McClain v. Metabolife Intern., Inc., No. 03-12776.

• Decision Date: 02 March 2005
• Docket Number: No. 03-12776.
• Parties: Johnny C. McCLAIN, Annie McClain, Plaintiffs-Appellees, Shirley Franks, wife, Wilmer Hudson, husband, et al., Plaintiffs-Appellees, Cross-Appellants, v. METABOLIFE INTERNATIONAL, INC., a corporation, Defendant-Appellant, Cross-Appellee.
• Court: U.S. Court of Appeals — Eleventh Circuit

401 F.3d 1233

Johnny C. McCLAIN, Annie McClain, Plaintiffs-Appellees Shirley Franks, wife, Wilmer Hudson, husband, et al., Plaintiffs-Appellees, Cross-Appellants, v. METABOLIFE INTERNATIONAL, INC., a corporation, Defendant-Appellant, Cross-Appellee.

No. 03-12776.

United States Court of Appeals, Eleventh Circuit.

March 2, 2005.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

John Patrick Kavanagh, Jr., Edward G. Bowron, Bowron, Latta & Wasden, P.C., Mobile, AL, Cavender Crosby Kimble, Balch & Bingham, LLP, Birmingham, AL, for Metabolife Intern., Inc.

A. David Fawal, Archie C. Lamb, Jr., Law Offices of Archie Lamb, LLC, Robert B. Roden, Shelby & Cartee, Birmingham, AL, for Plaintiffs-Appellees and Plaintiffs-Appellees, Cross-Appellants.

Evan M. Tager, Mayer, Brown, Rowe & Maw LLP, Washington, DC, for Chamber of Commerce of the U.S., Amicus Curiae.

Appeals from the United States District Court for the Northern District of Alabama.

Before ANDERSON and BIRCH, Circuit Judges, and ROYAL^*, District Judge.

ROYAL, District Judge:

This is an appeal of a jury verdict in a products liability action against Metabolife International, Inc. At trial Plaintiffs claimed that they suffered serious medical problems after taking Metabolife 356, an herbal weight-loss supplement, manufactured, marketed, and sold by Metabolife. After hearing the evidence, a jury returned a verdict in Plaintiffs' favor. Metabolife now appeals that verdict on the ground that the trial court erred in admitting the testimony of Plaintiffs' experts on the issue of causation. For the reasons discussed below, we find that the trial court erroneously admitted Plaintiffs' experts' testimony. Accordingly, we REVERSE and REMAND for proceedings below consistent with these rulings.

I. Background Information

Annie McClain, Shirley Franks, Connie Thornburg and Wilmer Hudson contend that they suffered serious injuries after taking Metabolife 356, an herbal appetite suppressant containing ephedrine and caffeine. Ephedrine occurs naturally in a plant called ma huang and has been used for decades for treating adults and children, especially in over-the-counter medicines.

Plaintiffs brought this action against Defendant Metabolife International, Inc., charging that Metabolife manufactured, marketed, and sold an unreasonably dangerous diet drug. Plaintiffs further contend that Metabolife knew that its product could cause heart attacks and strokes, but nonetheless, continued to sell the drug without adequate warning. All four Plaintiffs took the dietary aid. Plaintiffs Thornburg, Franks, and McCain suffered ischemic cerebral events (strokes), and Plaintiff Hudson suffered an acute myocardial infarction (heart attack).

Before trial Metabolife moved to exclude Plaintiffs' experts' testimony on medical causation asserting that Plaintiffs' experts' opinions lacked a reliable foundation for admission under the standards of Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). The trial court held a Daubert hearing, and Plaintiffs offered two expert witnesses to prove causation: James O'Donnell, Pharm. D., and Hashim Hakim, M.D., a neurologist. Dr. O'Donnell primarily offered opinions on general causation. Dr. Hakim offered testimony on both general and individual causation.

In its brief written order on the motion, the district court acknowledged its role as a gatekeeper under Fed.R.Evid. 702, but concluded that it lacked sufficient knowledge on the scientific subject matter to exclude the testimony presented and that Defendant had not produced competing testimony for it to determine that, as a matter of law, testimony from Plaintiffs' experts was inadmissible. Metabolife later filed a motion for reconsideration on the issue, and it was denied. The two experts testified at trial on the issues covered by Defendant's motion, and the jury returned a verdict for Plaintiffs. Defendant appealed contending that the district court abused it discretion in admitting Plaintiffs' experts' testimony on medical causation.

II. Legal Standard

This is a toxic tort case. Plaintiffs contend that the toxic combination of ephedrine and caffeine in the Metabolife 356 that they ingested harmed them. To prove their toxic tort claims, Plaintiffs must prove the toxicity of the ephedrine/caffeine combination and that it had a toxic effect on them causing the injuries that they suffered — ischemic strokes in three Plaintiffs and a heart attack in the other.

This type of proof requires expert testimony, and when a party offers expert testimony and the opposing party raises a Daubert challenge, the trial court must "make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field." Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999). This requirement for proof of the reliability of the expert's method comes from Fed.R.Evid. 702, which authorizes the admission of expert opinion testimony "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." Rule 702 lays the foundation for the trial court's Daubert analysis. 509 U.S. at 590, 113 S.Ct. 2786.

Daubert requires the trial court to act as a gatekeeper to insure that speculative and unreliable opinions do not reach the jury. Id. at 589 n.7, 597, 113 S.Ct. 2786. As a gatekeeper the court must do "a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue." Id. at 593-94, 113 S.Ct. 2786. The proposed testimony must derive from the scientific method; good grounds and appropriate validation must support it.¹ Id. at 590, 113 S.Ct 2786. "In short, the requirement that an expert's testimony pertain to `scientific knowledge' establishes a standard of evidentiary reliability." Id. The court must consider the testimony with the understanding that "[t]he burden of establishing qualification, reliability, and helpfulness rests on the proponent of the expert opinion...." United States v. Frazier, 387 F.3d 1244, 1260 (11th Cir.2004).²

The court of appeals reviews a trial court's Daubert rulings under an abuse of discretion standard. Gen. Elec. Co. v. Joiner, 522 U.S. 136, 140, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997). A "district court enjoys `considerable leeway' in making [reliability] determinations" under Daubert. Kumho, 526 U.S. at 152, 119 S.Ct. 1167. Thus, "[w]hen applying [the] abuse of discretion standard, we must affirm unless we at least determine that the district court has made a `clear error of judgment,' or has applied an incorrect legal standard." See Piamba Cortes v. Am. Airlines, Inc., 177 F.3d 1272, 1306 (11th Cir.1999) (quoting SunAmerica Corp. v. Sun Life Assurance Co. of Canada, 77 F.3d 1325, 1333 (11th Cir.1996)).

A trial court, however, abuses its discretion by failing to act as a gatekeeper. In this case the trial court essentially abdicated its gatekeeping role. Although the trial court conducted a Daubert hearing, and both witnesses were subject to a thorough and extensive examination, the court ultimately disavowed its ability to handle the Daubert issues.³ This abdication was in itself an abuse of discretion.⁴

Yet, even had the trial court fully accepted its role, it would have abused its discretion by admitting the experts' testimony. The record of their testimony in the pretrial hearing demonstrates that their testimony failed to satisfy the standards of reliability required under Daubert and its progeny. The admission of their testimony on medical causation in this toxic tort case substantially prejudiced Metabolife and authorizes reversal of the judgment. See Piamba Cortes, 177 F.3d at 1305.

In analyzing the experts' testimony, we note that toxic tort cases usually come in two broad categories: first, those cases in which the medical community generally recognizes the toxicity of the drug or chemical at issue, and second, those cases in which the medical community does not generally recognize the agent as both toxic and causing the injury plaintiff alleges. Examples of the first type include toxins like asbestos, which causes asbestosis and mesothelioma; silica, which causes silicosis; and cigarette smoke, which causes cancer. This case, involving Metabolife's combination of ephedrine and caffeine, falls into the second category. The medical community does not generally recognize the toxicity of this drug combination or ephedrine alone as causing the injuries Plaintiffs allege.

The court need not undertake an extensive Daubert analysis on the general toxicity question when the medical community recognizes that the agent causes the type of harm a plaintiff alleges. The battleground in this first category of cases focuses on plaintiff-specific questions: was plaintiff exposed to the toxin, was plaintiff exposed to enough of the toxin to cause the alleged injury, and did the toxin in fact cause the injury? A Daubert analysis in the first type of case deals with questions of individual causation to plaintiff.

In the second category of toxic tort cases, the Daubert analysis covers not only the expert's methodology for the plaintiff-specific questions about individual causation but also the general question of whether the drug or chemical can cause the harm plaintiff alleges.⁵ This is called general causation. "General causation is concerned with whether an agent increases the incidence of disease in a group and not whether the agent caused any given individual's disease." Michael D. Green et al., Reference Guide on Epidemiology, in REFERENCE MANUAL ON...