Metabolife wins ephedra court case

San Diego-based Metabolife International won a court battle March 2 when the U.S. Court of Appeals for the 11th Circuit reversed a November 2002 verdict against the company. The previous verdict in an Alabama court would have cost the company $4.1 million after four people claimed the company?s ephedra-based diet pills caused strokes or heart attacks.

The court threw out the earlier verdict, stating that it did not live up to the standard of scientific rigor needed in a toxic tort (or civil) case. In fact, Metabolife had previously tried to exclude the plaintiffs? experts? opinions, stating that they ?lacked a reliable foundation for admission? under standards set in Daubert v. Merrell Dow Pharmaceuticals Inc., 509 U.S. 579 (1993). Referring to the earlier judgment, the opinion reads, ?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.?

The appeals court continued, ?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.?

According to Marc Ullman, a partner in New York-based law firm Ullman, Shapiro and Ullman, the court?s judgment was actually quite simple. ?Basically, it means the 11th Circuit ruled that the plaintiffs? evidence on causation, that Metabolife actually caused the injury to the plaintiffs, was junk science. It didn?t pass the basic threshold where the judge should have even allowed the jury to hear their experts? testimony.?

Michael McGuffin, president of the American Herbal Products Association, said, ?This judge ripped up the experts? testimony. He says, ?In short, the expert does not support his opinions with sufficient data or reliable principles and fails to follow the basic methodology that experts should follow in toxic tort cases.? I think what he said is, ?The expert opinion was only opinion.? That?s striking to me. I can?t pretend to have read the 70-page judgment yet, but it appears as if it seriously throws into question any conclusion that anyone has drawn that the reason for the removal of ephedra from the marketplace had anything to do with a scientific conclusion.?

Ullman said that the material the plaintiffs were relying on—publicly available information such as adverse-events reports—overlapped with what the U.S. Food and Drug Administration used in banning ephedra. However, he noted, ?The court was careful to say that there is a difference between proving causation in a toxic tort case and public health decision-making.

?But, nevertheless you now have a federal court saying a couple of these studies specifically note their limitations in what they?re concluding, and this may raise issues as to whether or not the FDA read more into them than was justifiable.?

Short of an appeal to the Supreme Court, which is unlikely according to Ullman, the 11th Circuit is the final word. However, he also noted there is another ephedra case pending in the 3rd Circuit against NVE Pharmaceuticals Inc. A ruling against NVE in that case would mean a split decision in the two circuits, which, according to Ullman, would create a situation where the Supreme Court is more likely to review the cases.

Natural Foods Merchandiser volume XXVI/number 4/p. 14