Dr. Sladky was attempting to describe his recently restored medical practice that resumed on March 4, 2010, aptly using the present tense, or whether Dr. Sladky was attempting to paint an impressionistic picture of his long- term tenure at Emory, imprecisely using the present tense, the description of his 13 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 14 of 24 medical practice that he provided the special master and opposing counsel in his testimony cannot be reconciled with the interruptions in his medical practice caused by his substance abuse and licensure problems. Like his inaccurate CV, Dr. Sladky’s testimony was misleading as to his experience and qualifications to testify as an expert. Unfortunately, the hearing in this vaccine case is not the only time that Dr. Sladky’s testimony glossed over and hid the fact that he was prevented from practicing medicine for fifteen and a half months between 2008 and 2010, and that his license to practice medicine was on probation for over a year in 2010 and 2011. b. Dr. Sladky’s Testimony in Other Vaccine Cases before This Court Only two special masters, besides the special master presiding over this case, have commented on the hearing testimony of Dr. Sladky once his lack of candor was disclosed by the Secretary. In Roberts v. Sec’y of Health & Human Servs., No. 09-427V, 2013 WL 5314698, at *9 (Fed. Cl. Spec. Mstr. Aug. 29, 2013), the special master noted that Dr. Sladky had been on a probationary license to practice medicine when he submitted his expert reports in that case. Although Dr. Sladky’s hearing testimony in Roberts was provided after that probationary period had terminated, the special master was troubled by Dr. Sladky’s lack of candor, noting that “in discussing his qualifications at the hearing, no mention was made of [licensure suspension problems] and such information was glossed over.” Id. In Raymo v. Sec’y of Health & Human Servs., No. 11-654V, 2014 WL 1092274, at *14 (Fed. Cl. Spec. Mstr. Feb. 24, 2014), the special master noted, first, that Dr. Sladky “was properly licensed throughout his involvement with th[at] case.” Nonetheless, the special master observed that the CV provided by Dr. Sladky in Raymo, dated “January 5, 2009,” was inaccurate: I looked carefully at the testimony of Dr. Sladky and his CV, filed as Res. Ex. B. Although filed with his expert report in February 2012, his CV is dated January 5, 2009. His CV therefore was written or updated near the end of the period during which Dr. Sladky had agreed not to practice medicine. However, Dr. Sladky’s CV 14 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 15 of 24 does not reflect that he had taken leave from his hospital appointments. Id. at *15 (citation omitted). The special master then turned to the testimony provided by Dr. Sladky as to his qualifications as an expert: Doctor Sladky was . . . careful . . . to avoid perjuring himself. He testified that he began working at Emory University in 1995 and had recently retired and moved to a private practice in Atlanta. He did not mention that between 1995 and 2012 there were periods when he had a suspended medical license or practiced only on a probationary basis. When asked to describe his day-to-day activities while at Emory and in his current position, he carefully prefaced his answer with “when I was on service.” This preface could reflect the difference in his roles when performing medical duties versus his administrative or teaching duties. Alternatively, it could be considered a carefully crafted answer to avoid giving perjured testimony. By specifying that his answer pertained to the time periods when he was practicing medicine, he avoided the necessity of indicating that there were periods when he was not able to practice medicine due to the suspension of his medical license. Id. (citations omitted). This special master, too, was troubled by Dr. Sladky’s avoidance of the topic of his licensure problems. The following passage reflects the special master’s conclusions as to the misleading nature of the testimony provided by Dr. Sladky: I administer an oath to witnesses that requires that they tell the whole truth. Neither . . . nor Dr. Sladky told the whole truth. Both demonstrated a lack of candor that, although not related directly to the substance of their 15 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 16 of 24 causation opinions, reflect[s] their willingness to, at the very least, shade the truth. . . . In the case of Dr. Sladky, it appears that he so feared the loss of his position and income as a case reviewer for respondent that he withheld facts concerning his medical license suspension. Id. at *16. Thus, in both Roberts and Raymo, Dr. Sladky’s testimony was viewed in a negative light because of his misleading statements regarding his medical practice and qualifications to opine as an expert. 4. Credibility and Reliability Determinations in Other Vaccine Cases Based on Dr. Sladky’s Lack of Candor The credibility and reliability determinations regarding the overall value of Dr. Sladky’s opinions in Roberts and Raymo are not exactly the same. In Roberts, the special master merely noted that Dr. Sladky’s representations regarding his qualifications were “questionable,” and that the recently revealed information about his licensure problems gave her “pause.” 2013 WL 5314698, at *9. Her conclusion regarding his opinions, based on the candor issue as well as the substantive content of his opinions, was that she “d[id] not find Dr. Sladky’s testimony as reliable and persuasive as the testimony of [two of the petitioners’ experts].” Id. In Raymo, on the other hand, Dr. Sladky’s credibility was destroyed by his lack of candor regarding his licensure problems. The special master considered not only Dr. Sladky’s lack of candor in the case before her, but also his lack of candor in other vaccine cases: Standing alone, the basis for Dr. Sladky’s disciplinary action might not affect the reliability of his expert opinions. However, his failure to disclose the disciplinary action to respondent, his authoring of expert opinions while he did not have an active medical license, and the failure to reflect his voluntary leave from medical practice due to a substance abuse problem on the CV filed in this case all cast doubt about his credibility 16 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 17 of 24 as a witness. Raymo, 2014 WL 1092274, at *15. She therefore did not rely at all on the opinion of Dr. Sladky for her entitlement decision in that case. It is perhaps noteworthy that petitioners in both Roberts and Raymo prevailed on entitlement, at least in part because the expert opinion of Dr. Sladky was of lessened or no value to respondent’s arguments in those cases. Raymo, 2014 WL 1092274, at *17 (“Because I attach no weight to the opinions of Drs. Sladky and . . . , [petitioners’ expert’s] opinion is largely unrebutted.”); Roberts, 2013 WL 5314698, at *11 (basing her decision regarding entitlement on the special master’s “review of the evidence and an assessment of the reliability of the opinions of the various expert witnesses”). B. The Special Master’s Assessment of Dr. Sladky’s Credibility and Reliability in This Case The special master’s ruling on the credibility and reliability of Dr. Sladky, rendered after the parties hotly contested the importance of the Secretary’s disclosures, is ambiguous. In the section of the opinion devoted to Dr. Sladky’s credibility and reliability as an expert, the special master states: The Secretary does not dispute that Dr. Sladky should have disclosed the information concerning his health issues and the effect they had on his ability to practice medicine. The failure to disclose this important information bears on his credibility and reliability as an expert witness. However, the lack of disclosure and (implicit) misrepresentation about qualifications does not entirely negate Dr. Sladky’s opinion. Dr. Sladky established his opinion almost three years before his license was suspended and it has not changed throughout the course of these proceedings. As the Secretary asserted, it does not appear that Dr. Sladky’s personal health issues or his licensure problems affected his opinions in any way. In addition, Dr. Sladky’s opinions are consistent with the 17 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 18 of 24 opinions of other witnesses. This corroboration shows that Dr. Sladky’s opinions retain some value. Opin. at 7 (citations and footnote omitted). A later comment on the credibility and reliability of Dr. Sladky is presented in a footnote: The [causation] analysis in the text does not rely upon Dr. Sladky’s opinion extensively. Thus, under the circumstances in which the Secretary presented the opinion of a different doctor, the problems in Dr. Sladky’s licensing and the non-disclosure of these problems ha[ve] minimal effect on this case. Id. at 71 n.51. 1. Minimizing the Importance of Dr. Sladky’s Misrepresentations and Misleading Testimony for Credibility and Reliability Determinations The court observes, first, that the special master appears to dismiss Dr. Sladky’s substance abuse problem and lack of candor as relatively unimportant. See Opin. at 71 n.51; see also supra note 8. The special master notes, for example, that Dr. Sladky never saw Jessie as a patient, and comments that petitioner did not establish “that a suspension of a license to practice medicine means that the person may not provide opinions based upon the person’s training and experience.” Opin. at 6. The more salient issue, in the court’s view, is whether a physician engaged as an expert by the Secretary should have revealed to respondent’s counsel that his expert report was created, at least in part, during a time period when the physician’s license to practice medicine was suspended. At this late date, it may not be helpful to inquire whether the special master’s assumptions regarding the severity and duration of Dr. Sladky’s substance abuse problem are correct. See Opin. at 7 (“Dr. Sladky established his opinion almost three years before his license was suspended and it has not changed throughout the course of these proceedings. As the Secretary asserted, it does not appear that Dr. Sladky’s personal health issues or his licensure problems affected his opinions in any way.”). The court cannot ignore, however, the fact 18 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 19 of 24 that the special master improperly conflated Dr. Sladky’s 2005 expert report with his 2010 expert report and hearing testimony, in a manner that minimizes Dr. Sladky’s credibility problems: [T]he lack of disclosure and (implicit) misrepresentation about qualifications does not entirely negate Dr. Sladky’s opinion. Dr. Sladky established his opinion almost three years before his license was suspended and it has not changed throughout the course of these proceedings. Opin. at 7 (emphasis added). Dr. Sladky provided more than one opinion in this case, as the record clearly shows. At the time of the filing of Dr. Sladky’s first report, petitioner’s expert Dr. Steinman had not yet opined on causation and the subsidiary issues relevant to causation. Dr. Sladky’s second expert report is not a carbon copy of his first report – it was filed “to address the issues raised by petitioner’s expert, Dr. Steinman.” Resp.’s Status Report of January 27, 2010, at 1; see Tr. at 279 (direct examination confirming that Dr. Sladky’s second report, Ex. P, “was in response to Dr. Steinman’s report”); Ex. P at 1 (“I have been asked to comment on supplementary opinions which have been provided to this court regarding the above referenced matter. I have not previously reviewed these documents as they were submitted after I prepared my initial report in 2005.”). Dr. Sladky’s opinions on many issues considered by the special master were presented in his second expert report or later at the hearing; it cannot be said that Dr. Sladky’s sole opinion was presented first in 2005 and never changed thereafter. To the extent that a specific Dr. Sladky opinion disagrees with a specific proposition advanced by Dr. Steinman in this case, Dr. Sladky’s opinion is necessarily of a 2010 vintage, not a 2005 vintage. See Tr. at 321-22 (noting that he had only worked on this case, after 2005, not long “before we came here [for the 2010 hearing]”). To obtain some of these 2010 vintage opinions, Dr. Sladky was cross-examined about his second report, which was signed and filed in 2010. Id. at 353. He was also examined as to his (2010 vintage) view of certain opinions 19 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 20 of 24 of Dr. Steinman. Id. at 371-72, 381-82, 389-90, 396, 402-03.9 Therefore, it cannot be said that Dr. Sladky’s opinion did not change or was consistent after 2005. In the court’s view, the proposition that Dr. Sladky’s supposedly “reliable” 2005 opinions somehow validate later opinions tainted by a documented substance abuse problem, disciplinary actions preventing him from practicing medicine, and a lack of candor, is flawed. Dr. Sladky’s hearing testimony, it should be noted, contains some consistent opinions but also contains some newly-proffered opinions, and these 2010 vintage opinions were considered by the special master in his decision.10 The body of Dr. Sladky’s oral testimony, which was highly- detailed and went far beyond the analysis presented in his five-page 2005 expert report, must largely stand or fall based on Dr. Sladky’s credibility when he was testifying in 2010. The only other flaw in the special master’s analysis of the “credibility and reliability” of Dr. Sladky worth noting is that of an illogical reliance on “corroboration.” Opin. at 7. Dr. Sladky’s opinions retain some value, according to the special master, because Dr. Sladky’s opinions are consistent with the opinions of other witnesses. This corroboration shows that Dr. Sladky’s opinions retain some value. Id. (footnote omitted). One could interpret this statement as suggesting that the fact-finder may abdicate his role as the assessor of credibility of expert witnesses whenever the witness in question offers statements that are in harmony with 9/ These transcript citations are limited to instances where Dr. Steinman was mentioned by name. There are other examples in Dr. Sladky’s testimony where propositions advanced by Dr. Steinman were referenced but his name was not. 10/ To cite one example, Dr. Sladky’s opinion regarding the significance of a certain reflex test was cited by the special master. Opin. at 11 n.6, 28. That particular Dr. Sladky opinion was not presented in 2005. See Ex. I. Although certain opinions, such as Dr. Sladky’s opinion regarding the timing of the onset of Jessie’s disease, did not evolve in any substantive way, many other Dr. Sladky opinions were disclosed or refined in 2010. 20 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 21 of 24 statements from other expert witnesses.11 Such a practice would avoid making credibility determinations in the first instance and would proceed directly to the weighing of available evidence without first determining whether that evidence is reliable. This approach violates binding precedent which requires special masters to assess the credibility, in appropriate instances, of expert witnesses: Finders of fact are entitled – indeed, expected – to make determinations as to the reliability of the evidence presented to them and, if appropriate, as to the credibility of the persons presenting that evidence. . . . In this case, the special master applied the correct legal standard and found, based in part on the unconvincing nature of the expert evidence and the lack of credibility of the petitioners’ expert, that the petitioners failed to prove causation by a preponderance of the evidence. Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1326 (Fed. Cir. 2010) (emphasis added). If there has ever been an appropriate instance in a Vaccine Act case where a special master must first assess the credibility of an expert witness, Dr. Sladky’s testimony and opinions provide that circumstance. In the court’s view, before the special master can assess whether Dr. Sladky’s opinions are convincing or persuasive, he must first determine whether or not Dr. Sladky is a credible witness providing reliable opinions. 11/ An additional weakness in the special master’s reliance on the “corroboration” of Dr. Sladky’s opinions is the special master’s imprecise characterization of this corroboration as corroboration provided by “other witnesses.” Opin. at 7 & n.4. The corroboration for Dr. Sladky’s diagnosis of Jessie’s illness, for example, is provided not by any testifying witness, affidavit or declaration, but by the special master’s interpretation of excerpts from Jessie’s medical records. See Pet.’s Mot. at 16 (“None of these four physicians [upon whose commentary in Jessie’s medical records the special master relied] provided any written opinions to be considered or testimony at the hearing.”); Opin. at 7 n.4 (“Dr. Sladky’s opinion matches the diagnosis of Mr. Contreras’s treating neurologist [who did not testify at the hearing or provide a declaration].”), 25-26 (citing medical records found in Exs. 7, 82), 29-30 & nn.23-24 (citing medical records found in Ex. 7). 21 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 22 of 24 2. Lack of Clarity as to the Assessment of Dr. Sladky’s Credibility and Reliability The court has attempted to reconcile the special master’s statements regarding Dr. Sladky’s credibility and reliability. These statements include: (1) “Dr. Sladky’s opinions retain some value”; (2) “The analysis in the text does not rely upon Dr. Sladky’s opinion extensively”; and, (3) “[U]nder the circumstances in which the Secretary presented the opinion of a different doctor, the problems in Dr. Sladky’s licensing and the non-disclosure of these problems ha[ve] minimal effect on this case.” Opin. at 7, 71 n.51. These statements, in the court’s view, lack precision and frustrate review. Furthermore, not only are these statements vague, but the text of the decision contradicts the assertion that Dr. Sladky’s opinions have not been relied upon extensively. The special master’s decision includes extensive citations to Dr. Sladky’s specific opinions on a number of issues relevant to the special master’s decision on entitlement. Reference is made to Dr. Sladky’s opinions on almost every decisive issue in this case – these references are found on pages 11 n.6, 17, 27-29, 36-37, 46 & n.35, 48-52, 54, 59-60, 65-68, 70-71, and 74 of the special master’s decision. Dr. Sladky’s substance abuse, licensure problems and lack of candor may indeed have had “minimal effect” on the special master’s ruling on entitlement, but the effect of the disclosure of these issues remains ambiguous. The special master’s decision reviewed here does not clearly state the special master’s determinations regarding the credibility of Dr. Sladky and the reliability of Dr. Sladky’s opinions. The court therefore remands this case to the special master. III. Instructions for Remand Three clarifications are needed before the court can determine whether the special master has abused his discretion in relying on the expert opinions of Dr. Sladky. First, 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 22 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 23 of 24 Dr. Sladky’s credibility and reliability as an expert.12 Second, the special master must compare Dr. Sladky’s credibility to the credibility of the experts for petitioner and the witnesses testifying for petitioner. These clarified credibility determinations should then be integrated into the special master’s decision in a manner that presents a clear ruling on entitlement for this court’s review.13 Third, for the sake of judicial economy, the special master must present an alternative ruling on causation which completely disregards all of Dr. Sladky’s opinions and testimony. This alternative ruling should be adequately detailed to provide this court with holdings that may either be sustained or vacated should this court (or a higher court) determine that Dr. Sladky’s testimony should not have been considered at all in this case once the disclosures regarding Dr. Sladky had been provided by the Secretary to the special master. In the unique circumstances of this case, it would be inefficient to further delay proceedings with another remand to the special master should this court find manifest error in the special master’s level of reliance on the opinions of Dr. Sladky.14 CONCLUSION For all of the above-stated reasons, the court remands this case to the special master so that his credibility and reliability determinations, as well as his holdings regarding causation, are clearly presented for review. Specifically, for this court 12/ 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 in this case, not whether his opinions, as buttressed by other expert opinion and evidence, were persuasive on particular issues. See Opin. at 7 (“The failure to disclose this important information bears on [Dr. Sladky’s] credibility and reliability as an expert witness.”) (citations omitted). 13/ The special master may choose to revise his substantive rulings in this case based on his clarified credibility rulings, or may re-issue the substantive rulings of the opinion with only minor modifications which clarify the sections discussing the credibility of witnesses and the reliability of expert opinion in this case. 14/ The court issues no holding here as to the appropriateness of any particular level of reliance on Dr. Sladky’s opinions. It is the potential for a ruling requiring the exclusion of Dr. Sladky’s opinions and testimony that militates for an alternative finding on causation. 23 Case 1:05-vv-00626-RHH Document 212 Filed 06/16/14 Page 24 of 24 to determine whether or not the special master’s evidentiary rulings regarding Dr. Sladky’s opinions were manifestly erroneous, the special master must follow the instructions for remand provided in this opinion. See, e.g., Piscopo, 66 Fed. Cl. at 53 (“Determinations as to the qualification of experts and the admissibility of their testimony, including an evaluation of whether the opinion is reliable and relevant, are generally within the discretion of a trial judge, and are reviewed for an abuse of discretion, [and] only overturned if manifestly erroneous.”) (citations omitted). The court cannot undertake a review of the special master’s ultimate ruling on entitlement without the clarifications specified in this opinion. Accordingly, it is hereby ORDERED that (1) Petitioner’s Motion for Review, filed December 19, 2013, is GRANTED; (2) The decision of the special master, filed November 19, 2013, is SET ASIDE and VACATED; (3) This case is REMANDED to the special master, pursuant to Vaccine Rule 27(c), for proceedings in accordance with the principles of law and the instructions set forth in this opinion; and (4) The parties shall separately FILE any proposed redactions to this opinion, with the text to be redacted clearly marked out or otherwise indicated in brackets, on or before June 6, 2014. /s/Lynn J. Bush LYNN J. BUSH Senior Judge 24 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_05-vv-00626-2 Date issued/filed: 2015-05-06 Pages: 29 Docket text: JUDGE VACCINE REPORTED OPINION re: 223 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Judge Lynn J. Bush. (kh) Copy to parties. -------------------------------------------------------------------------------- Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 1 of 29 In the United States Court of Federal Claims No. 05-626 V (Filed May 6, 2015)1 * * * * * * * * * * * * * * * JESSIE CONTRERAS, * * National Childhood Vaccine Petitioner, * Injury Act of 1986, 42 U.S.C. * §§ 300aa-1 to -34 (2012); v. * Review of Credibility * Determination; Deferential SECRETARY OF HEALTH AND * Review of the Fact Findings of HUMAN SERVICES, * the Special Master. * Respondent. * * * * * * * * * * * * * * * * Jeffrey S. Pop, Beverly Hills, CA, for petitioner. Kristina E. Grigorian, Beverly Hills, CA, of counsel. Linda S. Renzi, United States Department of Justice, with whom were Joyce R. Branda, Acting Assistant Attorney General, Rupa Bhattacharyya, Director, Vincent J. Matanoski, Deputy Director, Voris E. Johnson, Jr., Assistant Director, Washington, DC, for respondent. ________________________________ OPINION AND ORDER ________________________________ BUSH, Senior Judge. 1/ Pursuant to Rule 18(b) of Appendix B of the Rules of the United States Court of Federal Claims, this Opinion and Order was initially filed under seal on April 17, 2015. Pursuant to ¶ 4 of the ordering language, the parties were to propose redactions of the information contained therein on or before May 1, 2015. No proposed redactions were submitted to the court. Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 2 of 29 Now pending before the court is petitioner’s motion for review of the special master’s decision upon a second remand from this court, see Contreras v. Sec’y of Health & Human Servs., No. 05-626V, 2014 WL 8098606 (Fed. Cl. Spec. Mstr. Oct. 24, 2014) (Contreras V),2 which denied Jessie Contreras’s petition for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (2012) (the Vaccine Act).3 Under the standard of review applicable here, the special master’s denial of petitioner’s entitlement to compensation under the Vaccine Act survives review. For this reason, the court denies petitioner’s motion for review filed November 21, 2014. BACKGROUND I. Factual History Along with Contreras V, prior decisions in this case provide a factual background for Jessie’s alleged vaccine injury of transverse myelitis (TM) and Guillain-Barré Syndrome (GBS). See, e.g., Contreras v. Sec’y of Health & Human Servs., 116 Fed. Cl. 472 (2014) (Contreras IV); Contreras v. Sec’y of Health & Human Servs., No. 05-626V, 2013 WL 6698382 (Fed. Cl. Spec. Mstr. Nov. 19, 2013) (Contreras III), vacated, 116 Fed. Cl. 472 (2014); Contreras v. Sec’y of Health & Human Servs., 107 Fed. Cl. 280 (2012) (Contreras II); Contreras v. Sec’y of Health & Human Servs., No. 05-626V, 2012 WL 1441315 (Fed. Cl. Spec. Mstr. Apr. 5, 2012) (Contreras I), vacated, 107 Fed. Cl. 280. The alleged injury occurred in 2003 when Jessie was thirteen, approximately twenty-four hours after Jessie received inoculations containing the hepatitis B vaccine and the tetanus- diptheria vaccine. Jessie is now almost twenty-five years of age. The court reserves further discussion of the factual background of this case for the analysis section of this opinion. II. Procedural History 2/ The court cites not to the Westlaw version of the special master’s opinion on remand, but follows the practice of the parties and cites to the opinion version (Contreras V or Opin.) available on this court’s website. 3/ Hereinafter the court will refer to Mr. Contreras as “petitioner” or “Jessie,” because he was thirteen years old at the time of his alleged vaccine injury. 2 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 3 of 29 In Contreras I, the special master denied petitioner entitlement to compensation under the Vaccine Act. In Contreras II, this court vacated that opinion and remanded the case to the special master for a revised causation analysis. In Contreras III, the special master issued a revised causation analysis which again denied petitioner entitlement to compensation. Before the special master issued his decision, however, on May 1, 2013 the Secretary filed a status report revealing previously undisclosed information regarding one of respondent’s experts, Dr. John T. Sladky, M.D. The general nature of the information concerned alcohol abuse and the suspension of Dr. Sladky’s license to practice medicine. Dr. Sladky carefully avoided revealing this negative information in documents he supplied to the court and in his testimony before the special master.4 In Contreras IV, in light of the recently-divulged information regarding Dr. Sladky, the court again remanded this case to the special master in order to obtain three clarifications of his fact findings as to Jessie’s entitlement to compensation under the Act. These clarifications required by the court were set forth in the “Instructions for Remand” section of Contreras IV: (1) 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. (2) The special master must compare Dr. Sladky’s credibility to the credibility of the experts for petitioner and the witnesses testifying for petitioner. These clarified credibility determinations should then be integrated into the special master’s decision in a manner that presents a clear ruling on entitlement for this court’s review. (3) The special master must present an alternative ruling on causation which completely disregards all of Dr. Sladky’s opinions and testimony. 4/ A full recitation of Dr. Sladky’s misleading misrepresentations and lack of candor, in this Vaccine Act case and in others, is provided in Contreras IV and Contreras V. 3 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 4 of 29 Contreras IV, 116 Fed. Cl. at 484 (formatting slightly altered and footnotes omitted). The special master’s opinion in Contreras V is structured to respond to these three questions on remand. See Opin. at 2, 13. DISCUSSION I. Standard of Review This court has jurisdiction to review the decision of a special master in a Vaccine Act case. 42 U.S.C. § 300aa-12(e)(2). “Under the Vaccine Act, the Court of Federal Claims reviews the decision of the special master to determine if it is ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law[.]’” de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1350 (Fed. Cir. 2008) (quoting 42 U.S.C. § 300aa-12(e)(2)(B) and citing Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1277 (Fed. Cir. 2005)) (alteration in original). This court uses three distinct standards of review in Vaccine Act cases, depending upon which aspect of a special master’s judgment is under scrutiny: These standards vary in application as well as degree of deference. Each standard applies to a different aspect of the judgment. Fact findings are reviewed . . . under the arbitrary and capricious standard; legal questions under the “not in accordance with law” standard; and discretionary rulings under the abuse of discretion standard. Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). The third standard of review, abuse of discretion, is applicable when the special master excludes evidence or otherwise limits the record upon which he relies. See id. As this court has stated, the third standard applies to the special master’s evidentiary rulings, including those regarding the qualifications of an expert: Notably, such [discretionary] rulings include determinations regarding the qualification of expert 4 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 5 of 29 witnesses and the reliability of expert testimony. Piscopo v. Sec’y of Health & Human Servs., 66 Fed. Cl. 49, 53 (2005); see [Gen. Elec. Co. v. Joiner, 522 U.S. 136, 142-43 (1997)] (holding that “abuse of discretion is the proper standard of review of a [trial] court’s evidentiary rulings,” including determinations regarding the reliability of expert testimony under [Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993))]; [Terran ex rel. Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999)] (reviewing for abuse of discretion the Special Master’s decision to reject as unreliable the testimony of the petitioner’s expert). Determinations subject to review for abuse of discretion must be sustained unless “manifestly erroneous.” Piscopo, 66 Fed. Cl. at 53; see Milmark Servs., Inc. v. United States, 731 F.2d 855, 860 (Fed. Cir. 1984) (holding that decisions that lie within the trial court’s discretion are to be sustained unless “manifestly erroneous”). Jarvis v. Sec’y of Dep’t of Health & Human Servs., 99 Fed. Cl. 47, 59 (2011). Thus, a special master’s determination as to the reliability of expert witness testimony is reviewed under the abuse of discretion, or manifestly erroneous, standard. Terran, 195 F.3d at 1316 (citing Burns v. Sec’y of Dep’t of Health & Human Servs., 3 F.3d 415, 416-17 (1993)); Jarvis, 99 Fed. Cl. at 59. The United States Supreme Court has also stated that a fact-finder’s decision to admit or exclude expert testimony is reviewed for abuse of discretion, and that this review is deferential. Joiner, 522 U.S. at 143 (citing Koon v. United States, 518 U.S. 81, 98-99 (1996)). On the particular topic of a fact-finder’s determination as to the credibility of a testifying witness, the United States Court of Appeals for the Federal Circuit has often stated that such determinations are “‘virtually unreviewable.’” E.g., Bradley v. Sec’y of Dep’t of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993) (quoting Hambsch v. Dep’t of Treasury, 796 F.2d 430, 436 (Fed. Cir. 1986)). The court has found no authority, however, which states that a credibility determination is immune from review, particularly where, as here, extrinsic 5 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 6 of 29 evidence has subsequently been disclosed which shows a lack of candor on the part of an expert witness. For this reason, the court reviews the special master’s determinations regarding Dr. Sladky’s credibility and the reliability of Dr. Sladky’s expert opinions for manifest error. II. Analysis As a threshold matter, the court examines the scope of the remand ordered by Contreras IV, which appears to have created, or at least to have contributed to, some confusion. See Pet’r’s Mot. at 1 n.1 (stating that the “procedural state of the case is unclear”); Resp’t’s Resp. at 7 n.4 (arguing that some of petitioner’s arguments are “beyond the scope of the Court’s remand”). Contreras IV clearly indicated, however, that both the special master’s denial of entitlement and his assessment of the credibility and reliability of medical opinions are within the scope of the latest remand. See Contreras IV, 116 Fed. Cl. at 484 (requiring clarified credibility/reliability determinations and an integration of these determinations into the special master’s entitlement decision, as well as an alternative finding on entitlement which excludes Dr. Sladky’s evidence). Because Contreras V does not restate the special master’s entitlement decision set forth in Contreras III, but merely references that decision as the embodiment of the special master’s entitlement decision, the parties were not prevented from contesting the lengthy entitlement analysis which was provided by Contreras III. See Contreras V, at 37 (“For the reasons explained in [this opinion], Dr. Sladky is sufficiently credible and sufficiently reliable that his evidence should remain in the record. Thus, the outcome of [Contreras III], a denial of compensation, does not differ.”). Therefore, even though Contreras III was vacated by this court, the analysis contained in that decision was incorporated into Contreras V by the special master, and that entitlement decision remains within the scope of the court’s remand. In light of the foregoing, the scope of the remand ordered by Contreras IV included, at least, the following three elements: (1) clarified credibility/reliability determinations for the medical opinions offered by the parties’ experts and witnesses in this case; (2) the entitlement decision set forth in Contreras III (supplemented by the clarifications of the special master’s credibility/reliability determinations set forth in Contreras V); and, (3) the alternative entitlement decision rendered in Contreras V which excluded Dr. Sladky’s evidence. These 6 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 7 of 29 three aspects of Contreras III and Contreras V were set forth as the proper subject for petitioner’s motion for review and the Secretary’s response brief. These three topics also provide the general outline for the court’s opinion here. A. The Special Master’s Reliance on Dr. Sladky’s Medical Opinions Was an Abuse of Discretion 1. Credibility/Reliability in the Context of Later-Disclosed Misrepresentations and Lack of Candor The court acknowledges, as does the special master in Contreras V, that there is no binding precedent from the Federal Circuit as to the proper course of action to be followed when an expert’s lack of candor and misrepresentations regarding his credentials are discovered after a bench trial or hearing. Opin. at 20. Nor is the court aware of any precedent from the Supreme Court that directly addresses this specific question. The special master examined a number of cases for guidance and appears particularly influenced by Elcock v. Kmart Corp., 233 F.3d 734 (3d Cir. 2000). Opin. at 17-18. The court does not find Elcock particularly helpful because much of the instruction in that opinion is focused on the trial court’s limited role in assisting a jury to find facts. See 233 F.3d at 751 n.8 (warning that an aggressive approach to assessing the credibility of an expert might “improperly impinge on the province of the ultimate fact-finder, to whom issues concerning the general credibility of witnesses are ordinarily reserved”). Where there is no jury, as here, the credibility/reliability question must be approached differently. The Secretary cited to United States v. Shaffer Equip. Co., 11 F.3d 450, 458-59 (4th Cir. 1993) when she revealed Dr. Sladky’s transgressions, Opin. at 10, and the court finds this case to be more helpful. Although the special master noted differences between the circumstances in Shaffer and the circumstances in this case (in that case the government’s attorneys unethically delayed the revelation of their deceitful witness problem), Shaffer offers almost exactly the same underlying factual scenario as this case – an important witness is discovered to have repeatedly misrepresented his credentials to his employer and various judicial officers. A brief examination of Shaffer is instructive. The basic fact scenario in Shaffer involved a key government employee who 7 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 8 of 29 directed environmental clean-up efforts at a polluted site, oversaw the creation of the administrative record of the clean-up efforts, and testified in support of the government’s claims seeking to recoup clean-up costs from the landowners. 11 F.3d at 453-55. This employee lied about his educational credentials on his government employment application, his resume, and in depositions or testimony in various lawsuits. Id. at 454-55. The trial court, finding that the government’s attorneys had violated their duty of candor to the court by not disclosing the credibility problem for this witness, dismissed the government’s claims in their entirety. Id. at 456. On appeal, the United States Court of Appeals for the Fourth Circuit first discussed the fundamental requirement for truth in court proceedings: Our adversary system for the resolution of disputes rests on the unshakable foundation that truth is the object of the system’s process which is designed for the purpose of dispensing justice. However, because no one has an exclusive insight into truth, the process depends on the adversarial presentation of evidence, precedent and custom, and argument to reasoned conclusions – all directed with unwavering effort to what, in good faith, is believed to be true on matters material to the disposition. Even the slightest accommodation of deceit or a lack of candor in any material respect quickly erodes the validity of the process. As soon as the process falters in that respect, the people are then justified in abandoning support for the system in favor of one where honesty is preeminent. Shaffer, 11 F.3d at 457. In the case before the Fourth Circuit, the government’s key employee was “responsible for making” the administrative record of the clean- up, and his “credentials, capability and credibility [we]re relevant to the examination of the administrative record in this case.” Id. at 460. The appeals court concluded that “[t]he fact that the government’s agent in charge of monitoring expenses and selecting responses [to the presence of hazardous waste] filed fraudulent documents with the federal government and perjured himself repeatedly in connection with his federal employment is, we think, of primary 8 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 9 of 29 relevance to an examination of the integrity and reliability of the administrative record.” Id. Thus, this employee’s credibility was material to the outcome of the dispute before the trial court. Id. at 461. The appeals court did not agree with the trial court, however, that the extreme sanction of dismissal was the appropriate resolution with regard to the credibility and lack of candor problems in the government’s presentation of its case. Instead, the circuit court’s approach was to caution that a trial court was required to not only exercise its inherent power to dismiss with restraint, but that it could only exercise that power after considering several factors. These factors, which in the court’s view evince an obvious general applicability to situations in which candor to a court has been lacking, were set forth by the circuit court as follows: (1) the degree of the wrongdoer’s culpability; (2) the extent of the client’s blameworthiness if the wrongful conduct is committed by its attorney, recognizing that we seldom dismiss claims against blameless clients; (3) the prejudice to the judicial process and the administration of justice; (4) the prejudice to the victim; (5) the availability of other sanctions to rectify the wrong by punishing culpable persons, compensating harmed persons, and deterring similar conduct in the future; and (6) the public interest. Shaffer, 11 F.3d at 462-63. The court notes, in particular, the Fourth Circuit’s interest in the deterrence of similar conduct in the future, as well as its interest in safeguarding public access to judicial proceedings untainted by deception. The special master here does not appear to have considered either deterrence or the public interest in his credibility and reliability findings regarding Dr. Sladky, or in his decision to rely upon Dr. Sladky’s evidence in this case. Dr. Sladky’s evidence on every topic, save his credentials, has been accorded full and undiminished weight in Contreras III and Contreras V.5 According to the special 5/ The special master was obliged by the remand to also provide an alternative finding on (continued...) 9 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 10 of 29 master’s opinion: 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. Opin. at 31. In the court’s view, the special master’s reliance on Dr. Sladky’s testimony and opinions constitutes manifest error and an abuse of discretion. In his latest opinion, the special master ably surveys cases which show the range of measures that a judicial officer may take in response to the disclosure of negative information reducing a witness’s credibility. Opin. at 16-26. It is difficult to establish a bright-line rule for Vaccine Act proceedings from these cases, for a number of reasons. Some of the cases discussed by the special master address the admissibility of witness testimony, and give basic guidance as to when a trial judge should permit a witness with credibility problems to testify in front of a jury. See, e.g., In re Heparin Prods. Liab. Litig., 803 F. Supp. 2d 712, 752 (N.D. Ohio 2011) (admitting some testimony and excluding other testimony by a medical expert and indicating that the trial judge would “provide a cautionary instruction informing the jury that Dr. Burch lied under oath in this proceeding and others about some aspects of his credentials, and his opinions are therefore subject to greater scrutiny”). Because a special master is the ultimate fact-finder and does not instruct a jury, these evidentiary rulings in the context of jury trials are not as relevant to the issue presented in this case. Even when a bench trial ruling regarding a witness’s below-average credibility is presented in the cases cited by the special master, it is impossible to discern a rule for solving the problem of an expert witness who consistently misrepresents his credentials. In an unreported decision cited by the special master, a United States District Court was adjudicating a damages dispute after liability had already been decided when one of the damages experts 5(...continued) entitlement which excluded Dr. Sladky’s evidence. For this alternative finding, the special master’s assessment of Dr. Sladky’s credibility and reliability was irrelevant. 10 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 11 of 29 misrepresented his recently-expired credential. Pikas v. Williams Cos., No. 8-cv- 101-GKF-PJC, 2013 WL 622234, at *1 (N.D. Okla. Feb. 20, 2013). The district court refused to strike the expert’s declarations, without much explanation, other than to state that his opinions were “helpful to understanding the issues before the court.” Id. at *2. As the special master noted here, not only did Dr. Sladky repeatedly misrepresent that he was currently licensed in Pennsylvania (although that license had expired almost ten years before the filing in this case of his inaccurate curriculum vitae), he also repeatedly misled a number of special masters as to his licensure in Georgia and his medical practice. Opin. at 24-26. The court does not view Pikas as persuasive authority – it presents neither a thorough analysis nor an analogous fact-pattern. The court finds more persuasive authority in In re Unisys Sav. Plan Litig., 173 F.3d 145 (3d Cir. 1999), a precedential decision also cited by the special master. The United States Court of Appeals for the Third Circuit affirmed the trial court’s decision to exclude expert testimony because “[w]e would be hard pressed to require a District Court judge sitting in a non-jury case who credibly and with reason found that he could not believe a witness to nevertheless hear the witness’s direct examination, cross-examination, and rebuttal examination in an extended trial when he knew that he would only reject it as unbelievable.” Id. at 157. The trial judge could not believe the expert because his credibility and reliability had been diminished for a number of reasons, including the provision of conflicting testimony regarding his credentials. Id. at 156-57. It is important to note that the Third Circuit in Unisys appears to have found rough equivalence among the terms “credibility,” “reliability,” “believability” and “weight to be accorded expert testimony,” because such terms are used interchangeably in its analysis. Id. at 156-58. The court finds this analytical construct persuasive, and concludes that an expert witness who is not credible does not, as a general rule, provide reliable expert testimony. Even if a pattern of misrepresentation is seen by the fact-finder as less consequential in its effect on an expert witness’s credibility and reliability, the court cannot read persuasive caselaw as permitting a fact-finder to brush past the credibility problem merely because the only documented misrepresentations in the record were on the subject of the expert’s qualifications. In similar cases, a rational approach is to diminish the weight of that expert’s testimony or to subject that expert’s testimony to stricter scrutiny. See, e.g., Harkabi v. SanDisk Corp., 11 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 12 of 29 891 F. Supp. 2d 527, 539 (S.D.N.Y. 2012) (noting that an expert, Dr. Johnson, had twice exaggerated her credentials in that litigation and stating that “this Court discounts Dr. Johnson’s opinions and views them skeptically”); Roberts v. Sec’y of Health & Human Servs., No. 09-427V, 2013 WL 5314698, at *9 (Fed. Cl. Spec. Mstr. Aug. 29, 2013) (finding the opinions of Dr. Sladky to be less reliable and of less weight than those of the petitioners’ experts due, in part, to his lack of candor regarding his licensure problems). The court sees no sign that the special master in this case discounted the substantive testimony and opinions provided by Dr. Sladky, despite being confronted with far more information regarding Dr. Sladky’s pattern of misrepresentations as to his credentials than had been presented to the special master in Roberts. In another Vaccine Act case, the chief special master thoroughly explored the issue of Dr. Sladky’s credibility and reliability, as well as the pattern of misrepresentations in his work for respondent in a number of cases, when she discussed two expert “witnesses with ethical challenges.” Raymo v. Sec’y of Health & Human Servs., No. 11-654V, 2014 WL 1092274, at *14 (Fed. Cl. Spec. Mstr. Feb. 24, 2014). The chief special master carefully examined the importance of truthfulness as a factor in credibility and reliability: Standing alone, the basis for Dr. Sladky’s disciplinary action might not affect the reliability of his expert opinions. However, his failure to disclose the disciplinary action to respondent, his authoring of expert opinions while he did not have an active medical license, and the failure to reflect his voluntary leave from medical practice due to a substance abuse problem on the [curriculum vitae] filed in this case all cast doubt about his credibility as a witness. Id. at *15. The court notes that the chief special master, like the Third Circuit in Unisys, treated credibility and reliability as related and roughly equivalent concepts. See id. at *13-15 (employing the terms credibility and reliability interchangeably). The chief special master in Raymo concluded that she must exclude Dr. Sladky’s opinions: 12 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 13 of 29 Although both Dr. Becker and Dr. Sladky are well qualified to opine, I cannot rely on their opinions. I administer an oath to witnesses that requires that they tell the whole truth. Neither Dr. Becker nor Dr. Sladky told the whole truth. Both demonstrated a lack of candor that, although not related directly to the substance of their causation opinions, reflect their willingness to, at the very least, shade the truth. In the case of Dr. Becker, he attempted to pass off another’s work as his own. In the case of Dr. Sladky, it appears that he so feared the loss of his position and income as a case reviewer for respondent that he withheld facts concerning his medical license suspension. I thus do not rely at all on their expert opinions in this case. 2014 WL 1092274, at *16. The court notes that the chief special master in Raymo based her decision to exclude Dr. Sladky’s opinions on her knowledge of a limited number of misrepresentations by Dr. Sladky, whereas the special master in this case has now reviewed a more complete record yet he continues to rely on Dr. Sladky’s opinions. Having reviewed the most persuasive cases discussing, in a non-jury setting, the significance of: (1) truthfulness in judicial proceedings; (2) lack of candor to the court; (3) misrepresentations of an expert witness’s credentials; (4) the importance of deterrence of similar behavior; and, (5) the close connection between credibility and reliability, the court believes that in the circumstances of this case it was manifest error for the special master to fail to exclude Dr. Sladky’s evidence, or at the very least, to significantly discount the reliability and weight of Dr. Sladky’s opinions. Although a variety of meaningful responses to Dr. Sladky’s “ethical challenges” might have been appropriate, it was an abuse of discretion to completely ignore those ethical challenges in weighing the reliability of Dr. Sladky’s opinions. See Opin. at 27 n.17 (“The reliability of Dr. Sladky’s opinion does not take into account the lack of disclosures that diminish his credibility.”). In other words, the special master’s conclusions that “Dr. Sladky satisfies the minimal standard for credibility,” id. at 31, and that Dr. Sladky’s opinions on diagnosis, timing, and causation were reliable, id. at 29-31, constitute manifest error. 13 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 14 of 29 2. Credibility and Reliability Cannot Be Viewed as Distinct and Severable Concepts The special master analyzed Dr. Sladky’s credibility and reliability separately, and treated these two terms as distinct aspects of an expert’s evidence. It appears that the special master believes that an expert witness can be judged to be not credible, but can at the same time be judged to be a source of reliable expert testimony. The court provides here a few excerpts from Contreras V to illustrate the special master’s logical construct. First, after a lengthy discussion of Dr. Sladky’s lack of candor with the Secretary and this court, the special master notes: 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. Opin. at 25 (discussing one “factor weighing against Dr. Sladky’s credibility”). Nonetheless, the special master balanced Dr. Sladky’s credibility “negatives” with what he apparently viewed as credibility “positives”: 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 . . . as shading the truth. . . . 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. 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 14 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 15 of 29 accurate, honest, and forthcoming. Id. at 26 (citations omitted). The court notes that this is an odd test for credibility, which apparently calculates whether the number of instances of known deceptions are outweighed by instances of what appear to be truthful and accurate statements. The special master cites as authority for this approach the dissent rejected in Unisys. Id. After recounting elements in Dr. Sladky’s testimony which could be viewed as favoring petitioner’s cause, the special master stated that “[f]or his substantive opinions, Dr. Sladky appeared credible,” and that “[o]n the whole, Dr. Sladky’s candor on substantive matters offsets his lack of disclosures regarding personal matters.” Opin. at 27. The special master then concluded that “Dr. Sladky is sufficiently credible that his testimony should be evaluated for its reliability.” Id. In the court’s view, the first half of the credibility/reliability analysis in Contreras V, which apparently gives Dr. Sladky a passing credibility score because his misrepresentations as to his qualifications were outnumbered by “forthcoming” statements interpreting medical science, is neither logical nor grounded in persuasive authority. In Shaffer, for example, the government’s attorneys, despite their ethical lapses, ceased to rely on their key witness once they knew he had repeatedly lied about his credentials. 11 F.3d at 455. They clearly had no expectation that the fact-finder would credit his testimony after his untruths had been revealed. The court sees no logical reason why a pattern of misrepresentation and lack of candor should be seen as a minor factor in the determination of the credibility of a witness which can be overshadowed by testimony which contains no apparent falsehoods. In persuasive caselaw, courts typically consider an expert’s misrepresentations as to his qualifications to be serious transgressions. See, e.g., In re Vioxx Prods., 489 F. Supp. 2d 587, 591-94 (E.D. La. 2007) (granting a new trial because a testifying cardiologist with an expired board certification had asserted that he was “board certified,” and commenting that the expert’s “misrepresentation call[s] into question the Court’s acceptance of him as an expert witness, [and] also sheds an unfavorable light upon his propensity for truthfulness”). In a non-jury setting, where the judge or other judicial officer is the ultimate finder of fact, such misrepresentations are a dominant factor in credibility 15 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 16 of 29 determinations, not a minor one. See, e.g., Bonar v. Dean Witter Reynolds, Inc., 835 F.2d 1378, 1383-86 (11th Cir. 1988) (finding that where the testifying expert for the prevailing party had perjured himself as to his qualifications, a lower court had abused its discretion when it refused to vacate the portion of an arbitration award which relied upon that expert’s testimony); In re WRT Energy Corp., 282 B.R. 343, 371 (Bkrtcy. W.D. La. 2001) (“The court cannot trust the word of an expert witness who would brazenly lie about her credentials and then further lie when caught. If she would lie about her academic credentials, there is no reason to believe that she would not provide erroneous and/or misleading valuation testimony if she believed it would benefit her client. The court, therefore, will not ascribe any weight to the evidence supplied by [this expert].”). In cases which do not involve juries, the court has found no authority for the proposition that a judicial officer should establish his or her credibility determination by balancing known lies or deceptions against representations which appear to be forthright. Thus, the court finds the first half of the special master’s credibility/reliability analysis to constitute manifest error and an abuse of discretion, because it runs counter to reason and persuasive authority. The court turns now to the special master’s assessment of the reliability of the evidence provided by Dr. Sladky. As stated supra, the special master excluded Dr. Sladky’s lack of candor and misrepresentations from the inquiry into the reliability of Dr. Sladky’s evidence. Opin. at 27 n.17. Instead of clarifying the impact of Dr. Sladky’s credibility problems upon the reliability of his evidence, as this court attempted to request in its remand, the special master performed a Daubert analysis of Dr. Sladky’s opinions provided in this case. Id. at 27. The special master acknowledged that there is some imprecision in the use of the terms credibility and reliability in Vaccine Act cases and elsewhere. Id. at 20 n.13 (citations omitted). To the extent that the remand instructions in Contreras IV may have contributed to the special master’s decision to divorce credibility from reliability, the court regrets any ambiguity in that opinion. The court utilized both terms, credibility and reliability, in its remand instructions because each of these terms is present in precedential cases discussing the credibility of expert witnesses in the Vaccine Program. See, e.g., Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (holding that “this court has unambiguously explained that special masters are expected to consider the credibility of expert witnesses in 16 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 17 of 29 evaluating petitions for compensation under the Vaccine Act”); Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (noting that a special master weighs both “the credibility of the experts and the relative persuasiveness of their competing theories”) (citation omitted); Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1325-26 (Fed. Cir. 2010) (“Assessments as to the reliability of expert testimony often turn on credibility determinations . . . .”) (citations omitted); Andreu ex rel. Andreu v. Sec’y of Dep’t of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009) (distinguishing credibility, as a measurement of candor, from the assessment of the weight of scientific evidence). In light of the varying precedential formulations of the credibility inquiry, the court included both credibility and reliability in its instructions for remand so that no aspect of Dr. Sladky’s diminished credibility would be overlooked by the special master. See Contreras IV, 116 Fed. Cl. at 484 (stating 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 also attempted to explain the purpose of its request for a clarified credibility determination: 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 in this case, not whether his opinions, as buttressed by other expert opinion and evidence, were persuasive on particular issues. Id. at 484 n.12. In Contreras V, the special master concluded that Dr. Sladky’s diminished credibility was not relevant to the determination of the reliability of Dr. Sladky’s testimony and opinions. In Contreras III, he came to the opposite conclusion: “The failure to disclose this important information [regarding Dr. Sladky’s alcoholism and licensure problems] bears on [Dr. Sladky’s] credibility and reliability as an expert witness.” 2013 WL 6698382, at *5 (citations omitted). 17 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 18 of 29 Perhaps this is merely a question of imprecision as to the meaning of the term “reliability.” In the court’s view, once Dr. Sladky’s misrepresentations and lack of candor came to light, the question necessarily became one of credibility and reliability as these terms refer to trustworthiness, not as to the scientific legitimacy of his opinions that might be tested through Daubert or other means. The court cannot wholly separate credibility from reliability in this case. As noted supra, courts generally find a strong connection between an expert’s credibility and the reliability of that expert’s opinions; further, these determinations are not unrelated to the question of how much weight should be accorded to a particular expert’s opinion, or whether such an opinion is ultimately found to be persuasive. E.g., Porter, 663 F.3d at 1250-51; Broekelschen, 618 F.3d at 1347; Moberly, 592 F.3d at 1325-26; Unisys, 173 F.3d at 156-58; Harkabi, 891 F. Supp. 2d at 539; Raymo, 2014 WL 1092274, at *16; Roberts, 2013 WL 5314698, at *9. The court finds nothing in the special master’s assessment of Dr. Sladky’s “reliability,” under Daubert, to redeem the special master’s determination that Dr. Sladky “satisfies the minimal standard for credibility.” Opin. at 31. 3. The Special Master’s Credibility and Reliability Determinations Cannot Stand The abuse of discretion standard applicable here is highly deferential, as noted supra. In the particular circumstances of this case, however, the court finds that the special master failed to integrate a rational credibility determination into his ruling on entitlement in Contreras III. It would have been rational to have excluded Dr. Sladky’s evidence, as did the chief special master in Raymo. It could have been rational to have considered Dr. Sladky’s evidence while assigning that evidence diminished weight and greater scrutiny. The special master in this case chose neither of these rational courses of action. Based on this court’s review of relevant authority, and particularly in light of the need for deterrence of similar behavior from experts guiding special masters in Vaccine Act cases, the court finds that the special master’s credibility and reliability determinations in Contreras V constitute manifest error and an abuse of discretion. B. The Special Master’s Denial of Entitlement to Compensation in Contreras III, Tainted by Unqualified Reliance on Dr. Sladky’s Testimony and Opinions, Cannot Be Sustained 18 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 19 of 29 1. Dr. Sladky’s Testimony and Opinions Were Sufficiently Important to the Result in Contreras III to Invalidate That Ruling If Dr. Sladky had been merely a peripheral witness in this litigation, the special master’s unqualified (and inappropriate) reliance on Dr. Sladky’s testimony and opinions for his entitlement ruling in Contreras III might have been harmless error. But as the special master clearly shows in Contreras V, Dr. Sladky’s testimony and opinions were considered for rulings on Jessie’s diagnosis, Opin. at 39, 41; the timing of onset, id. at 44-47; the theory of causation, id. at 53- 56; and, albeit minimally, any logical sequence of cause and effect connecting Jessie’s vaccinations to his alleged vaccine injury, id. at 57. Because Contreras III and the special master’s findings on entitlement therein, as clarified by Contreras V, rely on Dr. Sladky’s testimony and opinions as if he had no credibility problems at all, the court finds that the entitlement ruling in Contreras III is tainted by the special master’s manifest error and cannot be sustained. 2. Less Significant Errors in Contreras III and Contreras V a. Diagnosis Not Required in Jessie’s Case The special master’s causation analysis in Contreras I began with his diagnosis of Jessie’s alleged vaccine injury; the special master found preponderant evidence of a sole diagnosis of TM, not TM and GBS. Contreras I, 2012 WL 1441315, at *8. In Contreras II, this court opined that diagnosis by a special master of an alleged vaccine injury is not appropriate except in limited circumstances, none of which applied in this case. Contreras II, 107 Fed. Cl. at 293-95 (citing Locane v. Sec’y of Health & Human Servs., 685 F.3d 1375, 1381 n.3 (Fed. Cir. 2012); Lombardi v. Sec’y of Health & Human Servs., 656 F.3d 1343, 1351 (Fed. Cir. 2011); Broekelschen, 618 F.3d at 1346). In Contreras III, the special master again began his causation analysis with a diagnosis of Jessie’s alleged vaccine injury, although he asserted that his “finding that Mr. Contreras did not suffer GBS appears to be in accord with this [court’s] instruction [in Contreras II] because Dr. Lake (not the undersigned) diagnosed Mr. Contreras’s illness.” Contreras III, 2013 WL 6698382, at *25 n.24. Although Dr. Lake never testified and never submitted a report in this case, the special master relied on Dr. Lake’s notes in Jessie’s medical records, among other sources of information, to 19 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 20 of 29 diagnose Jessie with TM, not TM and GBS. The court restates here its concern regarding the special master’s threshold inquiry into the diagnosis of Jessie’s alleged vaccine injury. In a typical Vaccine Act case adding this threshold inquiry does not serve a useful purpose and may actually cause significant harm: If . . . the petitioner’s array of symptoms is diagnosed, perhaps wrongly, by the special master, as an initial step in the causation-in-fact analysis, that petitioner’s case could be drastically compromised. The testimony mustered by the petitioner might focus on a causation mechanism that could persuasively link a vaccine to petitioner’s proffered diagnosis, but that same testimony might be unpersuasive as to causation of the diagnosis assigned by the special master. The special master’s fact findings as to the diagnosis of the petitioner’s illness, under an overbroad reading of Broekelschen, would be virtually unassailable upon review. The petitioner, in essence, would be forced to prove causation-in-fact of an illness diagnosed by the special master based on his reading of the evidence. Contreras II, 107 Fed. Cl. at 295. Once Contreras II issued, however, the precedential landscape changed somewhat, and a threshold inquiry into diagnosis was approved in another decision by the Federal Circuit. See Hibbard v. Sec’y of Health & Human Servs., 698 F.3d 1355 (Fed. Cir. 2012). The court sees no authorization in Hibbard for the type of causation analysis conducted here, however. In Hibbard, the Federal Circuit broached the diagnosis topic by first summarizing three cases where a special master correctly conducted a threshold diagnosis inquiry as a supplement to the causation inquiry set forth in Althen: In previous cases, this court has sanctioned an approach similar to the one taken in this case, in which a special master has addressed the nature of the injury suffered 20 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 21 of 29 before addressing the question whether there is a viable medical theory by which a vaccine can cause the injury claimed by the petitioner. See Locane, 685 F.3d 1375; Lombardi v. Sec’y of Health & Human Servs., 656 F.3d 1343 (Fed. Cir. 2011); Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir. 2010). In each of those cases, there was a dispute as to the nature of the petitioner’s injury, and in each case the special master’s findings on the nature of the injury that the petitioner incurred were sufficient to resolve the case because the special master found that the injury the petitioner incurred was not one that could have been vaccine-induced according to the petitioner’s medical theory. Hibbard, 698 F.3d at 1365. Thus, Hibbard teaches that in some cases where a significant dispute as to diagnosis has been presented by the parties, and where a specific diagnosis is sufficient to resolve the case, a special master may diagnose the alleged vaccine injury. Here, however, as this court stated in Contreras II, there was no significant dispute as to the type of illness Jessie suffered, and a diagnosis of TM versus TM plus GBS was not considered by the parties, or even by the special master, to be crucial to the resolution of this case. Yet the special master apparently believes that even in these circumstances it was appropriate for the special master to diagnose Jessie’s alleged vaccine injury before conducting the causation analysis required by Althen. The court disagrees, and turns to Hibbard for further guidance. In Hibbard, the causation analysis was distinguishable from the analysis required in this case. Although the parties agreed that Ms. Hibbard’s chronic nerve condition was dysautonomia, they disagreed as to whether an intermediate injury, autonomic neuropathy, linked the vaccine to her chronic condition. Hibbard, 698 F.3d at 1358. In such a circumstance, where the damage caused by autonomic neuropathy was posited to have caused the chronic condition of dysautonomia, the special master rightly inquired as to whether Ms. Hibbard had ever experienced autonomic neuropathy. Her entire medical theory depended on 21 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 22 of 29 that crucial intermediate step: The issue that the special master addressed in this case is whether Ms. Hibbard suffers from autonomic neuropathy. As [her expert’s] report and testimony made clear, that was a necessary component of her theory of vaccine-induced injury. Therefore, even assuming the medical plausibility of Ms. Hibbard’s theory of causation – that the vaccine triggered an immune response that damaged her autonomic nerves – her failure to show that she had autonomic neuropathy would be fatal to her case. Hibbard, 698 F.3d at 1365. Here, in contrast, the theory advanced by Jessie’s experts did not rely on a crucial, intermediate injury in whose absence Jessie’s petition would necessarily have been dismissed. For the reasons stated in Contreras II, and in light of the Federal Circuit’s decision in Hibbard, the court continues to believe that, except in unusual circumstances, a threshold inquiry by the special master into the diagnosis of the alleged vaccine injury is not appropriate. Most cases can be decided through the Althen framework, by establishing through a preponderance of the evidence: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury. Althen, 418 F.3d at 1278. The Althen framework, often referred to as the three Althen prongs, allows the typical petitioner to attempt to prove his or her own prima facie case, and does not require that the petitioner defend against the diagnostic fact-finding of a special master. The court does not believe that a threshold inquiry into the specific diagnosis of Jessie’s alleged vaccine injury was appropriate in this case.6 6/ By itself, this error is harmless, because the special master has made it clear that his (continued...) 22 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 23 of 29 b. Althen Prong One Burden Was Inappropriately Heightened Althen prong one examines whether a petitioner has established “a medical theory causally connecting the vaccination and the injury.” 418 F.3d at 1278. The special master did not make any findings of fact regarding Althen prong one in Contreras I, but was required to do so by Contreras II. In Contreras III, the special master found that petitioner’s evidence did not establish, by a preponderance of the evidence, the reliability of the causation mechanism posited by petitioner’s experts. See Contreras III, 2013 WL 6698382, at *39 (“Mr. Contreras has not provided preponderant evidence that demonstrates the reliability of the proposition that the hepatitis B vaccine can cause transverse myelitis (or GBS) via molecular mimicry with respect to the Daubert factors.”). In Contreras V, the special master again concluded that petitioner “failed to show the persuasiveness of [his expert’s] theory as measured against the Daubert factors.” Opin. at 56. In Contreras V, the special master expounded upon his ruling on Althen prong one, noting, in particular, that the petitioner’s expert Dr. Steinman relied upon a causation theory founded on the mechanism of “molecular mimicry,” a theory which has some credence in the scientific community. Opin. at 56 (noting that Dr. Steinman’s theory is a “plausible construct”); see also Contreras III, 2013 WL 6698382, at *34 (“Molecular mimicry appears in articles published in highly regarded medical journals and Dr. Steinman has written some of these articles.”). The special master also mentioned that petitioner might have buttressed the persuasiveness of his expert’s theory with evidence of testability and peer review, 6(...continued) findings as to the timing prong of Althen apply whether Jessie experienced TM, or TM and GBS. See Contreras V, at 43 (noting that the opinion of respondent’s expert regarding the timing issue, which was ultimately the most persuasive evidence considered by the special master, would not change if Jessie had TM and GBS, as opposed to TM only); Contreras III, 2013 WL 6698382, at *25 (stating that “the medically-acceptable time-frame for the onset of transverse myelitis after vaccination would remain an issue even if Mr. Contreras were found to suffer from GBS in addition to transverse myelitis”); see also Contreras I, 2012 WL 1441315, at *8 (“It is important to emphasize that the same result would be reached if Mr. Contreras suffered from both transverse myelitis and Guillain-Barré syndrome. The outcome of Mr. Contreras’s case depends on the interval between his vaccinations and the onset of his disease, not on the specific disease.”). 23 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 24 of 29 but that such evidence was lacking in this case. Opin. at 53. In the end, the special master ruled that “plausibility does not satisfy Mr. Contreras’s burden” on Althen prong one. Id. at 56 (citing Moberly, 592 F.3d at 1322). Plausibility, however, in many cases may be enough to satisfy Althen prong one. See, e.g., Hibbard, 698 F.3d at 1365 (stating that under Althen prong one “Ms. Hibbard had to show . . . the medical plausibility of her theory of causation”); [M.S.B.] ex rel. Bast v. Sec’y of Health & Human Servs., 117 Fed. Cl. 104, 119 (2014) (stating that the burden for Althen prong one is for the petitioner to “put forth a biologically plausible theory explaining how the vaccines could have caused the sustained injury”); Hirmiz v. Sec’y of Health & Human Services, No. 06-371V, 2014 WL 4638375, at *15 (Fed. Cl. Spec. Mstr.) (describing the burden under Althen prong one as “petitioners’ burden of demonstrating a plausible medical theory”), aff’d, 119 Fed. Cl. 209 (2014). Althen prong one merely demands a threshold level of scientific reliability for an expert’s proposed biological mechanism which can cause a vaccine injury. Any reliance on Moberly by the special master to reject plausible biological mechanisms, Opin. at 56 (citing Moberly, 592 F.3d at 1322), is misplaced. The discussion of plausibility in Moberly does not focus on Althen prong one specifically, and has no relevance to the question of whether a plausible medical theory satisfies Althen prong one. Instead, the Federal Circuit in Moberly simply required “some indicia of reliability” regarding the medical theory advanced by petitioners for the purposes of satisfying Althen prong one. 592 F.3d at 1324. Moberly does indicate that plausibility, in general, is insufficient for a petitioner to establish overall causation-in-fact in Vaccine Act cases. See 592 F.3d at 1322 (distinguishing a lower plausibility standard from the preponderant standard for evidence of causation-in-fact). But that guidance refers to petitioner’s overall burden to prove causation under the Vaccine Act, not petitioner’s specific burden under Althen prong one. See id. (citing 42 U.S.C. § 300aa-13(a)(1)(A)). The court has found no evidence that a plausible medical theory is per se inadequate to satisfy Althen prong one. A recent decision of the Federal Circuit, which again focused on the overall causation-in-fact burden for petitioners under the Vaccine Act, also discusses plausibility: 24 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 25 of 29 [I]n the past we have made clear that simply identifying a “plausible” theory of causation is insufficient for a petitioner to meet her burden of proof. Moberly, 592 F.3d at 1322. Instead, the statutory standard of preponderance of the evidence requires a petitioner to demonstrate that the vaccine more likely than not caused the condition alleged. See id. (“[P]roof of a ‘plausible’ or ‘possible’ causal link . . . is not the statutory standard.”); see also 42 U.S.C. § 300aa-13(a)(1). LaLonde v. Sec’y of Health & Human Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014). But this same decision also references Hibbard and the burden on petitioners to prove the “medical plausibility” of their proposed biological mechanism so as to satisfy Althen prong one. Id. at 1340 (citing Hibbard, 698 F.3d at 1365). Thus, while plausibility is not enough to show that a particular vaccine caused a particular injury, this is a separate question from the inquiry required by Althen prong one. See, e.g., Veryzer v. Sec’y of Health & Human Servs., 100 Fed. Cl. 344, 352 (2011) (explaining that plausibility goes to Althen prong one, because “plausibility is confined properly to general causation – the biological or medical theory put forward – [not] Althen’s second prong . . . examining specific or legal causation”), aff’d, 475 F. App’x 765 (Fed. Cir. 2012). The inquiry for Althen prong one has often been described as the question of whether a particular vaccine “can” cause a particular type of injury. See, e.g., Hibbard, 698 F.3d at 1365 (describing the inquiry for Althen prong one as “the separate (and frequently more difficult) question whether there is a medical theory, supported by ‘reputable medical or scientific explanation,’ by which a vaccine can cause the kind of injury that the petitioner claims to have suffered” (citing Althen, 418 F.3d at 1278)). In other words, the petitioner must present a “viable” medical theory. Id. The special master did not apply this precedential standard in his Althen prong one analysis, because he required more than a plausible medical theory. Perhaps this error was based on a misreading of the discussion of plausibility in Moberly and LaLonde. The court has reviewed the expert reports and hearing transcripts in this case. Dr. Steinman’s molecular mimicry theory appears to be far more reliable and viable than the theories criticized and rejected in LaLonde and Moberly. See, e.g., 25 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 26 of 29 Barone v. Sec’y of Health & Human Servs., No. 11-707V, 2014 WL 6834557, at *8 (Fed. Cl. Spec. Mstr. Nov. 12, 2014) (listing cases accepting molecular mimicry as a reliable medical theory for vaccine injuries). Respondent’s most persuasive expert in this case testified that molecular mimicry has been the subject of study for a number of years, and that there is some evidence that molecular mimicry is linked to auto-immune diseases, a category of diseases which includes TM and GBS. Hearing Transcript at 419, 426. Because the special master’s analysis of Althen prong one imposed a higher burden on petitioner than is appropriate under Federal Circuit precedent, and because the record evidence regarding Dr. Steinman’s proposed biological mechanism appears to present a sufficiently reliable scientific theory, the special master’s ruling on Althen prong one in this case was in error.7 C. Although the Special Master Abused His Discretion When Relying on Dr. Sladky’s Testimony and Opinions, His Alternate Ruling on Althen Prong Three Which Ignores Dr. Sladky’s Testimony and Opinions Survives Review The special master has consistently ruled, in Contreras I, Contreras III, and Contreras V, that twenty-four hours is too short a time-frame for Jessie’s vaccinations to have caused TM, or a combination of TM and GBS. For this reason, the special master denied Jessie entitlement to compensation under the Vaccine Act because the preponderance of the evidence as to Althen prong three did not weigh in his favor. See Althen, 418 F.3d at 1278 (requiring that a petitioner establish a “proximate temporal relationship between vaccination and injury”). As this court noted in Contreras II, petitioner was required to show that the onset of Jessie’s alleged vaccine injury occurred within a “medically- acceptable time-frame.” 107 Fed. Cl. at 302-03. In Contreras V, as required by Contreras IV, the special master removed all evidence provided by Dr. Sladky and reweighed the remaining evidence which related to Althen prong three. The expert opinions on this issue differed, and the scientific studies in the extensive record contained somewhat ambiguous evidence 7/ This, too, is harmless error, because petitioner needed to prevail on all three Althen prongs to establish entitlement to compensation, and a special master may focus on just one Althen prong to deny entitlement. See, e.g., Hibbard, 698 F.3d at 1364-65. 26 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 27 of 29 as to a medically-acceptable time-frame for the onset of TM, or of TM and GBS. The court finds, nonetheless, that the special master rationally weighed this evidence and rationally relied upon respondent’s other expert, Dr. Whitton. Dr. Whitton opined that twenty-four hours was too short a time for either TM or GBS to develop after vaccination, even if molecular mimicry had been triggered by Jessie’s vaccinations. Dr. Whitton’s opinion was buttressed by his persuasive analysis of numerous scientific articles. The special master carefully considered the views of opposing experts and the totality of the evidence, and concluded that Dr. Sladky’s evidence added little to the [Althen prong three] 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. Opin. at 51-52. Because Jessie’s alleged vaccine injury did not occur within a medically-acceptable time-frame, the special master denied entitlement in this case. The special master’s alternative fact-finding as to Althen prong three which excluded Dr. Sladky’s evidence contains no error of law or abuse of discretion. The special master applied the appropriate standard for establishing a proximate temporal relationship between a vaccine and a vaccine injury. Opin. at 51-52. As for the special master’s evidentiary rulings, the court notes that special masters have broad discretion in determining the reliability of scientific evidence. E.g., Terran, 195 F.3d at 1316. Under this standard, the court has examined the alternative Althen prong three analysis in Contreras V, which references and relies heavily on Contreras III, for any manifest error in the consideration of the evidence presented by the parties. There is no sign that the special master erroneously excluded petitioner’s scientific evidence as unreliable. Nor, in the court’s view, is the special master’s alternative ruling on Althen prong three arbitrary or capricious. It is important to note that the court’s review 27 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 28 of 29 of the special master’s weighing of the evidence is highly deferential. See, e.g., Munn, 970 F.2d at 870 (“This is a standard [of review] well understood to be the most deferential possible.”) (citations omitted). As long as the special master’s findings of fact and conclusions regarding the preponderance of the evidence going to Althen prong three are reasonable, this court must sustain the special master’s entitlement decision. See, e.g., Broekelschen, 618 F.3d at 1348 (“‘[R]eversible error is “extremely difficult to demonstrate” if the special master “has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision.”’” (quoting Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991))) (alteration in original). Under this highly deferential standard of review, the special master’s alternative Althen prong three analysis, which is rational, survives review. The court turns to petitioner’s arguments in this regard. Petitioner first invites the court to reweigh the record evidence as to the timing issue. Pet’r’s Mot. at 23-24. This reviewing court “does not reweigh the factual evidence or assess whether the special master correctly evaluated the evidence, nor does it examine the probative value of the evidence.” Porter, 663 F.3d at 1254 (citations omitted). Thus, the court must defer to the fact-finding role of the special master and cannot reconsider the expert opinions and other evidence cited by petitioner. Second, petitioner attacks Dr. Whitton, whose opinion was persuasive on the timing issue. None of these criticisms of Dr. Whitton’s expertise, opinions or credibility renders the special master’s reliance on Dr. Whitton’s opinions arbitrary or capricious. Although Dr. Whitton may not have been the ideal expert in every respect, the court finds that the special master’s reliance on Dr. Whitton’s opinions was rational. In addition, although petitioner attempts to portray Dr. Whitton as applying an inappropriate “scientific certainty” standard when rendering his opinions, Pet’r’s Mot. at 24-25, it is clear that the special master applied the correct preponderance standard to the parties’ evidence which related to Althen prong three. Under the highly deferential standard of review that applies here, the court finds nothing arbitrary or capricious in the special master’s alternative ruling on Althen prong three. CONCLUSION For the above-stated reasons, the court sustains the entitlement decision of 28 Case 1:05-vv-00626-RHH Document 225 Filed 05/06/15 Page 29 of 29 the special master which did not rely on the evidence of Dr. Sladky. Accordingly, it is hereby ORDERED that (1) Petitioner’s Motion for Review, filed November 21, 2014, is DENIED; (2) The decision of the special master, filed October 24, 2014, is SUSTAINED; (3) The Clerk’s Office is directed to ENTER final judgment in accordance with the special master’s decision of October 24, 2014; and (4) The parties shall separately FILE any proposed redactions to this opinion, with the text to be redacted clearly marked out or otherwise indicated in brackets, on or before May 1, 2015. /s/Lynn J. Bush LYNN J. BUSH Senior Judge 29 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_05-vv-00626-3 Date issued/filed: 2015-09-17 Pages: 3 Docket text: PUBLIC DECISION (Originally filed: 08/17/2015) regarding 229 DECISION Interim Fees Stipulation. Signed by Special Master Christian J. Moran. (tpj) Copy to parties. -------------------------------------------------------------------------------- Case 1:05-vv-00626-RHH Document 232 Filed 09/17/15 Page 1 of 3 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: August 17, 2015 * SECRETARY OF HEALTH * Attorneys’ fees and costs; interim AND HUMAN SERVICES, * award; amount to which respondent * does not object. Respondent. * * * * * * * * * * * * * * * * * * * * * * Jeffrey S. Pop, Beverly Hills, CA, for petitioner; Linda S. Renzi, United States Dep’t of Justice, Washington, DC, for respondent. UNPUBLISHED DECISION ON INTERIM ATTORNEYS’ FEES AND COSTS1 Mr. Jessie Contreras sought compensation through the National Childhood Vaccine Injury Compensation Program, codified at 42 U.S.C. § 300aa—10 through 34 (2006), claiming the vaccinations he received, particularly the hepatitis B vaccine, caused his neurologic problems. After extensive proceedings, including a lengthy attempt at alternative dispute resolution and six substitutive rulings, the judgment of the Court of Federal Claims was that Mr. Contreras is not entitled to an award of compensation.2 Mr. Contreras has appealed this judgment to the Federal Circuit. No. 15-5097 (Fed. Cir. June 19, 2015). 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. 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. Case 1:05-vv-00626-RHH Document 232 Filed 09/17/15 Page 2 of 3 While the case was pending, the undersigned previously awarded Mr. Contreras interim attorneys’ expert costs. Decision, issued May 3, 2013. The present decision concerns Mr. Contreras’s attorneys’ fees. Mr. Contreras seeks an award for work his attorney, Jeffrey S. Popp, performed through May 27, 2015. On July 29, 2015, respondent filed a stipulation of fact concerning interim attorneys’ fees and costs in the above-captioned matter. Previously, petitioner informally submitted a draft application for interim attorneys’ fees and costs to respondent for review. Upon review of petitioner’s application, respondent raised objections to certain items. Based on subsequent discussions, petitioner amended his application to request $333,550.00, an amount to which respondent does not object. The Court awards this amount. Regardless of whether they entitled to compensation, petitioners who bring their petition in good faith and who have a reasonable basis for the petition may be awarded attorneys’ fees and costs. See 42 U.S.C. § 300aa–15(e)(1). Respondent does not contend that Mr. Contreras fails to satisfy this standard. Thus, Mr. Contreras is entitled to an award of attorneys’ fees and costs. After a determination that Mr. Contreras is entitled to an award of interim attorneys’ fees and costs, the next question is to decide the reasonable amount. A review of the materials offered in support of petitioner’s draft application for interim attorneys’ fees and costs indicates that the (reduced) requested amount is reasonable. Therefore, Mr. Contreras is awarded the amount to which respondent did not object. There is no just reason to delay the entry of judgment on interim attorneys’ fees and costs. Therefore, in the absence of a motion for review filed under RCFC Appendix B, the clerk of court shall enter judgment in petitioner’s favor. Those fees and costs are awarded as follows: 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 and remanded the case again. 116 Fed. Cl. 472 (2014) (“Contreras 4”). On the second remand, the undersigned again found that Mr. Contreras did not meet his burden of proof for entitlement to an award. 2014 WL 8098606 (Fed. Cl. Spec. Mstr. Oct. 24, 2014) (“Contreras 5”). Mr. Contreras again filed a motion for review of the special master’s decision, and the Court denied the motion for review. 121 Fed. Cl. 230 (2015) (“Contreras 6”). 2 Case 1:05-vv-00626-RHH Document 232 Filed 09/17/15 Page 3 of 3 A lump sum payment of $333,550.00, in the form of a check payable to petitioner and petitioner’s counsel of record, Jeffrey S. Pop. The Clerk shall enter judgment accordingly.3 The court thanks the parties for their cooperative efforts in resolving this matter. IT IS SO ORDERED. s/ Christian J. Moran Christian J. Moran Special Master 3 Pursuant to Vaccine Rule 11(a), the parties can expedite entry of judgment by each party filing a notice renouncing the right to seek review by a United States Court of Federal Claims judge. 3 ================================================================================ DOCUMENT 4: USCOURTS-cofc-1_05-vv-00626-4 Date issued/filed: 2017-12-06 Pages: 11 Docket text: PUBLIC DECISION (Originally filed: 11/22/2017) regarding 278 DECISION Stipulation/Proffer Signed by Chief Special Master Nora Beth Dorsey. (tlf) Copy to parties. -------------------------------------------------------------------------------- Case 1:05-vv-00626-RHH Document 282 Filed 12/06/17 Page 1 of 11 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: November 22, 20171 Refiled in Redacted Form: December 6, 2017 * * * * * * * * * * * * * * * UNPUBLISHED J.C.R., * * No. 05-626V Petitioner, * v. * Chief Special Master Dorsey * SECRETARY OF HEALTH * Decision Based on Stipulation; AND HUMAN SERVICES, * Tetanus; Hepatitis B (“Hep B”); * Transverse Myelitis (“TM”); Guillan Respondent. * Barre Syndrome (“GBS”). * * * * * * * * * * * * * * * * Jeffrey Pop, Jeffrey S. Pop & Associates, Beverly Hills, CA, for petitioner. Linda Renzi, U.S. Department of Justice, Washington, D.C., for respondent. DECISION BASED ON STIPULATION On June 15, 2005, J.C. filed a petition in the National Vaccine Injury Compensation Program on behalf of his son, J.C.R.2 (“petitioner”). The petition alleged that J.C.R. developed transverse myelitis (“TM”) and/or Guillain-Barre syndrome (“GBS”) as a result of receiving the Hepatitis B (“Hep. B”) and Tetanus vaccines on June 16, 2003. On November 21, 2017, the parties filed a stipulation3 in which they stated that a decision should be entered awarding compensation. Respondent denies that the Tetanus and/or Hep. B 1 When this decision was originally filed, the undersigned advised the parties of her intent to post it on the United States Court of Federal Claims’ website, in accordance with the E-Government Act of 2002. 44 U.S.C. §3501 note (2012) (Federal management and Promotion of Electronic Government Services). In accordance with Vaccine Rule 18(b), petitioner filed a motion to redact certain information. This decision is being reissued with minimal changes, including redaction of the petitioner and his father’s names in the case caption to initials. Except for those changes and this footnote, no other substantive changes have been made. 2 During the course of the proceedings, the case caption was amended to reflect that J.C.R. reached the age of majority. Additionally, on November 20, 2017, petitioner filed an unopposed motion to amend the case caption to reflect that petitioner’s given name is J.C.R. The undersigned granted petitioner’s motion and the case caption was amended on November 21, 2017. 3 On November 15, 2017, the parties filed a stipulation in which they stated that a decision should be entered awarding compensation, and the undersigned issued a Decision based on the 1 Case 1:05-vv-00626-RHH Document 282 Filed 12/06/17 Page 2 of 11 vaccinations caused or significantly aggravated petitioner’s condition, or caused him any other injury. Nevertheless, the parties agree to the joint stipulation, attached hereto as Appendix A. The undersigned finds the stipulation reasonable and adopts it as the decision of the Court in awarding damages, on the terms set forth therein. The parties stipulate that petitioner shall receive the following compensation: a. A lump sum of $1,248,834.30, in the form of a check payable to petitioner, Mr. J.C.R. This represents compensation for first year expenses in the amount of $48,328.00; past and future lost wages in the amount of $960,377.30 (future wages have been reduced to net present value); and actual and projected pain and suffering in the amount of $240,129.00 (projected pain and suffering has been reduced to net present value); and b. A lump sum in the amount of $261,189.23, representing compensation for satisfaction of the State of California Medicaid Lien in the form of a check payable to petitioner and: Department of Health Care Services DHCS Account NO: C95483627A-VAC03 DCHS case name: J.C.R. Recovery Branch – MS 4720 P.O. Box 997421 Sacramento, CA 95899-7421 Petitioner agrees to endorse this payment to the Department of Health Care Services; and c. An amount sufficient to purchase the annuity contract described in paragraph 10 of the Stipulation. These amounts represent compensation for all damages that would be available under 42 U.S.C. §300aa-15(a). Stipulation at ¶8. The undersigned approves the requested amount for petitioner’s compensation. Accordingly, an award should be made consistent with the stipulation. parties’ stipulation the same day. On November 20, 2017, respondent contacted the Court to report an error in the November 15, 2017 stipulation. On the same day, respondent filed a joint motion to strike the November 15, 2017 Decision and the underlying stipulation upon which it was based. On November 21, 2017, the undersigned issued an Order striking the original decision and stipulation. 2 Case 1:05-vv-00626-RHH Document 282 Filed 12/06/17 Page 3 of 11 In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of Court SHALL ENTER JUDGMENT in accordance with the terms of the parties’ stipulation.4 IT IS SO ORDERED s/Nora Beth Dorsey Nora Beth Dorsey Chief Special Master 4 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of notice renouncing the right to seek review. 3 CCaassee 1 1:0:055--vvvv--0000662266--RRHHHH D Dooccuummeennt t2 28727 F Filieledd 1 121/0/261/1/177 P Paaggee 4 1 o of f1 81 CCaassee 1 1:0:055--vvvv--0000662266--RRHHHH D Dooccuummeennt t2 28727 F Filieledd 1 121/0/261/1/177 P Paaggee 5 2 o of f1 81 CCaassee 1 1:0:055--vvvv--0000662266--RRHHHH D Dooccuummeennt t2 28727 F Filieledd 1 121/0/261/1/177 P Paaggee 6 3 o of f1 81 CCaassee 1 1:0:055--vvvv--0000662266--RRHHHH D Dooccuummeennt t2 28727 F Filieledd 1 121/0/261/1/177 P Paaggee 7 4 o of f1 81 CCaassee 1 1:0:055--vvvv--0000662266--RRHHHH D Dooccuummeennt t2 28727 F Filieledd 1 121/0/261/1/177 P Paaggee 8 5 o of f1 81 CCaassee 1 1:0:055--vvvv--0000662266--RRHHHH D Dooccuummeennt t2 28727 F Filieledd 1 121/0/261/1/177 P Paaggee 9 6 o of f1 81 CCaasese 1 1:0:055-v-vv-v0-000662266-R-RHHHH D Doocucummeennt 2t 28727 F Fileiledd 1 121/0/261/1/177 P Paaggee 1 70 ooff 811 CCaasese 1 1:0:055-v-vv-v0-000662266-R-RHHHH D Doocucummeennt 2t 28727 F Fileiledd 1 121/0/261/1/177 P Paaggee 1 81 ooff 811