A Recusal Refusal · Sep 15, 06:00 PM

On July 31, 2007, Special Master Denise Vowell of the U.S. Court of Federal Claims issued an order regarding Jane Doe/03 v. HHS, wherein the petitioner alleged that her systemic lupus erythematosus was the direct consequence of a Hepatitis B vaccination.

The order arose in response to a request by petitioner’s counsel that her case be reassigned to a different Special Master; he asserted that advice offered by Vowell during a telephone conference revealed that she had “prejudged” the facts and evidence. Vowell chose not to recuse herself, but referred the matter to the Chief Special Master, who will ultimately decide the question of reassignment.

This order should be of particular interest to autism litigation watchers, since Special Master Vowell is one of the three Special Masters assigned to adjudicate petitions in the Omnibus Autism Proceeding. (The other two are Hon. George Hastings and Hon. Patricia Campbell-Smith.) The order addresses:

the role of the Special Master in adjudication of Vaccine Court proceedings;

rules of evidence in vaccine cases;

legal precedent in cases involving Dr. Mark Geier (the author of studies upon which both the Doe petitioner and Omnibus Autism Proceeding petitioners have intended to rely);

the evidentiary reliability of conclusions derived from data from the Vaccine Adverse Event Reporting System (VAERS); and

what does and does not constitute judicial bias.

In the interest of brevity and readability for my visitors unaccustomed to legal style, I offer a slightly edited version of the order. I have eliminated a number of legal references and all but two footnotes. I have also excluded some body text (most of it pertaining to anonymization of the order, case scheduling and document production), and have noted elisions with […]. Those who wish to read the full text of the order can find it on the website of the U.S. Court of Federal Claims.

IN THE UNITED STATES COURT OF FEDERAL CLAIMS
OFFICE OF SPECIAL MASTERS

JANE DOE/03, Petitioner,
v.
SECRETARY OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, Respondent

ORDER

Filed: July 31, 2007
Reissued August 14, 2007
[petitioner’s name redacted upon request]

On July 13, 2007, petitioner filed a motion to reassign this case to another special master, contending that statements made during a Vaccine Rule 5 status conference on July 10, 2007 rendered such reassignment “necessary for the efficient administration of justice” under Vaccine Rule 3(c). Respondent filed a brief opposing the motion on July 23, 2007.

Petitioner’s motion evinces a misapprehension of the statutory role of the special master and the specific purpose of a status conference held under Vaccine Rule 5. Treating this motion as one for recusal, I find that there is no reasonable basis for me to recuse myself in this matter. However, in view of the Chief Special Master’s statutory authority pursuant to 42 U.S.C. § 300aa-12(d) to designate a special master to handle a case, I am referring petitioner’s motion to the Chief Special Master for his decision on whether this case should be reassigned.

I. Background

[…] In his eleven page opinion, [petitioner’s expert] Dr. [Jeffrey] Alper referenced and summarized several medical articles. Among these, Dr. Alper mentioned a study by “D.A. Geier,” describing it as a “case controlled epidemiologic study” of adverse events involving hepatitis B vaccines reported to the vaccine adverse event reporting system. Later on the same page of his report, Dr. Alper referenced “[a]nother study by the same author” on the risk of developing an autoimmune disease following hepatitis B vaccination. […] Respondent filed a Vaccine Rule 43(c) report accompanied by the expert medical opinion of Dr. Bento Mascarenhas […]

The record being complete […] and the parties having tentatively agreed on a hearing date of September 14, 2007, I set a Vaccine Rule 5 status conference for July 10, 2007. Vaccine Rule 5 is entitled “Informal Review and Tentative Findings and Conclusions.” The rule requires a special master to conduct an informal conference “to review the materials submitted, evaluate the respective positions, and orally present tentative findings and conclusions.” It is intended to be a candid discussion of the merits of the parties’ evidence, arguments, and positions. Section VI of the Guidelines for Practice Under The National Vaccine Injury Compensation Program (6) [“Guidelines”] provides additional information concerning the Rule 5 status conference. That section is set forth in its entirety below:

Under the Program, claim resolution will be more expeditious and less formal than under traditional litigation. To this end, Vaccine Rule 5 sets forth a procedure that should speed and simplify the decision-making process. Under the Rule, the special master, after reviewing the petition and respondent’s report, conducts an informal conference (either in person or by telephone) at which the special master (1) gives each party an opportunity to address the other’s position, (2) states a tentative view as to the merits of the case, and (3) establishes with the parties what issues remain to be addressed and the most efficient means for deciding those issues.

The success of the “Rule 5 conference” depends upon the completeness of the petition and respondent’s report. For that reason, it is essential that each party develop fully its case before filing the petition or report, and set forth fully and completely the substance of its case therein. Information cannot be withheld or acquired later to be supplied at subsequent stages of the proceedings. The benefits from this early, full discussion of the case’s substance include:

  •  early notice of any deficiencies in the case in time to rectify such deficiencies;

  •  a third party’s view of the merits of the case, possibly fostering settlement;

  •  if settlement is not possible, an opportunity to narrow the issues through stipulation;

  •  if further proceedings are necessary, a discussion of the nature and timing of such proceedings; and

  •  where appropriate, a final decision.

Please note, however, that any tentative conclusions noted by the special master at the Rule 5 conference are just that – tentative, as well as “off the record.” The special master’s comments will not have any official status and cannot be “relied upon” in any formal sense. Additional evidence, argument, or further consideration by the special master may change the special master’s view of the case. (underlining added).

During this telephonic Rule 5 status conference, I followed my usual practice of having my law clerk take notes while I discussed problem areas and strengths of each side’s case with the dual goals of encouraging the parties to consider settlement and of focusing evidentiary presentations for any subsequent hearing. […]

I then noted two problem areas in petitioner’s case: the destruction of some of the medical records for the time period around onset of petitioner’s symptoms, and Dr. Alper’s citation of articles principally authored by Dr. Mark Geier. I suggested that, in view of the criticisms leveled at Dr. Geier and his research, petitioner would be better served if her expert could opine favorably at the hearing without relying on the cited articles. I indicated that there was no need to file these articles because I had already read them. I did not prohibit petitioner from filing any article. To place my remarks in context, Dr. Alper’s report discussed several other articles and referenced ten other articles supporting his view of vaccine causation and I expressed no other opinion on Dr. Alper’s report.

I did not offer any opinion on whether petitioner can establish vaccine causation of her condition, only that I found that the articles authored by Dr. Geier unpersuasive and not scientifically sound, based on my prior reading of the articles and critiques of them. I am also aware that Dr. Geier is trained as a geneticist and obstetrician, not an immunologist, epidemiologist, or rheumatologist, and that my fellow special masters (8) and several other judges (9) have opined unfavorably on his qualifications and testimony as an expert.

(8) Thompson v. Sec’y, HHS, No. 99-436V (2003) (special master found Dr. Geier unqualified to testify about infantile spasms and found his testimony filled with speculation); Haim v. Sec’y, HHS, No. 90-1031V (1993) (“Dr. Geier’s testimony is not reliable, or grounded in scientific methodology and procedure. His testimony is merely subjective belief and unsupported speculation.”); Marascalco v. Sec’y, HHS, No. 90-1571V (1993) (where the special master described Dr. Geier’s testimony as intellectually dishonest); Aldridge v. Sec’y, HHS, No. 90-2475V (1992) (special master found Dr. Geier’s reliance on statement from two outdated medical textbooks which was not included in the current edition to be disingenuous. “Were Dr. Geier an attorney, he would fall below the ethical standards for representation.”); Ormechea v. Sec’y, HHS, No. 90-1683V (1992) (“Because Dr. Geier has made a profession of testifying in matters to which his professional background [obstetrics and genetics] is unrelated, his testimony is of limited value to the court.”); Daly v. Sec’y, HHS, No. 90-590V (1991) (”[T]his court is inclined not to allow Dr. Geier to testify before it on issues of Table injuries. Dr. Geier clearly lacks the expertise to evaluate the symptomatology of the Table injuries and render an opinion thereon.”).

(9) Piscopo v. Sec’y, HHS (2005) (special master did not abuse his discretion in determining that Dr. Geier did not have the education, training or experience to proffer a reliable opinion on the cause of petitioner’s autoimmune disorder); Graham v. Wyeth Laboratories (10th Cir. 1990) (Dr. Geier’s calculation error was of sufficient magnitude so as to warrant a new trial);
Doe v. Ortho-Clinical Diagnostics (M.D.N.C. 2006) (excluding Dr. Geier’s testimony as based on “hypothesis and speculation.”); Redfoot v. B.F. Ascher & Co. (N.D. Ca 2007) (excluding Dr. Geier as an expert, finding his testimony “not reliable.”) Pease v. American Cyanamid Co. (D. Md 1992) (in granting summary judgment, trial judge noted inconsistencies in Dr. Geier’s opinion); Jones v. Lederle Laboratories, American Cyanamid Co. (E.D. NY 1992) (“the court was unimpressed with the qualifications, veracity, and bona fides” of Dr. Geier); and Militrano v. Lederle Laboratories, American Cyanamid Co. (2003) (characterizing Dr. Geier’s affidavit as “conclusory and scattershot” and “undermined by many of the materials submitted in support of it”).

I then turned to respondent’s case, noting a more significant and systemic problem with respondent’s expert report, in that Dr. Mascarenhas appeared to be applying a far higher standard for determining causation than is actually required by the Vaccine Act. I then quoted several sections of Dr. Mascarenhas’ report in which he appeared to require scientific certainty rather than probability before he would accept that a vaccine caused petitioner’s illness.

Counsel for both sides commented on my evaluation of the case, with petitioner’s counsel responding affirmatively to my comments and respondent’s counsel indicating that she was aware that her expert had difficulty separating medical certainty from legal causation. After inquiring whether the parties saw any likelihood of settling this case and receiving indications that they did not, we discussed the hearing location and logistics of witness testimony.

II. Discussion

The legislative history of the Vaccine Act has been set forth at length in numerous opinions of special masters, judges of the Court of Federal Claims, and in opinions of the Federal Circuit. I will not repeat that history here, except to note that, by design, special masters are not merely passive recipients of information.

[…] As Judge Wolski of the Court of Federal Claims has noted: “instead of being passive recipients of information, such as jurors, special masters are given an active role in determining the facts relevant to Vaccine Act petitions. One reason that proceedings are more expeditious in the hands of special masters is that special masters have the expertise and experience to know the type of information that is most probative of a claim.” Doe v. Sec’y, HHS (2007).

Special masters are required to consider all “relevant medical and scientific evidence contained in the record,” but are not required to give any particular “diagnosis, conclusion, judgment, test result, report, or summary” any weight. Section 300aa-13(b)(1) (emphasis added). “Nothing in the [Vaccine Act] requires the special master to concur with medical expert opinions as to the interpretation of scientific studies.” Munn v. Sec’y, HHS (1990). As noted in Van Epps v. Sec’y, HHS (1992), even an uncontroverted expert opinion is not binding on a special master. See also, Thibaudeau v. Sec’y, HHS (1991) (trier of fact not required to accept even an uncontradicted expert opinion). Special masters have wide discretion in how they conduct proceedings in vaccine injury cases. Guillory v. U.S. (2003).

Vaccine Rule 8 requires the consideration of “relevant and reliable evidence.” In other courts, the determination that scientific evidence is relevant and reliable is performed by the judge in a gatekeeping role. If the proponent of scientific or technical evidence cannot establish its reliability, the evidence is excluded before trial. Daubert v. Merrell Dow Pharmaceuticals., Inc. (1993). Daubert has been applied to Vaccine Act cases by Terran ex rel. Terran v. Secretary of Health and Human Services (1999). Within the Vaccine Program, that gatekeeping function may be performed by considering the evidence and determining its reliability as a threshold matter — excluding it before trial — or by hearing the evidence and deciding not to rely upon it in rendering an opinion.

Research purporting to show vaccine causation of various conditions which is based solely or primarily on VAERS data may not meet the reliability standards articulated in Daubert because the VAERS database is based on a passive surveillance system with inherent biases. See Respondent’s Exhibit H (one of many articles critical of research based primarily on VAERS data because of the flaws inherent in the data collection process). See also, Ryman v. Sec’y, HHS (2005) (special master not required to accord substantial weight to VAERS reports)

My comments regarding the Geier articles were not a prejudgment of the ultimate causation question or of the evidence presented by petitioner up to this point, and in context, could not reasonably be interpreted as such. Just as jurors are not expected to leave their common sense and knowledge of the ways of the world at the courthouse door, special masters are not required to disregard obvious problems in evidentiary reliability. When a conclusion is drawn from an artificially narrow sample population, that conclusion is inherently suspect as applied to any group other than that sample population. In the case of VAERS data, conclusions drawn only from the sample population of those who report vaccine reactions (which include both mandatory and highly discretionary reports) cannot be reliably applied to other populations. I also note that those reporting “vaccine reactions” are not required to be health care providers.

In hearing other Vaccine Act cases, I have encountered medical witnesses who were unaware of scientific criticism leveled at articles or studies upon which they based their opinions. The nature of the criticism and the degree to which the expert relied on the challenged data are factors affecting the weight I have given to that expert’s ultimate opinion on causation. In attempting to assist this petitioner in presenting the strongest possible case for vaccine causation of her illness, I urged her counsel to caution her expert against relying on the Geier articles he cited. If efforts to implement Vaccine Rule 5’s guidance are routinely answered by motions to reassign cases based on “prejudgment” of the issues, special masters may cease having candid discussions at such conferences and let the chips fall where they may when an expert’s opinion is challenged at the causation hearing on the basis that it relied upon discredited or unreliable evidence.

In the instant case, I did not exclude petitioner’s expert’s opinion; in fact, I sought to make it stronger by recommending that petitioner remove a potential basis for questioning it. I did not rule that [Dr. Geier’s article] is inadmissible as unreliable evidence, although I might well do so if such a motion were to be made. I merely indicated my familiarity with the cited article and my conclusion that research of this nature based on VAERS data has significant reliability problems. If Dr. Alper chooses to base his testimony on the Geiers’ research, in whole or in part, I will consider and evaluate that testimony based on all the evidence before me, including [the respondents’ exhibits].

Finding no reasonable basis for petitioner’s request for case reassignment, I decline to recuse myself. However, this case is referred to the Chief Special Master for his decision on case reassignment.

IT IS SO ORDERED.
s/ Denise K. Vowell
Special Master

Comments


  1. “I suggested that, in view of the criticisms leveled at Dr. Geier and his research, petitioner would be better served if her expert could opine favorably at the hearing without relying on the cited articles.”

    No kidding.

    — Joseph    Sep 15, 08:11 PM    #

  2. Time for Geier to take up selling Amway or something. The jig is up on his expert witness thing.

    — isles    Sep 15, 11:40 PM    #

  3. Ok So the Geiers are not Gods but who has the science to go against them?

    I mean when they analyse mercury in the majority of their cases they are on virgin ground. Who else even bothers to look at mercury except in a theoretical sense?

    John Fryer MSc BSc Advanced Analytical Chemist

    — John Fryer    Nov 6, 05:39 AM    #

  4. Who else even bothers to look at mercury except in a theoretical sense?

    that would be toxicologists. If you want one that has discussed publicly his attempts to confirm mercury intoxication in “heavy metal poison diagnosed” kids, that would be Dr. Brent.

    Guess what? In 100% of the cases presented to him, the alt-med approach to diagnosing heavy metal intoxication was wrong.

    As to the Geiers, they also dely on the porphyrin test, which even the DAN! ‘expert’ stated wasn’t a proven valid test.

    — Matt    Jun 7, 02:39 PM    #