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Public debate over Ritalin is robust. Class actions against the drug’s manufacturer are not. Despite the participation of two tobacco litigation heavyweights, judges this spring threw out two of five class actions filed last year against New Jersey-based Novartis Pharmaceuticals Corp., the manufacturer of Ritalin. And on July 25, a federal judge in Florida dismissed a third Ritalin class action at the request of the plaintiffs’ lawyers. John Coale and Richard Scruggs, who were leaders on the plaintiffs’ side of the tobacco wars, point to the difficulty in the early stages of tobacco litigation and say they’ve only begun the Ritalin fight. “Right now we’re getting the kinks ironed out,” says Coale, who hopes a successful appeal of one of the cases will provide a legal opening for other suits. He is involved in three Ritalin cases, including those lost by plaintiffs in the spring. But lawyers for Novartis and two nonprofit groups that were also sued say that the plaintiffs are trying to use the courts to short-circuit legitimate scientific debate over attention deficit disorder and attention deficit hyperactivity disorder, the conditions that Ritalin and its generic siblings are used to treat. TEXAS BEGINNING The first of the class actions was filed last year in Texas by Dallas’ Waters & Kraus. According to Coale, the Texas lawyers were contacted by Scruggs, a lawyer in Pascagoula, Miss., whose firm, Scruggs, Millette, Bozeman & Dent, is estimated to have earned more than $1 billion in fees from representing state governments in tobacco litigation. Scruggs, in turn, brought in Coale, a member of the Castano coalition of plaintiffs’ law firms that has sued the tobacco and gun industries. Coale and Scruggs, working with the Texans and other plaintiffs’ lawyers, soon filed class actions in California and New Jersey. A second set of lawyers filed similar class actions in Puerto Rico and Florida. The cases differ slightly from one another, but all charge that the American Psychiatric Association (APA) and a patients’ group called Children and Adults with Attention-Deficit/ Hyperactivity Disorder colluded with Novartis (and its predecessor, Ciba-Geigy Corp.) to expand the market for Ritalin by creating a far-too-broad definition of attention deficit disorder and attention deficit hyperactivity disorder. “Whether there is such a thing as ADD, the criteria are so subjective that they’re meaningless,” says Coale, referring to attention deficit disorder. The result, the plaintiffs claim, has been the unnecessary and harmful drugging of millions of American children. Novartis denies that it conspired with the patients’ organization or the psychiatric association to gin up the Ritalin market. Dorothy Watson, general counsel for the drug maker, calls the allegations preposterous. “Our concern is that people get the appropriate treatment when their child is diagnosed with these disorders,” she says. The cases didn’t get far before running into trouble. In California, senior federal Judge Rudi M. Brewster of the Southern District ruled that the plaintiffs had failed to plead a valid cause of action and stated that the lawsuit targeted speech protected by the U.S. and California constitutions. Vess v. Ciba-Geigy Corp., No. 00-1839 (S.D. Calif.). The case is on appeal to the 9th U.S. Circuit Court of Appeals. And in Texas, federal Judge Hilda G. Tagle of the Southern District ruled in May that, despite two tries at amending the original complaint, the plaintiffs had failed to state a cause of action in that case as well. Hernandez v. Ciba-Geigy, No. 00-82 (S.D. Texas). Motions to dismiss are pending in the Puerto Rico and New Jersey cases. A motion to dismiss in Florida became moot when the plaintiffs’ lawyers decided in July to withdraw the case. This isn’t Coale’s first run at Ritalin. In the 1980s he and other lawyers filed an unsuccessful wave of Ritalin lawsuits, including a case against the psychiatric association and a Georgia school board. According to Novartis, Ritalin has been proven safe and effective in more than 45 years on the market. The company’s patent protection expired in the 1970s. Now only about one-fifth of the market for methylphenidate — Ritalin’s generic name — is filled by Novartis’ brand-name product, according to James A. O’Neal of Minneapolis’ Faegre & Benson. O’Neal is the company’s lead lawyer on the Ritalin lawsuits. Still, the use of Ritalin and other psychiatric drugs in children makes many people uneasy, adding to media and public attention. The defendants say they fear that controversy stirred up by the lawsuits may discourage parents from allowing their children to be treated with drugs in appropriate cases. “We think this is interfering with parents who are trying to deal with serious issues with their children and is an unfair distraction,” says David B. Siegel of Washington, D.C.’s Crowell & Moring. Siegal is one of the lawyers representing the APA. The group publishes the Diagnostic and Statistical Manual of Mental Disorders, which the plaintiffs claim defines attention disorders far too broadly. The plaintiffs say that they are trying to rein in a drug that is being overprescribed with little thought to the consequences. “Thirty years ago, the scientific community sat on their hands,” Coale says. “We’re coming in where they failed.” CONNECTICUT STATUTE Meanwhile, in July, Connecticut passed a law to prevent teachers and other school officials from recommending drugs for school children. The bill’s sponsor, state Rep. Lenny Winkler, an emergency room nurse, says that pediatricians often prescribe drugs to kids, responding to the wishes of teachers or parents, without spending enough time evaluating their patients. According to Winkler, she has been contacted by legislators in other states who are interested in sponsoring similar bills in their states. A group that for years has been highly critical of Ritalin, Prozac and other psychiatric drugs is the Citizens’ Committee for Human Rights, a group that is closely tied to the Church of Scientology. Coale, a Scientologist, calls the issue of Scientology involvement a red herring. He says the committee has nothing to do with the current lawsuits, an assertion backed up by the group.

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