Opinion
Civil Action No. 99-2326-KHV
December 28, 2000
MEMORANDUM AND ORDER
Mark and Cheryl Miller bring this products liability action against Pfizer Inc. This matter comes before the Court on the Order To Show Cause issued on August 18, 2000. After careful consideration of the responses to its order, the Court determines that it will appoint an outside expert to assist in evaluating whether Dr. David Healy's methodology is proper under Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993), and whether defendant's Motion To Exclude The Testimony Of David Healy (Doc. #217) filed on April 18, 2000 should be sustained.
Legal Standard
Rule 702, Fed.R.Evid., provides that a witness who is qualified by knowledge, skill, experience, training or education may testify in the form of opinion or otherwise as to scientific, technical or other specialized knowledge if such testimony will assist the trier of fact to understand the evidence or to determine a fact in issue, "if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case." Under Daubert, when expert testimony is offered, a district court must determine at the outset, pursuant to Rule 104(a), Fed.R.Evid., whether the expert testimony is reliable and whether it will assist the trier of fact to understand or determine a fact in issue. See id. at 592. The district court may consider several nondispositive factors in determining whether a particular scientific theory or technique is reliable. These factors include (1) whether the proffered technique can and has been tested; (2) whether the technique or theory has been subject to peer review; (3) the known or potential rate of error; and (4) the general acceptance of a technique in the relevant scientific community. Id. at 593-94. The proponent of expert testimony must show "a grounding in the methods and procedures of science which must be based on actual knowledge and not subjective belief or unaccepted speculation." Mitchell v. Gencorp. Inc., 165 F.3d 778, 780 (10th Cir. 1999). An expert's qualifications are relevant to the reliability inquiry. See United States v. Taylor, 154 F.3d 675, 683 (7th Cir. 1998); In re Indep. Serv. Org. Antitrust Litig., 85 F. Supp.2d 1130, 1163 (D.Kan. 2000).
This statement of the rule incorporates the most recent amendment on December 1, 2000. The Court uses its discretion under 28 U.S.C. § 2074(a) to apply the amended rule to the proceeding now in progress since the new language merely codifies the existing standards for Rule 702 and does not present any substantive change in the law.
Background
On the early morning of July 27, 1997, Cheryl Miller discovered that her 13-year-old son Matthew had committed suicide. Prior to the suicide, Matthew had started taking Zoloft, a selective serotonin reuptake inhibitor (SSRI). On the date of the incident, Matthew had been on the drug for a week. Following the suicide, plaintiffs filed suit against Pfizer, alleging that it had not adequately warned of Zoloft's propensity to heighten tendencies towards akathasia, a drug-induced mental confusion and physical agitation, and suicide. Complaint at 12 (Doc. #1). Plaintiffs offer Dr. Healy as an expert in psychopharmacology and suicidology, for the purpose of testifying about SSRI drugs and their propensity to induce suicide. If allowed, Dr. Healy would also specifically testify about Zoloft's possible role in causing Matthew's suicide. Defendant seeks to exclude Dr. Healy's testimony because (1) it is unreliable; (2) he misapplied Koch's Postulates; (3) he failed to satisfy the standards set out in Daubert; (4) his opinions are not based on data on which others in the field would reasonably rely; and (5) he is unqualified to offer opinions regarding warnings, regulatory matters and suicidology. Reply In Support Of Defendant Pfizer Inc.'s Motion To Exclude The Testimony Of David Healy at 1-3, 21-22 (Doc. #425). Plaintiffs respond that Dr. Healy is sufficiently qualified to offer opinions which he has arrived at through reliable scientific methodologies. Plaintiffs' Brief In Support Of Response To Pfizer Motion In Limine To Exclude Testimony Of Dr. Healy at 33-34 (Doc. #357).
In reviewing the briefing on defendant's motion to exclude Dr. Healy's testimony, and related briefs, the Court concluded that an independent expert might prove quite helpful in resolving the issue. Pursuant to D. Kan. Rule 26, the Court ordered the parties to show cause why such an expert should not be appointed. Order To Show Cause (Doc. #454). Plaintiffs agreed that an expert would be helpful. Plaintiffs' Response To "Show Cause" Order (Doc. #456). Defendant argues that the Court's lack of comfort with Dr. Healy's testimony is reason enough to exclude his testimony, without further proceedings. Defendant Pfizer Inc.'s Response To The Court's Order To Show Cause at 1 (Doc. #457). Defendant's reasoning would lead to a regime without Daubert hearings because the Court would merely exclude any questionable expert without further hearings on the matter. This clearly does not satisfy the gate-keeping function of Daubert. Defendant also re-argues its motion to exclude Dr. Healy and attempts to bolster it with responses to the concerns expressed in the Court's show cause order.
Analysis
After careful consideration, this Court cannot endorse either side's position regarding the testimony of Dr. Healy. Specifically, Dr. Healy used Koch's Postulates, among other methods, to arrive at his conclusions about the relationship between Zoloft (sertraline) and suicide. The postulates are a series of factors which are designed to assist in determining whether a drug may cause a certain reaction. On this record, it appears that the postulates are an acceptable scientific methodology to determine the existence of causation, but it is unclear whether Dr. Healy has properly applied them. Following the principles laid forth in Daubert, the Court will therefore hold a hearing to determine the admissibility of evidence regarding that methodology, as applied by Dr. Healy.
Dr. Healy also relied on case reports, challenge/de-challenge/re-challenge experiments, and information gleaned from Pfizer's own studies.
At this time, the Court anticipates that the independent expert will review all of the materials which have been submitted in connection with defendant's Daubert motion; prepare a written report which discusses his or her opinions with regard to the factors outlined in Daubert; and testify at the Daubert hearing and possibly at trial. Among other things, the independent expert will examine the causal relationship (if any) between Zoloft and other SSRI drugs, akathisia and suicide; whether the causal relationship (if any) can be established without randomized control trials; whether the case study method proposed by Dr. Healy is generally accepted within the scientific community; whether Dr. Healy has properly applied Koch's Postulates; whether Dr. Healy has sufficiently accounted for alternative explanations for Matthew's suicide; the factors which are properly part of Koch's Postulates and the proper weighing of those factors; whether the calculations based on the Hindmarch study and the Ryder Report represent acceptable scientific methodology in this field; whether Dr. Healy's studies as a whole are scientifically adequate to justify his conclusions; and what knowledge, experience and qualifications permit an expert to express scientifically legitimate opinions regarding suicidology and FDA regulatory warnings.
Plaintiffs have proposed Dr. Marcia Angell as an outside expert. While Dr. Angell has expertise in the use of science in courtrooms and appears to be equally critically of plaintiffs' lawyers and pharmaceutical companies, she apparently is not an expert in psychopharmocology or suicidology. Plaintiff's Supplemental Response To "Show Cause" Order And Reply To Pfizer's Response at 2-3 (Doc. #458). The Court is more interested in an expert who possesses knowledge in the areas outlined above. The Court therefore orders the parties to consult in good faith to determine whether they can jointly propose such an expert. If not, under D. Kan. Rule 26.4, each party shall nominate three experts who satisfy the foregoing criteria. The Court may appoint one of those nominees. It also reserves the right to appoint an expert of its own choosing and in selecting such an expert the Court would solicit the assistance of the American Association for the Advancement of Science, and in particular, its Advisory Committee on Court Appointed Scientific Experts. A brochure which explains the work of that Committee is attached to this order.
IT IS THEREFORE ORDERED that on or before January 18, 2000, the parties shall submit either a joint nomination for an independent expert or separate lists of three proposed expert witnesses. The submissions shall include the expert's qualifications and their proposed duties.