Nelson v. American Sterilizer Co., Docket No. 199685

Decision Date16 May 1997
Docket NumberDocket No. 199685
Citation223 Mich.App. 485,566 N.W.2d 671
Parties, Prod.Liab.Rep. (CCH) P 14,962 Pearline NELSON, Plaintiff-Appellant, v. AMERICAN STERILIZER COMPANY, Michael Glaz, and Ronald Maloney, Defendants-Appellees. (On Remand)
CourtCourt of Appeal of Michigan — District of US

Reynolds, Beeby & Magnuson, P.C. by Frank K. Mandlebaum and Elizabeth A. Fellows (Skadden, Arps, Slate, Meagher & Flom by Bert L. Wolff, New York City, of counsel), Troy, for Defendants-Appellees.

Before NEFF, P.J., and GRIBBS and YOUNG, JJ.

ON REMAND

NEFF, Presiding Judge.

This tort action arises from plaintiff's inhalation exposure to a chemical known as ethylene oxide (EtO), a fumigant used, among other things, for sterilizing heat and moisture sensitive medical equipment. The trial court barred plaintiff's experts from testifying regarding the issue of causation, after ruling that the experts' conclusion that chronic, low-level inhalation exposure to EtO causes steatohepatitis in humans lacked sufficient scientific grounding. The court then dismissed plaintiff's action. In our original opinion, we found, in part, that the trial court had erroneously both excluded the proffered expert testimony and dismissed the action. Nelson v. American Sterilizer Co., 212 Mich.App. 589, 538 N.W.2d 80 (1995). Our Supreme Court, in lieu of granting leave to appeal, vacated our judgment, in part, however, and remanded this case to us so that we might reconsider our earlier determination of error in light of MRE 702, with specific attention devoted to defendants' argument concerning the appropriateness of plaintiff's expert witnesses' reliance on animal studies in preference to existing epidemiological studies. Nelson v. American Sterilizer Co., 453 Mich. 943, 554 N.W.2d 898 (1996). On remand, we conclude that the trial court correctly barred plaintiff's experts from testifying on the issue of causation with regard to plaintiff's liver disease. Where, as here, no epidemiological study has found a statistically significant link between EtO exposure and steatohepatitis in humans and the results of animal studies are inconclusive at best, the expert testimony fails to exhibit the level of reliability required by MRE 702. We now affirm in part, reverse in part, and remand.

I

Plaintiff produced two causation experts, both of whom were her treating physicians, whose testimony may be summarized as follows. First, no existing epidemiological studies report an association between inhalation exposure to EtO and the incidence of liver disease in humans. Second, existing animal studies demonstrate that certain known concentrations of EtO introduced into the body through inhalation over certain known periods targets the livers of test animals and induces hepatotoxicity in those animals. Third, plaintiff was exposed to unknown concentrations of EtO for unknown durations. Fourth, plaintiff's clinical findings were consistent with the liver abnormalities found in rodents exposed to EtO through inhalation. Fifth, because EtO reaches the livers of rodents and causes hepatotoxicity in rodents, it likewise reaches the livers of humans and causes hepatotoxicity. Sixth, plaintiff's exposure to unknown concentrations of EtO for unknown durations resulted in plaintiff's liver disease. Both experts employed a differential diagnosis technique to reach a diagnostic conclusion by exclusion of all other known causes of plaintiff's steatohepatitis.

II

The question whether chronic inhalation exposure to EtO causes steatohepatitis in humans is scientific in nature, and it is to the scientific community that the law must look for the answer. For this reason, expert witnesses are indispensable in this case. But that is not to say that the trial court's hands were inexorably tied, or that it must have accepted uncritically any sort of opinion espoused by either party's proffered experts merely because their credentials rendered them qualified to testify. To the contrary, under the rules of evidence, the trial court was charged with ensuring that any and all scientific testimony to be admitted was not only relevant, but also reliable. Amorello v. Monsanto Corp., 186 Mich.App. 324, 331-332, 463 N.W.2d 487 (1990). See Kelley v. Murray, 176 Mich.App. 74, 79, 438 N.W.2d 882 (1989).

The primary source of this obligation is MRE 702, which clearly contemplates some degree of regulation of the subjects and theories about which an expert may testify. The degree of discretion this evidentiary rule affords a trial court is at the heart of the resolution of the question now before this Court.

A

MRE 702 provides, in pertinent part, that if "recognized scientific ... knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue," then an expert "may testify thereto." (Emphasis added.) Accordingly, MRE 702 restricts the subject of an expert's testimony to "recognized scientific ... knowledge." There are no Michigan appellate cases that expressly construe the phrase "recognized scientific knowledge." Some guidance may be taken, however, from Amorello, supra.

In Amorello, supra at 332, 463 N.W.2d 487, this Court opined that the facts and data upon which an expert relies in formulating an opinion must be reliable. The Court then concluded that the plaintiffs had failed to demonstrate the admissibility of the opinion testimony of their expert to the effect that PCB exposure caused the plaintiffs' health problems because the plaintiffs' had failed to offer evidence to rebut the defendants' claims that the testimony did not have a reasonable medical or reliable scientific basis and was unsupported by scientific and medical literature. Amorello, supra at 331-332, 463 N.W.2d 487.

We also take guidance from an application of the rules of construction to the phrase "recognized scientific knowledge." The interpretation of a court rule is subject to the same principles that govern statutory construction. Michigan Basic Property Ins. Ass'n v. Hackert Furniture Distributing Co., Inc., 194 Mich.App. 230, 234, 486 N.W.2d 68 (1992). All words and phrases are to be construed and understood according to the common and approved usage of the language. In re Public Service Comm's Determination, No. 2, 204 Mich.App. 350, 353, 514 N.W.2d 775 (1994). Reference to a dictionary is appropriate to ascertain the ordinary meaning of a word. Popma v. Auto Club Ins. Ass'n, 446 Mich. 460, 470, 521 N.W.2d 831 (1994).

The word "recognized" connotes a general acknowledgment of the existence, validity, authority, or genuineness of a fact, claim, or concept. Black's Law Dictionary (6th ed.), p. 1271; Webster's New World Dictionary, Third College Edition, p. 1121. The adjective "scientific" connotes a grounding in the principles, procedures, and methods of science. Id., p. 1202; Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 590, 113 S.Ct. 2786, 2795, 125 L.Ed.2d 469 (1993). Finally, the word "knowledge" connotes more than subjective belief or unsupported speculation. Id. at 590, 113 S.Ct. at 2795. The word " 'applies to any body of known facts or to any body of ideas inferred from such facts or accepted as truths on good grounds.' " Id., quoting Webster's Third New International Dictionary, p. 1252 (1986).

We conclude that MRE 702 requires a trial court to determine the evidentiary reliability or trustworthiness of the facts and data underlying an expert's testimony before that testimony may be admitted. To determine whether the requisite standard of reliability has been met, the court must determine whether the proposed testimony is derived from "recognized scientific knowledge." To be derived from recognized scientific knowledge, the proposed testimony must contain inferences or assertions the source of which rests in an application of scientific methods. Additionally, the inferences or assertions must be supported by appropriate objective and independent validation based on what is known, e.g., scientific and medical literature. This is not to say, however, that the subject of the scientific testimony must be known to a certainty, Daubert, supra at 590, 113 S.Ct. at 2795. As long as the basic methodology and principles employed by an expert to reach a conclusion are sound and create a trustworthy foundation for the conclusion reached, the expert testimony is admissible no matter how novel. Id. at 596, 113 S.Ct. at 2798; see Richardson v. Richardson-Merrell, Inc., 273 U.S. App DC 32, 41, 857 F.2d 823 (1988).

B

Having set forth the legal principles that will guide our resolution of the question before us, we now turn to a discussion of the evidentiary reliability of the causation testimony of plaintiff's experts. We begin with a brief review of the scientific methodology employed in the study of disease causation to illustrate the nature of the evidence we must examine and apply to this case, and to address defendants' contention that the studies relied upon by plaintiff provide an insufficient basis for her experts' opinions.

Scientific studies concerning disease causation come in several forms, two of which are cohort epidemiological studies and in vivo animal studies. Defendants' experts rely on human epidemiological studies, and to a lesser degree on in vivo animal studies, to support their conclusion that plaintiff's exposure to EtO was not the cause of her liver disease. Plaintiff's experts rely solely on in vivo animal studies to support their causation opinions.

Epidemiology is the study of the distribution of disease in populations and the risk factors associated with particular diseases. Wade-Greaux v. Whitehall Laboratories, Inc., 874 F.Supp. 1441, 1451 (D.Virgin Islands, 1994), aff'd. 46 F.3d 1120 (C.A.3, 1994); Smith v. Ortho...

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