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Pharmaceutical giant Wyeth Inc. is appealing a Miami-Dade County Circuit Court judge’s decision to grant class action status to a product liability lawsuit seeking medical monitoring for 300,000 Florida women who took the hormone-replacement drug Prempro. The drug has been linked to increased risk of cardiovascular disease and cancer. The suit, originally filed in Miami-Dade in July 2002, was one of the first of about 20 around the country filed after release of a critical study of the drug by the Women’s Health Initiative. The lawsuit seeks court-supervised, company-paid medical monitoring, “without limitation or exhaustion,” to detect and treat ailments linked to the medication. The class action was certified in February by Miami-Dade County Circuit Judge Lawrence Schwartz to represent the interests of Florida women between the ages of 50 and 79 who took the drug for at least six months. The class is limited to women have not shown disease symptoms. The suit also names as a defendant Eckerd Corp. of Florida, at whose stores the drug was retailed. The chain was sold to CVS Corp. late last year. Wyeth has filed a notice of appeal of Schwartz’s decision to the 3rd District Court of Appeal. Lawyers for Wyeth did not return calls seeking comment. The notice does not indicate the grounds of the appeal. Steven K. Hunter, a partner at Hunter Williams & Lynch in Miami who is representing the class, said in an interview that “the class as a whole has an increased risk of serious health problems. With the monitoring program, maybe they can avoid the entire problem.” New Jersey-based Wyeth has challenged the results of the federally funded study done by the Women’s Health Initiative, arguing that its findings do not justify the plaintiffs’ demand for Wyeth-paid monitoring. Such monitoring would include physical examinations, magnetic resonance imaging tests, CT scans and biopsies. Wyeth spokesman Doug Petkus said the Women’s Health Initiative investigators “have not recommended any special screening.” Wyeth’s local counsel, Ace Blackburn, a partner at Cooney Matson Lance Blackburn Richards & O’Connor in Fort Lauderdale, did not return a call for comment. HORSE URINE Prempro is derived from the urine of pregnant mares. It was approved by the Food and Drug Administration for marketing at the end of 1994 in tablet form. About 6 million women across the country took Prempro. Wyeth, Hunter said, touted Prempro as effective treatment for a myriad of diseases, including Alzheimer’s disease, vision problems, tooth loss, heart disease and colon cancer. But the FDA had not approved Prempro for treatment of any of these conditions. Demand for hormone replacement therapy soared, Hunter said, after a New York gynecologist, Robert Wilson, wrote a best-selling book, “Feminine Forever.” Wilson did not disclose that Wyeth paid him to write the book, Hunter said. According to the Miami-Dade suit, Wyeth spent roughly $40 million advertising the drug, using supermodel Lauren Hutton as the product spokeswoman. The company grossed about $950 million in sales from 1994 through the end of 2002. The federally funded Women’s Health Initiative study involved 16,000 women throughout the country. It was cut short in 2002 when it determined that the drug, which consists of conjugated estrogen plus progestrin, was statistically associated with a 41 percent increase in strokes in the study group, a 29 percent increase in heart attacks, a 100 percent increase in blood clots, a 22 percent increase in “total cardiovascular disease” and a 26 percent increase in breast cancer. After the study results were published, prescriptions for the drug dropped to about 25 percent of their prior level, when roughly 20 million prescriptions for the drug were written annually. Prempro is still on the market, but the FDA mandated warnings on the drug’s container notifying consumers of the increased risks documented by the study. EARLY DETECTION SOUGHT Hunter’s client is elementary school teacher Arlene Gottlieb of northern Miami-Dade County, who is the class representative for the estimated 300,000 post-menopausal women. “Not everybody wants to go through what you have to go through as the class representative,” Hunter said. “You have to answer a lot of questions from lawyers about the state of your health, your history and so forth.” The suit alleges negligence on the part of the defendants for failing to provide consumers with adequate warning of the drug’s risks and for continuing to sell and distribute it. It contends that “medical monitoring is medically reasonable and necessary in order to provide for the early detection and prevention of catastrophic disability and/or death.” Without monitoring, the suit states, about 9,000 of the 300,000 Florida women who took the drug will develop otherwise preventable illnesses in the next decade as a result of taking Prempro. In his order approving the class action, Schwartz said he was not ruling on the ultimate merits of the claims or defenses, only on “whether the parties’ contentions may be properly addressed on a classwide basis.” They could, he wrote in his order, because “Wyeth has acted identically with respect to each Florida class member, each of whom was prescribed and injested high dose Prempro for a minimum of six months.”

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