Blackwell v. Wyeth

• Decision Date: 07 May 2009
• Docket Number: No. 112, September Term, 2008.,112, September Term, 2008.
• Citation: 408 Md. 575,971 A.2d 235
• Parties: Pamela BLACKWELL et al. v. WYETH d/b/a/ Wyeth, Inc., et al.
• Court: Court of Special Appeals of Maryland

971 A.2d 235

408 Md. 575

Pamela BLACKWELL et al. v. WYETH d/b/a/ Wyeth, Inc., et al.

No. 112, September Term, 2008.

Court of Appeals of Maryland.

May 7, 2009.

Thomas F. Yost, Jr. (Thomas F. Yost, Jr., P.A., Baltimore), on brief, for Appellants.

Daniel J. Thomasch (Joseph Evall, Lauren J. Elliott, Richard W. Mark, and Sean Shields, Orrick, Herrington & Sutcliffe LLP, New York City; Raymond G. Mullady, Jr., Orrick, Herrington & Sutcliffe LLP, Washington, DC), all on brief, for Appellees.

Dino S. Sangiamo, Stephen E. Marshall, David S. Gray, Venable LLP, Baltimore, brief of Amicus Curiae Merck & Co., Inc.

Argued Before BELL, C.J., HARRELL, BATTAGLIA, GREENE, MURPHY, ADKINS and BARBERA, JJ.

BATTAGLIA, Judge.

In this case, we address the boundaries of Frye-Reed¹ 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' qualifications 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 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' 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-Reed⁹ 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 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, "[f]ounded 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.2006) ("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).

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:

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 certain; 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, supr...