Blackwell v. Wyeth

BATTAGLIA, Judge. In this case, we address the boundaries of Frye-Reed 1 with respect to a hypothesis proffered, on behalf of Pamela and Ernest Blackwell, Petitioner, by their expert, Dr. Mark Geier, involving whether the presence of the preservative “thimerosal” 2 in childhood vaccines, causes neurological defects, such as autism, 3 as well as his and four other individuals’ qualifica ⁵⁷⁸ tions to be experts under Maryland Rule 5-702, 4 in a suit against Wyeth, Inc., Respondent. Pamela and Ernest Blackwell, parents and next friends of Jamarr Blackwell, sued the drug manufacturer Wyeth, Inc., its affiliates, 5 and others, 6 alleging that Jamarr’s autism and ⁵⁷⁹ mental retardation were caused by thimerosal-laden vaccines administered to Jamarr, when he was a baby, between the years 1985 and 1986. 7 . After Wyeth moved in limine to preclude the testimony of the Blackwells’ experts on grounds that the causal connection between thimerosal and autism is not generally accepted in the relevant scientific community and that the experts were not qualified to testify to such a causal connection, a 10-day evidentiary hearing was held before Judge Stuart R. Berger of the Circuit Court for Baltimore City, in which he addressed the seminal question of “whether the plaintiffs can support their claim of general causation with science that utilized methods and theories that are generally accepted in the relevant disciplines.” After hearing the testimony of numerous experts presented by both sides, 8 Judge Berger issued a 57-page Memorandum Opinion, ultimately concluding that the Blackwells had failed to demonstrate that the bases of their proffered experts’ opinions, including the theory of causation and the analytical framework in support thereof, were generally accepted as reliable in the relevant scientific community.

Judge Berger also concluded that the Blackwells’ experts were not qualified to testify under Maryland Rule 5-702. Summary judgment was entered in favor of Wyeth, and the Blackwells appealed; we granted certiorari prior to any proceedings in the Court of Special Appeals, Blackwell v. Wyeth, 406 Md. 442 , 959 A.2d 792 (2008), to address two questions: 1. Did the Circuit Court improperly apply the Reed-Frye general acceptance standard to the Blackwells’ experts’ ⁵⁸⁰ conclusions, rather than the bases upon which they reached their causation opinions, and impermissibly conduct a trial on the merits by using a heightened scientific certainty standard to determine the admissibility of their expert testimony? 2. Did the Circuit Court apply an erroneous legal standard and abuse its discretion in concluding that the Blackwells’ experts’ testimony is inadmissible because it does not meet the requirements of Md. Rule 5-702?

We shall affirm and conclude that Judge Berger appropriately precluded the Blackwells’ experts’ testimony under Frye- Reed 9 and did not abuse his discretion in the application of Maryland Rule 5-702. I. Background In this case we must address the application of Frye-Reed to theories proffered as scientific and alleged to have been premised on scientifically accepted methodologies. To place ⁵⁸¹ this quandary within the appropriate context, we shall begin by discussing the purpose of scientific inquiry and the scientific method, as well as our framework for the admission of expert testimony. 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.” See Susan Haack, Of Truth, in Science and in Law, 73 Brook. L.Rev. 985, 985-86 (2008). 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. 10 At the heart of this search for knowledge is the use of scientific method — or the analytical process by which a hypothesis is tested and analyzed and conclusions or theories are developed. This process has also been described as empirical study, that being study, “[fjounded on practical experience, rather than on reasoning alone, but not established scientifically ... [or] testing a hypothesis by careful observation, hence rationally based on experience.” Stedman’s Medical Dictionary 632 (28th ed.2Q06) (“empiric”). 11 In basic terms, the development of a theory, using the scientific method or empirical testing, follows characteristic steps: 1.

Observations of some phenomenon are made. For example, the movements of planets (which move in more complex orbits than the stars). ⁵⁸² 2. Possible explanations (theories) are proposed for what is observed. (For the movement of planets, one such theory, radical at the time of its first suggestion, was that the movements of planets could be explained by a theory that placed the Sun and not the Earth at the center of our solar system.) 3.

Hypotheses are logically derived from the theories. (If the Sun is the center of the solar system, then certain other observations should be true. If the Earth is the center of the solar system, that would lead to different predictions.) 4. Studies are designed to test the hypotheses.

In essence, the study makes new observations that might disconfirm the hypothesis and thereby falsify the theory. Different theories have different implications and lead to different hypotheses. (Ideally, a study can be devised whose outcome will disconfirm one theory’s hypotheses and not the other’s. This is called a “critical experiment” because it permits a head-to-head test of two or more theories, and helps to determine which has done the best job of accounting for the relevant phenomena. , Sometimes scientific controversies persist for a very long time because no commonly agreed upon critical experiment can be conducted.) 5.

The results of such empirical tests lead to revision or abandonment of older theories or the creation of still newer and hopefully better theories. 6. The process repeats itself as more empirical tests are conducted and theories undergo continued re-evaluation. David L. Faigman, Michael J. Saks, Joseph Sanders & Edward K. Cheng, 1 Modern Scientific Evidence: The Law and Science of Expert Testimony, at 263-64 (2008). Specifically, once a theory is conceived based on an observable phenomenon, a hypothesis, which is “[a] conjecture advanced for heuristic purposes, cast in a form that is amenable to confirmation or refutation by conducting of definable experiments and the critical assembly of empiric data,” Stedman’s, supra, at 938, is developed, which defines the scope of an experiment.

Studies then are designed to test the hypothesis and gather data: ⁵⁸³ To real scientists a finding of fact is only as good as the methods used to find it. Scientific method is the logic by which the observations are made. Well designed methods permit observations that lead to valid, useful, informative answers to the questions that had been framed by the researcher. For scientists, the key word in the phrase “scientific method” is method.

Methodology — the logic of research design, measures, and procedures — is the engine that generates knowledge that is scientific. While for lawyers and judges credibility is the key to figuring out which witnesses are speaking truth and which are not, for scientists the way to figure out which one of several contradictory studies is most likely correct is to scrutinize the methodology. Faigman, supra, at 260 (emphasis in original). Once data is compiled, analysis occurs, from which conclusions are drawn; the hypothesis either remains viable or is disproven: Note that a hypothesis or a theory is never proven or confirmed to be true.

Testing is capable only of disconfirming. But theories that withstand such attempts at falsification better and longer become accepted, at least until something better comes along. The opposite approach can readily be seen in non-scientific activities of numerous kinds, where investigators engage in a search for evidence that confirms their suspicions. This confirmatory bias is based on the erroneous assumption that a theory is confirmed by the accumulation of facts consistent with the theory. ...

It is the diligent search for inconsistencies, for falsification, that really puts a theory to the test. A theory that can withstand such scrutiny is one that deserves credence. Id. at 264. “At any time there is a whole continuum of scientific ideas, claims, and theories: some [are] so well-warranted by such strong evidence that it is most unlikely they will have to be revised; some not quite so well-warranted but still pretty solidly established; some promising but as yet far from eer ⁵⁸⁴ tain; some new and exciting but highly speculative and as yet untested; and some so wild that few mainstream scientists are willing even to listen.” Haack, supra, at 996. The strength, therefore, of a scientific theory is measured, in part, by its validity, which is “the extent to which something measures what it purports to measure.” Faigman, supra, at 269.

See also Samuel R. Gross & Jennifer L. Mnookin, Expert Information and Expert Evidence: A Preliminary Taxonomy, 34 Seton Hall L.Rev. 141, 146^47 (2003) (discussing the distinction between field validity, which is whether a given “field of knowledge ... has credible tools to produce valid answers,” and method validity, which is whether “the methods that were used in this instance [were] capable of producing valid answers”). See generally Faigman, supra, Ch. 5, “Scientific Method: The Logic of Drawing Inferences from Empirical Evidence,” (discussing numerous research designs, methods of measurement, sampling, relationships among variables and threats to validity). The second variable affecting the strength of a scientific theory is its reliability, which has been defined as, [RJeliability refers to the ability of a measure to produce the same result each time it is applied to the same thing. Reliability refers to consistency, or reproducibility.

If each time a person steps on to a bathroom scale it gives a different reading (while the person’s weight has not changed), then the scale is said to lack reliability. Faigman, supra, at 269 (italics in original). Both validity and reliability, then, affect whether a scientific theory is accepted in the field in which it is offered. General acceptance by other members of the relevant scientific field became the standard for acceptance of a theory, as a result of the opinion of the United States Court of Appeals for the District of Columbia Circuit in Frye v. United States, 293 F. 1013, 1014 (D.C.Cir.1923): Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define.

Somewhere in this twilight zone the evidential force of the principle must be recognized, and while ⁵⁸⁵ courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs. (Emphasis added). The Frye “general acceptance” standard was adopted by this Court in Reed v. State, 288 Md. 374 , 391 A.2d 364 (1978), in which we recognized that the standard did reflect assessment of a theory’s validity and reliability. In Reed, we were confronted with whether voiceprint recognition, consisting of the use of a spectrograph machine to match patterns in an individual’s voice, was admissible, for identification purposes, in a rape case.

We concluded that the trial judge erred in admitting the evidence. Id. at 399-400, 391 A.2d at 377 . In so doing, Judge John C. Eldridge, writing for this Court, recognized that scientific methodologies or techniques must be generally accepted prior to the admission into evidence of the conclusions reached: On occasion, the validity and reliability of a scientific technique may be so broadly and generally accepted in the scientific community that a trial court may take judicial notice of its reliability. Such is commonly the case today with regard to ballistics tests, fingerprint identification, blood tests, and the like.

Similarly, a trial court might take judicial notice of the invalidity or unreliability of procedures widely recognized in the scientific community as bogus or experimental. However, if the reliability of a particular technique cannot be judicially noticed, it is necessary that the reliability be demonstrated before testimony based on the technique can be introduced into evidence. Although this demonstration will normally include testimony by witnesses, a court can and should also take notice of law journal articles, articles from reliable sources that appear in scientific journals, and other publications which bear on the degree of acceptance by recognized experts that a particular process has achieved. ⁵⁸⁶ Id. at 380 , 391 A.2d at 367 (internal citations removed). In adopting the Frye test of general acceptance, Judge Eldridge gave guidance regarding its application: That is to say, before a scientific opinion will be received as evidence at trial, the basis of that opinion must be shown to be generally accepted as reliable within the expert’s particular scientific field.

Thus, according to the Frye standard, if a new scientific technique’s validity is in controversy in the relevant scientific community, or if it is generally regarded as an experimental technique, then expert testimony based upon its validity cannot be admitted into evidence. The identity of the relevant scientific community is, of course, a matter which depends upon the particular technique in question. In general, members of the relevant scientific community will include those whose scientific background and training are sufficient to allow them to comprehend and understand the process and form a judgment about it. In unusual circumstances, a few courts have held that the experts thus qualified might properly be from a somewhat narrower field.

Id. at 381-82, 391 A.2d at 368 (internal citations omitted). We recognized in Reed that seminal scientific technologies may be rejected, because the “Frye standard retards somewhat the admission of proof based on new methods of scientific investigation by requiring that they attain sufficient currency and status to gain the general acceptance of the relevant scientific community,” id. at 385, 391 A.2d at 370 , quoting United States v. Addison, 498 F.2d 741, 743-44 (D.C.Cir.1974), in that “[f]airness to a litigant would seem to require that before the results of a scientific process can be used against him, he is entitled to a scientific judgment on the reliability of that process.” Id. at 385, 391 A.2d at 369-70 (emphasis in original). We further recognized that, “Frye was deliberately intended to interpose a substantial obstacle to the unrestrained admission of evidence based upon new scientific principles” because “[l]ay jurors tend to give considerable weight to ‘scientific’ evidence when presented by ‘experts’ with impressive credentials.” Id. at 386 , 391 A.2d at 370 , quoting ⁵⁸⁷ People v. Kelly, 17 Cal.3d 24 , 130 Cal.Rptr. 144 , 549 P.2d 1240, 1245 (1976). Accordingly, we concluded that, “fa]s long as the scientific community remains significantly divided, results of controversial techniques will not be admitted, and all [litigants] will face the same burdens.

If, on the other hand, a novel scientific process does achieve general acceptance in the scientific community, there will likely be as little dispute over its reliability as there is now concerning other areas of forensic science which have been deemed admissible under the Frye standard, such as blood tests, ballistics tests, etc.” Id. at 388, 391 A.2d at 371 . Since 1978, we have had occasion to elaborate on the application of Frye-Reed to various aspects of the scientific method as well as specific methodologies. In Wilson v. State, 370 Md. 191 , 803 A.2d 1034 (2002), we addressed whether a trial judge erred in rejecting expert opinion testimony, based upon a generally-accepted statistical calculus — the product rule. 12 Wilson had been accused of murder after a second child of his, with a different mother, had died during a night when Wilson was the caretaker. Wilson interposed a SIDS, or Sudden Infant Death Syndrome, defense.

At trial, the State proffered the testimony of two experts, who, using the product rule, would. have testified that the probability of a child dying with SIDS with cerebral swelling was 1 and 100,000 — arrived at by multiplying the statistic that 1 child per 1,000 live births die of SIDS by the statistic that 1 in 10 SIDS deaths involve cerebral swelling — and that the chance of two SIDS deaths occurring in the same family was 1 in 4,000,000— arrived at by squaring the rate of 1 child per 2,000 live births to reach the chance of two children dying from SIDS in the same family. Wilson moved in limine to exclude the testimony of the State’s experts, but the trial judge denied the motion. At trial, the experts testified, and in closing argu ⁵⁸⁸ ment, the State specifically referred to the experts’ statistics, stating, “[i]f you multiply his numbers, instead of 1 in 4 million, you get 1 in 10 million that the man sitting here is innocent.” Id. at 200 , 803 A.2d at 1039 . The Court of Special Appeals affirmed the conviction, and we granted certiorari to consider whether the Frye-Reed standard applies to the application of statistical methods, which we answered in the affirmative.

Id. at 196, 202-03 , 803 A.2d at 1036,1040-41 , citing Armstead v. State, 342 Md. 38 , 673 A.2d 221 (1996). After reiterating the bases of Frye-Reed that, “before a scientific expert opinion may be received in evidence, the basis of that opinion must be shown to be generally accepted as reliable within the expert’s particular scientific field,” id. at 203, 803 A.2d at 1041 , we addressed whether the use of a generally accepted technique required acceptance of conclusions derived from its use. We concluded that it was not mandated, because one of the necessary predicates to the application of the product rule — mutual independence of events — was not considered; genetics may have been the link between the two infants’ deaths: We hold that the trial court erred in admitting expert testimony based on the product rule because a condition necessary to the proper application of the product rule was lacking: there was inadequate proof of the independence of Brandi and Garrett’s deaths. As evidenced by the authorities above cited, there is not general agreement in the scientific community as to the relationship between SIDS deaths within a single family.

Stated another way, there is not general agreement in the medical community that multiple SIDS deaths in a .single family are genetically unrelated. The literature continues to reflect a lively debate concerning the role of genetics in SIDS. * * * In light of the widespread disagreement as to the causes of SIDS, we are unable to find general acceptance of the notion that there is no genetic component to SIDS. Una ⁵⁸⁹ nimity is not required for general acceptance, but it is clear to us that a genuine controversy exists within the relevant scientific community. In sum, there was inadequate proof of the statistical independence of SIDS deaths within a single family.

Therefore, based on the current state of medical opinion, the product rule should not be employed in calculating the likelihood of multiple SIDS deaths within a single family. Id. at 209, 210-11 , 803 A.2d at 1044-45 (citations omitted). Accepted methodology, then, does not mandate acceptance of conclusions ostensibly developed therefrom. We also have had the opportunity to apply Frye-Reed when considering whether a theory, which had been accepted in the scientific and legal communities, continues to meet the standard.

Comparative Bullet Lead Analysis (CBLA), by which two bullets are compared to see if they originate from the same original molten source, had gained currency as admissible scientific evidence prior to Clemons v. State, 392 Md. 339 , 896 A.2d 1059 (2006). In Clemons , the State presented an FBI CBLA expert, who testified that a bullet found at a crime scene and bullets found in a gun possessed by Clemons, seized two days after the crime, originated from the same original source. Clemons moved in limine to exclude the expert’s testimony, arguing that an essential premise of CBLA theory was no longer generally accepted in the relevant scientific community — that bullets originating from a given ingot or vat of lead were uniquely homogenous. The trial judge admitted the evidence, and the Court of Special Appeals affirmed the conviction.

We reversed, holding that the trial judge erred in admitting the CBLA testimony, because it was no longer generally accepted in the field of metallurgy that the elemental composition of the molten source for the creation of bullets was uniform, homogenous or unique. In so holding, we engaged in an in-depth review of the CBLA technique, observing, Recently the assumptions regarding that uniformity or homogeneity of the molten source and the uniqueness of each molten source that provide the foundation for CBLA have ⁵⁹⁰ come under attack by the relevant scientific community of analytical chemists and metallurgists[,] Id. at 368 , 896 A.2d 1059,1076 , and concluded: We conclude that CBLA does not satisfy the requirement under the Frye-Reed test for the admissibility of scientific expert testimony because several fundamental assumptions underlying the process are not generally accepted by the scientific community. Therefore, we reverse the judgment of the Court of Special Appeals and remand the case to the Circuit Court for Prince George’s County for a new trial. Id. at 372 , 896 A.2d at 1079 (emphasis added).

More recently, in Montgomery Mutual Insurance Company v. Chesson, 399 Md. 314 , 923 A.2d 939 (2007), we considered whether a trial judge erred in denying a defendant’s in limine motion for a Frye-Reed hearing to determine the admissibility of expert testimony that exposure to mold caused certain physical ailments, described as either sick building syndrome or bio-toxic illness, “a combination of ailments associated with exposure to modern buildings that lack proper ventilation.” Chesson, 399 Md. at 317 n. 1, 923 A.2d at 940 -41 n. 1. Montgomery Mutual, a workers’ compensation insurer, alleged that the claimant’s expert’s theory, regarding a causal connection between mold exposure and certain human health effects, had not been generally accepted within the relevant scientific community, nor had the tests used in developing the theory. The trial judge denied the motion without holding a hearing, and the Court of Special Appeals affirmed, stating, inter alia, that the experts utilized medical tests that were generally accepted in the scientific community. Montgomery Mutual Ins.

Co. v. Chesson, 170 Md.App. 551, 570-71 , 907 A.2d 873, 885 (2006). We reversed and remanded, recognizing that the tests utilized, as well as the results and theory, must be subjected to Frye-Reed scrutiny: In the case sub judice, the Court of Special Appeals held that it was unnecessary for the Circuit Court to hold a Frye-Reed hearing, reasoning (1) that [the expert’s] medical diagnosis was not a proper subject for Frye-Reed analysis, ⁵⁹¹ and (2) that the tests ¡"the expert] used in reaching his medical diagnoses are generally accepted in the medical community, and are therefore not subject to Frye-Reed analysis. We disagree and hold that, based on this record, the Circuit Court should have held a Frye-Reed hearing to determine whether the medical community generally accepts the theory that mold exposure causes the illnesses that respondents claimed to have suffered, and the propriety of the tests [the expert] employed to reach his medical conclusions. Chesson, 399 Md. at 328 , 923 A.2d at 947 (citations omitted) (emphasis added).

See also State v. Smullen, 380 Md. 233, 266, 268 , 844 A.2d 429, 448, 449-50 (2004) (noting that the battered-spouse syndrome is a novel scientific theory that would have been subjected to Frye had not the Maryland General Assembly expressly made it admissible, in a case addressing whether battered-spouse syndrome could be used as a self-defense). From even a limited review of our Frye-Reed history, it can be seen that our jurisprudence engages trial judges in a serious gate-keeping function, to differentiate serious science from “junk science.” Commentators on the Frye standard have recognized the importance of this role: Courts therefore have a duty to ensure that experts are presenting reliable testimony. This obligation is especially acute because unlike ordinary fact witnesses, who typically come from a very limited pool of witness[es], there is usually an almost unlimited pool of experts. For example, many qualified experts could testify in a typical medical malpractice case.

While attorneys are stuck with the testimonial limitations of the available fact witnesses, an attorney who needs an expert can “shop” for an expert with a pleasing courtroom manner who will agree with the attorney’s theory of the case. Some of these potential expert witnesses will be venal “hired guns.” As Judge Jack Weinstein has noted, “[a]n ⁵⁹² expert can be found to testify to the truth of almost any factual theory, no matter how frivolous.” Ordinary fact witnesses may also have their biases, but attorneys can only take advantage of these biases if the witnesses already exist; they cannot normally shop for an ordinary fact witness. By contrast, attorneys can seek expert witnesses who will parrot the attorneys’ line, and, indeed, implicitly “bribe” them to do so. Moreover, ordinary biases, such as a familial or friendly relationship to one of the parties, can typically be brought out on cross-examination.

Some authorities have argued that cross-examination will also reveal an expert witness’ bias to the jury. However, it [is] not at all clear how opposing counsel can discredit a “hired gun” expert for taking money for his testimony, given that opposing counsel will have his own expert — who may be scrupulously honest — on his payroll. In any event, even if the biases of hired guns can be revealed through cross-examination, that does not resolve the problems caused by expert-shopping. Not all, and perhaps not even most experts who testify to opinions outside the mainstream of their field are venal hired guns.

Our system assumes, perhaps optimistically, that the jury can determine if an expert is lying. But what if the expert is simply shading the truth? Or, even more likely, what if the expert is simply eccentric or outside the mainstream? Parties have every incentive to hire “outlier” experts with sincere but extreme views so long as they can conceal the outlier status.

There is no reason to hire an expert, for example, who will tell the jury that a client’s losses are worth $150,000 if an attorney can find an equally credible expert willing to testify that the true figure is $300,000. Moreover, there is no ethical obligation on attorneys to hire mainstream experts. Indeed, their duty to zealously advocate for their clients may require them to hire outliers if it would help their client’s case. David E. Bernstein, Frye, Frye Again: The Past, Present, and Future of the General Acceptance Test, 2 Bureau of National Affairs Expert Evidence Report (Feb. 18, 2002) ⁵⁹³ (footnotes omitted) (emphasis in original), available at http:// litigationcenter.bna .com/pie2/lit.nsf7id/BNAP-57HQ4Q?Open Document (last visited May 5, 2009).

II

Procedural History On June 9, 2004, the Blackwells filed a 22-count complaint against various thimerosal manufacturers, numerous manufacturers of thimerosal-laden products, and BG & E, alleging that mercury contained in their products or emissions caused their son Jamarr’s autism. Wyeth, as the manufacturer of a thimerosal-laden product, was sued for defective design, breach of warranty of fitness for a specific purpose, failure to warn, strict liability, negligence, defect in manufacturing, common law fraud, negligent misrepresentation, fraudulent misrepresentation, fraudulent misrepresentation through another, deceptive trade practices under the Maryland Consumer Protection Act, breach of implied warranties, intentional infliction of emotional distress, and civil battery. Wyeth moved to preclude the testimony of five experts offered by the Blackwells under Frye-Reed, arguing that the experts’ theory, that thimerosal caused Jamarr’s autism, and the various methodologies employed in reaching that conclusion, were not generally accepted in the relevant scientific community. Wyeth also alleged that the Blackwells’ experts were not qualified to testify under Maryland Rule 5-702.

The Blackwells filed reciprocal motions regarding a number of Wyeth’s experts. Between August 18-29, 2007, Judge Stuart R. Berger of the Circuit Court for Baltimore City conducted a Frye-Reed hearing on these motions, 13 wherein testimony was adduced ⁵⁹⁴ from each of the Blackwells’ experts — Mark Geier, M.D., Ph.D.; Stephen Siebert, M.D., M.P.H.; Elisabeth Mumper, M.D.; Richard Carlton Deth, Ph.D.; and Boyd Haley, Ph.D.— and from Wyeth’s five proposed experts — Peter M. Layde, M.D., M.Sc, Paul Kostyniak, Ph.D., Joseph Buxbaum, Ph.D., Kwame Anane-Yeboa, M.D., ánd Bryna Siegel, Ph.D. (of whom only Drs. Yeboa and Buxbaum were challenged by the Blackwells).

In an order supported by an extensive memorandum opinion, Judge Berger granted Wyeth’s Motion to Preclude Testimony of Plaintiffs Expert Witnesses, pursuant to Frye-Reed and Maryland' Rule 5-702, and denied the Black-wells’ Motion to Exclude Certain Defense Experts and Certain ⁵⁹⁵ Expert Testimony. Thereafter, Judge Berger granted Wyeth’s motion for summary judgment, finding “no genuine dispute as to any material fact.” The Blackwells noted an appeal to the Court of Special Appeals, and this Court granted certiorari prior to any proceedings in the intermediate appellate court, to address the exclusion of the Blackwells’ experts’ testimony. 14 III. Discussion Before us, the Blackwells argue that the Judge erred in his Frye-Reed analysis, because he denied the admissibility of their experts’ theory, that thimerosal in the vaccines produced by Wyeth and administered to their son, Jamarr, caused his autism, because it was not generally accepted in the relevant scientific community, 15 and because their experts were not qualified to testify about a causal relationship between thimerosal and autism, under Maryland Rule 5-702. The Blackwells argue, in essence, that the trial judge impermissibly determined the element of causation on summary judgment and precluded the jury from appropriate fact-finding. ⁵⁹⁶ Wyeth argues that the trial judge properly precluded the testimony of the Blackwells’ experts, because they were not qualified under Rule 5-702 and because their conclusions and analyses were not accepted in the relevant scientific community- A. Frye-Reed Analysis The essence of the instant case is the application of the Frye-Reed test to the analysis undertaken by an expert where the underlying data and methods for gathering this data are generally accepted in the scientific community but applied to support a novel theory.

In reaching his ultimate conclusion that “the plaintiffs ... failed in their burden of proving that the bases of the expert witnesses’ testimony are generally accepted as reliable within the relevant scientific field,” Judge Berger discussed the importance of the threshold determination with which he was vested. He noted that “[ujnder Reed, the proponent of an expert witness bears the burden of proving the basis of the witness’ opinion is generally accepted as reliable within the relevant scientific field.” He also observed that the Frye-Reed test “ ‘was deliberately intended to interpose a substantial obstacle to the unrestrained admission of evidence based upon new scientific principles,’ ” quoting Chesson, 399 Md. at 328 , 923 A.2d at 946 , in turn quoting Reed, 283 Md. at 386 , 391 A.2d at 370 , that the test posed a minimum threshold for the admissibility of scientific evidence in Maryland, and that trial courts continued to retain discretion to exclude such testimony on other grounds — such as lack of helpfulness or expert qualification. In discerning the factual predicates developed during the hearing, which have not been challenged for clear error, 16 Judge Berger found that “[tjhimerosal is an organic mercury-based compound,” that has been used in “various vaccines and other biological and pharmaceutical products since the 1930’s,” ⁵⁹⁷ and that it was undisputed that Jamarr had received a diphtheria tetanus and whole-cell pertussis vaccine (“DTP”), at 2 months, 4 months, 6 months and 18 months, pursuant to the Centers for Disease Control and Prevention’s published recommended schedule, as well as a hemophilia influenza type b (“Hib”) vaccine. According to Judge Beger, “[b]oth the DTP vaccine and the Hib vaccine contained 50 micrograms of thimerosal, which results in approximately 25 micrograms of mercury in each vaccination.” Judge Berger also found that “[i]n July of 1999, the Public Health Service and the American Academy of Pediatrics issued a joint statement recommending the removal of thimerosal from vaccines” as a precautionary measure, and that “[b]y March of 2001, all vaccines on the recommended childhood immunization schedule were available without thimerosal.” Turning to the issue of Jamarr’s developmental challenges, Judge Berger found that, “autism or autism spectrum disorder (“ASD”) are pervasive developmental disorders that are characterized by sustained impairments in social interaction, sustained impairments in verbal and nonverbal communication skills, and restricted, repetitive and stereotyped patterns of behaviors or interests,” and that “[u]nder the American Psychiatric Association’s Diagnostic and Statistical Manual ... the onset of autistic disorder is prior to three years of age.” His review of the scientific literature regarding autism’s causes, and in particular, the findings of the National Academy of Sciences’ Institute of Medicine’s (hereinafter “IOM”) 2001 and 2004 Committees, 17 led him to note that the 2001 IOM Committee, which was tasked with evaluating “the alleged connection between thimerosal-containing vaccines and a broad range of neurodevelopmental disorders including autism, ADHD, and speech or language delay,” concluded: ⁵⁹⁸ The hypothesis that thimerosal exposure through the recommended childhood immunization schedule has caused neurodevelopmental disorders is not supported by clinical or experimental evidence. * * * [T]he evidence is inadequate to accept or reject a causal relationship between thimerosal exposures from childhood vaccines and the neurodevelopmental disorders of autism, ADHD, and speech and language delay.

These conclusions were founded upon the following bases: (a) low-dose thimerosal exposure in humans has not been demonstrated to be associated with effects on the nervous system; (b) neurodevelopmental effects have been demonstrated for prenatal but not postnatal exposures to low doses of ethyl-mercury; (c) the toxicological information regarding ethylmercury, particularly at low doses, is limited; (d) thimerosal exposure from vaccines has not proven to result in mercury levels associated with toxic responses; (e) signs and symptoms of mercury poisonings are not identical to autism, ADHD, or speech or language delay; (f) autism is thought primarily to originate from prenatal injury; and (g) there is no evidence that ethylmercury causes any of the pathophysiological changes known to be associated with autism, such as genetic defects, and there are no well-developed pathological markers of ADHD or delay of speech or language that could be compared to effects of ethylmercury on the nervous system. The 2001 IOM Committee Report was succeeded in 2004 by another IOM Committee, which, Judge Berger found, again attempted to assess whether a causal link between the administration of thimerosal and autism had been proven in the scientific community. To assess causality, “the 2004 IOM ⁵⁹⁹ Committee used the categories of causal conclusions developed by previous IOM committees, namely: (1) no evidence; (2) evidence is inadequate to accept or reject a causal relationship; (3) evidence favors rejection of a causal relationship; (4) evidence favors acceptance of a causal relationship; (5) evidence establishes a causal relationship,” according to Judge Berger’s review. In that context, he continued, the 2004 Committee reviewed a vast body of literature on the subject and considered extensive presentations and submissions made by scientists during an open scientific meeting, ultimately concluding, “that the evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism.” This rejection, Judge Berger found, was in large part, based on “[ejpidemiological studies examining [thimerosal] and autism, including three controlled observation studies (Hviid et al., 2003; Miller, 2004; Verstraeten, et al., 2003) and two uncontrolled observational studies (Madsen, et al, 2003; Stehr-Green, et al., 2003),” all of which, “consistently provided evidence of no association between [thimerosal] and autism, despite the fact that these studies utilized different methods and examined different populations (in Sweden, Denmark, the United States and the United Kingdom).” As Judge Berger found, the 2004 IOM Committee ultimately determined that the link between thimerosal and autism was largely speculative: In the absence of experimental or human evidence that vaccination (either the MMR vaccine or the preservative thimerosal) affects metabolic, developmental, immune or other physiological or molecular mechanisms that are causally related to the development of autism, the committee concludes that the hypotheses generated to date are theoretical only.

Given the lack of direct evidence for a biological mechanism and the fact that all well-designed epidemiological studies provide evidence of no association between thimerosal and autism, the committee recommends that cost-benefit assess ⁶⁰⁰ ments regarding the use of thimerosal-containing versus thimerosal-free vaccines and other biological or pharmaceutical products, whether in the United States or other countries, should not include autism as a potential risk. Judge Berger also acknowledged that a “plethora of venerable publications reject[ ] the plaintiffs’ theoretical link between thimerosal-containing vaccines and autism,” including the Global Advisory Committee on Vaccine Safety, which advises the World Health Organization on health related issues, the Centers for Disease Control and Prevention, the American Academy of Pediatrics, and the National Institutes of Health, all of which have taken the position that thimerosal vaccines do not cause or contribute to autism. He stated that epidemiology, or “the science that studies the distribution of diseases within populations,” was the “single most relevant field of science to the general causation issue presented in this case, i.e., whether thimerosal-containing vaccines can cause autism,” and recognized that none of the Blackwells’ experts was qualified as an expert in epidemiology. Turning to the opinions rendered by the Blackwells’ primary expert, 18 Dr. Mark Geier, Judge Berger looked first at Dr. Geier’s analytical framework, whereby he purported to have completed an epidemiological analysis on scientifically accepted data compiled in various third-party databases: the Vaccine Adverse Effect Reporting System (VAERS), the Vaccine Safety Datalink, the Department of Education database, and the California Department of Social Services database.

He then subjected Dr. Geier’s conclusion, that thimerosal in vaccines causes autism in a small number of genetically susceptible individuals, to Frye-Reed, scrutiny. Judge Berger began by observing that the only published epidemiological studies purporting to show a causal link between thimerosal-containing vaccines and autism were the studies undertaken by Dr. Mark Geier and his son, Dr. David ⁶⁰¹ Geier, which suggested that the VAERS database could be extrapolated to show a causal connection between thimerosal and autism. He recognized the distinction between the use of data that is scientifically accepted and analysis purportedly based on that data, when the analysis employed is inappropriate to the data produced, which is dependent on the context in which it was produced and the hypothesis under scrutiny: It is significant to this Court that the 10M Committee criticized the technique utilized in Lone of the Geier studies] ... expressly noting that: VAERS cannot be used to calculate incidence rates because the VAERS database does not have complete reporting of all adverse events and because many report events lack a confirmed diagnosis or confirmed attribution to vaccine. Admittedly, Dr. Geier acknowledged that [this study] is controversial.

Indeed, the American Academy of Pediatrics (“AAP”), in a May, 2003 posting to their website, strongly denounced the Geier and Geier publication ... stating: This paper uses data from the [VAERS] inappropriately and contains numerous conceptual and scientific flaws, omissions of fact, inaccuracies, and misstatements .... failfing] to acknowledge the inherent limitations of the VAERS database when drawing conclusions of adverse event associations ... [and] [comparing the occurrence of late onset, chronic conditions like autism by using acute vaccine reactions like fever, pain and vomiting (presumably attributable to other vaccine components) as controls makes no sense as a measure of relative adverse event rates. Dr. Geier presented several additional publications that also contained studies in which the Geiers compared adverse event reports filed with VAERS with regard to thimerosalcontaining and thimerosal-free vaccines. In each of the studies, Geier and Geier continued assigning (despite the absence of total mercury exposive data), a higher cumulative thimerosal total to one group of children (those who filed a VAERS report regarding a TCV) than the other group ⁶⁰² (those who filed a VAERS report regarding a thimerosalfree vaccine.) As a result, Geier and Geier concluded that the greater the total exposure to mercury from thimerosal, the greater the risk of neurological disorders. Critically, with regard to the pre-2004 published Geier and Geier VAERS database studies, the [IOM] opined: (1) [t]he three studies have serious methodological limitations that make their results uninterpretable; (2) [t]he results of their studies are likewise improbable; (3) [t]he articles also lack a complete and transparent description of their methods and underlying data, making it difficult to confirm or evaluate their findings.

Accordingly, the 2004 IOM Committee concluded that the Geier and Geier VAERS studies were not helpful with regard to the causation issue it considered, that is, whether thimerosal-containing vaccines can cause autism or autistic spectrum disorders. The 2004 IOM Committee Report concluded: As a result of these significant methodological limitations, the committee finds the results of [Geier and Geier’s]' studies to be uninterpretable and, as such, they are noncontributory with respect to causality. In addition, Geier and Geier analyzed the VSP database on no less than two occasions. The Geiers presented to the 2004 IOM Committee an unpublished analysis of USD data, but did not describe the basis for their calculation or their methods leading the 2004 IOM Committee to conclude that it “found the results of their analysis using VSP data uninterpretable, primarily due to the lack of a complete description of their methods.” Finally, the 2004 IOM Report reviewed Geier and Geier’s Department of Education database and found that “[t]hese studies are characterized by serious methodological problems.” Judge Berger concluded that, as a result of flawed analysis of acceptable data, Dr. Geier’s epidemiological studies did not pass scrutiny under Frye-Reed: ⁶⁰³ In sum, the plaintiffs rely on Dr. Geier’s six epidemiological studies that purport to find an association between thimerosal in vaccines and autism.

However, this Court finds that Dr. Geier’s epidemiological studies do not constitute generally accepted bases for plaintiffs’ causation opinions inasmuch as those studies have been rejected by the 'relevant scientific community due to severe methodological flaws that render them unreliable. Indeed, the venerable IOM Committee concluded that Dr. Geier’s studies were not only flawed metthodologically, but “uninterpretable.” and therefore “noncontñbutory. ” As a result, this Court finds expressly that Dr. Geier’s epidemiological studies are not generally accepted in the scientific community because they utilize a methodology that is fundamentally flawed. * * * For the purposes of the Frye-Reed test, the “relevant scientific community” includes the full community of scientists with sufficient training and expertise to permit them to comprehend novel scientific methods, and may not properly be restricted to those who practice or otherwise adhere to the methods at issue. Reed, v. United States [State], supra, 283 Md. at 444 , 391 A.2d 364 . For the reasons stated in this Memorandum Opinion, the plaintiffs have failed to satisfy their burden of proof under Frye-Reed, because they have failed to show that, the methodologies 'underlying their expert witness’ opinions are generally accepted to be reliable in the relevant scientific community.

The consensus of the scientific community with expertise relevant to the issue of general causation in this case is reflected by the comprehensive and venerable report published by the Institute of Medicine in 2004. Moreover, other organizations have issued statements that comport with the comprehensive analysis supplied in the 2004 IOM Committee Report. ⁶⁰⁴ * * * It is well established that where an expert witness offers a novel medical theory of causation, the bases of the expert’s opinion, including the theory of causation, and the methodologies, must all be generally accepted or reliable in the relevant scientific community. See Montgomery Mut. Ins.

Co. v. Chesson, supra, 399 Md. at 327 , 923 A.2d 939 (2007). This Court finds that it is generally accepted in the relevant scientific community that autism is genetic in origin except in rare instances of prenatal exposures to certain substances at defined periods during pregnancy. Further, for the reasons explicated in this Memorandum Opinion, this Court notes that it is generally accepted in the relevant scientific community that thimerosal in vaccines does not cause or contribute to neurodevelopmental disorders such as autism. Critical to this Court’s analysis is the 2004 IOM Report.

IOM Reports are highly regarded in the relevant scientific community, and their reliability has been recognized by numerous courts.... After careful consideration by this Court, the 2004 Committee’s finding that “the evidence favors rejection of a causal relationship between thimerosalcontaining vaccines and autism” is generally accepted in the relevant scientific community. After reviewing the testimony and evidence, this Court finds that the fields of epidemiology and toxicology and genetics are central to many of the issues in this case, including the causation issues that have been presented in this proceeding. For the reasons stated in this Memorandum Opinion, Dr. Geier’s epidemiological studies purporting to show an association between thimerosal-containing vaccines and autism were not conducted in accordance with generally accepted epidemiological methods.

(Emphasis added). Although we have not in the past had occasion to scrutinize the analytical phase of a scientific process underlying a novel scientific opinion, where the underlying data may otherwise be generally accepted in the scientific community, various federal ⁶⁰⁵ courts have had occasion to scrutinize the reliability of the analytical framework utilized by an expert in formulating a novel theory of science, and to them we turn, recognizing that they utilized the Daubert standard rather than Frye . 19 We explore what they have opined, nevertheless, when they are speaking about reliability. The Supreme Court in General Electric Company v. Joiner, 522 U.S. 136 , 118 S.Ct. 512 , 139 L.Ed.2d 508 (1997), recognized that the analysis employed by an expert must be reliable. In Joiner , an electrician, alleging that his small cell lung cancer was caused by exposure to polychlorinated biphenyls (PCBs) and to furans and dioxins (PCB derivatives), sued the manufacturers of the products and attempted to introduce expert testimony linking his exposure to the chemicals to his small cell lung cancer.

The trial judge excluded the testimony, reasoning that the expert’s conclusions did not rise above “subjective belief or unsupported speculation,” Joiner v. General Electric Co., 864 F.Supp. 1310, 1326 (N.D.Ga.1994), and then granted summary judgment in favor of the manufacturer. The Court of Appeals for the Eleventh Circuit reversed, Joiner v. General Electric Co., 78 F.3d 524 , 533 (11th Cir. 1996), holding that the District Court should not have excluded expert testimony that merely “drew different conclusions from the research than did each of the experts,” and that the ⁶⁰⁶ court should have permitted the “jury to decide the correctness of competing expert opinions.” The Supreme Court reversed the Eleventh Circuit and excluded the expert’s testimony. The Court recognized that the analysis of data or extrapolation requires more than mere conjecture to pass reliability scrutiny: [Joiner] claims that because the District Court’s disagreement was with the conclusion that the experts drew from the studies, the District Court committed legal error and was properly reversed by the Court of Appeals. But conclusions and methodology are not entirely distinct from one another.

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. Joiner, 522 U.S. at 146 , 118 S.Ct. at 519 , 139 L.Ed.2d at 518-19 , citing Turpin v. Merrell Dow Pharmaceuticals, Inc., 959 F.2d 1349, 1360-61 (6th Cir.1992) (When “[t]he analytical gap between the evidence presented and the inferences to be drawn on the ultimate issue of human birth defects is too wide .... a jury should not be asked to speculate on the issue of causation.”).

In calling attention to the “analytical gap” between existing data and the opinion proffered by an expert, the Court admonished against reliance solely on an expert’s word that his conclusion is appropriate to the underlying data and methods. Id. This concept of “analytical gap” had been employed by federal courts before Joiner, see Lust v. Merrell Dow Pharmaceuticals, Inc., 89 F.3d 594 , 598 (9th Cir.1996) (“When a scientist claims to rely on a method practiced by most scientists, yet presents conclusions that are shared by no other scientist, the [trial] court should be wary that the method has not been faithfully applied.”), and even before Daubert. See Christophersen v. Allied-Signal Corp., 939 F.2d 1106, 1115 (5th Cir.1991) (en banc) (“When analyzing the validity of an expert’s methodology, we seek to determine ⁶⁰⁷ whether it connects the facts to the conclusion in a scientifically valid way.

We answer this question by applying the Frye test: whether the methodology or reasoning that the expert uses to connect the facts to his conclusion is generally accepted within the relevant scientific community.”). Since Joiner, the concept of the “analytical gap” also has been applied by numerous federal appellate courts. See, e.g., Bland v. Verizon Wireless, L.L.C., 538 F.3d 893, 898 (8th Cir.2008) (affirming a trial judge’s exclusion of expert testimony from plaintiff’s treating physician, who linked plaintiffs exercised-induced asthma to her inhalation and ingestion of freon that was allegedly sprayed into her water bottle by a Verizon employee, and holding that there was “simply too great an analytical gap” between “the data identified and [the expert’s] proffered opinion” because the expert “lacked knowledge regarding what level of exposure to freon constitutes an appreciable risk of causing asthma and the specific concentration and degree of [plaintiffs] exposure to the freon”); Ruggiero v. Warner-Lambert Co., 424 F.8d 249, 254-255 (2d Cir.2005) (excluding expert testimony that medication was capable of causing or exacerbating cirrhosis because the expert’s failure to consider other causes when employing differential diagnosis created “too great an analytical gap between the data and the opinion proffered”); United States v. Mamah, 332 F.3d 475, 478 (7th Cir.2003) (discussing the “analytical gap” when holding, “[t]he problem with the proposed testimony in this case does not lie in the quality of [the experts’] research .... [but in] the absence of an empirical link between that research and the opinion that [defendant] likely gave a false confession”). The “analytical gap” concept also has been employed by some of our sister states in a Frye analysis.

In Goeb v. Tharaldson, 615 N.W.2d 800, 816 (Minn.2000), for example, the Minnesota Supreme Court upheld the exclusion of export testimony because the methodology was unreliable and the conclusions proffered exhibited “too great a leap” from the data gathered. The Goebs had sued a pesticide applicator, Tharaldson, and Dow Chemical, the manufacturer, alleging ⁶⁰⁸ that exposure to the insecticide Dursaban, after it was sprayed in the house into which they were moving, caused injury to them and their child. The Goebs offered the testimony of two experts, both of whom would have testified, based on the Goebs’ medical records referring to adverse health affects, as well as on the toxic levels of the chemical chlorpyifos in their bodies, 20 that the Goebs were suffering from organophosphate 21 poisoning caused by their exposure to Dursaban. Id. at 806-08 .

Dow had argued that the experts’ conclusion should be excluded under Frye because the Goebs’ level of exposure was not factored into their analysis. After the expert testimony was excluded, the Goebs sought review, arguing that the experts’ testimony had been based upon generally accepted methodologies. The court affirmed, accepting the contention that the experts had used generally accepted methods in completing their tests, but rejecting the experts’ analysis when affirming the trial judge’s conclusion “that [the expert] made too great a leap to get from ‘mere exposure of an unquantified amount of Dursban’ to his conclusions about appellants’ illnesses.” Id. at 816. See also Kane v. Motorola Inc., 385 Ill.App.3d 214 , 221-22, 268 Ill.Dec. 688 , 779 N.E.2d 302 (2002) (discussing Joiner and the “analytical gap” concept when applying a Frye analysis).

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 identified in the Joiner opinion 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,” see Chesson, 399 Md. at 327 , 923 A.2d at 947 , and the data he relies upon was ⁶⁰⁹ 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. See, e.g., Mark R. Geier & David A. Geier, Neurodevelopmental Disorders after Thlrmrosal-Containing Vaccines: A Brief Communication, 228 Experimental Biology and Med. 660, 660-64 (2003) (relying on VAERS data); Mark R. Geier & David A. Geier, Thimerosal in Childhood Vaccines, Neurodevelopment Disorders, and, Heart Disease in the United States, 8 J. Am.

Physicians and Surgeons, Spring 2003, at 6-11 (relying on VAERS data); David A. Geier & Mark R. Geier, An Assessment of the Impact of Thimerosal on Childhood Neurodevelopmental Disorders, 6 Pediatric Rehabilitation, Apr.-June 2003, at 97-102 (relying on VAERS data); David A. Geier & Mark R. Geier, A Comparative Evaluation of the Effects of MMR Immunization and Mercury Doses from Thimerosal-Containing Childhood Vaccines on the Population Prevalence of Autism, 10 Med. Sci. Monitor, Mar. 2004, at P133-39 (relying on Department of Education data); David A. Geier & Mark R. Geier, Neurodevelopmental Disorders Following Thimerosal-Containing Childhood Immunizations: A Follow-Up Analysis, 23 Int’l J. of Toxicology 369, 369-376 (2004) (relying on VAERS data); Mark R. Geier & David A. Geier, The Potential Importance of Steroids in the Treatment of Autism Spectrum Disorders and Other Disorders Involving Mercury Toxicity, 64 Med. Hypotheses 946, 946-954 (2005) (merely suggesting a series of experiments that need to be conducted to potentially develop steroid treatments to reduce the affects of mercury poisoning); David A. Geier & Mark R. Geier, A