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In a huge victory for pharmaceutical giant Wyeth, a Florida appeals court on Wednesday halted a class action suit that claimed its hormone replacement drug could harm hundreds of thousands of Florida women. A three-judge panel of the state’s 3rd District Court of Appeal unanimously held in Wyeth Inc. v. Arlene Gottlieb that the claims were not common enough for the case to move forward as a class action. Instead, women who claim they may suffer future health problems because of their use of the drug Prempro will have to file individual suits against Wyeth. The Wyeth decision reverses a ruling last February by Miami-Dade Circuit Judge Lawrence A. Schwartz certifying the class. It was the latest class action setback for Miami attorney Stanley Rosenblatt, who represented the class, which was estimated to include 300,000 Florida women. The appeals court said the case did not meet the standard for a class action because “individual issues of law and fact exist.” The decision was written by Judge Angel A. Cortinas. Chief Judge Gerald B. Cope Jr. and Judge Linda Ann Wells concurred. The panel also found that the class representative, Arlene Gottlieb, was not a suitable representative of the class because her circumstances were much different than other purported members of the class. “This is really a triumph for Wyeth and its careful approach to marketing and labeling and advertising,” said Bruce Rogow, a Fort Lauderdale, Fla., appellate attorney who represented the Madison, N.J.-based drug manufacturer. The plaintiffs were represented by Rosenblatt, who did not return a call for comment. Rosenblatt and his wife, Susan, are awaiting a state Supreme Court decision on whether the $145 billion punitive damages verdict they won in 2000 for the class of ailing Florida smokers will stand. Prempro was first approved by the Food and Drug Administration in 1994 to combat the effects of menopause, osteoporosis and heart disease in women. In 2003, Wyeth added a warning to the Prempro packaging, stating that a 2002 study had found the drug’s key components could increase a patient’s risk for heart disease, stroke and embolisms. Wyeth also notified physicians of the findings and reduced the dosage to the lowest possible effective level. Gottlieb began taking Prempro in 1998 and stopped after she became aware of the 2002 study. She has not developed any symptoms or medical conditions. In 2004, Stanley Rosenblatt filed a product liability suit against Wyeth Inc. and Wyeth Pharmaceuticals, the maker of Prempro. The plaintiffs alleged negligence in the development, manufacturing, marketing and sale of the drug. They sought the establishment of a program under which the drugmaker would pay for monitoring the class members’ health for any diseases that could develop due to the patients’ exposure to Prempro. Wyeth argued on appeal that a medical monitoring program was not appropriate for a drug that has not been deemed dangerous by the FDA. The company said certifying a class also would be inappropriate because members of the class did not share enough common factors. Their level of risk for certain diseases sometimes attributed to Prempro would vary depending on drug dosage, length of time taking the drug, obesity and family medical history, Wyeth argued. The plaintiffs argued, however, that variations among the plaintiffs should not defeat class certification, because the varying levels of exposure and other health risk factors did not alter the outcome of the 2002 study that found that Prempro increased the risk of certain health conditions. The 3rd DCA held that claims that Prempro may cause future health problems depend too much on each individual class member, and on what Wyeth knew at the time each class member was prescribed Prempro. The 3rd DCA also said the negligence claims made by class members would have to be proved individually, because knowledge about the drug’s side effects changed during the 10 years after it was first approved for use, but before the warning label was included on Prempro packaging. “Had Wyeth’s knowledge and warnings to its users remained static during the 10-year period, plaintiffs would have had a much stronger claim that negligence may be shown through common proof,” the 3rd DCA said. This article originally appeared in the Daily Business Review , a publication of ALM.

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