"The Conclusion is Ethereal" · 2009-05-10 14:00

Maryland High Court Dismisses Autism-Mercury Lawsuit

On Thursday, May 7, the Court of Appeals of Maryland affirmed the December 2007 decision of the Circuit Court for Baltimore City in Blackwell v. Wyeth, excluding the testimony of geneticist Dr. Mark Geier, chemist Prof. Boyd Haley, pediatrician Dr. Elizabeth Mumper, pharmacologist Prof. Richard C. Deth and psychologist Dr. Stephen Siebert. All had been retained to support the claim that thimerosal, a mercury-based antibacterial contained in certain vaccines, brought about the plaintiffs’ son’s autism.

The complaint originally alleged that the child was harmed by both industrial mercury emissions and thimerosal-containing vaccines, and named as defendants pharmaceutical manufacturers Wyeth, Merck and Eli Lilly, chemical manufacturers Sigma-Aldrich, American International Chemical and Spectrum Laboratory Products, and Baltimore Gas & Electric Company. As the time for trial and admission of experts drew near, charges against all defendants but Wyeth were dismissed.

After a ten-day hearing featuring testimony by experts for both parties, Judge Stuart Berger found that neither the thimerosal-autism causation hypothesis nor the analyses supporting it were generally accepted in the relevant scientific community, determined that the plaintiffs’ experts were unqualified to testify about a causal relationship between thimerosal and autism, denied the admissibility of their testimony, and dismissed the complaint.

The plaintiffs appealed, arguing that the trial judge impermissibly ruled on the matter of causation, applying the “general acceptance” standard to their experts’ conclusions rather than to the process by which they reached their opinions, impermissibly evaluated the merit of their claim by using a heightened scientific certainty standard to determine the admissibility of their experts’ testimony, and thereby prevented a jury from being empanelled and engaging in appropriate fact-finding.

The Baltimore court’s decision focused primarily on the testimony of Dr. Geier, who was introduced as the plaintiffs’ chief expert in epidemiology. Upon review, the Court of Appeals agreed with Judge Berger that although Dr. Geier may have used data collected in generally accepted ways, the “analytical gap” between those data and his conclusions was too great to justify the results of his analysis. The court further agreed that neither Dr. Geier’s methods nor his theory of autism causation were generally accepted in the relevant scientific community, and that neither he nor Prof. Haley, Dr. Mumper, Prof. Deth or Dr. Siebert possessed sufficient knowledge, skill, experience, training, or education — especially in the discipline of epidemiology — to proffer reliable expert testimony on the “complex and novel” hypothesis of a causal relationship between thimerosal and autism.

From the opinion:

The quest for truth in the courtroom and the quest for knowledge in science are not necessarily intersecting endeavors. A trial, on the one hand, may be quick and determinative; it is a process by which “advocates for each side present evidence in the light most favorable to their case, and the finder of fact sifts through it and assesses whether it establishes guilt or liability to the required degree of proof.” The search for knowledge in science, on the other hand, is rarely quick or final; rather, it represents an ongoing cycle, in which each inquiry into an observable phenomenon is but one aspect of an ongoing quest. (p. 5)

The Supreme Court in General Electric Company v. Joiner… recognized that the analysis of data or extrapolation requires more than mere conjecture to pass reliability scrutiny:

“…Trained experts commonly extrapolate from existing data. But nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.”

Generally accepted methodology, therefore, must be coupled with generally accepted analysis in order to avoid the pitfalls of an “analytical gap.” Dr. Geier’s faulty extrapolation from VAERS data, a potentially reliable source, manifests the ipsa dixit because his conclusion is ethereal. The conclusion is ethereal because the bases of the expert’s opinion, including the theory of causation, and the methodologies, are not “generally accepted as reliable within the expert’s particular scientific field,” and the data he relies upon was not tested nor gathered for the purpose of testing the hypothesis that thimerosal in vaccines causes autism. None of Dr. Geier’s research aimed at establishing a link between thimerosal and autism, moreover, is based upon sound methodology.

Based on Judge Berger’s rejection of Dr. Geier’s underlying hypothesis and methodology, i.e. the identification of specific genes and differential diagnosis, we hold that Judge Berger’s ultimate determination — that Dr. Geier’s genetic susceptibility theory is no more than hypothesis and conjecture, devoid of a generally accepted methodology to support it — should not be disturbed by us. (pp. 32-33, 36, 47)

Before us, the Blackwells urge that Judge Berger abused his discretion by disqualifying their witnesses from testifying. Wyeth, having addressed the experts’ credentials during voir dire, reasserts that the Blackwells’ experts lack the necessary knowledge, expertise, training or education to offer an opinion about a causal relationship between thimerosal and autism. Although we agree with the Blackwells that generally there is “no reason why a person who has acquired sufficient knowledge in an area should be disqualified as a medical expert merely because he is not a specialist or merely because he has never personally performed a particular procedure,” we cannot say, in this case, that Judge Berger abused his discretion by adhering to “artificial classifications” of a specialty’s title, without concern for “the witness’ knowledge” and ability to convey valuable information to jurors.

When a novel theory of science is presented, however, its reliability and validity are dependent not only on the application of generally acceptable methodology and analyses, but also upon the knowledge, skill, experience, training or education of the scientist who purports to utilize them, because the expert must embody expertise in the relevant scientific field to be able to give an opinion regarding the results of the process of scientific discovery.

In the present case, clearly the level of complexity regarding the establishment of a causal relationship between the administration of a vaccine containing thimerosal and the onset of autism is complex; to the extent that “establishing” such a conclusion is even possible, it involves the extrapolation from, and scientific review of, numerous studies spanning a gamut of fields and methodologies, and most particularly, available epidemiological studies. As Blackwells’ counsel stated during oral argument before this Court, their experts’ causal conclusions are based on: (1) peer reviewed published epidemiological studies; (2) in vitro studies; (3) toxicological studies; (4) pharmacokinetic studies that discuss the distribution of mercury throughout the body; (5) diagnostic tests of blood “to determine the level of glutathione in the body, which is a molecule necessary to eliminate mercury”; (6) porphyrin urine analysis to determine mercury toxicity; (7) differential diagnosis; and (8) “extrapolation from animal studies and from other in vitro studies.”

Judge Berger, therefore, did not abuse his discretion when he required a specificity of knowledge, skill, experience, training or education related to the resolution of the lawsuit, and concluded that Drs. Geier’s, Haley’s, Deth’s, Mumper’s and Siebert’s fields of expertise were not relevant to the specific bodies of science that purport to maintain generally acceptable scientific methods and analyses related to autism and its causes. Based upon all of the foregoing analysis, we agree with the well-reasoned and cogent opinion of Judge Berger. (pp. 50, 58-62)

The plaintiffs have been ordered to pay all costs involved in appealing the Baltimore court’s decision. Should they seek reversal of the Court of Appeals ruling, their next step will be to petition for a writ of certiorari to the U.S. Supreme Court. Approximately 7,500 such petitions are filed every year; approximately 80-150 are granted, most of them involving significant questions of constitutional law, including questions about the constitutionality of state laws. Given that Blackwell v. Wyeth raises no such questions, and given the clear articulation of the court’s rationale offered in the original dismissal and the Court of Appeals opinion, it seems unlikely that this case or any of the other thimerosal claims filed simultaneously in 2002 by plaintiffs’ attorney Thomas Yost Esq. will make their way to the nation’s court of last resort. And given this latest addition to the ever-flowing stream of judicial and administrative decisions rejecting the methodology and qualifications of proponents of the thimerosal causation hypothesis, it seems unlikely that any of the parents persuaded to believe their ethereal conclusions will be awarded the damages they have been persuaded to believe are their rightful due.

* Ipse dixit – “Because I said so.”

Comments


  1. Geier, Mumper, Haley, Deth – don’t they ever get that they are being humiliated?

    — isles    2009-05-10 20:59    #

  2. ego dixit autem
    omnibus respondit
    informatio Mercurium est bovis fimus maximus

    as every schoolboy lawyer knows :)

    — laurentius rex    2009-05-11 04:51    #

  3. “Res ipsa loquitur” is the doctrine I think of when I see the argument that a child was vaccinated and then became autistic. The thing speaks for itself! Except that it doesn’t, which is why plaintiffs need those expert witnesses.

    So far, the vaccine-autism plaintiffs have gotten nowhere under the old Frye standard, which is still used in some states such as Maryland, and the newer Daubert standard which was applied in the Court of Federal Claims. The plaintiffs are probably going to have to come up with a radically different approach, and a different set of experts, if they plan to proceed with their cases after they get out of the vaccine injury compensation program.

    — Anne    2009-05-11 18:12    #

  4. Anne,

    It wouldn’t hurt if the plaintiffs had some actual science behind them, either.

    I think what a lot of the vaccines-cause-autism people have been overlooking (perhaps deliberately) is that the reason they keep getting their butts kicked is that their experts are no good. Mumper, Deth and the Geiers may be sharp enough to fool a bunch of parents desperate for some hope, but they aren’t fooling anybody else.

    The “radically different approach” the plaintiffs SHOULD try is to listen to the REAL experts and drop this fruitless lawsuit before it costs them another dime.

    Perhaps they CAN win with a different strategy or a different set of “experts”, but winning in court won’t change the fact that the data don’t support their claim.

    — Prometheus    2009-05-12 11:42    #

  5. None of Dr. Geier’s research aimed at establishing a link between thimerosal and autism, moreover, is based upon sound methodology.

    Ouch.

    I wish that comments like that would get greater press at autism "conferences" for parents.

    It is too bad that so many have been led down this very bad path. Unfortunately, there are still years of wrangling with the Omnibus appeal, and even that won't put an end to this.

    — Sullivan    2009-05-12 17:50    #