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special to the national law journal Paul Rheingold, a partner at New York’s Rheingold, Valet, Rheingold, Shkolnik & McCartney, and his firm represent plaintiffs in products liability cases, including ephedra suits. He is co-chair of the Ephedra Litigation Group of the Assocation of Trial Lawyers of America. At a time when Congress is considering limiting lawsuits against suppliers of medical products, it is worth examining what role such suits can play in helping to remove dangerous products from the market. Especially where governmental regulation is weak, the value of private litigation should be protected. Such is the case with ephedra. Ephedra, the Chinese herb known also as ma huang, has enjoyed many years of sale in this country free of significant Food and Drug Agency (FDA) regulation because of special legislation for all herbal products, the Dietary Supplement Health Education Act of 1994. The act allowed ephedra and other herbal products to be sold as supplements rather than as drugs, removing the suppliers from obligations to prove that the herbs are safe or effective, or even that they were produced under the quality-control rules the FDA had for drug products. Ephedra, among the herbal products given this free pass from regulation, turned out to be the most dangerous. Indeed, a recent study showed that although its sales accounted for less than 1% of the herbal market, 64% of the reports of adverse reactions to poison control centers around the country dealt with ephedra. Medical articles have documented serious reactions to ephedra, including stroke, heart attacks, seizures and sudden death. Suits against the many suppliers of ephedra-containing products started in the mid 1990s, first as a trickle and now a flood. There are thousands of suits pending around the country, involving heavily promoted products such as Xenadrine, Metabolife 356, Hydroxycut and Ripped Fuel, as well as many generic-type products put out by mom-and-pop companies. Some of these suits are high-profile ones, involving the deaths of athletes. Given the lag time from filing to trial, we are only now beginning to see verdicts against ephedra manufacturers. In February, a Texas jury awarded $1 million to the estate of a 24-year-old man who died suddenly ( Scurlock v. Twinlabs). Last year, a federal jury in Alabama awarded $4.1 million collectively to four persons who claimed strokes and heart attacks from the use of Metabolife 356 ( McClain v. Metabolife International). And for every trial, there have been a large number of settlements for similar injuries in ephedra users. Plaintiffs’ lawyers have banded together nationally in a litigation group operated by the Association of Trial Lawyers of America, sharing information and a listserv. The plaintiffs’ bar also has conducted discovery that exposed allegedly fraudulent conduct on the part of the suppliers, including one that had spiked its product with synthetic ephedra. In a case now on trial in California against Cytodyne Technologies Inc., proof has been presented that false “before and after” photos were used in Xenadrine ads. In Oklahoma litigation involving Hydroxycut, discovery has shown that research put forward to show the efficacy and safety of the product may not have been reported accurately. The suits have had both a direct and an indirect effect upon the availability of ephedra-containing products. The direct effect is the fear that has been created in the sellers of these products that the imposition of liability will damage their enterprises, especially if insurance coverage is exceeded. The indirect effect of the litigation has been to lead underwriters at insurance companies to decline to cover liability arising out of the sale of ephedra products. In the past 12 months, several companies have written an “ephedra exclusion” into their policies. Lacking insurance, a number of ephedra sellers, including Health and Nutrition Systems Inc., have recently announced that they will discontinue ephedra products. Many other companies in the past few months have reformulated their brand products, substituting other herbal substances. The lawsuits and the threat of damages did more to rid the marketplace of a dangerous substance than governmental regulation. The U.S. government passed up numerous opportunities to regulate ephedra. The problems started when Congress passed the dietary supplement act in 1994. But even though that law did substantially tie the hands of the FDA, the FDA has not been as powerless as it made itself appear. It backed down from several attempts in the late 1990s to control the use of ephedra, sometimes due to political pressure. As recently as February, the FDA again failed to act when it took a weak measure in response to a report on ephedra it had commissioned from the Rand Institute. The FDA merely proposed increased warnings on ephedra products. And it is not just ephedra that needs close regulation; there are other dangerous herbal products on the market. Tort reform caps will only further inhibit the salutary role of the civil lawsuit in preventing dangerous behavior.

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