Expert Article Library

Expert Testimony Based on Unreliable Methods Must be Excluded

Case Name: McClain v. Metabolife International, Inc. (

Court: US Court of Appeals for the Eleventh Circuit, on appeal from the US District Ct. of Alabama

Date: March 2, 2005

Expert: Medical Doctor—Physician--Neurologist. Pharmacology. Dr. James O’Donnell, Pharm D. (Plaintiff). Hashim Hakim, M.D., Neurologist (Plaintiff).

Issues: Application of Daubert in toxic tort cases

Summary of case: Four individuals suffered a stroke or heart attack after taking the herbal supplement, Metabolife 356 containing ephedrine and caffeine. They claim defendants manufactured, marketed, and sold an unreasonably dangerous diet drug.

Role of the expert: O’Donnell testified on general causation, how the mixture of ephedrine and caffeine can cause strokes or heart attacks. Hakim testified on general and individual causation, that Metabolife 356 caused strokes in three plaintiffs and a heart attack in the fourth. Metabolife did not offer any competing expert testimony.

Expert analysis: The district court abused its discretion in allowing the experts to testify. Both opinions did not meet the requirements set by Daubert. The pharmacologist’s opinions, while testable, were not tested nor sufficiently supported by the scientific community in the form of clinical trials or long-term studies, and was not peer reviewed. Also, the studies he referred to did not support his conclusions. He drew speculative correlations about Metabolife’s toxicity from questionable principles of pharmacology and drew unsubstantiated analogies between ephedrine and phenylpropanolamine, and relied on FDA’s withdrawn proposals to severely restrict sale of diet supplements containing ephedrine and anecdotal consumer complaints to establish medical causation. His lack of testimony about the dose-response levels (“the hallmark of basic toxicology”) combined with vague testimony about significant individual variations left ambiguity which undermined his opinions.

Hakim’s expert testimony was flawed for the same reasons as O’Donnell. The medical doctor could not reliably show that ephedrine and caffeine cause strokes in general or individually in the Plaintiffs.

Summary prepared by J. Price, Student, University of California, Berkeley School of Law (Boalt Hall)