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Saying the plaintiffs’ experts took unreliable “leaps of faith,” a federal appeals panel has thrown out a $3.5 million verdict for four people who claimed they suffered strokes or heart attacks as a result of taking the weight loss supplement Metabolife 356. Wednesday’s decision was the latest chapter in the legal saga over the appetite suppressant’s primary ingredient, ephedra. Last year the Food and Drug Administration banned ephedra from over-the-counter sales because reactions to the drug were “conclusively linked to significant adverse health outcomes, including heart ailments and strokes.” Later this month a federal judge in New York is expected to hear arguments about a proposed global class action settlement in which San Diego-based Metabolife International would pay — up to $1.05 million for anyone who was injured by taking Metabolife 356. Philadelphia lawyer Arnold Levin, who negotiated the deal on behalf of the proposed class, said the 11th Circuit’s decision shows the wisdom of the settlement. “There is uncertainty in litigation,” said Levin. THREE STROKES AND A HEART ATTACK That point may not be lost on the four plaintiffs in the 11th Circuit case: Annie McClain, Connie Thornburg, Shirley Franks and Wilmer Hudson. In 2001, they sued Metabolife in the U.S. District Court in Birmingham, Ala., claiming the supplement — which was promoted as aiding weight control and boosting sports performance and energy — caused their strokes or, in the case of Hudson, a heart attack. A key point in the case was a battle over expert witnesses, a regular part of products liability litigation since the U.S. Supreme Court in 1993 gave federal judges more power to decide who could testify in those kinds of cases. The high court in Daubert v. Merrell Dow Pharmaceuticals Inc., 509 U.S. 579, said a trial judge must decide if the proposed reasoning or methodology underlying the expert’s testimony is “scientifically valid.” The Metabolife trial judge, Senior Judge William M. Acker Jr., said he would allow the plaintiffs’ experts — a pharmacist and a neurologist — to testify. But the judge expressed reservations about his own ability to make a decision on the credibility of the witnesses. “Trying to cope in this case without a pharmacological, or a medical, or a chemical, or a scientific background, the court cannot fully and fairly appreciate and evaluate the methodology employed by either of these witnesses,” Acker wrote. When Metabolife appealed the $3.5 million verdict, judges of the 11th Circuit found Acker had “essentially abdicated” his role as the gatekeeper to expert testimony and committed “an abuse of discretion” that could toss the verdict. However, the decision by Judge C. Ashley Royal, a Middle District of Georgia judge sitting on the 11th Circuit by special designation, criticized more than Acker’s reluctance to make a ruling on the experts. TOO MANY IFS, 11TH CIRCUIT SAYS Joined by 11th Circuit Judges R. Lanier Anderson III and Stanley F. Birch Jr., Royal attacked the conclusions of James O’Donnell, the pharmacist, and Hashim Hakim, the neurologist. Royal wrote that O’Donnell “left a trail of equivocation” by making statements about the supplement sprinkled with “if,” “may” and “can” that did not prove that Metabolife 356 caused the plaintiffs’ strokes and heart attack. Royal quoted O’Donnell as explaining that the ephedrine and caffeine combination in Metabolife 356 “can elevate blood pressure and stimulate the heart, and it has been reported to be associated with strokes and heart attacks. … [T]his may be dangerous for some patients.” The panel concluded, Royal wrote, that “neither O’Donnell or Hakim utilized a reliable methodology to prove that use of Metabolife 356 actually causes strokes or heart attacks, either generally or in the plaintiffs. “The medical literature does not support such opinions,” he added. One of the plaintiffs’ lawyers, A. David Fawal of Birmingham, Ala., said he was considering asking the full 11th Circuit or the U.S. Supreme Court to review the decision, adding he thought the panel “misapplied” the Daubert rules. “The judges on the court are not supposed to substitute their view of chemistry” for those of the proposed experts, added Fawal. John Kavanaugh of Mobile, Ala., who represented Metabolife, said he was pleased by the ruling, asserting that the ruling vindicates the company’s view that the case never should have gone to trial. Jan Strode, a Metabolife spokeswoman, said despite the win in the 11th Circuit, the company is still going forward with the proposed global settlement. Metabolife International still sells five weight loss products, including a caffeine-free dietary supplement, according to the company’s Web site. The case is McClain v. Metabolife, No. 03-12776 (11th. Cir. March 2, 2005).

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