New York, NY - The U.S. District Court for the Southern District of New York issued an opinion to explain, elaborate and refine its determinations regarding the exclusion of and admissibility of 'generic' expert testimony in litigation involving personal injury or wrongful death caused by dietary supplements containing Ephedra. The litigation is In re Ephedra Prod. Liab. Litig. (No. 04-1598 S.D.N.Y.)

Previously, the district court granted in part and denied in part the respective motions of the defendants' coordinating counsel (the DCC) and plaintiffs' coordinating counsel (the PCC) to exclude the testimony of certain 'generic' experts. Specifically, the court held that the PCC's experts shall not be permitted to testify with 'medical certainty' or 'scientific certainty' that ephedra caused the alleged injuries. However, they will be permitted to testify that ephedra may be a contributing cause of stroke, cardiac injury, and seizure in some people. A Memorandum Order further detailing and elaborating on these ruling and including other holdings, such as more particularized rulings on the opinions offered by Dr. James Knochel and Dr. Kristie L. Ebi, will be filed.

Considering the issue of what generic opinion may be given by the PCC's generic experts, the court concluded that the following generic opinion is reliable to be admitted under Rule 702: 'Ephedra products may be a contributing cause of stroke and cardiac injury in some people.'

Although the court concluded the PCC's generic opinion, as modified, is admissible, it said certain qualifications are in order. The first refers to one aspect of cardiac injury, known as the 'QT interval.' The district court found the PCC failed to meet its burden of showing the reliability of its experts' opinions regarding adverse effects of Ephedra on the QT interval. That aspect of their opinion, therefore, was excluded under Rule 702.

As to heat injury, the DCC's examination of Knochel established that his opinion that Ephedra can impair heat dissipation lacked a sufficiently reliable basis, as did his use of data regarding cocaine in making inferences about Ephedra. Thus, such testimony, the district court concluded, was excluded.

On the other hand, the district court found those parts of Knochel's report that described, without reference to Ephedra or ephedrine, the normal physiology of heat regulation and the disease process and treatment of heat-related illness were sufficiently reliable to be admissible. So was his testimony that Ephedra increases metabolism and thus causes a modest increase in the heat generated by the body.

Turning to the PCC's motion to exclude the testimony of one of the DCC's experts, namely, Ebi, the district court summarized his opinion as follows: 'I have determined that there is no valid scientific evidence from which to conclude, using generally accepted scientific methods, that ephedra or ephedrine causes stroke, seizure, acute myocardial infarction, or sudden cardiac death.' The court found Ebi's opinion could be made reliable under Rule 702 by twice replacing the word 'scientific' with the word 'epidemiological.'