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Now that the Food and Drug Administration has banned the dietary supplement ephedra from the marketplace, one might assume manufacturers are going to be hard pressed to defend it in court. That’s not necessarily true, say lawyers who represent some of the companies. Two manufacturers are suing to overturn the FDA’s ban. NVE Inc. v. Department of Health and Human Servs., No. 04-999 (D.N.J.). And though they failed to obtain a temporary restraining order to prevent it from taking effect on April 12, that was only round one. They believe they have a fighting chance to overturn it at trial, the lead lawyer said. Even if the ban holds, it’s not clear it will affect trials. These are among the uncertainties lawyers are grappling with in the wake of last week’s action, which was the first time the FDA banned a dietary supplement since the adoption of the 1994 Dietary Supplement Health and Education Act. Until the move by the FDA, which took many by surprise when it announced its intention last December, the law seemed to leave the supplement industry largely unregulated. Christopher Grell represented the plaintiff in one of only a half-dozen ephedra cases that have gone to trial, and also represents about 20 clients who have lawsuits pending. He isn’t convinced the ban will help. “A lot will depend on the courts’ rulings,” said Grell, a solo practitioner in Oakland, Calif. If a defense expert testifies that the product is safe, a judge still might not let him ask about the ban, he said. Steven Kirsch, national counsel for NVE, the company suing to overturn the ban, agrees that it may not affect trials. He represented plaintiffs during the breast implant litigation. Though the implants were banned, the judge never let the jury know. Still, Kirsch conceded, jurors may already be informed by publicity, and this would pose a problem for defense lawyers in voir dire. But the partner at Murnane, Conlin, White & Brandt in St. Paul, Minn., didn’t sound overly concerned. NVE, of Andover, N.J., has yet to face a trial. It has fewer than 50 lawsuits. Seven suits were dismissed, and three settled “for a couple of thousand dollars each,” he said. Richard Vollertsen, who won the first plaintiff’s verdict, thinks the ban will be upheld and cases will benefit. But in the larger scheme, he isn’t sure if that’s important — or even a positive development. “I hope that the ban signals a greater willingness on the part of the FDA to step up and do what needs to be done,” said Vollertsen of Anchorage, Alaska’s Atkinson, Conway & Gagnon. “My concern is that the FDA, being so subject to political influence — that the ban is not indicative of their true willingness to regulate the industry.” One problem, he said, is that under the 1994 law, companies are not required to prove that dietary supplements are safe before bringing them to market. That allows manufacturers to immediately introduce “ephedra-free” replacements like bitter orange, which may be no safer, he said. In fact, it’s already featured in a Consumer Reports cover story called “Dangerous Supplements.” But the FDA will have to gather scientific evidence, as it did for years before it banned ephedra. “That’s how the industry is going to stay ahead of the posse,” Vollertsen said. He wonders if the ban has killed all chance of reform. Senator Dick Durbin, D-Ill., sponsored a bill that would bring the industry under FDA oversight. In a year, it’s gathered only four co-sponsors. NVE’s lawyers have their own reform fears-the flip side of Vollertsen’s. If they beat the ban in court, they worry, will Congress compensate with legislation?

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